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NEWS -- Tokens.com Acquires Startup Slang Team and Its Ecommerce IP
TORONTO, June 29, 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 announce that the team behind Startup Slang has joined its subsidiary, Metaverse Group. Metaverse Group will also have exclusive access to the "Shoppable" metaverse technology developed by Startup Slang that links in-game purchase transactions to Shopify Plus storefronts.
Startup Slang was the first to connect a mobile game to a Shopify Plus store. This technology is the first of its kind and can be seen in the popular interior home decor game called "Design Home". Design Home is a mobile game that has been downloaded over 100 million times in the Apple and Android app stores. The game allows players to decorate interior design spaces with pieces that can be purchased directly from popular interior decor brands in the physical world. This new technology further bridges the gap between the physical and virtual world using middleware solutions and creates a seamless shopping experience.
This technology allows Metaverse Group to build customizable gamified experiences for brands looking to reach new audiences and sell their product in an immersive and seamless way. As leaders in web3 development, Metaverse Group’s services position brands to make an easy shift from two-dimensional to three-dimensional marketing.
"We know that three dimensional marketing is the way of the future, this is evident with all the money tech giants like Apple are spending in creating wearable headsets," said Andrew Kiguel, CEO of Tokens.com. "It has been challenging finding the right solutions to connect products in digital experiences to ecommerce but by acquiring the Startup Slang team and their IP, this gives Metaverse Group an added advantage to further enhance gamified shopping experiences."
"By joining our Shoppable metaverse technology with Tokens.com and Metaverse Group, we plan to scale these types of deployments and allow brands to add an additional ecommerce source of revenue to their businesses through the metaverse. This will be a pivotal move towards the public's mass adoption of the metaverse," said Damiano Raveenthiran, founder and former CEO of Startup Slang.
Brands and businesses interested in learning more about new ecommerce offerings can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230629483379/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 Acquires Startup Slang Team and Its Ecommerce IP
TORONTO, June 29, 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 announce that the team behind Startup Slang has joined its subsidiary, Metaverse Group. Metaverse Group will also have exclusive access to the "Shoppable" metaverse technology developed by Startup Slang that links in-game purchase transactions to Shopify Plus storefronts.
Startup Slang was the first to connect a mobile game to a Shopify Plus store. This technology is the first of its kind and can be seen in the popular interior home decor game called "Design Home". Design Home is a mobile game that has been downloaded over 100 million times in the Apple and Android app stores. The game allows players to decorate interior design spaces with pieces that can be purchased directly from popular interior decor brands in the physical world. This new technology further bridges the gap between the physical and virtual world using middleware solutions and creates a seamless shopping experience.
This technology allows Metaverse Group to build customizable gamified experiences for brands looking to reach new audiences and sell their product in an immersive and seamless way. As leaders in web3 development, Metaverse Group’s services position brands to make an easy shift from two-dimensional to three-dimensional marketing.
"We know that three dimensional marketing is the way of the future, this is evident with all the money tech giants like Apple are spending in creating wearable headsets," said Andrew Kiguel, CEO of Tokens.com. "It has been challenging finding the right solutions to connect products in digital experiences to ecommerce but by acquiring the Startup Slang team and their IP, this gives Metaverse Group an added advantage to further enhance gamified shopping experiences."
"By joining our Shoppable metaverse technology with Tokens.com and Metaverse Group, we plan to scale these types of deployments and allow brands to add an additional ecommerce source of revenue to their businesses through the metaverse. This will be a pivotal move towards the public's mass adoption of the metaverse," said Damiano Raveenthiran, founder and former CEO of Startup Slang.
Brands and businesses interested in learning more about new ecommerce offerings can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230629483379/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 Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting
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 interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois.
An oral presentation titled, Safety and Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988], brief highlights include:
NEWS -- Provectus Biopharmaceuticals Establishes Research Collaboration with University of Tennessee College of Veterinary Medicine to Investigate Pharmaceutical-Grade Small Molecule Immunotherapy Rose Bengal Sodium for Canine Soft Tissue Sarcomas
KNOXVILLE, TN, June 28, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has initiated a new sponsored research program with the University of Tennessee College of Veterinary Medicine (UTCVM) to assess the safety and preliminary efficacy of intralesional injection of a formulation of Provectus’s pharmaceutical-grade RBS for canine soft tissue sarcomas. UTCVM’s lead principal investigator of this work is clinical pathologist, comparative cancer biologist, and Assistant Professor Nora Springer, DVM, PhD, DACVP.
This preclinical and clinical veterinary study is being undertaken as part of the State of Tennessee’s funding to develop animal health drug products in partnership with state universities that have agriculture and veterinary medicine programs and the Company.
Soft tissue sarcomas are common malignant neoplasms in dogs that are locally invasive and have a high prevalence of recurrence after surgical excision. These tumors are often located on the extremities, where complete surgical excision is challenging because minimal soft tissues hinder the ability to gain adequate tumor margins while maintaining the ability to close the surgical wound. Adjuvant chemotherapeutic protocols do not improve either time to recurrence or overall survival with incompletely excised soft tissue sarcomas. Radical measures, such as limb amputation, are often required to ensure complete excision for limb sarcomas and this option is frequently unpalatable to patient owners. Therefore, intralesional injection resulting in tumor ablation may be an ideal treatment modality for soft tissue sarcomas.
Dr. Springer graduated from Marietta College with a Bachelor of Science in Chemistry, LaGuardia Community College with an Associate in Applied Science in Veterinary Technology, Kansas State University with a Doctor of Veterinary Medicine (DVM), and Cornell University with a Doctor of Philosophy (PhD) in Translational Medicine. She completed the American College of Veterinary Pathologists (ACVP) certifying examination to become a Diplomate Member (DACVP), and has co-authored a number of medical journal publications to date.
Dominic Rodrigues, Vice Chairman of Provectus’s Board said, “We are excited to commence this canine cancer study with the University of Tennessee College of Veterinary Medicine and Dr. Nora Springer to accelerate our animal health drug development program. We believe that the Company’s adult cancer clinical and pediatric preclinical data to date can meaningfully contribute to Dr. Springer’s canine cancer work, and vice versa because spontaneous cancers in dogs share many features with human cancers.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo drug discovery programs in oncology, hematology, wound healing, and animal health; and preclinical in vitro drug discovery programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://ClinicalTrials.gov. For additional information about Provectus, please visit the Company’s website at https://www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of:
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Provectus Biopharmaceuticals Announces Stockholder Approval to Undertake Reverse Split of Outstanding Equities and Reduce Number of Authorized Equities by Same Ratio
KNOXVILLE, TN, June 26, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company’s shareholders have approved the proposals of Provectus’s Board of Directors (Board) to seek the authority to undertake a reverse stock split and an authorized share reduction.
At the Company’s Annual Meeting of Stockholders held in Knoxville, Tennessee on June 21, 2023, shareholders also approved the Board’s recommendations of four other proposals: the election of directors, an advisory vote on the approval of the compensation of Provectus’s named executive officers, an advisory vote on the frequency of the aforementioned advisory vote on compensation, and the ratification of the Company’s independent registered public accounting firm.
Ed Pershing, Chairman of Provectus’s Board said, “I want to express my sincere appreciation and the sincere appreciation of our directors, officers, employees, and staff to all of our stockholders for your active participation in the voting process as well as your support of our business direction and management, as evidenced by these favorable voting results. Your continued interest in and support of Provectus is welcomed and greatly appreciated.”
Mr. Pershing added, “The Company’s Board understands its responsibility to evaluate and determine whether and when a reverse stock split of Provectus’s outstanding equities and reduction of authorized shares are in the best interests of the Company and our stockholders.”
A copy of Provectus’s Form 8-K filed on June 22, 2023, which provided details of shareholder voting on the Board’s six proposals and included a brief description of and the vote tabulation for each proposal, may be found here:
https://www.sec.gov/ix?doc=/Archives/edgar/data/315545/000149315223022116/form8-k.htm.
Proposal #1 (election of directors) passed with [an average of] 44% FOR of shares outstanding and 96% FOR of shares voted.
Proposal #2 (advisory vote on compensation) passed with 43% FOR of shares outstanding and 94% FOR of shares voted.
Proposal #3 (one-year frequency of advisory vote on compensation) passed with 43% FOR of shares outstanding and 94% FOR of shares voted.
Proposal #4 (independent accounting firm) passed with 67% FOR of shares outstanding and 99% FOR of shares voted.
Proposal #5 (reverse stock split) passed with 61% FOR of shares outstanding and 90% FOR of shares voted.
Proposal #6 (authorized share reduction) passed with 61% FOR of shares outstanding and 91% FOR of shares voted.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; in vivo proof-of-concept programs in oncology, hematology, wound healing, and animal health; and in vitro programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://ClinicalTrials.gov. For additional information about Provectus, please visit the Company’s website at https://www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of:
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Oncolytics Biotech's® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial
Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial
If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer
Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials
SAN DIEGO, CA and CALGARY, AB, June 22, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.
"We are delighted at being selected by the Precision Promise panel of experts," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Our next step is to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval."
Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care."
Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, "Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep's immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option."
Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.
Pelareorep in Pancreatic Cancer
Pelareorep's inclusion in Precision Promise is supported by prior clinical data in pancreatic cancer that suggests it synergizes with checkpoint inhibition and chemotherapy. These prior data include phase 1/2 results showing a 69% objective response rate (ORR, n = 13) in a cohort of first-line advanced/metastatic PDAC patients treated with pelareorep combined with atezolizumab, gemcitabine, and nab-paclitaxel. This compares to an average ORR of ~25% reported in relevant historical control trials1-4. In addition, a phase 2 study of pelareorep plus gemcitabine that included 29 evaluable chemotherapy-naïve pancreatic cancer patients showed a median overall survival (mOS) of 10.2 months and a one-year survival rate of 45%, compared to historical control trials showing mOS of approximately 6.7 months and one-year survival rates of approximately 20 – 22%, respectively1,5-6. A subsequent phase 2 study of pelareorep plus checkpoint inhibition without chemotherapy in pancreatic cancer patients who progressed after first-line treatment showed a 42% disease control rate (n = 12), post-treatment increases in PD-L1+ cells, and a correlation between clinical response and increased activation of anti-cancer CD8+ T cells.
References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070
5. Conroy et al. N Engl J Med 2011; 364:1817-1825. DOI: 10.1056/NEJMoa1011923
6. Goldstein et al. JNCI J Natl Cancer Inst (2015) 107(2): DOI:10.1093/jnci/dju413
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 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 design and anticipated benefits of the Precision Promise study, including our belief that the study, if successful, will support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma; our plan to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into the study; our expectation that we will be in a position to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024; our 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, we 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. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our 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-biotechs-pelareorep-selected-for-inclusion-in-precision-promisesm-pivotal-phase-3-platform-trial-301857678.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2023/22/c8207.html
NEWS -- FuelPositive Announces Closing of First $3.5 Million Tranche of Private Placement and Debt Conversion
WATERLOO, Ontario, June 21, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (the “Company”), a leading Green Ammonia company is pleased to announce that it has completed the first tranche of its $7,500,000 non-brokered private placement and has issued 53,870,699 units (each, a “Unit”), at a price of $0.065 per Unit, for gross proceeds of $3,501,595. 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 June 21, 2026. 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 Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election.
“We are extremely pleased with closing the first $3,500,000 tranche of our active $7,500,000 financing,” says Ian Clifford, CEO and Board Chair of FuelPositive. “We are grateful to our existing shareholders for their ongoing support and welcome many new strategic investors who share FuelPositive’s values and goals. This is an important financial milestone that provides the necessary runway to reach several major milestones this year. We look forward to updating our shareholders on our progress over the coming months. Stay tuned as the coming months should be the most exciting in our Company’s history.”
The first tranche of the Offering was completed pursuant to the Listed Issuer Financing Exemption (the “LIFE Exemption”) as outlined in Part 5A of National Instrument 45-106 - Prospectus Exemptions (“NI 45-106”). As a result, the Units issued to subscribers in the first tranche of the Offering are not subject to resale restrictions in accordance with Canadian securities laws.
The Company intends to conduct a further tranche of the Offering to bring the total gross proceeds from the Offering up to $7,500,000. This additional tranche of the Offering is expected to be completed on or before June 30, 2023. It will be open to purchasers pursuant to the Accredited Investor Exemption outlined in Part 2 of NI 45-106, as well as to purchasers resident in Canada pursuant to the LIFE Exemption. An offering document related to the portion of the Offering conducted under the LIFE Exemption is accessible under the Company’s profile at www.sedar.com and on the Company’s website at: https://www.fuelpositive.com. Prospective investors should read this offering document before making an investment decision.
The securities issued in the Offering pursuant to the LIFE Exemption will not be subject to a hold period in accordance with Canadian securities laws. All other securities issued in the Offering will be subject to a statutory hold period of four-months-and-one-day following issuance.
In connection with the completion of the first tranche of the Offering, the Company paid $96,210 and issued 1,480,150 Warrants to certain arms-length third parties (the “Finders”) who assisted in introducing subscribers to the Offering. The Warrants issued to the Finders and any common shares of the Company issuable upon exercise of those Warrants are subject to restrictions on resale in accordance with Canadian securities laws until October 22, 2023. The Company anticipates paying finders’ fees to eligible third parties in connection with the completion of the additional tranche of the Offering. Closing of the additional tranche of the Offering remains subject to the approval of the TSX Venture Exchange.
Debt Settlement
The Company also announces that it has reached agreements with a certain arms-length creditors to the Company to settle (the “Settlements”) outstanding indebtedness totaling $1,436,248 through the issuance of 22,096,123 Units at a price of $0.065 per Unit. All Units issued in connection with the Settlement will be subject to restrictions on resale for a period of four-months-and-one-day following issuance in accordance with applicable securities laws. Completion of the Settlement remains subject to the approval of the TSX Venture Exchange.
“Preserving capital for operations and commercialization is a priority for the Company. The conversion of over $1 million of existing debt to shares is a beneficial mechanism to help preserve operating capital. We thank our various suppliers and lenders for participating in this conversion opportunity,” added Ian Clifford.
For enquiries related to investment in this Offering, 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 -- Navidea Biopharmaceuticals, Inc. Announces Distribution of Series K Preferred Stock to Holders of its Common Stock
DUBLIN, Ohio, June 16, 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 its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series K Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on June 27, 2023. The shares of Series K Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on June 27, 2023. The outstanding shares of Series K Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series K Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series K Preferred Stock).
All shares of Series K Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series K Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.
The Series K Preferred Stock will be uncertificated, and no shares of Series K Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series K Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
Further details regarding the Series K Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230616215293/en/
Contacts
Navidea Biopharmaceuticals, Inc.
G2G Ventures – Executive Consultant
Theodore Gerbick
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Receives $7.5 Million Cash from Cardinal Health in Lieu of Contingent Milestone Payment
Continuing the Company’s Fix, Fund, Propel approach, the cash payment from Cardinal Health aligns strategic goals while solidifying immediate capital for funding Phase IIb and Phase III trials.
DUBLIN, Ohio, June 16, 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 on June 14, 2023 it entered into an amendment (the "Amendment") to the Asset Purchase Agreement, dated November 23, 2016 (the "Purchase Agreement"), between the Company and Cardinal Health 414, LLC ("Cardinal Health 414"), an affiliate of Cardinal Health, Inc. (NYSE: CAH). Under the terms of the Amendment, Cardinal Health 414 paid the Company $7.5 million in cash on June 14, 2023 and the Company waived its right to receive any contingent Milestone Payment that might otherwise become due and payable under the Purchase Agreement. The cash payment from Cardinal Health 414 provides immediate capital for the Company’s Phase IIb (NAV3-32) and Phase III (NAV3-33) trials and related operations. Building on a history of partnership between the Company and Cardinal Health, the Amendment also aligns and supports growth goals related to LYMPHOSEEK® for both organizations.
Prior to entering into the Amendment with Cardinal Health 414, the Company and Keystone Capital Partners ("Keystone") agreed to terminate the letter of intent between them which outlined the material terms of the Company’s proposed sale of the Milestone Payment to Keystone for $8 million. Supported by G2G Ventures as Executive Consultants, the Company determined that the Amendment with Cardinal Health 414 provided greater certainty of closing and accelerated funding without the inclusion of dilutive warrants. Keystone remains a trusted partner of the Company and is expected to continue to assist the Company in its future financing efforts. The powerful combination of accelerated funding, strategic partnership and continued capital access allows the Company to expand its clinical trial base while delivering shareholder value.
"The amendment with Cardinal Health and equity line from Keystone Partners offers immediate capital and continuing positive support for Navidea’s pioneering work," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "This is a great example of how a focused approach can drive the business forward, surface opportunities, strengthen relationships, and create shareholder return."
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 Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 46,500 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at https://cardinalhealth.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 their team.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230616130485/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures- Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Plus Therapeutics to Participate in the 2023 Healthcare Virtual Conference Presented by Maxim Group LLC and Hosted by M-Vest
AUSTIN, Texas, June 14, 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, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to participate in a fireside chat at the 2023 Healthcare Virtual Conference, presented by Maxim Group LLC and hosted by M-Vest, on Wednesday, June 21, 2023 at 3:30 p.m. ET.
The conference will take place June 20-22, 2023, and will be hosted live on M-Vest and available under the For Investors tab of the Plus Therapeutics website at https://www.plustherapeutics.com. To attend virtually, sign up to become an M-Vest member here: Reserve Your Seat.
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) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Announces Participation at Upcoming SNO Pediatric Conference and SNMMI Annual Meeting
Company to showcase pipeline developments across lead programs in recurrent glioblastoma and leptomeningeal metastases in two poster presentations at SNMMI Annual Meeting
AUSTIN, Texas, June 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 will exhibit at both the Society for NeuroOncology’s (SNO) Pediatric Conference, taking place June 22-24, 2023 in Washington, D.C., and the Society of Nuclear Medicine & Molecular Imaging’s (SNMMI) Annual Meeting, taking place June 24-27, 2023 in Chicago, Illinois.
In addition, at the SNMMI Annual Meeting, Norman LaFrance, M.D., Chief Medical Officer, will present data from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM), respectively.
Details of SNMMI poster presentations:
A copy of the presentations 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.
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 -- Tokens.com Completes Acquisition of Metaverse Group
TORONTO, June 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that builds web3 businesses and owns an inventory of digital assets, is pleased to announce that it has closed its acquisition of all of the issued and outstanding shares from the minority shareholders of Metaverse Group LTD that the Company does not already own. In addition, Metaverse Group has launched a new website, which can be visited at https://metaversegroup.com, reflecting its expanding business branding.
As consideration for the acquisition, Tokens.com has issued 20,576,941 common shares to the minority Metaverse Group shareholders. Each minority Metaverse Group shareholder will receive 0.347 Tokens.com shares per Metaverse Group share. The Tokens.com shares to be issued as part of this transaction will be subject to contractual escrow provisions over a nine month period. In addition, an aggregate of 3,105,650 options to purchase shares of Tokens.com and 694,000 RSUs of Tokens.com were issued as replacement securities to certain security holders of Metaverse Group. This transaction has been approved by the board of directors of both entities, Metaverse Group shareholders, and the NEO Exchange.
The integration of the two entities will further enhance the synergies between the two entities, including Hulk Labs, the gaming unit of Tokens.com. The gamification capabilities of Hulk Labs will enhance Metaverse Groups services offered to clients. The merger will enable the development of new, immersive experiences within the metaverse, combining the best of gaming and virtual reality. Furthermore, the amalgamation is expected to bring additional synergies in corporate overhead, investor relations, public relations, and human resources.
Metaverse Group also continues to build its software development capabilities across various web2 and web3 metaverses. This includes web2 metaverses such as Robolox, which has an estimated 65 million users daily. Metaverse Group is platform agnostic and is able to deliver value within all types of 3D virtual realities. In addition, Metaverse Group is looking at expanding its service capabilities to headsets, which will allow its clients to build on such platforms like the forthcoming Apple VR Headset set for release later this year.
Tokens.com will actively seek to acquire other companies that align with its vision and mission. The company believes that these strategic acquisitions will further strengthen its position in web3 and accelerate its growth.
Tokens.com intends to gradually pivot from its staking operations to focus on the building of Metaverse Group and Hulk Labs. In the future, the Company may seek to sell part or all of its staking inventory to finance further growth in its businesses.
"The staking business has provided a strong cushion of capital for our business since inception," said Andrew Kiguel, CEO. "As the Company grows, we need to evaluate where we can achieve the highest risk adjusted returns. With token values peaking in 2021 and staking rewards declining for large cap tokens, we are evaluating the most strategic and rewarding ways to use the digital assets on behalf of shareholders." added Kiguel.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
About Hulk Labs
Hulk Labs is a web3 gaming studio. Gaming is the largest category in the entertainment industry with revenues exceeding both film and music, consisting of over 3.2 billion gamers in 2022. It is predicted that web3 gaming will grow from 1 to 100 million users by 2025. Hulk is developing web3 wallet and data products, while using our expertise to provide web3 gaming consultation services to brands. Hulk is designing and building web3 enabled mobile games with superior tokenomic models, and our technology natively integrated. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses and owns an inventory of digital assets.
For further information please visit https://hulklabs.com.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law
View source version on businesswire.com: https://www.businesswire.com/news/home/20230605005137/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 Completes Acquisition of Metaverse Group
TORONTO, June 05, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that builds web3 businesses and owns an inventory of digital assets, is pleased to announce that it has closed its acquisition of all of the issued and outstanding shares from the minority shareholders of Metaverse Group LTD that the Company does not already own. In addition, Metaverse Group has launched a new website, which can be visited at https://metaversegroup.com, reflecting its expanding business branding.
As consideration for the acquisition, Tokens.com has issued 20,576,941 common shares to the minority Metaverse Group shareholders. Each minority Metaverse Group shareholder will receive 0.347 Tokens.com shares per Metaverse Group share. The Tokens.com shares to be issued as part of this transaction will be subject to contractual escrow provisions over a nine month period. In addition, an aggregate of 3,105,650 options to purchase shares of Tokens.com and 694,000 RSUs of Tokens.com were issued as replacement securities to certain security holders of Metaverse Group. This transaction has been approved by the board of directors of both entities, Metaverse Group shareholders, and the NEO Exchange.
The integration of the two entities will further enhance the synergies between the two entities, including Hulk Labs, the gaming unit of Tokens.com. The gamification capabilities of Hulk Labs will enhance Metaverse Groups services offered to clients. The merger will enable the development of new, immersive experiences within the metaverse, combining the best of gaming and virtual reality. Furthermore, the amalgamation is expected to bring additional synergies in corporate overhead, investor relations, public relations, and human resources.
Metaverse Group also continues to build its software development capabilities across various web2 and web3 metaverses. This includes web2 metaverses such as Robolox, which has an estimated 65 million users daily. Metaverse Group is platform agnostic and is able to deliver value within all types of 3D virtual realities. In addition, Metaverse Group is looking at expanding its service capabilities to headsets, which will allow its clients to build on such platforms like the forthcoming Apple VR Headset set for release later this year.
Tokens.com will actively seek to acquire other companies that align with its vision and mission. The company believes that these strategic acquisitions will further strengthen its position in web3 and accelerate its growth.
Tokens.com intends to gradually pivot from its staking operations to focus on the building of Metaverse Group and Hulk Labs. In the future, the Company may seek to sell part or all of its staking inventory to finance further growth in its businesses.
"The staking business has provided a strong cushion of capital for our business since inception," said Andrew Kiguel, CEO. "As the Company grows, we need to evaluate where we can achieve the highest risk adjusted returns. With token values peaking in 2021 and staking rewards declining for large cap tokens, we are evaluating the most strategic and rewarding ways to use the digital assets on behalf of shareholders." added Kiguel.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
About Hulk Labs
Hulk Labs is a web3 gaming studio. Gaming is the largest category in the entertainment industry with revenues exceeding both film and music, consisting of over 3.2 billion gamers in 2022. It is predicted that web3 gaming will grow from 1 to 100 million users by 2025. Hulk is developing web3 wallet and data products, while using our expertise to provide web3 gaming consultation services to brands. Hulk is designing and building web3 enabled mobile games with superior tokenomic models, and our technology natively integrated. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses and owns an inventory of digital assets.
For further information please visit https://hulklabs.com.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law
View source version on businesswire.com: https://www.businesswire.com/news/home/20230605005137/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Oncolytics Biotech® Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial that Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate
Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy
37.5% confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel monotherapy
12-month progression-free survival rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy and 0% for pelareorep-paclitaxel-avelumab
Oncolytics' HR+/HER2- breast cancer program now phase 3-ready and advancing to a registrational study of pelareorep-paclitaxel combination
Data to be discussed during a key opinion leader webinar today, June 5th at 8:00 a.m. ET (registration link here)
SAN DIEGO and CALGARY, AB, June 5, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced updated results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer, which include data featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, as well as additional new data and analyses.
BRACELET-1 enrolled 48 patients, including 45 that were randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. All participants enrolled in the trial had previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. No patients in BRACELET-1 received chemotherapy for metastatic disease prior to enrolling in the trial.
Updated data from BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date. Confirmed overall response rate (ORR) in these cohorts was 37.5% and 13.3%, respectively. As previously reported, ORR at week-16 (the trial's primary endpoint) in the pelareorep plus paclitaxel and paclitaxel monotherapy cohorts was 31.3% and 20%, respectively. Overall survival data from the trial continue to mature.
"BRACELET-1's positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar robust improvements in PFS and ORR in less heavily pre-treated patients," said Dr. Matt Coffey, President and Chief Executive Officer. "Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program's registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep's path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients."
A summary of response and PFS data from all 48 patients enrolled in BRACELET-1 is shown below.
Additional updated BRACELET-1 data 1:
Key biomarker and safety findings from BRACELET-1 include:
NEWS -- Navidea Biopharmaceuticals, Inc. Receives NYSE American Notice
DUBLIN, Ohio, June 02, 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 it received a Notice (the "Notice") on June 1, 2023 from the NYSE American LLC (the "NYSE American") stating that the Company is not in compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide ("Company Guide").
The Notice stated that because the Company’s common stock had been trading for a low price per share for a substantial period of time, the Company was not in compliance with Section 1003(f)(v) of the Company Guide. The NYSE American staff determined that the Company’s continued listing is predicated on it demonstrating sustained price improvement within a reasonable period of time or effecting a reverse stock split of its common stock, which the staff determined to be until December 1, 2023, and could be extended to the Company’s next annual meeting of shareholders to be held in 2023. The Company intends to regain compliance with the NYSE American’s continued listing standards by undertaking a measure or measures that are considered necessary and in the best interests of the Company and its shareholders.
The Notice has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on the NYSE American under the symbol "NAVB". The Company remains subject to the conditions set forth in the NYSE American’s letters dated January 28, 2022 and April 8, 2022 for stockholders’ equity noncompliance. The Company will continue to be included in the list of NYSE American noncompliant issuers and the below compliance (".BC") indicator will continue to be disseminated with the Company’s ticker symbol(s). The website posting and .BC indicator will be removed when the Company has regained compliance with all applicable continued listing standards. Additionally, the Notice does not result in the immediate delisting of the Company’s stock from the NYSE American. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. The Company is actively engaged in discussions with the NYSE American and is developing plans to regain compliance with the NYSE American’s continued listing standards within the time period indicated.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230602005389/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- FuelPositive Earns Best Places to Work Award by HRD Canada, Fostering Pride and Engagement
WATERLOO, Ontario, June 02, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”), a leading Green Ammonia company, is delighted to announce its recognition as a winner of the esteemed Best Places to Work award in 2023 by Human Resources Director Canada, the world’s leading independent HR publisher.
“We are immensely proud to be acknowledged as one of Canada's best places to work. This accolade underscores the tireless efforts and unwavering dedication of our employees to our company's mission and values. Our employees are the heart of our organization, and we are committed to fostering a supportive and inclusive workplace where they can thrive, learn, and grow," expressed Nelson Leite, Chief Operating Officer, with deep appreciation.
“FuelPositive remains dedicated to cultivating an inclusive culture where employees are engaged and contribute to the development of practical, clean, and sustainable emissions-free solutions. Being included in this esteemed list signifies our commitment to building a strong and vibrant organization," emphasized Cheryl Allen, Manager of Human Resources, highlighting the significance of the award.
“Understanding the needs and aspirations of our employees forms a crucial part of our HR strategy. After all, it is through their exceptional skills and behaviours that we achieve our desired outcomes," shared Maja Cekrlija, Senior Human Resources Consultant, underscoring the importance of employee satisfaction.
To view the complete list of winners and join us in celebrating the remarkable organizations recognized, please visit the following link: https://www.hcamag.com/ca/best-in-hr/best-places-to-work-in-canada-best-places-to-work-2023/445029
Luna Clifford, Director of Strategic Partnerships and Alliances, and Ian Clifford, CEO and Board Chair added, “FuelPositive is honoured by this recognition, which reflects our unwavering dedication to creating a workplace that fosters pride, engagement, and a sense of belonging. At the outset of the Company, we worked diligently to establish the mission and values for FuelPositive that would attract the most dedicated people from around the world! All of us remain committed to driving innovation, promoting sustainability, and lighting the way toward a brighter future.”
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.
For HR enquiries, please contact:
mailto://hr@fuelpositive.com
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
United States & International
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Canada
Transcend Capital
mailto://et@transcendcapitalinc.com
NEWS -- Navidea Biopharmaceuticals, Inc. Welcomes Jill Bieker Stefanelli, Ph.D. to Board of Directors; Alexander L. Cappello Steps Down
In line with the Company’s Fix, Fund, Propel approach, Jill Bieker Stefanelli, Ph.D. joins Board, adding precision medicine and product development depth in support of stated strategy to advance innovative technology to market. Separately, Alexander L. Cappello steps down.
DUBLIN, Ohio, June 01, 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 Jill Bieker Stefanelli, Ph.D. has joined the Company’s Board of Directors, adding deep experience developing and advancing precision medicine products in line with Navidea’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market. Separately, Alexander L. Cappello has stepped down from the Company’s Board.
Results-Driven, Experienced, Precision Medicine Leader and Strategist
Jill Bieker Stefanelli, Ph.D. joins Navidea’s Board of Directors with demonstrated experience leading fast-paced organizations focused on transformative precision medicine. Dr. Stefanelli’s career and expertise within pharma and commercial client markets strengthen the Board’s ability to guide product strategy, partnership development, and delivery of shareholder value.
"Dr. Stefanelli adds a strong and experienced voice who will press the business forward," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "She is a true scientist and an expert in the industry, with a career progression that includes research, commercial development, product strategy and proven leadership at all levels. Dr. Stefanelli understands our vision, and offers perspective to help lead Navidea’s technology and assets to the forefront."
Dr. Stefanelli is currently the founding consultant of a consulting practice focused on supporting Precision Medicine Companies including genomics, digital pathology, artificial intelligence, therapeutics, and medical devices as a Consultant, Scientific Advisor, or Independent Board Member. Previously, her experience includes serving as President, Board Member, and Chief Business Officer at Paige, as Senior Vice President and Head of Partnerships at Invitae/ArcherDX, as Clinical Commercial Development Lead at Life Technologies, as a Genomics Specialist at Roche Diagnostics, and in science and microbiology roles with Genewiz, USDA APHIS and Sandia National Laboratories. Dr. Stefanelli earned a B.S. in Animal Sciences & Industry, M.S. in Food Science/Microbiology, and Ph.D. in Molecular Medicine and Diagnostic Pathology within the Department of Diagnostic Medicine/Pathobiology from the Veterinary School of Medicine at Kansas State University. Her teaching experience includes instruction related to veterinary virology, food microbiology and automation in microbiology, and Dr. Stefanelli has published in peer reviewed journals throughout her career.
Separately, Alexander L. Cappello, after having joined Navidea in 2021 and recently serving as Chair of the Board, has decided to step down to pursue opportunities outside the organization.
"We thank Mr. Cappello for his contribution," said John K. Scott, Jr, Navidea’s Vice Chair of the Board. "We wish him the very best in pursuit of his next opportunity, and continue our focus on developing processes and growth strategies led by Navidea’s team of experts and our experienced partners in G2G Ventures."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230601006095/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Plus Therapeutics Provides Company Update Today
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), 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 provide a comprehensive update of the Company’s recent activity and progress to date during a presentation at the 2023 Virtual June Investor Summit on Thursday, June 1, 2023, at 2:00 p.m. ET.
The presentation will provide a comprehensive update on Plus Therapeutics’ clinical and preclinical development programs. Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation can be found here and will be available along with an updated Company presentation under the For Investors tab of the Plus website at https://www.plustherapeutics.com. A webcast replay will also be accessible 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) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- FuelPositive Announces $7.5 Million Private Placement
WATERLOO, Ontario, May 30, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (the “Company”), a leading Green Ammonia company, is pleased to announce its upcoming non-brokered private placement (the “Offering”) to raise up to $7,500,000. The Offering supports FuelPositive's unwavering commitment to revolutionizing the Green Ammonia industry by commercializing its sustainable solutions.
The Offering will consist of up to 115,384,615 units of the Company (each, a “Unit”) priced at $0.065 per Unit. Each Unit will consist 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 within thirty-six months following the closing date of the Offering. 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 Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election.
Ian Clifford, Board Chair and CEO, expressed his support for the Offering, stating, “We are introducing this financing to incorporate the newly implemented 'Listed Issuer Financing Exemption' (LIFE). I am often asked how non-accredited investors can participate in FuelPositive financings, and I am pleased that the LIFE structure enables new and existing shareholders, who may not qualify as accredited investors, to participate equally. Additionally, we anticipate that the enhanced liquidity resulting from this Offering will contribute to greater growth for the Company. The Company's pioneering green ammonia technology and decentralized business model holds immense potential to reshape the ammonia industry, fostering a greener future for generations to come. The net proceeds from this financing will help ensure FuelPositive’s leadership and “first-mover” position in the multi-billion dollar sustainable and green ammonia industry.”
The net proceeds from this Offering will only be utilized for further development of demonstration systems for the commercial production of green ammonia, and for general working capital purposes. It is important to note that the Company intends to allocate proceeds only to compensate for services provided to the Company in the ordinary course of business, without making any payments to persons conducting investor relations activities.
The Offering will be open to purchasers pursuant to the Accredited Investor Exemption outlined in Part 2 of National Instrument 45-106 - Prospectus Exemptions (“NI 45-106”), as well as to purchasers resident in Canada, excluding Quebec, in an amount up to 76,923,077 Units pursuant to the Listed Issuer Financing Exemption as outlined in Part 5A of NI-45-106. There will be an offering document related to the portion of the Offering conducted under the Listed Issuer Financing Exemption accessible under the Company’s profile at https://www.sedar.com and on the Company’s website at: https://www.fuelpositive.com. Prospective investors should read this offering document before making an investment decision.
The securities issued in the Offering pursuant to the Listed Issuer Financing Exemption will not be subject to a hold period in accordance with Canadian securities laws. All other securities issued in the Offering will be subject to a statutory hold period of four-months-and-one-day following issuance. The Company will pay finders’ fees to eligible parties who have assisted in introducing subscribers to the Offering. Closing of the Offering remains subject to the approval of the TSX Venture Exchange.
For enquiries related to investment in this Offering, 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 Announces Topline Results from Recurrent Glioblastoma External Control Analysis at ASCO 2023
AUSTIN, Texas, May 30, 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 a new analysis from its partner Medidata, a Dassault Systèmes company, was accepted for online publication at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago, Illinois.
The abstract titled, “Clinical characterization of patients with recurrent glioblastoma in trials involving CED and non-CED treatment [#417610],” included data sourced from Medidata’s more than 30,000 clinical trials involving more than nine million de-identified participants. Aggregate summary statistics comparing bevacizumab and convection-enhanced delivery (CED) patients were based on combined study-level and patient-level data using sample size weighted means, incidence and overall survival.
A total of 799 patients were evaluated from MEDS and studies referenced in D’Amico [J Neurooncol 2021]. Both cohorts (bevacizumab and CED, respectively) were comparable in terms of median age (56 years vs. 55 years), Caucasian race (91% vs. 93%), male sex (68% vs. 65%) and median overall survival (7.9 months vs. 8.4 months).
“The purpose of this analysis was to determine whether bevacizumab patients could form an appropriate external control for evaluating overall survival in current and upcoming CED trials,” said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. “The results of this analysis provide confidence in the use of an external control arm formed from aggregated clinical trial data of patients previously treated with bevacizumab to interpret the results of the ReSPECT-GBM Phase 1/2 trials. Thus far, our clinical outcomes are promising compared to those using an external control. In a potential future pivotal trial, the use of a historical control arm will enable Plus Therapeutics to more rapidly enroll the trial while simultaneously reducing trial costs.”
In April 2022, the Company entered into an expanded partnership with Medidata to utilize the Synthetic Control Arm® platform in its Phase 2 trial for rGBM, in a manner that has historically been favorably received by the U.S. Food and Drug Administration.
About the Synthetic Control Arm®
Medidata’s Synthetic Control Arm (SCA) – a type of external control – is formed by carefully selecting patients from Medidata’s extensive repository of historical clinical trials to match the baseline demographic and disease characteristics of the patients treated with the new investigational product. Case studies have shown that SCAs can effectively mimic a classic randomized control and, therefore, can be used to accurately interpret the treatment effects of an investigational product.
SCAs can help enhance the scientific validity of single-arm trials and, in certain indications, enhance randomized clinical trials to expose fewer prospective patients to control and/or ineffective or existing standard-of-care treatments that might not provide a benefit to the patient. This is done while still providing highly valid scientific evidence. These factors can influence a patient’s willingness to participate in a trial where there is a very poor prognosis and perceived inadequate standard of care.
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 -- Oncolytics Biotech® to Host Key Opinion Leader Webinar on Data from the Randomized BRACELET-1 Trial in HR+/HER2- Metastatic Breast Cancer Being Presented at the Upcoming ASCO Annual Meeting
Key opinion leader webinar to take place on June 5, 2023 at 8:00 a.m. ET
SAN DIEGO and CALGARY, AB, May 26, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) announced that it will host a key opinion leader webinar to discuss data from the randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic breast cancer, which will be featured in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. The webinar will take place on Monday, June 5, 2023 at 8:00 a.m. ET.
The webinar will feature key opinion leaders (KOLs) Richard Vile, Ph.D., (Mayo Clinic), Aleix Prat, M.D., Ph.D. (Clínic Barcelona), and Martine J. Piccart, M.D., Ph.D. (Université Libre de Bruxelles), who will join the Oncolytics management team for a discussion on the current treatment landscape for HR+/HER2- metastatic breast cancer, as well as BRACELET-1's results.
A live question and answer session will follow a formal presentation and roundtable discussion with the KOLs. To register for the event, please click here.
About the KOLs
Richard Vile, Ph.D. is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology program and co-director of the Gene and Virus Therapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology. Dr. Vile received his B.A. in Biochemistry from the University of Oxford and his Ph.D. in Viral Vectors from the University of London.
Aleix Prat, M.D., Ph.D., is a co-founder and Chief Scientific Officer at REVEAL GENOMICS, the Director of the Oncology Institute at Hospital Clínic Barcelona (Spain), Professor of Medicine at the University of Barcelona, and Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Lab at IDIBAPS.
He is the past President of the Spanish Breast Cancer Cooperative Research Group (SOLTI) and was named a member of the Executive Board of The Breast International Group (BIG) in 2018, an international non-profit organization that includes more than 60 cooperative groups from around the world, more than 10,000 experts and it is linked to more than 3,000 hospitals.
Over his career, he obtained worldwide prestige as a research scientist in the field of breast cancer genomics and biomarker development. In 2008, he became a postdoctoral research associate (2008-2012) at the Lineberger Comprehensive Cancer Center (University of North Carolina at Chapel Hill, USA) in the Laboratory of Prof. Charles M. Perou, a world-renowned translational researcher in breast cancer. During this postdoctoral experience, he discovered and characterized a new molecular subtype of breast cancer, a Claudin-low (Prat et al. Breast Cancer Research 2010; Citations: 1,518). In addition, he participated in The Cancer Genome Atlas breast cancer project (Nature 2012; Citations: 4,661), which is the most important molecular characterization study that has ever been performed in breast cancer.
Since 2007, Dr. Prat has actively taken part in a total of 262 publications with 26,881 citations and 140 communications in international congresses.
Martine J. Piccart, M.D., Ph.D., is an Honorary Professor of Oncology at the Université Libre de Bruxelles (ULB), Belgium, and Scientific Director at the Institut Jules Bordet.
She is a co-founder and chair of the Breast International Group (BIG), uniting more than 60 academic research groups from around the world, running over 30 trials, and developing numerous research programs. AURORA, a study to better understand metastatic breast cancer, is the most ambitious of these.
Dr. Piccart is the past president of the European Organisation for Research and Treatment of Cancer (EORTC), the European Society for Medical Oncology (ESMO), and the European Cancer Organisation (ECCO). She served on the ASCO and American Association for Cancer Research (AACR) Boards. Author or co-author of more than 540 peer-reviewed publications, she has received numerous prestigious awards, including the Jill Rose Award, the William L. McGuire Award, the Umberto Veronesi Award for the Future Fight against Cancer, the 2013 David A. Karnofsky Memorial Award, the Leopold Griffuel Award and the Bob Pinedo Award in 2018.
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 clinical trials evaluating 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
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-key-opinion-leader-webinar-on-data-from-the-randomized-bracelet-1-trial-in-hrher2--metastatic-breast-cancer-being-presented-at-the-upcoming-asco-annual-meeting-301835449.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/May2023/26/c3949.html
NEWS -- Plus Therapeutics to Present at the 2023 Virtual June Investor Summit
AUSTIN, Texas, May 25, 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, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, will present at the 2023 Virtual June Investor Summit on Thursday, June 1, 2023, at 2:00 p.m. ET.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation can be found here and will be available under the For Investors tab of the Plus website at https://www.plustherapeutics.com. A webcast replay will also be accessible 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) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Navidea Biopharmaceuticals, Inc. Investors Purchase $1.1 Million in Preferred Shares at Market
Following the Company’s Fix, Fund, Propel approach, the sale of Preferred Shares totaling $1.1 million to new existing investors underscores improved confidence in Navidea’s progress toward advancing its innovative technology to market.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the sale of Preferred Shares totaling $1.1 million to new existing investors, further supporting the Company’s Fix, Fund, Propel approach and helping to advance Navidea’s innovative technology to market.
Funding Adds Confidence and Fuel for Progress
Supported by G2G Ventures, executive consultants to Navidea with demonstrated expertise in building infrastructure, rigorous process, and proven growth strategies, the Company’s stated Fix, Fund, Propel framework to implement change initiatives which drive effective processes, improve liquidity, and create growth continue to take shape with the recent promotion of Michael Blue, M.D., FACEP to Chief Medical Officer and the sale of $1.1 million in preferred shares to new existing shareholders in the Company. The announced sale provides additional capital to fuel Navidea’s focused efforts to advance the Company’s NAV3-32 and NAV3-33 clinical trials toward completion.
“The additional investment from new existing investors signals growing optimism from our shareholders in the progress we are making to refocus on strategic priorities,” said Dr. Michael Blue, Chief Medical Officer of Navidea. “With G2G’s guidance, and continued support from our partners and shareholders, our experts remain focused on delivering Navidea’s transformative technology to market. We’re making good progress, and staying true to our Fix, Fund and Propel approach. Our opportunity is to improve lives around the world while providing value to our stakeholders, and we expect to continue working to reach those goals.”
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
The securities being sold to the single investor have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon conversion of the preferred shares.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230522005739/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Lineage Cell Therapeutics Expected to Be Added to Russell 3000® Index
CARLSBAD, Calif., May 22, 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 reported that the Company is expected to be added to the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective as of the U.S. market open on June 26, 2023, according to a preliminary list of additions posted to the FTSE Russell website, following the close of the U.S. markets on May 19, 2023.
Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of April 28, 2023, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year following reconstitution, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"We are pleased that Lineage is expected to be added into the Russell 3000 Index next month. Our inclusion among larger market cap companies should help to expand investor awareness, increase institutional ownership, and provide additional liquidity in our stock," stated Brian M. Culley, Lineage CEO, "This recognition of our progress comes during an exciting time, as our partners Roche and Genentech enroll patients in a Phase 2a clinical trial of OpRegen® for the treatment of dry age-related macular degeneration, as we prepare for further clinical testing of our OPC1 treatment for spinal cord injury, and as we advance our other treatments for cancer, hearing loss, and vision loss. Overall, we believe a deeper understanding of Lineage’s strategic objectives can help increase support for our novel and exciting approach to cell transplant medicine."
About FTSE Russell
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20.1 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information on the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell 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.
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 expectation that Lineage will be added to the Russell 3000 Index at reconstitution and the impacts to Lineage as a result thereof; the significance of the Phase 2a clinical study of OpRegen; the timing of anticipated clinical activity related to our programs; the potential future achievements of our clinical, preclinical and development programs; our ability to broaden awareness of and increase support for our business; and the potential of our cell therapy platform. 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 positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; 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; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230522005300/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 Regains Compliance with Nasdaq Listing Requirements
AUSTIN, Texas, May 16, 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 it has received notification from The Nasdaq Stock Market LLC that the staff has determined that for the last 10 consecutive business days, from May 1, 2023 to May 12, 2023, the closing bid price of the Company’s common stock has been at $1.00 per share or greater. Therefore, the Company has regained compliance with Listing Rule 5550(a)(2). Accordingly, Nasdaq has advised that the matter is now closed.
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/.
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 -- NightHawk Biosciences Provides Q1 2023 Business Update
DURHAM, N.C., May 15, 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 March 31, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We continue to invest in and advance our research and biomanufacturing efforts, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities. We are making steady progress and look forward to providing further updates.”
2023 Financial Results
NEWS -- Plus Therapeutics to Present in EndBrainCancer Initiative Virtual Educational Event
AUSTIN, Texas, May 12, 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 Norman LaFrance, M.D., Chief Medical Officer and Senior Vice President, will participate in the “Know All Your Treatment Options 2023” virtual educational event organized by EndBrainCancer Initiative (EBCI).
Presentation Details
Topic: A Novel Targeted Radiotherapeutic for Brain Cancer: The ReSPECT Trials
Date: Friday, May 19, 2023
Time: Event begins at 2:00 p.m. ET (11:00 a.m. PT); Dr. LaFrance to present at 3:00 p.m. ET (12:00 p.m. PT)
Access: Registration is free and must be completed by end of day Tuesday, May 16, 2023: https://lnkd.in/gArPRzCC. The event will be livestreamed on EBCI’s Facebook Page at and will be made available on its YouTube Channel two weeks following the event.
About EBCI
The EndBrainCancer Initiative | Chris Elliott Fund is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, FDA-approved treatments, devices, specialists, advanced treatments and clinical trials. We believe that IMMEDIATE ACCESS to these options provides the patient community with the best HOPE for survival and sustained quality of life. https://www.EndBrainCancer.org
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 -- Tokens.com Reports Financial Results for Q2 2023
TORONTO, May 11, 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 six months ended March 31, 2023 ("Q2-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q2-2023 Operation Highlights:
NEWS -- Tokens.com Reports Financial Results for Q2 2023
TORONTO, May 11, 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 six months ended March 31, 2023 ("Q2-2023"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q2-2023 Operation Highlights:
NEWS -- Oncolytics Biotech® Announces Voting Results from the Annual General Meeting of Shareholders
SAN DIEGO and CALGARY, AB, May 10, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the voting results from its Annual General Meeting (AGM) of Shareholders held on Tuesday, May 9, 2023. A total of 44% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.
On a vote by ballot, the seven nominees proposed by the Corporation were elected as Directors of Oncolytics to serve until the Corporation's next Annual Meeting of Shareholders or until their successors are elected or appointed, with shares represented at the meeting voting in favor of individual nominees as follows:
In addition to the election of all nominees listed as directors in the management information circular, dated March 20, 2023, Oncolytics shareholders approved all other resolutions placed before the meeting. These included fixing the number of directors of the Corporation for the ensuing year at seven, appointing the auditors for the Corporation for the ensuing year, approving the issuance of common shares pursuant to unallocated stock options under its stock option plan, approving the issuance of common share pursuant to unallocated share awards under its share award plan, and amendments to each of the stock option plan and share award plan to increase the number of shares reserved for issuance under the plans from 10% to 14% of the number of issued and outstanding common shares.
For more details on the matters covered at the annual meeting, please refer to the Corporation's management information circular available on SEDAR at https://www.sedar.com. Final voting results on all matters voted on at the annual meeting will also be filed on SEDAR.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-voting-results-from-the-annual-general-meeting-of-shareholders-301820767.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/May2023/10/c7097.html
NEWS -- Lineage Receives Grant From California Institute for Regenerative Medicine (CIRM)
Award Will Support 1st Annual Spinal Cord Injury Investor Symposium To Be Held June 29, 2023
CARLSBAD, Calif., May 09, 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 Company has received a grant from the California Institute for Regenerative Medicine (CIRM), to support the 1st Annual Spinal Cord Injury Investor Symposium ("SCIIS"), a newly created forum to discuss the recent innovation, advancements, and challenges in the treatment of spinal cord injury (SCI). The SCIIS is being presented by Lineage and the Christopher & Dana Reeve Foundation. This event aims to bring together a diverse set of parties over the common interest of the development of new therapeutic interventions for SCI. The collaborative effort is intended to increase disease awareness, elevate the probability of success in product development, and promote clinical trial participation through a focus on patient appropriate clinical endpoints and an opportunity for investment and partnerships among and between for-profit and non-profit organizations. To support the SCIIS and these goals, CIRM has awarded Lineage an Education Conference II Grant, with a total award value of $50,000. This award recognizes the SCIIS as an important mission-specific conference, which will allow for the exchange of scientific information, create opportunities to accelerate the development of stem cell therapies to patients, increase the likelihood of successful treatments reaching patients, addresses an unmet clinical need, and can be impactful to CIRM’s overall mission.
"The approaches to and treatment of spinal cord injury are in need of innovation and modernization. This conference was created to help identify, discuss, and address gaps in the product development process and bring new options and ideas to patients in need of better solutions," stated Brian M. Culley, Lineage CEO. "At Lineage, our approach focuses on transplanting and replacing lost or damaged spinal cord cells in an effort to restore function and improve quality of life, but there are many programs in industry and academia which may help patients and we need events like the SCIIS to drive collaboration and cooperation across the field. We are proud to have the support of CIRM and other leading entities in spinal cord injury advocacy and therapeutic development, as we work to bring greater awareness to the field. The development of our OPC1 product candidate was one of the first clinical trials supported by CIRM and we are grateful to the agency for its continued commitment to SCI. This funding will help support the inaugural SCIIS and its mission to empower a diverse group of healthcare companies, key opinion leaders, patients and caregivers, policy makers, government representatives and others to connect and work together towards a common purpose: encouraging acceleration in SCI research, clinical trials and product development."
About the California Institute for Regenerative Medicine (CIRM)
CIRM, California's Stem Cell Agency, was created by the voters of California in 2004 with the passing of Proposition 71, which authorized $3 billion in funding for stem cell research in California. The agency funds stem cell research at institutions and companies throughout California (as well as institutions and companies outside of the state that conduct a portion of their research in California) with the goal of accelerating treatments to patients with unmet medical needs. In 2020, California voters approved to continue funding California's Stem Cell Agency through the passage of Proposition 14. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world as well as to accelerate stem cell treatments to patients with unmet medical needs. By promoting and encouraging the growth of the stem cell biotechnology sector, the agency is also helping attract the best scientists to the state and establishing California as a global leader in stem cell research. For more information, please visit https://www.cirm.ca.gov/ and follow the agency on Twitter: @CIRMnews.
About the 1st Annual Spinal Cord Injury Investor Symposium
The 1st Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 29, 2023, at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. This event will bring together both public and private companies developing new treatment options for people with spinal cord injury, alongside leaders in the spinal cord injury medical and advocacy communities. A number of important topics will be discussed, including current treatment approaches, the impact of SCI, SCI clinical trial participation and ensuring persons with lived experience perspectives, needs & priorities are appropriately captured, including with new clinical assessment tools. Advance registration is required for attendance. For more information about the conference, please visit http://scisymposium.com/ or follow the conversation on Twitter @SCISymposium, using the hashtag #SCIsymposium.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
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 effect of the SCIIS, including increasing disease awareness, the probability of success in product development, clinical trial participation, or investment and partnerships; the ability of cell transplant therapy approaches, including OPC1, to improve recovery, allow a patient to regain more function than what could otherwise be expected, or improve a patient’s quality of life. 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 the SCIIS will not accelerate SCI research, clinical trials or product development; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230509005188/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Navidea Biopharmaceuticals, Inc. Drives Strategy Forward, Shifts Approach for Communications
The company introduces Fix, Fund, Propel approach to further focus on strategic objectives; will publish financial and corporate development highlights via press release in lieu of conference call and webcast for Q1 2023 results.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the introduction of a Fix, Fund, Propel approach to driving the Company’s strategy forward; The Company will issue a press release detailing financial highlights and corporate developments in lieu of hosting conference call and webcast for the first quarter ended March 31st, 2023.
Fix, Fund, Propel
G2G Ventures, executive consultants to Navidea, with demonstrated expertise in building infrastructure, rigorous process, and proven growth strategies, is supporting the Company’s strategic planning and change initiatives to drive effective processes, improve liquidity, and create growth. The Company, with G2G’s support, has adopted a Fix, Fund, Propel framework to enact change within the organization.
NEWS -- Tokens.com to Release its Financial Results for Q2-2023 on May 11, 2023
TORONTO, May 08, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and web3 gaming, is pleased to share that it will release its financial results for the three and six months ended March 31, 2023 ("Q2-2023") on Thursday, May 11th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q2-2023 financial results starting at 10:00 am ET on Friday, May 12th, 2023.
Date: May 12th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_z-2prE_DRPuiIMDFsNAznA
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modelling and game development studio. Crypto gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram 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/20230508005144/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com to Release its Financial Results for Q2-2023 on May 11, 2023
TORONTO, May 08, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and web3 gaming, is pleased to share that it will release its financial results for the three and six months ended March 31, 2023 ("Q2-2023") on Thursday, May 11th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q2-2023 financial results starting at 10:00 am ET on Friday, May 12th, 2023.
Date: May 12th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_z-2prE_DRPuiIMDFsNAznA
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modelling and game development studio. Crypto gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram 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/20230508005144/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 -- FuelPositive Partners With Transcend Capital to Strengthen Investor Relations
WATERLOO, Ontario, May 08, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (“FuelPositive” or the “Company”), a leading Green Ammonia company, is excited to announce its new collaboration with Transcend Capital Inc. (“Transcend”) to expand its investor relations and communications services throughout Canada, subject to final acceptance by the TSX Venture Exchange.
Transcend, a Vancouver-based full-service investor relations company, is well-known for its successful market awareness campaigns that help micro, small and mid-cap public companies gain valued industry exposure through its extensive network of retail and institutional clients.
FuelPositive is delighted to have Mr. Etienne Moshevich, the principal of Transcend, perform shareholder communications services as well as serve as a key point of contact between Canadian investors and the Company.
“I am honoured to be joining the FuelPositive team and excited about the opportunities ahead,” says Etienne Moshevich. “I am confident that FuelPositive is poised to achieve some significant milestones this year, and I look forward to helping the Company expand its reach and attract new investors worldwide.”
“FuelPositive is currently at a pivotal point in its growth, which makes our investor communications and capital markets strategy more crucial than ever before,” emphasized Ian Clifford, CEO and Board Chair of FuelPositive. “RBMG, our United States investor relations firm, has laid a strong foundation for us and is continuing to build on it. With the addition of Etienne Moshevich to our Investor Relations team, we are confident that we can expand our presence in the Canadian market. Etienne brings a wealth of expertise in working with both strategic institutional and retail investors, and his knowledge of the Canadian market will be invaluable to us. We are excited to welcome him and Transcend to our already well-rounded Investor Relations team.”
In consideration for its services, Transcend will be paid a monthly fee of $10,000 per month for a twelve-month period starting immediately and ending on May 30th 2024. The Company has also granted 1,200,000 options to Transcend priced at $0.10 per share and exercisable until May 4th, 2026. The options will vest in four equal parts over a twelve-month period, with the first part vesting after three months.
More information about Transcend Capital can be found on their website at: https://www.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.
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
United States & International
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Canada
Transcend Capital
mailto://et@transcendcapitalinc.com
NEWS -- Lineage Cell Therapeutics to Report First Quarter 2023 Financial Results and Provide Business Update on May 11, 2023
CARLSBAD, Calif., May 04, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2023 financial and operating results on Thursday, May 11, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 11, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on May 11th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 18, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 8339383.
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/20230504005102/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 Provides Operational and Strategic Update and Successfully Fills Initial Pre-Sales Commitments
Highlights:
NEWS -- Plus Therapeutics Expands Collaboration with Piramal Pharma Solutions to Meet Increase in Investigational Drug Demand for Ongoing and Planned Clinical Trials
New supply agreement includes additional lots of intermediate drug product to support the manufacture of the rhenium (186Re) obisbemeda radiotherapeutic
AUSTIN, Texas, May 02, 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 an expansion of its collaboration with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug product to meet the increase in demand for its lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for ongoing and planned clinical trials.
The new supply agreement builds on the Master Services Agreement which the Company and PPS entered into in 2021 for the development, manufacture and supply of rhenium (186Re) obisbemeda.
“We significantly grew our clinical trial programs for central nervous system cancers in 2022 and we expect to continue this momentum into 2023,” said Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “Our strategic partnership with PPS will support our robust supply chain and manufacturing processes to keep ahead of our planned clinical development expansion and lay the groundwork for commercialization in the future.”
“The expansion of our collaboration with Plus Therapeutics validates the breadth and scale of our capabilities as a leading CDMO,” said Peter DeYoung, Chief Executive Officer of Piramal Pharma Solutions. “Our services allow us to deliver solutions that benefit our partners and ultimately patients.”
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug product. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited.
For more information visit: https://www.piramalpharmasolutions.com | LinkedIn| Facebook | Twitter
About Piramal Pharma Limited
Piramal Pharma Limited (PPL, NSE: PPLPHARMA | BSE: 543635), offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, Allergan India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.
For more information visit: https://www.piramal.com/pharma | LinkedIn | Facebook | Twitter.
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
For Piramal Pharma Media Queries
Rajiv Banerjee
Group Head - Corporate Communications
mailto://rajiv.banerjee@piramal.com
For Piramal Pharma Investors
Gagan Borana
General Manager - Investor Relations & Sustainability
mailto://gagan.borana@piramal.com
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Intent to sell Cardinal Milestone Payment for $8 Million; Secures New $2.75 Million Equity Line of Credit
Fresh capital for funding Phase IIb and Phase III trials, expands growth, and fuels shareholder value
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announces the execution of a letter of intent to sale the Cardinal Milestone Payment for $8 million and execution of a new $2.75 million Equity Line of Credit, led by a longtime Navidea investor, to provide substantial funding for the Company’s Phase IIb (NAV3-32) and Phase III (NAV3-33) trials and expand operations.
The Company’s uniquely structured capital raise will provide access to up to $10.75 million and propels the organization forward by providing substantial funding for the Company’s current Phase IIb and Phase III trials. Working closely together with its trusted partner and longtime investor, the Company has agreed to sell the Cardinal Milestone Payment for $8 million, subject to execution of final documentation. This sale will bring in immediate capital into the Company, along with access up to $2.75 million with use of an Equity Line of Credit. This powerful combination of capital access allows the Company to expand its clinical trial base – driving additional shareholder value.
“This capital infusion provides an immediate and positive impact on the trajectory of the Company’s pioneering work - empowering accelerated progress in areas of focus for 2023 and 2024,” said Dr. Jason Myers. “G2G and Navidea, now with the added support of this new partnership, are excited to demonstrate our combined ability to advance innovative science and drive shareholder return.”
“Our goal is to partner with trusted investors who share our vision to drive Phase IIb and Phase III trials to completion, enhance our operational capabilities, and continue our strategy of cultivating growth,” said Board of Directors, Director Josh Wilson. “This partnership and structure creates exceptional enterprise value and provides the fuel needed for growth now and into the future.”
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230427006002/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures- Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
AI
