Tag: Biotechnology

Release – Cadrenal Therapeutics Reports First-Quarter 2025 Financial Results and Provides Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Leadership appointment strengthens strategic and development capabilities

FDA Type D Meeting provides additional guidance for advancing the clinical development of tecarfarin

Collaboration Agreement with Abbott (NYSE: ABT) validates the need for new anticoagulation options

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.

“In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024,” said Quang X. Pham, Chairman & CEO. “The appointment of James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer positions us for success in reviewing potential assets to add to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with the FDA provided additional guidance in the design of a pivotal trial.”

Highlights from the Quarter Ended March 31, 2025, and Other Recent Events:

Leadership Advances

In February 2025, Cadrenal appointed James J. Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company’s pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy.

Regulatory Update

In February 2025, Cadrenal met with the U.S. Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review.

Collaboration Agreement with Abbott

In March 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise.

Operational Milestones

During the quarter, Cadrenal successfully completed the technical transfer and manufacturing of its tecarfarin drug substance (API) from a CDMO site located in Asia to a CDMO site in the United States. This initiative was done to support the company’s clinical and regulatory development strategy for tecarfarin and to improve supply chain security.

Cadrenal also conducted strategic market opportunity research for multiple indications, including patients with left ventricular assist devices. This research indicates that tecarfarin is uniquely positioned to provide clinical value to patients in the rapidly growing LVAD market, which is projected to nearly double by 2032. This research also showed that tecarfarin has the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients.

Participation in Key Investor, Medical, and Business Development Conferences

Cadrenal was active during the first quarter in several significant conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Investor interactions included participation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, a Company presentation at the BIO CEO and Investor Conference in New York, and, after the close of the quarter, a Company presentation at the Centri Capital Conference at Nasdaq headquarters in New York. Shortly after the quarter’s close, Cadrenal participated in the 18th National Conference on Anticoagulation Therapy in Washington, D.C.

Strategic Development Collaborations

Cadrenal continues to explore opportunities to add to the Company’s clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with LVADs and for other indications requiring chronic anticoagulation.

First Quarter 2025 Financial Highlights

Research and development expenses for the quarter ended March 31, 2025, were $1.7 million compared to $0.6 million for the same period in 2024. General and administrative expenses for the quarter ended March 31, 2025, were $2.3 million compared to $1.1 million for the same period in 2024. Cadrenal reported a net loss of $3.8 million for the quarter ending March 31, 2025, compared to $1.7 million for the same period in 2024.

On March 31, 2025, Cadrenal had cash and cash equivalents of $7.3 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 1.9 million shares of common stock outstanding as of March 31, 2025.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the appointment of James Ferguson, M.D., FACC, FAHA, as the Company’s Chief Medical Officer positioning the Company for success in reviewing potential assets to add to its portfolio and designing and executing its clinical program for tecarfarin; the finalized Collaboration Agreement with Abbott validating the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs); Abbott sharing insights from recent HeartMate 3™ clinical trials and supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise; the LVAD market projected to nearly double by 2032; and tecarfarin having the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to utilize Abbott’s expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal clinical trial for tecarfarin in LVAD patients by Cadrenal; for tecarfarin to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

View full release here.

Corporate and Investor Relations

Paul Sagan

LaVoieHealthScience

(617) 865-0041

psagan@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Release – GeoVax Expands Gedeptin(R) Patent Portfolio

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Allowed Patent Claims Cover the Synergistic Combination of Gedeptin® Therapy with Radiation As a Targeted Approach for Solid Tumors

Atlanta, GA – May 7, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against solid tumors and infectious diseases, announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance related to U.S. patent application 17/502,101 entitled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”. The allowed claims further strengthen GeoVax’s intellectual property position in the oncology space.

The allowed claims describe a method for treating solid tumors—including glioblastoma, breast, prostate, head and neck, glioma, and lung cancers—through the direct intratumoral administration of an adenoviral vector encoding purine nucleoside phosphorylase (Ad/PNP), followed by local administration of the prodrug fludarabine phosphate (F-araAMP), and subsequent radiation therapy. This triple-combination strategy is designed to generate local, targeted cytotoxic activity within the tumor microenvironment while minimizing systemic toxicity.

The allowed patent joins the growing Gedeptin intellectual property portfolio, which was exclusively licensed to GeoVax through a prior agreement with PNP Therapeutics, Inc. and the University of Alabama at Birmingham (UAB)/Southern Research. Under the agreement, GeoVax has assumed all licensing rights and IP prosecution responsibilities for the Gedeptin platform.

David Dodd, Chairman and CEO of GeoVax, commented, “This allowed patent underscores the clinical and commercial promise of our Gedeptin platform and demonstrates our commitment to expanding therapeutic options for patients with difficult-to-treat cancers. While the claims do not directly mirror our ongoing clinical programs, they establish a critical foundation for future directions, including potential integration with advanced delivery systems for tumors that are challenging to access.”

Dodd continued, “The USPTO’s recognition of this therapeutic method further validates our approach and underscores the growing value of our wholly owned, co-owned, and in-licensed intellectual property estate, now standing at over 135 granted or pending patent applications spread across 23 distinct patent families”.

Having successfully completed a Phase 1/2a study, as monotherapy in advanced head and Neck cancer patients, Gedeptin is scheduled to begin a Phase 2 trial in combination with an Immune Check Inhibitor (ICI) for patients with first recurrence of head and neck cancer. The newly allowed claims provide further protection as GeoVax explores expanded applications, including novel device-based delivery approaches in potential partnership with interventional oncology companies.

About Gedeptin

Gedeptin is a viral-vectored gene therapy that employs a non-replicating adenoviral vector encoding the E. coli enzyme purine nucleoside phosphorylase (PNP). When injected directly into a tumor and followed by systemic administration of the prodrug fludarabine phosphate, PNP enzymatically converts the prodrug into a cytotoxic metabolite (fluoroadenine), resulting in selective killing of tumor cells by disrupting RNA and protein synthesis.

This tumor-targeted approach offers several key advantages:

  • Localized cytotoxicity with reduced systemic side effects,
  • Potential synergy with immune checkpoint inhibitors (ICIs),
  • Applicability across multiple solid tumor types, particularly those accessible for intratumoral injection.

Gedeptin will soon be evaluated in a Phase 2 clinical trial for patients with first recurrence of head and neck cancer in combination with an approved ICI. It has been granted Orphan Drug Designation by the U.S. FDA for intratumoral treatment of oral and pharyngeal cancers.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – CORRECTION: MAIA Biotechnology Announces $1.08 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 05, 2025 11:45pm EDT Download as PDF

This is a correction of the announcement. The initial exercise date and term of the warrants purchased in the private placement have been corrected to one year following issuance and have a term of six years from the initial issuance date. All other aspects of the announcement remain the same.

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 719,999 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.05 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.08 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released May 5, 2025

Release – MAIA Biotechnology Announces $1.08 Million Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

May 05, 2025 4:05pm EDT Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 719,999 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.05 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.08 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released May 5, 2025

Ocugen to Host Conference Call on Friday, May 9 at 8:30 A.M. ET to Discuss Business Updates and First Quarter 2025 Financial Results

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on Ocugen

MALVERN, Pa., May 02, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Friday, May 9, 2025.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 1773288
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

GeoVax Labs (GOVX) – 1Q25 Reported With Pipeline Strategy Updates

Posted on by cpereira@noblefcm.com


Friday, May 02, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Quarter Included Contract Revenues. GeoVax reported a 1Q25 loss of $5.4 million or $(0.45) per share, a smaller loss than we had expected. The quarter included $1.6 million in Contract Revenue from the BARDA contract in preparation for the Phase 2 trial. Since the contract was cancelled on April 11, 2025, the 2Q25 results will include some final contract work. Cash on March 31, 2025, was $7.4 million.

CM04S1 Continues Development With Focus On Immunocompromised Patients. The current focus of CM04S1 development is in immunocompromised patients, a population estimated at 40 million patients in the US alone. Data from the Phase 1 and Phase 2 clinical trials for CM04S1 was presented at the 25th World Vaccine Congress. The two Phase 2 trials in chronic lymphocytic leukemia and stem cell transplants continue to enroll patients, while the Phase 2 Healthy Adult Booster trial is expected to report data during 2Q25.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Nutriband Inc. (NTRB) – Fiscal 2025 Reported With Product Progress Updates

Posted on by cpereira@noblefcm.com


Thursday, May 01, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Fiscal Year 2025 Reported. Nutriband reported its financial results for FY2025, ended January 31, 2025, with a 4Q25 loss of $5.5 million or ($0.50) per share and a loss of $10.5 million or $(0.99) per share. Preparations for the abuse-deterrence clinical testing continue, with an NDA expected toward 4Q25 or early 2026. As of January 31, 2025, the cash balance was $4.3 million.

Revenue For The Pocono Pharmaceutical Division Met Expectations. The Pocono Pharmaceutical division revenue for FY2025 was $2.1 million, with 4Q25 consistent with previous quarters. Gross margin improved in 4Q25 to 45% of sales, the highest level of the year. Nutriband has extended its contract manufacturing collaboration with KT tape, the kinesiology tape company, with modest growth in our projections for FY2026.


Get the Full Report

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Release – Tonix Pharmaceuticals Presented Preclinical Data on Gastric Cancer Models at the American Association for Cancer Research (AACR) 2025 Annual Meeting

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on Tonix Pharmaceuticals

April 29, 2025 9:05am EDT

Combination treatment of TFF2 with anti-PD1 antibody was associated with the activation of cancer-killing CD8+ T Cells and limiting immune evasion by tumor cells

TNX-1700 is in preclinical development for gastric and colorectal cancers

CHATHAM, N.J., April 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in a poster presentation at the American Association for Cancer Research (AACR) 2025 Annual Meeting, held April 25-30, 2025, in Chicago, IL. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. The presentation titled, “TFF2-mediated CXCR4 partial agonism outperforms CXCR4 antagonism in reducing murine gastric cancer by suppressing PMN-MDSC generation,” demonstrated positive data in gastric cancer animal models. In the AACR presentation, a fusion protein of murine trefoil factor family member 2- murine serum albumin (mTFF2-MSA) was studied. Tonix is developing human TFF2-human serum albumin (hTFF2-HAS) as TNX-1700.

“The combination therapy of mTFF2-MSA with anti-PD1 treatment shows promise in reducing immunosuppression in the tumor microenvironment (TME) in animal models,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to develop TNX-1700 (TFF2-HAS) as the lead program in our immuno-oncology pipeline, by testing potential dosing strategies, and establishing potential clinical biomarkers through preclinical models.”

Immunosuppressive neutrophils, also known as polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs), are a major component in solid tumors that significantly hinder anti-tumor activity1,2. Despite being short-lived, their continuous replenishment from the bone marrow sustains their potent immunosuppression in the TME3. Stromal cells in the TME promote immunosuppression by recruiting MDSCs via secretion of CXCL12. Trefoil Factor 2 (TFF2), a secreted peptide of the trefoil factor family, has displayed activity as a partial agonist of CXCR44,5. Data presented in the poster demonstrated that TFF2-MSA selectively reduces immunosuppressive neutrophils and cancer-driven granulopoiesis. Treatment with TFF2-MSA, in combination with an anti-PD1 antibody, induced robust anti-tumoral CD8+ T cell responses, inhibiting tumor invasion. TFF2 reduction correlated with elevated PMN-MDSCs in gastric cancer patients, highlighting the potential negative correlation between TFF2 and PMN-MDSCs levels.

About Trefoil Factor Family Member 2 (TFF2)

Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 (rTFF2-HSA) for the treatment of gastric and colon cancers under a license from Columbia University. The inventor of the core technology at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8+ T cells. He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth. Dr. Wang proposed the concept of employing rTFF2 in combination with other therapies in cancer prevention and early treatment.

1Kim W, et al. PD-1 Signaling Promotes Tumor-Infiltrating Myeloid-Derived Suppressor Cells and Gastric Tumorigenesis in Mice. Gastroenterology. 2021 Feb;160(3):781-796
2Veglia F, et al. Analysis of classical neutrophils and polymorphonuclear myeloid-derived suppressor cells in cancer patients and tumor-bearing mice. J Exp Med. 2021 Apr 5;218(4):e20201803.
3Colligan SH, et al. Inhibiting the biogenesis of myeloid-derived suppressor cells enhances immunotherapy efficacy against mammary tumor progression. J Clin Invest. 2022 Dec1;132(23):e158661.
4Dubeykovskaya Z, et al. Secreted trefoil factor 2 activates the CXCR4 receptor in epithelial and lymphocytic cancer cell lines. J Biol Chem. 2009 Feb 6;284(6):3650-62.
5Dubeykovskaya Z, et al. Neural innervation stimulates splenic TFF2 to arrest myeloid cell expansion and cancer. Nat Commun. 2016 Feb 4;7:10517.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released April 29, 2025

Release – GeoVax Highlights Strong Clinical Results Following Presentation of Multi-Antigen COVID-19 Vaccine at the 25th Annual World Vaccine Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GEO-CM04S1 Demonstrates Durable T Cell and Antibody Responses in Healthy and Immunocompromised Populations

ATLANTA, GA, April 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today recapped the successful presentation of new clinical data on its multi-antigen SARS-CoV-2 vaccine candidate, GEO-CM04S1, delivered at the 25th Annual World Vaccine Congress in Washington, D.C.

The presentation, titled “Phase 2b Study Results That Evaluated and Compared GeoVax’s Multi-Antigen Vaccine Candidate (GEO-CM04S1) to an Approved Vaccine Against COVID-19,” was given by Don J. Diamond, Ph.D. on April 24, 2025. It highlighted results across several Phase 1 and 2 clinical trials, including studies involving healthy volunteers as well as immunocompromised patients such as stem cell transplant recipients and those with chronic lymphocytic leukemia (CLL).

GEO-CM04S1, based on the synthetic Modified Vaccinia Ankara (MVA) vector platform, uniquely expresses both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2—resulting in broad and durable immune responses even in populations that have historically responded poorly to mRNA vaccines.

Key Highlights from the Clinical Data Presented

Robust Immune Response in Healthy Adults

  • In a Phase 1 trial, 100% of participants (34/34) seroconverted (i.e., produced antibodies) for Spike IgG, and 94% (32/34) for Nucleocapsid IgG.
  • 98% (48/49) demonstrated a T cell response to either antigen following vaccination.
  • No serious safety concerns were reported across varying dose levels.

Comparable Immunogenicity at Lower Doses (Phase 2 Booster Trial)

  • Healthy volunteers who had previously received mRNA or protein-based COVID-19 vaccines were boosted with GEO-CM04S1 at two dose levels (10⁷ vs 10⁸ pfu).
  • Spike, RBD, and Nucleocapsid IgG antibody responses, as well as neutralization titers against multiple COVID-19 variants (including XBB.1.5), increased significantly at both dose levels with no meaningful differences between them.
  • T cell responses increased significantly post-vaccination, regardless of baseline immunity.

Superior Performance in Immunocompromised Populations

  • In stem cell transplant recipients, GEO-CM04S1 induced ELISA antibody titers and T cell responses that exceeded those observed in healthy volunteers.
  • In a randomized Phase 2 trial comparing GEO-CM04S1 to the Pfizer-BioNTech (Comirnaty®) vaccine in patients with Chronic Lymphocytic Leukemia, GEO-CM04S1 demonstrated a significantly higher T cell response rate.
    • At Day 56 of the study: 6 of 15 patients in the GEO-CM04S1 arm achieved ≥3-fold increases in Spike or Nucleocapsid-specific T cells versus 2 of 14 in the Comirnaty arm.
    • The Data and Safety Monitoring Board (DSMB) recommended halting enrollment in the Pfizer arm due to underperformance, while continuing enrollment of the GEO-CM04S1 arm.

“We were pleased to share these promising results with global leaders in vaccinology,” said Don J. Diamond, Ph.D. “The data underscore the value of our dual-antigen approach, particularly for patients underserved by existing single-antigen vaccines. GEO-CM04S1 not only drives strong antibody and T cell immunity in healthy adults, but also in the immunocompromised—a population historically underserved by single-antigen mRNA vaccines.”

David A. Dodd, Chairman, President, and CEO of GeoVax, added: “The clinical performance of GEO-CM04S1 across diverse and high-risk populations supports our mission to deliver broad and lasting protection through next-generation vaccines. Our data continues to demonstrate strong, durable immune responses in both healthy and immunocompromised populations—a critical feature of our vaccine for public health preparedness. As we continue to advance this program, these results reinforce our confidence in the MVA platform as a foundation for addressing future public health threats.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on the Modified Vaccinia Ankara (MVA) vector originally developed at City of Hope. Its multi-antigen design expresses both Spike and Nucleocapsid proteins of SARS-CoV-2, promoting broad, cross-reactive immunity. The vaccine is being evaluated in three ongoing Phase 2 clinical trials.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – Cocrystal Pharma’s Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

April 24, 2025

 Download as PDF

  • Norovirus GII.17 variants have overtaken GII.4 as the most prevalent strain and significantly increased norovirus outbreaks in the U.S. and European countries in 2024-2025
  • Cocrystal Pharma’s pan-viral protease inhibitor CDI-988 shows superior broad-spectrum antiviral activity against major norovirus variants including GII.4 and GII.17 strains
  • Company reported favorable safety and tolerability of CDI-988 in Phase 1 and plans to initiate a human challenge study in 2025 for the treatment and prevention of norovirus infection

BOTHELL, Wash., April 24, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its investigative drug candidate CDI-988 was shown to bind to the highly conserved region of the GII.17 protease with excellent potency, similar to that shown across a range of GII.4 norovirus variants that had been the dominant worldwide strains until this year. The high resolution GII.17 protease crystal structures used in determining CDI-988’s activity were obtained using the Company’s proprietary structure-based platform technology. Cocrystal plans to initiate a human norovirus challenge study in 2025 in the U.S. to evaluate CDI-988 as a potential prevention and treatment of norovirus infection.

“Norovirus is the most common cause of acute gastroenteritis worldwide, yet there are no approved antiviral treatments or vaccines available to combat it,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Norovirus antiviral and vaccine development has been extremely challenging due to high diversity among variants that include 10 genogroups and 49 genotypes. We are gratified to have determined the first crystal structure of GII.17 protease and demonstrated broad-spectrum antiviral activity of CDI-988 against newly circulating major norovirus GII.17 variants. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral antiviral to be used for both prevention and treatment of norovirus infection.”

“Norovirus is a noteworthy research target considering that each year an estimated 685 million cases and approximately 50,000 child deaths are attributed to this virus worldwide, leading to a societal cost estimated at $60 billion,” said James Martin, Cocrystal’s CFO and co-CEO. “We are addressing the urgent need for norovirus and other emerging viral outbreaks through our platform technology that facilitates the rapid, efficient development of potentially highly effective and safe direct-acting antivirals.”

Pan-Viral Inhibitor CDI-988
CDI-988 is a protease inhibitor specifically designed and developed as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. The Company has completed a single-center, randomized, double-blind Phase 1 study in healthy adults evaluating safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo.

Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Cocrystal’s plans to initiate a human challenge study in 2025 for its oral norovirus product candidate, the potential efficacy of such product candidate, and the potential market for such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulations affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed with our development programs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

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Source: Cocrystal Pharma, Inc.

Released April 24, 2025

Release – GeoVax to Report First Quarter 2025 Financial Results and Provide Corporate Update on May 1, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, April 23, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report first quarter 2025 financial results on Thursday, May 1, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – GeoVax Appoints Dr. Senthil Ranganathan as Vice President, Technical Development and CMC Operations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

  • Last updated: 22 April 2025
  • Created: 22 April 2025
  • Hits: 49

Recognized Biologics Executive to Oversee Critical Expansion of U.S.-Based Development Capabilities

ATLANTA, GA, April 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced the appointment of Senthil Ranganathan, Ph.D. as Vice President, Technical Development and CMC Operations. Dr. Ranganathan brings over 20 years of experience in biologics development to commercialization across vaccines, cell and gene therapies, monoclonal antibodies, and viral vector products.

This appointment comes at a pivotal time for GeoVax as it advances a comprehensive portfolio of infectious disease vaccines and cancer therapies, positioning the Company to address significant unmet medical needs, contributing to biodefense readiness, and improving vaccine and therapeutic equity through innovation and onshoring.

David Dodd, Chairman & CEO of GeoVax, stated: “We are delighted to welcome Senthil to GeoVax. His track record and expertise in a breadth of biologics development and preparation for registration and subsequent commercialization will support and enhance our progress as we proceed towards the authorization and subsequent commercialization stages for our exciting development portfolio.”

Dr. Ranganathan has held senior leadership roles across industry-leading biopharmaceutical companies, most recently serving as Head of Process Development CMC for the Boston site of National Resilience. He previously led global CMC and manufacturing operations at Athersys, Zymeworks, and Alder Biopharmaceuticals (acquired by Lundbeck Biopharmaceuticals). His career has spanned the development and validation of cell and gene therapies, vaccines, bispecific antibodies, and other biologics—from pre-IND through licensure and commercialization.

He holds a Ph.D. in Biochemistry from Loyola University Chicago and has authored numerous regulatory submissions and publications in support of breakthrough vaccines, biologics, and therapies.

“I am honored to join GeoVax during such a critical stage of the Company’s growth and development,” said Dr. Ranganathan. “I look forward to working with the outstanding GeoVax team as we develop and execute the roadmap that will bring the GeoVax portfolio to benefit patients and communities worldwide.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – GeoVax Provides Update on BARDA Project NextGen and Outlines 2025 Business Momentum

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments

ATLANTA, GA, April 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin®), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process.

GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans—and over 400 million people globally—who remain inadequately protected by the current authorized COVID-19 vaccines.  Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines.

The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses.  Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative.

“While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,” said David Dodd, Chairman and CEO of GeoVax.

Continued Progress Across a Catalyst-Rich Pipeline

GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs

GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:

  • Healthy Adult Booster Trial – Enrollment is complete; data readout expected in H1 2025.
  • CLL Patient Study (Immunocompromised patient study) – Ongoing enrollment; interim results resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
  • Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) – Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.

GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.

Gedeptin®: Advancing into Phase 2 in Solid Tumors

GeoVax’s oncology program, utilizing the Gedeptin® technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients.  The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.

GEO-MVA: Addressing Biosecurity and Global Vaccine Equity

GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025.  GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.

Advanced Manufacturing: Scaling MVA for Global Reach

GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production—including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience.

Outlook for 2025

Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency.

“Our scientific foundation is strong and our strategy is clear,” added Dodd. “GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We’re advancing with purpose and fully prepared to deliver on the promise of our development program.”

For further details on GeoVax’s programs and progress, visit www.geovax.com.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696