Category: Health

Cardiff Oncology (CRDF) – FY2025 Reported With Onvansertib Phase 2b Data Review

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, February 26, 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.

FY2026 Reported With Onvansertib Review. Cardiff reported a FY2025 loss of $45.8 million or $(0.69) per share and reviewed the clinical data for onvansertib, its drug for RAS-mutated metastatic colorectal cancer (mCRC). Updated plans for Phase 3 are expected after discussions with the FDA during 1H26. On December 31, 2025, Cardiff ended the year with $58.3 million in cash and equivalents, which it believes can fund operations through 1Q27.

Phase 2 CRDF-004 Trial Design. The CDRF-004 Phase 2 trial was designed to test two doses of onvansertib in combination with two standard-of-care (SOC) regimens against each standard of care regimen alone. It enrolled 110 patients with RAS-mutated mCRC. The primary endpoint was objective response rate (ORR).


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Biotech’s 2026 Capital Window: Why Clinical-Stage Companies Are Preparing Now

Posted on by slightbourne@noblecapitalmarkets.com

Clinical development is inherently capital intensive. As programs move from early-stage studies into Phase 2 and Phase 3 trials, costs typically rise due to expanded enrollment, multi-site coordination, manufacturing scale-up, and regulatory preparation.

Companies such as Eledon Pharmaceuticals, which is advancing immune-modulating therapies, and Cardiff Oncology, focused on targeted oncology treatments including onvansertib, illustrate the type of clinical-stage businesses navigating these funding dynamics. As programs mature, capital planning becomes increasingly tied to milestone timing.

Similarly, Ocugen, with gene therapy and ophthalmology-focused programs, and Cocrystal Pharma, which develops antiviral therapeutics, operate in segments where development timelines and regulatory pathways can require sustained financial flexibility.

Even companies earlier in commercialization strategy development, such as Nutriband, which is advancing transdermal pharmaceutical technologies, must balance product advancement with capital market realities.

These examples reflect a broader sector pattern: advancing innovation requires consistent access to funding.

The Importance of the Catalyst Calendar

Biotech financing windows often open around meaningful clinical or regulatory catalysts. Positive data can strengthen negotiating leverage. But waiting until after results are announced can introduce risk — particularly if broader market conditions shift.

With 2026 shaping up to include a number of anticipated data readouts across the industry, companies are evaluating whether to raise capital ahead of milestones, opportunistically during periods of sector strength, or in response to results.

Preparation matters.

Management teams that establish investor visibility and maintain consistent communication before catalysts emerge may find themselves better positioned if and when market windows open.

M&A Activity Is a Tailwind — Not a Strategy

Large pharmaceutical companies continue to evaluate external pipelines to supplement internal research efforts. Periodic acquisition activity can improve sentiment across small-cap biotech and help reset valuation benchmarks.

However, M&A remains selective and unpredictable. Most clinical-stage companies must plan under the assumption that equity or structured financing will remain the primary funding path.

For investors, that distinction is important.

Why Capital Strategy Matters for Shareholders

In small-cap biotech, capital access influences more than just cash runway. It can affect development pace, trial continuity, partnership leverage, and dilution levels.

A company that secures funding under stable market conditions may retain greater operational flexibility. One that is forced to raise under pressure may encounter less favorable terms.

As 2026 approaches, the differentiator may not simply be who generates data — but who manages capital strategy effectively alongside clinical execution.

Biotech remains data-driven and inherently volatile. Yet improving sector sentiment and a growing milestone calendar suggest that capital formation decisions could play a defining role in shaping outcomes over the next 12–18 months.

For small-cap investors, understanding both the science and the financing strategy may be equally important in the year ahead.

Cadrenal Therapeutics (CVKD) – CAD-1005 Phase 2 Results Announced, With FDA Guidance Meeting Scheduled

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, February 25, 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.

Cadrenal Announced Phase 2 Data With End-of-Phase-2 Meeting Scheduled. Cadrenal announced data from the Phase 2 trial of its anti-thrombotic CAD-1005 (formerly known as VLX-1005) for HIT, or heparin-induced thrombocytopenia. Cadrenal has also been granted an End-of-Phase 2 meeting with the FDA to discuss the trial results and design of a Phase 3 trial. These are important milestones in the development of CAD-1005.

Phase 2 Produced Unexpected Findings. The Phase 2 trial tested safety and efficacy of CAD-1005 in patients receiving standard anticoagulant therapy. Its Primary Endpoint was designed to show CAD-1005 improved platelet recovery, testing platelet count recovery as a biomarker for thrombosis and outcome. This Primary Endpoint did not meet statistical significance, and did not find a correlation between platelet count normalization and thrombotic events.


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Release – Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CRDF

February 24, 2026

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Reported positive update from Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating:
• Robust ORR of 72.2% (vs 43.2% with combined SoC of FOLFOX/bev and FOLFIRI/bev)
• Significant improvement in PFS over combined SoC (HR: 0.37, p<0.05)

Data support selection of 30 mg onvansertib dose in combination with FOLFIRI/bev for planned registrational program; detailed data and registrational plans expected in the first half of 2026

SAN DIEGO, Feb. 24, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the full year ended December 31, 2025, and provided a business update.

“Cardiff Oncology has entered 2026 with strong clinical momentum and a clear path for advancing onvansertib, our lead program, in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Our focus in 2025 was on rigorous clinical execution, which allowed us to generate increasingly compelling evidence supporting onvansertib’s potential to improve patient outcomes in RAS-mutated mCRC, culminating in the latest positive data cut announced earlier this year. The CRDF-004 trial demonstrated a consistent, dose-dependent treatment benefit when onvansertib was added to FOLFIRI/bev, including a near 30% improvement in response rate over the control arm and encouraging durability trends as measured by progression-free survival. These data are in line with what we had previously seen in our second-line trial in bev-naive patients treated with onvansertib + FOLFIRI/bev. Given that it has been over two decades since there has been meaningful innovation for this patient population, we believe these results represent a transformative step forward.”

Continued Dr. Mohindru, “Based on these results, we plan to advance the 30 mg dose of onvansertib with FOLFIRI/bev into our proposed registrational program and expect to provide detailed data and registrational plans after discussions with the FDA in the first half of 2026. As we transition into late-stage clinical development and continue to strengthen our leadership and operational teams, we remain focused on disciplined execution, progressing our lead program toward a potential new standard of care in first-line RAS-mutated mCRC.”

Company highlights for the quarter ended December 31, 2025, and subsequent weeks

Positive update from randomized Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (“mCRC”) support advancement of the onvansertib program into registrational development

  • In January 2026, Cardiff reported a positive update from CRDF-004, a randomized Phase 2 trial evaluating onvansertib in combination with standard of care (“SoC”) regimens in patients with first-line RAS-mutated mCRC. As of the January 22, 2026 cutoff in the intent-to-treat population, the 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) of 72.2%, compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed.
  • Based on these results, the Company expects to advance the 30 mg dose of onvansertib in combination with FOLFIRI/bev into planned registrational development. Cardiff expects to share detailed Phase 2 CRDF-004 data and, after discussions with the FDA, provide registrational plans for onvansertib in combination with FOLFIRI/bev in first-line RAS-mutated mCRC in the first half of 2026.

Executive leadership team transitioned to support late-stage development

  • In January 2026, Cardiff announced executive leadership changes to support the Company’s transition into late-stage clinical development and advancement toward key clinical and corporate milestones. Mani Mohindru, PhD, a member of Cardiff’s Board of Directors since 2021 and an experienced biotechnology executive, was appointed interim Chief Executive Officer. Brigitte Lindsay was promoted to Chief Accounting Officer, ensuring continuity within the Company’s finance function. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.

Presentation of investigator-sponsored clinical data in chronic myelomonocytic leukemia (“CMML”) at the American Society of Hematology (“ASH”) Annual Meeting

  • In December 2025, clinical data from an investigator-sponsored Phase 1 trial evaluating onvansertib monotherapy in CMML were presented at ASH 2025. In the dose-escalation trial (N=9), onvansertib was generally well-tolerated and demonstrated preliminary efficacy in approximately 40% of patients, including one patient achieving an optimal bone marrow response. These clinical findings further validate onvansertib’s potential activity across both hematologic and solid tumors.

Full Year 2025 Financial Results

Liquidity and Cash Runway

As of December 31, 2025, Cardiff Oncology had approximately $58.3 million in cash, cash equivalents, and short-term investments. Based on its current operating and clinical plans and projected expenditures, the Company believes that its existing cash resources are sufficient to fund operations into the first quarter of 2027.

Operating Results

Total operating expenses for the year ended December 31, 2025 were approximately $49.6 million, compared to $49.3 million for the year ended December 31, 2024. The $0.3 million increase was primarily attributable to an increase in SG&A expense, driven mainly by strategic advisory services and incremental employee separation costs recorded in the current period. This increase was partially offset by lower R&D expenses related to clinical trial activity and outside services. The reduction in R&D expenses was partially offset by an increase in stock-based compensation expense during the current period.

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; 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
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

View full release here.

Release – GeoVax Announces Oncology Advisory Board to Advance Gedeptin® Development Across Solid Tumors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Members Bring Deep Expertise in Immuno-Oncology, Translational Medicine, and Checkpoint Inhibitor Combination Strategies

ATLANTA, GA – February 24, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for cancers and infectious diseases, today announced the formation of its Oncology Advisory Board with the appointment of three internationally recognized leaders in immuno-oncology, translational medicine, and clinical development.

This Advisory Board will play a central role in guiding the scientific, translational, and clinical advancement of GeoVax’s oncology program, focused primarily on Gedeptin®, the company’s gene-directed enzyme prodrug therapeutic (GDEPT).  GeoVax plans to conduct a Phase 2 trial with Gedeptin in the neoadjuvant setting, pairing it with an immune checkpoint inhibitor (ICI) in locally advanced head and neck squamous cell carcinoma. In parallel, it will be evaluating combination Gedeptin + ICI strategies across additional solid tumor indications.

Oncology Advisory Board Members

Chas Bountra, PhD, OBE
Professor of Translational Medicine, University of Oxford
Former Pro-Vice-Chancellor for Innovation, University of Oxford
Former Vice President & Head of Biology, GlaxoSmithKline

Dr. Bountra brings extensive leadership spanning academia, biotech, and global pharmaceutical R&D. He is widely recognized for building translational drug discovery engines, advancing novel therapeutic modalities into the clinic, and creating high-impact academic–industry partnerships. His expertise in translational medicine, drug development strategy, and innovation ecosystems will support Gedeptin’s progression from proof-of-concept to clinically scalable development programs aligned with regulatory and partnership pathways.

Marc S. Ernstoff, MD
Director, Experimental Cell Therapy, Dartmouth Health
Former Chief, Immuno-Oncology Branch, National Cancer Institute (NIH)

Dr. Ernstoff is a recognized pioneer in cancer immunotherapy with significant experience across cytokine therapy, checkpoint inhibitors, and combination immuno-oncology trials. His career includes leadership roles at the National Cancer Institute, Roswell Park Comprehensive Cancer Center, Dartmouth-Hitchcock, and Yale, with direct involvement in numerous landmark immunotherapy studies. His expertise will inform Gedeptin’s clinical positioning, trial design considerations, and biomarker-driven evaluation alongside immune checkpoint inhibitors, as well as its potential role in immune-sensitizing solid tumors.

Anthony J. Olszanski, MD, RPh
Professor of Medicine and Vice Chair for Clinical Research
Fox Chase Cancer Center

Dr. Olszanski is a nationally recognized leader in early-phase oncology drug development, with deep experience running first-in-human and Phase 1/2 trials across solid tumors, including multiple checkpoint inhibitor combinations, oncolytic approaches, and novel immune-modulating agents. His background in clinical pharmacology and trial execution will be instrumental as GeoVax advances Gedeptin into combination, neoadjuvant, and expansion-stage clinical settings.

Strategic Focus: Advancing Gedeptin in Combination Immuno-Oncology

This Oncology Advisory Board, with expertise in oncology and translational medicine, reflects GeoVax’s increasing focus on Gedeptin as a differentiated immune-sensitizing platform, particularly in combination with immune checkpoint inhibitors. Gedeptin’s intratumoral delivery and localized tumor-debulking mechanism are designed to enhance antigen release and immune activation within the tumor microenvironment – an approach that may complement and extend the efficacy of systemic checkpoint blockade.

In addition to scientific strategy, these advisors will provide integrated guidance on clinical trial design, translational biomarker strategy, patient selection, and regulatory-aligned development pathways as Gedeptin advances through combination and neoadjuvant clinical programs.

David A. Dodd, Chairman & Chief Executive Officer of GeoVax, commented: “The addition of these three exceptional oncology leaders significantly strengthens our scientific and clinical foundation as we advance Gedeptin into its next stage of development. Their collective experience – from early drug discovery through late-stage immuno-oncology trials and regulatory strategy – directly aligns with our goal of positioning Gedeptin as a novel immune-sensitizing therapy across solid tumors.”

Kelly T. McKee, MD, Chief Medical Officer of GeoVax, added: “Gedeptin sits at the intersection of localized tumor control and systemic immune activation. As checkpoint inhibitors move earlier in treatment paradigms, including neoadjuvant settings, expert guidance on trial design, patient selection, and translational endpoints is critical as we move into clinically consequential combination strategies. We anticipate that this Advisory Board will provide precisely that level of integrated scientific and clinical insight.”

About Gedeptin®

Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following systemic administration of a prodrug, the encoded enzyme converts it into a cytotoxic agent directly within the tumor microenvironment, selectively destroying tumor cells while promoting immune recognition. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and has received Orphan Drug Designation for oral and pharyngeal cancers.

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’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. 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:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MAIA Biotechnology’s Phase 3 Momentum Demonstrates Potential Breakthrough Anticancer Opportunity in $50 Billion Immunotherapy Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 24, 2026 8:45am EST

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Ongoing Phase 3 full approval clinical trial of ateganosine holds high probability of technical success for interim and full analysis

FDA Fast Track designation offers clear pathway for ateganosine as third-line therapy for non-small cell lung cancer (NSCLC)

First and only direct telomere-targeting anticancer agent in clinical development anywhere

MAIA CEO details development pipeline in letter to shareholders

CHICAGO, Feb. 24, 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 published a 2026 Letter to Shareholders by Founder and CEO Vlad Vitoc, M.D. featuring the Company’s strong momentum in clinical trials of its lead molecule, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). As a potential breakthrough therapy, ateganosine holds substantial commercial opportunity in a $50 billion global immunotherapy market.1

As stated in the Letter, Dr. Vitoc wrote, “Our development strategy intentionally targets the third-line (3L) NSCLC population, where the unmet need is urgent. No established standard of care exists in 3L treatment, with most oncologists currently treating 3L patients with chemotherapy, leading to particularly poor clinical outcomes. In clinical studies, ateganosine sequenced with an immune checkpoint inhibitor (CPI) has demonstrated outcomes that exceed those historically achieved with either CPI-based therapy or chemotherapy alone. These findings position ateganosine not as a competitor to CPIs, but as the foundation of a new treatment category designed specifically for advanced NSCLC following CPI and chemotherapy failure. By focusing on a third-line population with no defined standard of care, we are addressing an underserved group of approximately 50,000 patients annually in the United States and creating a differentiated, incremental revenue opportunity outside of the CPI market.

“Ateganosine could mark the start of a new therapeutic category in cancer treatment and could become the standard of care for multiple cancer indications,” Dr. Vitoc added. “The commercial opportunity for ateganosine could be immense.”

Dr. Vitoc concluded his Letter with the following statement: “As we move forward, we are optimistic about the progress and potential outcomes of our advanced trials and the broader promise of ateganosine. We are grateful to our stockholders, employees, partners and investigators, for their continued support and commitment. With strong momentum and a clear path ahead, we believe MAIA Biotechnology’s future is bright and rich with opportunity.”

MAIA’s 2026 Letter to Shareholders is available in its entirety at ir.maiabiotech.com.

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 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

1 Immune Checkpoint Inhibitors Market Analysis by Mordor Intelligence, July 2025

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Source: MAIA Biotechnology, Inc.

Released February 24, 2026

Release – Cadrenal Therapeutics Announces Phase 2 Results with Encouraging Reductions in Thrombotic Events for CAD-1005 in HIT, Supporting Clinical Advancement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Greater than 25% absolute reduction in thrombotic events with CAD-1005 versus placebo on a background of standard anticoagulant therapy, despite no difference in platelet count recovery

End-of-Phase 2 Meeting Scheduled for March 2026

PONTE VEDRA, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced encouraging results from a Phase 2 trial evaluating CAD-1005 (formerly VLX-1005) in patients with heparin-induced thrombocytopenia (HIT), a severe pro-thrombotic reaction to heparin, the most commonly used parenteral anticoagulant.

This randomized, blinded, placebo-controlled trial evaluated the safety and efficacy of CAD-1005, a selective inhibitor of 12-lipoxygenase (12-LOX), a critical immune signaling pathway implicated in HIT, in patients receiving standard anticoagulant therapy. To potentially validate a new surrogate endpoint, the previous investigational new drug sponsor, Veralox Therapeutics, selected platelet count recovery rate as the primary endpoint. Their trial did not meet this primary endpoint. The secondary endpoint was the incidence of new or worsening thrombotic events, including radiologic progression, which showed encouraging results. The study concluded in December 2025 following the transfer of program ownership from Veralox to Cadrenal. Although CAD-1005 did not significantly affect platelet recovery rate, CAD-1005-treated patients had fewer thrombotic events.

Highlights:

  • Primary Endpoint: Thrombotic events continued to occur even after platelet count recovery in both groups. Platelet recovery rates were similar between the CAD-1005 and placebo arms. Platelet count recovery did not appear to be a surrogate marker for clinical efficacy.
  • Key Secondary Endpoint: A high rate of thrombotic events (>75%) was observed in the placebo group, with fewer thrombotic events in the CAD-1005 group (50%), although the study was not powered to detect statistical significance. Adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT may be more effective than anticoagulants alone in preventing thrombotic events.

Building on these secondary endpoint results, Cadrenal has been granted an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registration path. The Company considers this meeting a significant milestone in the development of CAD-1005, the only 12-LOX inhibitor in clinical development worldwide.

“The encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm is strong support for the company’s decision to acquire this asset and rapidly progress its development,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “Inhibition of 12-LOX is an exciting therapeutic frontier, potentially targeting numerous inflammatory, thrombotic, and metabolic conditions.”

“We learned two very important things from this study, the only blinded placebo-controlled trial ever conducted in HIT,” said James Ferguson, MD, Chief Medical Officer of Cadrenal Therapeutics. “First, platelet count recovery was not an appropriate surrogate endpoint for clinical efficacy in a trial in which standard therapy event rates were strikingly high. Secondly, despite the relatively small number of patients, the reduction in thrombotic events with CAD-1005 is extremely encouraging. CAD-1005 could represent a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT.”

“Our field (HIT) is full of anticoagulant use in the absence of randomized prospective trials,” said Steven E. McKenzie, MD, PhD, Professor of Medicine at Thomas Jefferson University and a member of the study steering committee. “We are enthusiastic about CAD-1005 in addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder.”

Detailed trial results will be presented at a future scientific meeting.

About Heparin-Induced Thrombocytopenia (HIT)

Heparin is the most widely used in-hospital anticoagulant, with over 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, dramatically lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.

About CAD-1005

CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency.

About the Study

The study was originally planned to enroll 60 patients, but was stopped in December 2025 after program ownership transferred to Cadrenal. Analysis of all existing trial data was recently completed. The final dataset includes 24 patients with a presumptive diagnosis of HIT, randomized to receive either CAD-1005 or a matching placebo; all patients received concomitant standard anticoagulant therapy, either argatroban or bivalirudin. The primary endpoint was the rate of platelet count recovery; a key secondary endpoint was the development of new or worsening thrombotic events, the composite of death, stroke, systemic embolism, myocardial infarction, deep venous thrombosis, superficial vein thrombosis, or skin necrosis. Primary analyses focused on 17 patients in whom HIT was confirmed by a central lab functional assay.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of 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 under development.

The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for the treatment of patients with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral, clinical-stage Factor XIa inhibitor designed for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company 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 adding an inhibitor of 12-LOX to standard anticoagulants to block the immunological mechanisms driving HIT being more effective than anticoagulants alone in preventing thrombotic events; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for the Cadrenal’s decision to acquire this asset and rapidly progress its clinical development; full trial results being presented at a future scientific meeting; the reduction in thrombotic events with CAD-1005 being extremely encouraging, despite the relatively small number of patients; CAD-1005 representing a major step forward as the only first-line therapy targeting the immune mechanisms responsible for HIT; The EOP2 meeting being a significant milestone in the development of CAD-1005; CAD-1005 addressing both the underlying immune mechanism and the unmet medical need for this serious thrombotic disorder; the encouraging trend toward reduced thrombotic events in the CAD-1005 treatment arm being strong support for Cadrenal’s decision to acquire this asset and rapidly progress its development; CAD -1005 addressing the underlying immune drivers of HIT; and presenting detailed trial results at a future scientific meeting. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to advance the clinical development of CAD-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; CAD-1005 having the ability to address the underlying immune mechanism and the unmet medical need for the serious thrombotic disorder; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for CAD-1005’s potential to be a treatment option for HIT, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements 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.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – Greenwich LifeSciences Announces Acceptance of Two Abstracts at AACR Annual Meeting 2026

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GLSI

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February 24, 2026 6:00am EST

STAFFORD, Texas, Feb. 24, 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 announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, including two corresponding posters.

The AACR 2026 conference will be held from April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference.

CEO Snehal Patel commented, “One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01.”

About the AACR Annual Meeting 2026

The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 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 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.

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: flamingo-01@greenwichlifesciences.com

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: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

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Source: Greenwich LifeSciences, Inc.

Released February 24, 2026

Gilead to Acquire Arcellx in $7.8B Bet on Next-Gen CAR-T Leadership

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences (Nasdaq: GILD) is doubling down on cell therapy. The Foster City–based biopharma announced it will acquire Arcellx (Nasdaq: ACLX) in a transaction valued at approximately $7.8 billion in equity value, giving Gilead full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.

Kite, a Gilead company, has partnered with Arcellx since 2022 to co-develop and co-commercialize anito-cel. Under the new agreement, Gilead will acquire all outstanding shares of Arcellx it does not already own for $115 per share in cash, plus one non-transferable contingent value right (CVR) worth $5 per share if cumulative global net sales of anito-cel reach $6.0 billion from launch through year-end 2029.

The $115 cash component represents a 68% premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026. Gilead already owns approximately 11.5% of Arcellx’s outstanding common stock. The transaction, approved by both companies’ boards, is expected to close in the second quarter of 2026, subject to customary conditions including the tender of a majority of outstanding shares, regulatory approvals and other standard closing requirements.

If completed, the acquisition would eliminate profit-sharing, milestone payments and royalty obligations tied to the existing collaboration, streamlining economics as Gilead prepares for potential commercialization.

The timing is notable. The U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) for anito-cel as a fourth-line treatment for adult patients with relapsed or refractory multiple myeloma. The application is supported by results from a Phase 1 study and the pivotal Phase 2 iMMagine1 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 23, 2026.

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, according to company disclosures. Multiple myeloma remains an area of high unmet need, particularly among heavily pretreated patients who often face diminishing responses, increasing toxicity and fewer therapeutic options over time.

Full ownership provides Gilead with greater flexibility to align development strategy, scale manufacturing through Kite, and potentially explore expansion into earlier lines of therapy, subject to clinical outcomes and regulatory review.

Beyond anito-cel, Gilead is also acquiring Arcellx’s D-Domain CAR platform, which has generated proprietary target-binding domains designed to improve specificity and binding affinity. The platform may support future CAR T-cell programs, bispecific constructs and in vivo cell therapy approaches, further strengthening Gilead’s oncology pipeline.

Management indicated that, upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.

For investors, the acquisition highlights a broader trend in large-cap biotech capital deployment. Established companies are increasingly seeking full ownership of late-stage oncology assets to simplify economics, reduce long-term partnership obligations and consolidate strategic control ahead of potential commercialization milestones.

Cell therapy remains one of the most capital-intensive areas of oncology, requiring specialized manufacturing, logistics and commercial infrastructure. Gilead’s move signals confidence in both the asset and its ability to integrate development and commercialization within its existing cell therapy platform.

The next key inflection point will be the FDA’s review decision later this year, which will shape the commercial trajectory of anito-cel and the long-term impact of the acquisition.

Release – The Oncology Institute Appoints Kim Tzoumakas to Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TOI

Feb 23, 2026

PDF Version

CERRITOS, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, today announced the appointment of Kim Tzoumakas to its Board of Directors, effective February 23, 2026. Ms. Tzoumakas brings more than two decades of executive leadership experience across oncology, pharmacy services and healthcare operations. Notably, she is Chief Executive Officer for VytlOne National Pharmacy Services, and previously held the CEO role at 21st Century Oncology, where she successfully led the organization through a multi-year operational turnaround, culminating in its strategic sale. She also has served on the board of several private and public healthcare companies including SeaSpine, Coherus BioSciences, Ob Hospitalist Group and most recently, VytlOne.

“We are thrilled to welcome Kim to our Board of Directors,” said Daniel Virnich, MD, CEO of The Oncology Institute. “Her deep experience in both oncology and pharmacy services are particularly relevant at this point in TOI’s journey as we expand our care delivery model across employed and MSO networks and grow our pharmacy business. Kim’s proven track record of expanding access, improving cost management, and advancing integrated care delivery models, will be invaluable as to our company and further strengthen our already outstanding board of directors.”

“It’s an honor to have been selected as a Board member of The Oncology Institute,” said Ms. Tzoumakas. “I look forward to utilizing my background and experience in healthcare services to advise this dedicated team and help them accomplish their mission of improving cancer outcomes and streamlining the patient journey.”

About The Oncology Institute (www.theoncologyinstitute.com):
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.

Media
The Oncology Institute, Inc.
marketing@theoncologyinstitute.com

Investors
ICR Healthcare
TOI@icrhealthcare.com

Cocrystal Pharma (COCP) – CDI-988 Norovirus Phase 1 Data to be Presented at ICAR 2026

Posted on by slightbourne@noblecapitalmarkets.com


Friday, February 20, 2026

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. 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.

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.

CDI-988 Data Selected For Presentation At ICAR. Cocrystal announced that it has been selected to present data from its Phase 1 clinical trial and updates from the ongoing Phase 1b challenge study testing CDI-988 against norovirus infection at the 38th International Conference on Antiviral Research, to be held April 27 to May 1 in Prague, Czech Republic. We see the presentation at this important conference as recognition of the potential of CDI-988 for an indication that has serious medical and economic consequences.

Phase 1 and 1b Data Expected. We expect Dr. Sam Lee, President and Co-CEO, to present initial Phase 1 safety and tolerability data. Previously announced data from the single ascending dose (SAD) and multiple ascending dose (MAD) study showed safety and tolerability across all dose cohorts tested. Additional data from the ongoing Phase 1b norovirus challenge study testing CDI-988 as both a prophylactic and therapeutic may also be included.


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*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. 

Release – Cocrystal Pharma’s First Oral Norovirus Protease Inhibitor CDI-988 to be Featured at the International Society for Antiviral Research Conference (ICAR) 2026

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

February 19, 2026

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  • CDI‑988 is the first oral antiviral drug candidate being developed for prevention and treatment of norovirus infections
  • Company to present Phase 1 data and updates from ongoing Phase 1b study conducted at Emory University School of Medicine
  • No approved antiviral therapies or vaccines for norovirus infections demonstrate an immediate market need

BOTHELL, Wash., Feb. 19, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that initial progress of a norovirus challenge study with its direct-acting, oral protease inhibitor CDI-988 will be presented at the 39th International Conference on Antiviral Research (ICAR2026), being held April 27–May 1 in Prague, Czech Republic. CDI-988 is the first oral antiviral drug candidate under development for the prevention and treatment of acute norovirus gastroenteritis.

Sam Lee, Ph.D., Cocrystal President and co-CEO, will discuss the ongoing Phase 1b challenge study evaluating CDI-988 as both a potential prophylactic and therapeutic option for norovirus infection. CDI-988 was designed and developed using the Company’s proprietary structure-based drug discovery platform technology as a pan-viral protease inhibitor, targeting 3CL viral proteases. Based on its novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential oral treatment for both noroviruses and coronaviruses.

“ICAR is widely regarded as the premier international conference for antiviral research, and it is a privilege to be selected to present our work to this antiviral research community,” said Dr. Lee. “We are excited to further advance CDI-988 into a Phase 1b norovirus challenge study at Emory University School of Medicine. CDI‑988 is our first pan-viral protease inhibitor developed for the treatment of acute norovirus gastroenteritis and also represents a significant step toward a potential treatment for patients suffering from chronic norovirus infection.”

About ICAR2026

The International Society for Antiviral Research (ISAR) is an internationally recognized organization of scientists working across the basic, applied, translational and clinical aspects of antiviral research. The annual International Conference on Antiviral Research (ICAR), the Society’s main event, brings together virologists, chemists, clinicians, pharmacologists, biologists and regulatory representatives focused on antiviral agents and therapies. Topics include novel and broad‑spectrum antivirals, host‑targeted approaches, vaccines, pandemic preparedness and emerging or re‑emerging viral threats, with a strong emphasis on interdisciplinary collaboration among academia, industry, government and non‑profit organizations.

About Norovirus

Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. This infection spreads rapidly in semi-closed and crowded settings such as hospitals, nursing homes, cruise ships, schools, disaster-relief shelters and military facilities, where close contact makes outbreaks especially difficult to control. Norovirus causes an estimated 200,000 deaths worldwide each year at a societal cost of approximately $60 billion. In the U.S., norovirus is responsible for about 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, with an estimated annual economic burden of $10.6 billion.

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 influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies to create viable 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 the potential of CDI-988 as an oral treatment for both norovirus and coronavirus infections. 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, the impact of future interest rate changes on the economy, tariffs and the resulting litigation, and geopolitical conflicts including those in Ukraine, Latin America and Middle East 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 for and otherwise proceed with the planned norovirus study or subsequent studies as well as similar problems with our vendors and our current and any future clinical research organizations (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. 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, 2024 and the Prospectus dated September 25, 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.

Contact:

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

# # #

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Source: Cocrystal Pharma, Inc.

Released February 19, 2026

NeuroSense Therapeutics Ltd. (NRSN) – Post-Phase 2b Analysis Demonstrates Survival Benefit and Mortality Risk Reduction

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, February 19, 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.

PrimeC Demonstrates Survival Benefit and 65% Mortality Risk Reduction. NeuroSense announced a Post-Phase 2b Analysis of its trial testing PrimeC in ALS. New data shows PrimeC patients had an additional 14 months (about 70%) survival with 65% reduction in risk of death. These improvements in overall survival correlate with previous Phase 2b Paradigm data that showed improvements in several endpoints of function, biomarkers, and survival.

New Data Shows Continued Improvement In Survival. The newly released data show the PrimeC treated patients had a median survival benefit of 36.3 months compared with 21.4 months for the group that received placebo then PrimeC during the extension study. This improvement of about 14.9 months was a benefit of 70% in survival. The Hazard Ratio (HR, the probability of an event occurring) reduced risk of death by 65% (p=0.0037).


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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.