Category: Health

Release – Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GLSI

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December 15, 2025 6:00am EST

STAFFORD, Texas, Dec. 15, 2025 (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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01.

  • A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. This arm does not have a direct placebo comparator arm, thus these two methods were used.
  • 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. See the summary of the Phase IIb results below.
  • The first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years.

In addition to announcing this first analysis of the recurrence rate data in the open label non-HLA-A*02 arm of FLAMINGO-01, the Company previously reported promising observations showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, 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 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 250 patient non-HLA-A*02 data set, 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. Since the 250 non-HLA-A*02 patients do not have a placebo arm for a direct comparison, the following two methods were used, yielding the 80% reduction in recurrence rate observation:

  • Method 1: The recurrence rate of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for this population in the Katherine study who received TDM1 (Kadcyla), which is about 3.5-4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100. The data suggests an approximately 80% reduction in recurrence rate after the GLSI-100 PIS is completed as compared to the TDM1 arm of the Katherine study at a similar timepoint.
  • Method 2: The recurrence rate during the first 6 months of vaccination or PIS period when the patient may not be fully protected or protected at all, which covered an exposure period of 100 patient years, was compared to the recurrence rate after the PIS is completed and after peak immunity is believed to be achieved, which covered an exposure period of 132 patient years. The exposure period (patient years) is defined as the cumulative number of years all patients are followed in a period. The data suggests that the peak immunity is lowering the recurrence rate by approximately 80% after the PIS is completed as compared to the recurrence rate during the PIS period.
    • For the first 6 months of vaccination or PIS, the theoretical maximum patient years would be 250 patients at 0.5 years each or 125 patient years. Thus 100 completed patient years represents 80% of the maximum potential patient years and within 3 to 6 months all vaccinations during this period may be completed.
    • For the period after the PIS is completed, the theoretical maximum patient years would be 250 patients at 3.5 years of follow-up each or 875 patient years. Thus 132 completed patient years represents 15% of the maximum potential patient years and represents an average of 9 months of follow-up time after the PIS for patients who have completed the PIS.

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.

CEO Snehal Patel commented, “We are very excited to announce in our 100th press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. We are equally excited to see a positive trend in the recurrence rate in the non-HLA-A*02 arm of FLAMINGO-01, as assessed multiple ways, that is trending similarly to the Phase IIb trial results where HLA-A*02 patients were treated. Despite these being preliminary results that will mature and can change with time, seeing a reduction in expected recurrence rates that is trending towards a low HR of 0.2, which represents an 80% reduction in recurrence rate, is very encouraging and which is why along with the similarly promising safety and immune response data to date, we will seek to continue to treat non-HLA-A*02 patients in a placebo controlled manner in the study. We will continue to analyze the data and may provide updates at any time.”

Previously Published Phase IIb Data

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 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 December 15, 2025

DLH Holdings (DLHC) – Looking Toward a Brighter Future

Posted on by slightbourne@noblecapitalmarkets.com


Monday, December 15, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

Overview. Fiscal 2025, and the start of fiscal 2026, continued the loss of contracts to small business set asides. While the loss of the Head Start contract and the expected eventual loss of all of the CMOP locations is impacting operating results today, we believe the resolution of these set aside contracts removes a big overhang from the business and enables the Company to grow from a solid base of higher value-added technology-powered applications business.

4Q25. Revenue fell 15.8% y-o-y to $81.2 million, driven by the loss of CMOP locations, as well as other set aside contracts. Gross margin fell to 17.1% from 19.9% a year ago. DLH reported a net loss of $920,000, or a loss of $0.06/sh., compared with net income of $2.3 million, or EPS of $0.16, in 4Q24. Adjusted EBITDA fell to $6.6 million from $10.7 million. We were at $83.5 million, $250,000, $0.02/sh., and $8.15 million, respectively.


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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. 

Release – Cadrenal’s Anticoagulation Platform Is Expanding in a $40 Billion Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, FL / ACCESS Newswire / December 12, 2025 / Cadrenal Therapeutics (NASDAQ:CVKD) believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void with therapeutics being designed for the specific patient groups who struggle most with a 70-year-old drug (warfarin).

Tecarfarin, the Company’s late-stage asset, is the kind of drug candidate you notice only after you understand how fragile the current standard really is. Patients with end-stage kidney disease plus atrial fibrillation and advanced comorbidities do not get predictable outcomes from existing anticoagulants. Tecarfarin was engineered to solve that problem. Stable. Controlled. Reversible. The design reflects clinical demands that have gone unanswered for years. This is where Cadrenal begins to differ. It is not trying to win a popularity contest. It is trying to find a better solution to the shortcomings of current therapies.

That shift has been visible since August. Cadrenal advanced manufacturing readiness. It added clinical depth inside the leadership ranks. And it expanded the pipeline in a way that instantly upgraded the company’s strategic position. The acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for Heparin-Induced Thrombocytopenia (“HIT”), is expected to be a game changer. It is a signal that Cadrenal intends to play on a larger scale.

Expansion That Changes the Stakes

With that, Cadrenal no longer behaves like a one-asset microcap. It behaves like a company constructing a multi-shot clinical platform inside the $40 billion anticoagulation market. The acquisition of a Factor XIa portfolio opened the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed. When you combine that with tecarfarin’s chronic-care positioning, you get a company with meaningful reach across multiple high-value treatment environments.

The addition of VLX-1005 further expands the pipeline. HIT is one of the most dangerous complications in hospital care, and treatment options remain limited. A Phase 2 asset with existing regulatory advantages gives Cadrenal an immediate foothold in a space where clinicians are hungry for better solutions. This kind of diversification is not common among companies of this size. It changes the conversation about Cadrenal’s potential.

The valuation does not appear to have kept pace with the expansion. The stock still appears to trade as if the Company is a single-asset story with a narrow path ahead. Meanwhile, Cadrenal sits on a portfolio with three mechanistic approaches and multiple clinical catalysts. That gap between perception and reality is where opportunity usually forms. It does not stay open forever.

Underdog Periods Have an Expiration Date

Investors are beginning to rediscover the story. Still, it appears the market continues to price Cadrenal for what it was, not for what it is building. Companies that solve real problems in anticoagulation do not stay in microcap territory. Not when they have differentiated assets, expanding clinical programs, and designations that potentially derisk the regulatory pathway. Cadrenal has put all those elements in motion.

This could be the last period during which anyone can underestimate the Company. Tecarfarin is approaching Phase 3 trial readiness. VLX-1005 is entering a phase where clinical data becomes increasingly important. The Factor XIa platform gives the company hospital relevance that most microcaps never achieve. These are not theoretical advantages. They exist today. And bigger companies are hungry to add late-stage assets to their portfolios, and many of their drugs are coming off patent in this decade.

The underdog label still fits, but potentially not for long. Cadrenal is preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival. The market has been slow to adjust, but pipelines like this eventually speak loudly. When Cadrenal’s data hits, the story could flip from overlooked to obvious, and the window for catching the mispricing could close fast.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist 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 statements regarding the Company being misread by the market; Warfarin persisting due to a lack of innovation; designing therapeutics for patient groups who struggle most with a 70-year-old drug; finding a better solution to the shortcomings of current therapies; the acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for HIT being a game changer; signaling Cadrenal intends to play on a larger scale; the acquisition of a Factor XIa portfolio opening the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the conversation about Cadrenal’s potential; the gap between perception and reality being where opportunity usually forms; investors beginning to rediscover the story; this being the last period during which anyone can underestimate the Company; Tecarfarin approaching Phase 3 trial readiness; the underdog label still fitting, but potentially not for long; preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival, and the story flipping from overlooked to obvious; and the window for catching the mispricing closing fast when Cadrenal’s data hits. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to use the acquisition of a Factor XIa portfolio to open the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the 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.

Accuracy & Disclosure Statement: Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.

At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM may hold shares of Cadrenal Therapeutics and may sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.

Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.

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SOURCE: Cadrenal Therapeutics

Cadrenal Therapeutics (CVKD) – New Anticoagulant Acquired For Heparin-Induced Thrombocytopenia.

Posted on by slightbourne@noblecapitalmarkets.com


Friday, December 12, 2025

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

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

Cadrenal Continues Build Its Anticoagulation Pipeline. Cadrenal has acquired VLX-1005, a platelet inhibitor from Veralox Therapeutics, adding another novel small-molecule anti-coagulant to its pipeline. VLX-1005 is a selective inhibitor of 12-LOX, an enzyme that initiates a signaling pathway for platelet-mediated inflammation and leads to heparin induced thrombocytopenia (HIT). VLX-1005 has Orphan Drug Designation from the FDA and EMA.

VLX-1005 Has Completed A Phase 2 Clinical Trial. Two Phase 1 studies showed safety and tolerability, followed by a Phase 2 trial in patients with suspected heparin induced thrombocytopenia (HIT). Interim results to date showed reductions in thromboembolic events.


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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 – MAIA’s Ateganosine Surges Ahead with Breakthrough Momentum as Pivotal Phase 3 Trial Initiates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 1:00pm EST Download as PDF

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — Ateganosine (THIO, 6-thio-2′-deoxyguanosine), a first-in-class telomere-targeting therapy under development by MAIA Biotechnology (NYSE American: MAIA), appears to be gaining increasing attention in the oncology community as emerging clinical results continue to surpass expectations in advanced non-small cell lung cancer (NSCLC). With the therapy’s Phase 2 trial ongoing and a pivotal Phase 3 program initiated this week, ateganosine is being closely watched as one of the most distinctive investigational approaches in solid-tumor treatment today.

We believe that MAIA has positioned itself at the forefront of a new scientific category in oncology. To our knowledge, Ateganosine remains the only direct telomere-targeting anticancer agent currently in clinical development anywhere—a key distinction in a treatment landscape where most therapeutic advances build upon established mechanisms rather than introduce entirely new ones.

According to management, statistical assessments of the Phase 3 trial points to a very high probability of technical success for regulatory approval of ateganosine.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

A Dual Mechanism Unlike Existing Therapies

Ateganosine works through a dual mechanism of action that we believe differentiates it from existing chemotherapies, targeted agents, and immunotherapies.

First, the molecule is selectively incorporated into cancer-cell telomeres by telomerase, an enzyme active in more than 80% of human cancers. This incorporation disrupts telomeric structure and function, driving selective cancer-cell death.

Simultaneously, this disruption generates micronuclei carrying ateganosine-modified telomeric DNA fragments. These fragments interact with immune cells and trigger a potent immunogenic response involving both the cGAS/STING innate pathway and adaptive T-cell activation, further promoting tumor regression.

This integrated telomere-targeting–plus–immune-activation model represents a mechanism that to our knowledge is not seen in current NSCLC treatments and may hold implications for broader solid-tumor indications.

Phase 3 Outcomes are the Next Step

The launch of a Phase 3 trial reflects growing confidence in the maturing clinical profile. With NSCLC remaining one of the largest and most challenging oncology markets globally, in our opinion, the commercial opportunity for a first-in-class therapy with this level of early performance is substantial.

As the only telomere-targeting agent in clinical development that we are aware of, ateganosine could mark the start of a new therapeutic category. Should its results to date translate into later-stage confirmation, we believe the therapy could emerge as a major entrant in next-generation cancer treatment.

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

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Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – GeoVax Addresses Identification of New Mpox Variant

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Continued Mpox Evolution Underscores Dependence on a Single Global Supplier, Reinforcing the Critical Importance of GeoVax’s Accelerated GEO-MVA Program

Atlanta, GA – December 11, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today addressed reports from UK health authorities confirming the emergence of a newly evolved “recombinant” Mpox strain. Early analysis indicates the variant contains genetic elements from both Clade I and Clade II Mpox viruses, highlighting the ongoing evolution of the pathogen and the potential implications for disease severity, transmissibility, and vaccine readiness.

The discovery of this recombinant strain comes at a time when global Mpox vaccine supply remains concentrated in a single manufacturer – creating risks around preparedness, surge capacity, and geopolitical access. GEO-MVA is uniquely positioned in developing an expanded supply of MVA vaccine, bolstering domestic and global resilience.

GeoVax Highlights Strategic and Public Health Implications

  • The virus continues to evolve. Simultaneous circulation of multiple Mpox clades creates ongoing risk for recombination and changing outbreak behavior.
  • Global supply remains dangerously concentrated. A single-vendor global supply model heightens vulnerability for stockpile readiness and equitable vaccine distribution.
  • GEO-MVA is progressing as the first U.S.-based Mpox/smallpox vaccine. GeoVax aims to deliver a scalable, domestically manufactured solution that supports national biodefense and global supply diversification.
  • Clinical and manufacturing progress advancing: Final fill-finish activities of GEO-MVA are scheduled to be completed by year-end, with first-in-human studies planned upon regulatory clearance.

“The emergence of a recombinant Mpox strain is a timely reminder that viral evolution does not pause,” said David Dodd, Chairman & CEO of GeoVax. “With global vaccine supply dependent on a single provider, the risks to preparedness, national security, and market stability are clear. We are developing GEO-MVA to meet this strategic need – a U.S.-manufactured Mpox vaccine capable of supporting both domestic requirements and global demand.”

Favorable EMA Development Pathway Accelerates GEO-MVA

GeoVax recently received positive Scientific Advice from the European Medicines Agency (EMA) confirming that the Company may proceed directly to a single Phase 3 immuno-bridging trial with no Phase 1 or Phase 2 trials required to support a Marketing Authorization Application (MAA) for GEO-MVA. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also affirmed the adequacy of GeoVax’s proposed nonclinical package and agreed with the Company’s immunogenicity endpoints for demonstrating non-inferiority to the licensed comparator vaccine.

This guidance provides a significant acceleration of the regulatory timeline, a de-risked development path, and a potentially earlier commercialization opportunity across all 27 EU member states. As reinforced in a subsequent regulatory communication, the EMA’s pathway positions GeoVax for expedited approval, reduced development cost, and earlier revenue generation as the Company advances GEO-MVA toward Phase 3.

About GEO-MVA

GEO-MVA is GeoVax’s next-generation Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine, engineered to provide a durable, broad immune response with both civilian and biodefense (“dual-use”) applicability. Key attributes include:

  • U.S.-Based Manufacturing Pathway: GEO-MVA is being developed as the first U.S.-manufactured Mpox/Smallpox vaccine, reducing reliance on foreign suppliers and supporting national security priorities.
  • Dual-Use Capability: Designed to meet both public health needs and Strategic National Stockpile requirements.
  • Robust Multi-Antigen Immunity: MVA enables broad antigen presentation to support strong humoral and T-cell responses.
  • Scalable Modern Production: GeoVax’s planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce cost, and support global self-sufficiency.
  • Regulatory Momentum: EMA’s streamlined approach provides a clear, accelerated pathway for clinical advancement and commercialization.

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MAIA Biotechnology Announces First Patient Dosed in THIO-104 Phase 3 Pivotal Trial Evaluating Ateganosine as Third-Line Treatment for Advanced Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 9:00am EST Download as PDF

Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy

CHICAGO, Dec. 11, 2025 (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 first patient has been dosed in the Company’s THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).

The multicenter, open-label trial of patients who are resistant to CPI and chemotherapy treatments, is 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 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway.

“Our strategy to bring our telomere-targeting treatment to market is proceeding according to plan as we advance our ateganosine program to a Phase 3 trial. This larger trial will provide us a robust dataset to support our case for commercial approval by the U.S. FDA,” said Vlad Vitoc, M.D., CEO of MAIA. “We have many sites in several countries already screening patients, and with our first patient dosed, we have achieved a key milestone along our path to potential FDA commercial approval. We expect to see Phase 3 results consistent with Phase 2 trial data showing median survival of 17.8 months compared to approximately six months of survival from chemotherapy. We are confident that ateganosine could become the new treatment standard for patients suffering from this devastating disease.”

Ateganosine sequenced with a CPI has shown exceptional efficacy in third-line NSCLC patients. As of September 17, 2025, the observed progression free survival (PFS) in THIO-101 was 5.6 months, more than double the standard of care PFS of 2.5 months. One patient that began therapy in March 2023 has shown survival of 30 months, or 912 days. 

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

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
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

  • Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
  • It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
  • Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant – regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

VLX-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. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist 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 statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the 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

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Release – MAIA Leadership Continues Insider Buying in 2025 and Trial Data Signals Breakout Potential

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 11, 2025 8:00am EST Download as PDF

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — A recent round of open-market purchases marks another display of confidence as the small molecule telomere-targeting cancer therapy by MAIA Biotechnology, Inc. (NYSE American: MAIA) advances through mid- to late-stage clinical development. Newly filed disclosures show that CEO Dr. Vlad Vitoc and other board members acquired approximately 182,445 shares between November 21 and 28, 2025. Insiders’ participation has been viewed by the market as a strong signal of alignment, conviction, and belief in the long-term value creation potential of the ateganosine platform.

The latest insider buying arrives as ateganosine continues to deliver encouraging results. These outcomes have strengthened internal and external confidence that MAIA’s novel telomere-targeting approach may represent a meaningful new therapeutic pathway for patients with advanced non-small cell lung cancer (NSCLC).

Taken together—material insider buying at market prices, sustained insider participation across 2025 financings, and strengthening clinical signals—MAIA’s leadership continues to demonstrate a unified stance: confidence in the company’s strategy, confidence in ateganosine’s growing body of clinical evidence, and confidence in the opportunity ahead as the program advances toward later-stage development. To date, Directors and Officers hold 4,480,120 shares or 12.95% of the company.

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

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Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – MAIA Takes Aim at a $50B Immunotherapy Market with Breakthrough Telomere-Targeting Approach

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 10, 2025 2:00pm EST Download as PDF

CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer respond to CPIs or chemotherapy.

This is a segment that existing therapies leave behind. And it is the segment where we believe that ateganosine, developed by MAIA, may soon become one of the most consequential entrants in years.

A Market Dominated by Checkpoint Inhibitors—But Vulnerable at Its Edges

CPI therapies remain the backbone of NSCLC treatment in patients who don’t have an actionable mutation. Collectively, the category generated approximately $50 billion in global sales in 2024, anchored by five major agents approved for NSCLC. The therapeutic concentration in lung cancer is striking:

  • >30% of all NSCLC drug sales come from CPIs
  • >40% of all CPI global sales originate from NSCLC alone

Merck’s Keytruda, the category-defining CPI, reported $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30% of its total sales. Keytruda is expected to approach $35 billion by 2027—just before biosimilars begin entering the market in 2028.

While CPIs have transformed outcomes for some patients, in our opinion their limitations remain clear: patients without actionable mutations, and those who become CPI-refractory, still experience extremely poor prognosis and limited therapeutic benefit. We believe this treatment gap has become one of the industry’s largest unmet needs.

Telomere-Targeting: A New Pathway for a Hard-to-Treat Population

We believe that MAIA’s ateganosine represents the first drug in a new class. Unlike targeted therapies requiring EGFR, ALK, KRAS, or other mutations—and unlike immunotherapies dependent on PD-1/PD-L1 dynamics—ateganosine has been designed to exploit a universal feature of cancer cells: telomerase activity, present in more than 80% of human tumors.

Its dual mechanism has been designed to disrupt telomeres to trigger direct cancer cell death while simultaneously enabling the immune system to respond to cancer. MAIA was recently awarded Fast Track Designation by the U.S. FDA for the treatment of NSCLC in patients resistant to immunotherapy and chemotherapy, and is initiating a Phase 3 THIO-104 trial.

A Commercial Opportunity That Extends Across Oncology

With the NSCLC market now valued at $34.1 billion—projected to nearly double to $68.8 billion by 2033—the implications of a first-in-class therapy are substantial. In the United States alone, roughly 180,000 patients enter the NSCLC treatment ecosystem every year.

But ateganosine’s opportunity does not end with lung cancer. The candidate already carries FDA Orphan Drug Designations (ODDs) for:

  • Glioblastoma (market: $2.2B → $3.2B growth expected)
  • Hepatocellular carcinoma (HCC) (mortality: 0.8M; sales: $3.8B)
  • Small cell lung cancer (SCLC) (mortality: 0.3M; sales: $2.8B)

Each ODD offers seven years of U.S. market exclusivity upon regulatory FDA approval and access to tax credits—advantages that strengthen MAIA’s long-term market positioning.

A Strategic Inflection Point for the Entire NSCLC Treatment Landscape

The oncology market is poised for a shift as developers seek to fill in gaps in the treatment landscape. The next decade is expected to reward novel mechanisms, and in our opinioin advanced NSCLC represents the clearest example of that gap.

Telomere-targeting therapeutics may be the next foundation in that evolution. If ateganosine’s outcomes are successful, the therapy could become a defining entrant in a space where treatment failure has long been accepted as inevitable. Statistical assessments points to a high probability of technical success for regulatory approval of ateganosine.

In our opinion, MAIA is now positioned at the center of this turning point—scientifically and strategically.

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

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Source: MAIA Biotechnology, Inc.

Released December 10, 2025

Release – GeoVax Announces Addition of Renowned Global Experts to its Scientific Advisory Board

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Newly Appointed Members Include Leaders in Vaccine Immunology, T-Cell Science, and Clinical Research

Atlanta, GA -December 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancers, today announced an update to its Scientific Advisory Board (SAB), welcoming internationally recognized experts whose work spans vaccine design, T-cell immunology, viral pathogenesis, and immunocompromised-host medicine.

This strategic expansion is designed to support GeoVax’s current and future development efforts with MVA and its multi-antigen MVA vector platform for vaccines targeting biothreat pathogens and vulnerable or currently underserved populations such as those from low- and middle-income countries, and immunocompromised patients. Future additions to the GeoVax SAB will support its oncology immunotherapy pipeline.

Newly Announced SAB Members

Joining Prof. Teresa Lambe, PhD, OBE, FMedSci – Calleva Head of Vaccine Immunology, Oxford Vaccine Group / Jenner Institute, University of Oxford, whose appointment to the GeoVax SAB was previously announced, are the following:

  • Dr. Alessandro Sette, Dr of Biological Sciences – Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology

An authority in T-cell epitope mapping and immune correlates of protection, Dr. Sette leads the NIH Immune Epitope Database (IEDB) and is widely recognized by defining T-cell immunity across SARS-CoV-2, Mpox, and Ebola.

  • Prof. Lance Turtle, PhD, MBBS, FRCP, DTMH – Chair in Immunity and Infectious Diseases, University of Liverpool / Royal Liverpool Hospital

A clinician-scientist specializing in viral pathogenesis and post-infection immune recovery, Prof. Turtle’s research provides key translational insights into long-term immunity and emerging pathogen preparedness.

  • Prof. Thushan I. de Silva, MBBS, PhD, MRCP – Professor of Infectious Diseases and Immunology, University of Sheffield

An expert in human viral immunology, vaccine responses, and global immunosurveillance, Prof. de Silva leads studies across Europe, Asia, and Africa evaluating population-level vaccine immunity and viral evolution.

  • Dr. Joshua A. Hill, MD, FIDSA – Associate Professor, University of Washington School of Medicine / Fred Hutchinson Cancer Center

A leading infectious-disease expert focusing on vaccine response in immunocompromised and transplant patients, Dr. Hill’s work aligns with GeoVax’s emphasis on protecting high-risk, under-served populations.

David Dodd, GeoVax Chairman & CEO, commented: “By assembling this exceptional team of global experts, we are further strengthening GeoVax’s position at the forefront of vaccine innovation. Their combined experience – from antigen design to human immunology and clinical translation – perfectly aligns with our mission to deliver durable, broad-spectrum protection to both global and immunocompromised populations.”

Dr. Kelly McKee, Chief Medical Officer, added: “The addition of these renowned experts ensures that our clinical strategy is guided by cutting-edge immunology insight and global research expertise. Their collaboration will be instrumental as GeoVax advances vaccines and immunotherapies designed to protect those who remain most vulnerable – particularly those in low and middle income countries (LMICs), and immunocompromised patients who have been underserved by traditional approaches or currently available vaccines”

Dr. Mark Newman, Chief Scientific Officer, stated: “This expanded SAB strengthens multiple aspects of our R&D platform. With direct input from some of the world’s most respected scientific leaders, we can ensure that our vaccine and immunotherapy candidates deliver real-world impact.”

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MustGrow Reports Significant U.S. Potato Yield and Economic Performance in Large Scale Field Trials Utilizing TerraSanteᵀᴹ

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

Dec 10, 2025 | News Releases

MustGrow Reports Significant U.S. Potato Yield and Economic Performance in Large Scale Field Trials Utilizing TerraSanteTM

  • Mustard-derived organic TerraSanteTM focuses on crop yields, soil and soil microbiome health, and nutrient/water use efficiencies;
  • Large scale field trial showed 2 ton per acre yield increase with larger size potatoes and less culls equating to approximately US$5,000 increase in value per acre; and
  • Significant soil health benefit when applied in combination with the current grower standard program.

SASKATOON, Saskatchewan, Canada, December 10, 2025 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow“), a leading provider of biological and regenerative agriculture solutions, is pleased to announce outstanding performance metrics on its organic TerraSanteTM biofertility product applied to potato farming acres in Washington State and Idaho, based on customer performance data.

In its use by a Washington State farming customer, TerraSanteTM demonstrated a consistent and substantial potato yield, size, and quality increase at a dose rate of 11 lbs/acre.  This customer performance data was generated on a large-scale commercial potato field.  With the increase in size, quality and yield, the farmer estimated an approximate US$5,000 increase in value per acre at a cost of only US$180 per acre for TerraSanteTM.  Work done in fields in Idaho has also shown significant benefits to the soil and health of the potato crops when used within a currently established grower production program.

These large-scale field trial results are consistent with small plot results that MustGrow has completed in the U.S. with TerraSanteTM, as outlined in the following table:

The following figures illustrate TerraSanteTM ‘wet-able’ powder being mixed into liquid format and applied through typical spray equipment.

MustGrow’s mustard-derived TerraSanteTM organic biofertilizer is a soluble mixable form containing nutritious plant proteins and carbohydrates that feed the soil and soil microbes.  TerraSanteTM is currently registered and approved for sale in California, Florida, Arizona, Idaho, Oregon, and Washington State, under Organic OMRI Listed® certification and California’s Organic Input Material (OIM) Program.

In 2024, the United States Department of Agriculture (USDA) reported 927,000 potato acres harvested for US$4.6 billion of value sold.(1)

TerraSanteTM for Soil and Ecological Health

MustGrow’s biofertility program focuses on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.  Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being applied with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

TerraSanteTM, an organic biofertilizer in soluble mixable form, contains nutritious plant proteins and carbohydrates that feed the soil and soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health.  These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress.  TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance.  There are no artificial additives or preservatives used during its manufacturing.

To learn more about TerraSanteTM, visit TerraSanteTM – MustGrow

Notes:
1) Potatoes 2024 Summary 09/26/2025

About MustGrow

MustGrow Biologics Corp. is a fully integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming.  The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers.  In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products.  These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers.  Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies.  The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 110 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg.  MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 69.1 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow’s Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Forward-looking statements in this news release, including statements about: the impact and significance of customer performance data and field testing, the increase in value of yields and the costs of such increase in value, if any, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

Neither the TSX Venture Exchange, nor their Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2025 MustGrow Biologics Corp. All rights reserved.

Greenwich LifeSciences, Inc. (GLSI) – Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestones

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, December 10, 2025

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

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

Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestone. Greenwich Pharmaceuticals has completed enrollment in the open-label arm (non HLA-A*2 patients) in the Phase 3 FLAMINGO-01 trial, its trial testing GLSI-100 for prevention of breast cancer recurrence in high-risk patients. The patients are stratified according to their HLA (human leukocyte antigen) types, immune system characteristics that classify an individual’s potential response to antigens. Over 1,000 patients have been screened for the trial at over 140 clinical sites in the US and Europe.

Greenwich Pharmaceuticals Presented At the NobleCon21 Conference. CEO Snehal Patel spoke at the annual NobleCon21 conference. He presented a brief summary of GLSI-100 and the clinical trial, followed by a fireside chat discussion, and questions from the audience. To listen to the presentation, click here.


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