(GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Ireland.
The Company’s application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the 2nd leading cause of death from cancer in women in Ireland with 883 deaths in 2022.
The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent’s University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.
CEO Snehal Patel commented, “We have visited St. Vincent’s multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site.”
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
Swiss pharmaceutical leader Roche has announced an agreement to acquire clinical-stage biopharmaceutical company 89bio, Inc. in a deal valued at up to $3.5 billion. The acquisition is set to strengthen Roche’s cardiovascular, renal, and metabolism portfolio, particularly its capabilities in treating metabolic dysfunction-associated steatohepatitis (MASH).
Under the terms of the agreement, 89bio shareholders will receive $14.50 per share in cash at closing, along with a non-tradeable contingent value right (CVR) providing up to an additional $6.00 per share contingent on specific milestones. The CVR payments are linked to the commercial success and sales performance of 89bio’s lead candidate, pegozafermin, a novel fibroblast growth factor 21 (FGF21) analog designed for patients with moderate to severe MASH and severe hypertriglyceridemia.
Pegozafermin is currently in Phase 3 clinical trials and is engineered to provide extended biological activity through a proprietary glycoPEGylated technology. The therapy aims to address critical unmet medical needs in liver and cardiometabolic diseases, including patients with advanced fibrosis and compensated cirrhosis. Its potential best-in-disease profile makes it a significant addition to Roche’s portfolio, enhancing the company’s efforts to provide innovative treatment options to patients worldwide.
The contingent payments under the CVR are structured to reward milestone achievements, including the first commercial sale of pegozafermin in F4 MASH cirrhotic patients, and annual global sales thresholds of $3 billion and $4 billion in subsequent years. This structure aligns shareholder incentives with the commercial success of the therapy while reflecting the high growth potential of 89bio’s pipeline.
The acquisition is subject to customary closing conditions, including the tender of a majority of 89bio’s outstanding shares and regulatory approvals. Roche plans to complete the transaction in the fourth quarter of 2025, after which 89bio will become part of Roche’s Pharmaceuticals Division. Until the closing, 89bio will continue to operate independently, maintaining its focus on the development of innovative therapies for liver and cardiometabolic diseases.
Financial advisors for 89bio include Moelis & Company LLC and Centerview Partners LLC, with Gibson, Dunn & Crutcher LLP serving as legal counsel. Citi and Sidley Austin LLP act as Roche’s financial and legal advisors.
The acquisition positions Roche to potentially transform the standard of care for patients with metabolic liver diseases while leveraging 89bio’s advanced clinical pipeline. Analysts view the deal as a strategic move to capture emerging opportunities in high-growth therapeutics, combining 89bio’s innovative platform with Roche’s global development, manufacturing, and commercialization capabilities.
Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1)
Planning adaptive Phase 2/3 study
Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic
CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the in-licensing of worldwide rights to TNX-4800 (formerly known as mAb 2217LS)1, which is a long-acting human monoclonal antibody that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans. TNX-4800 is being developed for annual seasonal use, as one subcutaneous dose administered in the Spring to protect against Lyme disease through Fall, or the entire tick season in the U.S. TNX-4800 was developed by researchers at UMass Chan Medical School, which is licensing the technology to Tonix. There are currently no FDA-approved vaccines or prophylactics to protect against Lyme Disease.
“Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year,”2 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Licensing TNX-4800 expands our infectious disease pipeline with a potentially differentiated, single-dose approach that can be given each Spring to provide protection within two days and protect through Fall, which is the entire tick season in the U.S. We believe TNX-4800’s long-acting monoclonal antibody prophylaxis could play an important role for preventing Lyme for millions of people who live, work, and vacation in regions endemic for Lyme disease. TNX-4800’s novel mechanism of blocking the maturation of Borrelia in the midgut of infected ticks is consistent with Tonix’s focus on innovation. We look forward to advancing the TNX-4800 program.”
“Preventing Lyme disease is an urgent public health priority, and more than thirty years of clinical experience confirm that monoclonal antibodies can be delivered safely and can be effective in preventing infections,” said Mark Klempner, M.D., Professor of Medicine at UMass Chan Medical School and leader of the research team that discovered and developed mAb 2217LS. “We are delighted to be collaborating with Tonix on the development of this program. TNX-4800 is a single dose and provides immediate immunity to the bacteria that causes Lyme disease, which is very different from Lyme disease vaccine programs currently in development.”
Terence R. Flotte, MD, Provost, Dean and Executive Deputy Vice Chancellor of UMass Chan Medical School, said, “We are proud to partner with Tonix Pharmaceuticals to advance the development of our novel monoclonal antibody as a prophylactic for Lyme disease, which is an urgent and growing public health challenge in the United States and around the world. This collaboration reflects UMass Chan’s enduring commitment to translational research that addresses unmet medical needs, and we are excited to work with Tonix to bring forward science-driven solutions that have the potential to prevent infection and protect vulnerable populations.”
TNX-4800 is a fully human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. By binding OspA, TNX-4800 blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The mAb 2217LS1 was derived from mAb 2217 by amino acid substitutions that crystallizable fragment (Fc) domain to prolong the serum half-life. A single administration in the Spring is designed to maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of the major Borrelia genospecies from ticks to animals. TNX-4800 sidesteps the multidose schedules required for OspA vaccines in development3 and FDA-approved vaccines that have been withdrawn from the market due to concerns about increased risk of autoimmunity. 4 Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA).
About Lyme Disease In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed, and even with treatment, up to 20% of cases may progress to a Post-Treatment Lyme Disease Syndrome (PTLDS) called “Chronic Lyme” or “Long Lyme”. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue and other symptoms.5
About Borrelia Burgdorferi In infected deer ticks, Borrelia’s OspA binds to tick-gut receptor TROSPA and helps it adhere to the midgut lining. During a tick bite Borrelia downregulates OspA, upregulates OspC, and activates motility genes. Borrelia undergoes a metamorphic-like transformation becoming highly flagellated and mobile, which facilitates migration to the salivary glands and invasion of human host tissues. The mAb 2217LS blocks the metamorphic-like transformation of Borrelia in the tick’s midgut preventing transmission of the bacteria. Lyme-causing Borrelia exposed or infected individuals, rarely make antibodies against OspA which allows for people to be reinfected despite having immunity to OspC. Consequently we expect that protection against Borrelia would require annual prophylaxis.
About Monoclonal Antibody Prophylaxis Two long-acting monoclonal antibody products6,7 have won FDA approval for prophylaxis against respiratory syncytial virus (RSV). AstraZeneca (in partnership with Sanofi) markets Beyfortus™ (nirsevimab) and Merck markets Enflonsia™ (clesrovimab).
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’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.
This press release and further information about Tonix can be found at www.tonixpharma.com.
UMass Chan Medical School UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at www.umassmed.edu.
3Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn over concerns about an increased risk of autoimmune arthritis triggered by molecular mimicry, particularly in HLADRB1*0401 (“DR4+”) individuals. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. doi: 10.1017/S0950268806007096. Epub 2006 Aug 8. PMID: 16893489; PMCID: PMC2870557.
4Pfizer and Valneva’s VLA15 vaccine candidate has been specifically engineered and clinically evaluated to mitigate the autoimmune concerns that contributed to the withdrawal of earlier OspA-based vaccines. Comstedt P, et al. Vaccine. 2015 33(44):5982-8. doi: 10.1016/j.vaccine.2015.07.095. Epub 2015 Aug 13. PMID: 26277070.
5National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.
6Sanofi Press Release. “May 29, 2025. Press Release: Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs.“ https://bit.ly/40DeJGf
7June 9, 2025. Merck Press Release. “U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season” https://bit.ly/4kkXDE8.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to 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 forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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.
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.
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants
BOTHELL, Wash., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 2,764,710 shares of its common stock at a purchase price of $1.70 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that are exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, were approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.
The common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.
Forward-Looking Statements
The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Cadrenal Acquires Complimentary Cardiovascular Products. Cadrenal announced that it has acquired the anti-coagulant assets of eXlthera Pharmaceuticals. The products include frunexian, a Pre-Phase-2 anti-coagulant drug that inhibits a different step in the coagulation cascade from tecarfarin. Frunexian is in development for different indications and could extend Cadrenal’s product line to additional indications that are not served by current drugs. The acquisition also includes an oral formulation and other research-stage molecules.
Frunexian Has Several Distinguishing Features. The lead product from eXlthera is frunexian, a Factor XIa inhibitor. Most of the DOAC (direct-acting oral anticoagulant) class target Factor Xa and have been developed for long-term use on an outpatient basis. In contrast, frunexian targets Factor XIa, a different component of the coagulation cascade.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Multi-Antigen COVID-19 Vaccine Candidate Outperforms mRNA Comparator; Enrollment Now Limited to GEO-CM04S1 Arm
ATLANTA, GA – September 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today showcased positive interim results for its lead COVID-19 vaccine candidate, GEO-CM04S1 at the XXI International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2025) in Krakow, Poland.
The presentation by Alexey V. Danilov, MD, PhD, Professor, Department of Hematology and Transplantation at City of Hope, detailed data from an ongoing randomized Phase 2 trial (NCT05672355) comparing GEO-CM04S1 to a standard-of-care mRNA vaccine in patients with chronic lymphocytic leukemia (CLL).
Key Takeaways
Differentiated Performance: The proportion of CLL patients receiving GEO-CM04S1 that achieved the study’s primary immune endpoint met the statistical requirement to continue enrollment, while those in the mRNA COVID-19 vaccine arm did not.
Enrollment Shifted to GEO-CM04S1: Following interim analysis and following the recommendation of the Data Safety Monitoring Board, further enrollment is proceeding exclusively in the GEO-CM04S1 arm.
Durable Market Potential: CLL patients represent a high-need, underserved market where first-generation COVID-19 vaccines are often inadequate.
Favorable Safety Profile: Both vaccines were well tolerated, with no grade ≥3 adverse events reported.
“These data reinforce the value proposition of our multi-antigen MVA platform,” said David Dodd, Chairman & CEO of GeoVax. “Immunocompromised patients, including those with CLL, have not been adequately protected by current vaccines. GEO-CM04S1 is demonstrating the ability to overcome this gap, representing not only a clinical breakthrough but also a compelling commercial opportunity.”
About GEO-CM04S1
GEO-CM04S1 is a next-generation COVID-19 vaccine built on a Modified Vaccinia Ankara (MVA) vector. Unlike first-generation vaccines, GEO-CM04S1 encodes both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2 to drive broad, cross-variant, and durable immune protection. The vaccine is currently in three Phase 2 clinical trials:
As a primary vaccine for immunocompromised patients with blood cancers or post-transplant status,
As a booster in CLL patients, and
As a more robust COVID-19 booster in previously mRNA-vaccinated healthy adults.
Strategic Opportunity
With millions of immunocompromised patients worldwide, including those with CLL and other hematologic malignancies, GEO-CM04S1 addresses a significant unmet medical and commercial need. The vaccine’s ability to induce nucleocapsid-specific responses sets it apart from existing single-antigen mRNA products, positioning GeoVax to lead in a multi-billion-dollar market segment where durable protection remains elusive.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settings
Company is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk
PONTE VEDRA, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced the acquisition of the assets of eXIthera Pharmaceuticals (“eXIthera”), including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors. The acquisition significantly enhances Cadrenal’s pipeline, adding drug candidates that address large and underserved segments of the current $38 billion global anticoagulation market.
eXIthera’s lead asset, frunexian, is a first-in-class, Phase 2-ready intravenous (IV) Factor XIa inhibitor designed for acute care settings where contact activation of coagulation by medical devices plays a significant role, such as cardiopulmonary bypass, catheter thrombosis, and other blood-contacting implanted cardiac devices. The acquisition also includes EP-7327, an oral Factor XIa inhibitor, for the prevention and treatment of major thrombotic conditions.
“With this acquisition, Cadrenal is the only company in the world developing a novel vitamin K antagonist (tecarfarin) and Factor XIa inhibitors, a promising new class of anticoagulants,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “These newly acquired assets will expand Cadrenal’s capabilities in an effort to address even more critical gaps in current antithrombotic treatment, especially for patients for whom current therapies are unreliable or carry excessive bleeding risk.”
Unlike current anticoagulants on the market, which increase the risk of bleeding by broadly impairing coagulation, eXIthera’s compounds are mechanism-based inhibitors of Factor XIa, offering high potency, selectivity, and tunable pharmacokinetics. Factor XIa inhibition is one of the most active and exciting areas of current thrombosis research.
“This acquisition reinforces Cadrenal’s long-term vision of becoming a category leader in anticoagulation,” added Pham. “With tecarfarin planning a trial in patients with end-stage kidney disease transitioning to dialysis, our plans for LVAD patients, and the current addition of frunexian and EP-7327, we believe that Cadrenal is strategically positioned to deliver differentiated therapeutics across the entire spectrum of patients with cardiovascular thrombotic risk.”
Assets Acquired:
Frunexian: Phase 2-ready IV Factor XIa agent for acute anticoagulation
EP-7327: IND-ready oral small molecule candidate for chronic indications
Extensive portfolio of additional novel FXIa small molecules
Under a pre-existing license agreement, Sichuan Haisco Pharmaceuticals retains rights to frunexian in China, having completed a successful Phase 1 trial there. Under the terms of the license, Cadrenal will be entitled to receive royalties on future sales of frunexian in China.
Deal Terms Overview:
Under the terms of the acquisition agreement, eXIthera will receive milestone payments from Cadrenal totaling up to $15 million, contingent upon the realization of certain future clinical and regulatory milestones. Additionally, eXIthera will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets.
About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven.
Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the acquisition significantly enhancing Cadrenal’s pipeline and addressing large and underserved segments of the global anticoagulation market; the size of the global anticoagulation market; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment with the acquisition; Cadrenal becoming a leader in anticoagulation; commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; Cadrenal’s receipt of royalties on future sales of frunexian in China; the payment to eXIthera of milestone payments by the Company totaling up to $15 million contingent upon the realization of certain future clinical and regulatory milestones as well as global sales of the acquired assets upon future commercialization; Cadrenal’s ability to focus capital deployment on advancing the clinical development of tecarfarin and the acquired assets; and tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Cadrenal’s ability to deliver differentiated therapeutics across the entire spectrum of cardiovascular thrombotic risk and overcome the gaps in anticoagulation therapy; the potential of EP-7327 for the prevention and treatment of major thrombotic conditions; Cadrenal’s ability to address even more critical gaps in current antithrombotic treatment; the payment of milestone payments and royalties; Cadrenal successfully advancing tecarfarin and the acquired assets into clinical practice; the commencement of a trial in patients with end-stage kidney disease transitioning to dialysis; tecarfarin addressing the unmet needs in anticoagulation therapy; tecarfarin reducing the clinical complexities of managing Vitamin K antagonists and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Upfront fees and near-term development milestone payments totaling up to $7.5 million
Potential sales milestones of $180 million or more in first 10 years of commercialization
Royalties equaling 25% of net sales
Ocugen to manufacture and supply OCU400
MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today executed a licensing agreement with Kwangdong Pharmaceutical, Co., Ltd., (“Kwangdong”) one of the leading pharmaceutical companies in Korea, for the exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).
Pursuant to the License Agreement, Ocugen will receive upfront license fees and near-term development milestones equaling up to $7.5 million. The Company will be entitled to sales milestones of $1.5 million for every $15 million of sales in Korea, projected to reach $180 million or more in the first 10 years of commercialization. Additionally, Ocugen will receive a royalty of 25% on net sales of OCU400 generated by Kwangdong. Ocugen will manufacture the commercial supply of OCU400 under terms of a supply agreement.
There are an estimated 7,000 individuals in the Republic of Korea with RP, which represents approximately 7% of the U.S. market. OCU400 provides the opportunity for our partner to help thousands of patients facing vision loss. Upon regulatory approval of OCU400 in Korea, we believe Kwangdong will become a leader in the field of ophthalmic gene therapy in Korea.
“We are excited to partner with Kwangdong as our first regional partner in the development and commercialization of our modifier gene therapies across the globe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “OCU400 is a potential one-time therapy for life to treat RP and upon local regulatory approval, patients in Korea with this devastating condition will be able to access OCU400 through Kwangdong.”
Kwangdong, a top five pharmaceutical and healthcare company in Korea, has a diverse portfolio of products including prescription pharmaceuticals and over-the-counter healthcare products. The company is actively involved in research and development innovation including transformational late-stage, high-impact technologies.
“Kwangdong is very excited to have the opportunity to provide a new treatment option to Korean patients suffering from RP and the healthcare professionals treating them,” said SungWon Choi, CEO & Chairman of Kwangdong. “From the company’s perspective, this deal with Ocugen is especially meaningful as it allows us to further strengthen our ophthalmology portfolio, alongside our existing pipeline for presbyopia and pediatric myopia. Once the ongoing clinical trial of OCU400 is completed, Kwangdong will make every effort to bring the product to the Korean market as quickly as possible.”
Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. Biologics License Application (BLA) filing in 2026.
Kwangdong intends to utilize Ocugen’s clinical data and BLA filing as part of their regulatory submission for approval in Korea.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.
About Kwangdong Pharmaceutical Co., Ltd Kwangdong Pharmaceutical Co., Ltd is a South Korean human healthcare company founded in 1963. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company’s business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical’s vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.
Cautionary Note on Forward-Looking Statements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto, the risks that the license agreement with Kwangdong will not lead to the current anticipated benefits to Ocugen, including projected sales royalties and milestones, therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(“SEC”),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
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.
GLSI-100 Received Fast Track Designation. Greenwich LifeSciences announced that GLSI-100 has received Fast Track designation from the FDA. In the near term, this designation allows GLSI increased communications and more FDA meetings regarding regulatory requirements for its clinical trial data and use of biomarkers. Once the FLAMINGO-01 trial is completed, GLSI will be eligible to apply for Accelerated Approval and Priority Review, potentially shortening the time to market.
The Designation Mirrors The Trial Entry Criteria. GLSI-100 has received Fast Track Designation from the FDA for the treatment of “patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival…” This includes the clinical trial entry criteria and endpoints for the current double-blind arms of the trial.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants
BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.70 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,529,420 shares of common stock at an exercise price of $1.50 per share that will be exercisable upon issuance and will expire twenty-four months from the effective date of the registration statement covering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about September 15, 2025, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $4.7 million. The potential additional gross proceeds to the Company from the warrants, if fully-exercised on a cash basis, will be approximately $8.3 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.
The common stock (or common stock equivalents in lieu thereof, but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-271883) that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 26, 2023. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.
Forward-Looking Statements
The information in this press release includes “forward-looking statements.” Any statements other than statements of historical fact contained herein, including statements as to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology.
BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9thInternational Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevention and treatment of norovirus infection.
“It was an honor to share highlights of our CDI-988 Phase 1 data with global norovirus experts at the leading calicivirus scientific meeting,” said Dr. Lee. “The recent completion of Phase 1 study and U.S. Food and Drug Administration’s (FDA) Investigation New Drug (IND) clearance for the next study mark significant milestones for our clinical development of CDI-988.”
CDI-988 was rationally designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In vitro potency data and high-resolution crystal structures have shown broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17, the strain responsible for the majority of circulating infections.
Dr. Lee also discussed previously reported Phase 1 results demonstrating CDI-988’s favorable safety and tolerability profile, with no serious adverse events. Earlier this week, Cocrystal announced FDA authorization to proceed with a Phase 1b human challenge study to evaluate CDI-988 as a potential norovirus prophylaxis and treatment. The study is expected to begin before year end.
The Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates at this year’s conference engaged with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.
Protease Inhibitor CDI-988 CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. It targets a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.
Norovirus Infection Norovirus, the leading cause of viral gastroenteritis worldwide, spreads rapidly in community settings such as hospitals, nursing homes, childcare facilities, schools and cruise ships. It causes nausea, vomiting, diarrhea, abdominal pain and dehydration, and is responsible for an estimated $60 billion worldwide in direct healthcare costs and lost productivity.
Cocrystal Structure-Based Platform Technology CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.
About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 as a potential antiviral for the prevention and treatment of norovirus infection, and the Company’s plan to initiate a Phase 1b study in 2025. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials and our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.
As of June 30, 2025,
Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1.
Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025).
Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival.
“THIO-101 continues to reveal impressive efficacy with observed progression free survival of 5.6 months, which is more than double the standard of care PFS of just 2.5 months. The data also demonstrates the durability of ateganosine treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are seeking further validation of ateganosine’s strong efficacy in our THIO-101 Phase 2 expansion trial, which began enrolling patients in July 2025.”
Details of THIO-101, including efficacy data and safety findings, are included in MAIA’s poster for the 2025 IASLC World Conference on Lung Cancer (WCLC), available at maiabiotech.com/publications.
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.
ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th.
Nutriband is continuing to expand its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary. The company produced a record six months, reporting revenue of $1,289,884, up 50.87% YOY.
Progress continues on the development of AVERSA Fentanyl, Nutriband is reminding exiting shareholders and updating new shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before submission.
If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances.
AVERSA Buprenorphine, which is the company’s second application for AVERSA, is projected to reach peak annual sales of up to $130 million.
As of July 31, 2025, Nutriband’s cash reserves stand at $6.9 million, supporting the company’s ongoing development and commercialization efforts for AVERSA Fentanyl. The company’s total assets are valued at $10.17 million, with stockholders’ equity amounting to $8.5 million.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from Company’s websites or any other website if not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
For more information, contact:
Nutriband Inc. Phone: 407-377-6695 Email: info@nutriband.com
