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Release – MAIA Biotechnology Reports Strong Enrollment and Dosing Momentum in Pivotal Phase 3 Non-Small Cell Lung Cancer Trial

Posted on June 5, 2026June 5, 2026 by [email protected]

June 04, 2026 9:45am EDTDownload as PDF

MAIA’s novel telomere-targeting therapy being evaluated as a third-line treatment for advanced non-small cell lung cancer

CHICAGO, June 04, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today provided a patient enrollment update for its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries.

Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, commented, “Enrollment and dosing in our Phase 3 study is progressing at a strong pace. Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027.”

Dr. Vitoc has previously stated that statistical assessments of MAIA’s lead therapeutic, ateganosine, suggest a high probability of technical success in the THIO-104 full approval trial if Phase 3 data is consistent with Phase 2 THIO-101 trial results. Median overall survival was 17.8 months in parts A and B of the Phase 2 trial. With chemotherapy, which is the standard utilized treatment for 3L NSCLC patients, expected survival in a heavily pre-treated population is 5.8 months.¹

Ateganosine is a first-of-its-kind dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. As a potential breakthrough therapeutic, ateganosine holds substantial commercial opportunity in a projected $70 billion global NSCLC treatment market by 2030.²

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine as a 3L NSCLC treatment.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

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
[email protected]

¹ Girard N, et al. J Thorac Onc 2009;12:1544-1549
² Research and Markets, Non-Small Cell Lung Cancer (NSCLC) Global Market Trends and Regional Growth Insights 2026-2030, March 2026

Source: MAIA Biotechnology, Inc.

Released June 4, 2026

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on June 3, 2026June 3, 2026 by [email protected]

June 03, 2026

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BOTHELL, Wash., June 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company developing novel therapeutics to meet the growing need for effective, safe antiviral treatments, has appointed James Sapirstein Chief Executive Officer, effective immediately. The Company also plans to appoint Mr. Sapirstein as a member of the Board of Directors. He has extensive pharmaceutical industry leadership and development experience. Mr. Sapirstein replaces Sam Lee and Jim Martin, who served as Co-Chief Executive Officers. Sam Lee will continue as President and transition to Chief Scientific Officer, and Jim Martin will continue as Chief Financial Officer.

“James brings the right experience in the biopharma business as we’re accelerating the advancement of multiple clinical programs,” said Roger Kornberg, Ph.D., Chairman of Cocrystal Pharma. “We have known him for many years, and our management team and board are appreciative of his decision to join us as Chief Executive Officer.”

Mr. Sapirstein commented, “Cocrystal’s pipeline comprises transformative antivirals developed using its structure based drug discovery platform. We are well positioned with the right technology and team to create meaningful benefits for patients as well as our shareholders. The potential to address the need for new antivirals is highly motivating for me with my product development and launch background.”

Mr. Sapirstein has participated in or led 23 product launches. He has also driven numerous business development transactions. Mr. Sapirstein was Chief Executive Officer of Contravir Pharmaceuticals, served as the founding Chief Executive Officer of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories.

Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

Mr. Sapirstein is a member of several industry boards and previously served as Chairman of BioNJ as well as Biotechnology Innovation Organization board member for more than a decade. He is also a founding member of the board of advisors of the Miami Biotech Collective.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal Pharma is leveraging its structure based drug discovery platform technology to design next generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off target effects, offering potentially safer, broad spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

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 identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. This technology permits the development of novel broad spectrum antivirals.

About Cocrystal Pharma

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 to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on June 3, 2026June 3, 2026 by [email protected]

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being researched as a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on June 3, 2026June 3, 2026 by [email protected]

June 03, 2026 9:45am EDT

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

About Ateganosine

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo^®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo^®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on June 3, 2026June 5, 2026 by [email protected]

Research News and Market Data on MAIA

June 03, 2026 9:45am EDTDownload as PDF

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

About Ateganosine

About THIO-101 Phase 2 Clinical Trial

About MAIA Biotechnology, Inc.

Forward Looking Statements

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

Released June 3, 2026

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on June 3, 2026June 5, 2026 by [email protected]

Research News and Market Data on CVKD

Lead asset CAD-1005 being researched for prevention of life-threatening blood clots in patients with Heparin-induced Thrombocytopenia (HIT), targets $2 billion peak annual revenue potential

12-LOX could play a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis, and is a potential target for therapy and prevention of cancer

Late-stage anticoagulant tecarfarin has U.S. Food and Drug Administration (FDA) Orphan Drug and Fast Track designations for high-risk patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and those patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs)

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, without limitation, statements regarding the Company showcasing its Phase 3-ready CAD-1005 and novel 12-LOX platform at BIO 2026; CAD-1005 being researched for the prevention of life-threatening blood clots in patients with HIT; CAD-1005 targeting $2 billion peak annual revenue potential; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including diabetes, obesity, atherosclerosis, and microvascular thrombosis; 12-LOX being a potential target for therapy and prevention of cancer; the Company advancing novel therapies for life-threatening immune and thrombotic conditions; the Company’s participation in BIO 2026, taking place June 22-25, 2026, at the San Diego Convention Center; the Company’s executive management team hosting partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-LOX inhibitor being investigated for the treatment of patients with HIT, and tecarfarin, a late-stage oral VKA being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal; Cadrenal preparing to initiate its Phase 3 registration trial for CAD-1005; the Company believing it is uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades; the Company engaging with potential partners who share its vision of the potential to bring this breakthrough mechanism to patients; CAD-1005 being a potential first-in-class solution for HIT; CAD-1005 being investigated to target the root cause of HIT; CAD-1005 being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT; CAD-1005 reducing thrombotic events in patients with HIT; Cadrenal leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform; 12-LOX playing a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity; 12-LOX being a potential target for therapy and prevention of cancer; the Company’s platform representing a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents; Cadrenal aiming to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications; tecarfarin being a potentially superior anticoagulant for complex cases; Cadrenal presenting opportunities for tecarfarin, its late-stage oral anticoagulant, at BIO 2026; tecarfarin being designed with the goal of being a uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and DOACs; Cadrenal advancing novel therapies for life-threatening immune and thrombotic conditions; CAD-1005 being researched as a first-in-class 12-LOX inhibitor for treating HIT; the development of second-generation 12-LOX oral therapeutics for chronic indications; tecarfarin preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices; and frunexian being used in acute hospital settings. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on June 3, 2026June 5, 2026 by [email protected]

Research News and Market Data on COCP

June 03, 2026

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Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

About Cocrystal Pharma

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 the Company’s potential to address the need for new antivirals through its research and development of product candidates. 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, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. 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.

Investor Contact:

Nicolas Johnson
Russo Partners
[email protected]
(303) 482-6405

Media Contact:

David Schull
Russo Partners
[email protected]
(858) 717-2310

Attachment

Cocrystal Pharma Inc.

Cocrystal Pharma Inc.

Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Infectious Disease Therapeutics Development Experience

Source: Cocrystal Pharma, Inc.

Released June 3, 2026

Release – Cardiff Oncology Announces Presentation of Positive Results from its Randomized, Controlled Phase 2 Trial of Onvansertib in First-Line RAS-Mutated mCRC at the 2026 ASCO Annual Meeting

Posted on June 2, 2026June 2, 2026 by [email protected]

Research News and Market Data on CRDF

June 2, 2026

PDF Version

- The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -

- 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -

- Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -

– Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -

– Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -

– Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib –

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.

“RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers,” said Dr. Lenz. “With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients.”

Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026):
In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Safety/Tolerability:
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

“We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC,” said Mani Mohindru, PhD, President and Chief Executive Officer. “The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months.”

The ASCO presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.

Conference Call and Webcast
The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.

CRDF-004 Trial Design
The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; ; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. with respect to our license agreement with Nerviano; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]

Release – MAIA Biotechnology Announces Open Market Purchases by CEO and Director

Posted on June 2, 2026June 2, 2026 by [email protected]

Research News and Market Data on MAIA

June 02, 2026 9:45am EDT Download as PDF

CHICAGO, June 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that its founder and CEO Vlad Vitoc, M.D. and Director Stan V. Smith, Ph.D. have increased their ownership positions through open market purchases.

Approximately 72,700 shares of MAIA common stock were purchased by Dr. Vitoc on June 6, 2026, at an average common stock price of $1.3877. Approximately 75,000 shares of MAIA common stock were purchased by Dr. Smith on June 6, 2026, at an average common stock price of $1.336.

“Our continuing investments underscore our strong confidence in the telomere-targeting immuno-oncology platform we’ve established,” said Dr. Vitoc. “As the ateganosine program advances toward later-stage development, we believe ateganosine could become an important new standard of care for patients with advanced non-small cell lung cancer.”

“MAIA continues to advance what I believe is a differentiated approach to cancer treatment with strong scientific rationale and encouraging clinical momentum,” Dr. Smith added. “I’m a strong believer in the incredible potential future that MAIA has in contributing to the patients and investors alike.”

To date, directors and officers of MAIA hold a 20.46% stake in the Company.

About Ateganosine

About MAIA Biotechnology, Inc.

Forward Looking Statements

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Source: MAIA Biotechnology, Inc.

MAIA Biotechnology (MAIA) – Phase 3 THIO-104 Trial Design Presented At ASCO

Posted on June 2, 2026June 2, 2026 by [email protected]

Tuesday, June 02, 2026

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.

Phase 3 THIO-104 Design Is Consistent With Expectations. MAIA presented a poster on May 31, 2026, at the Annual ASCO (American Society of Clinical Oncology) Meeting. The poster detailed the design of its ongoing Phase 3 THIO-104 trial that tests ateganosine (aka THIO) in combination with the checkpoint inhibitor cemiplimab as a third-line treatment for patients with non-small cell lung cancer (NSCLC) who have become resistant to CPI treatment and chemotherapy.

Trial Design Is Consistent With Results From Phase 2 THIO-101 Trial. The patient population, selected dose, and combination regimen with Ateganosine 180mg and cemiplimab (Libtayo, from Regeneron) are the same as those in the Phase 2 THIO-101 study. At last analysis as of June 30, 2025, this regimen showed a median observed Overall Survival (OS) of 17.8 months, compared with published studies reporting an OS of 5.8 months.

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Greenwich LifeSciences, Inc. (GLSI) – Additional Phase 3 FLAMINGO-01 Data Presented At ASCO Meeting

Posted on June 2, 2026June 2, 2026 by [email protected]

Tuesday, June 02, 2026

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.

Additional Data Presented At ASCO. Greenwich LifeSciences presented an abstract and poster at the ASCO Annual Meeting. The data assessed non-HLA-A*02 patients in the open-label arm after six monthly doses of GLA-100. The data show statistically significant injection site reaction (ISR) and immune response at baseline, with increases over time.

Patients Were Evaluated After Initial Immune Stimulation. Patients received the Primary Immunization Series (PIS), consisting of six vaccinations over the first six months of the trial. The fourth, fifth, and sixth vaccinations showed a significant increase in the percentage of patients showing an ISR compared to baseline. Of the 247 patients enrolled, 208 had both baseline vaccination and assessments at 4, 5, or 6 months.

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Release – GeoVax CEO Welcomes FIFA World Cup 2026 While Addressing Biothreat Readiness

Posted on June 1, 2026June 1, 2026 by [email protected]

Research News and Market Data on GOVX

Largest FIFA Tournament in History Expected to Draw 6.5 Million Attendees Across North America and More Than 1.2 Million International Visitors to U.S. Host Cities Amid Growing Concerns Regarding Mpox, Ebola, Hantavirus, Measles, and Other Emerging Infectious Disease Threats

ATLANTA, GA – June 1, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today welcomed the upcoming FIFA World Cup 2026 and highlighted the importance of public health readiness, healthcare capacity, and biodefense capabilities as North America prepares to host the largest sporting event in history.

According to a recent economic impact analysis conducted by Oxford Economics and Tourism Economics, FIFA World Cup 2026 is expected to attract approximately 6.5 million attendees across the United States, Canada, and Mexico, including more than 1.2 million international visitors traveling to U.S. host cities alone. For public health authorities, healthcare systems, emergency management agencies, and national security planners, the tournament represents a real-world test of disease surveillance, healthcare capacity, emergency response coordination, vaccine availability, and critical public health infrastructure at a scale rarely encountered outside of a global crisis.

The event arrives amid a period of increasing infectious disease activity marked by ongoing Clade I mpox transmission, the escalating Bundibugyo Ebola outbreak in Central Africa, renewed concern surrounding zoonotic pathogens such as hantavirus and avian influenza, and growing measles outbreaks in multiple regions. Together, these developments reinforce a broader reality: biological threats are becoming more global, more interconnected, and increasingly simultaneous.

“FIFA 2026 represents more than a sporting event. It is a large-scale operational challenge occurring in an era of persistent biological risk,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “When millions of people move across borders, transportation networks, and densely populated urban environments over a compressed period of time, health security becomes an operational necessity. The ability to detect, monitor, and respond rapidly to emerging infectious disease threats will be as important as the infrastructure supporting the tournament itself.”

Mass gatherings do not create outbreaks. However, they can amplify the operational consequences of existing vulnerabilities. Millions of visitors moving through airports, public transportation systems, hotels, entertainment venues, and urban centers create conditions that test disease surveillance systems, laboratory capacity, healthcare surge capabilities, public communication networks, and cross-jurisdictional coordination.

Recent outbreaks have reinforced the reality that governments can no longer focus on a single pathogen at a time. The continued spread of mpox beyond historically endemic regions, the emergence of more virulent viral strains, and the ongoing Bundibugyo Ebola outbreak, which currently lacks a broadly licensed vaccine specifically approved for widespread deployment, underscore the need for flexible response capabilities able to address multiple evolving threats simultaneously.

“The central challenge is no longer responding to a single outbreak,” continued Dodd. “Governments and health systems increasingly require the ability to manage multiple biological threats at once. Health security today means more than surveillance. It requires manufacturing capacity, supply-chain diversification, stockpile availability, operational coordination, and the ability to rapidly deploy effective countermeasures when and where they are needed.”

GeoVax believes several priorities warrant increased attention as FIFA 2026 approaches:

Expanding domestic vaccine manufacturing capacity
Diversifying critical medical countermeasure supply chains
Enhancing disease surveillance and rapid-response capabilities
Supporting adaptable vaccine platform technologies
Strengthening public-private health security partnerships
Improving stockpile management and deployment logistics

A New Era of Biological Risk

The World Cup does not create vulnerabilities. It has the potential to expose them.

Recent mpox outbreaks demonstrated how rapidly demand for vaccines and medical countermeasures can outpace available supply. The Bundibugyo Ebola outbreak has highlighted continuing gaps in available tools for emerging pathogen variants. At the same time, concerns regarding zoonotic spillover events, international mobility, and supply-chain concentration have reinforced the importance of scalable manufacturing capacity, diversified sourcing, flexible vaccine technologies, and geographically distributed biodefense infrastructure.

The ongoing mpox environment has also highlighted the strategic importance of poxvirus vaccine availability. Today, global supply of MVA-based poxvirus vaccines remains concentrated among a single non-U.S. manufacturer, creating potential constraints during periods of heightened demand. Expanding manufacturing capacity and strengthening supply diversity may play an important role in future health security efforts.

GeoVax’s development portfolio is anchored by GEO-MVA, an MVA-based poxvirus vaccine candidate being advanced for protection against mpox and smallpox and intended to support a more diversified global poxvirus vaccine supply. GeoVax is also advancing Gedeptin^®, an immuno-oncology program designed to enhance anti-tumor immune responses in solid tumors. The Company’s broader technology portfolio includes preclinical vaccine candidates targeting hemorrhagic fever pathogens, including Ebola and Marburg viruses, which have demonstrated encouraging efficacy in animal studies and may provide future strategic optionality for biodefense and global health applications.

“As the world comes together to celebrate FIFA World Cup 2026, we extend our congratulations to the athletes who have dedicated years to reaching this global stage and to the organizers responsible for bringing this remarkable event to life,” concluded Dodd. “The success of gatherings like these depends not only on what happens on the field, but also on the public health systems, healthcare infrastructure, and operational planning that support them behind the scenes. By investing in manufacturing capacity, disease surveillance, and biodefense capabilities today, we can help ensure that the world’s attention remains focused where it belongs – on the athletes, the competition, and the spirit of international cooperation.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin^®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Greenwich LifeSciences Provides Update Regarding Form 10-K Filing

Posted on June 1, 2026 by [email protected]

Research News and Market Data on GLSI

Download as PDFJune 01, 2026 6:00am EDT

STAFFORD, Texas, June 01, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on its Form 10-K filing for the fiscal year ending December 31, 2025.

The Form 10-K for the fiscal year ending December 31, 2025, continues to be audited by our new auditor and we believe it is in the final approval steps. The Form 10-K also includes the 2024 audit that was previously audited by the prior auditor. As previously indicated, the accounts payable adjustments are related to the large global Phase III clinical trial underway and the unexpectedly large increase in screening and patient enrollment in Europe in 2024 and 2025. Both auditors in a dual auditor filing must agree in order to make timely filings, which did not occur in March or April, and such coordination is still required as part of the final approval steps.

The Company believes that it did not contribute to the delays in filing and instead did everything possible to file on time. The Company provided the 10K filing information with large increases to accounts payable to the auditors for review in early February 2026 and requested and anticipated an early filing. The Company has further improved its accounts payable estimations using current clinical trial data in its financials for Form 10-Q for the period ending March 31, 2026.

The Company believes that the accounts payable adjustments are not material to the Company or its investors and does not change the fundamentals of the Company. The shift in expenses does not change the cash balance or the net cash used in operating activities of the Company. As previously announced, the Company’s ending cash balance as of March 31, 2026 is approximately $10.5 million, which the Company believes is an improvement over 2025 ending cash balances, and includes the retirement of over 75% of accounts payable for the fiscal year ending December 31, 2025. This $10.5 million cash balance is more than the 2025 net cash used in operating activities which is approximately $9.9 million. The above figures are unaudited and are subject to change following the completion of the Company’s financial audit for the year ending December 31, 2025 and the review for the period ending March 31, 2026.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
- The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster can be downloaded here.
- The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
- As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
- Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released June 1, 2026