MALVERN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the closing of its previously announced registered direct offering pursuant to a securities purchase agreement with Janus Henderson Investors, a global asset management firm, for the purchase and sale of 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share (closing price on August 7, 2025) and accompanying warrant. The warrants have an exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire two years following the date of issuance. The warrants are callable by the Company when the VWAP of the Company’s common stock exceeds $2.50 per share for at least five of a trailing 30 trading day period.
Noble Capital Markets, Inc. acted as the sole placement agent in connection with the offering. Maxim Group LLC and Titan Partners Group, a division of American Capital Partners, acted as independent financial advisors in connection with the offering.
The gross proceeds to the Company were approximately $20 million before deducting the placement agent fees and other estimated offering expenses, which the Company anticipates will extend the Company’s cash runway into the second quarter of 2026. The Company may receive up to $30 million of additional gross proceeds if the warrants are exercised in full. The Company anticipates that combined offering proceeds of $50 million with warrant exercise will extend the Company’s cash runway into the first quarter of 2027. The offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the U.S. Securities and Exchange Commission (“SEC”), which was declared effective on May 1, 2024. The offering was made only by means of a prospectus forming a part of the effective registration statement relating to the offering. A prospectus supplement relating to the shares of common stock and warrants has been filed by the Company with the SEC. Copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110, Boca Raton, FL 33432.
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.
AboutOcugen,Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “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. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expected cash runway, whether the warrants will be exercised and various other factors. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press 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.
Cadrenal Reports 2Q With Product News. Cadrenal reported a 2Q25 loss of $3.7 million or $(1.87) per share. During the quarter, the company announced a design modification for the upcoming tecarfarin clinical trial. The company also transferred its manufacturing technology to a CDMO and completed production scale-up in preparation for clinical trials. Cash on June 30, 2025 was $5.6 million.
New Trial Focuses On First Months Of Dialysis. As described in our Research Note on August 7 , the new trial design reflects recent research showing the first four to six months after the start of renal dialysis are an ultra-high-risk period for cardiac events including myocardial infarction, stroke, embolism, and death. The design change will be testing tecarfarin as an anticoagulant to reduce these events. The clinical site activation and trial enrollment are expected to begin around year-end.
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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.
FDA PDUFA goal date ofAugust15, 2025, for TNX‑102SL for fibromyalgia: if approved by FDA, TNX‑102SL would be the first new drug for fibromyalgia in more than 16years
InJune2025, the Company was added to the Russell3000® and Russell2000® Indexes following the annual reconstitution
Phase3RESILIENT results published in peer-reviewed journal, PainMedicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102SL; generally well tolerated
Cash and cash equivalents of $125.3million reported as ofJune 30, 2025; current cash runway expected to fund operations into the third quarterof2026
CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent operational highlights.
“With the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, we are excited about the potential to make this important new therapy available to patients in the fourth quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “FDA considers fibromyalgia a serious condition and awarded TNX-102 SL Fast Track designation last year. There has been no new treatment for this debilitating condition approved in over 16 years. Additionally, our RESILIENT Phase 3 study results were recently published in the peer-reviewed journal, Pain Medicine.”
Dr. Lederman continued, “Our pipeline momentum remains strong. In the second quarter, we dosed the first patient in the U.S. Department of Defense (DoD)-funded, investigator-initiated, OASIS trial of TNX-102 SL for acute stress reaction. We also presented new data for our live-virus vaccine, TNX-801, which demonstrated durable single-dose protection against mpox and rabbitpox in animal models. We previously reported positive Phase 1 safety and pharmacokinetic data for TNX-1500, advancing this next-generation anti-CD40L antibody toward a Phase 2 kidney-transplant study. We are well-positioned to translate these milestones into meaningful value for patients and shareholders alike.”
Key Investigational Product Candidates
Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg): two tablets (5.6 mg), once-daily at bedtime for fibromyalgia (FM) – a centrally-acting, non-opioid analgesic.
In June 2025, Tonix presented a poster at the European Congress of Rheumatology (EULAR 2025) demonstrating that TNX‑102 SL produced statistically significant, durable (14‑week) pain reduction across two Phase 3 trials.
In July 2025, Tonix announced online publication of full results from the confirmatory Phase 3 RESILIENT trial of TNX‑102 SL in the peer-reviewed journal Pain Medicine, showing once‑nightly 5.6 mg achieved a statistically significant reduction in fibromyalgia pain versus placebo and was well tolerated; the data confirm the earlier RELIEF study and support the ongoing New Drug Application (NDA) review with an August 15, 2025 PDUFA goal date.
TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
In May 2025, the first patient was dosed in the Phase 2 investigator initiated OASIS trial evaluating a two week course of TNX102 SL 5.6 mg to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD); the study is sponsored by the University of North Carolina and supported by a $3 million U.S. Department of Defense grant, with topline results expected in the second half of 2026.
Immunology Pipeline
TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders
In May 2025, Tonix reported positive topline data from a Phase 1 single‑ascending‑dose study in healthy volunteers: TNX‑1500 met all safety, pharmacokinetic and pharmacodynamic goals, blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses with intravenous (i.v.) administration, and showed a 34–38‑day mean half‑life that supports monthly i.v. dosing—supporting the path for a planned Phase 2 study to evaluate TNX-1500 for prevention of rejection in kidney allogeneic transplant.
TNX-801 (recombinant horsepox virus, minimally replicative live-virus vaccine): potential vaccine to protect against mpox and smallpox.
In April 2025, Tonix presented new preclinical data on TNX-801 at the World Vaccine Congress Washington 2025 showing a single subcutaneous (s.c.) dose protected animals from mpox and rabbitpox for at least six months, remained well tolerated even in immunocompromised models, and met key attributes in the WHO’s preferred target product profile for mpox vaccines.
Corporate and Partnerships
In May 2025, Tonix appointed Joseph Hand, Esq. as General Counsel and Executive Vice President of Operations, adding more than two decades of legal and operational expertise as the Company prepares for potential TNX‑102 SL commercialization.
In June 2025, Tonix announced that commercial veteran James Hunter joined its Board of Directors, bringing forty years of go‑to‑market experience to strengthen strategy and governance ahead of the expected TNX‑102 SL launch.
In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among institutional investors as Tonix approaches key regulatory milestones.
Financials
As of June 30, 2025, Tonix had $125.3 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $31.4 million for the six months ended June 30, 2025, compared to $27.5 million for the same period in 2024.
The Company believes that, based on its current operating plan, its cash on hand at June 30, 2025, together with $51.5 million in net proceeds received from equity offerings during the third quarter 2025, will fund planned operating and capital expenditures into the third quarter of 2026.
Second Quarter 2025 Financial Results
Net product revenue for the three months ended June 30, 2025 was approximately $2.0 million, compared to $2.2 million for the same period in 2024; revenue again reflected combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of sales for the three months ended June 30, 2025 was approximately $3.3 million, compared to $3.4 million for the same period in 2024.
Research and development expenses for the three months ended June 30, 2025 were $10.8 million, compared to $9.7 million for the same period in 2024. The increase was predominately due to increased clinical expenses, nonclinical expenses and manufacturing expenses, reflecting spend on pipeline priorities.
Selling, general and administrative expenses for the three months ended June 30, 2025 were $16.2 million, compared to $7.5 million in 2024. The increase is predominately due to spend on sales and marketing to progress pre-launch activities related to the potential FDA approval of TNX-102 SL for fibromyalgia.
Net loss available to common stockholders was $28.3 million, or $3.86 per share (basic and diluted), for the second quarter 2025, compared to a net loss of $78.8 million, or $1,920.85 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the second quarter 2025 were 7,327,257 compared to 41,011 for the same period in 2024.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for fibromyalgia and for which a PDUFA goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA had also granted Fast Track designation to TNX-102 SL for fibromyalgia. TNX-102 SL is also 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 Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.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 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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.
Brian Korb astr partners (917) 653-5122 brian.korb@astrpartners.com
Media Contact Ray Jordan Putnam Insights ray@putnaminsights.com (949) 245-5432
Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million
Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role
Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectively
GAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectively
Pivotal Phase 3 trial of Hydronidone (F351) in CHB-associated liver fibrosis demonstrated statistically significant fibrosis regression after 52 weeks of treatment; Phase 2 trial in the United States evaluating Hydronidone for the treatment of MASH-associated liver fibrosis expected to initiate in 2H 2025, pending regulatory approval
Successfully launched Etorel (nintedanib ethanesulfonate soft capsules) in the PRC for the treatment of SSc-ILD and PF-ILD
Announced NMPA approval for clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications with Phase 2/3 trial anticipated in 2H 2025
First volunteer dosed in Phase 1 clinical trial of F230 for treatment of PAH
SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the second quarter ended June 30, 2025 and provided a business and leadership update.
Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre’s fibrosis focused pipeline. Ping Zhang, Executive Chairman, has been appointed Interim Chief Executive Officer, and will lead the company’s day-to-day operations and strategic global expansion.
“I want to thank Dr. Ying for his contributions and dedication during his tenure as CEO. His deep background in research and discovery will be invaluable to advance our science and continued innovation,” said Mr. Zhang. “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.”
“Looking ahead, we are thrilled with the rapid progress we have made towards expanding our commercial footprint and advancing our pipeline of fibrosis-first therapies. Our lead compound, Hydronidone, demonstrated statistically significant fibrosis regression in patients with CHB-associated liver fibrosis in a pivotal Phase 3 trial in the PRC, a critical step that not only underscores the potential of Hydronidone, but also lays the foundation to expand into additional fibrotic indications,” continued Mr. Zhang. “In the second half of 2025 we are well-positioned to grow our footprint in the United States with our planned Phase 2 trial evaluating Hydronidone in MASH-associated liver fibrosis, while continuing to advance our robust pipeline in the PRC, highlighted by a new Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications expected to initiate later this year. In addition, Gyre Pharmaceuticals remains on track to file an NDA for Hydronidone with the NMPA in the third quarter of 2025 to potentially support our growing commercial portfolio.”
Second Quarter Business Highlights and Upcoming Milestones
Commercial Portfolio Expansion
ETUARY® (pirfenidone): Generated $23.5 million in sales of ETUARY® for the quarter ended June 30, 2025, compared to $25.1 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): In June 2025, Gyre launched Etorel in the PRC for the treatment of systemic sclerosis-associated ILD, and progressive fibrosing ILD, and generated sales of $1.6 million in the first partial quarter of launch.
Contiva (avatrombopag maleate tablets): In March 2025, Gyre initiated commercialization of Contiva in the PRC for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, and generated sales for $1.5 million in the second quarter of 2025.
Pipeline Development Updates
Hydronidone:
In May 2025, Gyre reported positive results from its pivotal Phase 3 trial of Hydronidone for chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC, which demonstrated statistically significant regression in liver fibrosis after 52 weeks compared to placebo. In addition, Hydronidone met a key secondary endpoint with statistically significant inflammation improvement without fibrosis progression at Week 52 versus the placebo arm. Hydronidone was well tolerated with a comparable incidence of serious adverse events (4.88% vs. 6.45% in the placebo group) and no discontinuations due to adverse events in either group. Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical conference. Based on these results, Gyre intends to file a New Drug Application (“NDA”) with the PRC’s National Medical Products Administration (“NMPA”) in the third quarter of 2025.
Gyre previously submitted an investigational new drug application (“IND”) for the treatment of liver fibrosis associated with a broad spectrum of chronic liver diseases with the U.S. Food and Drug Administration and conducted a Phase 1 trial of Hydronidone in healthy volunteers for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis. The Company is currently conducting an internal review to determine whether a new IND will be required for a Phase 2 trial in MASH-associated liver fibrosis. The Phase 2 trial is expected to start in the second half of 2025, subject to regulatory feedback.
ETUARY® (Pirfenidone):
Gyre plans to initiate an adaptive Phase 2/3 trial of pirfenidone for radiation-induced lung injury (“RILI”), including cases complicated by immune-related pneumonitis across top oncology centers in the PRC in the second half of 2025.
F573:
F573 is a caspase inhibitor and potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 for ALF/ACLF is expected by the end of 2026.
F230:
In June 2025, the first volunteer was successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A receptor agonist, for the treatment of pulmonary arterial hypertension (“PAH”) in the PRC.
F528:
F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.
Corporate Updates
In August 2025, Ping Zhang was appointed interim CEO as Dr. Han Ying transitions to a scientific leadership role. Mr. Zhang, who was appointed Executive Chairman in March 2025, has served on Gyre’s Board of Directors since January 2025.
In May 2025, Gyre completed an underwritten public offering of 2,555,555 shares of its common stock at a public offering price of $9.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $23.0 million.
In the third quarter of 2025, BJContinent Pharmaceuticals Limited increased its capital contribution in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.) by $1.28 million in exchange for 9,184,910 additional shares. As a result, the Company’s indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7%.
Financial Results
Cash Position
As of June 30, 2025, Gyre held $36.5 million in cash and cash equivalents, $17.9 million in short-term bank deposits, and $21.5 million in long-term certificates of deposit, totaling $75.9 million. The increase of cash and cash equivalents mainly includes net proceeds of approximately $21.3 million received from the May 2025 underwritten public offering.
Financial Results for the Three Months Ended June 30, 2025
Revenues: Revenues for the three months ended June 30, 2025 were $26.8 million, compared to $25.2 million for the same period in 2024. The $1.6 million increase was primarily driven by a $1.6 million increase in revenue as a result of Etorel’s commercial launch in June 2025 and a $1.5 million increase in revenue from the sales of Contiva. These increases were offset by a $1.5 million decline in ETUARY® sales.
Gyre anticipates revenue growth over the remainder of the year, driven by the commercial launch of Etorel in June 2025 and the continued expansion of Contiva.
Cost of Revenues: For the three months ended June 30, 2025, cost of revenues was $1.2 million, compared to $0.8 million for the same period in 2024. The $0.4 million increase was primarily driven by a $0.2 million increase in the costs associated with Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.2 million increase in ETUARY®’s cost due to the higher plant, property and equipment depreciation from a plant renovation.
Selling and Marketing Expense: For the three months ended June 30, 2025, selling and marketing expense was $15.2 million, compared to $14.4 million for the same period in 2024. The $0.8 million increase was primarily attributable to a $0.9 million increase in payroll costs, driven by higher headcount and increase of sales in the three months ended June 30, 2025, partially offset by $0.1 million decrease in promotion and conference expenses.
Research and Development Expense: For the three months ended June 30, 2025, research and development expense was $3.4 million, compared to $3.3 million for the same period in 2024. The $0.1 million increase was primarily attributable to a $0.1 million increase in clinical trial costs, primarily related to data analysis costs for Hydronidone, and a $0.1 million increase in staff costs. These increases were partially offset by a $0.1 million decrease in materials and utilities expenses.
General and Administrative Expense: For the three months ended June 30, 2025, general and administrative expense was $4.8 million, compared to $3.4 million for the same period in 2024. The $1.4 million increase was primarily driven a $0.5 million increase in professional fees, and a $0.9 million increase in functional and administrative department’s personnel and stock compensation costs.
Income from Operations: For the three months ended June 30, 2025, income from operations was $2.2 million, compared to $3.2 million income from operation for the same period in 2024. The $1.0 million decrease was primarily driven by $2.6 million increase in total operating expenses, partially offset by a $1.6 million increase in revenue.
Net Income: For the three months ended June 30, 2025, net income was $1.6 million, compared to $4.5 million net income for the same period in 2024.
Non-GAAP Adjusted Net Income: For the three months ended June 30, 2025, non-GAAP adjusted net income was $2.9 million, compared to $3.1 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $1.7 million, partially offset by an increase in revenue of $1.6 million.
Financial Results for the Six Months Ended June 30, 2025
Revenues: Revenues for the six months ended June 30, 2025 were $48.8 million, compared to $52.4 million for the same period in 2024. The $3.6 million decrease was primarily driven by a $6.8 million decline in ETUARY® sales, partially offset by the increase in new product sales of Contiva by $1.8 million and Etorel by $1.6 million. The decrease in ETUARY® sales was mainly due to lower sales volume compared to the first half of 2024, when revenues were elevated by a one-time rural marketing campaign that was not repeated in 2025. Additionally, weaker economic conditions in China and increased competition in the IPF treatment market also contributed to the decline. During the first half of 2025, marketing funds were intentionally shifted to support the launches of Etorel and Contiva.
Gyre anticipates revenue growth over the remainder of the year, driven by the continued expansion of Contiva in March 2025 and the commercial launch of Etorel in June 2025.
Cost of Revenues: For the six months ended June 30, 2025, cost of revenues was $2.0 million, compared to $1.7 million for the same period in 2024. The $0.3 million increase was primarily driven by a $0.1 million increase in stock-based compensation and a $0.2 million increase in the costs of Etorel and Contiva, in line with the corresponding increase in their sales.
Selling and Marketing Expense: For the six months ended June 30, 2025, selling and marketing expense was $26.0 million, compared to $26.9 million for the same period in 2024. The $0.9 million decrease was primarily driven by a reduction in commission costs due to the decrease of sales.
Research and Development Expense: For the six months ended June 30, 2025, research and development expense was $6.5 million, compared to $5.5 million for the same period in 2024. The $1.0 million increase was primarily attributable to a $1.5 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone. This increase was offset by a $0.3 million decrease in materials and utilities expenses and a $0.1 million decrease in facilities, depreciation and other.
General and Administrative Expense: For the six months ended June 30, 2025, general and administrative expense was $9.8 million, compared to $6.8 million for the same period in 2024. The $3.0 million increase was primarily driven a $0.6 million increase in professional fees, a $1.6 million increase in functional and administrative department’s personnel and stock compensation costs, and a $0.8 million increase in miscellaneous expense, mainly due to the increase for the annual meeting expense.
Income from Operations: For the six months ended June 30, 2025, income from operations was $4.4 million, compared to $11.3 million income from operation for the same period in 2024. The $6.9 million decrease was primarily driven by a $3.6 million decrease in revenue and $3.3 million increase in total operating expenses.
Net Income: For the six months ended June 30, 2025, net income was $5.3 million, compared to $14.5 million net income for the same period in 2024.
Non-GAAP Adjusted Net Income: For the six months ended June 30, 2025, non-GAAP adjusted net income was $5.8 million, compared to $11.3 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the decline in revenue of $3.6 million and increase in operating expenses of $1.9 million.
Full Year 2025 Financial Guidance
For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of Etorel and Contiva and sales of ETUARY®.
Guidance Range
Total Revenue
$118 to $128 million
Please note that total revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.
Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021 and NDA filing is expected in the third quarter of 2025. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of the initiation of Gyre’s Phase 2 trial in the U.S. for Hydronidone for the treatment of MASH-associated liver fibrosis, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA for Hydronidone for the treatment of CHB-related liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, and IND submission of F528 in COPD, the expectations regarding commercial revenues from the sales of Etorel and Contiva maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors: David Zhang Gyre Therapeutics david.zhang@gyretx.com
Sheridan will temporarily step aside as CEO to enter the Irish Presidential Election.
Company Chairman and President, Serguei Melnik will take over as interim CEO over the course of the campaign and election period.
ORLANDO, Fla., Aug. 11, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has announced that Company CEO, Gareth Sheridan will be stepping aside from his role for three months to enter the Irish Presidential election. The Nomination Hearings followed by the Election will take place over the course of September and October.
During this period, Co-Founder and Chairman, Serguei Melnik will take over the responsibilities of CEO and guide the company through the final 2025 framework towards the target NDA filing in 2026. Mr. Melnik, a corporate strategy expert will continue to execute the Company’s strategic development and focus on shareholder value. Mr. Melnik has over 20 years experience in Capital markets.
“I have made the decision to temporarily step aside as CEO following the support and encouragement I have received asking me to put my name forward for the election for President of Ireland. Rest assured, Nutriband is in very safe hands. While most often we talk about AVERSA as our big opportunity, it is our tight knit team that is really our core asset. I look forward to watching Nutriband continue to hit its planned targets between now and December,” said Mr. Sheridan.
The FDA recently granted Nutriband’s meeting request for AVERSA Fentanyl
AVERSA FENTANYL has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA FENTANYL has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA FENTANYL available in all major medical markets in the world.
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
____________________________________________________ 1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
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 the Company’s websites or any other website is 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, Forms 10-K’s and Forms 10-Q’s, 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.
Announces strategic clinical trial plans for tecarfarin in patients with End-Stage Kidney Disease (ESKD) transitioning to dialysis
Tecarfarin can potentially address critical treatment gaps in patients with ESKD
Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial
PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today reported its financial results for the second quarter ended June 30, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.
“We continue to advance our goal of developing transformative therapeutics to address the gaps in current anticoagulation therapy for patients with complex needs,” said Quang X. Pham, Chairman & CEO. “This commitment is reflected in our strategic plan to initiate a clinical trial for tecarfarin in end-stage kidney disease (ESKD) for patients transitioning to dialysis. There is a critical need for safe, effective anticoagulants for use in ESKD patients, and tecarfarin’s orphan drug and fast-track designations in ESKD patients with atrial fibrillation (AFib) underscore this need. We are very excited to advance this program.”
“Strong operational execution is fundamental to advancing tecarfarin into late-stage trials,” continued Pham. “By successfully completing the technical transfer of tecarfarin to a U.S. site of a leading global CDMO and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness to supply our planned clinical trial and execute our development strategy.”
Highlights from the Quarter Ended June 30, 2025, and Other Recent Events:
Clinical Trial Developments
In August 2025, Cadrenal announced plans to initiate a clinical trial for its late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis, including those with and without atrial fibrillation (AFib). Site activation and screening for patient enrollment are planned to begin later this year.
The need is urgent for this population, as patients with severe kidney disease are at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality.
Cadrenal expects that this study will be a significant step forward in the continued development of tecarfarin in ESKD and other areas with real opportunities to improve patient outcomes with a potentially better anticoagulant.
Operational Milestones
CMC Readiness: Successfully completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) at a U.S. site of a leading global CDMO. During the second quarter of 2025, the Company manufactured tecarfarin clinical drug product and continued to make important advancements in CMC operations to support regulatory and clinical trial readiness.
Market Opportunity Research: During the quarter, the Company performed market research in indications where gaps exist in current anticoagulation therapies. This research reinforced that tecarfarin is uniquely positioned to provide potential clinical benefits in certain populations, such as patients with high-need cardiovascular conditions or renal impairment, where anticoagulation safety and predictability are highly important and valued.
Participation in Key Investor, Medical, and Business Development Conferences
Cadrenal continued to be active during the quarter in conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Key interactions included participation at the BIO International Convention in Boston, the Longwood Healthcare Leaders CEO conference in Miami, and the 18th National Conference on Anticoagulation Therapy in Washington, D.C.
Strategic Development Collaborations
Cadrenal continues to explore opportunities to expand the Company’s clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with ESKD and AFib, LVADs, and for other indications requiring chronic anticoagulation.
Stock Index Benchmarks
Effective June 30, 2025, Cadrenal was added to multiple Russell indexes, including the Russell 3000E and Russell Microcap families. These indexes are widely tracked by institutional investors and index funds, potentially broadening the Company’s shareholder base.
Second Quarter 2025 Financial Highlights
Research and development expenses for the quarter ended June 30, 2025, were $1.1 million compared to $1.3 million for the same period in 2024. General and administrative expenses for the quarter ended June 30, 2025, were $2.7 million compared to $1.2 million for the same period in 2024. Cadrenal reported a net loss of $3.7 million for the quarter ending June 30, 2025, compared to $2.4 million for the same period in 2024.
On June 30, 2025, Cadrenal had cash and cash equivalents of $5.6 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 2.0 million shares of common stock outstanding as of June 30, 2025.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current 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 off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven.
Tecarfarin received Orphan Drug Designation (ODD) and fast-track status 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).
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/and connect with us on LinkedIn.
Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; tecarfarin potentially addressing critical treatment gaps in patients with ESKD; planned clinical trial bringing a pivotal step forward in pursuit of ESKD+AFib registration trial; the Company’s execution of its development strategy; site activation and screening for patient enrollment are planned to begin later this year; the development of tecarfarin in ESKD and other areas improving patient outcomes with a potentially better anticoagulant; the Company’s advancements in CMC operations supporting regulatory and clinical trial readiness; tecarfarin being uniquely positioned to provide potential clinical benefits in certain populations where anticoagulation safety and predictability are highly important and valued; the Company’s ability to expand its clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with ESKD and AFib, LVADs, and for other indications requiring chronic anticoagulation; the Company’s ability to develop transformative therapeutics to address limitations of current anticoagulation therapy; and the Company’s advancement of an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; the Company’s execution of its development strategy; the development of tecarfarin in ESKD and other areas improving patient outcomes with a potentially better anticoagulant; the Company’s advancements in CMC operations supporting regulatory and clinical trial readiness; the Company’s ability to expand its clinical pipeline and collaborate with potential development partners; the Company’s ability to develop transformative therapeutics to address limitations of current anticoagulation therapy; and other assets 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.
MALVERN, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it has entered into a securities purchase agreement with Janus Henderson Investors, a global asset management firm, to purchase 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share (closing price on August 7, 2025) and accompanying warrant in a registered direct offering. The warrants have an exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire two years following the date of issuance. The warrants are callable by the Company when the VWAP of the Company’s common stock exceeds $2.50 per share for at least five of a trailing 30 trading day period.
Noble Capital Markets, Inc. acting as the sole placement agent in connection with the offering.
The gross proceeds to the Company are expected to be approximately $20 million before deducting the placement agent fees and other estimated offering expenses. The Company may receive up to $30 million of additional gross proceeds if the warrants are exercised in full. The offering is expected to close on or about August 11, 2025, subject to the satisfaction of customary closing conditions. The offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the U.S. Securities and Exchange Commission (“SEC”), which was declared effective on May 1, 2024. The offering is made only by means of a prospectus forming a part of the effective registration statement relating to the offering. A prospectus supplement relating to the shares of common stock and warrants will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110 Boca Raton, FL 33432.
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.
AboutOcugen,Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “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. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the satisfaction of customary closing conditions related to the offering, completion of the offering, whether the warrants will be exercised and various other factors. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
When, Not If. We continue to believe it is a matter of when, not if, DLH begins to capitalize on the large opportunity set for its mission critical skill set. Current disruptions in Federal government contracting will pass, and DLH’s capabilities, in areas such as digital transformation, cybersecurity, and addressing critical public health issues, align well with the government’s goals.
Still Accumulating. Mink Brook Asset Management continues to accumulate DLHC shares, including 5,900 shares at the end of last week. Mink Brook now owns 2,389,350 DLHC shares, representing 16.6% of the outstanding common, up from 2,164,058 shares at the end of May.
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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.
FDA grants meeting for AVERSA™ FENTANYL (abuse deterrent transdermal system) to provide feedback on the Chemistry, Manufacturing, and Controls plans for the product through commercialization.
Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
ORLANDO, Fla., Aug. 08, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Food and Drug Administration (US FDA) has granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). The purpose of the meeting is to specifically provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA) and subsequent commercialization.
The meeting is scheduled as a virtual face-to-face meeting to be held on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).
Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them.
AVERSA FENTANYL has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA FENTANYL has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA FENTANYL available in all major medical markets in the world.
The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
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 the Company’s websites or any other website is not part of this press release.
About Kindeva
At Kindeva, we manufacture more tomorrows for patients worldwide. With best-in-class facilities and comprehensive CDMO services, we offer more than manufacturing—we deliver strategic value. Our global network of 10 manufacturing and R&D sites offer exceptional integrated knowledge and capabilities, including Annex 1-compliant state-of-the-art aseptic fill finish capacity and next-generation sustainable inhalation propellant technology. By combining expertise in injectable, pulmonary, nasal and dermal drug delivery, we help meet the demands of today and deliver the possibilities of tomorrow. Find out more at https://www.kindevadd.com.
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, Forms 10-K’s and Forms 10-Q’s, 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.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Hits headwinds in Q2. GoHealth reported Q2 revenue of $94.0 million, below our $110.0 million forecast, as Medicare Advantage softness and CMS policy shifts weighed on volumes. Revenue declined 11% year-over-year. Despite the top-line miss, adj. EBITDA loss of $11.3 million beat our expected loss of $13.2 million, reflecting ongoing cost discipline and benefits from automation initiatives underway in agent workflows.
Recapitalization improves liquidity, alleviates covenant concerns. The company secured $80 million in new term loans and amended its credit agreement to eliminate principal payments through 2026. Liquidity covenants were reduced to a single minimum cash test. While the 4.77 million Class A shares issued represent roughly 20% dilution, we believe the transaction aligns lender and shareholder incentives and resolves the going concern issue.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB), a media and consumer products company known for building influential, creator-led brands, today announced a strategic licensing partnership with TSC Product Lab to launch Mesa Mia by Jenny Martinez—a dynamic new food brand inspired by the bold flavors, rich traditions, and spirit of Latin cooking.
Mesa Mia by Jenny Martinez will offer a curated line of food products designed to bring delicious, authentic meals to the kitchens of Jenny’s fans with ease and flair. The product assortment will include chips, salsas, proteins, meals, drink mixes, and more. This collaboration unites Xcel’s expertise in omnichannel brand development with TSC Product Lab’s strength in product innovation with Jenny’s beloved cooking style.
“We are proud to partner with Jenny and TSC Product Lab to turn her passion and vibrant personality into a brand that will inspire families across the country,” said Robert W. D’Loren, Chairman and CEO of Xcel Brands.
Jenny Martinez—Latina home cook, social media powerhouse, and creator of the brand Mesa Mia by Jenny Martinez—has cultivated a following by sharing colorful, flavorful dishes and heartfelt stories from her kitchen. Her approachable style, combined with a deep love for family and culture, resonates with millions of home cooks seeking connection through food.
“I created Mesa Mia so everyone can bring the joy of Latin cooking into their kitchen with ease. Every Mesa Mia product is a celebration of my family’s traditions and the love we share through food,” said Jenny Martinez. “These are the flavors I grew up with, and I’m so proud to bring a little piece of my cooking into your home.”
Rick Lapine, President of TSC Product Lab, added, “Mesa Mia is a celebration of culture, flavor, and connection—and working with Jenny to bring it to life has been nothing short of inspiring. This is more than a product launch—it’s a movement rooted in love and flavor.”
Mesa Mia Live by Jenny Martinez continues Xcel Brands’ commitment to developing creator-led businesses that speak to how people live, cook, and celebrate today. For more information, please visit www.xcelbrands.com and www.mesamia.com
About Xcel Brands Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands TowerHill by Christie Brinkley, LB70 by Lloyd Boston, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford, and a brand in development with Coco Rocha and also holds noncontrolling interests or long-term license agreements in the Isaac Mizrahi brand, Orme Live and Mesa Mia by Jenny Martinez brands. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone and consisting of over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 43 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.
AboutTSCLab Products The Sneaky Chef Product Lab (“TSC”) is a cost-effective product development and sourcing company specializing in innovative solutions for the home. The Company’s mission is to create products and brands for leading retailers. Since 2007, TSC has built a diverse portfolio of owned, private label and exclusively licensed brands and has partnered with such legacy names such as Martha Stewart, Sodastream, GreenPan and Calvin Klein. Its network of retail partners includes HSN, QVC, Walmart, Amazon and TJX Companies among others. Led by Rick Lapine, an industry veteran with decades of experience, TSC is supported by a full-time team of passionate experts, bringing over 30 years of combined expertise in sourcing and production. This team has helped establish TSC as a trusted partner for efficient product development, manufacturing, and logistics, with the capability to execute projects rapidly and reliably.
AboutJenny Martinez
Jenny Martinez is well-known across social media platforms for sharing her authentic Mexican family recipes to the delight of millions of fans on TikTok and Instagram. Jenny was born in Mexico and moved to Los Angeles at age four, yet she has never lost touch with her Mexican heritage. The traditional recipes she shares with her followers have been passed down for generations in her family. Although she later mastered her culinary arts on her own, Jenny started by learning most of her mother’s recipes at the age of thirteen. Jenny considers a well-fed family the key to a happy family and believes that dinner should be celebrated every day. Food brings people together, and Jenny’s videos and recipes convey the spirit of family and community. She lives with her family in Los Angeles, California. Jenny’s first cookbook My Mexican Mesa, Y Listo! (Simon & Schuster) debuted in Spring 2024 featuring 100 recipes ranging from breakfast, appetizers & entrees to desserts, and even cocktails! Providing family-style recipes for every occasion & beautifully photographed to capture the authentic spirit of the cuisine, the cookbook is a must-have for home cooks looking for their next delicious meal. In 2024, Jenny launched her own line of cookware and dinnerware/tabletop at over 600 department stores nationally, as well as a spice line sold in grocery stores and online.
Jenny is represented by John Frierson at The Bureau New York City and managed by Lisa Shotland. Her attorney is Phil Daniels at Ginsburg Daniels Kallis LLP
GEO-CM04S1 Offers Solution to Overcome HHS-Cited mRNA Deficiencies – Potentially Offering Broader, More Durable Protection
ATLANTA, GA – August 7, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen, MVA-based vaccines and solid tumor immunotherapies, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) decision to terminate nearly $500 million in BARDA-funded mRNA vaccine development contracts.
This action reflects a policy shift, underscored by HHS Secretary Kennedy addressing fundamental concerns around mRNA vaccines. In a post on X, Secretary Kennedy stated: “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract”. The Secretary added that this is due to a concept known as “antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus constantly mutates”. GeoVax’s vaccine candidates, including GEO-CM04S1 for COVID-19, are designed to induce immunity using multiple antigens. GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, enabling broader and more durable protection – even as the virus mutates. Data from clinical studies have demonstrated that GEO-CM04S1 induces immune responses across variants, from the original Wuhan strain through Omicron, even in immunocompromised patients.
“Secretary Kennedy’s remarks spotlight the exact issue our platform was designed to overcome,” said David Dodd, Chairman and CEO of GeoVax. “The mRNA approach, with its single-target design, appears limited relative to durability and antigenic shift. GEO-CM04S1’s multi-antigen construct represents a promising solution – with clinical data demonstrating broader immunity and addressing the mRNA shortcomings Kennedy described, including among the most vulnerable immunocompromised patients.”
Why GeoVax’s MVA-Based Vaccines Align with U.S. Priorities
Multi‑antigen breadth and durability – GeoVax’s COVID-19 vaccine candidate, GEO‑CM04S1, expresses both SARS‑CoV‑2 Spike and Nucleocapsid proteins – inducing robust and durable antibody and T‑cell immunity in Phase 2 trials. Notably, in a trial among Chronic Lymphocytic Leukemia (CLL) patients, the mRNA comparator arm was halted for failing to meet immune‑response benchmarks, while GEO‑CM04S1 exceeded interim endpoints, with the remainder of the ongoing study only including the GEO-CM04S1 arm.
Safety for vulnerable populations – MVA does not replicate in human cells and has been FDA‑approved for use in immunocompromised individuals, pregnant women, and children. This makes it a validated vaccine platform with broad safety.
Manufacturing innovation and U.S. resilience – GeoVax is advancing AGE.1 manufacturing processes for MVA-based vaccines such as GEO-CM04S1 which is expected to support scalable, decentralized U.S. vaccine manufacturing, providing faster production, higher yield at a reduced cost – a strategic advantage for public health resilience.
Broad infectious-disease pipeline – Beyond COVID‑19, GeoVax is pursuing MVA‑based vaccines targeting hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg), Zika, and Mpox/Smallpox. This diversified pipeline aligns with HHS, NIH, FDA, and WHO priorities for pandemic preparedness and biodefense.
GeoVax: Delivering on the “Safer, Broader” Vision
GeoVax applauds the call to shift toward multi-antigen vaccine designs with validated safety profiles and resilience to viral mutation. The MVA‑based platform delivers on these goals:
Evidence‑backed safety for immunocompromised, pediatric, and pregnant populations.
Broader immune responses with Spike plus Nucleocapsid antigens.
Strategic manufacturing design for domestic scale and surge capacity.
Multi‑disease readiness across COVID‑19, hemorrhagic fevers, Zika, and Mpox/Smallpox.
Next Steps: Turning Rhetoric into Resilience
GeoVax urges HHS to proactively support robust, evidence-backed alternatives – including multi-antigen platforms like MVA as part of a diversified, resilient biomedical countermeasure arsenal.
GeoVax invites HHS and other federal partners to collaborate under the FDA’s Commissioner’s National Priority Voucher (CNPV) program and other mechanisms to accelerate regulatory and funding support for GEO-CM04S1 and GEO-MVA, both of which are uniquely positioned to protect high-risk populations and enhance U.S. biomanufacturing self-sufficiency.
Dodd added: “We must now invest in platforms that reflect what we’ve learned. GeoVax stands ready to lead this transition. Our MVA platform already has a safety track record and is delivering early efficacy where mRNA appears to have fallen short. We stand ready and prepared to assist in supporting HHS’s bold reset into a long-term strategy for national immunization security.”
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.
CHICAGO, Aug. 07, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced the execution of strategic capital and governance actions that are expected to significantly enhance its financial flexibility and long-term positioning along with its financial results for the three and six months ended June 30, 2025.
Strategic Capital and Governance Actions
Secured new senior secured superpriority term loan facility, including $80.0 million in new-money term loans and $35.0 million in roll-up loans, to support working capital and strategic flexibility heading into the Medicare annual enrollment period.
Expect additional liquidity in the term loan to allow us to maintain compliance with our debt covenants and fund our operations for the next 12 months and beyond.
Amended existing credit agreement to waive near-term principal payments through 2026 and reset financial covenants.
Created debt basket capacity of up to $250.0 million under the new superpriority term loan facility and amended credit agreement, to pursue potential transformative transactions.
Issued an aggregate of 4,766,219 shares of Class A common stock to lenders, reinforcing alignment with long-term stockholder value creation.
Appointed three new directors to the Company’s board of directors and accepted resignations from three existing directors to align governance with GoHealth’s forward-looking strategic direction.
“Our strategic capital and governance actions reflect our commitment to long-term stockholder value creation and our belief that GoHealth is structurally and strategically positioned to lead in a consolidating industry,” said Vijay Kotte, CEO of GoHealth. “With the new credit facility and the access to immediate and expandable capital it provides, we believe we are operating from a position of strength as we continue to serve the Medicare market, pursue disciplined growth and assess transformative opportunities.”
“The amendment to our existing credit agreement provides important financial flexibility,” said Brendan Shanahan, CFO of GoHealth. “Through this strategic financing arrangement, we have the ability to evaluate and pursue strategic transactions. We believe these enhancements position us to act decisively and responsibly in support of our strategic objectives.”
Additional information, including with respect to the Company’s preliminary financial results for the three and six months ended June 30, 2025, is included in the tables at the end of this press release.
Conference Call Details
The Company will host a conference call today, Thursday, August 7, 2025 at 8:00 a.m. (ET) to discuss recent strategic capital and governance actions. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.
About GoHealth, Inc.
GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.
Investor Relations:
John Shave
JShave@gohealth.com
Media Relations:
Pressinquiries@gohealth.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, liquidity, business strategy and plans and objectives of management for future operations, including, among others, statements regarding the expected results of the strategic capital and governance actions announced hereby, our expected growth, pursuit of strategic alternatives and strategic objectives, long-term value creation, magnitude of expected impairments, our capital structure, future capital expenditures, debt service obligations, ability to continue as a going concern, adoption and use of artificial intelligence technologies, the impact on our business from regulatory changes, the impact on our business from the acquisition of e-TeleQuote Insurance, Inc. (“e-TeleQuote”) and our ability to successfully integrate e-TeleQuote’s operations, technologies and employees into our business, are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including our inability to realize our expectations with respect to the strategic capital and governance actions announced hereby, our inability to execute on strategic alternatives or strategic objectives, our level of indebtedness, our level of liquidity, and the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025 (“Q1 2025 Quarterly Report on Form 10-Q”), our forthcoming Quarterly Report on Form 10-Q for the second quarter ended June 30, 2025 (“Q2 2025 Quarterly Report on Form 10-Q”) and in our other filings with the Securities and Exchange Commission. The factors described in our 2024 Annual Report on Form 10-K, our Q1 2025 Quarterly Report on Form 10-Q and our forthcoming Q2 2025 Quarterly Report on Form 10-Q should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in our other filings with the Securities and Exchange Commission.
You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
