Category: Health

Release – Tonix Pharmaceuticals Presents Updates on Preclinical Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting 2026

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Research News and Market Data on TNXP

April 23, 2026 7:00am EDTDownload as PDF

TNX-1700 (TFF2-albumin fusion protein) reversed aging-associated gastric inflammation and significantly attenuated tumor progression in aged gastric microenvironment in preclinical models

TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals

TNX-4700 (human anti-BTLA monoclonal antibody) demonstrated potent, high-affinity binding and functional antagonism

BERKELEY HEIGHTS, N.J., April 23, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, held April 17-22, 2026, in San Diego, California.

“We are pleased to report encouraging preclinical data on our TFF2-albumin fusion protein (TNX-1700) and our anti-BTLA monoclonal antibody (mAb) (TNX-4700) at AACR,” said Bruce Daugherty, PhD, MBA, Executive Vice President of Research at Tonix Pharmaceuticals. “TNX-1700 and TNX-4700 are investigational immuno-oncology candidates in pre-clinical development. TNX-1700 is in development for the treatment of gastric and colorectal cancer in combination with PD-1 inhibitors. TNX-4700 is in development for the treatment of potentially several cancers since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment and generally correlates with reduced overall survival.”

Abstract #: 6822 Oral Presentation: “TFF2 Deficiency Amplifies IL-1β–Driven Inflammation and Promotes Aging-Associated Gastric Tumor Progression”

  • Presenting author: Shuang Li, MD, PhD, Postdoctoral Research Scientist in the Timothy C. Wang, MD, Laboratory at the Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

Aging is a major risk factor for gastric cancer, but the underlying mechanisms remain poorly defined. The stomach undergoes profound epithelial and immune remodeling during aging. TFF2 is a mucosal protective factor implicated in epithelial repair and immune regulation. However, whether TFF2 regulates age-associated inflammation and tumor progression remains unknown.

TFF2-expressing epithelial cells were reduced in the stomachs of aged mice compared to young mice, with corresponding reductions in tissue and circulating TFF2 levels. Decline of TFF2 led to elevated IL-1β and promoted gastric inflammaging. The murine version of TNX-1700 (mTNX-1700 or TFF2-MSA) treatment reversed aging-associated inflammation. The aged stomach exhibited increased susceptibility to tumor progression. Myeloid-derived stem cells (MDSCs) accumulated and overexpressed IL-1β, interacting with IL-1R1⁺ cancer associated fibroblasts (CAFs). mTNX-1700 attenuated tumor progression in the aged gastric microenvironment.

Poster Presentation #7940: “Pharmacokinetics of TNX-1700 in Non-Human Primates and Human FcRn/Serum Albumin Transgenic Mice”

  • Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

TNX-1700 was evaluated in double-transgenic mice expressing human FcRn and human serum albumin (HSA) and in non-human primates. All animals survived without clinical signs or greater than 10% body-weight loss. TNX-1700 exhibited dose-independent, linear pharmacokinetics, with comparable pharmacokinetic profiles and exposure observed across species and doses. TNX-1700 substantially extends the half-life of TFF2 and achieves durable systemic exposure, supporting its potential as a therapeutic candidate for gastric cancer.

Poster Presentation #6550: In Vitro Characterization of Fully Human Antagonistic Anti-BTLA Monoclonal Antibodies

  • Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

B and T Lymphocyte Attenuator (BTLA) is a promising target in immuno-oncology since its ligand HVEM (herpesvirus entry mediator) is expressed in and upregulated in the tumor microenvironment of many cancers and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic activity when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

Tonix studied several anti-BTLA mAbs, which demonstrated potent, high-affinity binding and functional antagonism of BTLA in vitro. Antagonists with reduced FcgRI binding and no binding to FcgRIIB may improve pharmacokinetics and confer a reduced risk of FcR-dependent adverse events, such as cytokine release syndrome or other immune-mediated toxicities.

Copies of the two poster presentations are available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

About Trefoil Factor Family Member 2 (TFF2)
Human TFF2 is a secreted protein expressed in gastrointestinal mucosa where it functions to protect and repair the mucosal lining. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms, including its activity as a partial agonist of CXCR4 that modulates myeloid cell trafficking to reduce accumulation of immunosuppressive neutrophils.

About TNX-1700
TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical and pre-Investigational New Drug (IND) stage of development as a treatment of gastric and colorectal cancer in combination with PD-1 blockade.1 The Company in-licensed TFF2 technology from Columbia University. TNX-1700 is an immunotherapy being developed to treat gastric and colorectal cancers in combination with PD-1 blockers. Results of preclinical testing demonstrated that a mouse version of TNX-1700 was able to evoke an increase in anti-tumor immunity in combination with anti-PD-1 in several mouse models of gastric cancer by reducing immunosuppressive neutrophils and activating anti-tumoral CD8+ T cell responses. TNX-1700 administered as both monotherapy and in combination with anti-PD-1 dramatically reduced metastasis and increased survival in these models; these findings were recently published.1 TNX-1700 addresses a central mechanism of therapeutic resistance to anti-PD-1 therapy in gastric cancer by targeting the CXCR4-driven myeloid axis to normalize cancer-induced myelopoiesis and reprogram the tumor microenvironment.

About BTLA
BTLA (B and T lymphocyte attenuator) is a protein on the surface of tumor infiltrating lymphocytes. Targeting BTLA is a promising target in immuno-oncology since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment of many cancers including melanoma, non-small cell lung cancer, colorectal cancer, gastric cancer, glioblastoma, and prostate cancer and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic effects when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

About TNX-4700
Tonix is developing TNX-4700 (anti-BTLA) mAb for immuno-oncology indications. The mAb technology was licensed from Curia.

Citations:

  1. Qian J, et al. Cancer Cell. 2025. 43(8):1512-1529.e11.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

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Source: Tonix Pharmaceuticals Holding Corp.

Released April 23, 2026

Release – Greenwich LifeSciences Announces Acceptance of Abstract at ASCO 2026

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Research News and Market Data on GLSI

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April 23, 2026 6:00am EDT

STAFFORD, Texas, April 23, 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 an abstract has been accepted for publication at the upcoming 2026 ASCO Annual Meeting along with a corresponding poster presentation.

The 2026 ASCO Annual Meeting will be held from May 28 to June 2, 2026. The full text of the abstract and poster will be available on June 1, 2026, the day of the presentation.

CEO Snehal Patel commented, ” We look forward to meeting many of our principal investigators at the conference. Our abstract will be the second abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01 presenting preliminary injection site reaction immune response data from the non-HLA-A*02 open-label arm.”

In addition to ASCO, the Company plans to attend ESMO Breast, BIO partnering, and investor conferences in the coming months.

About the 2026 ASCO Annual Meeting

ASCO is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: https://conferences.asco.org/am/attend.

About FLAMINGO-01 Open Label Phase III Data

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

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

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

About GLSI-100 Phase IIb Study

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

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

About FLAMINGO-01 and GLSI-100

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

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

About Breast Cancer and HER2/neu Positivity

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

About Greenwich LifeSciences, Inc.

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

Forward-Looking Statement Disclaimer

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

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

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

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Source: Greenwich LifeSciences, Inc.

Released April 23, 2026

Amneal Pharmaceuticals Moves to Acquire Kashiv BioSciences in $1.1B+ Deal to Dominate the Biosimilar Wave

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Amneal Pharmaceuticals (Nasdaq: AMRX) announced on April 21 that it has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, LLC in a transaction that could exceed $1.1 billion in total value — a strategic bet on one of the most significant inflection points in the pharmaceutical industry in decades.

The deal structure includes $375 million in cash and $375 million in equity payable at closing, plus up to $350 million in potential payments tied to regulatory milestones, royalties, and funding of operations through closing. The Manila Times The transaction is subject to Amneal shareholder approval, regulatory clearance, and customary closing conditions, with an expected close in the second half of 2026. The Manila Times

What Kashiv Brings to the Table

Kashiv isn’t just another acquisition target — it’s a rare asset. Kashiv BioSciences is a vertically integrated biopharmaceutical company among the few U.S.-based firms to both manufacture and receive marketing authorization for multiple biosimilars Business Wire, giving it end-to-end capabilities that most companies in the space simply don’t have. That combination of R&D, clinical, manufacturing, and regulatory infrastructure is precisely what Amneal is paying a premium to absorb.

The combined entity is designed to function as a fully integrated global biosimilars platform — built to scale and launch multiple new biosimilar products each year.

The Market Opportunity Driving This Deal

The timing is deliberate. More than $300 billion in global biologics are expected to lose exclusivity over the next decade, and as biosimilars expand patient access while delivering meaningful savings, adoption is accelerating across physicians, patients, and payers. The Manila Times Amneal is positioning itself ahead of that wave rather than chasing it.

The company highlighted $400 million to $500 million in anticipated financial benefits from the transaction, along with a path to maintain a modest leverage profile. TipRanks That’s not a speculative projection — Kashiv already has commercial biosimilars on the market and a robust pipeline moving through regulatory channels.

Strong Financial Momentum Behind the Move

The acquisition announcement came alongside strong preliminary Q1 2026 results that gave management the confidence to pull the trigger. For the quarter ended March 31, 2026, revenue climbed 4% to $723 million, with net income reaching $78 million and significant margin expansion driven by Specialty segment growth and a higher-value product mix. TipRanks On the strength of those results, Amneal raised its standalone full-year 2026 guidance, positioning the Kashiv acquisition as an accelerator of an already-strengthening growth trajectory. TipRanks

Transaction Oversight and Advisors

The transaction was endorsed by an independent conflicts committee TipRanks, a notable governance detail given the pre-existing commercial relationship between the two companies. J.P. Morgan Securities is serving as financial advisor to Kashiv, with Holland & Knight LLP as legal counsel.

The Bottom Line

This deal is a direct statement about where pharmaceutical value creation is headed. As blockbuster biologics lose patent protection at an accelerating clip, the companies with the infrastructure to develop, manufacture, and commercialize biosimilars at scale will control a growing share of one of healthcare’s most important markets. Amneal is making its move now — and the Kashiv acquisition gives it the fully integrated platform to compete at the highest level.

Greenwich LifeSciences, Inc. (GLSI) – Preliminary FLAMINGO-01 Data Presented At AACR

Posted on by [email protected]


Wednesday, April 22, 2026

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

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

Phase 3 FLAMINGO-01 Data Presented. Greenwich LifeSciences and the FLAMINGO-01 Steering Committee made two presentations at the American Association of Cancer Research (AACR) 2026 Meeting. One detailed the FLAMINGO-01 trial design while the other presented preliminary results from delayed-type hypersensitivity (DTH) response data showing a statistically significant immune response.

First Poster Presentation Included DTH Data. As discussed in our Research Note on March 18, the company announced a preliminary analysis of recurrence rates in the non-HLA-A*02 arm. Immune responses to GP2 were measured using Delayed-Type Hypersensitivity (DTH) skin tests at baseline, then after 4 or 6 months. This open-label arm of the trial has enrolled about 250 patients, with data reported for 191 patients who completed the six-monthly doses of GLSI-100 at four-month or six-month evaluation points.


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Release – Cardiff Oncology to Present Updated Phase 2 Data of Onvansertib in First-Line RAS-Mutated mCRC in a Rapid Oral Session at ASCO 2026

Posted on by [email protected]
Cardiff Oncology, Inc. logo

Research News and Market Data on CDRF

April 21, 2026

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SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced it will present updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The data will be reviewed in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2 in Chicago.

Rapid Oral Presentation Details:

Abstract Title: Onvansertib plus standard-of-care chemotherapy plus bevacizumab in first-line RAS-mutated metastatic colorectal cancer (mCRC): Interim results from the phase 2 randomized CRDF-004 trial
Abstract Number: 3510  
Session Title: Gastrointestinal Cancer—Colorectal and Anal 
Session Date and Time: June 2, 2026, 8:00-9:30 AM CDT  

The abstract will be publicly available on Thursday, May 21, 2026 on ASCO’s website, and the presentation will be made available on the Scientific Publications page of the Company’s website following its presentation.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

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

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements 
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact: 
Candice Masse 
astr partners 
[email protected]

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

Eli Lilly’s $7B Kelonia Bet Signals a New Era for CAR-T Therapy — and a Hunting Season for Biotech Targets

Posted on by [email protected]

Eli Lilly is writing another large check in its aggressive diversification push, this time targeting one of oncology’s most promising frontiers. The pharmaceutical giant announced Monday it has agreed to acquire Kelonia Therapeutics in a deal valued at up to $7 billion — $3.25 billion upfront with the remainder tied to clinical, regulatory, and commercial milestones. The transaction is expected to close in the second half of 2026.

The strategic rationale centers on Kelonia’s proprietary in vivo CAR-T technology — a next-generation approach to cancer immunotherapy that sets itself apart from everything currently on the market. Traditional CAR-T treatments require physicians to extract a patient’s T-cells, engineer them in a laboratory setting outside the body, then reinfuse them — a complex, time-consuming process requiring chemotherapy preconditioning and specialized academic medical centers capable of managing the procedure. Kelonia’s platform eliminates all of that. The therapy is delivered intravenously in a single infusion, reprogramming T-cells to attack cancer directly inside the body, with no preconditioning required.

The commercial implications are significant. The existing ex-vivo CAR-T market is already producing blockbuster revenue — Johnson & Johnson’s Carvykti generated nearly $1.9 billion in sales last year for multiple myeloma alone. Gilead recently paid $7.8 billion to acquire Arcellx and its competing asset. A one-time, broadly accessible in vivo alternative that sidesteps the logistical barriers of ex-vivo therapy could expand the addressable patient population dramatically and reach community oncology settings currently unable to administer existing treatments.

For Lilly, this deal is part of a deliberate strategy to reduce its dependence on GLP-1 drugs for obesity and diabetes — the products that have defined the company’s recent run. Management has been explicit: the goal is to deploy the cash flow generated by its weight-loss franchise into therapeutic diversification. Recent deals include Centessa Pharmaceuticals for sleep disorder drugs and Orna Therapeutics for cell therapy. Kelonia extends that footprint into hematology and potentially solid tumors.

What makes this acquisition particularly noteworthy for investors watching the oncology space is what it signals downstream. Lilly’s willingness to spend $3.25 billion upfront on a platform still in early clinical stages — while acknowledging that many early-stage bets will fail — reflects a maturing view of how large pharma is valuing novel modalities. Smaller biotech companies developing differentiated delivery mechanisms, novel immune engineering platforms, or next-generation cell therapies should expect intensifying M&A interest from strategic acquirers flush with capital.

The Kelonia deal also raises the stakes for any company developing competing in vivo CAR-T or similar tumor-targeting platforms. With Lilly now in the race alongside J&J and Gilead, the race to make cancer immunotherapy more accessible — and more scalable — is entering a new, better-funded chapter. For small and microcap biotech names working in adjacent spaces, that’s both a competitive threat and a significant validation of the underlying science.

Release – Greenwich LifeSciences Presents FLAMINGO-01 Phase III Trial Open Label Data Published at AACR Meeting 2026

Posted on by [email protected]

Research News and Market Data on GLSI

 Download as PDF April 20, 2026 6:00am EDT

STAFFORD, Texas, April 20, 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 presents the published abstract and poster from the AACR Meeting 2026.

The abstract is shown below and the poster being presented today can be seen and downloaded at the bottom of Phase III clinical trial tab on the Company’s website here.

  • This is the first abstract and poster presented jointly with the Steering Committee of FLAMINGO-01 with statistically significant delayed-type-hypersensitivity (DTH) immune response data, with subgroup analysis by the most prevalent HLA types.
  • In the non-HLA-A*02 open label arm where all patients (n=247) were treated with GLSI-100, immune responses to GP2 were measured at baseline and over time using skin tests and other methods. The other methods will be presented at a future conference.
  • A DTH reaction (redness and/or induration) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was also measured 48-72 hours after injection but is not reported here.
  • In this preliminary data analysis, there was a significant increase in percentage of patients experiencing a DTH reaction (redness) in month 4 or month 6 compared to baseline. There were 191 patients with both baseline and month 4 or 6 assessments.
  • The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
  • As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%. 
  • Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
  • Mechanism of Action: A positive immune response is an indicator that the immune system has been activated against recurring cancer cells, potentially leading to the prevention of metastatic breast cancer. The Company previously announced that in the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the Primary Immunization Series (PIS) is completed shows an approximately 70-80% reduction in recurrence rate. Thus, the immune response data is supporting the mechanism of action that reduces recurrences and prevents metastatic breast cancer.
  • This statistically significant non-HLA-A*02 open label arm immune response data is trending similarly to the immune response data in the HLA-A*02 patients in the Phase IIb study and the HLA-A*02 arms of FLAMINGO-01. The study is ongoing and data collection and cleaning continue, while some patients may still be in their PIS vaccination phase, so final results may vary.
  • A 1% per year recurrence rate is so low that the number of recurrence events is too few to correlate a negative or lack of immune response to recurrence. The same constraint existed with the Phase IIb data which has a similarly low recurrence rate per year. While DTH immune response may be valuable at an aggregate level looking at whole patient populations, the recurrence rate is too low to validate any immune response measure as a biomarker for individual patient treatment decisions. It is also likely that some responding patients may not exhibit any immune response but still could be protected by GLSI-100 vaccination, thus helping to preserve the blind on the randomized arms of FLAMINGO-01.

The immune response abstract and poster conclusion: The statistically significant increase in the incidence of DTH reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to HLA-A*02 patients. Patients treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.

In addition, the second poster describing the Phase III trial design, which is being presented on Tuesday, April 21, can be downloaded and seen on the website using the same link. This poster provides an update that over 1,300 patients have been screened to date in FLAMINGO-01. The new protocol amendment, which is still under regulatory review in certain countries, is not discussed.

CEO Snehal Patel commented, “This new immune response data further supports the combination of HLA-A*02 and non-HLA-A*02 patients in the same randomized arms. In the US, the FDA recently reviewed such protocol changes and the many non-HLA-A*02 patients on waiting lists that were previously screened are now being enrolled. The screen rate continues to be encouraging, reflecting the high patient interest in the study as we have now screened over 1,300 patients. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients together using the increased statistical power of a combined analysis of the two patient groups or to pursue subgroups based on planned multiple interim analyses.”

The abstract from today’s immune response data and the members of the Steering Committee follow:

Abstract Number: CT138 – Poster Section 52 on April 20, 2026, 2-5pm PT

Abstract Title: Preliminary delayed-type-hypersensitivity immune response results from open-label arm of on-going Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01

Snehal S. Patel1, Jaye Thompson1, F. Joseph Daugherty1, Francois-Clement Bidard2, William J. Gradishar3, Marcus Schmidt4, Miguel Martin5, Joyce A. O’Shaughnessy6, Hope S. Rugo7, Cesar A. Santa-Maria8, Laura M. Spring9, Mothaffar F. Rimawi10

1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL,4University Medical Center Mainz, Mainz, Germany,5GEICAM, Madrid, Spain,6Sarah Cannon Research Institute, Dallas, TX,7City of Hope Comprehensive Cancer Center, Duarte, CA,8Johns Hopkins University, Baltimore, MD,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX

Background: This Phase III trial is a prospective, randomized, double-blinded, multi-center study (NCT05232916) in HLA-A*02 patients at approximately 140 sites in the US and Europe. A third non-randomized arm of approximately 250 non-HLA-A*02 patients is now fully enrolled and preliminary immune response data is presented below. GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100.

Methods: After standard of care neoadjuvant and adjuvant therapy, 6 intradermal injections of GLSI-100 will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up. Immune responses to GP2 were measured over time using delayed-type-hypersensitivity (DTH) skin tests and injection site reactions (ISRs). The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA, 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy, 3) Exclude Stage IV, and 4) Completed at least 90% of planned trastuzumab-based therapy.

Results: All patients (n=247) were vaccinated with GLSI-100 and continue in treatment and follow-up. A DTH reaction (redness) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was measured 48-72 hours after injection. In this preliminary data analysis, there was a significant increase in percentage of subjects experiencing a DTH reaction in month 4 or month 6 compared to baseline. The frequency of DTH reactions increased by approximately 4x from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001). The study is ongoing and data collection and cleaning continue so final results may vary.

Conclusions: The increase in the incidence of DTH reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to the HLA-A*02 genotype. Subjects treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess: correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.

The Steering Committee authoring abstract CT138 is comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:

  • Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
  • Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
  • Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
  • Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
  • Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
  • Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
  • Dr. Hope S. Rugo – Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Professor Emeritus, University of California, San Francisco
  • Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital

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

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. 

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

About GLSI-100 Phase IIb Study

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

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

About FLAMINGO-01 and GLSI-100

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

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

About Breast Cancer and HER2/neu Positivity

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

About Greenwich LifeSciences, Inc.

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

Forward-Looking Statement Disclaimer

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

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

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

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Source: Greenwich LifeSciences, Inc.

Released April 20, 2026

Follow the M&A Money: Why Biotech IPOs Are Making a Comeback

Posted on by [email protected]

Biotech’s long IPO drought may finally be breaking — but don’t mistake a crack in the window for a wide-open door.

This week, two biopharma companies launched roadshows that signal a cautious return of investor appetite to the public markets. GLP-1 developer Kailera Therapeutics hit the road at a $1.9 billion valuation, while proteomics company Alamar Biosciences priced at $17 per share — the top of its marketed range — and opened trading on the Nasdaq Friday with a 33% pop, valuing the company at roughly $1.53 billion. The upsized offering raised $191.3 million, a meaningful signal that institutional demand is real, not manufactured.

But the story isn’t really about IPOs. It’s about M&A.

The primary engine driving this biotech resurgence is an aggressive acquisition cycle fueled by the pharmaceutical industry’s looming patent cliff. Major drug companies are racing to backfill pipelines before blockbuster drugs lose exclusivity, and that urgency is translating into deal flow at a historic pace. According to a Stifel report, 19 biopharma M&A transactions of $1 billion or more were announced between January 1 and April 7 alone — putting the industry on pace for its second-highest annual total ever. Marquee deals include Merck’s $6.7 billion acquisition of Terns Pharmaceuticals and Eli Lilly’s $6.3 billion upfront commitment for Centessa Pharmaceuticals, both announced last month.

That M&A velocity matters beyond the deal itself. When large acquisitions close, venture investors recycle that capital back into the ecosystem — funding the next generation of companies and, critically, making investors more willing to participate in secondary offerings and IPOs. It’s a flywheel, and right now it’s spinning.

Valuations in the private markets are reflecting it. Median pre-money valuations for venture-growth biopharma companies jumped from $65 million to $247 million in 2025, according to PitchBook’s Q4 2025 Biopharma VC Trends report. And the Russell 2000 Biotech Index is up 9.7% year-to-date, outperforming the S&P 500.

That said, the numbers tell a sobering parallel story: of the six biopharma companies that have gone public since January, four are currently trading below their offer price. The market is rewarding quality — and punishing everyone else.

The threshold to go public has risen considerably since the 2020–2021 boom years, when companies with minimal patient data could attract institutional money. Today, clinical-stage companies are bringing 50 or more patients’ worth of data to the roadshow. Pre-clinical companies aren’t even in the conversation.

For small and microcap investors, this environment requires nuance. The biotech IPO window is open — but narrowly, and selectively. Companies that are scientifically de-risked, operationally sound, and well-positioned relative to M&A comps are getting deals done. Everything else is waiting.

The broader implication: as Big Pharma’s acquisition appetite grows, smaller biotech names that could plausibly become targets deserve a closer look. The deals are getting done — the question is who’s next on the list.

Release – Cardiff Oncology Presents Preclinical Data on its PLK1 Inhibitor Onvansertib in Combination with a HER2-Targeted ADC at the 2026 AACR Annual Meeting

Posted on by [email protected]
Cardiff Oncology, Inc. logo

Research News and Market Data on CRDF

April 17, 2026

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Onvansertib in combination with trastuzumab deruxtecan demonstrated enhanced antitumor activity, including tumor regression and apoptosis in HER2-low breast cancer models, supporting its potential for patients with limited treatment options

SAN DIEGO, Calif., April 17, 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, will present new preclinical data in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego, California. These data highlight the potential of Cardiff’s highly specific oral PLK1 inhibitor, onvansertib, in combination with the HER2-targeted antibody-drug conjugate (ADC), trastuzumab deruxtecan (T-DXd), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.

“These preclinical findings highlight a potential new opportunity for onvansertib, demonstrating its ability to enhance the activity of ADCs, which are becoming mainstays in oncology across multiple indications,” said Tod Smeal, Ph.D., Chief Scientific Officer of Cardiff Oncology. “By enhancing and prolonging DNA damage, this combination appears to drive greater apoptosis than either agent alone, offering a promising new approach for patients whose cancers have become resistant to standard-of-care treatments.”

Poster Presentation Highlights:

  • Onvansertib + T-DXd synergistically inhibited the viability of HER2-low breast cancer cell lines, including fulvestrant- and CDK4/6i-resistant cells
  • In the resistant triple-negative breast cancer model and two hormone receptor-positive models, the combination drove tumor regression in nearly all mice, with complete response rates up to 62%
  • Increased tumor regression, improved tumor growth inhibition, and extended event-free survival across models
  • Combination showed favorable tolerability in vivo

Following the presentation on April 19, 2026 from 2:00–5:00 PM PT, the poster titled “PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models” will be available on the Scientific Publications page of the Company’s website.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

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

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

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

Release – MariMed Announces First Quarter 2026 Earnings Date

Posted on by [email protected]

Research News and Market Data on MRMD

April 15, 2026 5:00pm EDT Download as PDF

NORWOOD, Mass., April 15, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQB: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its first quarter 2026 financial results on May 13, 2026 after the markets close. Management will host a conference call on May 14, 2026 at 8:00 a.m. EDT to discuss financial results.

A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q1 2026 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. The Company is also recognized for delivering exceptional customer service at our 13 Thrive Dispensary retail locations across five states. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Company Contact:
Howard Schacter
Chief Communications Officer 
Email: [email protected]
Phone: (781) 277-0007

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Source: MariMed Inc.

Released April 15, 2026

Release – GeoVax Reports 2025 Year-End Financial Results and Provides Business Update

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Pivotal Phase 3 Trial for GEO-MVA (Mpox/Smallpox Vaccine)

Scheduled to Initiate During the Second Half of This Year

ATLANTA, GA, April 15, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced its financial results and key operational accomplishments for the year ended December 31, 2025.

“During 2025, we made significant progress advancing GEO-MVA toward late-stage clinical development, supported by regulatory alignment with the European Medicines Agency (EMA) and key manufacturing milestones,” stated David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe GEO-MVA represents a critically important opportunity to eliminate the current global supply constraint in orthopoxvirus vaccines, while supporting broader public health preparedness and biosecurity objectives. As such, we look forward to initiating the planned Phase 3 immuno-bridging study in the second half of this year, which represents the next key step in advancing GEO-MVA to regulatory approval and access, providing a critically needed supply source of MVA-vaccine.”

Mr. Dodd concluded, “As we look ahead, our priority is executing key GEO-MVA clinical and regulatory milestones, strengthening strategic partnerships, while selectively advancing other programs, addressing critical medical needs worldwide, while maximizing long-term value to shareholders and stakeholders.”

Corporate and Operational Highlights

Priority Program – GEO-MVA

GeoVax’s primary near-term strategic development focus is the advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. GEO-MVA is the Company’s most advanced program and its most direct path to potential regulatory approval and commercialization. GEO-MVA is being developed on an expedited regulatory pathway to address a documented global supply constraint in orthopoxvirus vaccines, while supporting both public health preparedness and biosecurity needs, including diversification of supply beyond a single foreign manufacture.

During 2025, the Company achieved several key milestones, advancing GEO-MVA toward late-stage development and commercial readiness: 

  • Regulatory Alignment: GeoVax received formal Scientific Advice from the European Medicines Agency (EMA), supporting a streamlined and accelerated development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without the need for prior Phase 1 or Phase 2 trials.
  • Phase 3 Readiness: The Company is preparing to initiate a pivotal Phase 3 clinical trial in the second half of 2026, representing the critical next step toward potential regulatory approval and product distribution.
  • Manufacturing Progress: GeoVax completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.

GeoVax believes GEO-MVA is uniquely positioned at the intersection of:

  • Recurring global mpox outbreaks and evolving viral strains
  • Depleted government stockpiles following recent outbreaks
  • Policy-driven demand for diversified and domestic vaccine supply

Given these dynamics, GEO-MVA is expected to play a central role in global orthopoxvirus preparedness strategies. The Company is actively aligning GEO-MVA with public health preparedness and biosecurity procurement frameworks, including engagement with international regulatory and governmental stakeholders.

Additional Progress Across Clinical Pipeline

Beyond GEO-MVA, GeoVax continues to advance a diversified pipeline spanning infectious diseases and oncology:

  • GEO-CM04S1 (COVID-19 Vaccine):
    • Advancing through multiple Phase 2 clinical trials targeting immunocompromised populations, including stem cell transplant and CLL patients.
    • Data readouts expected in 2026, including from a completed booster trial in healthy adults.
    • Interim DSMB findings in the CLL study indicated superior immune responses versus mRNA comparator, supporting continued development.
  • Gedeptin® (Oncology):
    • Completed Phase 1/2 clinical evaluation in advanced head and neck cancer.
    • Entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors.
    • Planning Phase 2 trial for first-line treatment in locally advanced head and neck squamous cell carcinoma (2027).

2025 Full Year Financial Results

Net Loss: Net loss for the year ended December 31, 2025, was $21.5 million, or $22.40 per share, as compared to $25.0 million, or $120.46 per share, for the year ended December 31, 2024.

Revenue: For the year ended December 31, 2025, the Company reported $2.5 million of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $4.0 million during 2024. In April 2025, GeoVax received notification that BARDA determined to terminate the contract for convenience to the government.

R&D Expenses: Research and development expenses were $18.1 million for 2025, compared to $23.7 million in 2024, with the overall decrease primarily related to discontinued costs associated with termination of the BARDA/RRPV contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs.

G&A Expenses: General and administrative expenses were $6.0 million for 2025, compared to $5.4 million in 2024, with the overall increase primarily due to higher personnel costs, investor relations consulting and other programmatic expenses, patent costs, and stock-based compensation expense.

Cash Position: GeoVax reported cash balances of $3.1 million on December 31, 2025, as compared to $5.5 on December 31, 2024.

Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.

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 biosecurity 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:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Release – MAIA Biotechnology Activates First U.S. Site for Ongoing International Phase 2 Expansion Trial of Novel Telomere Targeting Treatment Targeting Advanced Non-Small Cell Lung Cancer

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Research News and Market Data on MAIA

April 16, 2026 9:20am EDT Download as PDF

Exceptional measures of efficacy observed in THIO-101 Phase 2 trial to date include disease control, response rates, and survival data well above standard of care benchmarks

50,000 advanced NSCLC diagnoses in the U.S. annually

CHICAGO, April 16, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has activated the first U.S. clinical site in its Phase 2 THIO-101 expansion trial of its lead investigational therapy as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).

“We are thrilled to activate the expansion of our Phase 2 THIO-101 trial in the U.S., bringing our novel treatment to our country’s broad underserved NSCLC patient population. Every year, we estimate approximately 50,000 patients resistant to chemo and CPIs alone advance to third-line NSCLC in the U.S. The medical need is extensive,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA.

The trial’s expansion into the U.S. marks a key milestone for MAIA, which is expected to open a significantly larger patient pool for evaluation of ateganosine, a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In addition to the first location, Summit Medical Group in New Jersey, MAIA intends to open four additional sites in U.S. in 2026. The trial is ongoing in Europe and Asia with 44 active sites in 6 countries.

MAIA’s THIO-101 expansion study evaluates ateganosine in heavily pre-treated patients in 3L NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with cemiplimab (Libtayo®) and ateganosine monotherapy. Third-line treatment evaluation in the U.S. is funded by a prestigious $2.3 million grant from the National Institutes of Health (NIH).

“The activation of Summit Medical Group as our first U.S. clinical site is a landmark moment for the THIO-101 study. This is expected to further advance ateganosine as a potential best-in-class therapy for third-line NSCLC,” said Matthew Failor, MAIA’s Director of Clinical Operations. “Partnering with a premier institution like Summit should allow us to bring this highly innovative telomere-targeting approach to U.S. patients who have limited options.”

“We are proud to be the first U.S. site to offer patients access to MAIA’s innovative THIO-101 expansion trial and contribute to advancing a promising new treatment strategy in lung cancer,” added Charles J. Kim, M.D., Summit Health oncologist and principal investigator for the THIO-101 trial in New Jersey.

MAIA holds FDA Fast Track designation for its lead drug targeting advanced NSCLC. The Fast Track process is designed to facilitate development and expedite the review of drugs for serious conditions with no treatment options or limited low-efficacy therapies. If relevant criteria are met during the Fast Track process, a drug is eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

In 2025, THIO-101 delivered exceptional efficacy data for MAIA’s lead investigational drug sequenced with a checkpoint inhibitor including disease control, response rates, and survival data well above standard of care benchmarks. MAIA recently reported overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of the trial. The eight patients include one with survival of 33 months and four with survival over 30 months. The measures of 3L OS beyond 24 months exceed all known benchmarks for advanced NSCLC treatment. The THIO-101 treatment regimen has shown an acceptable safety profile to date in a heavily pre-treated population.

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-101 Phase 2 Clinical Trial

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

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Released April 16, 2026

Release – Tonix Pharmaceuticals Announces Publication of Steady-State Pharmacokinetics of TONMYA® After 20 Days of Daily Dosing in the Peer-Reviewed Journal, Clinical Pharmacology in Drug Development

Posted on by [email protected]

Research News and Market Data on TNXP

April 15, 2026 7:00am EDT

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TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years

TONMYA commercially launched in the U.S. in November 2025

BERKELEY HEIGHTS, N.J., April 15, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial stage biotechnology company, today announced the publication of a paper, “Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial,” in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA® (cyclobenzaprine HCl sublingual tablets) was investigated under the designation TNX-102 SL. The manuscript can be accessed at https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.70060.

“TONMYA’s sublingual tablet was developed for long-term daily dosing at bedtime to target the nonrestorative sleep associated with fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Therefore, the steady-state pharmacokinetic (PK) profile at Day 20 is more relevant to the product’s indicated dosing regimen than single dose PK. The dynamic changes in cyclobenzaprine concentrations from sublingual tablet dosing over 24 hours at Day 20 are believed to provide pharmacodynamic effects on the brain owing to rapid absorption and distribution. The sublingual tablet was designed with a basifying ingredient and cyclobenzaprine–mannitol eutectic to provide transmucosal absorption to speed uptake, deliver maximum plasma levels of cyclobenzaprine during the middle of the sleep phase, and bypass first-pass liver metabolism. This study supported TONMYA’s approval for the treatment of fibromyalgia in adults by the U.S. Food and Drug Administration (FDA) and elucidates how TONMYA’s pharmacokinetic profile is consistent with long-term daily dosing at bedtime.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The dynamic changes in cyclobenzaprine concentrations are magnified by the higher predicted percentage of receptors by cyclobenzaprine relative to norcyclobenzaprine occupied (i.e., 5-HT2A, α1-adrenergic, H1, and M1) during sleep hours after bedtime dosing. For example, 5-HT2A antagonism increases slow wave sleep (SWS) activity during non–rapid eye movement (NREM) sleep, and α1-adrenergic antagonism increases the time and continuity in REM sleep and reduces noradrenergic sympathetic tone, which has the potential to impair the quality of SWS.”

The publication reports findings from a single-center, randomized, open-label, multiple-dose, parallel-group pharmacokinetic study conducted in 60 healthy adult volunteers. Participants were randomized 1:1 to receive either sublingual cyclobenzaprine HCl 5.6 mg (two 2.8 mg tablets, the FDA approved dose of TONMYA for adults) or oral cyclobenzaprine HCl extended-release (ER) 30 mg capsules (AMRIX®) once daily for 20 consecutive days.

At steady state, exposure to both plasma cyclobenzaprine and norcyclobenzaprine for sublingual tablets (TNX-102 SL) 5.6 mg was substantially lower than that to the comparator listed drug, oral cyclobenzaprine HCl ER 30 mg capsules. Importantly, when exposures were normalized by dose, cyclobenzaprine bioavailability is higher for sublingual tablets at 5.6 mg relative to oral ER 30 mg capsules. Both treatments had comparable metabolic profiles of Phase I and II metabolites in human plasma. These pharmacokinetic results are consistent with the use of sublingual cyclobenzaprine HCl tablets at 5.6 mg to target nonrestorative sleep in fibromyalgia, reduce pain, and potentially improve other symptoms of the condition.

On Day 1, sublingual cyclobenzaprine was detectable within one hour of administration, with median time to peak plasma concentration (tmax) approximately three hours earlier than the oral ER capsule formulation (five vs. eight hours). At steady state on Day 20, the sublingual tmax remained two hours earlier (five vs. seven hours). The sublingual formulation demonstrated markedly higher cyclobenzaprine bioavailability when exposures were normalized by dose.

Daily morning administration of sublingual cyclobenzaprine HCl 5.6 mg over 20 days was generally safe and well tolerated. There were no serious adverse events or treatment discontinuations due to adverse events. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events with sublingual tablets occurring at rates higher than oral ER capsules were oral hypoesthesia, abnormal product taste, somnolence, back pain, and fatigue. Since TONMYA is intended for bedtime administration, the effects of somnolence are expected to be an attribute for bedtime dosing when sleepiness effects are beneficial. No metabolites unique to the sublingual route of administration were identified.

About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)
TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which, compared to the immediate-release oral cyclobenzaprine, provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. The reduction in norcyclobenzaprine, a potent inhibitor of the norepinephrine transporter (NET), is thought to be key to the durability of treatment response as NET inhibition is activating and disruptive to slow wave sleep. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress reaction (ASR)/acute stress disorder (ASD), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Source: Tonix Pharmaceuticals Holding Corp.

Released April 15, 2026