SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), plans to submit a formal NDA in the near future.
Mr. Ping Zhang, Executive Chairman of Gyre, stated, “I am very pleased to see the decision by the Chinese CDE to grant priority review to our NDA for F351. It underscores both the urgency of the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. HBV infection affects tens of millions of patients in China and a significant number of them will develop liver fibrosis and eventually cirrhosis. If approved, F351 could address the need for these patients. We thank the agency for their continued support to advance therapies for liver fibrosis patients in need of treatment and look forward to working closely with CDE to move F351 toward approval.”
About Priority Review Designation by the NMPA in China
Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process.
About Hydronidone (F351)
Hydronidone, also known as F351, is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in HSCs.
The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.
About CHB-Induced Liver Fibrosis
CHB-induced liver fibrosis is the accumulation of scar tissue (collagen) in the liver caused by persistent inflammation from hepatitis B virus. According to the World Health Organization, approximately 254 million people worldwide were living with CHB infection in 2022, with 1.2 million new infections each year, and 1.3 million deaths globally. CHB is the leading aetiology of liver fibrosis and liver cancer globally, with up to 36% of all CHB patients globally developing cirrhosis. CHB prevalence varies across geographies with China and the United States estimated to have among the highest number of CHB cases.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230. On March 2, 2026 Gyre announced its agreement to acquire Cullgen Inc., a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degraders and degrader antibody conjugate therapies.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone for the treatment of CHB-associated liver fibrosis and early cirrhosis and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
STAFFORD, Texas, March 17, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01.
6 Months of Additional Patient Data Since Last Update Shows Recurrence Rate of <1% per Year in Non-HLA-A*02 Patients Treated with GLSI-100, Following Completion of Primary Immunization Series (PIS)
This <1% Annual Recurrence Rate Observed in Non-HLA-A*02 Patients is Statistically Significantly Smaller Than a 4% Annual Recurrence Rate Over a Similar Time Period Observed in the Katherine Study (Kadcyla Treated Arm) Yielding an Approximately 70-80% Reduction in Recurrence Rate as Explained Below
The non-HLA-A*02 arm does not have a direct placebo comparator arm, thus a Kaplan Meier survival analysis is not possible, and the following method was used:
The <1% recurrence rate per year of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for a similar population in the Katherine study who received TDM1 (Kadcyla), which is about 4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100.
As of this data cut, the current recurrence rate of the non-HLA-A*02 patients treated with GLSI-100, following completion of the PIS over an average of 1.2 years of patient exposure, is statistically significantly smaller than a 4% annual recurrence rate over a similar time period observed in the Katherine study (0.7% versus 4% annual recurrence rate over 1.2 patient-years, 83% reduction in recurrence rate, Chi Square, p < 0.005). This preliminary data will continue to be updated and cleaned, so future and final results may vary. Future updates may be presented at upcoming conferences.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
Additional information about the non-HLA-A*02 arm follows:
Virtually all of the non-HLA-A*02 patients have completed the primary immunization series, which is the first 6 monthly vaccinations in the study.
Every 6 months approximately 110 patient-years are added to the non-HLA-A*02 patient data base.
Enhertu (T-DXd) treated patients can be enrolled in FLAMINGO-01. In the future, if Enhertu is approved for high risk patients in the adjuvant setting, more Enhertu treated patients could be enrolled in FLAMINGO-01 and may recur at a lower rate than if treated with Kadcyla. The recurrence rate assumptions in the design of FLAMINGO-01 include this possibility as well as other potential improvements in standard of care.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed compared to the recurrence rates comparable to those observed in the Katherine study of Kadcyla shows an approximately 70-80% reduction in recurrence rate.
This non-HLA-A*02 arm observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
The Journal of the American Medical Association (JAMA Neurology) publication highlights consistent clinical and biomarker findings from NeuroSense PARADIGM Phase 2b trial in ALS, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers
CAMBRIDGE, Mass., March 16, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology.
Earlier today, Mass General Brigham (MGB) and Barrow Neurological Institute (BNI) issued a joint announcement highlighting the publication and the contributions of the investigators involved in the PARADIGM trial. NeuroSense is honored to collaborate with these leading ALS research centers of excellence and their distinguished clinical teams in advancing research for people living with ALS.
PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension.
PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways.
The publication was authored by a distinguished international group of ALS investigators, including Merit Cudkowicz, MD, MSc (Mass General Brigham and Harvard Medical School), Vivian Drory, MD (Tel-Aviv Sourasky Medical Centre), Adriano Chiò, MD, PhD (University of Torino), Christian Lunetta, MD (IRCCS Maugeri), Christen Shoesmith, MD (London Health Sciences Centre), Ruben van Eijk,MD, PhD (UMC Utrecht), Jeffrey Rosenfeld, MD, PhD (Loma Linda University), and Jeremy Shefner, MD, PhD (Barrow Neurological Institute), together with additional collaborators across North America, Europe, and Israel.
Key highlights from the PARADIGM phase 2b study published
Strong safety and tolerability profile: PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events mild to moderate and transient.
Clinically meaningful functional outcomes: Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001).
Reduction in risk of major ALS complications: Early initiation of PrimeC was associated with a 64% relative reduction in risk of ALS-related complications (p=0.02), including respiratory failure, hospitalization, or death.
Biological evidence supporting disease modification: PrimeC treatment was associated with significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting its biological activity and reinforcing the potential for disease-modifying effects.
Supports advancement to Phase 3: These findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS.
“ALS is one of the most serious neurological diseases, and there is an urgent need for therapies that can meaningfully alter its course,” said Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School. “What is particularly noteworthy about the PARADIGM results is the consistency of the findings across clinical outcomes and disease-relevant biomarkers, in addition to good safety. These results provide a strong scientific rationale for continuing the clinical development of PrimeC and support its evaluation in a larger confirmatory Phase 3 trial.”
“What stands out about the PARADIGM study is the multiple clinical endpoints suggest the same level of clinical benefit and that multiple biomarkers are consistent with clinical endpoints,” said Jeremy M. Shefner, MD, PhD, Professor of Neurology at the Barrow Neurological Institute and corresponding author of the publication. “Together, these findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 trial designed to validate its impact for patients.”
“The publication of the PARADIGM results in the prestigious JAMA Neurology represents an important milestone for NeuroSense and for people living with ALS,” said Ferenc Tracik, MD, Chief Medical Officer of NeuroSense Therapeutics. “This article integrates PrimeC’s safety, clinical, and biomarker data over 18 months. The consistent findings of slower functional decline, reduced risk of ALS-related complications, and modulation of iron-regulatory and microRNA biomarkers strengthen confidence in PrimeC’s potential as a disease-modifying therapy. These findings directly informed the design of our Phase 3 trial, which has received FDA clearance to proceed.”
PARADIGM Study Overview
PARADIGM was a multinational Phase 2b randomized, double-blind, placebo-controlled clinical trial conducted at leading ALS referral centers in Italy, Canada, and Israel.
The study enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo for six months. The double-blind phase was followed by a 12-month open-label extension, during which all participants received PrimeC while maintaining blinding to original treatment assignment.
Even though the trial was not powered to demonstrate definitive efficacy, participants who received PrimeC from the outset maintained a clinically meaningful 7.92-point functional advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007), with the largest improvement observed in the bulbar domain (p=0.001), a key determinant of speech, swallowing, and quality of life in ALS.
In addition, ALS complication-free survival demonstrated a 64% relative risk reduction favoring early treatment (p=0.02), suggesting potential long-term clinical benefit.
Biomarker Findings
The trial also demonstrated biological activity consistent with PrimeC’s proposed multi-pathway mechanism.
Markers of iron metabolism, which are frequently dysregulated in ALS, showed favorable significant changes, including preservation of transferrin levels and stabilization of ferritin.
In parallel, plasma microRNA analysis revealed statistically significant downregulation of ALS-associated microRNAs miR-199a-3p, miR-199a-5p, miR-181a-5p, and miR-181b-5p, which have been linked to disease severity and prognosis.
Together, these findings provide biological evidence that PrimeC engages disease-relevant pathways and support its continued development as a potential disease-modifying therapy.
About PrimeC
PrimeC is an investigational fixed-dose oral combination therapy composed of celecoxib and ciprofloxacin in a synchronized extended-release formulation. The therapy is designed to simultaneously target multiple biological mechanisms implicated in ALS progression, including neuroinflammation, iron dysregulation, and microRNA dysregulation.
The therapeutic rationale for PrimeC is supported by preclinical evidence across ALS disease models and human induced pluripotent stem cell–derived motor neuron systems and has now been evaluated in a randomized Phase 2b clinical trial.
About NeuroSense Therapeutics
NeuroSense Therapeutics is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for people living with ALS and other neurodegenerative diseases. The company’s lead program, PrimeC, is designed to simultaneously target multiple biological pathways implicated in ALS progression.
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 regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 uncertainty regarding outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; 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.
Digital Represents 55% of 2025 Total Net Revenue and 56% of 2025 Total Segment Profit Reduced Debt by $23 Million Since the February 2025 Refinancing
PURCHASE, N.Y., March 16, 2026 (GLOBE NEWSWIRE) — Townsquare Media, Inc. (NYSE: TSQ) (“Townsquare”, the “Company,” “we,” “us” or “our”) announced today its financial results for the fourth quarter and year ended December 31, 2025.
“I am pleased to share that Townsquare’s fourth quarter and year end results met our previously issued net revenue and Adjusted EBITDA guidance, reflecting our team’s hard work in the current environment. We are proud that the execution of our Digital First Local Media strategy allowed us to deliver excellent results for our clients, while also outperforming competitors and gaining market share,” commented Bill Wilson, Chief Executive Officer of Townsquare Media, Inc. “In 2025, net revenue decreased -2.8% year-over-year excluding political, and -5.2% in total, and Adjusted EBITDA decreased -3.0% year-over-year excluding political, and -12.2% in total. Importantly, due to our strong expense management, Adjusted EBITDA margins excluding political were constant year-over-year, despite revenue declines. In addition, our full year net loss improved by $1.2 million year-over-year, to a net loss of $9.8 million.”
Mr. Wilson continued, “In 2025, Townsquare’s Digital business, which now represents 55% of the Company’s total net revenue and 56% of our total Segment Profit, was buoyed by the consistent strength of our differentiated programmatic digital advertising offering, including the success of our Media Partnership division (which we’re proud to announce has expanded from six to eleven partners in 2026), and the direct sales of our local owned and operated digital properties. Both of these digital revenue streams increased by +9% year-over-year in 2025, offsetting the significant short-term headwinds of declining search engine referral traffic we experienced in 2025, and leading to overall 2025 Digital Advertising revenue growth of +1.6% as compared to the prior year. I’m also pleased to share that we are starting to see early signs of digital audience stabilization, and are optimistic the negative remnant revenue headwinds presented by the year-over-year decline in search engine referral traffic will abate in the second half of 2026. In fact to start 2026, the traffic to our local mobile apps and websites grew sequentially month-over-month with both January and February online audience being larger than December, and thus our local remnant revenue in January and February was more than we generated in any month of Q4. I would also like to highlight the strong profit performance of Townsquare Interactive in 2025, which delivered Segment Profit growth of +17.4% year-over-year (+$3.7 million), and a Segment Profit margin of 34%, representing the highest Segment Profit margin in Townsquare Interactive’s 14-year history.”
“One of the largest benefits of our business model is significant cash generation. In 2025, despite having meaningfully higher interest expense obligations, we generated $30.6 million of cash flow from operations over the course of the year. We utilized this cash flow first and foremost to invest in our local business through organic, internal investments that support our revenue and profit growth, particularly our digital growth engine. In addition, we repaid $22.6 million of debt following our February 2025 refinancing through both voluntary and mandatory debt amortization, and made $13.2 million of dividend payments. Due to management’s and the Board of Director’s ongoing confidence in our business, the underlying strength of our digital advertising differentiation, and our consistent, strong free cash flow characteristics, which we believe is not reflected in our stock price to date, we plan to maintain the dividend at its current rate, despite the high implied dividend yield. Looking forward, we remain confident in our ability to build shareholder value for our investors through long-term net revenue, Adjusted EBITDA and cash flow growth, net leverage reduction, and future dividend payments,” concluded Mr. Wilson.
The Company announced today that its Board of Directors approved a quarterly cash dividend of $0.20 per share. The dividend will be payable on May 4, 2026 to shareholders of record as of the close of business on April 27, 2026. As of the last closing price, this reflects a dividend yield of approximately 11%.
Segment Reporting We have three reportable operating segments, Digital Advertising, Subscription Digital Marketing Solutions, and Broadcast Advertising. The Digital Advertising segment, marketed externally as Townsquare Ignite, includes digital advertising on our digital programmatic advertising platform and our owned and operated digital properties, and our first party data digital management platform. The Subscription Digital Marketing Solutions segment includes our subscription digital marketing solutions business, Townsquare Interactive. The Broadcast Advertising segment includes our local, regional, and national advertising products and solutions delivered via terrestrial radio broadcast, and other miscellaneous revenue that is associated with our broadcast advertising platform. The remainder of our business is reported in the Other category, which includes our live events business.
Fourth Quarter Results*
As compared to the fourth quarter of 2024:
Net revenue decreased 9.6%, and 4.5% excluding political
Net income decreased $29.8 million from net income of $25.0 million to a net loss of $4.8 million
Adjusted EBITDA decreased 30.9%, and 17.0% excluding political
Total Digital net revenue decreased 2.4%
Digital Advertising net revenue decreased 1.0%
Subscription Digital Marketing Solutions (“Townsquare Interactive”) net revenue decreased 5.6%
Total Digital Segment Profit decreased 14.8%
Digital Advertising Segment Profit decreased 28.0%
Subscription Digital Marketing Solutions Segment Profit increased 12.0%
Broadcast Advertising net revenue decreased 17.8%, and 7.9% excluding political
Net loss per diluted share was $0.32 and Adjusted Net Income per diluted share was $0.05
Repaid $5.9 million of our Senior Secured Credit Facility, including $3.0 million of the Revolver and $2.9 million of Term Loan
Full Year Results*
As compared to the year ended December 31, 2024:
Net revenue decreased 5.2%, and 2.8% excluding political
Net loss decreased $1.2 million from a net loss of $10.9 million to a net loss of $9.8 million
Adjusted EBITDA decreased 12.2%, and 3.0% excluding political
Total Digital net revenue increased 0.9%
Digital Advertising net revenue increased 1.6%
Subscription Digital Marketing Solutions net revenue decreased 0.7%
Total Digital Segment Profit decreased 1.7%
Digital Advertising Segment Profit decreased 11.7%
Subscription Digital Marketing Solutions Segment Profit increased 17.4%
Broadcast Advertising net revenue decreased 12.6%, and 8.0% excluding political
Entered into a five-year $490 million Credit Agreement, including a $470 million Senior Secured Term Loan Facility and a $20 million Revolving Credit Facility
Redeemed all of the Company’s outstanding 2026 Senior Secured Notes of $467.4 million
Reduced outstanding debt by $22.6 million since the February 2025 refinancing, including $14.6 million of our Term Loan and an $8.0 million net reduction of the outstanding Revolving Credit Facility
*See below for discussion of non-GAAP measures.
Guidance For the first quarter of 2026, net revenue is expected to be between $96 million and $98 million, and Adjusted EBITDA is expected to be between $16 million and $17 million.
For the full year 2026, net revenue is expected to be between $420 million and $440 million, and Adjusted EBITDA is expected to be between $87 million and $93 million.
Quarter Ended December 31, 2025 Compared to the Quarter Ended December 31, 2024
Net Revenue Net revenue for the three months ended December 31, 2025 decreased $11.3 million, or 9.6%, to $106.5 million as compared to $117.8 million in the same period in 2024. Broadcast Advertising net revenue decreased $9.9 million, or 17.8%, due to decreases in the purchases of advertising by our clients and decreases in political revenue. Subscription Digital Marketing Solutions net revenue decreased $1.1 million or 5.6%, due to reduced sales velocity as a result of lower sales headcount, and Digital Advertising net revenue decreased $0.4 million, or 1.0%, primarily due to decreases in remnant digital advertising revenue.
Excluding political revenue of $0.9 million and $7.2 million for the three months ended December 31, 2025 and 2024, respectively, net revenue decreased $5.0 million, or 4.5%, to $105.6 million, Broadcast Advertising net revenue decreased $3.9 million, or 7.9%, to $45.0 million, and Digital Advertising net revenue decreased $0.1 million, or 0.2%, to $41.5 million.
Net (Loss) Income For the three months ended December 31, 2025, we reported net loss of $4.8 million, a decrease of $29.8 million as compared to net income of $25.0 million in the same period last year. The decrease was due to a $15.1 million increase in the provision for income taxes, a $11.3 million decrease in net revenue and a $3.6 million increase in interest expense. Adjusted Net Income decreased $9.5 million to $0.8 million, as compared to $10.3 million for the same period last year.
Adjusted EBITDA Adjusted EBITDA for the three months ended December 31, 2025 decreased $9.6 million, or 30.9%, to $21.5 million, as compared to $31.2 million in the same period last year. Adjusted EBITDA (Excluding Political) decreased $4.3 million, or 17.0%, to $20.8 million, as compared to $25.1 million in the same period last year.
Year Ended December 31, 2025 Compared to the Year Ended December 31,2024
Net Revenue Net revenue for the year ended December 31, 2025 decreased $23.6 million, or 5.2%, to $427.4 million as compared to $451.0 million in the same period in 2024. Broadcast Advertising net revenue decreased $26.5 million, or 12.6%, due to decreases in the purchases of advertising by our clients and decreases in political revenue, and Subscription Digital Marketing Solutions net revenue decreased $0.5 million, or 0.7% due to reduced sales velocity as a result of lower sales headcount. These decreases were partially offset by an increase in Digital Advertising net revenue of $2.6 million, or 1.6%, and an increase in Other net revenue of $0.8 million, or 11.8%.
Excluding political revenue of $2.2 million and $13.4 million for the year ended December 31, 2025 and 2024, respectively, net revenue decreased $12.3 million, or 2.8% to $425.2 million, Broadcast Advertising net revenue decreased $15.8 million, or 8.0%, to $181.5 million, and Digital Advertising net revenue increased $3.1 million, or 2.0%, to $160.9 million.
Net Loss For the year ended December 31, 2025, we reported net loss of $9.8 million, an improvement of $1.2 million as compared to $10.9 million in the same period last year. The decrease in net loss was due to a $28.8 million decrease in non-cash impairment charges, an $8.5 million decrease in direct operating expenses, an $8.1 million increase in gain on sale and retirement of assets and a $3.4 million decrease in stock-based compensation. These amounts were partially offset by the $23.6 million decrease in net revenue discussed above, an $11.7 million increase in interest expense, a $6.7 million increase in transaction and business realignment cost, and a $5.1 million increase in other (expense) income. Adjusted Net Income decreased $14.8 million to $4.4 million as compared to $19.2 million for the same period last year.
Adjusted EBITDA Adjusted EBITDA for the year ended December 31, 2025 decreased $12.3 million, or 12.2% to $88.1 million, as compared to $100.4 million in the same period last year. Adjusted EBITDA (Excluding Political) decreased $2.7 million, or 3.0%, to $86.3 million, as compared to $89.0 million in the same period last year.
Liquidity and Capital Resources As of December 31, 2025, we had a total of $4.8 million of cash and cash equivalents and $457.4 million of outstanding indebtedness, representing 5.19x and 5.14x gross and net leverage, respectively, based on Adjusted EBITDA for the year ended December 31, 2025, of $88.1 million.
The table below presents a summary, as of March 9, 2026, of our outstanding common stock (net of treasury shares).
Security
Number Outstanding
Description
Class A common stock
15,789,817
One vote per share.
Class B common stock
815,296
10 votes per share.1
Class C common stock
500,000
No votes.1
Total
17,105,113
1 Each share converts into one share of Class A common stock upon transfer or at the option of the holder, subject to certain conditions, including compliance with FCC rules.
Conference Call Townsquare Media, Inc. will host a conference call to discuss certain fourth quarter 2025 financial results and 2026 guidance on Monday, March 16, 2026 at 8:00 a.m. Eastern Time. The conference call dial-in number is 1-800-717-1738 (U.S. & Canada) or 1-646-307-1865 (International) and the conference ID is “Townsquare.” A live webcast of the conference call will also be available on the investor relations page of the Company’s website at www.townsquaremedia.com.
A replay of the conference call will be available through March 23, 2026. To access the replay, please dial 1-844-512-2921 (U.S. and Canada) or 1-412-317-6671 (International) and enter confirmation code 1134751. A web-based archive of the conference call will also be available at the above website.
About Townsquare Media, Inc. Townsquare is a community-focused digital and broadcast media and digital marketing solutions company principally focused outside the top 50 markets in the U.S.Townsquare Ignite, our robust digital advertising division, specializes in helping businesses of all sizes connect with their target audience through data-driven, results based strategies, by utilizing a) our proprietary digital programmatic advertising technology stack with an in-house demand and data management platform and b) our owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data. Townsquare Interactive, our subscription digital marketing services business, partners with SMBs to help manage their digital presence by providing a SAAS business management platform, website design, creation and hosting, search engine optimization and other digital services. And through our portfolio of local radio stations strategically situated outside the Top 50 markets in the United States, we provide effective advertising solutions for our clients and relevant local content for our audiences. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com and www.townsquareignite.com.
Forward-Looking Statements Except for the historical information contained in this press release, the matters addressed are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “aim,” “anticipate,” “estimate,” “expect,” “forecast,” “outlook,” “potential,” “project,” “projection,” “plan,” “intend,” “seek,” “believe,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors. While it is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by us include the impact of general economic conditions in the United States, or in the specific markets in which we currently do business including supply chain disruptions, inflation, labor shortages and the effect on advertising activity, industry conditions, including existing competition, artificial intelligence and future competitive technologies, the popularity of radio as a broadcasting and advertising medium, cancellations, disruptions or postponements of advertising schedules in response to national or world events, our ability to develop and maintain digital technologies and hire and retain technical and sales talent, our dependence on key personnel, our capital expenditure requirements, our continued ability to identify suitable acquisition targets, and consummate and integrate any future acquisitions, legislative or regulatory requirements, risks and uncertainties relating to our leverage and changes in interest rates, our ability to obtain financing at times, in amounts and at rates considered appropriate by us, our ability to access the capital markets as and when needed and on terms that we consider favorable to us and other factors discussed in this section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report and under “Risk Factors” in our 2025 Annual Report on Form 10-K, for the year ended December 31, 2025, filed with the SEC on March 16, 2026, as well as other risks discussed from time to time in our filings with the SEC. Many of these factors are beyond our ability to predict or control. In addition, as a result of these and other factors, our past financial performance should not be relied on as an indication of future performance. The cautionary statements referred to in this section also should be considered in connection with any subsequent written or oral forward-looking statements that may be issued by us or persons acting on our behalf. The forward-looking statements included in this report are made only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures and Definitions In this press release, we refer to Adjusted EBITDA, Adjusted EBITDA (Excluding Political), Adjusted Net Income and Adjusted Net Income Per Share which are financial measures that have not been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).
We define Adjusted EBITDA as net income before the deduction of income taxes, interest expense, net, (gain) loss on repurchases and extinguishment of debt, transaction and business realignment costs, depreciation and amortization, stock-based compensation, impairments, net (gain) loss on sale and retirement of assets and other expense (income), net. We define Adjusted EBITDA (Excluding Political) as Adjusted EBITDA less political net revenue, net of a fifteen percent deduction to account for estimated national representative firm fees, music licensing fees and sales commissions expense. Adjusted Net Income is defined as net income before the deduction of transaction and business realignment costs, impairments, gain on sale of investment, change in fair value of investment, net (gain) loss on sale and retirement of assets, (gain) loss on repayments, repurchases and extinguishment of debt, gain on insurance recoveries and net income attributable to non-controlling interest, net of income taxes stated at the Company’s applicable statutory effective tax rate. Adjusted Net Income Per Share is defined as Adjusted Net Income divided by the weighted average shares outstanding. We define Net Leverage as our total outstanding indebtedness, net of our total cash balance as of December 31, 2025, divided by our Adjusted EBITDA for the twelve months ended December 31, 2025. These measures do not represent, and should not be considered as alternatives to or superior to, financial results and measures determined or calculated in accordance with GAAP. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. You should be aware that in the future we may incur expenses or charges that are the same as or similar to some of the adjustments in the presentation, and we do not infer that our future results will be unaffected by unusual or nonrecurring items. In addition, these non-GAAP measures may not be comparable to similarly-named measures reported by other companies.
We use Adjusted EBITDA and Adjusted EBITDA (Excluding Political) to facilitate company-to-company operating performance comparisons by backing out potential differences caused by variations in capital structures (affecting interest expense), taxation and the age and book depreciation of facilities and equipment (affecting relative depreciation expense), which may vary for different companies for reasons unrelated to operating performance, and to facilitate year over year comparisons, by backing out the impact of political revenue which varies depending on the election cycle and may be unrelated to operating performance. We use Adjusted Net Income and Adjusted Net Income Per Share to assess total company operating performance on a consistent basis. We use Net Leverage to measure the Company’s ability to handle its debt burden. We believe that these measures, when considered together with our GAAP financial results, provide management and investors with a more complete understanding of our business operating results, including underlying trends, by excluding the effects of loss (gain) on extinguishment and repurchases of debt, transaction costs, net (gain) loss on sale and retirement of assets and investments, business realignment costs and impairments. Further, while discretionary bonuses for members of management are not determined with reference to specific targets, our board of directors may consider Adjusted EBITDA, Adjusted EBITDA (Excluding Political), Adjusted Net Income, Adjusted Net Income Per Share, and Net Leverage when determining discretionary bonuses.
2025 Revenue up 7% Year-Over-Year to $614.9 Million
2025 Net Income of $5.1 Million vs. $7.8 Million in 2024
2025 Gross Profit up 30% Year-Over-Year to $105.6 Million
2025 Adjusted EBITDA up 42% Year-Over-Year to $56.4 Million
ATLANTA , March 16, 2026 (GLOBE NEWSWIRE) — Bitcoin Depot (Nasdaq: BTM) (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today reported financial results for the fourth quarter and full year ended December 31, 2025. Bitcoin Depot will host a conference call and webcast at 10:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.
“2025 was a strong year for Bitcoin Depot, with growth across the majority of our key operating and financial metrics,” said Scott Buchanan, CEO of Bitcoin Depot. “While fourth-quarter results declined year-over-year, this was primarily driven by recently enacted state regulations that introduced transaction size caps and, to a lesser extent, enhancements to our compliance standards that modestly affected near-term transaction activity. Importantly, we view both developments as constructive for the long-term health, credibility, and sustainability of the industry.”
“As the largest and most compliant crypto ATM operator in North America, we believe Bitcoin Depot is uniquely positioned to navigate this evolving regulatory environment and continue to gain share as the market matures,” Buchanan continued. “Subsequent to year-end, we further strengthened our growth profile by deploying our strong balance sheet and fintech platform to acquire Kutt, a peer-to-peer social betting platform. This acquisition marks our first entry into the P2P social betting market and reflects our broader strategy to thoughtfully diversify beyond our core Bitcoin ATM business while leveraging our payments infrastructure and compliance expertise.”
Fourth Quarter 2025 Financial Results
Revenue in the fourth quarter of 2025 was $116.0 million compared to $136.8 million in the fourth quarter of 2024. This decrease was driven by recently enacted state regulations and enhanced compliance standards.
Gross profit in the fourth quarter of 2025 was $15.3 million from $23.5 million for the fourth quarter of 2024. Gross profit margin in the fourth quarter of 2025 was 13.2% compared to 17.2% in the fourth quarter of 2024. Adjusted gross profit, a non-GAAP measure, in the fourth quarter of 2025 was $17.3 million compared to $25.4 million in the year ago quarter. Adjusted gross profit margin, a non-GAAP measure, in the fourth quarter of 2025 was 14.9% compared to 18.6% in the year ago quarter. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Total operating expenses in the fourth quarter of 2025 were $21.4 million compared to $15.0 million in the fourth quarter of 2025 due to higher legal services and compensation expense.
Net loss in the fourth quarter of 2025 was $24.9 million compared to net income of $5.4 million in the fourth quarter of 2024. The fourth quarter of 2025 included an $18.5 million accrual for an arbitration judgment liability. Net loss attributable to common shareholders in the fourth quarter of 2025 was $21.6 million, or $(2.08) per share, compared to a net loss of $6.6 million, or $(2.24) per share, in last year’s fourth quarter.
Adjusted EBITDA, a non-GAAP measure, in the fourth quarter of 2025 was $1.6 million compared to $13.0 million in the fourth quarter of 2024. The decrease was primarily due to the lower revenue and higher operating expenses. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Cash, cash equivalents, and cryptocurrencies as of December 31, 2025, totaled $76.6 million, up from $31.0 million at the end of 2024.
Net cash flows provided by operations in 2025 increased 51% to $34.0 million compared to $22.5 million in 2024.
2025 Financial Results
Revenue in 2025 increased 7% to $614.9 million compared to $573.7 million in 2024. This increase was driven by increased kiosk deployment and higher median transaction size.
Gross profit in 2025 increased 30% to $105.6 million from $81.5 million in 2024. Gross profit margin in 2025 increased 300 basis points to 17.2% compared to 14.2% in 2024. Adjusted gross profit, a non-GAAP measure, increased 24% to $113.3 million compared to $91.4 million in 2024. Adjusted gross profit margin, a non-GAAP measure, increased 250 basis points in 2025 to 18.4% compared to 15.9% in 2024. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Total operating expenses were $72.1 million in 2025 compared to $67.2 million in 2024 due to higher legal services expenses.
Net income in 2025 was $5.1 million compared to $7.8 million in 2024. 2025 included a $18.5 million accrual for an arbitration judgment liability. Net loss attributable to common shareholders was $5.8 million, or $(0.81) per share, from a net loss of $11.7 million, or $(4.21) per share, in 2024.
Adjusted EBITDA, a non-GAAP measure, in 2025 increased 42% to $56.4 million compared to $39.7 million in 2024. The increase was primarily due to the higher revenue and income from operations. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.
Outlook
The Company expects revenue for the core business in 2026 to be down in the range of 30% to 40%. This estimate reflects the uncertainty presented by the dynamic regulatory environment and enhanced compliance standards. While these will weigh on near-term results, we believe they will reinforce the integrity and sustainability of our business over the long term.
Conference Call
Bitcoin Depot will hold a conference call at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) today to discuss its financial results for the fourth quarter and full year ended December 31, 2025.
Call Date: Monday, March 16, 2025 Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time)
Phone Instructions U.S. and Canada (toll-free): 888-596-4144 U.S. (toll): 646-968-2525 Conference ID: 8347121
A replay of the call will be available beginning after 2:00 p.m. Eastern time through March 27, 2026.
U.S. & Canada (toll-free) replay number: 800-770-2030 U.S. toll number: 609-800-9909 Conference ID: 8347121
If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 949-574-3860.
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 and operates over 9,000 kiosk locations globally as of August 2025. Learn more at www.bitcoindepot.com.
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 of 1934, as amended. 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, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies. 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; risks relating to the uncertainty of our projected financial information; 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.
RESTON, Va., March 16, 2026 /PRNewswire/ — V2X, Inc. (NYSE: VVX) today announced a strategic collaboration with Elastic to accelerate search and analytics capabilities to better support joint government, defense, and intelligence community customers’ missions.
V2X is working with Elastic to integrate its industry-leading search and analytics capabilities to better meet stringent government and national security standards. By combining their expertise, the two companies will provide government and commercial organizations with faster access to critical information and improved decision-making while fully supporting demanding security and compliance mandates.
V2X and Elastic are driving advancements across key mission functions, including:
Multi-source data analysis: Through Elasticsearch, V2X is rapidly indexing, searching, and analyzing vast quantities of structured and unstructured data to generate actionable intelligence in real-time.
Optimized logistics and sustainment: Leveraging enhanced search visibility to improve supply chain tracking, predictive maintenance, and asset management.
Cyber and operational resilience: Detecting risks and anomalies faster through intelligent event correlation and data monitoring.
“Our partnership with Elastic allows V2X to embed world-class data search and analytics capabilities into our own workflows while also elevating what we can deliver for our customers,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “By utilizing Elasticsearch and Elastic Agent Builder, we can quickly surface mission-critical insights and improve security across the full lifecycle of government and defense operations.”
“Government missions depend on the ability to unify and interrogate vast volumes of structured and unstructured data,” said Chris Townsend, Global Vice President of Public Sector at Elastic. “By combining Elasticsearch with Elastic Agent Builder, V2X can surface actionable insight faster and strengthen decision-making across complex operational environments.”
V2X partners with industry leading technology providers like Elastic to expand its leadership in data-enabled mission solutions and accelerate digital transformation across all domains.
Disclaimer Capabilities described are subject to applicable contractual authorizations and accreditation processes.
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.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations [email protected] 719-637-5773
Saguenay, Québec–(Newsfile Corp. – March 16, 2026) – First Phosphate Corp. (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) (“First Phosphate” or the “Company“) is pleased to announce that it has finalized an agreement, on March 4, 2026, for a $16.7 million non-repayable contribution from the Government of Canada through Natural Resources Canada (“NRCan”) Global Partnerships Initiative (“GPI”).
This contribution funding will accelerate the development of the phosphate project in Bégin-Lamarche by developing the technical and engineering parameters – including processing circuits and equipment – needed to validate the ability to produce a phosphate concentrate that meets the quality requirements of the lithium iron phosphate (“LFP”) battery market. The work will be conducted based on the parameters established under the contract between First Phosphate and its definitive offtaker.
“Canada and our partners are putting real capital behind the secure and resilient critical mineral supply chains that our economies and defence industries rely on,” said The Honourable Tim Hodgson, Minister of Energy and Natural Resources. “By supporting companies like First Phosphate, we are helping deliver the minerals the world needs and the prosperity and security Canadians deserve.”
“We welcome this investment from the Government of Canada which supports the continued progress of our project and its strategic role in the LFP battery supply chain,” said John Passalacqua, CEO of First Phosphate. “Together, we are taking another step toward establishing an integrated phosphate-based LFP battery supply chain in Canada.”
The Bégin-Lamarche demonstration and feasibility project will help strengthen Canada’s strategic positioning within the LFP battery value chain through the development of domestic capacity to process apatite (phosphate concentrate) into high-purity phosphoric acid (“PPA”) for battery applications.
The project will develop a scalable Canadian process for the production of battery-grade phosphate concentrate, reducing dependence on foreign supply chains.
The project will generate significant economic benefits, including the creation of approximately 277 skilled jobs and the potential establishment of a Canadian phosphoric acid facility supported by local commercial production of phosphate concentrate.
The financial contribution is granted for the completion of a feasibility study of the Company’s integrated Bégin-Lamarche phosphate mine and processing project in Saguenay-Lac-Saint-Jean and covers eligible activities planned through 2028, in accordance with the terms of the agreement.
The scientific and technical disclosure for First Phosphate included in this news release has been reviewed and approved by Gilles Laverdière, P.Geo. Mr. Laverdière is Chief Geologist of First Phosphate and a Qualified Person under National Instrument 43-101 – Standards of Disclosure of Mineral Projects (“NI 43-101”).
About Natural Resources Canada
Natural Resources Canada (“NRCan”) is the federal department responsible for developing policies and programs to ensure the sustainable and responsible development of Canada’s natural resources. Through its initiatives and funding programs, including the Global Partnerships Initiative, NRCan supports projects that contribute to strengthening supply chains, industrial innovation, and Canada’s competitiveness in the critical and strategic minerals sectors.
About First Phosphate Corp
First Phosphate (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) is a mineral exploration and development and clean technology company dedicated to building and reshoring a vertically integrated mine-to-market supply chain for the production of LFP batteries in North America. Target markets include energy storage, data centers, robotics, mobility, and national security.
First Phosphate’s flagship Bégin-Lamarche property, located in Saguenay-Lac-Saint-Jean, Québec, Canada, represents a rare North American igneous phosphate resource producing high-purity phosphate characterized by very low levels of impurities.
Forward-Looking Information and Cautionary Statements
This release includes certain statements that may be deemed “forward-looking information”. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. In particular, this press release contains forward-looking information relating to, among other things: the Company’s compliance with the terms of the definitive agreement; the funding amount, anticipated benefits, timing, and potential outcomes of the GPI funding award under the contribution agreement with NRCan and the project funded thereby including, but not limited to, the strengthening of Canada’s strategic positioning within the LFP battery value chain, the development of domestic capacity to process apatite into high-purity PPA for battery applications, the development of a scalable Canadian process for the production of battery-grade phosphate concentrate, the reduction of dependence on foreign supply chains, and the contribution to significant economic benefits, including the creation of skilled jobs and the potential establishment of a Canadian phosphoric acid facility; and the Company’s plans for building and onshoring a vertically integrated mine-to-market LFP battery supply chain for North America. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include development and exploration successes, continued availability of capital and financing, and general economic, market or business conditions. These statements are based on a number of assumptions including, among other things, assumptions regarding general business and economic conditions; there being no significant disruptions affecting the activities of the Company or inability to access required project inputs; permitting and development of the projects being consistent with the Company’s expectations; the accuracy of the current mineral resource estimates for the Company and results of metallurgical testing; certain price assumptions for P2O5 and Fe2O3; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the Company’s relationship with First Nations and other Indigenous parties remaining consistent with the Company’s expectations; the Company’s relationship with other third party partners and suppliers remaining consistent with the Company’s expectations; and government relations and actions being consistent with Company expectations. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. The Company does not assume any obligation to update or revise its forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law. All forward-looking information contained in this release is qualified by these cautionary statements.
– 12-patient cohort fully enrolled with an average time since transplant of approximately 8 months
– 100% insulin independence achieved in 10 patients who are over 4 weeks post-transplant
– No signs of graft rejection or de novo donor-specific HLA antibodies
– Tegoprubart continues to demonstrate a favorable safety and tolerability profile
IRVINE, Calif, March 16, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute and presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the Advanced Technologies and Treatments for Diabetes (ATTD) conference, held March 11-14, 2026 in Barcelona, Spain.
The investigator-initiated pilot study enrolled 12 adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation at UChicago Medicine. Patients had a median duration of diabetes of approximately 33 years and mean hemoglobin A1C (“HbA1C”) of approximately 8.0% prior to transplantation. Participants received tegoprubart, Eledon’s anti-CD40L monoclonal antibody, as part of a calcineurin inhibitor-free immunosuppression regimen.
The data demonstrated rapid improvement in glycemic control following islet transplantation, with stable islet graft function observed across the cohort. All 10 patients who were more than four weeks post-transplant achieved both insulin independence and a most recent HbA1c below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors.
“T1D patients have been waiting decades for a potential functional cure, and it is very encouraging to see meaningful progress in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “These latest findings support the potential of tegoprubart to enable effective islet graft protection while avoiding the toxicities often associated with calcineurin inhibitors, and potentially enable access to islet cell transplantation for individuals living with T1D. We are proud to contribute to these important ongoing research efforts and support the work of Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”
“Breakthrough T1D is proud to fund the University of Chicago’s clinical trial testing tegoprubart as a novel immunosuppression alternative for use in islet cell transplants and we are very encouraged by the early data,” said Aaron Kowalski, Ph.D., CEO of Breakthrough T1D. “It is exciting to see islet transplant recipients in this trial who no longer need to administer insulin and who are experiencing fewer side effects than with traditional immunosuppressive regimens.”
This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.
About Islet Transplantation for Type 1 Diabetes
Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
STAFFORD, Texas, March 16, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01.
All US Sites Treating Patients with Commercially Manufactured GP2
The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US.
Within weeks following the FDA review, all approximately 40 US sites were supplied with commercially manufactured GP2 vials and these sites began treating patients with these vials immediately. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.
CEO Snehal Patel commented, “We have started to submit the same manufacturing information to European, UK, and Canadian regulators so that commercially manufactured GP2 can be approved for use by all approximately 160 sites participating in FLAMINGO-01. We are also planning to manufacture additional vials of GP2, seeking a capacity of 500,000 to 1 million vials of GP2 per year, and to make larger lots of GP2 active ingredient to build inventory for a potential commercial launch.”
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Strategic Portfolio Optimization Creating Long-Term Value
Cost Management Drives Restaurant Margin Improvement in Fourth Quarter
Full Year 2026 Financial Targets Introduced
DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today reported its financial results for the fourth quarter and full year ended December 28, 2025.
Effective January 1, 2025, the Company adopted a new fiscal calendar structure using four 13-week quarters, with a 53rd week added when necessary. The 2025 fiscal year ran from January 1, 2025, to December 28, 2025.
This fiscal calendar change created timing differences that impacted quarterly comparisons: the fourth quarter of 2025 had 91 days versus 92 days in the fourth quarter of 2024. Additionally, the New Year’s Eve holiday shifted from fiscal 2025 to fiscal 2026. The exclusion of New Year’s Eve in the current year impacted total GAAP revenues by approximately 2.5%, representing 37% of the total GAAP revenue decline for the quarter.
Highlights for the fourth quarter 2025 compared to the same quarter in 2024 are as follows:
Total GAAP revenues decreased 6.7% to $207 million from $222 million;
Consolidated comparable sales*decreased 1.8%;
GAAP net loss attributable to The ONE Group Hospitality, Inc. increased to $6 million from a net income of $2 million primarily related to a non-cash loss on impairment of $7 million related to the Grill optimization strategy;
Restaurant Operating Profit**increased by 10 basis points to 19.5% of owned restaurant net revenue, excluding Grill Concepts restaurants closed or to be closed, from 19.4%; and,
Adjusted EBITDA*** attributable to The ONE Group Hospitality, Inc. decreased to $28 million from $31 million, with approximately $3 million of the decrease attributable to the New Year’s Eve holiday shift from fiscal 2025 to fiscal 2026.
Highlights for the full year 2025 compared to the full year 2024 are as follows:
Total GAAP revenues increased 19.7% to $806 million from $673 million;
Consolidated comparable sales*decreased 3.7%;
GAAP net loss attributable to The ONE Group Hospitality, Inc. increased to $92 million from a net loss of $17 million due primarily to an increase in the income tax expenses of $69 million, primarily related to the establishment of a non-cash tax valuation allowance, and non-cash lease termination and exits costs of $7 million coupled with a non-cash impairment of $11 million related to the Grill optimization strategy;
Adjusted Operating Income**** increased 15.2% to $38 million from $33 million; and,
Adjusted EBITDA*** attributable to The ONE Group Hospitality, Inc. increased 16.3% to $89 million, excluding approximately $4 million attributable to two days in fiscal year 2025 versus fiscal year 2024, from $76 million.
“Guests continue to choose our differentiated Vibe Dining concepts when they want memorable experiences. In the fourth quarter, consolidated comparable sales improved by four percentage points sequentially from the third quarter, with every brand contributing. So far in the first quarter, we are delivering positive consolidated comparable sales. These results confirm that our strategy is working, even in a challenging consumer environment,” said Emanuel “Manny” Hilario, President and CEO of The ONE Group.
“Our disciplined cost management initiatives continue to drive results. In the fourth quarter, we expanded our restaurant operating margins, even while facing sales deleveraging. Looking ahead, our operational foundation remains strong, supported by beef supply and pricing secured through September 2026 and significant cost synergies from the Benihana acquisition that we believe we have yet to fully capture,” Hilario continued.
“In 2025, we took decisive action to optimize our portfolio and position the company for sustained long-term growth. We closed six underperforming Grill locations and identified up to five additional units for conversion to our higher-performing Benihana or STK formats through 2026. Our first RA Sushi to STK conversion in Scottsdale, Arizona has exceeded expectations, operating at a run rate of approximately $7 million in annualized sales on an approximate $1 million capital investment. This validates the strength of this repositioning strategy. Additionally, we advanced our asset-light growth strategy by securing development rights for ten Benihana and Benihana Express locations in the San Francisco Bay Area, representing the largest franchise agreement in our Company’s history. We have also secured a commitment for an additional franchised Benihana location and a licensed Benihana Express location in the Florida Keys,” Hilario concluded.
Strategic Portfolio Optimization
Grill Concepts Rationalization:
Closed six underperforming Grill locations in 2025 and one in 2026;
Identified up to five additional Grill units for conversion to Benihana or STK formats through 2026;
Conversion economics: approximately $1.0 to $1.5 million per conversion with a one-year payback; and
Expected outcome: 100% profitable Grill portfolio with enhanced margins.
Capital Efficiency Focus:
Prioritizing asset-light and conversion-driven growth;
Targeting new company-owned openings averaging $1.5 million or less in build-out costs;
Significant reduction in discretionary capital expenditures to strengthen balance sheet; and
Advancing existing pipeline of approximately 12 signed leases with limited new signings.
2025 Restaurant Development
Restaurant
Location
Opening Date
Owned Benihana
San Mateo, California
March 2025
Owned STK
Topanga, California
April 2025
Owned STK (relocation)
Los Angeles, California
May 2025
Franchised Benihana Express
Miami, Florida
June 2025
Owned STK (RA Sushi conversion)
Scottsdale, Arizona
October 2025
Sports Arena Benihana
UBS Arena in Elmont, New York
December 2025
Owned STK
Oak Brook, Illinois
December 2025
2026 Restaurant Development and Pipeline
Quarter-to-date Activity:
January 2026: Opened Company-owned Kona Grill in San Antonio, Texas (relocation)
February 2026: Converted franchised Benihana to owned in Monterey, California
Currently Under Construction (4 locations):
Owned STK in Phoenix, Arizona
Owned STK in New York, New York (relocation of an existing STK restaurant)
Owned Benihana in San Jose, California
Owned Benihana in Seattle, Washington
Asset-Light Expansion Highlights:
Ten-restaurant franchise development agreement for Benihana/Benihana Express in Greater San Francisco Bay Area, California
Accelerates West Coast expansion while maintaining capital discipline
Two-restaurant commitment for a franchised Benihana and a licensed Benihana Express in the Florida Keys
Partnership with experienced operator ensures quality execution
Liquidity
As of December 28, 2025, the Company held $24 million in cash and short-term credit card receivables and had $27 million available under our revolving credit facility, or a total of $51 million in short term liquidity. Under the current conditions, the Company’s credit facility does not have any financial covenants.
2026 Financial Targets
The Company is introducing the following financial targets, reflecting the benefits of portfolio optimization, operational improvements, and continued Benihana integration synergies.
Financial Results and Other Select DataUS$s in millions
Q1 2026 GuidanceMarch 29, 2026
2026 GuidanceDecember 27, 2026
Total GAAP revenues
$217 to $221
$840 to $855
Consolidated comparable sales
0% to 1%
1% to 3%
Managed, license and franchise fee revenues
$3.5 to $4.0
$14 to $15
Total owned operating expenses as a percentage of owned restaurant net revenue
82% to 83%
82% to 83%
Consolidated total G&A, excluding stock-based compensation
$13 to $14
Approx. $53
Consolidated Adjusted EBITDA(1)
$28 to $29
$100 to $110
Consolidated restaurant pre-opening expenses
$1 to $2
$5 to $6
Consolidated effective income tax rate
Approx. 10%
Consolidated total capital expenditures, net of allowances received by landlords
$38 to $42
Consolidated number of new system-wide venues
6 to 10 new venues
Note: As of January 1, 2025, we began reporting financial information on a fiscal quarter basis using four 13-week quarters with the addition of a 53rd week when necessary. Our fourth quarter of 2025 had 91 days. For 2026, our fiscal calendar began on December 29, 2025 and ends on December 27, 2026.
(1) We have not reconciled guidance for Consolidated Adjusted EBITDA to the corresponding GAAP financial measure because we do not provide guidance for the various reconciling items. We are unable to provide guidance for these reconciling items because we cannot determine their probable significance, as certain items are outside of our control and cannot be reasonably predicted since these items could vary significantly from period to period. Accordingly, reconciliations to the corresponding GAAP financial measure are not available without unreasonable effort.
Conference Call and Webcast
Emanuel “Manny” Hilario, President and Chief Executive Officer, and Nicole Thaung, Chief Financial Officer, will host a conference call and webcast today at 8:30 AM Eastern Time.
The conference call can be accessed live over the phone by dialing 412-542-4186. A replay will be available after the call and can be accessed by dialing 412-317-6671; the passcode is 10206228. The replay will be available until Friday, March 27, 2026.
The webcast can be accessed from the Investor Relations tab of The ONE Group’s website at www.togrp.com under “News / Events.”
About The ONE Group
The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group is recognized as one of “America’s Greatest Companies” (Newsweek, 2025), and Benihana is honored as one of ”America’s Best Brands for Value” (Forbes, 2025). The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:
STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
Kona Grill, a polished casual, bar-centric Grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.
Additional information about The ONE Group can be found at www.togrp.com.
Non-GAAP Definitions
We have evolved our definition of non-GAAP financial measures starting in Q4 2025. We use certain non-GAAP measures in analyzing operating performance and believe that the presentation of these measures provides investors and analysts with information that is beneficial to gaining an understanding of the Company’s financial results. Non-GAAP disclosures should not be viewed as a substitute for financial results determined in accordance with GAAP.
We exclude items management does not consider in the evaluation of its ongoing core operating performance from Adjusted EBITDA. Starting in Q4 2025, the Adjusted EBITDA attributable to closed Grill Concepts restaurants is excluded from Adjusted EBITDA. Reconciliations of these non-GAAP measures are included under “Reconciliation of Non-GAAP Measures” in this press release.
*Comparable sales represent total U.S. food and beverage sales at owned and managed units, a non-GAAP financial measure, opened for at least a full 24-months. This measure includes total revenue from our owned and managed locations. The Company monitors sales growth at its established restaurant base in addition to growth that results from restaurant acquisitions and new restaurant openings. Refer to the reconciliation of GAAP revenue to total food and beverage sales at owned and managed units in this press release.
**We define Adjusted EBITDA as net income (loss) before interest expense, provision for income taxes, depreciation and amortization, stock-based compensation, transition and integration expenses, loss on impairment of non-current assets, lease termination and exit expenses, transaction and exit costs, loss on early debt extinguishment, non-cash rent and the Adjusted EBITDA attributable to the closed Grill Concepts restaurants. Adjusted EBITDA has been presented in this press release and is a supplemental measure of financial performance that is not required by, or presented in accordance with, GAAP. Refer to the reconciliation of Net income (loss) to Adjusted EBITDA in this press release.
*** We define Restaurant Operating Profit as owned restaurant net revenue minus owned restaurant cost of sales and owned restaurant operating expenses. Restaurant Operating Profit has been presented in this press release and is a supplemental measure of financial performance that is not required by, or presented in accordance with, GAAP. Refer to the reconciliation of operating income to Restaurant Operating Profit in this press release.
**** We define Adjusted Operating Income as operating income (loss) before transition and integration expenses, loss on impairment of non-current assets, lease termination and exit expenses and transaction and exit costs. Not all the aforementioned items defining Adjusted Operating Income occur in each reporting period but have been included in our definitions of terms based on our historical activity. Adjusted Operating Income has been presented in this press release and is a supplemental measure of financial performance that is not required by, or presented in accordance with, GAAP. Refer to the reconciliation of operating income to Adjusted Operating Income in this press release.
Cautionary Statement on Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to 2025 results, the impact of the Benihana Inc. acquisition, portfolio optimization, restaurant openings and 2026 financial targets. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) our ability to integrate the new or acquired restaurants into our operations without disruptions to operations; (2) our ability to capture anticipated synergies; (3) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain employees; (4) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (5) our ability to successfully improve performance and cost, realize the benefits of our marketing efforts and achieve improved results as we focus on developing new management and license deals; (6) changes in applicable laws or regulations; (7) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (8) the impact of actual and potential changes in immigration policies, including potential labor shortages; (9) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; (10) risks related to our development and franchise partners; (11) risks related to geopolitical events; and (12) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.
Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group Hospitality, Inc. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
Joint Team Continues to Progress Towards Completing an Integrated Uncrewed Collaborative Combat Aircraft (UCCA) System for the German Air Force
SAN DIEGO, March 13, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, and its partner Airbus announced today that the joint team continues to take steps towards completing an integrated Uncrewed Collaborative Combat Aircraft (UCCA) offering for the German Air Force and towards a maiden flight with a sovereign European mission system, the Multiplatform Autonomous Reconfigurable and Secure (MARS) system.
The two companies are bringing their respective industry-leading capabilities to integrate, missionize, and ultimately produce and deliver the Airbus UCCA System and are scheduled to fly later this year.
“By combining the Kratos Valkyrie with our MARS mission system, we are offering the German customer exactly what Germany and Europe urgently need in the current geopolitical situation: a proven flying uncrewed combat aircraft with a sovereign European mission system that does not have to be developed from scratch in a time-consuming and costly manner”, said Marco Gumbrecht, Head of Key Account Germany at Airbus Defence and Space. “Our objective is to deliver credible combat capability in time of relevance, while assuring key sovereign aspects. And we are confident that we can do this at a very affordable price – which is a key driver for UCCAs.”
Steve Fendley, President of Kratos Unmanned Systems Division, said, “We could not be more excited about the opportunity, the capability we’re providing, and the teaming relationship with Airbus. By taking the flight-proven and in-production Valkyrie and integrating the Airbus MARS mission system, the Airbus-missionized Valkyrie UCCA is a multi-mission, affordable system that can operate independently, in teams of UAS, or in Manned-Unmanned-Teaming operations. Along with the technical and production backing Airbus and Kratos bring, we are realizing an optimal capability system that can be bought and deployed as ‘affordable mass’; the consistent discriminator identified in today’s peer to peer wargames.”
The Kratos Valkyrie is a high-performance, runway-flexible tactical unmanned aerial vehicle capable of long-range flights at high-subsonic speeds. Combining affordability, survivability, long-range, high-subsonic speeds, maneuverability and ability to carry flexible mission kit configurations and mix of lethal weapons from its internal weapons bay and wing stations, the Valkyrie provides unmatched operational flexibility at an affordable price for both Department of War (DoW) and international customers.
With a length of 9.1 m, a wingspan of 8.2 m, range of over 5,000 kilometres, maximum take-off weight (MTOW) of around three tons, the Valkyrie can fly at an altitude of up to 45,000 feet. The maiden flight of the Valkyrie already took place in the USA in 2019; and additional aircraft have been flying regularly since that time. The maiden flight of the Airbus variant is scheduled for 2026.
Fully autonomous or commanded by a Eurofighter, the Valkyrie is designed to be able to take on sensitive mission tasks that would pose too great a danger to the pilot. The UCCA can service kinetic and non-kinetic mission sets in several roles. For the German customer, Airbus and Kratos are initially focusing on a specific role to deliver credible combat air power on time and on target.
In Manching, Germany, Airbus is currently preparing two Kratos Valkyries for their first flight with its European mission system.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a global leader in providing augmented reality (“AR”) and artificial intelligence (“AI”) Software-as-a-Service (“SaaS”) solutions to beauty and fashion industries, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2025. The annual report can be accessed under the SEC Filing section on the Company’s investor relations website at https://ir.perfectcorp.com.
The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to 14F, No. 98 Minquan Road, Xindian District, New Taipei City 231, Taiwan, or via email at [email protected].
About Perfect Corp.
Perfect Corp. (NYSE: PERF) leverages ‘Beautiful AI’ innovations to make our world more beautiful. As a pioneer and leader in the space, Perfect Corp. works with over 650 partners around the globe to empower brands to embrace the digital-first world by transforming shopping journeys through digital tech innovations. Perfect Corp.’s suite of enterprise solutions delivers synergistic, technology-driven experiences that facilitate sustainable, ultra-personalized, and engaging shopping journeys through hyper-realistic virtual try-ons, AI-powered skin analyses, personalized product recommendation tools and many more Beautiful AI innovations. For more information, visit https://ir.perfectcorp.com.
TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200
Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance
Completed $20.0 million registered direct offering with Point72 on December 29, 2025
Approximately $207.6 million in cash and cash equivalents as of December 31, 2025
BERKELEY HEIGHTS, N.J., March 12, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent operational highlights.
“2025 was transformational for Tonix as we achieved FDA approval and began the U.S. commercial launch of TONMYA, our first fully in-house developed product and the first new medicine approved for fibromyalgia in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for long-term, once-daily bedtime dosing. We believe TONMYA now provides an alternative medicine for the approximately 10 million adults in the U.S. who suffer from fibromyalgia. We have the capabilities to engage healthcare providers and patients, having launched the product and an approximately 90-member salesforce. Early prescription trends reflect favorable prescriber uptake and repeat utilization consistent with our internal launch expectations. Our experienced commercial team is committed to growing awareness and adoption, facilitating patient access, and obtaining payer coverage as we strive to improve the fibromyalgia journey for patients and healthcare providers.”
Dr. Lederman continued, “We also meaningfully advanced our robust clinical pipeline in 2025. Tonix in-licensed TNX-4800, a long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, for which there are no FDA-approved vaccines or prophylactics. This program, developed by researchers at UMass Chan Medical School, anchors our clinical-stage infectious disease pipeline, and we plan to discuss Phase 2/3 development with the FDA this year. An additional highlight includes FDA clearance of the Investigational New Drug application (IND) for HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in major depressive disorder, which is expected to initiate enrollment in mid-2026. Looking ahead, our priorities are clear. We are driven to continue our momentum in 2026 as we focus on the successful commercialization of TONMYA, pipeline progress, and sustainable long-term value for patients and shareholders.”
Commercial Updates
TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults
In August 2025, the U.S. FDA approved TONMYA for the treatment of fibromyalgia in adults, making it the first new prescription medicine approved for this indication in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical trials of nearly 1,000 patients that demonstrated statistically significant reduction in daily pain scores compared to placebo.
On November 17, 2025, TONMYA became commercially available at pharmacies by prescription in the U.S. Approximately 90 sales representatives were deployed in the field in advance of the launch. Early prescription trends reflect favorable adoption rates by prescribers and patients, with prescription volumes increasing each full month post launch. Launch metrics for the period November 17, 2025–February 27, 2026 (launch-to-date), are as follows:
More than 1,500 healthcare providers have prescribed TONMYA to patients.
Approximately 2,500 patients have initiated treatment with TONMYA.
Cumulative prescriptions totaled approximately 4,200. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
The Company has contracted with existing wholesalers and specialty pharmacies for distribution and with companies to assist with prescription fulfillment and patient access. Tonix also has a robust patient access program and support services in place, including TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization.
The Company is prioritizing expanding payer engagement and establishing contracts with commercial payers, while also progressing discussions with Medicare and Medicaid.
Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease, which has no FDA-approved vaccines or prophylactics
In December 2025, Tonix announced plans to meet with the FDA in 2026 to explore Phase 2/3 development options, including a Phase 2 field study and a Phase 2 controlled human infection model (CHIM) study, which is also called a human challenge study. The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, the field study is expected to initiate enrollment in 2027 and the CHIM study in 2028.
Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in development for major depressive disorder (MDD)
In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 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, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026.
Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms. TNX-102 SL treatment has been associated with a low incidence of side effects common with traditional antidepressants, including weight gain, blood pressure changes, sexual dysfunction, and cognitive issues.
TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of PTSD
The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial is being conducted by the University of North Carolina under an investigator-initiated IND application. The OASIS trial examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026.
Immunology Pipeline TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody): third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders
In November 2025, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated clinical trial of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026 pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients.
In October 2025, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and pharmacokinetic and pharmacodynamic results and outlining next steps toward Phase 2 evaluation in allogenic kidney transplantation.
Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval
In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027.
Financial: Recent Highlights
Tonix had approximately $207.6 million of cash and cash equivalents as of December 31, 2025, compared to approximately $98.8 million as of December 31, 2024. Net cash used in operations was approximately $99.8 million for the full year ended December 31, 2025, compared to $60.9 million for the same period in 2024. Cash paid for capital expenditures for the full year ended December 31, 2025, were approximately $3.4 million compared to $0.1 million for the same period in 2024.
In December 2025, Tonix completed a $20.0 million registered direct offering with Point72 Asset Management. The net proceeds are being used to fund commercialization of marketed products, pipeline development, and general working capital. TD Cowen acted as sole placement agent for the offering. A.G.P./Alliance Global Partners acted as a financial advisor.
Subsequent to year-end, the Company has raised $8.6 million proceeds using its at-the-market (ATM) facility.
The Company believes that its cash resources at December 31, 2025, will meet its planned operating and capital expenditure requirements into the first quarter of 2027.
As of March 11, 2026, the Company had 13,405,401 shares of common stock outstanding.
Full Year 2025 Financial Results
Net product revenue for the full year 2025 was approximately $13.1 million, compared to $10.1 million in 2024. Net revenue from sales of Zembrace®, SymTouch®, and Tosymra® for the full year 2025 was approximately $11.7 million, compared to $10.1 million in 2024. Net revenue from sales of TONMYA for the period from launch on November 17, 2025, to December 31, 2025, was approximately $1.4 million. Cost of sales for the full year 2025 was approximately $6.6 million, compared to $7.8 million in 2024.
Research and development expenses for the full year 2025 were approximately $44.5 million, compared to $40.0 million in 2024. This increase is predominately due to pipeline prioritization period over period, and increased headcount.
Selling, general, and administrative expenses for the full year 2025 were $87.7 million, compared to $40.1 million in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA as well as increased headcount.
Net loss available to common stockholders was approximately $124.0 million, or $14.57 per basic and diluted share, for the full year 2025, compared to net loss available to common stockholders of $130.0 million, or $176.60 per basic and diluted share, in 2024. The basic and diluted weighted average common shares outstanding for the full year 2025 was 8,511,318 compared to 736,339 shares for 2024.
Fourth Quarter 2025 Financial Results
Net product revenue for the fourth quarter 2025 was approximately $5.4 million, compared to $2.6 million for the same period in 2024, and consisted of combined net sales of TONMYA™, Zembrace® SymTouch®, and Tosymra®. Cost of sales for the fourth quarter 2025 was approximately $1.1 million, compared to $1.2 million for the same period in 2024.
Research and development expenses for the fourth quarter 2025 were approximately $16.9 million, compared to $8.3 million for the same period in 2024. This increase is predominately due to pipeline prioritization period over period and increased headcount.
Selling, general, and administrative expenses for the fourth quarter 2025 were $35.7 million, compared to $15.6 million for the same period in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA and increased headcount.
Net loss available to common stockholders was $46.9 million, or $3.98 per basic and diluted share, for the fourth quarter 2025, compared to net loss available to common stockholders of $22.1 million, or $9.77 per basic and diluted share, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the fourth quarter 2025 was 11,798,945 compared to 2,263,535 shares for the same period in 2024.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYATM (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the Company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
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