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NEWS -- Navidea Biopharmaceuticals, Inc. Announces NYSE American’s Decision to Suspend Trading In Its Common Stock
The Company announced today that the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the NYSE American LLC upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. The company maintains strategic focus on its Fix, Fund, Propel approach.
DUBLIN, Ohio, October 06, 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 that the Listings Qualifications Panel (the "Panel") of the Committee for Review of the Board of Directors of the NYSE American LLC (the "Committee") upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. Accordingly, the staff of NYSE Regulation has suspended trading in the common stock of Navidea from the NYSE American. The Company anticipates that its common stock will begin trading on the over-the-counter (OTC) markets.
The Company has a right to request a review of the Panel’s decision to delist the common stock by the Committee by making a written request within 15 calendar days of the date of the Panel’s decision. The filing of an application with the Securities and Exchange Commission to delist the common stock is pending completion of all applicable procedures, including any appeal by the Company of the Panel’s decision. The Company is in the process of determining whether to request a review of the Panel’s decision.
In the event the Company’s common stock is delisted, the Company will continue to be a Securities and Exchange Commission ("SEC") reporting company. The Company may then also consider relisting its common stock on a national securities exchange in the future if the Company determines that doing so is in the best interest of the Company and its stockholders. The Panel’s decision does not affect Navidea’s business operations.
"We are respectful of the process and the perspective of the Exchange’s staff and Listings Qualifications Panel," said Craig A. Dais, Navidea’s Chief Financial Officer. "We also believe in the progress the Company continues to make, and the impact of the changes being made to move the Company forward. We will maintain our focus on exploring all strategic options which advance us toward the Company’s objectives, including continuing active discussions focused on licensing partnerships and other non-dilutive capital raise options, in order to meet the Company’s business goals and deliver value to our stockholders."
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 the Company’s progress, strategic options, business goals, 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 common stock is subject to delisting from the NYSE American under a currently pending delisting proceeding; 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/20231005935545/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results Show Evidence of Rapid Improvement of Outer Retinal Structure in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
CARLSBAD, Calif., October 05, 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 the results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), which were reviewed by multiple, independent reviewers, were presented at the 23rd EURETINA Congress. The presentation, "Time to retinal structure improvements following OpRegen subretinal delivery in patients with geographic atrophy (GA)," was presented by Adiel Barak, M.D., Professor of Ophthalmology, Vitreoretinal Unit Director, Tel Aviv Medical Center, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. 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 GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
"We are extremely pleased to see these additional observations of rapid improvements to outer retinal structure in the initial clinical study of OpRegen. These data suggest that OpRegen RPE cells may provide direct support to the patients’ remaining retinal cells within atrophic areas, and that the improvements to retinal structure can be detected within the first three months following a single administration. We look forward to additional, future clinical data updates on the OpRegen program from our partners, Roche and Genentech," stated Brian Culley, CEO of Lineage.
23rd EURETINA Congress Highlights:
All 5 patients enrolled in cohort 4 who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension, demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first 3 months after treatment.
NEWS -- Tokens.com Launches Yeti - A Web3 Gaming Dashboard
TORONTO, October 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that builds products and services that connect brands to consumers in 3D internet environments, is pleased to announce that its subsidiary, Hulk Labs ("Hulk"), has launched "Yeti" www.theyeti.gg. Yeti is a web3 gaming dashboard that provides advanced gaming analytics designed to maximize players' earnings. Additionally, Yeti is an early mover in offering ‘data as a service’ for the web3 gaming industry.
Yeti is targeted at web3 gamers, a user base that is estimated to grow as large as 100 million by 2025, according to CitiGPS. The overall global video game industry is estimated to generate over $170 billion annually, which is estimated to surpass the combined revenues of the Music and Film industries. It is expected that in the next 12 months there will be a vast number of web3 games launched. Yeti’s goal is to be the primary source of information for web3 games and the primary source for players to track their in-game performance.
"With the rapid growth occurring in the web3 gaming community, we have identified a gap in the market for analytical information on these games to support players and game developers," said Andrew Kiguel, CEO of Tokens.com. "We believe our technology in this area is the first of its kind and provides us with excellent exposure to Web3 gaming, the next big opportunity in the entertainment industry."
Web3 games are built upon open marketplaces and networks where users are in control of their in-game items, land and tokens; often creating small economies within the game powered by tokens and digital assets. Management sees an opportunity for Yeti to merge the Public Blockchain data with private in-game data, providing deeper insights to players, a value added data service to game developers and AI applications. TheYeti.gg gaming dashboard enables players to see in-game analytics and model out future outcomes. Over time, TheYeti.gg will also enable game developers to monetize their in-game data.
Join the Hulk team on X this Thursday October, 5 at 4:30 EST to learn more. Follow the link to join X Spaces https://x.com/i/spaces/1yoKMwvRARXJQ.
To learn more visit https://www.theyeti.gg and https://www.hulklabs.com. For developers and players interested in getting involved mailto://contact@tokens.com.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centers, and 3D branded content, ii) web2 and web3 game development and game analytics, and ii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs (Or "Hulk"), is a web3 gaming studio, with a focus on 3 key areas: i) Web3 game economics and branded games for clients. ii) Data analytics via the creation of a web3 gaming dashboard for players. iii) The creation of unique mobile games. With an estimated 3.2 billion gamers globally, and growing daily, Hulk Labs is positioned itself to be ahead of the shift in gaming as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games. Additionally, Hulk offers expert consultation services in web3 gaming to brands seeking to tap into this exciting space. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses. Hulk Labs operates at the forefront of the web3 gaming revolution.
Stay up to date and connect with us on X.
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 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/20231005579147/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 Launches Yeti - A Web3 Gaming Dashboard
TORONTO, October 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that builds products and services that connect brands to consumers in 3D internet environments, is pleased to announce that its subsidiary, Hulk Labs ("Hulk"), has launched "Yeti" www.theyeti.gg. Yeti is a web3 gaming dashboard that provides advanced gaming analytics designed to maximize players' earnings. Additionally, Yeti is an early mover in offering ‘data as a service’ for the web3 gaming industry.
Yeti is targeted at web3 gamers, a user base that is estimated to grow as large as 100 million by 2025, according to CitiGPS. The overall global video game industry is estimated to generate over $170 billion annually, which is estimated to surpass the combined revenues of the Music and Film industries. It is expected that in the next 12 months there will be a vast number of web3 games launched. Yeti’s goal is to be the primary source of information for web3 games and the primary source for players to track their in-game performance.
"With the rapid growth occurring in the web3 gaming community, we have identified a gap in the market for analytical information on these games to support players and game developers," said Andrew Kiguel, CEO of Tokens.com. "We believe our technology in this area is the first of its kind and provides us with excellent exposure to Web3 gaming, the next big opportunity in the entertainment industry."
Web3 games are built upon open marketplaces and networks where users are in control of their in-game items, land and tokens; often creating small economies within the game powered by tokens and digital assets. Management sees an opportunity for Yeti to merge the Public Blockchain data with private in-game data, providing deeper insights to players, a value added data service to game developers and AI applications. TheYeti.gg gaming dashboard enables players to see in-game analytics and model out future outcomes. Over time, TheYeti.gg will also enable game developers to monetize their in-game data.
Join the Hulk team on X this Thursday October, 5 at 4:30 EST to learn more. Follow the link to join X Spaces https://x.com/i/spaces/1yoKMwvRARXJQ.
To learn more visit https://www.theyeti.gg and https://www.hulklabs.com. For developers and players interested in getting involved mailto://contact@tokens.com.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centers, and 3D branded content, ii) web2 and web3 game development and game analytics, and ii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs (Or "Hulk"), is a web3 gaming studio, with a focus on 3 key areas: i) Web3 game economics and branded games for clients. ii) Data analytics via the creation of a web3 gaming dashboard for players. iii) The creation of unique mobile games. With an estimated 3.2 billion gamers globally, and growing daily, Hulk Labs is positioned itself to be ahead of the shift in gaming as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games. Additionally, Hulk offers expert consultation services in web3 gaming to brands seeking to tap into this exciting space. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses. Hulk Labs operates at the forefront of the web3 gaming revolution.
Stay up to date and connect with us on X.
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 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/20231005579147/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 -- Theriva Biologics to Participate in the Emerging Growth Conference
ROCKVILLE, Md., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that Company’s Management will provide a corporate update and participate in one-on-one investor meetings at the Emerging Growth Conference, to be held virtually from October 4-5, 2023.
The Emerging Growth Conference
Format: Corporate presentation and one-on-one investor meetings
Presentation Date: Thursday, October 5, 2023
Presentation Time: 9:40 AM ET
Registration Link: click here
The webcast of the presentation will also be available through the conference portal and on the Emerging Growth YouTube Channel. The replay of the presentation will be accessible in the “Investors” section of the company’s website, https://www.therivabio.com, under “Events.”
About Theriva Biologics, Inc.
Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
Source: Theriva Biologics, Inc.
NEWS -- THE PANCREATIC CANCER ACTION NETWORK SELECTS ONCOLYTICS BIOTECH® INC. TO RECEIVE $5 MILLION THERAPEUTIC ACCELERATOR AWARD TO DEVELOP LEADING-EDGE TREATMENTS
Innovative Multimillion-Dollar Grant Was Created in 2022 to Drive Biopharma Industry to Speed Development of Pancreatic Cancer Therapies
BOSTON and SAN DIEGO and CALGARY, AB, Sept. 26, 2023 /PRNewswire/ -- In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network (PanCAN) today announced Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC) as the recipient of its second annual PanCAN Therapeutic Accelerator Award. Oncolytics received this award in recognition of its promising work on pelareorep, an investigational immunotherapy treatment that introduces double-stranded RNA into cancer cells, which stimulates anticancer inflammatory effects, including innate and adaptive immune responses and the activation and recruitment of T cells into the tumor. This $5 million grant will enable Oncolytics to continue the next stage of its research focused on a clinical trial with Oncolytics' proprietary reovirus pelareorep in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. If results are encouraging, the treatment combination may be advanced to late-stage clinical development through the PanCAN Precision PromiseSM adaptive clinical trial platform.
The Pancreatic Cancer Action Network (PanCAN) is dedicated to fighting the world’s toughest cancer. In our urgent mission to save lives, we attack pancreatic cancer on all fronts: research, clinical initiatives, patient services and advocacy. Our effort is amplified by a nationwide network of grassroots support. We are determined to improve outcomes for today’s patients and those diagnosed in the future. (PRNewsfoto/Pancreatic Cancer Action Network)
The combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab was granted Fast Track designation by the FDA last year and has already been selected for inclusion in the Precision Promise clinical trial platform, which is anticipated to open in early 2024. Testing pelareorep in combination with FOLFIRINOX expands the approach so all patients with advanced pancreatic cancer could have the opportunity to benefit from this innovative immunotherapeutic approach.
The announcement of the Therapeutic Accelerator Award is being made in advance of PanCAN's annual Scientific Summit in Boston, which brings together PanCAN's Community for Progress, including research grant recipients, Scientific and Medical Advisors, industry partners and special guests to share ideas and build collaboration. Oncolytics was selected to receive the 2023 PanCAN Therapeutic Accelerator Award for $5 million through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.
Pancreatic cancer is notoriously aggressive and hard to treat. Current estimates suggest that the disease will be the second leading cause of cancer-related deaths in the United States before 2030. Most people with pancreatic cancer are diagnosed at a late stage when their tumor is inoperable, leaving these patients with few treatment options. And because the disease is significantly more resistant to chemotherapy than other cancers, it can even be difficult to treat in its earliest stages. Despite the fact that there is an urgent need for better outcomes for pancreatic cancer, research is often not prioritized because pancreatic cancer affects a relatively small population compared to other cancers, and clinical research can be risky and expensive.
"Today's five-year survival rate of 12% is too low and we need new treatment options now," said PanCAN Chief Science Officer Lynn Matrisian, PhD, MBA. "PanCAN launched our own clinical program to de-risk companies' investment through both the Therapeutic Accelerator Award and the Precision Promise platform to facilitate rapid advances in this disease."
PanCAN continues to take bold actions to improve the lives of everyone impacted by pancreatic cancer, including the investment of more than $208 million since 2003 to advance scientific research. PanCAN created the multimillion-dollar Therapeutic Accelerator Award in 2022 as a research investment focused on supporting companies working on new pancreatic cancer therapies that plan to conduct early-stage (Phase 1 and 2) clinical trials for these therapies.
"Oncolytics is so pleased to receive this innovative award and have the opportunity to work with PanCAN," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting. By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
Oncolytics plans to utilize the grant funding to study pelareorep in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic cancer who have not received prior cancer treatment. In addition, a separate group of patients will receive this combination along with a checkpoint inhibitor to verify synergies previously observed in this patient population. The goal of this research is to evaluate the safety and efficacy of these combination therapies. Efficacy will be assessed by measuring the effect of the treatments on tumor size, progression-free survival, and overall survival. In addition, immune responses to treatment will be assessed.
The funding offered through the PanCAN Therapeutic Accelerator Award represents an innovative and groundbreaking way for a non-profit to accelerate drug development. If the result of the clinical trial is positive, the hope is that the selected investigational treatment combination will be incorporated into the PanCAN Precision Promise adaptive clinical trial. While Precision Promise provides an effective approach for late-stage research on new pancreatic cancer therapies, many companies are not investing in the early-stage research necessary for late-stage studies and potential drug approval in this disease.
To learn more about PanCAN's research investments, visit https://pancan.org.
About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Media Contacts:
Charaighn Sesock
Public Relations
Pancreatic Cancer Action Network
Direct: 559-972-4877
mailto://charaighn@gmail.com
Jillian Scholten
Senior Manager, Public Relations
Pancreatic Cancer Action Network
Direct: 310-706-3360
Email: mailto://jscholten@pancan.org
Jon Patton
Director of IR & Communication
Oncolytics Biotech, Inc.
858-886-7813
mailto://jpatton@oncolytics.ca
View original content to download multimedia: https://www.prnewswire.com/news-releases/the-pancreatic-cancer-action-network-selects-oncolytics-biotech-inc-to-receive-5-million-therapeutic-accelerator-award-to-develop-leading-edge-treatments-301938335.html
SOURCE Pancreatic Cancer Action Network
NEWS -- FuelPositive is Making Ammonia!
Highlights:
WATERLOO, Ontario, Sept. 19, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) announces third-party certification of initial ammonia output. FuelPositive, a leading Green Ammonia company, has successfully completed a pivotal milestone with its commercial model FP300 system start-up and activation of catalyst, making the FP300 the first decentralized, containerized, operational Green Ammonia system in the world.
Over the past two weeks of operation and evaluation, the system operated flawlessly at maximum activation temperatures and pressures. The Company ensured its internal and industry safety protocols and risk mitigation practices were adhered to at every step.
Five samples of produced ammonia were collected at random times during the evaluation period. The samples were collected at the takeoff point of the systems separator and sent to Ortech Consulting Inc., a third-party testing laboratory in Toronto, Canada.
The third-party testing laboratory, Ortech Consulting Inc., confirmed FuelPositive’s internal mass spectrometer readings, indicating that each random sample of anhydrous ammonia was exactly on target. The results were consistent throughout the samples. Both the conversion rates and volume output exceeded the Company’s expectations.
Nelson Leite, Chief Operating Officer and Director, stated, “We are excited to report that we have completed a key initial validation of our full-scale ammonia pilot system. For this initial evaluation period, to follow safety protocols, we ran one converter at 50% catalyst density, with a set target of anhydrous ammonia output. The results, which were internally and third-party validated, confirmed that our target conversion rates and volume output of anhydrous ammonia were exceeded by 17%.”
Nelson Leite continued, “The next step for FuelPositive, currently underway, is to run the system at full catalyst density across all five converters to achieve the final stages of system validation. Once this step is completed, it will be third-party validated and disclosed. A Factory Acceptance Test (FAT) is the planned final step before farm readiness.”
Ian Clifford, Chief Executive Officer and Chair, stated, “At this watershed moment, with great gratitude and pride, we celebrate our team for the successful initial output of anhydrous ammonia, making the FuelPositive FP-300 the first decentralized, containerized, commercial-scale system of its kind. This is the moment in the evolution of the Company we have all been working towards and we are overjoyed to share this news with all our supporters today.”
Ian Clifford continued, “Everyone involved has been working tirelessly over the last several years to bring FuelPositive’s new technology from concept to commercialization. We are very proud to have successfully navigated and overcome Covid-related supply chain issues, challenging global capital markets and various delays brought on by regulatory approvals.”
Ian Clifford concluded, “The production of traditional gray ammonia is one of the most polluting manufacturing and distribution processes on the planet;1 paradoxically, ammonia, as a nitrogen fertilizer, is needed to feed our ever-growing world population. FuelPositive understands global food security, and, as a result, we made conscious choices to lead toward a sustainable future in agriculture and other critical sectors. This is why FuelPositive’s decentralized Green Ammonia system and business model stands alone, reframing the status quo of a multi-billion-dollar commodity industry.”
Nelson Leite added, “It’s extraordinary to consider where we are today in developing our innovative technology. Two years ago, when I joined the company, we were a small, dedicated group intensely focused on bringing our technology to market. In the ensuing months, we built a world-class technology and manufacturing team. Today, we announce that we have successfully operated FuelPositive’s core technology and first commercial system.”
Nelson Leite concluded, “Starting up the full-scale commercial system and producing pure anhydrous ammonia at an efficiency and conversion rate well beyond our expectations has been inspiring. These achievements confirm the capacity of our team and technology to meet the demands of customers around the world.”
Luna Clifford, Director of Strategic Partnerships, commented, “Since January 2021, we’ve grown alongside our technology and attracted respected team members, advisors and consultants who share our vision and mission. As we grow our relationships and our markets, we will continue to work with like-minded people and organizations in multiple sectors to mindfully address worldwide greenhouse emissions.”
Luna Clifford concluded, “FuelPositive's success will provide a platform for a wide range of strategic commercial, environmental, and social initiatives in line with our mission and values. The technology is innovative, the business model is transformative, and our mission and values are deeply impactful.”
Demonstration Project Partner and farmer Curtis Hiebert of eAcres Inc. stated, “This is the good news Canadian farmers have been waiting for! My family and I are relieved that FuelPositive has reached this important milestone towards the commercialization of its green ammonia technology. Canadian farmers have faced extreme fertilizer supply chain challenges caused both by price and supply uncertainty.2 Having the means to produce the fertilizer we need on the farm, when needed and at a price we can rely on, will significantly reduce our family’s concerns.”
Curtis Hiebert concluded, “In the past 50 years of using anhydrous ammonia as a nitrogen fertilizer, my family and I haven't seen a company near as passionate about what green ammonia can do as FuelPositive.”
FuelPositive to Host Live Corporate Update Webinar
FuelPositive’s CEO and Chair, Ian Clifford, and COO and Director, Nelson Leite, will be hosting a webinar to discuss current operations and upcoming milestones, followed by Q&A. You may submit your question(s) beforehand in the registration form linked below.
Date: Tuesday, September 26th, 2023
Time: 2pm ET
Webinar Registration
______________________
1 https://cen.acs.org/environment/green-chemistry/Industrial-ammonia-production-emits-CO2/97/i24
2 https://www.agcanada.com/daily/fertilizer-shortage-may-lead-to-spring-scramble
For further information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
416-535-8395
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital
mailto://et@transcendcapitalinc.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.
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 with respect to further testing and implementation of the FP300 system, 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.
NEWS -- Oncolytics Biotech® Announces Fireside Chat at the Cantor Global Healthcare Conference
SAN DIEGO and CALGARY, AB, Sept. 19, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced its participation in an analyst-led fireside chat at the Cantor Global Healthcare Conference 2023 with Chief Executive Officer Dr. Matt Coffey. The conference is taking place September 26-28, 2023 at the InterContinental Barclay Hotel in New York, NY. Additional details on the fireside chat can be found below.
Date: Wednesday, September 27, 2023
Time: 8:35 a.m. ET
Location: InterContinental Barclay Hotel New York, Track 1
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Cantor Fitzgerald representative, or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational 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
NEWS -- Lineage to Present at Cantor Fitzgerald 2023 Global Healthcare Conference on September 27, 2023
CARLSBAD, Calif., September 19, 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, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the Cantor Fitzgerald 2023 Global Healthcare Conference, in a fireside chat hosted by Kristen Kluska, Managing Director, Biotechnology Equity Research, Cantor Fitzgerald & Co., on September 27th, 2023 at 9:10am ET. The Cantor Fitzgerald 2023 Global Healthcare Conference is being held at the InterContinental New York Barclay Hotel.
Interested parties can register to view a replay of the presentation on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
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/20230919377385/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 -- RG6501 (OpRegen®) Phase 1/2a Additional Results to Be Featured at 23rd EURETINA Congress
CARLSBAD, Calif., September 13, 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 the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure from a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), which were reviewed by multiple, independent reviewers, will be presented at the 23rd EURETINA Congress. The meeting will be held in the RAI Amsterdam, The Netherlands from October 5-8, 2023. The presentation, "Time to retinal structure improvements following OpRegen subretinal delivery in patients with geographic atrophy (GA)," will be presented by Adiel Barak, M.D., Professor of Ophthalmology, Vitreoretinal Unit Director, Tel Aviv Medical Center, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. 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 GA secondary to AMD (ClinicalTrials.gov Identifier: https://media.zenfs.com/en/business-wire.com/8d4886b718605e6d147fbef515092961" rel="nofollow" target="_blank" >NCT05626114).
About EURETINA
EURETINA started life as the European Retina, Macula and Vitreous Society in June 2000. Since then, the organization has grown to over 4,500 members and its annual Congress attracts thousands of delegates. Its goal is to enable access to the same cutting-edge retina science worldwide. Through membership, annual Congress, Winter Meeting and always-on digital resource, the organization and its members share robust scientific and educational resources relating to retina. For more information, please visit https://euretina.org or follow the association on Twitter @EURetina.
About the Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to dry-form AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
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.
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 therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; 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 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/20230913712585/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 to Present at 2023 International Spinal Research Trust Network Meeting
CARLSBAD, Calif., September 11, 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, announced today that Gary S. Hogge, D.V.M., M.S., Ph.D., Lineage’s Senior Vice President, Clinical & Medical Affairs, will present at the 2023 International Spinal Research Trust (ISRT) Network Meeting, being held September 14 to 16, 2023, at the Holiday Inn Regent's Park, London, UK. Dr. Hogge’s presentations are entitled "Key Learnings from Dose Escalation Studies of OPC1 in Subacute Spinal Cord Injury (thoracic and cervical)," which is being presented on September 14th, 2023, at 16:50 GMT, and "Allogeneic Oligodendrocyte Progenitor Cells (LCTOPC1) in subacute thoracic and cervical SCI," which is being presented on September 16th, 2023, at 16:10 GMT. Both presentations are part of the SCI Clinical Trials Session, sponsored by The International Spinal Research Trust, Spinal Cord Outcomes Partnership Endeavor (SCOPE), Wings for Life and the Christopher and Dana Reeve Foundation.
Interested parties can register to view replays of the presentations on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Spinal Research UK
Spinal Research is the UK’s leading charity funding research around the world to develop effective treatments for Spinal Cord Injury. Today the organization plays a leadership role in shaping the international research strategy focused on spinal cord injury. This means funding and accelerating the most promising lines of research, as well as fostering collaborations between world-renowned scientific institutions. Its mission is to harness the power of international science to deliver revolutionary treatments. For more information, please visit https://spinal-research.org/.
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/20230911254167/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 Receives $1.9 Million Advance Payment from CPRIT and Plans to Present at the CPRIT Innovations in Cancer Prevention and Research Conference
AUSTIN, Texas, Sept. 11, 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 that the Company will present data from its ReSPECT-LM clinical trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases at the Cancer Prevention & Research Institute of Texas (CPRIT) Innovations in Cancer Prevention and Research Conference VI. The conference is taking place October 2-3, 2023, in Galveston, Tex. The poster presentation is titled, Report of Phase 1 Part A of the ReSPECT-LM Trial: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM).
The presentation will be showcased during the Poster Session on October 3, beginning at 7:00 a.m. A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
In August 2023, Plus Therapeutics received an advance payment of grant funds of approximately $1.9 million, as planned, as part of its overall $17.6 million award contract, which CPRIT executed in September 2022. The contract provides for funding from CPRIT over the three-year grant period starting on August 31, 2022, and follows the expected increase of development costs as the ReSPECT-LM clinical trial progresses to later stages.
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/ and https://respect-trials.com.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at https://cprit.state.tx.us.
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) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- FuelPositive Announces Closing of Non-Brokered Private Placement and Debt Conversion
WATERLOO, Ontario, Sept. 11, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”) is pleased to announce that it has closed a non-brokered private placement (the “Offering”) of 6,741,000 units (each, a “Unit”) at a price of $0.06 per Unit, for aggregate gross proceeds of $404,460. Each Unit consists of one common share of the Company and one common share purchase warrant (each, a “Warrant”), allowing holders to purchase an additional common share at an exercise price of $0.09 until September 11, 2026. In the event the volume-weighted average closing price of the Company’s common shares on the TSX Venture Exchange (the “TSXV”) exceeds $0.40 for ten consecutive trading days, the Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election.
All securities issued in the Offering are subject to a statutory hold period until January 12, 2024, in accordance with applicable securities laws. In connection with the Offering, the Company paid $12,352 and issued 205,870 Warrants to an arms-length third party (the “Finder”) who assisted in introducing a subscriber to the Offering.
The net proceeds from this Offering will be utilized for further development of demonstration systems for the commercial production of green ammonia, and for general working capital purposes.
Debt Settlement
The Company also announces that, at the request of the TSXV, it has revised the terms of its previously announced proposal to settle outstanding indebtedness totaling $133,000, as previously announced by the Company in its news release of August 1, 2023. The Company will now settle the indebtedness through the issuance of 2,046,154 common shares of the Company at a deemed price of $0.065 per common shares and will not issue an equivalent number of share purchase warrants.
The Company has also reached an agreement with an additional arm’s-length creditor to settle further outstanding indebtedness totaling US$25,000 through the issuance of 681,600 units (each, a “Settlement Unit”) at a deemed price of $0.05 per Settlement Unit. Each Settlement Unit consists of one common share of the Company and one common share purchase warrant, allowing the holder to purchase an additional common share at an exercise price of $0.065 for a period of thirty-six months subject to accelerated expiry in the event the volume-weighted average closing price of the Company’s common shares on the TSXV exceeds $0.40 for ten consecutive trading days.
Completion of the debt settlements remains subject to the approval of the TSX Venture Exchange. All securities issued in connection with the debt settlements will be subject to restrictions on resale for a period of four-months-and-one-day in accordance with applicable securities laws.
Warrant Repricing
The Company also announced that it was unable to secure the approval of the TSXV to the repricing of certain outstanding share purchase warrants, as announced by the Company in its news release of August 21, 2023. As a result, the warrants have expired without exercise, and in lieu of the expiration of the warrants the Company has provided the holders of the warrants with an opportunity to participate in the Offering.
Option Grant
Finally, the Company announces that it has granted an aggregate of 2,046,154 incentive stock options (the “Options”) to certain advisors. The Options vest immediately and are exercisable at a price of $0.09 until September 11, 2028.
For further information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital
mailto://et@transcendcapitalinc.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.
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.
NEWS -- Plus Therapeutics Enters into License Agreement for Cerebrospinal Fluid Tumor Cell Enumeration Assay
CNSide™ assay is the gold standard diagnostic cerebrospinal fluid (CSF) assay for patients with suspected central nervous system (CNS) cancers
As part of the agreement, Plus obtains a nonexclusive license and option for exclusivity for patients receiving CNS radiotherapy
AUSTIN, Texas, Sept. 08, 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 it has expanded its supply agreement with Biocept by acquiring an option to exclusively license Biocept's CNSide, a CSF-based tumor cell capture and enumeration platform, for patients receiving CNS radiotherapy. The option ensures that Plus Therapeutics has ongoing expanded access to the diagnostic CSF assay for patients with CNS cancers and can further develop and improve the assay specifically for patients with CNS cancers receiving radiotherapy.
“Thus far, in our ReSPECT-LM trial, we have had a very positive experience with the CNSide assay and think it has significant diagnostic potential,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The announced agreement is an important building block to ensure Plus Therapeutics remains at the forefront of CNS cancer therapy.”
Under the terms of the agreement, CNSide developer, Biocept, has granted Plus Therapeutics a non-exclusive license to its CNSide cell enumeration assay for Plus’ investigational therapy for leptomeningeal metastases (LM), rhenium (186Re) obisbemeda, and an option for an exclusive license to the assay. In exchange, Plus Therapeutics will provide $150,000 of its common stock to Biocept. Prior to January 1, 2025, Plus Therapeutics will have the option for exclusivity for the field of radiotherapy in exchange for a $1.0 million payment, to be exercised at Plus Therapeutics’ discretion.
“Use of the CNSide assay has the potential to substantially improve the diagnostic paradigm for patients with solid tumor leptomeningeal disease and could provide valuable information for these patients who have limited treatment options but where a targeted therapy may be beneficial,” said Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University’s Feinberg School of Medicine. “Paired with novel investigational therapeutics such as Plus Therapeutics’ rhenium (186Re) obisbemeda, the overall clinical management of these challenging patients could be transformed.”
CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer and melanoma which are leading causes of LM. CNSide provides a sensitive and specific quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or imaging monitoring.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.
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 as 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. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
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/.
About Biocept, Inc.
Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers. Biocept has developed and is commercializing the CNSide™ cerebrospinal fluid assay that detects cancer cells that have metastasized to the central nervous system. Biocept’s patented technology captures and quantitatively analyzes CSF tumor cells for tumor-associated molecular markers. For more information, https://visit www.biocept.com.
1 The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.
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 -- Oncolytics Biotech® Announces Full Exercise of Over-Allotment Option from Public Offering
CALGARY, AB, Sept. 7, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced that in connection with the previously announced underwritten public offering of US$15,000,750 (the "Offering") and the underwriting agreement dated August 1, 2023 (the "Underwriting Agreement"), Leede Jones Gable Inc. (the "Underwriter") has exercised their option (the "Over-Allotment Option"), in full, to purchase 1,000,050 units (the "Optioned Units") at US$2.25 for aggregate gross proceeds of US$2,250,112. The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.
Each Optioned Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances. Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Optioned Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter's Warrant Share") at an exercise price of US$2.25 per Underwriter's Warrant Share at any time up to 60 months following the Closing.
The Offering is being made by way of a prospectus supplement to the Company's short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.
The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the Company's anticipated use of proceeds from the Offering: the terms of the Warrants, the Compensation Warrants; the Company's plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, the Company may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. The Company may incur expenses or delays relating to such events outside of its control, which could have a material adverse impact on the Company's business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
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: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-full-exercise-of-over-allotment-option-from-public-offering-301920771.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Lineage Announces Initiation of Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications Under Partnership With Eterna Therapeutics
CARLSBAD, Calif., September 06, 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 the initiation of certain development activities to generate a novel hypoimmune induced pluripotent stem cell (iPSC) line under the Company’s exclusive option and license agreement (the "Agreement") with Eterna Therapeutics Inc. ("Eterna"). This marks the next step under the strategic collaboration announced in February 2023, under which Eterna is developing innovative engineered hypoimmune iPSC lines that Lineage will evaluate for differentiation into cell transplant product candidates for central nervous system (CNS) diseases and other neurology indications. Since announcing the deal earlier this year, Lineage has evaluated its development strategy with a group of leading neurology experts in the U.S. and abroad. As a result of these and other discussions, and an assessment of the competitive landscape, Lineage finalized its selection of specific gene edits for the initial cell lines to be developed by Eterna. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent the allogeneic NK cell response; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. Lineage expects that these edits would expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications and will further differentiate the cell line from others currently in use by competitors.
"Our partnership with Eterna reflects an important step in a corporate strategy intended to capitalize on our existing process development capabilities by combining them with cutting-edge cell engineering and editing technologies, to create novel and potentially superior product profiles," stated Brian M. Culley, Chief Executive Officer of Lineage. "This collaboration reflects our effort to broaden the application of our cell therapy platform and our plans for future success in this growing field. We look forward to leveraging our expertise to develop innovative cell transplant therapies that have the potential to transform the treatment of a wide range of diseases by capitalizing on the convergence of directed cell differentiation and manufacturing with modern gene editing technology."
"We are excited to move forward with the next phase of our partnership with Lineage," said Matt Angel, Ph.D., Chief Executive Officer and President of Eterna. "We believe that pluripotent cell therapies have the potential to significantly outperform traditional approaches in certain settings and that this milestone highlights Eterna’s capabilities for generating novel gene-edited iPSC lines using our mRNA cell engineering platform."
Under the Agreement, Eterna plans to conduct certain gene-editing activities and provide materials to Lineage for evaluation and Lineage will make payments to Eterna in connection with Eterna’s successful development and delivery to Lineage of certain materials. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell lines developed by Eterna for preclinical, clinical, and commercial purposes in the field of CNS diseases. Eterna is the exclusive licensee of the key intellectual property underlying this collaboration from its discovery partner Factor Bioscience.
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 life science 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 130 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 potential new cell lines into differentiated cell transplant therapies and potential product candidates, and the potential indications thereof, and that those product candidates may be superior to alternate therapies, 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, 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 license under the Agreement; that the potential benefits of the Agreement, including the potential development of new cell lines into new product candidates, or the success of those 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 subsequent 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/20230906418784/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 Participate in a Fireside Chat at the H.C. Wainwright 25th Annual Global Investment Conference
Oncolytics Biotech® Inc. Logo (PRNewsfoto/Oncolytics Biotech® Inc.)
SAN DIEGO and CALGARY, AB, Sept. 6, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference, which is taking place September 11-13, 2023 at the Lotte New York Palace Hotel in New York, NY. Additional details on the fireside chat can be found below.
Date: Tuesday, September 12, 2023
Time: 9:30 a.m. ET
Location: Lotte New York Palace Hotel, Adams Room 4th Floor
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright representative, or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
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SOURCE Oncolytics Biotech® Inc.
NEWS -- Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase
AUSTIN, Texas, Sept. 05, 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 Part B (Cohort 4) 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.
“The Phase 1/Part A data in the ReSPECT-LM clinical trial is encouraging,” said Norman LaFrance M.D., Chief Medical Officer of Plus Therapeutics. “In Phase 1/Part B, we plan to dose escalate to the maximum tolerated single dose while simultaneously collaborating with the U.S. Food and Drug Administration (FDA) to implement multiple dosing into the trial.”
The maximum total radiation activity administered in Phase 1/Part A was 26.4 millicuries (mCi). In Phase 1/Part B the maximum administered total radiation activity will be 110.0 mCi in cohort 7.
Positive data from Part A (Cohorts 1-3) of the ReSPECT-LM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of LM were presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference in August 2023. In summary, the findings in the Phase 1/Part A showed:
NEWS -- Tokens.com Announces Change of Auditor
TORONTO, September 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 web3 businesses, today announces that its board of directors (the "Board") has approved a change of the Company’s auditor.
The Company's former auditor, Raymond Chabot Grant Thornton LLP (the "Former Auditor" or "RCGT"), was not reappointed by the Board, effective as of August 3, 2023. The Board and the audit committee of the Board (the "Audit Committee") have appointed Davidson & Company LLP (the "Successor Auditor" or "Davidson") as the successor auditor of the Company, effective as of August 3, 2023.
"Tokens.com is grateful for the services provided by RCGT for the past two years," said Andrew Kiguel, CEO. "The Company is looking forward to a smooth transition with the Davidson team and planning for a successful FY2023 audit term."
There were no disagreements or unresolved issues with the Former Auditor on any matter of the audit scope or procedures, accounting principles or policies, or financial statement disclosure. There have been no "reportable events" (as defined in National Instrument 51-102 – Continuous Disclosure Obligations) between the Company and the Former Auditor. The Former Auditor did not provide a modified opinion in their auditor's report for the financial statements of the Company fiscal years ended September 30, 2022 and December 31, 2021.
A Notice of Change of Auditor (the "Notice"), together with the response letters from the Former Auditor and Successor Auditor have been reviewed by the Audit Committee and the Board and have been filed on www.sedar.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 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 modeling and game development studio. Web3 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/20230901289466/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 Change of Auditor
TORONTO, September 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 web3 businesses, today announces that its board of directors (the "Board") has approved a change of the Company’s auditor.
The Company's former auditor, Raymond Chabot Grant Thornton LLP (the "Former Auditor" or "RCGT"), was not reappointed by the Board, effective as of August 3, 2023. The Board and the audit committee of the Board (the "Audit Committee") have appointed Davidson & Company LLP (the "Successor Auditor" or "Davidson") as the successor auditor of the Company, effective as of August 3, 2023.
"Tokens.com is grateful for the services provided by RCGT for the past two years," said Andrew Kiguel, CEO. "The Company is looking forward to a smooth transition with the Davidson team and planning for a successful FY2023 audit term."
There were no disagreements or unresolved issues with the Former Auditor on any matter of the audit scope or procedures, accounting principles or policies, or financial statement disclosure. There have been no "reportable events" (as defined in National Instrument 51-102 – Continuous Disclosure Obligations) between the Company and the Former Auditor. The Former Auditor did not provide a modified opinion in their auditor's report for the financial statements of the Company fiscal years ended September 30, 2022 and December 31, 2021.
A Notice of Change of Auditor (the "Notice"), together with the response letters from the Former Auditor and Successor Auditor have been reviewed by the Audit Committee and the Board and have been filed on www.sedar.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 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 modeling and game development studio. Web3 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/20230901289466/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 Present at the H.C. Wainwright 25th Annual Global Investment Conference
AUSTIN, Texas, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, will present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023 at 3:00 p.m. ET at the Lotte New York Palace in New York, NY.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the H.C. Wainwright conference coordinator. An archived replay of the presentation will be available under the For Investors tab of the Plus website at https://www.plustherapeutics.com for 90 days following the event.
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 -- Lineage to Present at Baird 2023 Global Healthcare Conference and H.C. Wainwright & Co. 25th Annual Global Investment Conference
CARLSBAD, Calif., August 29, 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, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at Baird’s 2023 Global Healthcare Conference, in a fireside chat hosted by Jack K. Allen, CFA, Senior Research Analyst, Robert W. Baird & Co. Incorporated, on September 12th, 2023 at 12:50pm ET. Baird’s 2023 Global Healthcare Conference is being held at the InterContinental New York Barclay Hotel. In addition, Mr. Culley will also be presenting at the H.C. Wainwright 25th Annual Global Investment Conference, on September 13th, 2023 at 10:30am ET. The H.C. Wainwright 25th Annual Global Investment Conference is being held at the Lotte New York Palace Hotel.
Interested parties can register to view a replay of the H.C. Wainwright 25th Annual Global Investment Conference presentation on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
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/20230829135732/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 -- Fuelpositive corrects number of units issued in tranche
2023-08-24 19:25 ET - News Release
Mr. Ian Clifford reports
FUELPOSITIVE PROVIDES MINOR CORRECTION ON CLOSING OF SECOND TRANCHE OF PRIVATE PLACEMENT
Fuelpositive Corp. has provided an update to disclosure in its news release of July 19, 2023, announcing closing of the second tranche of its private placement. In connection with closing of the second tranche of the placement, the company issued 31,473,069 units, at a price of 6.5 cents per unit, for gross proceeds of $2,045,750, and not 31,443,069 units for gross proceeds of $2,043,800, as previously indicated.
The proceeds from the private placement will be utilized for further development of demonstration systems for the commercial production of green ammonia, and for general working capital purposes.
About Fuelpositive Corp.
Fuelpositive is a Canadian technology company committed to providing commercially viable and sustainable, cradle-to-cradle clean technology solutions, including an on-farm/on-site, 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/on-site, 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/on site, 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 per cent of the traditional grey ammonia produced today as fertilizer.
We seek Safe Harbor.
© 2023 Canjex Publishing Ltd. All rights reserved.
NEWS -- FuelPositive Seeks Approval for Warrant Repricing
WATERLOO, Ontario, Aug. 21, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (the “Company”), a leading Green Ammonia company, announces that it has applied to the TSX Venture Exchange to amend (the “Amendment”) the terms of a series of 8,249,823 share purchase warrants (collectively, the “Warrants”). The Warrants are currently exercisable at a price of $0.34, with 3,044,000 expiring on August 21, 2023, and 5,205,823 expiring on September 5, 2023.
Under the terms of the Amendment, the exercise price of the Warrants would be reduced to $0.06. As an additional incentive to encourage the exercise of the Warrants, upon exercise of each Warrant, the holder would be entitled to receive one common share and one additional share purchase warrant (each, an “Incentive Warrant”). Each Incentive Warrant will be exercisable at a price of $0.09 for a period of thirty-six months, subject to accelerated expiry in the event the volume-weighted average closing price of the Company's common shares on the TSX Venture Exchange exceeds $0.40 for ten consecutive trading days.
The Warrants were previously issued in connection with a non-brokered private placement completed by the Company, and not in compensation for any services provided to the Company. None of the Warrants are held by related parties or insiders of the Company, and no Warrants within this series have previously been exercised. Completion of the Amendment remains subject to the approval of the TSX Venture Exchange and will not take effect until such time as approval has been received.
For further information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital
mailto://et@transcendcapitalinc.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.
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 Amendment, 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.
NEWS -- NightHawk Biosciences Provides Q2 2023 Business Update
DURHAM, N.C., Aug. 14, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, today provided strategic, financial, and operational updates for the quarter ended June 30, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “Development of our biomanufacturing operations, continues to progress. Specifically, we continue to invest in our San Antonio facilities and are currently evaluating a variety of strategic options to advance these operations. In parallel, we are continuing our R&D activities, and are highly encouraged by the latest preclinical data. Towards this end, our strategy is to further develop these potential therapies through key milestones, with a focus on licensing or partnering these assets to maximize value for shareholders. We look forward to providing updates on these programs.”
Second Quarter 2023 Financial Results
NEWS -- Oncolytics Biotech® Reports Second Quarter 2023 Financial Results and Operational Highlights
SAN DIEGO and CALGARY, AB, Aug. 14, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the second quarter ended June 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.
"Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial."
To view rest of Oncolytics' Press Release including Financial Charts, follow link below:
https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-second-quarter-2023-financial-results-and-operational-highlights-301899635.html
NEWS -- CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial
Readout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage for potential regulatory submission to FDA and Health Canada as the first reversal agent for the blood thinner, Brilinta®
PRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up. The STAR-T trial is evaluating the ability of DrugSorb®-ATR to reduce perioperative bleeding due to the widely-used blood thinner, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We are very pleased to complete all patient related procedures in the STAR-T trial without a single study subject lost to follow-up. This is another critical step of the process delivered on time and with 100% success. We are focused on ensuring complete and high-quality study data collection, ultimately leading to database lock and triggering the statistical analyses that will provide the readouts of the trial. We continue to expect topline results by the end of the year."
Brilinta® is one of the leading "blood thinners" used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. However, in the up to 10% of patients that are not eligible for a cardiac stent and now require coronary artery bypass graft (CABG) surgery, Brilinta confers a risk of major fatal or life-threatening CABG-related bleeding as high as 50-65%, particularly if the surgery is performed within the first five days of receiving the drug. Waiting in the hospital to wash out the drug is the only acceptable alternative, but comes at high cost and potential clinical risk. The goal of using DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug from blood during the surgery when installed in the heart-lung machine. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study was conducted by many leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce "cytokine storm" and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2023, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@cytosorbents.com
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SOURCE CytoSorbents Corporation
NEWS -- Plus Therapeutics Reports ReSPECT-LM Phase 1 Trial Data at the 2023 SNO/ASCO CNS Cancer Conference
AUSTIN, Texas, Aug. 11, 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 reported positive data from the ReSPECT-LM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases (LM) at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference taking place August 10-12, 2023 in San Francisco, California.
“We are very encouraged by the initial safety and survival data in the ReSPECT-LM clinical trial following a single administration of a relatively low dose of rhenium (186Re) obisbemeda,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-LM clinical trial. “Based on the Phase 1 Part A data, we believe we can substantially dose escalate and develop a multiple dosing regimen that could yield meaningful clinical benefits including a survival benefit for the extremely tough clinical problem of leptomeningeal metastases.”
“Our principal corporate goal is to dramatically improve the health and length of life of patients that have the most lethal CNS cancers,” said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. “Similar to our promising Phase 1 and 2 data for glioblastoma, this most recent data indicates that LM, which is ten times more common than glioblastoma, may be similarly addressable with targeted radiotherapy using rhenium (186Re) obisbemeda.”
The poster presentation is titled, Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial [LMAP-21].
Findings in Brief:
NEWS -- Navidea Biopharmaceuticals, Inc. NAVB Requests Oral Hearing With NYSE Hearing Panel
Following the Company’s Fix, Fund, Propel approach, Navidea formally submitted a request for an oral hearing with New York Stock Exchange American (NYSE American) Hearing Panel to appeal potential delisting of its stock from the NYSE American.
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 formally submitted a request for an oral hearing with NYSE American Hearing Panel to appeal potential delisting of its stock from the New York Stock Exchange (NYSE American), while also continuing its Fix, Fund, Propel approach.
“We are taking the prudent steps required to make our case to the Exchange Hearing Panel,” said Craig A. Dais, Navidea’s Chief Financial Officer. “We certainly respect the process and the perspective of the Exchange. We also believe strongly in the progress the Company is making, and the impact of the changes being made to move the Company forward. We look forward to the opportunity for a hearing, in order to provide detail on our strategic plans to fully remedy the required compliance actions which allow the Company to continue trading on the NYSE American. At the same time, we will continue our focus on using our Fix, Fund, Propel approach to advance Navidea’s innovative technology to market, follow our strategy, and deliver value to our stockholders.”
NYSE American Delisting Appeal Details
With the support of the Company’s Board, together with G2G Ventures as executive consultants, Navidea is taking steps toward its intent to appeal the potential delisting from NYSE American.
NEWS -- Tokens.com Reports Financial Results for Q3 2023
TORONTO, August 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 builds web3 businesses and owns an inventory of digital assets, is pleased to report its financial results for the three months and nine months ended June 30, 2023 ("Q3-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q3-2023 Operation Highlights:
NEWS -- Tokens.com Reports Financial Results for Q3 2023
TORONTO, August 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 builds web3 businesses and owns an inventory of digital assets, is pleased to report its financial results for the three months and nine months ended June 30, 2023 ("Q3-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q3-2023 Operation Highlights:
NEWS -- Plus Therapeutics to Announce Second Quarter 2023 Financial Results and Host Conference Call on August 14, 2023
AUSTIN, Texas, Aug. 08, 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 second quarter 2023 financial results on Monday, August 14, 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
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 -- Plus Therapeutics Announces Key Opinion Leader Roundtable on New Clinical Trial Data Being Presented at the 2023 SNO/ASCO CNS Cancer Conference
Trial investigators and company management to discuss latest data from the ReSPECT-LM leptomeningeal metastases clinical trial
Webinar scheduled for Friday, August 11, 2023 at 8:00 a.m. ET
AUSTIN, Texas, Aug. 08, 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 a key opinion leader roundtable discussion to be held on Friday, August 11, 2023, 8:00 a.m. – 9:00 a.m. ET to discuss the latest data from the ReSPECT-LM clinical trial of rhenium (186Re) obisbemeda that will be presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference on August 10, 2023.
The webinar will feature a comprehensive discussion about the ongoing ReSPECT-LM Phase 1/2a dose escalation clinical trial, including key safety, tolerability, dosing, feasibility, and efficacy data. Speakers include:
NEWS -- Oncolytics Biotech® Successfully Raises US$15 Million to Advance Breast and Pancreatic Cancer Clinical Programs
CALGARY, Alberta, Aug. 8, 2023 /CNW/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced the closing (the "Closing") of the previously announced underwritten public offering of US$15,000,750 (the "Offering"). An institutional investor was a significant participant in the Offering. The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.
Leede Jones Gable Inc. acted as underwriter and bookrunner (the "Underwriter") in accordance with the terms of an underwriting agreement between the Company and the Underwriter dated as of August 1, 2023 (the "Underwriting Agreement"), pursuant to which Oncolytics issued 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 at a price of US$2.25 per Equity Unit. Each Equity Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances.
In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter's sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover the Underwriter's over-allotment position, if any, and for market stabilization purposes.
Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, at the Closing, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Equity Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter's Warrant Share") at an exercise price of US$2.25 per Underwriter's Warrant Share at any time up to 60 months following the Closing.
The Offering is being made by way of a prospectus supplement to the Company's short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.
The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the Company's anticipated use of proceeds from the Offering: the terms of the Warrants, the Compensation Warrants and the Over-Allotment Option; the Company's plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, the Company may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. The Company may incur expenses or delays relating to such events outside of its control, which could have a material adverse impact on the Company's business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
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: https://www.prnewswire.com/news-releases/oncolytics-biotech-successfully-raises-us15-million-to-advance-breast-and-pancreatic-cancer-clinical-programs-301895716.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/August2023/08/c2445.html
NEWS -- Theriva™ Biologics Reports Second Quarter 2023 Operational Highlights and Financial Results
ROCKVILLE, Md., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
“We are pleased by the continued progress in the first half of 2023 and look forward to executing on key priorities for our a systemically administered oncolytic adenovirus and lead program, VCN-01, in key indications and therapeutic combinations,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Notably, we have initiated dosing at U.S. sites for VIRAGE, the Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of intravenous VCN-01, which were well tolerated with safety profile consistent with prior clinical trials. VIRAGE remains on track to complete enrollment in the first quarter of 2024. Reaching this critical milestone adds to the strong momentum for the trial and we are further encouraged by the FDA’s decision to grant orphan drug designation to VCN-01 for patients with pancreatic cancer, for which there is an urgent need for new treatment options.”
Mr. Shallcross continued, “We are encouraged by the growing clinical data that underscores VCN-01’s multi-modal mechanism of action, alone or in combination with chemotherapy and immunotherapy products. At the upcoming annual ESMO Congress in Madrid, investigators will present survival data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which will provide the first clinical insights into the feasibility of combining VCN-01 with an immune checkpoint inhibitor. These results build on the impressive safety, biochemical and mechanistic data presented last year, demonstrating that VCN-01 improved tumor immunogenicity in previously immunotherapy refractory patients. In parallel, we look forward to upcoming discussions with regulatory agencies planned in the second half of 2023 to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Further, as we continue to explore the potentially broad synergistic clinical benefit of VCN-01, we remain committed to pursuing new oncolytic virus candidates to leverage our novel Albumin Shield technology, which has tremendous potential for our pipeline.”
For full Press Release including Financial Charts, go to the link below:
https://finance.yahoo.com/news/theriva-biologics-reports-second-quarter-120000783.html
NEWS -- Vivos Inc. Announces Certification of Three New IsoPet® Precision Radionuclide Therapy Regional Clinics
Richland WA, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that it certified three additional clinics to offer Isopet® Precision Radionuclide Therapy (PRT).
The three new clinics are the Myhre Equine Clinic, located in Rochester, New Hampshire, the Hopkinton Animal Hospital, located in Weare, New Hampshire and the Indian Creek Veterinary Hospital, located in Fort Wayne, Indiana.
The Myhre Clinic will be focused on providing equine tumor therapy and just recently successfully treated the Myhre Clinic’s first Isopet® equine patient for a melanoma tumor located on the tail. Hopkinton Animal Hospital and Indian Creek Veterinary Hospital are focused on small animal therapy.
Dr. Korenko stated, “We are excited about expanding the availability and awareness of the Isopet® Precision Radionuclide Therapy as a game changing treatment option for treating solid tumors. Pet parents need a reasonable driving distance to obtain the therapy and we are working diligently to continue to expand our reach domestically and in certain international markets. We now have seven Isopet® certified regional clinics located in Washington, Missouri, Maryland, New York, New Hampshire, and Indiana and are in active discussions related to new Isopet® clinic certifications in Wisconsin, Texas, California, and Washington.”
Vivos Inc. will be participating in three upcoming Veterinary conferences (Washington State Veterinary Medical Association, WSVMA – September 22-24, 2023, Veterinary Cancer Society, VCS - October 12-14 in Reno NV and the American Association of Equine Practitioners, AAEP – November 29 to December 3, 2023 in San Diego CA). We are excited about expanding the awareness of the Isopet® PRT treatment option to the professional veterinary community.
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an outpatient procedure, and the patient may return home without subsequent concern for radiation dose to family members.
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@VivosInc.co