CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer respond to CPIs or chemotherapy.
This is a segment that existing therapies leave behind. And it is the segment where we believe that ateganosine, developed by MAIA, may soon become one of the most consequential entrants in years.
A Market Dominated by Checkpoint Inhibitors—But Vulnerable at Its Edges
CPI therapies remain the backbone of NSCLC treatment in patients who don’t have an actionable mutation. Collectively, the category generated approximately $50 billion in global sales in 2024, anchored by five major agents approved for NSCLC. The therapeutic concentration in lung cancer is striking:
>30% of all NSCLC drug sales come from CPIs
>40% of all CPI global sales originate from NSCLC alone
Merck’s Keytruda, the category-defining CPI, reported $29.5 billion in revenue in 2024, with NSCLC representing an estimated 30% of its total sales. Keytruda is expected to approach $35 billion by 2027—just before biosimilars begin entering the market in 2028.
While CPIs have transformed outcomes for some patients, in our opinion their limitations remain clear: patients without actionable mutations, and those who become CPI-refractory, still experience extremely poor prognosis and limited therapeutic benefit. We believe this treatment gap has become one of the industry’s largest unmet needs.
Telomere-Targeting: A New Pathway for a Hard-to-Treat Population
We believe that MAIA’s ateganosine represents the first drug in a new class. Unlike targeted therapies requiring EGFR, ALK, KRAS, or other mutations—and unlike immunotherapies dependent on PD-1/PD-L1 dynamics—ateganosine has been designed to exploit a universal feature of cancer cells: telomerase activity, present in more than 80% of human tumors.
Its dual mechanism has been designed to disrupt telomeres to trigger direct cancer cell death while simultaneously enabling the immune system to respond to cancer. MAIA was recently awarded Fast Track Designation by the U.S. FDA for the treatment of NSCLC in patients resistant to immunotherapy and chemotherapy, and is initiating a Phase 3 THIO-104 trial.
A Commercial Opportunity That Extends Across Oncology
With the NSCLC market now valued at $34.1 billion—projected to nearly double to $68.8 billion by 2033—the implications of a first-in-class therapy are substantial. In the United States alone, roughly 180,000 patients enter the NSCLC treatment ecosystem every year.
But ateganosine’s opportunity does not end with lung cancer. The candidate already carries FDA Orphan Drug Designations (ODDs) for:
Small cell lung cancer (SCLC) (mortality: 0.3M; sales: $2.8B)
Each ODD offers seven years of U.S. market exclusivity upon regulatory FDA approval and access to tax credits—advantages that strengthen MAIA’s long-term market positioning.
A Strategic Inflection Point for the Entire NSCLC Treatment Landscape
The oncology market is poised for a shift as developers seek to fill in gaps in the treatment landscape. The next decade is expected to reward novel mechanisms, and in our opinioin advanced NSCLC represents the clearest example of that gap.
Telomere-targeting therapeutics may be the next foundation in that evolution. If ateganosine’s outcomes are successful, the therapy could become a defining entrant in a space where treatment failure has long been accepted as inevitable. Statistical assessments points to a high probability of technical success for regulatory approval of ateganosine.
In our opinion, MAIA is now positioned at the center of this turning point—scientifically and strategically.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Newly Appointed Members Include Leaders in Vaccine Immunology, T-Cell Science, and Clinical Research
Atlanta, GA -December 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancers, today announced an update to its Scientific Advisory Board (SAB), welcoming internationally recognized experts whose work spans vaccine design, T-cell immunology, viral pathogenesis, and immunocompromised-host medicine.
This strategic expansion is designed to support GeoVax’s current and future development efforts with MVA and its multi-antigen MVA vector platform for vaccines targeting biothreat pathogens and vulnerable or currently underserved populations such as those from low- and middle-income countries, and immunocompromised patients. Future additions to the GeoVax SAB will support its oncology immunotherapy pipeline.
Newly Announced SAB Members
Joining Prof. Teresa Lambe, PhD, OBE, FMedSci – Calleva Head of Vaccine Immunology, Oxford Vaccine Group / Jenner Institute, University of Oxford, whose appointment to the GeoVax SAB was previously announced, are the following:
Dr. Alessandro Sette, Dr of Biological Sciences – Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology
An authority in T-cell epitope mapping and immune correlates of protection, Dr. Sette leads the NIH Immune Epitope Database (IEDB) and is widely recognized by defining T-cell immunity across SARS-CoV-2, Mpox, and Ebola.
Prof. Lance Turtle, PhD, MBBS, FRCP, DTMH – Chair in Immunity and Infectious Diseases, University of Liverpool / Royal Liverpool Hospital
A clinician-scientist specializing in viral pathogenesis and post-infection immune recovery, Prof. Turtle’s research provides key translational insights into long-term immunity and emerging pathogen preparedness.
Prof. Thushan I. de Silva, MBBS, PhD, MRCP – Professor of Infectious Diseases and Immunology, University of Sheffield
An expert in human viral immunology, vaccine responses, and global immunosurveillance, Prof. de Silva leads studies across Europe, Asia, and Africa evaluating population-level vaccine immunity and viral evolution.
Dr. Joshua A. Hill, MD, FIDSA – Associate Professor, University of Washington School of Medicine / Fred Hutchinson Cancer Center
A leading infectious-disease expert focusing on vaccine response in immunocompromised and transplant patients, Dr. Hill’s work aligns with GeoVax’s emphasis on protecting high-risk, under-served populations.
David Dodd, GeoVax Chairman & CEO, commented: “By assembling this exceptional team of global experts, we are further strengthening GeoVax’s position at the forefront of vaccine innovation. Their combined experience – from antigen design to human immunology and clinical translation – perfectly aligns with our mission to deliver durable, broad-spectrum protection to both global and immunocompromised populations.”
Dr. Kelly McKee, Chief Medical Officer, added: “The addition of these renowned experts ensures that our clinical strategy is guided by cutting-edge immunology insight and global research expertise. Their collaboration will be instrumental as GeoVax advances vaccines and immunotherapies designed to protect those who remain most vulnerable – particularly those in low and middle income countries (LMICs), and immunocompromised patients who have been underserved by traditional approaches or currently available vaccines”
Dr. Mark Newman, Chief Scientific Officer, stated: “This expanded SAB strengthens multiple aspects of our R&D platform. With direct input from some of the world’s most respected scientific leaders, we can ensure that our vaccine and immunotherapy candidates deliver real-world impact.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
MustGrow Reports Significant U.S. Potato Yield and Economic Performance in Large Scale Field Trials Utilizing TerraSanteTM
Mustard-derived organic TerraSanteTM focuses on crop yields, soil and soil microbiome health, and nutrient/water use efficiencies;
Large scale field trial showed 2 ton per acre yield increase with larger size potatoes and less culls equating to approximately US$5,000 increase in value per acre; and
Significant soil health benefit when applied in combination with the current grower standard program.
SASKATOON, Saskatchewan, Canada, December 10, 2025 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow“), a leading provider of biological and regenerative agriculture solutions, is pleased to announce outstanding performance metrics on its organic TerraSanteTM biofertility product applied to potato farming acres in Washington State and Idaho, based on customer performance data.
In its use by a Washington State farming customer, TerraSanteTM demonstrated a consistent and substantial potato yield, size, and quality increase at a dose rate of 11 lbs/acre. This customer performance data was generated on a large-scale commercial potato field. With the increase in size, quality and yield, the farmer estimated an approximate US$5,000 increase in value per acre at a cost of only US$180 per acre for TerraSanteTM. Work done in fields in Idaho has also shown significant benefits to the soil and health of the potato crops when used within a currently established grower production program.
These large-scale field trial results are consistent with small plot results that MustGrow has completed in the U.S. with TerraSanteTM, as outlined in the following table: The following figures illustrate TerraSanteTM ‘wet-able’ powder being mixed into liquid format and applied through typical spray equipment.
MustGrow’s mustard-derived TerraSanteTM organic biofertilizer is a soluble mixable form containing nutritious plant proteins and carbohydrates that feed the soil and soil microbes. TerraSanteTM is currently registered and approved for sale in California, Florida, Arizona, Idaho, Oregon, and Washington State, under Organic OMRI Listed® certification and California’s Organic Input Material (OIM) Program.
In 2024, the United States Department of Agriculture (USDA) reported 927,000 potato acres harvested for US$4.6 billion of value sold.(1)
TerraSanteTM for Soil and Ecological Health
MustGrow’s biofertility program focuses on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being applied with the intention to improve not only the health of the soil, but also the surrounding ecological environment.
TerraSanteTM, an organic biofertilizer in soluble mixable form, contains nutritious plant proteins and carbohydrates that feed the soil and soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.
MustGrow Biologics Corp. is a fully integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 110 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 69.1 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow’s Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements in this news release, including statements about: the impact and significance of customer performance data and field testing, the increase in value of yields and the costs of such increase in value, if any, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
Neither the TSX Venture Exchange, nor their Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
Toronto, Ontario–(Newsfile Corp. – December 10, 2025) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) is pleased to announce it has been granted three new exploration licenses for polymetallic metals including gold, in the Brittany Peninsula of northwestern France through a wholly-owned French subsidiary of the Company.
President and CEO, Dr. Keith Barron commented, “The French government’s decision to grant us these permits is an excellent opportunity for Brittany and the Pays de la Loire to gain a deeper understanding of their subsurface resources and for France to find new sources of metals to secure the country’s supplies through exploration to be conducted by Company. It also marks a new opportunity for Aurania in a jurisdiction where institutional stability and high-quality infrastructure make exploration safe and more efficient than other areas in the world. The initial mining inventory studies conducted by the French Geological Survey (BRGM) confirmed the presence of gold associated with strategic metals over more than 150 km along the shear zone, and in some cases at exceptional grades. This demonstrates the strength of the hydrothermal activity that occurred in the region.”
Aurania announced the filing of an exploration permit named Epona back in 2023 (see press release dated July 24, 2023). Subsequently, in October 2023, the Company submitted two additional applications, Taranis and Bélénos, covering areas of 359.5 km² and 440.9 km² respectively. These areas are located in southern Brittany and northern Pays de la Loire in France (see map in Figure 1 below).
Since antiquity, Brittany has been an important producer of metals in Europe – supplying tin and gold to the Roman Empire, then base metals and silver during the Middle Ages, and later tin, antimony, and uranium during the Industrial Revolution. Despite this long history, no exploration has been conducted in the region since the 1980s, leaving its significant potential largely unexplored. With more than four decades of advances in exploration technologies, the application of modern exploration techniques potentially positions the Brittany Peninsula as a highly prospective area that can be considered a greenfield district.
The purpose of these permits is to explore the South Armorican Shear Zone, a major crustal fault where mineralization of antimony, tungsten, tin, zinc, and copper – accompanied by gold – and other metals have been deposited as indicated by the BRGM.
Figure 1: Location of Aurania’s permits in France.
With geology comparable to the Iberian Peninsula, the Bohemian Massif, Newfoundland and other Variscan terranes, the Armorican Massif stands out as a possible candidate to help meet Europe’s growing demand for strategic metals in a market environment largely dominated by China. The European Union launched the European Critical Raw Materials Act, a plan that aims to secure 10% of its metal supply from within Europe by 2030. Support for the mining industry was first expressed by the French government in 2022 after receiving the Varin Report and was later reinforced through the launch of a new national mineral inventory1. The areas selected by Aurania align with this plan, and show strong potential for strategic metals such as antimony, tungsten, and tin, as well as zinc and silver, with by-products of indium (see Figure 2).1
Figure 2: Geology of the permit areas and main commodities.
An advantage of the Armorican Massif is its potential richness in gold associated with the aforementioned metals, which enhances the likelihood of an economic discovery. In this respect, the area can be compared to the district currently being explored by New Found Gold in Newfoundland, Canada, where a similar dispersion of gold is observed along a shear zone within a comparable Cambrian to Ordovician geological environment.
Figure 3: Comparison on the same scale between the geology and gold showings at the Queensway permit (New Found Gold) located in Canada and the area of Aurania’s permits in France (modified from the map published in the 43-101 report, January 2023 Exploration Update: New Found Gold Corp.’s Queensway Gold Project, NL, Figure 7.17).
Aurania will proceed with stakeholder engagement, including outreach and dialogue with local landowners, while advancing preparations for an airborne geophysical survey and subsequent field activities.
Qualified Person
The geological information contained in this news release has been verified and approved by Jean-Paul Pallier, MSc., Vice-President Exploration of the Company. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.
About Aurania
Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and critical energy in Europe.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes that the Company’s exploration activities may be an excellent opportunity for Brittany and the Pays de la Loire to gain a deeper understanding of their subsurface resources, the purpose of obtaining the permits being to explore the South Armorican Shear Zone, that the Armorican Massif stands out as a possible candidate to help meet Europe’s growing demand for strategic metals, that an advantage of the Armorican Massif is its potential richness in gold associated with the aforementioned metals, which enhances the likelihood of an economic discovery, the Company’s next steps with respect to the permits and exploration activities conducted thereof, Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the tonnage and grade of mineralization which has the potential for economic extraction and processing, the merits and effectiveness of known process and recovery methods, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: failure to identify mineral resources; failure to convert estimated mineral resources to reserves; the inability to complete a feasibility study which recommends a production decision; the preliminary nature of metallurgical test results; the inability to recover and process mineralization using known mining methods; the presence of deleterious mineralization or the inability to process mineralization in an environmentally acceptable manner; commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.
1 In September 2023, President Emmanuel Macron announced the launch of a major update to France’s national mineral inventory, known as the Inventaire des Ressources Minérales (IRM). This initiative was designed to identify subsurface areas with potential mineral resources, reduce import dependence, and support re-industrialization efforts. The inventory is being led by the French Geological Survey (BRGM) and aligns with the EU’s Critical Raw Materials Act. https://www.brgm.fr/en/news/feature-article/mineral-resources-inventory-answers-questions-faq
NEW YORK–(BUSINESS WIRE)– Vince Holding Corp. (Nasdaq: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, today reported its financial results for the third quarter ended November 1, 2025.
Brendan Hoffman, Chief Executive Officer of VNCE said, “We are extremely proud of our third quarter performance, delivering healthy sales growth across all channels while exceeding expectations for both top and bottom line results. Our direct-to-consumer segment is showing broad-based strength benefiting from enhancements we have made to the customer experience. This includes the store renovations from earlier this year, as well as an e-commerce site refresh, increased marketing support, and the launch of drop-ship capabilities expanding the breadth and depth of our assortment online in the third quarter. This momentum has continued into the fourth quarter with a record holiday sales weekend in direct-to-consumer. As we look ahead, I’m more confident than ever in our trajectory as we successfully balance disciplined execution with strategic reinvestment to position the Vince Holding Corp. platform for sustained long-term profitable growth.”
In this press release, the Company is presenting its financial results in conformity with U.S. generally accepted accounting principles (“GAAP”) as well as on an “adjusted” basis. Adjusted results presented in this press release are non-GAAP financial measures. See “Non-GAAP Financial Measures” below for more information about the Company’s use of non-GAAP financial measures and Exhibit 3 and Exhibit 4 to this press release for a reconciliation of GAAP measures to such non-GAAP measures.
For the third quarter ended November 1, 2025:
Total Company net sales increased 6.2% to $85.1 million compared to $80.2 million in the third quarter of fiscal 2024. The year-over-year increase was driven by a 6.7% increase in the wholesale segment and a 5.5% increase in direct-to-consumer segment.
Gross profit was $41.9 million, or 49.2% of net sales, compared to gross profit of $40.1 million, or 50.0% of net sales, in the third quarter of fiscal 2024. The decrease in gross margin rate was primarily driven by approximately 260 basis points due to the unfavorable impact of higher tariffs and approximately 100 basis points due to increased freight costs, partially offset by a 140 basis points increase due to the favorable impact of lower product costing and higher pricing, and approximately 110 basis points due to the favorable impact of lower discounting.
Selling, general, and administrative expenses were $36.5 million, or 42.8% of sales, compared to $34.3 million, or 42.8% of sales, in the third quarter of fiscal 2024. The increase in SG&A dollars was primarily driven by compensation and benefits and marketing and advertising costs.
Income from operations was $5.4 million compared to income from operations of $5.8 million in the same period last year.
Income tax expense was $2.0 million compared to an income tax expense of $0 in the same period last year. The increase is due to the impact of applying the Company’s estimated annual effective tax rate to the year-to-date ordinary pre-tax income. In the prior comparative period, the Company had year-to-date ordinary pre-tax losses for the interim period and as such, the Company did not record any tax expense.
Net income was $2.7 million or $0.21 per diluted share compared to net income of $4.3 million or $0.34 per diluted share in the same period last year.
Adjusted EBITDA* was $6.5 million compared to $7.4 million in the same period last year.
The Company ended the quarter with 60 company-operated Vince stores, a net decrease of 1 store since the third quarter of fiscal 2024.
Third Quarter Review
Net sales increased 6.2% to $85.1 million as compared to the third quarter of fiscal 2024.
Wholesale segment sales increased 6.7% to $52.0 million compared to the third quarter of fiscal 2024.
Direct-to-consumer segment sales increased 5.5% to $33.1 million compared to the third quarter of fiscal 2024.
Income from operations excluding unallocated corporate expenses was $19.6 million compared to income from operations of $18.8 million in the same period last year.
Balance Sheet
At the end of the third quarter of fiscal 2025, total borrowings under the Company’s debt agreements totaled $36.1 million and the Company had $47.3 million of excess availability under its revolving credit facility.
Net inventory at the end of the third quarter of fiscal 2025 was $75.9 million compared to $63.8 million at the end of the third quarter of fiscal 2024. The year-over-year increase in inventory includes approximately $4.2 million of higher inventory carrying value due to tariffs.
During the quarter ended November 1, 2025, the Company issued and sold 370,878 shares of common stock under the Virtu At-the-Market Offering for aggregate net proceeds of $1,291 at an average price of $3.55 per share. The Company continues to have shares available under the program to exercise with proceeds to be used as sources, along with cash from operations, to fund future growth.
Outlook
For the fourth quarter of fiscal 2025 the Company expects the following:
Net sales to increase approximately 3% to 7% compared to the prior year period.
Adjusted operating income as a percentage of net sales to be approximately 0% to 2%.
Adjusted EBITDA as a percentage of net sales to be approximately 2% to 4%.
For fiscal 2025 the Company expects the following:
Net sales to increase approximately 2% to 3% compared to the prior year.
Adjusted operating income as a percentage of net sales to be approximately 2% to 3%.
Adjusted EBITDA as a percentage of net sales to be approximately 4% to 5%.
The above guidance for the fourth quarter of fiscal 2025 assumes $4 million to $5 million in expected incremental tariff costs, of which the Company expects to continue to partially offset through its mitigation strategies.
Strategic Partnership with Authentic Brands Group
On May 25, 2023, the Company announced that it completed the previously announced transaction (the “Authentic Transaction”) with Authentic Brands Group (“Authentic”).
In connection with the Authentic Transaction, VNCE entered into an exclusive, long-term license agreement (the “License Agreement”) with Authentic for usage of the contributed intellectual property for VNCE’s existing business in a manner consistent with the Company’s current wholesale, retail and e-commerce operations. The License Agreement contains an initial ten-year term and eight ten-year renewal options allowing VNCE to renew the agreement.
*Non-GAAP Financial Measures
In addition to reporting financial results in accordance with GAAP, the Company has provided, with respect to the financial results relating to the three and nine months ended November 1, 2025 and November 2, 2024, adjusted EBITDA, which is a non-GAAP measure. Adjusted EBITDA is calculated as earnings before interest, taxes, depreciation and amortization, share-based compensation, capitalized cloud computing amortization, ERC benefit, and gain on sale of Rebecca Taylor, Inc. and its wholly owned subsidiary (“Gain on Sale of Subsidiary”). For the three and nine months ended November 1, 2025 and November 2, 2024, respectively, the Company has provided adjusted income from operations, adjusted income (loss) before income taxes and equity in net income of equity method investment, adjusted income before equity in net income of equity method investment, adjusted net income, and adjusted earnings per share, which are non-GAAP measures, in order to eliminate the effect of the ERC benefit, Discrete Tax Effect Associated with ERC benefit, and Gain on Sale of Subsidiary.
The Company believes that the presentation of these non-GAAP measures facilitates an understanding of the Company’s continuing operations without the impact associated with the aforementioned items. While these types of events can and do recur periodically, they are excluded from the indicated financial information due to their impact on the comparability of earnings across periods. Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. A reconciliation of GAAP to non-GAAP results has been provided in Exhibit 3 and Exhibit 4 to this press release.
Conference Call
A conference call to discuss the third quarter results will be held today, December 9, 2025, at 8:30 a.m. ET, hosted by Vince Holding Corp. Chief Executive Officer, Brendan Hoffman, and Chief Financial Officer, Yuji Okumura. During the conference call, the Company may make comments concerning business and financial developments, trends and other business or financial matters. The Company’s comments, as well as other matters discussed during the conference call, may contain or constitute information that has not been previously disclosed.
Those who wish to participate in the call may do so by dialing (833) 470-1428, conference ID 579552. Any interested party will also have the opportunity to access the call via the Internet at http://investors.vince.com/. To listen to the live call, please go to the website at least 15 minutes early to register and download any necessary audio software. For those who cannot listen to the live broadcast, a recording will be available for 12 months after the date of the event. Recordings may be accessed at http://investors.vince.com.
ABOUT VINCE HOLDING CORP.
Vince Holding Corp. is a global retail company that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 46 full-price retail stores, 14 outlet stores, and its e-commerce site, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.
Forward-Looking Statements: This document, and any statements incorporated by reference herein contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include the statements under “Outlook” above as well as statements regarding, among other things, our current expectations about possible or assumed future results of operations of the Company and are indicated by words or phrases such as “may,” “will,” “should,” “believe,” “expect,” “seek,” “anticipate,” “intend,” “estimate,” “plan,” “target,” “project,” “forecast,” “envision” and other similar phrases. Although we believe the assumptions and expectations reflected in these forward-looking statements are reasonable, these assumptions and expectations may not prove to be correct and we may not achieve the results or benefits anticipated. These forward-looking statements are not guarantees of actual results, and our actual results may differ materially from those suggested in the forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, including, without limitation: changes to and unpredictability in the trade policies and tariffs imposed by the U.S. and the governments of other nations; our ability to maintain adequate cash flow from operations or availability under our revolving credit facility to meet our liquidity needs; general economic conditions; restrictions on our operations under our credit facilities; our ability to improve our profitability; our ability to maintain our larger wholesale partners; our ability to accurately forecast customer demand for our products; our ability to maintain the license agreement with ABG Vince, a subsidiary of Authentic Brands Group; ABG Vince’s expansion of the Vince brand into other categories and territories; ABG Vince’s approval rights and other actions; our ability to realize the benefits of our strategic initiatives; the execution of our customer strategy; our ability to make lease payments when due; our ability to open retail stores under favorable lease terms and operate and maintain new and existing retail stores successfully; our operating experience and brand recognition in international markets; our ability to remediate the identified material weakness in our internal control over financial reporting; our ability to comply with domestic and international laws, regulations and orders; increased scrutiny regarding our approach to sustainability matters and environmental, social and governance practices; competition in the apparel and fashion industry; the transition associated with the appointment of new chief executive officer and new chief financial officer; our ability to attract and retain key personnel; seasonal and quarterly variations in our revenue and income; the protection and enforcement of intellectual property rights relating to the Vince brand; our ability to successfully conclude remaining matters following the wind down of the Rebecca Taylor business; the extent of our foreign sourcing; our reliance on independent manufacturers; our ability to ensure the proper operation of the distribution facilities by third-party logistics providers; fluctuations in the price, availability and quality of raw materials; the ethical business and compliance practices of our independent manufacturers; our ability to mitigate system or data security issues, such as cyber or malware attacks, as well as other major system failures; our ability to adopt, optimize and improve our information technology systems, processes and functions; our ability to comply with privacy-related obligations; our status as a “controlled company”; our status as a “smaller reporting company”; and other factors as set forth from time to time in our Securities and Exchange Commission filings, including those described under “Item 1A—Risk Factors” in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We intend these forward-looking statements to speak only as of the time of this release and do not undertake to update or revise them as more information becomes available, except as required by law.
Patent Protects Novel Application of Gedeptin Therapy Across Multiple Solid Tumor Types; Supports Expansion of Gedeptin Product Platform
ATLANTA, GA – December 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against cancers and infectious diseases, today announced the issuance of U.S. Patent No. 12,453,760, titled “Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug”, by the United States Patent and Trademark Office (USPTO). The patent provides composition-of-matter and method-of-use protection for GeoVax’s Gedeptin® platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer.
The newly issued patent, which extends through 2045, enhances the Company’s intellectual property estate for Gedeptin and its use across a range of solid tumor cancers — consolidating GeoVax’s leadership in the field of targeted gene therapies and supporting ongoing clinical development plans.
“The issuance of this patent marks an important milestone in the advancement and protection of GeoVax’s oncology pipeline,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors.”
The Company is actively preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda®) in resectable head and neck cancer, in line with the recent shift toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers.
About Gedeptin®
Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) designed for targeted use in solid tumors. Delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP) and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers.
GeoVax plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab (Keytruda®) as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating the role of immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors.
Key Advantages of Gedeptin
Localized, tumor-selective cytotoxicity
Tumor agnostic – expansion potential across multiple solid tumors
Synergistic potential with checkpoint inhibitors
Favorable safety profile and orphan drug designation
Strong patent protection through 2045
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry
CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions.
“Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Her deep background in complex transactions, public company matters, and governance will be a significant asset as we commercialize our marketed products, advance our pipeline, manage our partnerships, and continue to execute on Tonix’s long-term strategy.”
Ms. Ishak joins Tonix from Lowenstein Sandler LLP, where she served since 2013 as Senior Counsel, and has advised Tonix since 2017 in structuring and negotiating financings, licensing and other strategic transactions, key commercial agreements, and employment-related contracts, and advising senior management and the Board of Directors on corporate strategy, governance, risk, and securities offerings and filings. In addition to Tonix, Ms. Ishak acted as outside general counsel, corporate secretary, and advisor to certain other public and private life sciences companies, as well as to investors. Previously, she was Senior Director, Legal and Assistant Corporate Secretary at Savient Pharmaceuticals, Inc., which developed, won US Food and Drug Administration (FDA) approval for, and launched KRYSTEXXA® (pegloticase), a biologic treatment for chronic gout in adults. Earlier in her career Ms. Ishak was a corporate associate at Fried, Frank, Harris, Shriver & Jacobson LLP. She received her J.D. from New York University School of Law and her B.A., with highest honors, from Rutgers College in New Brunswick, N.J.
“I am honored to join Tonix as General Counsel at such a pivotal moment in the Company’s evolution,” said Ms. Ishak. “Tonix has just launched the first therapy approved by the FDA for treating fibromyalgia in more than 15 years. Now the company is maximizing that science to expand into other conditions. It’s an exciting time at Tonix and there is immense opportunity to make a valuable contribution. I look forward to working closely with Seth, the leadership team, and the Board to support the Company’s next phase of growth.”
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication under development.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
VIRGINIA CITY, NEVADA, December 9, 2025 — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) and Comstock Metals LLC (“Comstock Metals”), a leader in the responsible recycling of end-of-life solar panels with the only certified, North American, zero-landfill solution, announced today that Comstock Metals has been recognized for exceptional growth, innovation, workforce excellence, and community partnerships that strengthen and diversify the regional economy.
“Comstock has historic and genuine roots in the communities of northern Nevada, and we are honored with EDAWN’s recognition of our continued commitment to innovation, growth and sustainability in the region,” stated Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “Our team’s dedication to excellence, combined with our rapidly growing investments in the region’s workforce and community, reflects our longstanding belief in the tremendous potential of this area. This award affirms our mission to help build a sustainable and thriving future for northern Nevada.”
Comstock Metals was also honored to receive official recognition from U.S. Senator Catherine Cortez Masto, U.S. Senator Jacky Rosen, and Nevada Governor Joe Lombardo. Their acknowledgments celebrate Comstock Metals achievements, leadership, and ongoing commitment to the people and economy of northern Nevada. This recognition from the Nevada leadership further recognizes the positive impact of Comstock Metals’ continued investment, innovation, and public-private partnerships within all of the communities of northern Nevada.
“Comstock Metals has positioned itself in the absolute best Nevada locations, for serving the southwest region of the U.S., where tens and ultimately hundreds of millions of end-of-life solar panels will otherwise endanger our lands, water and community ecosystems,” stated Dr. Fortunato Villamagna, President of Comstock Metals. “Our solutions cleanly repurpose and reuse all of these materials and prevent these hazardous wastes from contaminating our communities.”
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.
Comstock Social Media Policy
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.
Phase 1/2 trial confirms safety with repeated dosing supporting further development in early-stage disease and combination treatment settings
ATLANTA, GA – December 8, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing novel immunotherapies and vaccines for solid tumor cancers and infectious diseases, today announced the publication of a peer-reviewed article in JCO Oncology Advances, the American Society of Clinical Oncology’s (ASCO) open-access journal.
The manuscript, titled “A Phase 1/2 Study of Intratumoral Ad/PNP (Gedeptin) with Fludarabine Phosphate in Subjects with Recurrent Head and Neck Cancer”, reports findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT), administered via intratumoral injection followed by systemic fludarabine.
Study Overview: Evaluating Repeated Dosing in a Highly Refractory Population
The Phase 1/2 trial enrolled patients with recurrent head and neck cancers who had exhausted all standard treatment options and had undergone a median of four prior lines of systemic therapy. Patients received therapy on a 28 day schedule, each consisting of intratumoral Gedeptin injections followed by intravenous fludarabine.
Key results from the publication include:
Acceptable safety profile with no new safety signals: Serious adverse events were uncommon and generally unrelated to treatment. No deaths were attributed to study therapy.
Clinical evidence of disease stability: Three of eight patients (37.5%) in this cohort of patients with end-stage disease achieved stable disease.
Successful tumor transduction and PNP transgene expression: Tumor biopsies confirmed uptake and expression of the therapeutic E. coli PNP transgene in all evaluable patients, supporting the mechanistic foundation of the Gedeptin platform.
Study results suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy (e.g., with immune checkpoint inhibitors) may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward.
J. Marc Pipas, MD, Executive Medical Director, Oncology of GeoVax, stated: “This publication reinforces the strong scientific rationale underpinning the Gedeptin platform. Even in a highly refractory patient population with extensive prior treatment, repeated intratumoral dosing of Gedeptin demonstrated a favorable safety profile and evidence of disease stability. Importantly, correlative analyses confirmed robust tumor transduction and PNP expression, a critical mechanistic milestone for gene-directed enzyme prodrug therapy.”
Kelly T. McKee, MD, MPH, Chief Medical Officer of GeoVax, added: “These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit. This aligns with our strategy to advance Gedeptin into neoadjuvant studies for surgically resectable recurrent head and neck cancers.”
David Dodd, Chairman & CEO of GeoVax, stated: “The publication in the ASCO journal underscores both the scientific significance of this trial and the need for new approaches to treat recurrent head and neck cancers. Gedeptin’s targeted mechanism, combined with its repeat-dosing feasibility, offers a promising therapeutic option for patients. We look forward to expanding development into earlier disease settings and into rational combination regimens.”
About the Gedeptin® Platform
Gedeptin is a non-replicating adenoviral vector delivering the E. coli purine nucleoside phosphorylase (PNP) gene directly into tumor tissue. Following intratumoral injection, patients receive systemic fludarabine, which is converted in PNP-expressing tumor cells into a potent cytotoxic metabolite (2-fluoroadenine, F-Ade).
Key characteristics include:
Tumor-agnostic mechanism of action, driven by localized intratumoral activation of fludarabine into the potent cytotoxin F-Ade, enabling activity independent of tumor histology or proliferation rate.
Strong bystander effect, in which the activated F-Ade diffuses to neighboring cancer cells – allowing Gedeptin to kill tumor cells even when only a small fraction is directly transduced.
Immune-sensitizing properties that enhance tumor antigen visibility and may improve responses to immune checkpoint inhibitors.
Favorable safety profile, demonstrated across early Phase 1 and Phase 1/2 studies and supported by consistent tolerability in heavily pretreated solid tumor patients.
Gedeptin is now progressing toward combination-therapy in a neoadjuvant clinical program. Building on robust preclinical data showing that Gedeptin enhances tumor sensitivity to immune checkpoint blockade, GeoVax is advancing plans to evaluate Gedeptin with agents such as pembrolizumab aiming to strengthen antitumor immune activation.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumors. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received mRNA vaccines. In oncology, the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Seasoned Technology Executive to Drive AI, Digital Commerce, and Cybersecurity Innovation
JERICHO, N.Y., Dec. 8, 2025 /PRNewswire/ — Today, 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS), a leading provider of thoughtful expressions designed to help inspire customers to express and connect, announced the appointment of Alexander Zelikovsky as Chief Information Officer. Zelikovsky’s appointment accelerates the company’s ongoing transformation strategy under CEO Adolfo Villagomez.
As Chief Information Officer, Zelikovsky will lead an enterprise-wide technology strategy to accelerate the company’s digital transformation. His responsibilities include IT applications and platforms, data architecture, data management, cybersecurity, and business intelligence. Zelikovsky will also support the organization’s AI and business optimization efforts by ensuring the technology, data, and platforms are in place to help these initiatives succeed — strengthening the company’s ability to deliver exceptional customer-centric experiences and drive omnichannel growth. He will report directly to 1-800-FLOWERS.COM, Inc. CEO Adolfo Villagomez.
“Alex is a visionary technology leader with proven expertise leading digital transformation initiatives at scale,” said Adolfo Villagomez, CEO of 1-800-FLOWERS.COM, Inc. “His ability to position technology to fuel business growth, enhance operational efficiency, and deliver personalized customer experiences is all critical to driving our transformation strategy forward. His experience in enterprise modernization, AI, and cybersecurity will be instrumental in accelerating growth and innovation across our portfolio. We are thrilled to have Alex join the organization.”
Zelikovsky brings more than 25 years of technology leadership experience, transforming traditional businesses into digital enterprises at global scale. Most recently, he served as Executive Vice President and Global CIO at Pitney Bowes. Prior to that, he held divisional CIO and Head of Digital Technology roles at Kimberly-Clark for both the EMEA and Latin America regions, where he executed comprehensive IT transformation strategies that drove significant business turnarounds and operating profit growth.
“I’m excited to join 1-800-FLOWERS.COM at such a pivotal time in the company’s transformation,” said Zelikovsky. “Adolfo’s vision for building a consumer-centric organization resonates deeply with my approach to technology leadership. The company has built an exceptional portfolio of brands and understands the importance of delivering meaningful and personalized customer experiences. I look forward to partnering with the leadership team to harness technology, data, and innovation to deepen customer relationships, drive operational excellence, and accelerate growth across the business.”
Before joining Kimberly-Clark, Zelikovsky drove the development and execution of Bed Bath & Beyond’s omnichannel technology strategy and was instrumental in building out their multibillion-dollar digital commerce business. His journey into digital technology began at Amazon.com, where he was part of the team that pioneered Amazon’s global distribution network. He has also held senior technology and operations roles at Procter & Gamble and Sephora/LVMH.
Zelikovsky holds an MBA from the University of Chicago’s Booth School of Business and a bachelor’s degree from Brooklyn College, City University of New York. He is the author of “Achieving Stretch Goals Efficiently” and has served as an adjunct professor at Purdue University’s Krannert School of Management, where he developed and taught a graduate course in e-Commerce Strategy and Operations.
About 1-800-FLOWERS.COM, Inc. 1-800-FLOWERS.COM, Inc. is the premier destination for meaningful gifting, helping people express and connect through thoughtful giving. As an omnichannel retailer, the company’s portfolio includes more than 18 premium brands, such as 1-800-Flowers.com®, Harry & David®, PersonalizationMall.com®, and Things Remembered®. 1-800-FLOWERS.COM, Inc. also supports local community businesses nationwide through BloomNet®, its network of local florists and merchants, that enables same-day delivery. The company also operates Napco®, a leading resource for floral gifts and seasonal décor, and DesignPac Gifts, LLC, a manufacturer of gift baskets and towers
VIRGINIA CITY, NEVADA, December 8, 2025 – Comstock Inc. (NYSE American: LODE, the “Company”) today announced that one of its strategic investees, Bioleum Corporation (“Bioleum”), acquired Hexas Biomass Inc. (“Hexas”), a global leader in the development and deployment of purpose grown energy crops and biomaterials, including all of its intellectual properties and certain liabilities, in exchange for a purchase price of approximately $6.5 million comprised of approximately $3.5 million paid with 146,637 shares of Bioleum common stock at $24 per share, $500,000 in five annual cash payments of $100,000 each, commencing at closing, and $2.5 million of convertible debt, redeemable with cash payments payable from 5% of Hexas’ aggregate revenues or convertible into Bioleum common stock, also at a conversion price of $24 per share.
Hexas has developed a portfolio of proprietary intellectual properties for the propagation, production, harvesting, and processing of purpose grown crops with proven annual yields exceeding 25 to 30 dry metric tons per acre, or about 4 to 7 times the yields of traditional forestry species. Hexas’ crops are specifically designed to thrive in diverse environments, including marginal and underutilized lands. These crops enhance agricultural ecosystem without disrupting or competing with food production.
The combination of Bioleum’s high yield refining platform and Hexas’ high yield purpose grown crops enables the production of over 100 barrels of biofuel per acre of biomass production per year. For comparison, producers of soy and corn only net about 2 and 10 barrels of biofuel per acre per year, respectively. The production of Hexas’ purpose grown crops transforms marginal agricultural lands into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost domestic energy independence and expand rural economies using regenerative agricultural practices.
“Hexas was founded to make the highest and best use of natural resources by providing industries with access to abundant, carbon negative, and ecologically positive feedstocks,” said Wendy Owens, Hexas’ founder and chief executive officer. “Bioleum’s acquisition will help us to execute on that vision by accelerating commercialization and global deployment of our technologies in biofuels and multiple other biobased applications. We are very excited to continue our established track record of bioproducts leadership as we join Bioleum’s integrated system and growing team.”
“Incorporating a proprietary low-cost feedstock model into our system provides unprecedented benefits for our refining solutions and targeted supply chain partners,” added Kevin Kreisler, Bioleum’s chief executive officer. “While our solutions are designed to process most known forms of lignocellulosic biomass, the Hexas technologies will allow us to enhance, supplement, and/or dramatically expand locally available biomass by “anchoring” each of our owned and licensed refineries with a dedicated, perpetual feedstock supply, ensuring the reliability, consistency, scale, and pricing needed to minimize risk and maximize profitability.”
The U.S. DOE has previously estimated that America can produce over of one billion tons per year of waste wood and other forms of biomass for conversion into transportation fuels. That’s enough to produce more than 3 billion barrels of fuel per year with Bioleum’s refining solutions, but much of this biomass is widely dispersed and subject to regulatory, collection, and other sources of regional variability. Converting just 40 million underutilized acres of non-food producing land into profitable purpose grown biomass farms with Hexas’ high yield crops could provide enough feedstock to double that output while decreasing variability and risk for new renewable fuel projects.
Kreisler concluded, “Our ambition is to build shareholder value by systemically empowering agricultural, forestry, pulp and paper, renewable fuels, petroleum, energy, and mobility stakeholders to license and deploy our solutions across their respective industries at speeds that are far greater than Bioleum, or any other company, could ever achieve on its own. We are laser focused on developing, deploying, and enabling that system, and we couldn’t be more excited to complete this transaction.”
As part of Bioleum’s system, Hexas will continue servicing customers worldwide in the energy, including biofuels, structural and non-structural products sectors by supplying XanoFiber™ (and other purpose grown biomass from its proprietary giant grasses) to them as a low-cost, drop-in ready, reliable supply of biomass. Owens will continue to run Hexas as its president.
About Hexas Biomass Inc.
Hexas Biomass Inc. is an award-winning biomaterials company focused on the production of low-cost, plant-based raw materials that replace wood, food crops for fuel, and fossil fuel-based raw materials in multiple applications. Hexas’ proprietary purpose grown biomass leaves trees standing, farmland for food not fuel, and fossil fuels in the ground. Learn more at www.hexas.com.
About Bioleum Corporation
Bioleum Corporation develops and commercializes technologies that convert lignocellulosic biomass, such as purpose-grown crops and wood residues, into low-carbon fuels and refinery intermediates, including ethanol, SAF, renewable diesel, and gasoline. The company is advancing its first commercial facility in Oklahoma and operates pilot assets in Wisconsin, supported by partnerships spanning biomass supply, industrial integration, and research institutions. Learn more at www.bioleum.com.
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics.
Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
Contacts
For investor inquiries: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@comstockinc.com
Forward-Looking Statements
This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; divestitures, spin-offs or similar distribution transactions, future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, divestitures, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, spin-offs or similar distribution transactions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company or any other issuer.
STAFFORD, Texas, Dec. 08, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01.
In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are currently planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types (non-HLA-A*02) are planned to be treated with GLSI-100 in a third open label arm. The non-HLA-A*02 patients do not have the HLA-A*02 allele from either parent and represent about 55% of the patient population in FLAMINGO-01.
FLAMINGO-01 has achieved a major milestone by completing enrollment in the 250 patient open label non-HLA-A*02 arm of the Phase III trial, which is a result of the high screen rate and ensuing enrollment rate. The Company is continuing its review of the most recent data of this arm, including recurrence rates, which can be updated and/or published at any time.
The Company stopped enrolling in this arm earlier this year and is now approaching regulatory agencies to seek approval to continue enrollment of new non-HLA-A*02 patients in a randomized manner with a control arm. The Company has continued to screen a large number of these patients so that rapid enrollment of these screened patients can commence if regulatory approval is received.
The Company previously reported promising observations earlier this year showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, 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, where breast cancer recurrences were reduced up to 80% or more and no metastatic breast cancer recurrences were reported. A preliminary analysis suggests that these promising trends are continuing.
CEO Snehal Patel commented, “As we continue to analyze the immune response, safety, and recurrence rate data of the 250 patient non-HLA-A*02 data set, it is important to remember that all 250 patients received GLSI-100, which is 5 times more than the approximately 50 patients treated in the Phase IIb trial. We can compare the open label recurrence rate data of these 250 treated patients to the expected historical recurrence rate for this population, which is well known and recently reported, to the HLA-A*02 arms of FLAMINGO-01, and to the Phase IIb study. In addition, we may be able to compare the recurrence rate during the first 6 months of vaccination, also called the primary immunization series or PIS, to the recurrence rate after the PIS is completed and after peak immunity is achieved. We look forward to providing updates on this analysis at any time, including publications at conferences as we have previously done for the Phase IIb trial from 2020-2022.”
Mr. Patel added, “The use of GLSI-100 in the non-HLA-A*02 patient population is an invention by the Company, and the Company believes that any patent claims related to this invention are not subject to any license, royalties, or milestone payments. These patent claims should complement other patent claims that the Company has recently filed to potentially extend patent protection of GLSI-100 beyond 2040. The Company believes that this patient population could double the number of US and European patients eligible for GLSI-100 treatment to approximately 88,000 new patients per year with a market potential using the drug prices per year of Kadcyla or Enhertu in the range of $8-10 billion per year.”
Additional updates:
The non-HLA-A*02 types that are most commonly being enrolled in FLAMINGO-01 continue to be HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.
The enrollment of HLA-A*02 patients in the 500 patient randomized arms continues, unaffected by the end of enrollment in the non-HLA-A*02 arm, while the Company also seeks to increase the size of these HLA-A*02 arms such that enrollment is not stopped prior to any interim analyses.
Enhertu (trastuzumab Deruxtecan [T-DXd]) treated patients continue to be eligible for enrollment in FLAMINGO-01. The Company believes that GLSI-100 will synergize with any trastuzumab based treatment in the neoadjuvant or adjuvant settings, including Enhertu.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients 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: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada (“Agency”), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).
After outlining the remaining requirements, Health Canada confirmed that NeuroSense’s proposed next steps align with the Agency’s expectations. With additional clinical data recently generated and further supportive analyses underway, NeuroSense is now preparing for a pre-NDS meeting with Health Canada currently contemplated in April 2026.
Pending a successful outcome of this meeting and completion of the final submission components, the Company currently anticipates a potential NDS submission by mid-2026.
“This positive engagement reinforces our confidence in the regulatory pathway in Canada,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS.”
Additional details regarding the Canadian submission and contemplated timelines will be provided during NeuroSense’s upcoming investor webinar on December 8th, 2025. Registration for the webinar is available here.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and Alzheimer’s Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations, and include statements regarding the timing of a pre-NDA meeting with Health Canada and the timing of a potential NDS submission, and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of commencement of the Phase 3 trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that the pre-NDA meeting with Health Canada will be delayed or not occur; that the potential NDS submission will be delayed or not occur; Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
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