CALGARY, AB, Dec. 1, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.09 per common share payable on December 31, 2025, to shareholders of record at the close of business on December 15, 2025. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.
About InPlay Oil Corp.
InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634
RESTON, Va., Dec. 1, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX), announced it has been awarded a 10-year, $425 million indefinite-delivery, indefinite-quantity contract to modernize and upgrade cockpit displays for the U.S. Air Force F-16 fleet.
Under the contract, V2X will provide center display units (CDU’s) full kits, line-replaceable units, shop-replaceable units, and related support hardware for the combat jet.
“This is a great example of how smart modernization can deliver immediate mission enhancement,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “By upgrading the F-16 cockpit display at a significantly lower cost than full replacement, we are strengthening the digital backbone of the aircraft and enhancing operational effectiveness for decades to come.”
The award builds on past orders and represents the largest award we have received for the F-16 CDU program. V2X’s approach to cockpit modernization delivers cost-effective technology insertion with minimal retrofit, ensuring enhanced combat effectiveness while reducing overall lifecycle costs.
Work will be performed at V2X’s facility in Indianapolis, Indiana, and is expected to be completed by September 2035.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Vancouver, British Columbia–(Newsfile Corp. – November 25, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) provides its financial and operating results for the three and nine months ended September 30, 2025, declares a quarterly dividend payment to shareholders, and provides an operations update.
Q3 2025 Highlights
Attained quarterly production of 3,571 boe/d (99% heavy oil).
Generated quarterly revenue of $23.1 million.
Achieved total operating and transportation costs of $15.50/boe.
Delivered operating netback1 of $13.6 million or $41.39/boe for the quarter.
Realized quarterly adjusted funds flow from operations (“AFF”)1 of $10.1 million or $30.59/boe.
Initiated a 2025 fall drilling program with $5.2 million in capital expenditures1.
Generated quarterly free funds flow1 of $4.9 million.
Exited the third quarter with a positive working capital1 position of $11.0 million.
Paid a special dividend of $2.9 million ($0.03/share) to shareholders on August 15, 2025.
Paid a quarterly base dividend of $2.4 million ($0.025/share) to shareholders on September 12, 2025.
Purchased and cancelled 1.0 million shares for $1.9 million under the Company’s Normal Course Issuer Bid (“NCIB”).
Renewed the Company’s NCIB.
(1) Operating netback, adjusted funds flow from operations (AFF), free funds flow, capital expenditures, and working capital are non-IFRS measures, or when expressed on a per share or boe basis, non-IFRS ratio, that do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other entities. Non-IFRS financial measures and ratios are not standardized financial measures under IFRS and may not be comparable to similar financial measures disclosed by other issuers. Refer to the section “Non-IFRS and Other Specified Financial Measures”.
Selected financial and operational highlights should be read in conjunction with Hemisphere’s unaudited condensed interim consolidated financial statements and related notes, and the Management’s Discussion and Analysis for the three and nine months ended September 30, 2025 which are available on SEDAR+ at www.sedarplus.ca and on Hemisphere’s website at www.hemisphereenergy.ca. All amounts are expressed in Canadian dollars unless otherwise noted.
Quarterly Dividend
Hemisphere is pleased to announce that its Board of Directors has approved a quarterly cash dividend of $0.025 per common share in accordance with the Company’s dividend policy. The dividend will be paid on December 30, 2025 to shareholders of record as of the close of business on December 9, 2025. The dividend is designated as an eligible dividend for income tax purposes.
With the payment of the fourth quarter dividend, Hemisphere anticipates returning a minimum of $21.6 million to shareholders in 2025, including $9.6 million in quarterly base dividends, $5.8 million in two special dividends, and $6.2 million through NCIB share repurchases and cancellations. Based on the Company’s current market capitalization of $205 million (94.6 million shares issued and outstanding at a market close price of $2.17 per share on November 24, 2025), this represents an annualized yield of 10.5% to Hemisphere’s shareholders.
Operations Update
During the third quarter of 2025, Hemisphere’s production averaged 3,571 boe/d (99% heavy oil), representing a slight decrease of approximately 1% from the same period in 2024. The Company completed a number of workovers during the summer months, which contributed to production downtime during the quarter. However, September production of approximately 3,800 boe/d (99% heavy oil) was back in line with average levels of 3,830 boe/d (99% heavy oil) during the first six months of the year. This performance highlights the stability and low-decline characteristics of Hemisphere’s polymer flood assets in Atlee Buffalo, particularly given that no new wells had been placed on production since the Company’s third-quarter drilling program in 2024.
Throughout 2025, Hemisphere has taken a cautious approach to capital spending amid volatility in the global economy and oil markets, which resulted in delaying its drilling program until later in the year. In September the Company commenced a fall drilling program, which finished in early November. The new wells have just recently been put on production and will continue to be optimized over the coming months.
In October, Hemisphere successfully completed a scheduled facility turnaround and resolved unexpected issues with its power generation and injection systems. Although this short-term disruption will affect overall fourth-quarter production, all systems are now fully operational. November production has averaged approximately 3,800 boe/d (99% heavy oil, field estimate from November 1-22, 2025). Management anticipates fourth-quarter production will range between 3,400 – 3,500 boe/d (99% heavy oil) following this outage.
At the Company’s Marsden, Saskatchewan property, Hemisphere is continuing to evaluate its polymer pilot project. It has been approximately one year since injection commenced, and while an oil production response has not yet been noted, the data being collected is providing insights into reservoir performance. The Hemisphere team plans to advance its pilot project by evaluating the potential effects of producer/injector well spacing, polymer type and injection water, as well as reservoir heterogeneity and composition.
During its fall drilling program, Hemisphere attempted to test a second oil-bearing zone within its Marsden landbase. Unfortunately, drilling challenges prevented Hemisphere from being able to access the reservoir, and the Company is reviewing alternatives for future evaluation of the prospect.
Management anticipates WTI oil prices will average close to US$65 per barrel in 2025 and expects to exceed Hemisphere’s adjusted funds flow guidance estimate of $40 million for this price scenario, while projecting total capital expenditures to be on budget. This outlook holds despite the Company deferring its drilling program until late in the third quarter and experiencing unscheduled production downtime in the second half of the year. As a result, Hemisphere now estimates average annual 2025 production will be approximately 3,600 – 3,700 boe/d (99% heavy oil), compared to its original guidance of 3,900 boe/d (99% heavy oil).
The Company expects to release details on its 2026 guidance in January as part of its forward development planning. Supported by approximately $11 million in working capital, an undrawn credit facility, and strong cash flow from its low-decline production base, Hemisphere is well positioned with a robust balance sheet to pursue potential acquisition opportunities while continuing to deliver shareholder returns.
About Hemisphere Energy Corporation
Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood enhanced oil recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.
For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:
Don Simmons, President & Chief Executive Officer Telephone: (604) 685-9255 Email: info@hemisphereenergy.ca
CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).
With the FDA’s clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.
The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense’s Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile.
“This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We believe this progress lays a strong foundation for additional achievements across several fronts in the near future,” stated Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We recognize the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts.”
Based on prior successful discussions with the FDA and in line with its recent comments and recommendations, PARAGON is expected to be conducted in the U.S. and EU and include 300 people living with ALS randomized in a ratio of 2:1 (PrimeC : Placebo). The prospective, double-blind, 12-month placebo-controlled trial, has an open label extension to evaluate safety and efficacy of PrimeC. The trial will employ an adaptive design allowing for interim analyses to optimize sample size and assess early efficacy and futility boundaries.
Additional details regarding the PARAGON trial design and timelines will be provided in NeuroSense’s upcoming investor webinar on December 8th, 2025 and on NeuroSense’s website. Registration to the webinar is available here.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and Alzheimer’s Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
October 27, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce that the Company has begun moving its Lithium Extraction Facility (“Demonstration Plant”) to the Company’s facility at the Tonopah Airport, Nevada. This relocation will consolidate the Company’s operations, improve logistical efficiency, reduce costs and strengthen support for ongoing and future activities.
“The relocation of the Demonstration Plant will allow the Company to consolidate support for the development of Angel Island,” said Bill Willoughby, President and CEO of Century Lithium. “Thanks to the knowledge and efforts of our team, led by Senior Vice President Todd Fayram, Century’s process has undergone various configurations while performing a multitude of tests towards the development of Century Lithium’s patent-pending process for chloride leaching and Direct Lithium Extraction (DLE).”
Century Lithium’s end-to-end process begins by treating Angel Island claystone under optimized conditions using hydrochloric acid, followed by neutralization using sodium hydroxide, with both the acid and base components sustainably produced on-site through the electrolysis of salt water. Following filtration, the resulting lithium chloride solution is treated by DLE to selectively recover lithium and refined to produce high-purity, battery-grade lithium carbonate suitable for electric vehicle and energy storage applications.
By relocating the Demonstration Plant, Century Lithium will gain more space to conduct research and development on battery materials, including lithium metal and lithium iron phosphate. The new location will also allow the construction of a larger assay and metallurgical laboratory at Tonopah to support Angel Island’s current and future laboratory needs.
Century Lithium’s 20-acre site at the Tonopah Airport is home to Century Lithium’s field office for Angel Island. It was integral for the preparation and handling of the bulk sample material treated in the 3-year-long pilot plant program at Amargosa Valley. Going forward, Century Lithium’s Tonopah Airport facility will be used for research and development for Angel Island, project support and administration.
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced-stage lithium company, focused on developing its 100%-owned lithium project Angel Island in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make battery-grade lithium carbonate product samples from Angel Island’s lithium-bearing claystone at its Demonstration Plant in Amargosa Valley, Nevada.
Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery-grade lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan, expected to yield an estimated life-of-mine average of 34,000 tonnes per year of lithium carbonate over a 40-year mine-life.
Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”, and on the Frankfurt Stock Exchange under the symbol “C1Z”.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed, and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB), an industry-leading media and consumer products company specializing in building influencer-driven brands through social commerce and livestreaming, is proud to announce a new partnership between Longaberger and Shannon Doherty, creator of At Home with Shannon. Together, they will introduce a new collection designed to bring warmth, style, and functionality to every home.
With Longaberger’s long-standing tradition of American craftsmanship and Shannon’s approachable, family-centered lifestyle brand, this partnership blends heritage with heart. The collaboration celebrates the beauty of everyday living and reimagines the home as a place for connection, creativity, and comfort.
“I believe that home is where we build our memories and Longaberger has always represented the kind of home I try to create – warm, intentional and filled with heart. I am honored to bring my vision to a brand with such a beautiful legacy; and together, design pieces that help families celebrate those everyday moments,” said Shannon Doherty, founder of At Home with Shannon.
Robert W. D’Loren, Chairman and CEO of Xcel Brands, said, “Shannon’s authenticity and the genuine connection she has built with her community make her an ideal partner for Longaberger. Together, we are creating a vision for the modern home that honors tradition while celebrating how families live today.”
From cozy entertaining pieces to functional storage and timeless accents, each item will embody Longaberger’s handcrafted quality paired with Shannon’s signature warmth and approachability. This partnership continues Xcel Brands’ commitment to developing innovative, creator-led brands that connect deeply with today’s consumers through authenticity, design, and storytelling. For more information, visit www.longaberger.com or www.xcelbrands.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, 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. 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 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.
About Longaberger Longaberger, founded by Dave Longaberger in 1973, is an American home collectibles brand known for artisanal handcrafted products. For generations, Longaberger has manufactured handmade maple baskets and home products that are collected by a loyal community of customers. In 2019, Xcel Brands acquired The Longaberger Company and launched with a new digital social selling business model, offering timeless and modern décor products that inspire a highly engaged community. For more company information, visit the website at longaberger.com or on social media at @longaberger, #longaberger and #thelongabergerfamily.
About Shannon Doherty Shannon Doherty is the founder and voice behind At Home with Shannon, a lifestyle platform rooted in her life as a mom of four. She shares décor ideas, simple DIYs, family routines, and cooking inspiration through her social channels, reaching millions who appreciate real, heart-led content. Her approach to home is grounded in authenticity, accessibility, and joy.
Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026
More than 21 million US adults experience a major depressive episode each year
CHATHAM, N.J., Nov. 24, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults.
“There is a clear need for innovative therapies that address depression,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe TNX-102 SL offers a promising approach for individuals suffering from MDD. The unique pharmacological profile of TNX-102 SL is designed to target the disruptive sleep which is often associated with depression. Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms on the Beck Depression Inventory-II and the Montgomery-Asberg Depression Rating Scale (MADRS), respectively. We are excited to advance TNX-102 SL and look forward to evaluating its potential as a new treatment option for those affected by depression.”
The IND clearance enables Tonix to proceed with the potentially pivotal Phase 2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites. Eligible participants are 18 years or older and currently experiencing a moderate to severe major depressive episode. The study will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime to placebo, with the primary endpoint being the MADRS total score change from baseline at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep disturbance. Tonix plans to initiate enrollment of the study in mid-year 2026.
“TNX-102 SL is designed to target the disturbed sleep of depression, which is a novel mechanism of action,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL has been generally well tolerated in registrational studies of fibromyalgia patients. In the fibromyalgia studies, TNX-102 SL treatment was associated with a low incidence of side effects common with traditional antidepressants like weight gain, blood pressure changes, sexual dysfunction and cognitive issues.”
About Major Depressive Disorder Major Depressive Disorder (MDD) is a prevalent and serious psychiatric illness that affects adults of all ages, races, and backgrounds. It is characterized by persistent feelings of sadness or loss of interest, along with symptoms such as sleep and appetite disturbances, fatigue, difficulty concentrating, and thoughts of worthlessness or suicide. These symptoms must last at least two weeks and significantly impair daily functioning. In the United States, more than 21 million adults experience a major depressive episode each year. While several antidepressant medications are available, many individuals do not achieve adequate relief or discontinue treatment due to side effects like weight gain, sleep disruption, and sexual dysfunction. MDD is associated with increased risk of suicide and substantial impairment in quality of life, underscoring the urgent need for new, first-line therapies that are both effective and well-tolerated.
About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the persistent active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. TNX-102 SL is a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently FDA approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults under the brand name TONMYATM (cyclobenzaprine HCl sublingual tablets). TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder under an Investigator-initiated IND. In addition to MDD, Tonix also holds active INDs for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patents are important elements of Tonix’s proprietary composition. These patents are expected to provide TNX-102 SL U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2-ready 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 rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a a Phase 2-ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, 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, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication under development.
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 successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism. WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions. Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Air Quality Permit For Its First-Of-A-Kind, Industrial Scale Solar Panel Processing Facility
VIRGINIA CITY, NEVADA, November 24, 2025 — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) and Comstock Metals LLC (“Comstock Metals”), a leader in the responsible recycling of end-of-life solar panels with the only certified, north American, zero-landfill solution, announced today that it has received its notification of eligibility for an Air Quality Permit from the Nevada Division of Environmental Protection – Bureau of Air Pollution Control (NDEP-BAPC), subject to certain normal compliance conditions and public notice periods, for the processing of waste solar panels and photovoltaics for its industry-scale materials recovery facility located in Silver Springs, NV. This timely approval keeps our scale-up plans for commissioning our first industry-scale facility in Silver Springs, NV, right on schedule.
This notification follows the recently received notification of eligibility for a Written Determination Permit from the Nevada Division of Environmental Protection – Bureau of Sustainable Materials Management (NDEP-BSMM), also with the normal conditions and public notice period. These two major permits, once final, represent the complete scope of required regulatory approvals for commissioning the scale up of a facility designed for processing over 3 million panels per year from one, continuous production line, representing up to 100,000 tons per year of waste materials being processed. This facility integrates technologies for efficiently processing, conditioning, extracting, and recycling metal concentrates from photovoltaics. The Company previously reported that the equipment for the plant was ordered, and fabrication is also proceeding as planned with deliveries expected by year end, so that it can commence installation, testing, and commissioning of the industry-scale facility during the first quarter of 2026. The process for both Air and BSMM permits proceeded essentially as planned, since last Spring, when the final forms for both of these permits were submitted.
“We appreciate BAPC’s collaborative efforts in issuing this first major solar panel recycling Air Quality Permit and enabling the expansion of the only Nevada-based, zero-landfill, end-of-life solar panel solution serving this broad region and keeping these critical materials out of our landfills or from being sent offshore to foreign foundries, basically offshoring the problem,” said Dr. Fortunato Villamagna, President of Comstock Metals. “We are thankful for the strong working collaboration with our regulators and the remarkable support that we are experiencing from the broader community who increasingly understands and appreciates the critical societal value of preventing heavy metal contamination of our lands, water systems and communities.”
Most of the older U.S. solar panels in service have been deployed in the southwestern U.S., primarily California, Arizona, and Nevada, with decommissioning of these solar panels occurring now, accelerating supply and increasing the demand for environmentally responsible end-of-life solutions, negating potential legacy liability faced by our customers should the panels not be 100% recycled. Comstock has positioned itself to ensure the safe deconstruction and productive reuse of these important materials. Establishing our platform in Nevada establishes the leading solar recycling position over more than half the U.S. market for end-of-life panels and establishes a platform for rapid expansion across the rest of the United States.
“We have established both a technological and market leadership position in this rapidly growing end-of-life photovoltaic supply chain,” stated Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “Our metals team is already carefully and strategically assessing additional processing and storage sites as we look to capitalize and expand our platform in this rapidly growing end-of-life environmental dilemma. Comstock Metals is the only zero-landfill, end-of-life solution for these wasted solar panels. We are setting the standard for this entire industry and positioning ourselves for rapid expansions.”
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.
Comstock Social Media Policy
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries
Posters for Phase 2 and Phase 3 clinical trials available
CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immunotherapy of Cancer, held November 5-9, 2025, in National Harbor, MD. The Trials in Progress posters focus on MAIA’s ongoing Phase 2 THIO-101 expansion (Part C) and Phase 3 THIO-104 clinical trials of its first-in-class small molecule telomere targeting agent, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.
MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presenter at SITC 2025 commented, “It was a privilege to return to SITC for its 40th anniversary. This event was an ideal forum to highlight the continued success of our Phase 2 clinical trial. We are making steady progress in the expansion phase of this trial, with patient enrollment now underway in European Medicines Agency (EMA) countries. Sites in Hungary and Poland, which were instrumental in Parts A and B of the trial, are actively screening patients along Turkey and Taiwan, and we have 12 patients enrolled in the expansion to date. We expect further momentum in identifying and enrolling patients for THIO-101 Part C in the near term”.
“We also began screening patients in our Phase 3 trial, THIO-104, and noticed great excitement from physicians in the sites we’re bringing our trial to,” added MAIA CEO Vlad Vitoc, M.D. “In this population, third-line NSCLC patients resistant to chemo and immunotherapy, current treatments show overall survival (OS) of around 6 months, and based on the 17.8 months OS observed in THIO-101 to date, we believe that our Phase 3 trial could lead to an early commercial approval of ateganosine by the FDA. It’s only a matter of successful execution to bring our novel NSCLC treatment to this large patient population with significant unmet medical need.”
The posters presented at SITC 2025 feature trial designs for the Phase 2 and Phase 3 studies in advanced NSCLC patients receiving ateganosine followed by a checkpoint inhibitor, cemiplimab (Libtayo®). As of September 17, 2025, a patient that began therapy in March 2023 in the THIO-101 Phase 2 trial has shown survival of 30 months, or 912 days.
“A novel therapy with proven efficacy, such as ateganosine, could strengthen existing treatment strategies and further advance the principles of precision oncology in lung cancer care worldwide,” said Tomasz Jankowski, M.D., Ph.D., key investigator for THIO-101 in Poland and co-author of many of MAIA’s scientific posters. “In Poland, where improving outcomes in advanced NSCLC remains a central focus, ateganosine has the potential to become an important addition to the therapeutic landscape, offering new hope for patients and clinicians alike.”
The posters presented at SITC 2025 were attached as exhibits to a Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the “Commission”) on November 7, 2025 and available on the Commission’s website at www.sec.gov. In addition, the posters were made available on MAIA’s website at maiabiotech.com/publications on November 7, 2025.
Presentation 1: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress
Presentation 2: A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Company Also Names Industry Veteran Elizabeth Simer as COO
ATLANTA, Nov. 21, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (“Bitcoin Depot” or the “Company”) (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced a planned leadership transition designed to support the Company’s long-term strategy, operational scaling, and M&A objectives.
Bitcoin Depot’s Board of Directors has appointed Scott Buchanan, the Company’s current President and Chief Operating Officer, as Chief Executive Officer, effective January 1, 2026. Also at that time, Brandon Mintz, Founder, CEO, and Chairman of the Board, will move out of the CEO role and continue as Executive Chairman, dedicating more time to shaping Bitcoin Depot’s strategic vision, evaluating growth and M&A opportunities, and supporting the board in driving long-term value creation. From now until January 1, Mr. Mintz and Mr. Buchanan will work closely together to ensure a smooth transition into the CEO role. Buchanan has held senior leadership roles at Bitcoin Depot since 2019 and has been a key part of the Company’s growth as a public company. He has served as President since August 2025 and as COO and a board member since March 2022, including a period as acting chief financial officer.
“This year has been pivotal for Bitcoin Depot, marked by continued innovation and significant steps forward in executing our strategic priorities,” said Mintz. “This leadership evolution positions us to capitalize on the significant strategic, operational, and M&A opportunities ahead. Stepping out of the CEO role allows me to focus more directly on the Company’s long-term direction. Scott has shown extraordinary leadership and operational discipline, and I’m confident he will continue to elevate Bitcoin Depot as CEO.”
“I’m honored to step into the CEO role and continue advancing the strong vision Brandon has built,” said Buchanan. “With a renewed focus on operational excellence, strategic expansion, and thoughtful M&A evaluation, Bitcoin Depot is well-positioned to continue strengthening our leadership in the Bitcoin ATM market and broaden the value we bring to customers and partners every day.”
As part of the transition, Bitcoin Depot has also appointed Elizabeth Simer as Chief Operating Officer. Simer brings over 15 years of experience in operational, financial, and strategic leadership, including senior roles at Slickdeals, Square, Intuit, and Opportunity Financial. Previously, Simer held various product, marketing, and strategy positions at multiple Fortune 500 companies. In her new role, she will oversee kiosk footprint expansion, product development, and operational scaling initiatives.
“Bitcoin Depot is entering a compelling phase of its evolution, and I’m thrilled to join the team,” said Simer. “As the Company continues to grow with a strong foundation and clear vision, I look forward to supporting Scott and the team as we strengthen our operational capabilities and advance our strategic priorities.”
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 47 states and at thousands of name-brand retail locations in 31 states through its BDCheckout product. The Company has the largest market share in North America with over 9,000 kiosk locations as of August 2025. Learn more at www.bitcoindepot.com.
Cautionary Note Regarding Forward-Looking Statements This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Agreement. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
MALVERN, Pa., Nov. 20, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen will present at NobleCon21—Noble Capital Markets’ Twenty-First Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex in Boca Raton, FL.
“I look forward to sharing the meaningful progress Ocugen has made toward our goal of three BLAs in three years, along with updates on exciting near-term catalysts in 2026, during this important conference,” said Dr. Musunuri. “NobleCon provides a forum to differentiate Ocugen’s scientific platform among our peers in ophthalmology and share how we are addressing major blindness diseases with a single, one-time gene therapy for life.”
Details regarding the presentation and fireside chat are as follows: Date: Wednesday, December 3, 2025 Location: Presentation Room 2 Time: 1 p.m. ET
In addition to Dr. Musunuri’s session, members of Ocugen’s executive team will conduct one-on-one meetings with investors to highlight the Company’s business and clinical development strategy across its unique modifier gene therapy platform.
A high-definition video webcast of the presentation will be available the following day on the Company’s website, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website and on Channelchek, the investor portal created by Noble. The webcast will be archived on the Company’s website, the NobleCon website, and Channelchek.com for 90 days following the event.
About Ocugen, 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.
About Noble Capital Markets, Inc. Established in 1984, Noble Capital Markets (Noble) is an SEC/FINRA registered full-service broker-dealer offering investment/merchant banking and advisory services, with an award-winning research team, and a proprietary research distribution platform (Channelchek). Noble provides middle-market expertise to entrepreneurs, corporations, financial sponsors, and investors. In addition to its large scale in-person conference, NobleCon, Noble hosts multi-sector virtual conferences throughout the year. Over the more than 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com | www.nobleconference.com.
Cautionary Note on Forward-Looking Statements 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. 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.
SKYX is Expected to Supply 15,000 Units Including its Advanced Smart Plug & Play Technologies comprising Ceiling Lighting, Ceiling Fans, Recessed Lights, Down Lights, EXIT Signs, Emergency Lights, Indoor and Outdoor Wall Lights Among Other Advanced Smart Products
Landmark Companies are Prominent Developers with 27 Years of Experience Building Tens of Thousands of Units, Specializing in Modern Homes and Buildings with Over 3,000 Units in Development in Texas, Florida, and Colorado, Among Other Locations
SKYX and Landmark are Expected to Collaborate on Additional Upcoming Landmark Projects
SKYX’s Technologies Expansion Provides Additional Opportunities for Future Recurring Revenues Through Interchangeability, Upgrades, AI Services, Monitoring and Subscriptions, Among Others
MIAMI, Nov. 19, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 100 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today announced that it will supply its advanced smart plug and play technologies to a 340 unit residential development project in San Antonio, Texas. The project will include 88 townhomes and 252 apartments. The development is led by prominent developers Landmark Companies. Amenities will include swimming pools, a state-of-the-art gym, modern meeting and conference facilities, landscaped green spaces, and more.
SKYX is expected to provide over 15,000 units of its advanced and smart plug & play technologies, including ceiling lighting, recessed lights, downlights, wall lights, EXIT, and EMERGENCY lights, plug-in LED backlight mirrors among other SKYX products.
Landmark Companies are prominent developers with 27 years of experience building tens of thousands of units specializing in modern homes and buildings in Texas, Florida and Colorado, among other locations.
Julia Baytler, CEO of Landmark Companies, said; “We are excited to continue collaborating with SKYX and bring their innovative technologies into our Austin Manor project. At Landmark, our focus has always been on creating modern, high-quality living spaces that enhance the daily lives of our residents. By integrating SKYX’s advanced plug-and-play solutions, we are raising the standard of safety, convenience, and design for our communities, and we look forward to expanding this collaboration across future developments.”
Rani Kohen, Founder and Executive Chairman, of SKYX Platforms, said; “We are very happy to be working with prominent developers like Landmark Companies. We look forward to collaborating with them to enhance home values while creating safer, more advanced, and smarter buildings for the future.”
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
PONTE VEDRA, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today announced its Chairman and Chief Executive Officer, Quang X. Pham, received the prestigious BioFlorida, Inc. “Executive of the Year Award,” at the recently held Florida Innovation Conference, powered by BioFlorida, in Orlando.
As the voice of Florida’s life-science ecosystem, BioFlorida represents biotechnology, medical-technology, digital health and health system organizations across the state and is committed to advancing innovation, economic growth and patient-impacting therapies.
“Our Executive of the Year Award underscores the remarkable leadership and vision that Quang has brought to Cadrenal and to Florida’s biotech sector,” said Mark A. Glickman, CEO of BioFlorida. “He exemplifies the entrepreneurial spirit and patient-centric innovation that our state’s life sciences community stands for.”
Under Pham’s leadership, Cadrenal has uniquely positioned itself to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian). He founded Cadrenal after a distinguished career that includes founding other life-science and digital-health firms, as well as service as a U.S. Marine Corps officer.
“I am deeply honored to receive this recognition from BioFlorida,” said Pham. “BioFlorida has been by our side from day one. Our team is motivated every day by the patients who have few options for safe and effective anticoagulation. This award is a tribute to all of them.”
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company with a mission to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy. We bridge these gaps by developing novel and differentiated anticoagulants, or blood thinners, designed to provide greater predictability, increased stability, more precise control, and fewer bleeding complications. We currently have two clinical-stage assets: tecarfarin, an oral vitamin K antagonist (VKA) for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. By targeting underserved patient populations and advancing therapies designed for both chronic and acute use, we aim to reshape standards of care in anticoagulation. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding developing transformative therapeutics to overcome current gaps in anticoagulation therapy and positioning the Company to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to overcome current gaps in anticoagulation therapy, the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected 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.
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