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NEWS -- Tokens.com Makes Offer to Acquire Full Ownership of Metaverse Group
TORONTO, April 18, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse, and play-to-earn gaming, is pleased to announce that it has reached an agreement with the Board of Directors of Metaverse Group Ltd ("Metaverse Group") to acquire all of the issued and outstanding shares from the minority shareholders of Metaverse Group Ltd that the Company does not already own, with the effect that the Company will own 100% of shares of Metaverse Group after the transaction is completed. Tokens.com is currently the majority shareholder of Metaverse Group, owning approximately 55.2% of the issued and outstanding shares (on a non-diluted basis) and 50.2% of the issued and outstanding shares (on a fully diluted basis).
As at the end of December 31, 2022, Metaverse Group had US$6.1M (CAD$8.2M) in total assets, including US$2.7M (CAD$3.6M) in cash and US$2.1M ($2.8M) in NFT assets. Pro forma the transaction, as at December 31, 2022, Tokens.com would have US$17.7M (CAD$23.7M) of total assets, including US$5.5M (CAD$7.4) of cash, US$4.9M (CAD$6.6M) of tokens, and US$2.8M (CAD$3.8M) of NFT assets.
In addition, as at April 17th, 2023, the value of tokens owned by Tokens.com is US$8.6M (CAD$11.5M), an increase of US$3.7M (CAD$5.0M) or 75.5% since December 31st, 2022, the Company's last reporting date.
As consideration for the acquisition, Tokens.com will issue 24,380,000 common shares to the minority Metaverse Group shareholders. Each minority Metaverse Group shareholder will receive approximately 0.34 Tokens.com shares per Metaverse Group share. The Tokens.com shares to be issued as part of this transaction will be subject to contractual escrow provisions over a nine month period. This transaction has been approved by the board of directors of both entities and, pending approval of Metaverse Group Shareholders at a meeting scheduled to be held on April 26th, 2023, as well as approval by the NEO Exchange, is expected to close in May 2023.
The integration of the two entities will further enhance the synergies between the two entities, including Hulk Labs, the gaming unit of Tokens.com. The gamification capabilities of Hulk Labs will greatly enhance Metaverse Groups branded product offerings. Furthermore, the amalgamation is expected to bring additional synergies in areas such as corporate overhead, investor relations, public relations, and human resources.
"Since Metaverse Group’s inception in 2021, its team has been working closely with the Tokens.com team, delivering category-leading products for clients like Forever21 and DKNY," said Andrew Kiguel, CEO of Tokens.com. "Together, we look to generate additional growth and strengthen our combined balance sheet."
Lorne Sugarman, who currently holds the position of CEO at Metaverse Group, will assume the role of President, Operations at Tokens.com and will be appointed as a Director to the board of Tokens.com.
"I’m excited to be working with the team at Hulk and Tokens. I believe their skills and capabilities will enhance our future product offerings. We are constantly working to create better solutions for our clients," said Lorne Sugarman.
In addition to its staking operations and Metaverse Group, Tokens.com continues to own approximately 94% of Hulk Labs, its play-to-earn gaming subsidiary.
Completion of the transaction is subject to receipt of NEO Exchange approval and other customary closing conditions for transactions of this nature. No assurance or guarantee can be made that such conditions will be met or that the transaction will complete.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership of over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
About Hulk Labs
Hulk Labs is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that invests in web3 assets and businesses.
For further information please visit https://hulklabs.com.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230418005395/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Plus Therapeutics Completes Phase 1/Part A of the ReSPECT-LM Clinical Trial for Leptomeningeal Metastases
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the completion of Cohort 3 of the ReSPECT-LM Phase 1/2a dose-escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors less than one month since its initiation, demonstrating rapid enrollment. Additionally, the Company has expanded the number of clinical trial sites to include Northwestern Memorial Hospital in Chicago, marking the first expansion of the ReSPECT-LM trial beyond Texas. Thus far, 10 patients have been treated across three cohorts in the ReSPECT-LM Phase 1/Part A dose escalation clinical trial.
“We are excited to accelerate enrollment in our ReSPECT-LM clinical trial and look forward to working with our site partners to expand the reach of this study to new and existing patients, including our compassionate use program where we retreated a patient with LM who might benefit from this novel, well-tolerated therapy,” said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. “Throughout all three cohorts of this study, no dose-limiting toxicities have been observed with administered radiation doses of up to 26.4 millicuries, signaling the potential to maximize the potency of rhenium (186Re) obisbemeda in order to effectively destroy tumor cells within the cerebrospinal fluid. We are preparing to reconvene with the U.S. Food and Drug Administration (FDA) to provide data from Cohorts 1 through 3 and determine next steps for Part B of the Phase 1 trial.”
Previous Phase 1 data presented at the Society for Neuro-Oncology Annual Meeting in November 2022 has shown that a single administered dose of rhenium (186Re) obisbemeda was feasible, safe, and well-tolerated. Across two dosages, the four patients from Cohorts 1 and 2 experienced a decreased cerebrospinal fluid tumor cell count of 46% to 92% by 48 hours following treatment. The Company anticipates presenting the entire Phase 1/Part A data at medical meetings in the second half of 2023.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. ReSPECT-LM is funded, in part, by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer is the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Navidea Biopharmaceuticals, Inc. Enters Asset Purchase Agreement with Meilleur Technologies, Inc. for Rights to NAV4694
The Asset Purchase Agreement allows Meilleur Technologies, Inc. to develop and commercialize markets while Navidea Biopharmaceuticals, Inc. receives additional liquidity for focused growth.
DUBLIN, Ohio, April 13, 2023--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it has signed an Asset Purchase Agreement allowing Meilleur Technologies, Inc. (Meilleur), to acquire certain assets and assume certain liabilities of Navidea relating to developing and commercializing NAV4694 for a purchase price of $750,000 plus significant milestone and sales related future payments.
The agreement is related to NAV4694, a beta-amyloid imaging agent being evaluated as an aid in the differential diagnosis of early-onset Alzheimer’s disease, providing an exclusive license for Meilleur to develop and commercialize NAV4694 worldwide.
"This is a significant partnership and step forward for everyone involved," Rick Hiatt, President & CEO of Meilleur Technologies, Inc., said. "Meilleur is focused on enhancing access to key technologies which advance and improve brain health, and our transaction with Navidea aligns perfectly with our focus."
According to the terms of the agreement, Meilleur remitted a cash payment of $250,000 to the Company at closing and agreed to an additional cash payment of $500,000 to the Company within 60 days after the closing date. In addition, certain future milestone-related and contingent payments may be made by Meilleur to the Company, based on potential licensing events, regulatory submissions and regulatory approvals, and net sales of approved product derived from NAV4694.
"Our strategy includes building process rigor to advance our therapeutics and clinical trials while also cultivating growth in new markets," Dr. Jason Myers, owner and Founder of G2G Ventures, stated. "This partnership allows us to propel the former while developing the latter, and we are pleased to be working closely with Meilleur’s team of experts on the market development side."
About NAV4694
NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate intended for use in Positron Emission Tomography (PET) imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans. Beta-amyloid plaque pathology is widely used in the diagnosis of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. There is an ongoing NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for NAV4694 in AD.
About Meilleur Technologies
Meilleur Technologies’ vision is to globally develop diagnostics and technology that will impact patients with neurodegenerative disorders including Alzheimer's disease. Meilleur’s affiliate company, Cerveau Technologies, Inc., has recently announced its acquisition by Lantheus Holdings, Inc. which will continue to develop and scale Cerveau’s novel Tau tracer which is proving to be critical to the overall management of Neurodegenerative disease.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230413005842/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Joseph Meyer - Director of Finance and Accounting
mailto://jmeyer@navidea.com
(614)-793-7500 X 2370
NEWS -- Nanomix Announces Equity Investment from Senior Executive of Woodley Equipment Company, Ltd. at a Premium to Market
SAN LEANDRO, Calif, April 13, 2023 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced an equity investment from Mike Wickham, Managing Director of Woodley Equipment Company, Ltd. to which Mr. Wickman purchased 59,640 shares of the Company’s common stock at a price of $1.17 per share for an aggregate purchase price of $70,000. To date, Woodley has made a total of $570,000 of equity investments in the Company.
As announced on November 9, 2022, Nanomix and Woodley entered into an exclusive distribution agreement. Woodley will work with Nanomix to develop species specific ranges for the S1 critical infection panel and distribute the eLab system in the veterinary market for regions outside of the United States.
Thomas Schlumpberger, Chief Executive Officer of Nanomix, stated, “I am very pleased to receive Woodley’s additional equity investment which shows continued confidence in Nanomix and our technology. Woodley brings significant product development and commercial expertise that allows us to expand our efforts into the veterinary market earlier than planned. In addition, we plan to work with Woodley’s clinical research division on applications of the Nanomix POC solution.”
Mike Wickham, Managing Director of Woodley, commented, “Woodley supplies equipment for all aspects of laboratory diagnostics in the veterinary market with a specialization in emergency and critical care devices. We are excited to develop a POC device to treat animals and Woodley is proud to partner with Nanomix.”
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single sample. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nanomixdx.com.
For the latest insights, follow Nanomix on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- Oncolytics Biotech® to Participate in a Panel Presentation at Canaccord Genuity's Horizons in Oncology Virtual Conference
SAN DIEGO and CALGARY, AB, April 12, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Medical Officer Thomas Heineman, M.D., Ph.D., will participate in the Viral Immunotherapy – Moving Forward panel at Canaccord Genuity's Horizons in Oncology Virtual Conference, which is taking place virtually on April 20, 2023. Additional details on the panel presentation can be found below.
Date: Thursday, April 20, 2023
Time: 9:00 a.m. ET
Panel Title: Viral Immunotherapy – Moving Forward
A live webcast of the panel presentation will be available to registered attendees of the conference through the conference website. Company management will also be participating in virtual one-on-one investor meetings at the conference. To schedule a meeting, contact your Canaccord representative or email mailto://jpatton@oncolytics.ca.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss First Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Friday, May 5, 2023, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, April 12, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, May 5, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the first quarter 2023.
Conference Call & Webcast
Date: Friday, May 5, 2023
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 664-6383
Dial In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 3550-3191
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 503-191#.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
NEWS -- Plus Therapeutics to Announce First Quarter 2023 Financial Results and Host Conference Call on April 20, 2023
AUSTIN, Texas, April 12, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, announced that the Company will report first quarter 2023 financial results on Thursday, April 20, 2023, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics, Inc.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM trial; possible negative effects of 186RNL; the continued evaluation of 186RNL for LM including through evaluations via a second patient cohort; capital requirements, timing and speed of development; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; changes in the CPRIT program; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Oncolytics Biotech® Announces Filing and Mailing of the Management Information Circular in Connection with the Annual General Meeting of Shareholders
Your vote is important no matter how many votes you hold. Vote today.
Shareholders who have questions or need assistance with voting their shares should contact Oncolytics Biotech Inc.'s strategic advisor and proxy solicitation agent Laurel Hill Advisory Group by telephone at 1-877-452-7184 or by email at mailto://assistance@laurelhill.com
SAN DIEGO and CALGARY, AB, April 12, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) is pleased to announce its notice of the annual general meeting of shareholders and management information circular (the "Circular") are now available on the Company's website at: www.oncolyticsbiotech.com as well as under Oncolytics' profile on SEDAR (https://www.sedar.com). The Company is in the process of mailing the Circular and related materials for the annual general meeting to Oncolytics' shareholders.
Shareholder Meeting Details
The Company's annual general meeting of shareholders (the "Meeting") will be held virtually on Tuesday, May 9, 2023, at 4:00 p.m. (Toronto time), and the virtual meeting will be conducted via live audio webcast at https://virtual-meetings.tsxtrust.com/1458. While shareholders and duly appointed proxyholders will not be able to attend the Meeting in person, regardless of geographic location and ownership, they will have an equal opportunity to participate at the Meeting and vote on the matters considered at the Meeting. Detailed instructions about how to participate in the Meeting can be found in the Circular. The Circular also provides details of the proposals Oncolytics' shareholders will vote on at the Meeting.
Oncolytics has retained Laurel Hill Advisory Group ("Laurel Hill") as proxy solicitation agent and shareholder communications advisor to, among other things, assist in the solicitation of proxies. For these services, the Corporation will pay Laurel Hill an advisory fee of $35,000, in addition to certain out-of-pocket expenses. The Company may use Broadridge Financial Solutions Inc.'s QuickVote™ service to assist beneficial shareholders with voting. Our proxy solicitation agent, Laurel Hill, may contact certain beneficial shareholders who have not objected to the Company knowing who they are (non-objecting beneficial owners, or NOBOs) to conveniently obtain a vote directly over the telephone.
YOUR VOTE IS IMPORTANT. VOTE YOUR SHARES FOR ONCOLYTICS' DIRECTOR NOMINEES AND MEETING RESOLUTIONS AS SOON AS POSSIBLE.
Shareholders are encouraged to read the Circular and vote their shares as soon as possible. The deadline for voting your shares is 4:00 p.m. (Toronto time) on Friday, May 5, 2023.
Oncolytics' board of directors recommends that shareholders vote FOR all of the director nominees and meeting resolutions.
Shareholder Questions
Shareholders who have any questions or require assistance with voting may contact the Company's proxy solicitation agent and shareholder communications advisor:
Laurel Hill Advisory Group
Toll Free: 1-877-452-7184 (for shareholders in North America)
International: +1 416-304-0211 (for shareholders outside Canada and the US)
By Email: mailto://assistance@laurelhill.com
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Logo: https://mma.prnewswire.com/media/1808285/3981527/Oncolytics_Biotech_Grey.jpg
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SOURCE Oncolytics Biotech® Inc.
Your kind words are much appreciated and hopefully we will see more traffic here in the future.
NEWS -- Tokens.com Announces Promotions and Changes to C-Suite Positions
TORONTO, April 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce the promotion of two executives to its leadership team. Eric Abrahams has been promoted to Chief Operating Officer and Jonathan Okihiro to Chief Investment Officer. The two executives have demonstrated exceptional leadership in their previous roles and are well-equipped to lead the company forward in their new positions. In addition, Josh Doner, has been promoted to Group Lead at Hulk Labs, in addition to his role as Chief NFT Officer.
Eric Abrahams joined Tokens.com in 2021 as a Technical Consultant providing research analysis and later became the Lead Developer for the Tokens.com subsidiary, Hulk Labs, where he has played a crucial role in the growth of the company. In his new position, Eric will oversee all aspects of the company's operations. Eric brings years of experience in operations management to the role, and his skills and knowledge have been critical to the company's success.
Jonathan Okihiro joined Tokens.com in 2021 as a Crypto Investment Analyst, where he has led The Company's token research efforts, including strategic investments in Play-to-Earn games and the Metaverse. In his new role as CIO, Jonathan will be responsible for overseeing The Company's staking assets and token investment strategy.
Joshua Doner joined Tokens.com in 2021 as Chief NFT Officer, providing advisory on client projects across Tokens.com portfolio companies. Josh is a pioneer in the NFT space being among the first crypto wallets to ever purchase an NFT in 2017. He has extensive experience navigating various NFT Communities. Josh will be leading Hulk’s business transformation efforts alongside the experienced team at Tokens.com.
"We are thrilled to have Eric, Jonathan, and Josh take on these critical roles," said Tokens.com CEO, Andrew Kiguel. "Their exceptional experience, leadership, and dedication to the company have been invaluable, and I am confident that they will continue to play a key role in driving our growth and innovation."
The company would also like to thank Deven Soni, the former COO, for his service to the company. Deven played an integral role in the company's growth during his tenure. Management wishes him well in his new endeavours.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230405005133/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Announces Promotions and Changes to C-Suite Positions
TORONTO, April 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce the promotion of two executives to its leadership team. Eric Abrahams has been promoted to Chief Operating Officer and Jonathan Okihiro to Chief Investment Officer. The two executives have demonstrated exceptional leadership in their previous roles and are well-equipped to lead the company forward in their new positions. In addition, Josh Doner, has been promoted to Group Lead at Hulk Labs, in addition to his role as Chief NFT Officer.
Eric Abrahams joined Tokens.com in 2021 as a Technical Consultant providing research analysis and later became the Lead Developer for the Tokens.com subsidiary, Hulk Labs, where he has played a crucial role in the growth of the company. In his new position, Eric will oversee all aspects of the company's operations. Eric brings years of experience in operations management to the role, and his skills and knowledge have been critical to the company's success.
Jonathan Okihiro joined Tokens.com in 2021 as a Crypto Investment Analyst, where he has led The Company's token research efforts, including strategic investments in Play-to-Earn games and the Metaverse. In his new role as CIO, Jonathan will be responsible for overseeing The Company's staking assets and token investment strategy.
Joshua Doner joined Tokens.com in 2021 as Chief NFT Officer, providing advisory on client projects across Tokens.com portfolio companies. Josh is a pioneer in the NFT space being among the first crypto wallets to ever purchase an NFT in 2017. He has extensive experience navigating various NFT Communities. Josh will be leading Hulk’s business transformation efforts alongside the experienced team at Tokens.com.
"We are thrilled to have Eric, Jonathan, and Josh take on these critical roles," said Tokens.com CEO, Andrew Kiguel. "Their exceptional experience, leadership, and dedication to the company have been invaluable, and I am confident that they will continue to play a key role in driving our growth and innovation."
The company would also like to thank Deven Soni, the former COO, for his service to the company. Deven played an integral role in the company's growth during his tenure. Management wishes him well in his new endeavours.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230405005133/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- NightHawk Biosciences Provides 2022 Year End Business Update
DURHAM, N.C., March 31, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the year ended December 31, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are making progress on our transition towards biodefense and biomanufacturing through our Elusys and Scorpion subsidiaries as we wind down our HS-110 and PTX-35 oncology programs. Pursuant to this, we are investing in our biomanufacturing technologies and capabilities, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities, which we believe will position us well in the future. The manufacturing capabilities associated with these facilities are designed to streamline the development and delivery of life-saving medical countermeasures, while enabling us to offer excess capacity to third parties on a fee-for-service model.”
2022 Financial Results
NEWS -- Navidea Biopharmaceuticals, Inc. Hires G2G Ventures as Executive Consultants; Chief Medical Officer Steps Down
Executive Consulting buttresses senior management’s focus on performance and targeted growth. Chief Medical Officer, Michael Rosol, Ph.D., steps down.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announces the Company has hired G2G Ventures (G2G) as Executive Consultants to provide executive team support for Navidea’s aggressive growth plans. Separately, Michael Rosol, Ph.D., has stepped down as Chief Medical Officer for the Company.
Supporting the Company’s focus on targeted growth initiatives, Navidea has hired G2G Ventures, a specialized firm led by Dr. Jason Myers, former CEO of ArcherDx and a graduate of the Stanford University School of Medicine (Molecular Pharmacology) with a wealth of experience in creating, leading and growing innovative medical technology companies, as Executive Consultants. G2G Ventures’ hiring will drive the activation of the organization’s visionary objectives by infusing proven growth strategies into business development and operations, enhancing financial reporting capabilities, and leading effective investor communications.
"We are incredibly excited to work with this unique organization,” Dr. Jason Myers, Owner and Founder of G2G Ventures, said. “We have deep expertise in translating technologies into differentiated products, in building infrastructure and rigorous process, and in commercial strategies that drive new market development. We are eager to partner with Navidea to bring their underappreciated technology and assets to the forefront.”
After serving as Chief Medical Officer for the Navidea since 2018, Michael Rosol, Ph.D., has decided to step down to pursue opportunities outside the organization. The role of Chief Medical Officer will be assumed by existing leadership with coordinated support from G2G Ventures. Further, Dr. Rosol will provide transition consulting services to the Company to continue to support its progress and growth.
“We appreciate Dr. Rosol’s contributions towards advancing the science behind our therapeutics and clinical trials,” said Alex Cappello, Navidea’s Chairman of the Board. “We wish him the very best in the next chapter of his career and continue to look ahead with a focus on developing new market growth with the support of our team and our experienced partners in G2G Ventures.”
“I am very appreciative of my time at Navidea and am privileged to have worked with the outstanding team at the Company,” said Dr. Rosol. “I continue to be extremely enthusiastic about the science and potential of the Manocept platform to create positive impact in both the therapeutic and diagnostic spaces, including in the advancing Phase IIb and Phase III trials in rheumatoid arthritis.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230330005793/en/
Navidea Biopharmaceuticals, Inc.
Joseph Meyer - Director of Finance and Accounting
mailto://jmeyer@navidea.com
(614)-793-7500 X 2370
NEWS -- Lancia Italia Announced as Metaverse Group’s Automotive Partner for Metaverse Fashion Week 2023
TORONTO, March 28, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that its subsidiary, Metaverse Group, has partnered with Lancia Italia, to be its official automotive brand partner for Metaverse Fashion Week 2023.
Metaverse Fashion Week 2023 is set to take place from March 28th to 31st with the heart of the event in Metaverse Group’s Luxury District, where Lancia Italia will have its virtual showroom. The showroom is inspired by its physical Milan location thanks to the innovative materials, and precise attention to detail inspired by Italian architecture and design. The metaverse showroom will showcase two vehicles. The first being a virtual replica of the Lancia Ypsilon, the fashionable city car which appeals to customers who are conscious of style, elegance, and technology and the second being a new concept car to be revealed on April 15th. The concept car is a tease of what is to come as visitors will be able to see the vehicle's silhouette in the showroom under a veil.
"I am proud to announce that Lancia will be the Official Metaverse Group Automotive Brand of the 2023 Metaverse Fashion Week. Thanks to the participation at this exclusive and world-famous virtual event, Lancia will enter into the metaverse," stated Raffaele Russo, Managing Director of Lancia Italia.
Lancia is the first automaker to partner with Metaverse Group. This partnership with Lancia helps promote the European automaker to a larger audience given Metaverse Fashion Week's global presence. In turn, Metaverse Group has the opportunity to display its metaverse builds that were created using in-house services on a larger scale. Additionally, Metaverse Group advises best practices for web3 strategic plans to help complement the businesses' e-commerce strategies.
"As leaders in web3 community development, we are here to help guide and provide brands with new, exciting, and innovative ways to meet new objectives as web3 is gaining popularity daily," said Andrew Kiguel, CEO of Tokens.com and Executive Chairman of Metaverse Group. " We are thrilled to be partnering with Lancia on their web3 journey."
Brands and businesses interested in expanding into web3 can contact Metaverse Group at mailto://Info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership of over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Lancia
With 116 years of history, Lancia represents timeless Italian elegance, a brand that made people around the globe dream about, thanks to its iconic vehicles: the elegant Flaminia and Aurelia B24 Spider, the performing Delta, Stratos and 037, the eclectic Fulvia or Beta HPE and many others. Lancia is now ready to start its Renaissance with a 10-year strategic plan that is moving on very quickly.
Innovation and timeless design have always been the founding principles for the brand. And now sustainability, customer-centricity and social responsibility have as well become essential, because Lancia is determined to look to the future with great commitment and ambition.
Twitter @Lancia Facebook Lancia YouTube Lancia Instagram Lancia LinkedIn Lancia
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230328005217/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Lancia Italia Announced as Metaverse Group’s Automotive Partner for Metaverse Fashion Week 2023
TORONTO, March 28, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that its subsidiary, Metaverse Group, has partnered with Lancia Italia, to be its official automotive brand partner for Metaverse Fashion Week 2023.
Metaverse Fashion Week 2023 is set to take place from March 28th to 31st with the heart of the event in Metaverse Group’s Luxury District, where Lancia Italia will have its virtual showroom. The showroom is inspired by its physical Milan location thanks to the innovative materials, and precise attention to detail inspired by Italian architecture and design. The metaverse showroom will showcase two vehicles. The first being a virtual replica of the Lancia Ypsilon, the fashionable city car which appeals to customers who are conscious of style, elegance, and technology and the second being a new concept car to be revealed on April 15th. The concept car is a tease of what is to come as visitors will be able to see the vehicle's silhouette in the showroom under a veil.
"I am proud to announce that Lancia will be the Official Metaverse Group Automotive Brand of the 2023 Metaverse Fashion Week. Thanks to the participation at this exclusive and world-famous virtual event, Lancia will enter into the metaverse," stated Raffaele Russo, Managing Director of Lancia Italia.
Lancia is the first automaker to partner with Metaverse Group. This partnership with Lancia helps promote the European automaker to a larger audience given Metaverse Fashion Week's global presence. In turn, Metaverse Group has the opportunity to display its metaverse builds that were created using in-house services on a larger scale. Additionally, Metaverse Group advises best practices for web3 strategic plans to help complement the businesses' e-commerce strategies.
"As leaders in web3 community development, we are here to help guide and provide brands with new, exciting, and innovative ways to meet new objectives as web3 is gaining popularity daily," said Andrew Kiguel, CEO of Tokens.com and Executive Chairman of Metaverse Group. " We are thrilled to be partnering with Lancia on their web3 journey."
Brands and businesses interested in expanding into web3 can contact Metaverse Group at mailto://Info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership of over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Lancia
With 116 years of history, Lancia represents timeless Italian elegance, a brand that made people around the globe dream about, thanks to its iconic vehicles: the elegant Flaminia and Aurelia B24 Spider, the performing Delta, Stratos and 037, the eclectic Fulvia or Beta HPE and many others. Lancia is now ready to start its Renaissance with a 10-year strategic plan that is moving on very quickly.
Innovation and timeless design have always been the founding principles for the brand. And now sustainability, customer-centricity and social responsibility have as well become essential, because Lancia is determined to look to the future with great commitment and ambition.
Twitter @Lancia Facebook Lancia YouTube Lancia Instagram Lancia LinkedIn Lancia
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230328005217/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Oncolytics Biotech® to Participate in a Panel Presentation at Cantor Fitzgerald's The Future of Oncology Virtual Symposium
SAN DIEGO and CALGARY, AB, March 28, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, President and Chief Executive Officer, will participate in the Novel Mechanisms with Important Readouts panel at Cantor Fitzgerald's The Future of Oncology Virtual Symposium, which is taking place April 3-5, 2023 in a virtual format. Additional details on the panel presentation can be found below.
Date: Monday, April 3, 2023
Time: 11:00 a.m. ET
Panel Title: Novel Mechanisms with Important Readouts
A live webcast and archived replay of the panel presentation will be available to registered attendees of the symposium through the symposium website. Company management will also be participating in virtual one-on-one investor meetings at the symposium. To schedule a meeting, contact your Cantor Fitzgerald representative or email mailto://jpatton@oncolytics.ca.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-panel-presentation-at-cantor-fitzgeralds-the-future-of-oncology-virtual-symposium-301783111.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/March2023/28/c2095.html
NEWS -- Plus Therapeutics Successfully Treats First Patient in Cohort 8 of ReSPECT-GBM Phase 1/2a Trial
Company also enrolling ReSPECT-GBM Phase 2 trial
Presentation of data from Phase 1/2a and Phase 2 trials planned in 2023
AUSTIN, Texas, March 28, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the first patient in Cohort eight of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM) has been successfully treated.
The dose escalation phase of the trial has now treated 25 patients with no dose-limiting toxicities observed through 7 completed dosing cohorts. Cohort 8 is now enrolling using 41.5 millicuries (mCi) administered dose rhenium (186Re) obisbemeda with an infused volume of 16.34 milliliters (mL) which allows the treatment of large and morphologically complex tumors.
In parallel, the Company has treated five patients to date with rhenium (186Re) obisbemeda in the Phase 2 trial in recurrent GBM administering a dose of 22.3 mCi and 8.8 mL in small- to medium-sized tumors.
“Taken together, the safety and efficacy signals observed thus far in 30 treated recurrent GBM patients are very promising,” said Norman La France, M.D., President and Chief Medical Officer of Plus Therapeutics. “We remain on track in 2023 to continue to dose escalate to the yet unreached maximal tolerated dose, expand the number of clinical trial sites and present data from the Phase 1/2a and 2 trials in the second half of 2023.”
Thus far, no treatment emergent dose-limiting toxicities have been observed in either trial. The absorbed radiation doses from the 30 patients treated to date have resulted in an absorbed dose of up to 740 gray to the tumor.
The U.S. Food and Drug Administration granted both Orphan Drug designation and Fast Track designation to rhenium (186Re) obisbemeda for the treatment of GBM. More information about the ReSPECT-GBM trial may be found at https://ReSPECT-Trials.com and https://ClinicalTrials.gov (NCT01906385).
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- FuelPositive’s Pre-Sales Order Strategy: Progress Towards Profitability
WATERLOO, Ontario, March 27, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (“FuelPositive” or the “Company”), a leading Green Ammonia company, is thrilled to announce the success of its Pre-Order Sales Initiative. The Company has received commitments for the first production target batch of five systems. Since the implementation of the Pre-Order Sales Initiative, FuelPositive’s team has been systematically vetting each inquiry to select the best end-users for one of the Company’s FP300 systems. FuelPositive provides a dedicated solution to fit each individual requirement, through the process of educating the customer and building a value-based relationship. This strategy has resulted in a high conversion rate.
As a result of this initiative, FuelPositive has been able to expand its initial target from a batch of five to 30 systems, with many systems already assigned. This expansion of the target batch numbers emphasizes the confidence that customers have in FuelPositive and its technology.
In addition to the impressive sales figures, the Company is receiving at least one enquiry per day for its Containerized Green Ammonia Systems from all around the world. This global interest in FuelPositive's modular systems is a tribute to the company's mission and values, the necessity of its solutions, and their game-changing nature in the Green Ammonia technology sector.
"We are excited to see such positive results from our preorder sales initiative, and we are grateful for the confidence and support of our customers from around the world," said Ian Clifford, FuelPositive’s CEO and Board Chair. "Our team has worked tirelessly to create a technology that not only benefits our company but also redefines the status quo in the highly carbon-intense and dysfunctional global ammonia market. This achievement is a confirmation of FuelPositive’s dedication to dramatically reduce greenhouse emissions."
FuelPositive continues to progress towards commercial manufacturing of its products, with the sales pipeline well-positioned to drive growth and success. By focusing on data-driven insights and customer engagement, the company is poised to become a leader in the ammonia market, disrupting traditional business models and offering innovative solutions to meet the evolving needs of end-users.
For more information about FuelPositive's new Pre-Sales initiative or to place a pre-sales order, please contact mailto://sales@FuelPositive.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now.
The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy. FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
The Company began accepting pre-sale inquiries in August 2022. See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media enquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/999c9dc2-6bbd-43f1-97fc-d3f4869337c5
NEWS -- Q4 2022 Navidea Biopharmaceuticals Inc Earnings Call
Participants
Alexander L. Cappello; Independent Chairman; Navidea Biopharmaceuticals, Inc.
Erika L. Eves; VP of Finance & Administration and Principal Financial & Accounting Officer; Navidea Biopharmaceuticals, Inc.
Joseph W. Meyer; Controller; Navidea Biopharmaceuticals, Inc.
Michael Stanley Rosol; Senior VP & Chief Medical Officer; Navidea Biopharmaceuticals, Inc.
Edward English
Unidentified Participant
Presentation
Operator
Greetings, and welcome to the Navidea Biopharmaceuticals Fourth Quarter Earnings Call and Business Update. (Operator Instructions) And as a reminder, this conference is being recorded.
It is now my pleasure to introduce to you, Dr. Michael Rosol, Chief Medical Officer. Thank you, Mike. You may begin.
Michael Stanley Rosol
Thank you, and thank you all for joining us here today for the earnings call and business update. This call is being webcast live on our website, ir.navidea.com, and a replay will be made available. Following prepared remarks, we will be conducting a live Q&A session, as you've just heard.
Navidea's Chair of its Board of Directors, Mr. Alex Cappello; the Vice Chair of its Board of Directors, Mr. Kim Scott; its Vice President of Finance and Administration, Ms. Erika Eves; and its controller, Mr. Joe Meyer, are all joining me on the call today.
During the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Navidea's molecular diagnostics and immunotherapeutics, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks and uncertainties and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise. Investors should read carefully the risks and uncertainties described within the safe harbor section of our website as well as the risk factors included in the company's most recent quarterly and annual filings with the SEC.
As we begin our update and look back at events from Q4 to date, I thought it would be helpful to reiterate a few of our key areas of focus in our 2023 planning. One, we will continue RA, rheumatoid arthritis, Phase III trial success to full enrollment, NDA submission and FDA approval. Two, we'll fully fund the Phase III trial, and the Board of Directors is actively engaged in discussions with capital providers in support of our mission to identify this full RA trial funding. Our goal is to be fully funded this year. Three, we'll attract and retain the industry's top biopharmaceutical talent. As our RA development program success grows, so does the need to grow our team to help support key milestone achievements, identify and support key strategic relationships and initiate new PR IR efforts as a way to share our trial and milestone success.
As I mentioned a moment ago, on the financing front, the Board of Directors is actively engaged in our financing effort, and we hope to have news to announce there shortly. In the last quarter, we have advanced our clinical trials in rheumatoid arthritis as well as our pipeline in other diagnostic indications and in therapeutics. We continue to make solid progress on our Phase IIb trial in rheumatoid arthritis comparing imaging to biopsy. And during Q4, we presented at an international conference our updated promising preliminary results supporting tilmanocept's ability to distinguish the fibroid pathotype from the nonfibroid in the first 13 participants evaluated by the time of the presentation. These strong early results support our hypotheses and provide excellent data in support of tilmanocept imaging as a biomarker of CD206 expression in joints of patients with RA.
We also continue to enroll into the RA Phase III and are actively enrolling in 12 sites. We continue to advance our therapeutics and imaging applications through key existing collaborations with well-known institutions and investigators across the globe as we work to grow the company's intellectual property. We are proud of the progress we have made and the planning we are putting in place to benefit our associates and our shareholders here at Navidea. Regarding the CRG and Dr. Goldberg litigation matters, the company has that ruling that essentially bracket its exposure in both. We will continue to minimize exposure.
Now I'd like to provide a brief update specific to our clinical results. So I'll begin with the progress in our rheumatoid arthritis program. In NAV3-33, the Phase III, we continue to have good enrollment into this Phase III trial in RA. The initial indications we are pursuing for FDA approval are: one, early prediction of treatment response to a new or first-time anti-TNF alpha therapy; and two, identify RA patients with low level of localization of tilmanocept, who are less likely to respond to anti-TNF alpha therapy.
As we have discussed previously, there is a large unmet need for a reliable early predictor of whether a therapy is working in a patient with RA. Because if the drug is not working, the patient's disease is not being treated, and this can lead to long-term health consequences, along with unnecessary high drug costs for ineffective therapies that also bring with them possible side effects. Our Phase III trial will establish the ability of tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNF alpha therapy, addressing that unmet medical need.
In NAV3-32, our comparison study of tilmanocept imaging to joint biopsy, we remain in active recruitment. As we've announced and discussed previously, the preliminary results of this trial have been promising. Our aim is to recruit patients with each of the 3 pathotypes of RA to obtain comparative imaging and pathology results. And the trial is designed so that we enroll a minimum of 4 subjects in each of the 3 subtypes of RA: fibroid, diffuse myeloid and lympho-myeloid. So overall trial size has been expected to range between 12 and 24. To date, we have achieved our enrollment targets in 2 out of those -- 3 of those pathotype buckets, with patients having had both their imaging and joint biopsies completed.
The primary objective of this study is to assess the relationship between joint-specific tilmanocept uptake values and the pathobiology of the RA-involved joints. Knowledge of an individual RA patient's pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. There is a growing body of literature suggesting that those patients with the fibroid type of RA are much less responsive to the anti-TNF alpha drugs, and so a means of determining whether or not a patient has this particular pathotype is seen as extremely important to a number of key opinion leaders in rheumatology. As of this time, there is no reliable way of assessing a patient's pathotype of RA other than by doing a biopsy, and we have hypothesized that tilmanocept could provide this information.
So we presented updated preliminary results on the first 13 patients back at November's American College of Rheumatology meeting. That's the largest rheumatology conference in the world. These results presented there indicated that tilmanocept uptake in the RA-inflamed joints is able to discretely differentiate patients with the fibroid pathotype, that is patients with low macrophage involvement, from those having either the diffuse myeloid or lympho-myeloid types of RA, that is patients with higher macrophage involvement.
So these data also provides support for one of our indications in the Phase III trial. The ability to predict from a baseline scan alone, whether a patient is likely to receive a meaningful clinical benefit from an anti-TNF alpha therapy. Since, as I mentioned, there is increasing evidence that if a patient has the fibroid type of RA, they are less likely to receive significant clinical benefit from anti-TNF alpha therapy.
You might recall that in our previously completed Phase IIb study, NAV3-31, that contained a pilot arm looking at the efficacy of tilmanocept imaging at early prediction of treatment response, those patients who exhibited a low level of tilmanocept uptake in their joints on their baseline scan before they started therapy had an almost 90% nonresponse rate to anti-TNF alpha therapy using a clinical gold standard assessment. Importantly, these promising early results have opened up conversations with pharmaceutical companies who are developing therapeutics for RA, with the possibility of tilmanocept imaging being used as a biomarker in their drug development pipelines. The key differentiator between now and prior discussions we have had with these kind of companies is that we have this additional promising data in hand. And as we move forward and gather more data towards trial completion, if these current results hold, we will be in an even better position for discussions with companies with which to work.
We continue to make very good progress on automating the imaging quantification as well, which will have significant benefit for the commercial product. We are working closely with MIM Software, M-I-M, on a definitive agreement for them to be our commercial partner for image quantification of tilmanocept imaging in RA. So once again, MIM is a leading medical imaging software company based in Cleveland with a large footprint in the nuclear medicine space. We are currently integrating their existing image analysis workflow into our Phase III trial, and their software should be used for the image analysis for this trial as well as our normative database trial data.
The workflow for these trials is extremely well designed. And by integrating them into our trials at this stage, this should be helpful for development and integration of a fully automated workflow that they are developing. Already, they have completed a pilot study using data from our earlier trials, demonstrating that they can develop this fully automated application that should be able to robustly reproduce our quantitative imaging reads using our proprietary algorithm.
This is important for rollout of a commercial product. The ability to perform the quantitative imaging reads rapidly and reproducibly without having to have a bunch of people in the room actually drawing the reference regions of interest will help us go at large scale through this automated method, and that will be critical to large-scale adoption of tilmanocept for RA. Keep in mind that all of this, the image analysis methodology as well as the data upon which it is built, including the normative database you've heard us discuss before, is not only critical to driving the most accurate and sensitive objective read of our RA images, but it also serves as a significant barrier to entry to possible competitors in this space.
You might have also seen the conversion of a provisional patent application to an A1 patent application earlier this month. This application involves using clinical and serological markers in combination with our imaging readout to possibly improve our predictive capacity for treatment outcome over using our imaging alone. So we will have IP protection on combinatorial approaches as well if they work and if granted. We have data from the NAV3-31 Phase IIb trial that I just referenced that was completed a while ago that suggests this indeed might work.
In the diagnostics pipeline development, we've completed preclinical studies on gallium-68 tilmanocept for PET imaging and related next-generation Manocept imaging agents. We work on this in collaboration with researchers at the University of Alabama at Birmingham or UAB. We've also completed work on our NIH-funded preclinical studies for evaluating gallium-68 tilmanocept in various new imaging agents similar to tilmanocept in a mouse model of atherosclerosis.
Work on another important set of preclinical studies was completed with our collaborators at UAB. This work explored varying the molecular weights of tilmanocept-like constructs and evaluating their biodistributions, following intravenous injection with and without competitive blocking. Results showed that by varying the molecular weights of these compounds and introducing competitive blocking agents, it was possible to significantly increase localization of tilmanocept-like imaging and therapeutic constructs to target tissues like tumors while concurrently reducing localization to off-target organs such as the liver.
These results show a path to improving our diagnostic imaging and to greater and more effective targeted delivery of our therapeutic constructs to tumors and other sites of macrophage and valve pathology. We presented these results at the Society of Nuclear Medicine and Molecular Imaging meeting last summer, and these were electronically published on March 7 of this year in the Journal Molecular Imaging and Biology, and you can access that online.
On the therapeutic assets front, we are advancing our candidates in the oncology and anti-inflammatory spaces in preclinical studies with the goal of filing investigational new drug applications to advance to human trials in 2024. These filings will be significant inflection points and opportunities for licensing and partnering deals for the company. Work on new drug delivery constructs and new targeted payloads has also progressed. These new constructs carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages, for example. Results in mouse models have demonstrated that when administered alone or in combination with another cancer drug, these therapeutic constructs significantly reduce the rate of tumor growth by an average of 76%.
Some of our results covering new bisphosphonate payload constructs were presented at the Tumor Myeloid-Directed Therapy Summit meeting. More recently, on November 10, the full spectrum of results for the paclitaxel and novel bisphosphonate constructs were presented at the Annual Meeting of the Society for Immunotherapy of Cancer held in Boston. In addition, we completed what's called a maximum tolerated dose study in mice for our bisphosphonate-carrying construct. The results of this study will facilitate design of studies intended to evaluate anticancer efficacy of this construct in the future. All of our preclinical work with potential cancer immunotherapy constructs are intended to enable Navidea to choose a lead candidate for macro-type-, phenotype-altering drugs for oncology indications.
Preclinical studies are also ongoing in leishmaniasis. Leishmaniasis is a vector-borne chronic disease caused by a protozoan parasite that replicates in CD206-positive macrophages. It is transmitted to humans through the bite of infected sandflies found in parts of the tropics, subtropics and Southern Europe. It's rare in the United States, but in more tropical countries where the sandfly vectors are found, it is a common serious and potentially life-threatening disease. The U.S. FDA has designated leishmaniasis as a neglected tropical disease, making new therapeutics of this disease potentially eligible for what's called a priority review voucher that Navidea could sell potentially for more than enough to back cover the cost of development as well as accelerate a number of other pipeline candidates.
Previously, Navidea scientists and our collaborators at the NIH published research results demonstrating that high CD206 expressing macrophages play a role in the dominant form of the disease. This project has advanced significantly in the last year with results from 3 separate experiments showing that a novel construct created by Navidea has significant therapeutic potential to control leishmanial infections in mice. Concurrent with reduced numbers of these parasites, alterations in the immune status of the lesions that are caused by leishmaniasis were observed with potential implications for the mechanism of action of our novel therapeutic construct. Additional experiments are ongoing or our plan to follow up on these very promising initial results.
That brings me to our overall intellectual property front. We received notification of issuance of a patent from the United States Patent and Trademark Office for the company's application titled Compositions And Methods For Altering Macrophage Phenotype. This patent covers the ability of our constructs to stimulate an immune response against tumors through targeted delivery of payloads that change the nature of macrophages to make them more pro-inflammatory. Efficacy of these constructs has been demonstrated in preclinical studies, including the ones I just spoke about. We have also received notifications of issuance of patent application of patents in Israel and in Canada. Please refer to the earnings call press release from earlier today for more detail.
So we continue to submit new provisional applications and work on our pending ones. We have filed a new provisional patent application describing a new chemistry for addition of mannose sugars to our mannosylated dextran-based imaging and therapeutic constructs. This new chemistry results in a different linkage holding the mannose onto our constructs, one that is more stable than the linkage currently used, and is designed to facilitate commercial scale-up and production of our next-generation imaging and therapeutic constructs. In partnership with our excellent patent attorneys, we have an active IP protection strategy for the company that will provide needed protections and rights to both our current diagnostic and therapeutic agents as well as to our next-generation molecules and disease indications.
On the Lymphoseek front, regarding Lymphoseek Europe and the rest of the world, our strategy has been and remains to find the right partners for marketing and distribution for Lymphoseek and other company pipeline candidates in Europe and beyond. The reason for this is we are focusing on the long-term strategy of partnering for marketing and distribution.
On the drug manufacturing and supply front for both Lymphoseek and the RA product, we have been and continue to work with a new active pharmaceutical ingredient or API supplier as well as a final drug product supplier. Progress continues. And as of this time, we are advancing towards completion of these and readiness for clinical and commercial supply. This work has implications for Lymphoseek in China and Lymphoaim in India as we need to be able to supply a steady and reliable stream of product through our partners in these countries.
So these are just some of the highlights of the last quarter that we wanted to touch on for this update. We remain largely focused on the RA pipeline, specifically the Phase IIb imaging, the biopsy trial in the Phase III, while we continue to support and push progress on our other diagnostic and therapeutic indications.
As always, I want to thank the team here for their tireless efforts to keep things moving and our network of clinical trial sites and academic research collaborators for all of their hard work. Our business strategy remains to advance our pipeline products to key inflection points and seek appropriate partnerships for commercialization and marketing.
So with that, I'll close the update -- summary update. I want to thank you, and I'm going to turn it over to Erika now for the financials.
Erika L. Eves
Thank you, Mike. As announced last week, I will be leaving Navidea at the end of the month. Our current Controller, Joe Meyer, will be taking over many of my responsibilities. So I'd like to introduce all of you to Joe, who will now read the financial results for the fourth quarter and full year of 2022. Joe?
Joseph W. Meyer
Thanks, Erika. And for the first time, hello, everyone. Total revenues for the 3-month period ended December 31, 2022, were approximately $1,000 compared to $50,000 for the same period in 2021. Total revenues for the year ended December 31, 2022, were $66,000 compared to $532,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debt previously written off in 2015, the 2021 receipt of reimbursement from Cardinal Health of certain research and development costs, decreased grant revenue relative to small business innovation research from NIH supporting Manocept development and decreased license revenue from transitional sales up to Manocept in Europe.
Research and development expenses for Q4 were $1 million compared to $1.4 million for the same period in 2021. R&D expenses for the full year 2022 were $6.0 million compared to $5.1 million for the full year 2021. That year-over-year increase was primarily due to increased drug project expenses and increased employee compensation, including incentive-based awards, offset by decreased regulatory consulting expenses.
Selling, general and administrative expenses, or SG&A, for Q4 were $1.3 million compared to $2.3 million for the same period in 2021. SG&A expenses for the full year 2022 were $8 million compared to $7.5 million for the full year 2021. Following the ruling by the Texas Court in August 2022, the company recorded $2.6 million of legal fees in SG&A pursuant to the CRG judgment. The year-over-year increase was also due to increases in insurance and depreciation and amortization, partially offset by decreases in employee compensation, including fringe benefits and incentive-based awards, expenses related to European operations, travel, legal and professional services, investor relations and shareholder services, general office expenses, facilities costs, losses on the abandonment of certain intellectual property, and franchise taxes.
Navidea's net loss attributable to common stockholders for Q4 was $3.5 million or $0.11 per share compared to $3.7 million or $0.12 per share for the same period in 2021. Navidea's net loss attributable to common stockholders for the full year 2022 was $17.2 million or $0.56 per share compared to $11.7 million or $0.40 per share for the full year 2021. Navidea ended the fourth quarter of 2022 with approximately $2 million in cash and cash equivalents.
And with that, I'll throw it back to you, Mike.
Michael Stanley Rosol
Thank you, Joe and Erika. Thanks for everything, Erika, that you've done over the years, not just my years here, but before.
And now I'd like to open up the call to questions. I'll let the moderator do that more professionally than I just did. Joining me for the Q&A session, of course, will be the folks here in this room, myself, Erika, Joe. And then indeed, we have Alex Cappello, the Chair of our Board; as well as Mr. Kim Scott, the Vice Chair.
Question and Answer Session
Operator
(Operator Instructions) And the first question comes from the line of Edward English, a private investor.
Edward English
Mike, this is Eddie English. Before I ask my first question, though, I would like to extend a shout-out to Erika Eves for the 30-plus years of service and support, not only to Navidea but us, shareholders, and to wish her the very best in her new endeavors.
With that, Mike, the elephant in the room based on the report that came out this afternoon, in my mind, is the current cash position with only $2 million at the end of the fourth quarter and a historical cash burn rate of $800,000 to $1 million a month. Can you shed some light on how far in the future you all can operate with your existing cash reserves?
Michael Stanley Rosol
Eddie, thanks for the question, and I appreciate the shout-out. I'm sure Erika does to her.
Erika L. Eves
Thank you. Appreciate it.
Michael Stanley Rosol
Yes. In any event. So Eddie, great question. Really, it's no secret that the company has been in a resource limited environment, but we are optimistic that we'll have something to announce around capital infusion soon. As I mentioned, the Board -- members of the Board are working diligently on this, and that's really all that we can say about it at the current time. I appreciate the question, though. So that's really what we can say right now.
Edward English
Okay. One follow-up, and I'll abide by the rules and then go back in the queue because I have a few more. But my next question is around your plans to become NYSE-compliant by July 28. Are you all on schedule to meet that deadline? Or what can you tell us about that?
Michael Stanley Rosol
I'm going to let Erika use her great financial wisdom to have one -- she should have something to say on this last Q&A. Go for it, Erika.
Erika L. Eves
One final word for me. Yes. So obviously, one of the biggest issues facing us is the NYSE cure that is required, and I think the financing that the Board is currently working on should go a long way towards satisfying the requirements. And so I would say at this time, expectations are that we will indeed become -- regain compliance with NYSE by the end of the cure period.
Operator
And our next question comes from the line of [Bert Carlson] with -- another private investor.
Unidentified Participant
Yes. I appreciate you touching on Lymphoseek a few minutes ago. I wanted to -- hopefully, you can expand a little bit on that. I know that it's been 8 years since we've retained the international rights to selling Lymphoseek. And in all that time, it appears we've not been able to generate any significant revenue. And I wanted -- if you could put your honesty on this, is there something more specific that we could do to make this happen? Or is Lymphoseek a lost cause at this point?
Michael Stanley Rosol
Yes. Great question. I'm happy to answer and give you as much transparency as possible. So that's a summerlong story that I'll try to stick to a shorter version of. So as you and others know on this call, we -- Navidea had licensed the European rights to Lymphoseek to a company called Norgine. And they're a fine company. Their strategy, we might say, was probably not optimal strategy for penetrating the market of sentinel lymph node biopsy assessments or lymphoscintigraphy in Europe.
And it's not all just on their strategy. See, in Europe, there is a viable competitor for Lymphoseek. It's a version of -- it's a colloidal compound. There are different names, but one of the common names is Nanocoll. And it's a pretty good agent, right, for -- and it's relatively inexpensive. In fact, it's actually very inexpensive, and it's pretty good.
We and others, and there's a growing body of research that supports this, suspect or believe that there are advantages to Lymphoseek over this product that has really dominated the market in Europe for years. So Norgine didn't do maybe the optimal strategy for penetrating a market that already has a viable product. We do think there are advantages to it. And to be fair to Norgine, it's been years in the making that researchers have produced publications that support what I just said is our belief, that Lymphoseek has advantages.
So one thing we think Norgine did maybe that wasn't what we would do is they priced Lymphoseek at a premium without having enough of these data in hand to make the case in the very highly regulated European market to adopt Lymphoseek over a good product. That make sense? So what we have done is we brought back the rights, as you probably know, Lymphoseek Europe to Navidea. And we've spent a significant amount of time getting our API and drug product development processes in gear so that we could potentially supply the European market as well as the rest of the world with Lymphoseek and/or the RA product.
So with all of that said, we are actively in discussions with possible partners for Lymphoseek in Europe because it is not just us and some KOLs who believe there are advantages of Lymphoseek to Nanocoll or these Nanocoll and related products, but there are other possible partners who believe it as well. Having said that, it's -- there is a viable product out there, and so the case must be made strongly in a very highly regulated environment in Europe. So there are a lot of -- it's not quite as smooth sailing as it is in the United States. That's maybe too much flavor or detail for you. But it is a product that we think has advantages over the existing product that dominates, and we are in discussions. And if I didn't say that in this call, I think I did, we've said it before. And so we'll continue to have those and see what the market will bear, but we're optimistic. That's about as honest as I can be.
Operator
And the next question comes from the line of [Mike Rashal], a private investor.
Unidentified Participant
Yes. Erika, like everyone, we wish you well in the future. Thanks for your 31 years. And Joe, welcome on board. My question -- initial question is observation first. I think there's a great under-appreciation for this patent that you received on the M1/M2 reprogramming in the TAMs that I just felt the market appreciated it yet, and I don't know if many investors had appreciated it. To me, it seems quite outstanding.
But taking that as an observation, there's also been a lot of science developed, Dr. Rosol, over the last little while that M1/M2 programming, whether in reverse or inverse, also may be applicable in many other diseases and inflammations. Can you expand on that a little bit? And do you believe that you will be -- we'll be seeing patent applications on that in the future?
Michael Stanley Rosol
Yes. Thanks, Mike. Right on all counts and good questions. So some background for the folks who are so in-depth into the field. Very broadly speaking, there are -- macrophages can be pro-inflammatory, stimulate an immune response. That's the so-called M1 macrophages that you just heard Mike refer to. And then there are M2 macrophages that are more -- they have the opposite kind of effects. The wound healing, they quiet down the immune response. Some people would say, in tumors, paradoxically, they're pro-tumor, actually. So there are these kind of extremes of the macrophage in the macrophage world.
And looking at changing the phenotypes of the macrophage, driving them from one of those, the M1, for example, to the M2 or vice versa is a very hot topic across the world because macrophages are very powerful and prevalent cell type in the body, and they're involved in almost all diseases, really. And so the opportunities there to help people to treat diseases is enormous.
Macrophages play a key role in cancer growth and metastases. And in cancers, the macrophages that dominate in and around the cancers are the kind of wound-healing, so-called pro-tumor types of macrophages that actually act as a kind of force field around the tumors to prevent the body's natural immune response from attacking the tumors.
And so what we and many other organizations are doing across the globe related to specific cancer is we're looking at therapies that -- or treatments that might change the phenotype or the nature of the macrophage and drive them from the wound-healing M2s to the pro-inflammatory M1s. And if you can do that in people who have cancer and in those tumors themselves, you can then rally the body's immune response to attack the cancer.
And as of May of 2021, to give you an idea of how large these efforts are globally, to do just what I told, there were 606 clinical trials that we're running or have been completed just to do what I just said related to cancers. It's a huge field. And you know what's cool about it is, really, we're at the forefront of that, not necessarily in the progression of our therapeutic constructs into humans, but in the technology and what our drugs have been show -- what we have been able to show they can do in the in vitro or preclinical phases.
So we're right there at the leading edge of this incredibly large opportunity field or space to help patients and to treat a large number of diseases from cancers to others. I can get into that in a moment. And that patent that Mike referenced was about -- was giving us our intellectual property around using our constructs to change the phenotype of the nature of macrophages, as I just described. And yes, there are going to be a whole series of patents that follow suit or applications around that.
The fact that we can target macrophages of all type, the M1s, the M2s and everything in between, with our construct means that we can deliver all sorts of cool things, payloads, they're called loosely, to the macrophage. And we can perturb them and drive them in different directions. And we have a very flexible, adaptable molecule that has all sorts of really great advantages over what almost every other group out there is using. So I'm not just saying that because I work here. It's proved.
And so we have this great opportunity to be able to really shake up the world in these therapeutic domains. And one of the major thing holding us back as a small company, of course, has been resources, financial resources. So we're very good at making a lot happen with a little. And so our goal, of course, this year, and you've heard it before, but I believe significantly that things are different now than they used to be, our goal is to be fully funded so that we can help drive those things towards first-in-human trials, which is where we can -- those kinds of inflection points are opportunities for large investments, whether they be partnering or license deals or whatever, or whatever we might decide to do. So we're trying to drive them towards that.
So I might have gone astray from what you originally asked, but that patent is very important. There will be others coming along the way that are related. There are some already. You just don't know about it yet because they're not published. And this is a very hot and exciting area in not just cancer research but in other diseases.
So I've mentioned in cancer, you want to drive the M2 or wound-healing pro-tumor type macrophages to M1 pro-inflammatory. In many other diseases, including almost all inflammatory and infectious diseases, you want to do the opposite. You want to take the inflamed pro-inflammatory macrophages that are doing a lot of stuff to try to attack whatever the infectious agent is, but the body has a hard time controlling those things precisely. So what you want to do is you want to drive those towards the more wound healing-type. And we have data suggesting that we can do that with our dexamethasone constructs.
So we can perturb the macrophages and drive them in one direction or the other. And with that, the world is kind of our oyster, and almost every disease is touched by the macrophage, or the macrophage plays a central or critical role. So that's my spiel. Hopefully, I addressed your question, Mike.
Unidentified Participant
You did an excellent answer. So my follow-up on that is an observation that I can make, and maybe you can't opine on it. But I think it's opening up the IND that will really open this up to the world. And on that, do you have any other guideline you can give us into 2024 on your target range for that IND?
Michael Stanley Rosol
Yes, sorry. Thanks. I think that's still our goal and our objective. Obviously, it will be really helped -- will have significant help propelling us forward with full funding, but that is still an achievable goal because we've advanced some of these significantly in the preclinical space. And what you want to do to get towards that IND, the other kind of 2 dominoes that need to fall, roughly speaking or at a high level, are you need to establish that in preclinical models that your construct or your therapy is safe and tolerated, and there are some specific studies you have to do for that. But they're very well known and established and we can box those out, and we've already accounted for those in our time line.
And then the other thing you have to do is show that you can actually make the drug in a scalable fashion and it's reliable and safe to be injected. And so those are the other 2 dominoes that need to fall. It's fairly reasonable for us, we think, to get to those in the time lines you've seen with the caveat always we need to be resourced properly.
Operator
And the next question is a follow-up from Edward English, a private investor.
Edward English
Again, Dr. Rosol, I'm curious, I've noticed in what's available to us in the public and the securities and exchange filings that there haven't been any stocks granted to the Board of Directors since late November. I haven't seen any Form 4s. Has something changed with the compensation for the Board? Are they now receiving cash? Or can you elaborate on what's changed? And if so, why?
Michael Stanley Rosol
Go on, Erika, please.
Erika L. Eves
Yes. So in late 2021, the directors adopted a compensation plan for the next 12 months. Due to our funding situation, many of the directors have chosen to defer compensation until we achieve full funding. And so I can't really speak for the Board, but I believe that, that may have had something to do with their decision to not award themselves an additional package this year. I think that they are probably waiting until we feel like they don't have to defer any longer.
Alexander L. Cappello
Actually, several months ago, all of us were -- had cash payments suspended. So we've all been working several months without compensation and some for the whole year.
Edward English
Next question, a follow-up, and that will be my question for the day. You still have the third-party assessment for the use of the tilmanocept in the RA program. It's still out on the site, and it has revenue projections that are quite appealing. And I'm just curious if you all still stand by those projections. I think there's some $41 million in revenue projected for the year 2024. Have those projections slipped or changed in any way?
Michael Stanley Rosol
Yes, this is Mike. So the numbers, I think, are solid numbers in terms of the market potential and the growth curves even. Those are always based on modeling.
In terms of the time lines, I mean the -- we're doing our best to meet the time lines that are on the investor deck that is out there right now. But to be honest, some of these projections were based on opening up a full suite of sites or a larger number of sites at a certain stage and then going forward from that period. And we've been, frankly, in a resource limited environment for a while now.
So some of these things are just naturally going to be pushed forward unless -- and this is where it gets very complicated. So I'm not giving you double talk, I'm giving you real talk. Unless the -- we could open up more sites than we built into the original model. Enrollment is always something that we have some control over but not full. And then there are several other factors that are -- including the trial size, which is variable based on the response rate to the anti-TNF alpha therapies.
So you put all of that into the hopper, the resource limited environment where we have not been able to open up all the sites we wanted to yet and some of these other variables, and they can kind of counteract each other. So you end up with the same resolution of everything at the same time or might be driven forward or even happen earlier. So more likely than not, it gets pushed forward a little bit if you have to run a long time without a full complement of clinical trial sites open.
And that's kind of where we are now. So I hope that doesn't sound hand-wavy. But like those -- the first revenue generated may be pushed off a bit, but the numbers themselves and the trajectory, once it happens, we still stand by and believe because we have a good idea of the competitive landscape. And the data that we're bringing to the table so far are significantly better than anything I've seen out there. That make sense?
Edward English
Yes. If I could summarize, I think you're telling me the potential is still there and it's very robust, but the timing could go either way.
Michael Stanley Rosol
You got it. Yes.
Edward English
Okay. Well, I'll end it there and just say certainly looking forward to some news soon on your financing.
Operator
And the next question is a follow-up from [Mike Rashal], private investor.
Unidentified Participant
Yes. Dr. Rosol, 2 follow-up questions. You mentioned briefly that as you advance the science engagement, future funding partners improve. Are those still active talks ongoing on the RA [BP] partner potential? Is that still in the works and still progressing?
Michael Stanley Rosol
Thanks, Mike. Yes, that's a -- and there's a complicated answer behind that. The answer is yes, we're still in -- and I've said this, so I can say it now. We're in discussions related to the implementation of -- or the use of tilmanocept in partnership with other drug development companies. And those are -- there's a lot of interest in the NAV3-32 Phase IIb study for that.
In terms of the overall business partner for RA, I think there are opportunities to discuss as we roll with other possible -- with possible business partners as we roll into -- through the trials. But really, and again, to be honest, what I think, Mike Rosol, the place where you're in the best position to get the most bang for your buck is when you've completed the trials and have strong data in hand. From that point on to -- all the way to and into or through FDA approval, that puts you in the strongest position, I believe, because then you have a proved-out, to one degree or another, diagnostic.
So again, if you want me to be completely honest here, doing deals earlier, you usually -- you give up something because there's more risk, right? It's all about the rNPV, right? So the longer we can go, if we can be fully funded and drive this towards completion of a trial, good data, FDA NDA submission, believe me, then we're in the strongest position to do a deal.
So I think that's the strategy that you should pursue, at least if you can, and we're trying to do that strategy. It doesn't mean if something happens in the intervening months or so, we're not turning it away, we're listening. But we want to make the best that we can of what we've got here. And really, that's the story. So...
Unidentified Participant
Well, I think taking that approach of extracting the best value with the most informed and progressed results is -- would be the desired way to go. And I think I'll finish with the comment that you made in the rheumatoid arthritis treatment patent application that should encourage people on this and in 2 of the embodiments in 106 and 111. It was stated that the exciting perfect prediction and remarkable test responses were generated in that testing for the treatment. Can you expand on any of that? Because that just exemplifies and amplifies the potential of this RA, the results you were seeing in the treatment RA -- of the RA patent application. Can you comment?
Michael Stanley Rosol
Sure. So thanks for that. That patent is primarily about the -- using a combinatorial approach for achieving a better prediction capacity for our imaging agent for predicting treatment response in RA. And so we know that our -- that in the data so far, tilmanocept imaging is a very good predictor in the data so far of clinical outcome at 3 and 6 months.
And what we started to look at after the Phase IIb study was, could -- is it an independent and additive predictor to other clinical serological biomarkers, which for the most part or entire part have really kind of failed to be adequate on their own or even in combination? Although there's a lot of people looking at different combinations.
So we looked at our imaging prediction in combination with all sorts of different clinical and blood-based, that's what I mean by serological, biomarkers that are normally obtained in RA patients. And we looked at these in all sorts of different cool ways, and what we found was that it looks like -- and we only have limited data to date. But it might be that our -- if we take our very powerful imaging readout and combine it with some readily available and already validated clinical biomarkers, we might be able to improve our prediction capacity, in some circumstances, the upwards towards a sensitivity of 100, right, or perfect.
Never going to be perfect across the world, across everybody, across all time. But it's really about taking a combinatorial approach of our imaging readout with other biomarkers that are available. And it looks like there might be value there. And by filing that patent, then of course, we have the intellectual property protection.
And insofar as it relates to therapeutics, that should be therapeutic-agnostic. Although to date, we've only looked at the anti-TNF alphas. So the exciting thing there is, what we've learned to date is our imaging readout is an objective, independent predictor of whether or not a patient is getting better or not from treatment of an anti-TNF alpha or with an anti-TNF alpha. It's independent of all the other clinical and serological or blood-based biomarkers. That's one, and it's really strong.
If you add some of those, and we're looking to see which is the best combination, then you might improve your prediction, or not much closer because there's not even a lot of ceiling left, but even closer to the ceiling of getting it right all the time or most of the time or the vast majority of the time.
So that's really cool and promising. So we're really trying to get to what is the optimal predictive capacity for any patient. Is their drug going to work or not? Or is it working or not early? Now related to the therapeutics, it's less specific in that it's not really specifically outlined in that patent. However, the fact that we can deliver and we've demonstrated that we can deliver an imaging probe to RA-inflamed joints, and we can do this reliably, repeatedly and stably, it should not escape your attention that then we could easily swap that out for a therapeutic.
So we believe that we also have a potential powerful therapeutic in our hands, pardon the pun of hands. But -- and that remains to be explored more fully when the company is funding. But indeed, we have the potential for a powerful therapeutic. And what we're doing in that patent application is showing that on the diagnostics side, we really have all the bases covered. That make sense?
Unidentified Participant
Yes. So on a therapeutic, did you guys do -- have you done any preclinical, just small test to see if that therapeutic validated that concept you just talked about that's not in the patent? Have you tried anything? Or I imagine you have.
Michael Stanley Rosol
Yes. There were preclinical studies that have been done in the past, and there was some promise to those. So let me leave it at that. But really -- and we have a plan for how we can go forward and really flesh that out. But in the limited data that I've seen to date, and much of this predates my time here, there was already promise shown. And we know a lot more than we knew then, so I think it's only -- we're only in a better position.
Operator
There are no further questions at this time. And I would like to turn the floor back over to Dr. Mike Rosol for any closing comments.
Michael Stanley Rosol
All right. I think you've heard enough from me today. I want to thank you for joining us today for your engagement and all of your questions. Once again, I want to thank Erika for all her hard work here over the years. And welcome, Joe, here to the fray, at least the public-facing fray. I'm sure he's going to be great and have a fun time. And hopefully, we'll be talking to you, folks, before too long. So thank you, and have a great evening.
Operator
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.
NEWS -- Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal Metastases
First data readout of Phase 1/Part A trial expected second half of 2023
AUSTIN, Texas, March 22, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
This follows successful prior completion of Cohorts 1 and 2 as well as the recommendation of the trial’s Data and Safety Monitoring Board (DSMB) to advance into Cohort 3. Thus far, no dose-limiting toxicities have been observed with administered radiation doses of up to 26.4 millicuries. This dose represents a theoretical maximum absorbed radiation dose to the cerebral spinal fluid of approximately 200 gray.
“Through Cohorts 1 and 2 and the first patient in Cohort 3, the observed safety profile and clinical signs and symptoms coupled with biological tumor cell count data of patient response, even at low, early administered doses of radiation, are encouraging,” said Norman LaFrance MD, Chief Medical Officer of Plus Therapeutics. “We remain on track to meet our key 2023 milestones for LM including a U.S. Food and Drug Administration (FDA) meeting to determine the dose expansion regime, beginning with Part B of the Phase 1 trial, and presentations of the preliminary Phase 1/Part A data at medical meetings in the second half of 2023.”
At the 2022 Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), Plus Therapeutics presented Phase 1 data from the ReSPECT-LM trial demonstrating that a single administered dose of rhenium (186Re) obisbemeda was feasible, safe, and well-tolerated. Across two dosages, the four patients from Cohorts 1 and 2 experienced a decreased cerebrospinal fluid tumor cell count of 46% to 92% at 48 hours following treatment.
The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose, maximum feasible dose, safety and efficacy of a single administration of rhenium (186Re) obisbemeda via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. Additional details about the ReSPECT-LM trial are available at ClinicalTrials.gov (NCT05034497).
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. ReSPECT-LM is funded by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer is the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Results to Be Presented at 2023 Retinal Cell and Gene Therapy Innovation Summit
CARLSBAD, Calif., March 20, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that results from a Phase 1/2a clinical study of RG6501 (OpRegen), will be presented at the 2023 Retinal Cell and Gene Therapy Innovation Summit, organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The meeting will be held April 21st, 2023, at the Marriott New Orleans Warehouse Arts District in New Orleans, LA. The presentation, "Phase 1/2a Study of OpRegen in Patients with Geographic Atrophy (GA)," will be presented by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology at Hadassah-Hebrew University Medical Center. RG6501 (OpRegen) is a retinal pigment epithelium cell transplant therapy currently in development for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). It is being developed under an exclusive worldwide collaboration between Lineage, and Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with geographic atrophy secondary to age-related macular degeneration (ClinicalTrials.gov Identifier: NCT05626114).
The 2023 Retinal Cell and Gene Therapy Innovation Summit, "Defining the Preclinical to Clinical Roadmap" will feature presentations that emphasize clinical trial design for gene and cell-based therapies. Representatives from the biotech and pharma industries will come together with physicians and scientists to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal disease therapy options forward.
About the Foundation Fighting Blindness
The Foundation Fighting Blindness was established in 1971 by a passionate group of families driven to find treatments and cures for inherited retinal diseases that were affecting their loved ones. Today, the Foundation Fighting Blindness is the world’s leading private funder of retinal disease research. That funding has been a driving force behind the progress toward cures, including the identification of more than 270 genes linked to retinal disease, and the launch of over 40 clinical trials for potential treatments. For more information, please visit https://www.fightingblindness.org/ or follow the association on Twitter @FightBlindness.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230320005164/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Navidea Biopharmaceuticals to Host Fourth Quarter 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Tuesday, March 21, 2023 at 5:00 p.m. (EDT)
DUBLIN, Ohio, March 15, 2023--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Tuesday, March 21, 2023 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter and full year ended December 31, 2022.
Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Fourth Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, March 21, 2023
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13736745
Webcast Link: https://www.webcast-eqs.com/navidbioph20230321/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005347/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Q4 2022 Lineage Cell Therapeutics Inc Earnings Call
Participants
Brian M. Culley; CEO, President & Director; Lineage Cell Therapeutics, Inc.
Gary S. Hogge; SVP of Clinical & Medical Affairs; Lineage Cell Therapeutics, Inc.
Ioana C. Hone; Director of IR; Lineage Cell Therapeutics, Inc.
Jill Ann Howe; CFO & Principal Financial and Accounting Officer; Lineage Cell Therapeutics, Inc.
Jack Kilgannon Allen; Senior Research Analyst; Robert W. Baird & Co. Incorporated, Research Division
Joanne Lee
Joseph Pantginis; Director of Research & MD of Equity Research; H.C. Wainwright & Co, LLC, Research Division
Kristen Brianne Kluska; Analyst; Cantor Fitzgerald & Co., Research Division
William McKinnie Wood; Research Analyst; B. Riley Securities, Inc., Research Division
Presentation
Operator
Welcome to the Lineage Cell Therapeutics Fourth Quarter and Full Year 2022 Conference Call. (Operator Instructions) An audio webcast of this call is available on the Investors section of Lineage's website at www.lineagecell.com.
This call is subject to copyright and is property of Lineage. And recordings, reproductions or transmission of this call without the expressed written consent of Lineage are strictly prohibited. As a reminder, today's call is being recorded.
I would now like to introduce to you your host for today's call, Ioana Hone, Head of Investor Relations at Lineage. Ms. Hone, please go ahead.
Ioana C. Hone
Thanks, Mandeep. Good afternoon, and thank you for joining us.
A press release reporting our fourth quarter and full year 2022 financial results was issued earlier today, March 9, 2023, and can be found on the Investors section of our website.
Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward-looking statements within the meaning of federal securities laws. Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K. We caution you not to place undue reliance on any forward-looking statements which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings.
With us today are Brian Culley, our Chief Executive Officer; Jill Howe, our Chief Financial Officer; and Gary Hogge, our Senior Vice President of Clinical and Medical Affairs.
With that, I'd like to turn the call over to Brian.
Brian M. Culley
Thank you, Ioana, and good afternoon, everyone. Welcome to our full year 2022 call. We appreciate you joining us today.
2022 was another challenging year for biotech companies, but I think it was an exceptional one for Lineage. We worked successfully alongside Roche and Genentech to prepare OpRegen for its next clinical trial, and that trial is now open and enrolling new patients.
With the positive tailwinds from the OpRegen program in place, we made bold but financially responsible moves to expand our pipeline, adding a photoreceptor program, which capitalizes on our experience and success in ophthalmology and by adding an auditory neuron program, which is the first time we've shown that we can not only improve upon existing assets, but also create them from scratch in our R&D labs, vastly reducing any third-party financial obligations from these in-house product candidates.
2022 also marked a year of important and successful clinical and regulatory execution for the Lineage team as we advanced our clinical programs along their respective developmental pathways.
I realize this is a 2022 recap call, but I know a lot of investor attention is presently focused on the dry AMD landscape. So I thought that would be a better way to use my opening remarks.
Last month, FDA approved a complement inhibitor to treat dry AMD. And with this approval, the FDA has set a precedent that anatomical change in the form of photoreceptor preservation is an approvable endpoint in this condition. We believe this is an enormous regulatory decision for us because the data we have collected to date with OpRegen and its ability to improve outer retinal structure and either halt or even reverse the progression of GA is far greater than what has been demonstrated by either of the leading complement inhibitors.
Critics sometimes say that we've only shown these results in a small number of patients, but I will remind them that we are seeing changes which do not occur spontaneously, and we're reporting these via multiple independently verified analyses using objectively captured anatomical images. So on this basis, we believe these early and exceptional results are likely to be repeated in larger studies.
When I look at the error bars surrounding the point estimates on the Phase III trial for the complement inhibitor, which recently gained FDA approval for which only a small reduction in GA growth is provided, I think it's highly likely that all 5 OpRegen patients, which Roche and Genentech reported on at the ARVO Annual Meeting last year have shown greater reductions to the area of GA than all of the more than 1,200 patients treated in the clinical trials, which supported that drug's approval.
Furthermore, we have demonstrated not only anatomical changes but also functional improvements to patients' vision with an average of 7.6 letters gained among all Cohort 4 patients and increasing to 12.8 letters gained among the 5 patients who received extensive coverage of OpRegen cells across their GA and who additionally exhibited outer retinal structure improvements measured 12 months following transplant in our Phase I/IIa study.
Recently, a number of outlets have been reporting that a different complement inhibitor can provide functional benefits to vision. The evidence which that company provided was a post hoc exploratory analysis, which is something my former colleague likes to call drawing the target around the arrows after they're fired. This selective data cuts sought to make the case that patients on treatment were less likely to lose 15 letters at 12 months than patients on placebo.
Despite this data similarly being in a very small number of patients, representing only 5 to 10 patients of all patients treated on that trial, it actually was quite well received by the investment community. And for this reason, I will again draw the comparison that OpRegen data, which was reported at ARVO by Roche and Genentech showed 25% of patients in Cohort 4 gained at least 15 letters. They didn't avoid loss. They gained vision. So we're talking about comparisons, which are as large as a 30-letter delta between these approaches.
Obviously, it's a huge benefit for patients and the medical community to finally have something which may help some patients with their condition, but it appears to us that there is a tremendous amount of clinical benefit, which could still be provided. Benefits which monthly injections of complement inhibitors have not shown. It's very important for our results to continue being presented at major medical meetings and help the medical and investor communities become aware of the efficacy, safety and other attributes of our product candidate profile.
One of the additional potential advantages of the OpRegen product profile is in dosing and administration. OpRegen treatment involves a single 30-minute procedure rather than giving patients an injection every month or 2, year after year with all the compliance issues, which accompany it. For this reason, we often are asked how long our treatment lasts. But we don't yet know because we haven't reached a clear terminus or an indication of the benefit tapering.
I've mentioned on prior calls, that we have patient data going out as long as 5 years in some cases, including our very first patient with structural improvement who after 4 years has lost 30 letters in her untreated eye, which, by the way, was her better performing eye at baseline. But she was still 3 letters higher than her baseline level of visual acuity in her OpRegen-treated eye. Again, that's data coming 4 years post treatment in a disease which is widely viewed as inevitably progressive.
Long-term follow-up from the Phase I/IIa study is still ongoing, which allows us to continue to monitor evidence of the duration of treatment effect. And there may be more to come from deeper imaging analyses as well. Next month, some of that data from our Phase I/IIa trial will be made available at the 2023 ARVO Annual Meeting on April 25. That will be presented by Dr. Eyal Banin on behalf of Roche and Genentech. And as always, data updates are important disclosures, and we look forward to this next one happening in just a few weeks.
Meanwhile, we're excited about the ongoing Phase IIa study, which Roche and Genentech has launched to evaluate the safety and efficacy of OpRegen as well as certain delivery techniques. It is difficult to predict when that trial will have data available because it has an enrollment range of 30 to 60 patients. But regardless, the primary and secondary outcome measures for that study will all occur at 90 days. So the primary observation period is very brief compared to what we usually expect from dry AMD studies.
Genentech has disclosed 2 enrolling clinical sites so far in Cincinnati and Sacramento, both of whom participated in our Phase I/IIa study. Dr. Christopher Riemann, the PI from the Cincinnati Eye Institute is a former Lineage site PI who treated one of the original retinal restoration patients, and we appreciate his and Dr. Telander's continued participation in the OpRegen trial, and we expect more sites will be coming online this year.
Moving next to our spinal cord program. You'll recall that a lot of our work last year focused on activities to support regulatory interactions for OPC1, which we successfully completed as planned. Our response to an RMAT interaction with a comprehensive data package was submitted to FDA to support the use of the new delivery device, along with a clinical protocol synopsis for the small safety study we plan to conduct in sub-acute and chronic patients, and which I've discussed previously on several occasions.
We have been in active dialogue with FDA and have been responding to additional requests for information following our initial RMAT package submission. We anticipate another formal interaction to occur with FDA in the second quarter, a Type B meeting, which we hope will support submission of our planned IND amendment in the second half of this year. Assuming the necessary clearances are received, our plan is to initiate the open-label device safety clinical study known as the DOSED study in 5 to 10 patients with either subacute or chronic injuries as soon as we're able.
We also remain in frequent contact with the California Institute for Regenerative Medicine, and we continue to plan to apply for a grant to support the device safety study. As most of you are aware, CIRM guidelines state that an applicant must provide communication from FDA indicating that it's safe to proceed with a proposed clinical trial protocol. So therefore, the timing of the submission of our grant application will be contingent on and subsequent to receipt of FDA clearance to initiate the dose study.
For VAC2, we submitted our pre-IND meeting package as planned, actually a little bit earlier than we planned and have already received feedback from FDA. Our emphasis in the pre-IND package was to understand the FDA's view of our production process and the analytical methods, which we propose to use to manufacture and characterize our clinical material. Their feedback was generally positive and provided us with a clear and actionable path to an IND submission.
Any future IND filing would naturally be expected to include supporting clinical data from the Phase I study of VAC2 conducted by Cancer Research UK. We currently are still awaiting those data and were recently informed by Cancer Research UK that it's expected to be available during the second quarter of 2023. This data would be an important component of any potential IND so we will be in a better position to update you on our VAC plans at that time. In the meantime, we will continue to monitor the changing landscape of DC vaccine product candidates and their evolving clinical data.
We've also continued to engage in manufacturing and preclinical activities for our 2 new cell transplant programs in hearing loss and vision disorders, both of which were publicly launched last year. Initial preclinical studies from our photoreceptor program are currently ongoing, and we hope to be able to present top line preclinical data once the appropriate patent submissions have been made and as data become available.
Last month, we also announced the initiation of preclinical testing with our auditory neuron program in a collaboration with the University of Michigan with initial preclinical data anticipated to be available later this year. I'd like to remind everyone that Lineage's hearing loss program didn't even exist at the beginning of last year, and yet we've already started in vivo preclinical studies. Notably, we've been able to advance this program to that stage while spending less than $1 million of our R&D budget. We believe that speed and return on our R&D investment dollars are illustrative of the efficiency and versatility of the Lineage platform.
We showed the ability to advance from a little more than a product concept then develop new differentiation methods to generate intellectual property and execute on the manufacture of a specific cell type, then proceed into in vivo testing in less than 12 months and with an investment of less than $1 million. When we compare the money and time we invested to move a new program from concept into in vivo testing against the industry norms for a small molecule making the same journey, we find striking differences in the return on invested capital. And as we continue to improve our capabilities and our homegrown programs advance further, I think it will become increasingly apparent that the Lineage platform has tremendous untapped potential.
Our goal will be to unlock that value in the months and years ahead, both internally and through partnerships while still maintaining a prudent financial balance between the exciting progress occurring with OpRegen and our expansion activities with our pipeline.
This brings me next to a few comments about our most recent business development transaction. As you know from prior calls, I have said that we are emphasizing business development, and that includes in-licensing, out-licensing and joint development projects. Our most recent deal is an option agreement with Eterna Therapeutics, which gives us an affordable way to gain access to several new technologies, which fit within our overall strategic approach. These staged investments in technologies are intended to provide us with certain advantages and help set the foundation for the type of company we aim to become.
Because our confidence in the future success of OpRegen has increased upon the recent regulatory precedent set by FDA in dry AMD, we believe this is the right time to apply our technology in other areas. That is where the Eterna deal fits into our overall strategy. It provides us with an opportunity to gain experience in 3 new areas: gene editing, hypoimmunity and induced pluripotent stem cells or iPSCs. These 3 complement and are expected to bolster our in-house manufacturing and directed differentiation capabilities.
Gene editing offers us an opportunity to modify the behavior and functionality of cells and engineer new features before they are transplanted. This ex vivo editing allows us to fully characterize an edited cell line prior to it being administered to a patient. In some cases, we may look to add genes and thereby add functionality, while in other cases, we may look to delete genes, which may help with the tolerability or the durability of a transplant. Editing also gives us a competitive edge because it makes our products difficult to copy, and it may give them better clinical outcomes.
As we explained in the press release announcing the Eterna agreement, we will be utilizing a B2M deficient cell line, which is a feature associated with lower chances of transplant rejection. We don't see hypoimmunity as relevant to our existing programs because we've never received a reported rejection of our OpRegen or OPC1 cells and that's going out as long as 10 years in patients with spinal cord injury or as long as 5 years in patients with dry AMD. But the eye and spinal cord are known to be tolerant locations for cell transplants. If we want to expand our technology to other areas of the body, we need to consider whether hypoimmunity could be beneficial and ensure that all of our product candidates have an appropriate and suitable commercial product profile. We think hypoimmunity could be an interesting feature for potential new product candidates.
The third new aspect of this deal is the use of an iPSC line. We already have intellectual property for certain platform inventions and uses of iPSC cells, but exercising this option could lead to our first product candidate built from day 1 on an iPSC cell line. We know from experience that the quality and performance of iPSC lines can vary widely, and we'll be keen to see how these cells behave in our hands. Regardless, experience with both iPSC and ES lines is rare and we'll give Lineage yet another point of differentiation compared to the competition.
Overall, we're very excited about this deal because we believe it provides us with access to multiple new technologies but with a relatively modest cost structure. We anticipate providing updates under this collaboration later this year.
Overall, while many cell therapy and gene-editing companies struggled badly last year, reducing headcounts and/or deprioritizing programs, we broadened our pipeline and advanced each of our 5 programs. We made a number of key hires and expanded our research space in both California and Israel, but we did this with very responsible and stepwise investments to help ensure we have capital to reach additional milestones and important events.
I believe the company made exceptional progress in 2022 and our efforts during 2023 will remain focused on the further progression of our allogeneic cell therapy programs, making responsible investments in disease settings where we believe we can have a meaningful impact and the continued prioritization of both new and existing collaborations, all and each in support of our overarching vision of building Lineage into a leading cell therapy company.
With that, I'll now hand the call over to Jill for a discussion of our financials.
Jill Ann Howe
Thanks, Brian, and good afternoon, everyone.
Beginning with our balance sheet, I believe we continue to be efficient with our spending and are well capitalized to conduct the near-term activities, which Brian just outlined. Our reported cash, cash equivalents and marketable securities as of December 31, 2022, totaled $57.9 million, which is expected to support our planned operations into Q3 of 2024. Please note, this does not account for any of the Roche Genentech milestones, which we may receive nor for any business development or grant revenues, which we may receive during this same period.
Let me start with an overview of our fourth quarter 2022 operating results. Our revenue is generated primarily from licensing fees, collaboration revenues, royalties and research grants. Total revenues for the fourth quarter were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million for the same period in 2021. The increase was driven by the recognition of deferred collaboration revenues in connection with the Roche agreement, which we entered into in 2021.
Operating expenses are comprised of research and development expenses and general and administrative expenses. Total operating expense for the fourth quarter were $8.5 million, a decrease of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease in R&D expense due to the Roche collaboration. R&D expenses for the fourth quarter were $4.1 million, a decrease of $20.7 million as compared to $24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit in connection with the $50 million upfront payment received in early 2022 under the Roche collaboration. This decrease was partially offset by $0.1 million and $0.2 million in new expenses to support the development of the photoreceptor and auditory neuron cell therapy programs, respectively.
G&A expenses for the fourth quarter were $4.3 million, a decrease of $0.1 million as compared to $4.4 million for the same period in 2021. The decrease was driven by a $0.4 million in legal and litigation expenses. Loss from operations for the fourth quarter were $6.6 million. This is due to a decrease of $21.6 million as compared to $28.2 million for the same period in 2021, principally owing to Roche collaboration-related expense accruals of $21 million, as I had previously mentioned.
Other income for the fourth quarter was $0.3 million compared to other income of $0.2 million for the same period in 2021. This variance was primarily related to the change in the value of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period. The net loss for the fourth quarter was $6.4 million or $0.03 per share compared to a net loss of $29 million or $0.17 per share for the same period in 2021.
Now let me move on to our full year 2022 operating results. Revenues for the full year were $14.7 million. This represents an increase of $10.4 million compared to $4.3 million for the same period in 2021. Again, the increase is primarily related to revenues recognized from the $50 million upfront payment from the Roche collaboration. Total operating expense for the year was $36.5 million, a decrease of $15.6 million as compared to the $52.1 million for the same period in 2021.
Total R&D expense for the year was $14 million, a decrease of $19.9 million as compared to $33.9 million for the same period in 2021. The decrease was substantially driven by the prior year $21 million accrual for financial obligations payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.
Total G&A expenses for the year were $22.5 million. This is an increase of approximately $4.3 million as compared to $18.2 million for the same period in 2021. The increase was primarily attributable to $2.1 million in litigation and legal expenses, $1.3 million in salaries and related benefit fees and $0.9 million in share-based compensation expenses.
Losses from operations for the year were $22.5 million, a decrease of $26.7 million as compared to $49.2 million for the same period in 2021. Other income and expenses for the year netted an expense of $3.3 million compared to other income of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain on sale of marketable equity securities as well as exchange rate fluctuations related to our international subsidiaries for the applicable period.
The net loss for the year was $26.3 million or $0.15 per share compared to a net loss of $43 million or $0.26 per share for 2021. Overall, we intend to maintain the same spending discipline that we have adhered to for years and which has served us well in the past. The biotech markets continue to face uncertainty, so we believe that maintaining discipline with our spending will continue to allow us to maintain our plan to reach meaningful milestones and create value for shareholders from our investments in our programs.
Now let me hand the call back to Brian.
Brian M. Culley
Great. Thanks, Jill.
Circling back to the beginning of this call, I continue to think that Lineage is doing quite well in an otherwise strained environment for the biotech industry. We have been hitting our milestones and advancing our programs in a responsible and positive way. And I expect Jill and I will continue to apply the same financial discipline to our programs this coming year.
Our approach helped us land a valuable collaboration with Roche, and I believe it will continue to be an important attribute during 2023. And further out, as our programs demonstrate success in the clinic or in preclinical testing and potentially attract additional, nondilutive support, I believe, we'll have opportunities to accelerate our work across a number of parallel paths.
Broadly speaking, a few things we'll be working on this year and which you may want to watch for updates on include additional data from the completed Phase I/IIa trial of OpRegen, which we expect next month; additional regulatory progress with OPC1, which we will conduct during the second quarter of this year and which will support OPC1 returning to clinical testing. And we'll be doing our part to support the manufacturing and Phase IIa study of OpRegen being conducted by Roche and Genentech, the results of which we believe could be a seminal event, not only for Lineage but also for the entire GA field.
In addition, we've planted a few seeds to prepare for the future, including our new preclinical programs and the Eterna option deal which gives us affordable access to new technology, which we can combine with our existing capabilities and the furtherance of our goal of using the transplant of whole cells to change the course of disease in new and exciting ways.
And with that, Mandeep, we are ready to respond to any analyst questions that there may be.
Question and Answer Session
Operator
(Operator Instructions) Our first question comes from the line of Jack Allen from Baird.
Jack Kilgannon Allen
Great. Congratulations to the team on all the progress made over the course of the quarter. Brian, you did a great job laying out some of your thoughts around the recent news in geographic atrophy, but I was wondering if you could dive a little bit more deeply into some of the conversations you have with your partner Roche on the heels of this announcement. Any sense as to how soon we could see data? I know you did make a comment as you said earlier, but I'd love to hear any more feedback from the ground there? And then I have one quick follow-up as well.
Brian M. Culley
Yes. Thanks, Jack, for the question. The shortest possible answer is no, nothing to add. The biggest challenge, I think, is the enrollment range being 30 to 60, makes it really difficult to say when, where and how the public disclosure of data will occur, whether it will come in pieces or major medical meetings and so forth. But I do suspect that as we get closer to that event for those events, that we might be in an opportunity to provide more clarity and expectation around it.
Jack Kilgannon Allen
Great. Great. And then my other question, a little bit out of the box here. I'm not sure if you've seen the news coming from some of the medical suppliers here. But it's been hard to get your hands on nonhuman primates or at least it could become more pressing to get your hands on non-human primates given some of the updates from some of the players in the space. I was wondering if you had any comment as it relates to your preclinical activities and the use of these valuable research assets and how you're factoring that into the timelines there?
Brian M. Culley
It's a great question. Part of the answer is that we do not do any nonhuman primate testing. So we haven't -- we're not susceptible to a supply challenge. But by chance, I was looking early this morning at a similar company's slide deck and noticed that they were reporting a lot of data in NHP. And it occurred to me, I wonder if that is an issue for them. It's not for us. I don't know how others are managing it, but we have, ever since COVID began, we have worked to ensure that our supply chains are in good order, and we benefit by being a multinational company in that way. But specifically to NHPs, we don't have any clinical -- excuse me, any preclinical activity utilizing that particular species.
Jack Kilgannon Allen
Great. I congratulate you again on all the progress made over the course of the quarter.
Operator
Our next question comes from the line of Mayank Mamtani from B. Riley Securities.
William McKinnie Wood
This is William Wood on Mayank Mamtani. Congratulations, Brian, to you and the team, really excited to see all the progress you've been making and looking forward to the upcoming work. A couple of questions here from us. We're excited, obviously, to see that you've got the upcoming OpRegen data at ARVO in April. Would be -- I know you've touched on this already a little bit, but it would be great to hear what we might be able to see as far as new or incremental maybe surrounding or remind us how your OTT anatomical results tend to correlate with visual acuity given pretty long follow-up that you've had now all treatment. And then also to clarify, have you or your partner Roche seen the value of cutting BCVA data in terms of a rate of vision loss by greater than 15 letters or 3 lines?
Brian M. Culley
I appreciate the questions, William. I'm going to hand off to Gary to speak to those. Thank you.
Gary S. Hogge
Yes. So obviously, there's a lot of new and buzz around the BCVA and cutting it -- looking at 3-line loss over time. The good thing is that we examine it closely throughout and in the Cohort 4, which is the optical population that is involved in those studies, we haven't had a 3-line loss in any of our Cohort 4 patients. So that's certainly something to be intrigued about. Smaller numbers we know, but it looks like we've maintained those visual improvements that we've observed over time we reported out.
And the data coming up at ARVO, we'll focus on looking at different analysis of the OCT assessment. And how quickly those changes occur and how they tie into the visual acuity improvements, particularly in those patients that showed signs of outer retinal structural improvement. And so we're very excited to have this data, again, presented by an entirely independent analysis.
William McKinnie Wood
I appreciate that extra color there. And then also just to clarify, do you know the timing of the release of ARVO abstracts and then whether you expect that the abstract presenter may comment on the Phase II enrollment status since there is a meaningful overlap in trial sites there?
Gary S. Hogge
Yes. So as per the ARVO website, it will be available sometime in early March, so perhaps in the next week or 2. With regards to Dr. Banin and his ability to comment on the future or the ongoing study that is conducted by Genentech and Roche, I don't think he'll be able to offer any additional comments at this time.
Brian M. Culley
And William, I'm going to add here. I don't think I'm putting Roche on the spot. But as a general matter, when we were running the Phase I/IIa, these were the first 24 people on the planet to ever receive this experimental therapy. Now that there is a basket of safety and efficacy data available, it makes me think that the conversation between a prospective patient on the clinical trial and their doctor might go a little differently because they could actually show some results that are available in the public domain. So I am hopeful, although I have no specific information because the trial is just underway, but I'm hopeful that enrollment will go faster than it was when we were running it.
William McKinnie Wood
Got it. That's really helpful. And then one last one, switching gears. In regard to your ANP1, there's obviously been a number of players in the hearing space, a lot of them incorporating Intratympanic administration. Just curious what your plans are on delivering the cells into the inner ear. I know you mentioned that it could be a good combo for cochlear implants, but I don't think you're going to be limiting to that. Maybe just walk us through your plans there.
Brian M. Culley
Yes. So I think what the right way for me to describe is that we have a lot of good ideas, but they need to be tested. And so we're not today in a position to say a whole lot more about an intended patient population or exactly what the right clinical application will be. There are many causes of hearing loss. We're going to follow the data that's collected. And right now, we're just at the very earliest stages of that process. So it's difficult, but I think as we reject some hypotheses, reject some options and begin to narrow down what we think is the best approach, that will be something we'll look forward to sharing when we are able to do so and feel confident in that information.
Operator
Our next question comes from the line of Kristen Kluska from Cantor Fitzgerald.
Kristen Brianne Kluska
So we've talked a lot about how a GA approval in general, could help to better educate the market. But perhaps I'll ask you the question from a different direction. How do you think that the emergence of these commercial complement inhibitors can help frame eligible patients by the time OpRegen potentially reaches the market? So I know you've shown that if patients are perhaps too far along towards legal blind status, they may not be eligible. So do you think that patients should they be compliant on these complement inhibitors could become eligible given there's at least some slowing of the progression?
Brian M. Culley
I love it. We have a market leader that is going to condition a market to accept a new therapy in an environment where there are no approved therapies today. And I think there are a couple of places where that could be beneficial. There are technologies out there that are helping people to identify this disease earlier. So I think we're going to see an increase in the prevalence through identification of patients. And I think most companies with these therapies in development are thinking that earlier patients are sort of more suited for therapy. And I also think that the aging population is going to increase the incidence of the condition.
So if you imagine that when my dad was first diagnosed with dry AMD that he would have been told, "We're sorry, there's nothing we can do for you, Mr. Culley." But now, he would be brought in. He would have a specific caregiver. Presumably he would be on therapy. And now he's a little bit of a captured population.
So if you come along with the second, third or fourth treatment in a disease setting, you benefit from the precedent and the awareness of an educated patient population. So I would not feel so positively about it if we had a MeToo therapy. But because our therapy is so wildly different, and I'm hopeful we'll continue to look so different in terms of its product profile, I think that it's actually a big positive for us.
Kristen Brianne Kluska
Okay. And given the data here and of course, the validation from Genentech and Roche, I'm wondering how you're thinking about this pathway with some of your earlier candidates as you start to do some work here? So do you like potentially establishing some proof-of-concept data in-house before potentially seeking partnerships similar to what you saw here? And then can you detail for us some of the preclinical work that you're intending to conduct near term?
Brian M. Culley
So with respect to the strategic component of your question, which has to do with partnering, I think the answer is that it very much depends on the cost of development that you're facing, your probability of success, the macroeconomic business environment you're in, your cost of capital, all of these factors are sort of fun decisions that companies with multiple assets get to make.
So we don't have a priority, a plan to either partner or not partner any of our assets. We look at them as assets that have optionality and flexibility. We just try and make them as valuable as possible so that if we do elect to enter into a partnership that we can find that partnership to be financially rewarding and strategically valuable. And that means partnering with people who have high capabilities and are going to increase the probability of success.
I do think from an approach that the success that we've had so far and we will continue with the OpRegen program does create a certain amount of a halo effect on other assets. Clearly, we are working with different cell types, and so there's not a perfect apples-to-apples comparison. But conceptually, the notion that cells are capable of doing things that are beyond the reach of small molecules is a notion that we think is being borne out in the setting of dry AMD, and we believe will be applicable in other settings.
And I could refer to this morning there was a trial that was unsuccessful in the setting of spinal cord injury utilizing a particular scaffold. There were no biologics involved. It was just pure scaffold. Unfortunately for patients, that was not a study that was successful. But again, to me, that is another reminder in the field that sometimes the standard or expected approaches just aren't quite strong enough when the condition is very severe as in the case of cells that are dying off that goes far beyond a single pathway and getting to the level of the entire cell or the cell has been destroyed through an accident or some sort of trauma such as the case of spinal cord injury.
Kristen Brianne Kluska
Thank you, Brian. Looking forward to seeing the data in a few weeks.
Operator
Our next question comes from the line of Joe Pantginis from H.C. Wainwright.
Joseph Pantginis
So Brian, I wanted to focus on your 2 leading regulatory discussions, and I'll start with VAC2 if you don't mind. So obviously, you talked about the pre-IND discussions right now are surrounding production processes as well as characterization of the cells. So I was curious how do those processes differ, if any, from what CRUK is doing?
Brian M. Culley
Thank you, Joe, for that question. I would say that the similarities in the process, they exist, but one of the reasons that we exercise the option is that we saw an opportunity to improve upon those processes. I want to be really clear for everyone listening that each cell type that we try to manufacture demands and requires its own unique set of steps. So we do not have a one-size-fits-all differentiation secret sauce that we apply to different cell types. It really is a laborious effort to figure out how to get these cells to behave in the way that we want so that we're only manufacturing the cells which we desire to be used in the clinic.
So in the setting of the DCs, which we manufacture, we've made great strides in improving the characterization of those cells and some of that data and information has been provided to FDA so that they can see what we would plan to use going forward.
So there definitely are some differences relative to what we were making -- or excuse me, what was being used by CRUK. But at the end of the day, there are release criteria and properties that are consistent across the material. So it's not like it's a different cell type that would necessarily lead to large differences in clinical behavior. We really have been satisfied with the clinical performance. We're looking more to how we can optimize it, how can we scale and get better production costs and make it more affordable and allogeneic off-the-shelf option for patients and how can we increase the potency, perhaps lower the dose. These are all things that we are working on to see if we can improve a product profile in what is otherwise very much a challenging clinical setting.
Joseph Pantginis
That's really helpful. And then just switching over to OPC1. I was hoping to get even some broad strokes at the minimum, the types of questions that have been going back and forth between you and the FDA and how that's translated into what your wish list looks like going into the Type B meeting?
Brian M. Culley
That's a great question. I would say the vast majority of the content in the materials that we've been sharing with the FDA and the questions they've been coming back with have to do with the new device. This is a device that has not been used before for this purpose. And so they have a lot of questions about how it will be used and how it will perform.
What provides us with some comfort and confidence is that the components that actually go into or touch the patient are the same. The cells that are being used are the same as before. The needle is the same type of needle. Everything that's different with the Neurgain device is actually external to the patient.
So I think from a performance perspective, I feel confident that we will have a good outcome from this study. But nevertheless, the FDA is going to be prudent and want to understand how do all these manipulators work, how do they attach, what happens in a fail situation? What's the worst case scenario? Very standard types of information-seeking questions that we've been getting. And I'll ask Gary if there's anything that he -- that comes to mind that he'd like to add to that question, Joe.
Gary S. Hogge
Yes. Just to add that there's nothing unexpected, but many of these are first time in human use when they assembled together as an entire component. And so they want a demonstration of if you pass the cell through, is it still viable and potent ones that goes through the needle and syringe. Are the components -- what's the pH of the components, what's the software look like? They are all questions that we've got to address. Many of them involve very complex detailed reports and analysis, and that's what the back-and-forth questions have been. Nothing unexpected, but many -- much of it takes time.
Operator
Our final question comes from the line of Jason McCarthy from Maxim Group.
Joanne Lee
This is Joanne Lee on the call for Jason. Just 2 around OpRegen. My first one is regarding the recent approval from Apellis, which we noticed was purely based on disease trajectory with no benefit on visual acuity. Now that we've seen a willingness from the FDA to prove based solely on structural changes in geographic atrophy, does the upcoming data at ARVO take a greater importance for OpRegen? And how does this impact the importance of also demonstrating functional benefit in patients with GA?
Brian M. Culley
Thank you for the question, Joanne. I think that the ARVO data is going to be important because there will be parts of that data that have not been shared before. And we're working with a product candidate that is being discussed as being capable of creating anatomical changes far beyond that of the leading candidate and the more recently approved complement inhibitor. So I think any new data on our approach is definitely meaningful to the field.
With respect to the second part of your question, how does it change the calculus on function? I think it's notable that the data from that recently approved asset essentially proves with statistical significance that they do not affect the visual field. So I think that the opportunity to provide a greater clinical benefit in patients is sitting there for the taking for whichever approach and whichever company can find it because the standard of care clearly has -- unquestionably has no effect on visual function. So I see that as a great opportunity, and I think that we are one of the most important contenders to grab that opportunity.
Joanne Lee
Got it. I appreciate the details. And then just given the differences in mechanism behind complement inhibition and retinal restoration, how would you expect a one-and-done treatment like OpRegen could fit in with complement targeting drugs like Empaveli and others. Would this be something patients could perhaps take and then afterwards on a follow-up receive complement inhibition to further prevent damage? Curious to see how you'd imagine OpRegen could be positioned in the treatment landscape?
Brian M. Culley
I imagine myself as a patient looking at 2 product profiles, one that requires a monthly or every other month injection in the eye. And I'm an elderly individual who has difficulty getting to a clinic 6 to 12 times a year and comparing that with a onetime procedure approximately 30 minutes, and I'm awake for it with multiple years, maybe a lifetime of benefit. So I think the product profile just screams preference, but I'm going to invite Dr. Hogge to add to my thoughts.
Gary S. Hogge
I think there's 2 ways you can look at it and both favor, hopefully, patient outcome. OpRegen potentially be used first and then follow up with a complement inhibitor. So if you take care of rest of GA (inaudible) RPE and keep the photoreceptors healthy. And then given it is an aged eye, then complement inhibition may further set up opportunities to succeed and be established for long-term benefit.
Alternately, if you keep complement inhibition first, decreased inflammatory cascade is ongoing, put in OpRegen cells, and they may be even more likely to succeed. But bottom line, the earlier intervention -- the early identification of a much larger patient pool will help both patients and physicians treating them.
Brian M. Culley
Thank you, Joanne. I'm going to actually combine your question a little bit with the question that we got from Kristen Kluska from Cantor because one of the sort of fun ways I think about the complement inhibitor is that it's sort of like one of those tower defense video games where it's slowing a process. So you can imagine there will be more patients in the hot zone, the addressable zone that could be treated by us. So in terms of the utility of OpRegen if a complement inhibitor becomes established, I think, again, you could see a greater number of patients that exist in that addressable patient population spectrum because some of the very early individuals with dry AMD who get on to complement inhibition, if, in fact, they are on for years and there's 20% or so less progression, they might still be within an addressable profile for our product at some point in the future.
Joanne Lee
Great. Appreciate the additional color. Congratulations on all the progress, and we'll be looking forward to the data at ARVO.
Operator
I would now like to turn the call over to Brian Culley for closing remarks.
Brian M. Culley
Well, thank you, everyone. We absolutely and sincerely appreciate your support of Lineage as we look to position ourselves as a leader in cell therapy and cell transplant medicine. Thank you very much for joining the call today, and have a great rest of your week.
Operator
Thank you, ladies and gentlemen. This does conclude today's call. Thank you for your participation. You may now disconnect.
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results to Be Featured at 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Presentation by Eyal Banin, M.D., Ph.D.
CARLSBAD, Calif., March 06, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), will be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2023). The meeting will be held April 23 – 27, 2023 at the Ernest N. Morial Convention Center in New Orleans, LA. The presentation, "Exploratory optical coherence tomography (OCT) analysis in patients with geographic atrophy (GA) treated by OpRegen: Results from the Phase 1/2a trial" will be featured as part of the Paper Session, on April 25, 2023 between 12:30 PM to 12:45 PM MDT, by Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology at Hadassah-Hebrew University Medical Center (presentation number 2826, session number 331). RG6501 (OpRegen) is a retinal pigment epithelium cell transplant therapy currently in development for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). It is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with geographic atrophy secondary to age-related macular degeneration (ClinicalTrials.gov Identifier: NCT05626114).
The Association for Research in Vision and Ophthalmology, Inc. (ARVO) was founded in 1928 in Washington, DC by a group of 73 ophthalmologists. ARVO is the largest and most respected eye and vision research organization in the world. ARVO members include nearly 11,000 researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. For more information, please visit https://www.arvo.org/ or follow the association on Twitter @ARVOInfo.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230306005224/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results and Provide Business Update on March 9, 2023
CARLSBAD, Calif., March 02, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2022 financial and operating results on Thursday, March 9, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, March 9, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call on March 9th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5707771.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230302005045/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://r@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Metaverse Fashion Week 2023 Returning to Tokens.com’s Luxury District
TORONTO, March 01, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that Tokens.com subsidiary, Metaverse Group, will play a major role in Metaverse Fashion Week 2023 (MVFW23). Metaverse Group’s Luxury District within Decentraland will serve as the event’s base, hosting global brands such as Dolce & Gabbana and DKNY. Beyond land rentals, Metaverse Group will be providing in-house design and architectural services to build out digital metaverse experiences for several clients participating in the event.
MVFW23 is scheduled to take place from March 28-31, 2023 spanning across three metaverses including Decentraland, Over, and Spatial, and will be open to all attendees at no cost. The Luxury Fashion District located in Metaverse Group’s Fashion Street Estate is a key destination that will be hosting virtual fashion shows, retail shops selling digital wearables, musical artists, and virtual parties.
Now in its second year, MVFW23 will include more immersive digital experiences hosted by some of the world’s leading fashion houses. Some experiences announced to date are below:
NEWS -- Metaverse Fashion Week 2023 Returning to Tokens.com’s Luxury District
TORONTO, March 01, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that Tokens.com subsidiary, Metaverse Group, will play a major role in Metaverse Fashion Week 2023 (MVFW23). Metaverse Group’s Luxury District within Decentraland will serve as the event’s base, hosting global brands such as Dolce & Gabbana and DKNY. Beyond land rentals, Metaverse Group will be providing in-house design and architectural services to build out digital metaverse experiences for several clients participating in the event.
MVFW23 is scheduled to take place from March 28-31, 2023 spanning across three metaverses including Decentraland, Over, and Spatial, and will be open to all attendees at no cost. The Luxury Fashion District located in Metaverse Group’s Fashion Street Estate is a key destination that will be hosting virtual fashion shows, retail shops selling digital wearables, musical artists, and virtual parties.
Now in its second year, MVFW23 will include more immersive digital experiences hosted by some of the world’s leading fashion houses. Some experiences announced to date are below:
NEWS -- Lineage Enters Into Option and License Agreement With Eterna Therapeutics to Develop Hypoimmune Pluripotent Cell Lines for Multiple Neurology Indications
CARLSBAD, Calif., February 22, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies to replace and restore specific cell types of the human body, today announced that it has entered into an exclusive option and license agreement (the "Agreement") with Eterna Therapeutics Inc. ("Eterna") for the development of novel beta 2 microglobulin (B2M)-deficient induced pluripotent stem cell (iPSC) lines, which Lineage will evaluate for development into differentiated cell transplant therapies. The new cell lines to be developed by Eterna will support the potential creation of additional product candidates at Lineage, specifically for the treatment of certain central nervous system (CNS) disorders and other neurology indications. Eterna is the exclusive licensee of the key intellectual property underlying this collaboration from its discovery partner Factor Bioscience.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230222005324/en/
"This agreement provides the opportunity to combine insights obtained from our dry age-related macular degeneration program with new tools, to broaden the scope of our technology and may help deliver solutions for a wider range of diseases. The engineering of desirable properties into cell lines can also lead to treatments that are highly differentiated from our competitors," stated Brian M. Culley, Lineage’s CEO. "The initial cell lines we envision bringing into the clinic through this agreement will utilize proprietary mRNA-based gene-editing technology developed by Eterna’s CEO, Dr. Matt Angel. It is natural that we would look to introduce aspects of gene editing, hypoimmunity, and additional pluripotent cell lines alongside our existing directed differentiation capabilities in the furtherance of our overall goal of becoming a comprehensive leader in cell therapy."
Under the Agreement, Eterna plans to conduct certain gene-editing activities and provide materials to Lineage for evaluation. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell lines for preclinical, clinical, and commercial purposes in the field of CNS diseases. A feature of the starting cell line is the targeted deletion of the B2M gene, which is designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells. Lineage expects this attribute will expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications. Additional planned gene edits may further differentiate the cell line from others currently in use by competitors. Financial terms were not disclosed.
"The cell therapy expertise demonstrated by Lineage makes them an attractive partner to deploy our mRNA cell engineering platform for the generation of novel gene-edited iPSC lines for neurological applications," said Matt Angel, Ph.D., CEO of Eterna. "At Eterna, we have expertise in creating gene-edited iPSC lines using our extensively patented mRNA cell engineering technologies. We look forward to collaborating with the Lineage team on this project and working with them to develop these powerful tools for the generation of new, intelligently-engineered cell therapy product candidates in the CNS space."
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
About Eterna Therapeutics Inc.
Eterna Therapeutics is a preclinical-stage biotechnology company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines. Eterna has in-licensed a portfolio of over 100 patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSlice™ and UltraSlice™ gene-editing proteins, and the ToRNAdo™ mRNA delivery system from Factor Bioscience. NoveSlice™, UltraSlice™, and ToRNAdo™ are trademarks of Factor Bioscience. For more information, please visit https://www.eternatx.com.
About Factor Bioscience Inc.
Founded in 2011, Factor Bioscience develops technologies for engineering cells to advance the study and treatment of disease. Factor’s gene-editing technologies enable the precise deletion, insertion, and repair of DNA sequences in living cells to correct disease-causing mutations, make cells resistant to infection and degenerative disease, modulate the expression of immunoregulatory proteins to enable the generation of durable allogeneic cell therapies, and engineer immune cells to more effectively fight cancer. Factor’s cell-reprogramming technologies enable the generation of clonal lines of pluripotent stem cells that can be expanded and differentiated into any desired cell type for the development of regenerative cell therapies. For more information, visit https://www.factorbio.com.
Lineage Cell Therapeutics Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our plans to develop new cell lines into differentiated cell transplant therapies and potential product candidates, and the potential indications thereof, including as a result of the Agreement with Eterna; our expectations regarding the utility of edited cell lines, the effect of such cells lines on our overall technology, and any related clinical activities; our ability to differentiate a cell line from those of competitors, to broaden our overall capabilities, to deliver solutions for a wider range of diseases, and to develop treatments that are differentiated from our competitors as a result of the Agreement. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage or Eterna may fail to fully perform under the Agreement or that Lineage, in its sole discretion, may elect not to exercise its option under the Agreement; that the potential benefits of the Agreement, including the potential development of new cell lines into new product candidates may not be realized; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230222005324/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Friday, March 3, 2023, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Feb. 21, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, March 3, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2022.
Conference Call & Webcast
Date: Friday, March 3, 2023
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 664-6383
Dial In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 4947-4770
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 474-770#.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-recent-operational-highlights-301750201.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- FuelPositive’s Team updates on Green Ammonia Converter Progress and Continues System Testing in Extreme Outdoor Weather Conditions
FuelPositive Converter
FP300 Conversion Module Validation
WATERLOO, Ontario, Feb. 17, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) initiated system testing of its on-farm, containerized Green Ammonia production system to test its resilience to extreme outdoor weather conditions in anticipation of deployment in Manitoba, Canada.
Fully Climatized Containerized Modules
Currently, the system components have been operating extremely well under winter conditions. The system is climate controlled and designed to be fully operational between -50 C and +45 C.
“FuelPositive has successfully built our containerized modules as fully climatized systems, capable of working in extreme temperatures, ranging from minus 50 C to plus 45 C. The units are temperature controlled and built to the strictest hazardous area classifications with redundant monitoring. Our systems are engineered to run without any operator intervention or operator input,” stated Nelson Leite, COO of the Company.
Green Ammonia Converter Readiness
We are excited to report further progress with our proprietary and specialty Green Ammonia converters, as shown in the attached image in our lab, as they are being in-house tested for independent third-party validation.
Our Converters play a major role in our systems unique ability to convert input gasses of hydrogen and nitrogen into Green Ammonia in a safe, reliable, and highly efficient manner.
“The converters life cycle is expected to be approximately 30 years and each converter perform at rates that make our system extremely efficient. Our modular design ensures that our Green Ammonia production process operates safely and effectively when dealing with off-grid power fluctuations and peak power versus off-peak power utilization, in real time,” stated Nelson Leite. “The FP300 is the first of its kind in the world and is the culmination of the creativity and engineering skill of many minds. We have assembled a brilliant team that is making a serious impact on this groundbreaking technology every day,” added Leite.
“We continue to run final testing on our various ultra-high purity (UHP) gases with week-after-week of successful testing, in extreme conditions, at our facility in Waterloo. I am very pleased with our progress as all tests have met or exceeded our expectations so far,” said Francisco Mora, Lead Chemical Engineer, in charge of the testing. “We have built our manufacturing and lab from scratch and it’s great to be a part of a company pioneering this important sustainable technology,” added Mora.
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now.
The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer. The Company began accepting pre-sale inquiries in August 2022. See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements. These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Investor inquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media enquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3f248442-aafd-4139-96db-505b0dca0b74
NEWS -- Tokens.com Reports Financial Results for Q1 2023
TORONTO, February 14, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse, and play-to-earn gaming, is pleased to report its financial results for three months ended December 31, 2022 ("Q1-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q1-2023 Operation Highlights:
- Tokens.com’s subsidiary, Metaverse Group Ltd, fully leased its digital real estate in two popular Decentraland neighborhoods. The land was occupied by a diverse collection of esteemed brands and businesses.
- Metaverse Group hosted its first metaverse music festival in Decentraland on its Music Hub property.
- Metaverse Group successfully acquired CocoNFT, an NFT platform for non crypto-native creators.
- Tokens.com and Metaverse Group have partnered with the AIR MILES® Reward Program to become the first brand-agnostic loyalty program of the metaverse.
- Hulk Labs signed a partnership agreement with Aftermath Islands Limited, a controlled subsidiary of Liquid Avatar Technologies.
- Hulk Labs has successfully integrated over a thousand player wallets into its network, with a primary focus on Africa.
- Hulk Labs acquired a validator node license for Splinterlands, one of the longest running and most active play-to-earn games, and entered into a broad partnership with the Splinterlands team.
- Tokens.com liquidated some of its tokens in inventory in favour of holding cash, in consideration of volatile crypto prices and the ongoing turmoil caused by the bankruptcy of FTX and BlockFi.
Management is focused on building its web3 businesses, Metaverse Group and Hulk Labs. Those businesses are focused on innovation in the web3 sector in ways that are not tied to the performance of cryptocurrencies. Both businesses have made great strides in providing corporate and brand partners with new ways to engage their customers.
Metaverse Group and Hulk Labs both became revenue positive in 2022 through focus on innovative services and through building proprietary intellectual property. The Company’s strategy is to limit its crypto exposure to Layer 1 cryptocurrencies such as Ethereum and Polkadot, while also building sustainable and profitable businesses that leverage web3 and blockchain technology. This strategy provides investors with the potential upside in crypto prices and the growing use cases for blockchain technology.
"In 2022, Tokens.com was successful in laying down the foundation for two new operating segments being Metaverse Group and Hulk Labs in the metaverse and gaming sectors, respectively. These subsidiaries are now revenue positive, but still in the very early stages of their growth. For 2023, management is focused on scaling growth within those operations to generate more significant levels of revenue," said Andrew Kiguel, CEO.
Q1-2023 Financial Highlights
- The Company achieved revenue of $152k for the three months ended December 31, 2022, compared to $326k for the three months ended December 31, 2021 ("Q1-2022").
- Total cash and cryptocurrency holdings of $10.4 million, or CAD$13.5 million as of December 31, 2022.
- Staking revenue was $40k for the three months ended December 31, 2022, compared to $216k for the three months ended December 31, 2021.
- Increased Ethereum holdings to 3,273, as of the date of this press release.
- Average gross staking yields of 6.9% for Q1-2023, compared to 4.6% for Q1-2022, due to a change in token mix.
- Metaverse Group continued to gain traction in its metaverse consulting business, with consulting revenue of $85k and lease revenue of $23k during Q1-2023.
- Operating expenses were $718k for the three months ended December 31, 2022, compared to $3.3 million for the three months ended December 31, 2021.
- A non-cash loss on revaluation of its cryptocurrency assets of $1.3 million for Q1-2023, compared to a loss of $829k for Q1-2022. Loss on disposal of digital assets was $102k for the three months ended December 31, 2022, compared to a gain of $1.5 million during the three months ended December 31, 2021.
- A net loss and comprehensive loss for the three months ended December 31, 2022, attributable to Tokens.com, of $1.6 million, compared to net loss of $3.7 million and comprehensive loss of $1.6 million, attributable to Tokens.com, for the three months ended December 31, 2022.
Continuous Disclosure
Further to a review by the staff of the Ontario Securities Commission (the "OSC") of the Company’s continuous disclosure, the Q1-2023 MD&A includes enhanced disclosures with respect to the Company’s staking operations and custody of its assets.
As a result of having to make such enhanced disclosure after the OSC review, the Company has been placed on the public list of Refilings and Errors in accordance with OSC Staff Notice 51-711 (Revised) - Refilings and Corrections of Errors for a period of three years, effective today.
A complete financial reporting package, including the Unaudited Condensed Consolidated Interim Financial Statements and Management’s Discussion & Analysis, is available on our corporate website (www.tokens.com), and the SEDAR website (www.sedar.com).
An investor call has been scheduled to discuss the Company’s Q1-2023 financial results, hosted by CEO Andrew Kiguel, starting at 10:00 am ET on February 15, 2023.
Conference Call Details:
Date: February 15, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_hmo4N8q2RIawvs51C1-nRg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded technology company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse real estate and ecomm3 solutions operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
As a result of each of the three business segments owning digital assets, Tokens.com is required to mark-to-market these digital assets at the end of every reporting quarter. As a result, the Company's financial statements will have non-cash related gains or losses based on the market performance of the digital assets owned from quarter-to-quarter. These non-cash revaluations of owned digital assets do not impact the operations or growth within our business segments. The digital assets are owned for the purpose of generating revenue within each business segment. In some instances, the Company may choose to dispose of certain assets if they no longer meet our ownership criteria.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230214005854/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Reports Financial Results for Q1 2023
TORONTO, February 14, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse, and play-to-earn gaming, is pleased to report its financial results for three months ended December 31, 2022 ("Q1-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q1-2023 Operation Highlights:
- Tokens.com’s subsidiary, Metaverse Group Ltd, fully leased its digital real estate in two popular Decentraland neighborhoods. The land was occupied by a diverse collection of esteemed brands and businesses.
- Metaverse Group hosted its first metaverse music festival in Decentraland on its Music Hub property.
- Metaverse Group successfully acquired CocoNFT, an NFT platform for non crypto-native creators.
- Tokens.com and Metaverse Group have partnered with the AIR MILES® Reward Program to become the first brand-agnostic loyalty program of the metaverse.
- Hulk Labs signed a partnership agreement with Aftermath Islands Limited, a controlled subsidiary of Liquid Avatar Technologies.
- Hulk Labs has successfully integrated over a thousand player wallets into its network, with a primary focus on Africa.
- Hulk Labs acquired a validator node license for Splinterlands, one of the longest running and most active play-to-earn games, and entered into a broad partnership with the Splinterlands team.
- Tokens.com liquidated some of its tokens in inventory in favour of holding cash, in consideration of volatile crypto prices and the ongoing turmoil caused by the bankruptcy of FTX and BlockFi.
Management is focused on building its web3 businesses, Metaverse Group and Hulk Labs. Those businesses are focused on innovation in the web3 sector in ways that are not tied to the performance of cryptocurrencies. Both businesses have made great strides in providing corporate and brand partners with new ways to engage their customers.
Metaverse Group and Hulk Labs both became revenue positive in 2022 through focus on innovative services and through building proprietary intellectual property. The Company’s strategy is to limit its crypto exposure to Layer 1 cryptocurrencies such as Ethereum and Polkadot, while also building sustainable and profitable businesses that leverage web3 and blockchain technology. This strategy provides investors with the potential upside in crypto prices and the growing use cases for blockchain technology.
"In 2022, Tokens.com was successful in laying down the foundation for two new operating segments being Metaverse Group and Hulk Labs in the metaverse and gaming sectors, respectively. These subsidiaries are now revenue positive, but still in the very early stages of their growth. For 2023, management is focused on scaling growth within those operations to generate more significant levels of revenue," said Andrew Kiguel, CEO.
Q1-2023 Financial Highlights
- The Company achieved revenue of $152k for the three months ended December 31, 2022, compared to $326k for the three months ended December 31, 2021 ("Q1-2022").
- Total cash and cryptocurrency holdings of $10.4 million, or CAD$13.5 million as of December 31, 2022.
- Staking revenue was $40k for the three months ended December 31, 2022, compared to $216k for the three months ended December 31, 2021.
- Increased Ethereum holdings to 3,273, as of the date of this press release.
- Average gross staking yields of 6.9% for Q1-2023, compared to 4.6% for Q1-2022, due to a change in token mix.
- Metaverse Group continued to gain traction in its metaverse consulting business, with consulting revenue of $85k and lease revenue of $23k during Q1-2023.
- Operating expenses were $718k for the three months ended December 31, 2022, compared to $3.3 million for the three months ended December 31, 2021.
- A non-cash loss on revaluation of its cryptocurrency assets of $1.3 million for Q1-2023, compared to a loss of $829k for Q1-2022. Loss on disposal of digital assets was $102k for the three months ended December 31, 2022, compared to a gain of $1.5 million during the three months ended December 31, 2021.
- A net loss and comprehensive loss for the three months ended December 31, 2022, attributable to Tokens.com, of $1.6 million, compared to net loss of $3.7 million and comprehensive loss of $1.6 million, attributable to Tokens.com, for the three months ended December 31, 2022.
Continuous Disclosure
Further to a review by the staff of the Ontario Securities Commission (the "OSC") of the Company’s continuous disclosure, the Q1-2023 MD&A includes enhanced disclosures with respect to the Company’s staking operations and custody of its assets.
As a result of having to make such enhanced disclosure after the OSC review, the Company has been placed on the public list of Refilings and Errors in accordance with OSC Staff Notice 51-711 (Revised) - Refilings and Corrections of Errors for a period of three years, effective today.
A complete financial reporting package, including the Unaudited Condensed Consolidated Interim Financial Statements and Management’s Discussion & Analysis, is available on our corporate website (www.tokens.com), and the SEDAR website (www.sedar.com).
An investor call has been scheduled to discuss the Company’s Q1-2023 financial results, hosted by CEO Andrew Kiguel, starting at 10:00 am ET on February 15, 2023.
Conference Call Details:
Date: February 15, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_hmo4N8q2RIawvs51C1-nRg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded technology company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse real estate and ecomm3 solutions operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
As a result of each of the three business segments owning digital assets, Tokens.com is required to mark-to-market these digital assets at the end of every reporting quarter. As a result, the Company's financial statements will have non-cash related gains or losses based on the market performance of the digital assets owned from quarter-to-quarter. These non-cash revaluations of owned digital assets do not impact the operations or growth within our business segments. The digital assets are owned for the purpose of generating revenue within each business segment. In some instances, the Company may choose to dispose of certain assets if they no longer meet our ownership criteria.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230214005854/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call on February 23, 2023
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, announced that the Company will report fourth quarter and full year 2022 financial results on Thursday, February 23, 2023, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the 'For Investor' section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics, Inc.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM trial; possible negative effects of 186RNL; the continued evaluation of 186RNL for LM including through evaluations via a second patient cohort; capital requirements, timing and speed of development; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; changes in the CPRIT program; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- FuelPositive Provides Update on Progress of its Farm Ready Green Ammonia System and Sales Pipeline
WATERLOO, Ontario, Feb. 10, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) provided an update today on the progress of its on-farm, containerized Green Ammonia production system and its current Sales Pipeline for 2023 and beyond.
System Readiness
System preparation - safety protocols and testing - certification.
FuelPositive is happy to announce that its on-farm, containerized Green Ammonia production system is now over 80% complete and its farm readiness impending, having overcome global supply chain delays the Company faced throughout 2022.
Both the hydrogen and nitrogen input modules are now fully operational, farm ready and are surpassing both quantity output and purity targets.
Nelson Leite, COO and Board Director stated: “We are thrilled with the near farm readiness of the system today. Final factory commissioning of our proprietary Green Ammonia synthesis module is currently underway, and the system will be producing Green Ammonia as soon as all safety certifications are completed. As illustrated in the the photograph below, our on-farm containerized Green Ammonia system is now a commercial scale, 100 tonne per year, highly engineered system that is monitored and controlled at over 140 points, which allows FuelPositive to measure and ensure, in real-time, the most optimal operating parameters, on-site.”
Green Ammonia synthesis module
Martin Cina, Director of Project Execution and Nelson Leite, COO – next to FuelPositive proprietary Green Ammonia synthesis module
“Additionally, the system is so robustly engineered that we expect the service life of our systems to be measured in decades, beyond the anticipated 30-year mark. In other words, these are permanent on-site systems, that will be producing Green Ammonia at a steady rate of supply and stable cost to the end-user for decades,” added Leite.
Farm Readiness
Site preparation: “We are working closely with the Hiebert’s, our first pilot system recipients. They are ready and excited to welcome their first FuelPositive system on farm and they have completed the necessary permitting and site configuration for the shipment and installation of our first pilot. We will provide further updates as we prepare to deliver and commission our technology in Manitoba,” said Leite
Sales Pipeline
Qualified sales leads have surpassed expectations.
“We’ve deliberately held off on announcing any progress on our sales pipeline up until this point. We wanted to ensure that we had a critical mass of interest that was relevant to report to our stakeholders.” Stated Ian Clifford, CEO and Board Chair. “I’m very pleased to say that we have reached that point! With over 100 inquiries coming in from around the world, as of today we have jointly prequalified 42 of those who are fully matched to receive one or more of our systems. Obviously, we cannot meet that level of demand within the next 12 months in our current facilities, with our existing infrastructure, but it’s a good problem to have! That means that we are now planning for heavy batch manufacturing in our current facilities, with the intention of building towards high output serial production in a purpose-built facility, as soon as practical,” continued Clifford.
FuelPositive’s pre-qualification criteria includes such factors as: type of farming; crop mix; types of nitrogen fertilizers utilized in the past, present and future; sources of green electricity; cost of green electricity; and other specific geographic and political considerations for the integration of our technology on site. The FP300 produces 300KG a day, or just over 100 metric tonnes of Green Anhydrous Ammonia per year on a base model system, with most sales inquiries requiring multiple systems.
“The demand for FuelPositive’s scalable and modular Green Ammonia Technology is not exclusively within the realm of agriculture. We have interest coming in from multiple sectors, including marine, aviation, chemical processing, grid storage, Northern remote and rural communities, and water purification,” added Clifford.
New Corporate & Sales Headquarters
As previously announced, FuelPositive has opened corporate offices at 420 Weber Street in Waterloo, Ontario which will serve as the corporate and sales headquarters. “Staff have now expanded into this modern space, situated just blocks from our manufacturing facility and steps away from Laurier University and University of Waterloo with whom we work closely,” said Nelson Leite. “This will provide us with more room to grow as we build our sales and engineering teams.”
Manufacturing and R&D Lab Open & Completed
The initial manufacturing facility and R&D lab at 99 Northland in Waterloo, Ontario is fully operational. The final validation of FuelPositive’s scalable and modular Green Ammonia Technology is being conducted there, and batch manufacturing will be carried out at 99 Northland until the Company is ready to move to the larger, purpose-built manufacturing facility.
Announced in August 2022, FuelPositive has identified a site near its Waterloo facilities where it will be custom-building a factory with its land development partner. It will be a large, state-of-the-art facility, up to 140,000 square feet, and will meet the Company’s needs when it switches from batch manufacturing to serial or assembly line manufacturing.
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized green ammonia (NH3) production system that eliminates carbon emissions from the production of green ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now.
The FuelPositive on-farm/onsite, containerized green ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for green ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
The Company began accepting pre-sale inquiries in August 2022. See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media enquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/93356148-7247-4ef9-acdd-9442598fa4a6
NEWS -- Tokens.com to Release its Financial Results for Q1-2023 on February 14, 2023
TORONTO, February 10, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to share that it will release its financial results for the three months ended December 31, 2022 ("Q1 2023") on Tuesday February 14th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q1 2023 financial results starting at 10:00 am ET on February 15th, 2023.
Date: February 15th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_hmo4N8q2RIawvs51C1-nRg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modelling and game development studio. Crypto gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230210005046/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com to Release its Financial Results for Q1-2023 on February 14, 2023
TORONTO, February 10, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to share that it will release its financial results for the three months ended December 31, 2022 ("Q1 2023") on Tuesday February 14th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q1 2023 financial results starting at 10:00 am ET on February 15th, 2023.
Date: February 15th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_hmo4N8q2RIawvs51C1-nRg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modelling and game development studio. Crypto gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230210005046/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Lineage Provides Update on Auditory Neuronal Cell Transplant Program for the Treatment of Hearing Loss
CARLSBAD, Calif., February 08, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on its auditory neuronal cell therapy program (ANP1), for the treatment of hearing loss, with an initial focus on auditory neuropathy spectrum disorders. Preclinical testing of ANP1 has begun through a collaboration with the University of Michigan and Yehoash Raphael, Ph.D., The R. Jamison and Betty Williams Professor of Otolaryngology, Department of Otolaryngology-Head and Neck Surgery and Lab Director at the University of Michigan Kresge Hearing Research Institute. Dr. Raphael will serve as Principal Investigator and direct initial preclinical testing in collaboration with the company. Hearing loss is a significant unmet medical need, and by 2050, nearly 2.5 billion people are estimated to be impacted by listening impairments across the globe.
"ANP1 is an internally-developed program and which we believe is illustrative of the efficiency and versatility of our technology," stated Brian Culley, Lineage CEO. "In less than one year, we created new methods of differentiation which successfully advanced a new product candidate from the concept stage to the successful manufacture of a discrete cell type at clinically testable scale. Along the way, we generated new intellectual property and advanced that product candidate into preclinical testing. This new pipeline program was created with less than $1.0 million of investment from our R&D budget and without the use of third party grants or intellectual property. This efficiency comes in part from the extensive experience we gained from our prior development of other cell types. With each new cell type we derive, our in-house expertise grows and we elucidate some of the secrets of differentiation kinetics across various lineages. Moreover, because our pipeline assets are pre-validated, meaning they are specific cell types known to perform defined tasks in the human body, we mitigate certain risks and inefficiencies of working on targets with low clinical relevance. We believe our insights and capabilities provide us with a leading position in the cell transplant space."
Dr. Raphael added, "Patients with sensorineural hearing loss due to absence of auditory neurons cannot benefit from cochlear implants. Despite extensive efforts using traditional molecular approaches or more recently, gene therapy, there still are no FDA-approved pharmacological options for these patients. ANP1 takes a different approach: it targets the auditory nerve with an allogeneic population of replacement cells to replace the missing auditory neurons. This offers a novel and potentially more clinically measurable effect than narrow and targeted methods. Rather than changing just one gene or one pathway, replacing the entire cell may be more broadly applicable across a large number of patients. There are many questions to answer, and I am excited to be working with Lineage on this bold new initiative for the potential betterment of the hearing in patients with auditory neuropathies."
Dr. Raphael is an expert in hearing loss research whose interests include inner ear biology, protection and regeneration, gene therapy, genetic deafness and stem cell therapy. Research interests in his lab include repair and regeneration in the inner ear, tissue engineering technologies as applied to the cochlea and vestibular organs, and hereditary deafness. Dr. Raphael is the recipient of numerous awards and honors and has published extensively in the area of hearing loss, with more than 200 publications.
Auditory neuropathy is a challenging hearing disorder in which the inner ear successfully detects sound but has a problem with sending signals from the ear to the brain, currently accounting for approximately 10% of cases of sensorineural hearing loss (SNHL) in children. Current state of the art medical knowledge suggests that auditory neuropathies play a substantial role in hearing impairments and deafness. Hearing depends on a series of complex steps that change sound waves in the air into electrical signals. The auditory nerve then carries these signals to the brain. Auditory neuropathy can be caused by a number of factors including damage to the auditory neurons or loss of these neurons. Researchers are still seeking effective treatments for those affected with auditory neuropathy.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential use of ANP1 for the treatment of hearing loss; the broad potential for Lineage’s regenerative medicine platform and Lineage’s ability to advance and expand the same, including Lineage’s ability to manufacture new specific and differentiated cell types on anticipated timelines and budgets; and the potential for Lineage’s investigational allogeneic cell therapies to generate clinical outcomes beyond the reach of traditional methods and provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: unexpected safety or efficacy data observed during preclinical trials; changes in expected or existing competition; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Disclaimer: Title provided for identification purposes only. The views and opinions expressed are those of the individual only and do not necessarily reflect the positions of the University of Michigan.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230208005248/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics Completes Enrollment in Second ReSPECT-LM Phase 1 Trial Cohort of Rhenium (¹86Re) Obisbemeda for the Treatment of Leptomeningeal Metastases
Topline feasibility, safety and biological response data from Phase 1/Part A anticipated in the second half of 2023
AUSTIN, Texas, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced completion of enrollment in Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM).
“Based on the significant clinical need in LM and promising early data, we continue to see increasing interest from top U.S. cancer centers in the ReSPECT-LM Phase 1/2a trial,” said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. “Next steps, following the Data and Safety Monitoring Board (DSMB) review anticipated next month, will be completing enrollment in the Phase 1/Part A, followed by a meeting with the U.S. FDA to consider dose expansion in the Phase 1/Part B trial. Additionally, initial data from the Phase 1/Part A is anticipated in the second half of 2023.”
At the 2022 Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), Plus Therapeutics presented Phase 1 data from the ReSPECT-LM trial demonstrating that a single administered dose of rhenium (186Re) obisbemeda was feasible, safe and well-tolerated across two dosages in four patients from Cohorts 1 and 2, with patients experiencing a decreased cerebrospinal fluid tumor cell count at 48 hours following treatment of 46% to 92%.
The ReSPECT-LM trial (NCT05034497) is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose, maximum feasible dose, safety and efficacy of a single administration of rhenium (186Re) obisbemeda via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.
The U.S. Food and Drug Administration has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. ReSPECT-LM is funded by a three-year $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the disease spreads to the cerebrospinal fluid (CSF) and central nervous system that can originate from solid tumors, primary brain tumors, or hematological malignancies. Breast cancer is the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Lung cancer and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with one-year and two-year survival of just 7% and 3% respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Nanomix Appoints Finance Veteran Chris Hetterly as Chief Financial Officer
SAN LEANDRO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in mobile, affordable, point-of-care (POC) diagnostics, today announced the appointment of Christopher R. Hetterly as Chief Financial Officer (CFO).
Mr. Hetterly is a financial executive and entrepreneur, with over 25 years of financial leadership and banking experience. Previously, Mr. Hetterly was the CFO of Octagos Health, a healthcare Software-as-a-Service (SaaS) company. Prior to that, he was a CFO at Madrona Ventures portfolio companies. Mr. Hetterly was the Head of Technology Finance at GE Capital, Wells Fargo, and East West Bank, in addition to being CFO/CIO at Palo Alto Capital. He has raised capital from seed stage to IPO and beyond, and has experience in debt and equity financing, corporate development, business development, with particular expertise in building finance teams and leading in high growth environments. Mr. Hetterly has raised over $10 billion in capital in his career for well-known names such as eBay, Netflix and Symantec amongst others, and his financing experience includes venture capital, corporate, mezzanine, lease, bank credit line, LBO, IPO and secondary public sources. He graduated from Brown University with a BA from the Honors Program.
Thomas Schlumpberger, Nanomix CEO, stated, “We are excited to welcome Chris to the Nanomix management team as our CFO. Chris has more than 25 years in senior financial roles encompassing debt and equity financing, corporate development, and business development. His experience and leadership will be invaluable as we work to establish our technology as a standard of care in POC diagnostics.”
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nanomixdx.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304