Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Tonix Announced Acquisition of A Non-Opioid Pain Reliever. Tonix continues to build its neurological pain pipeline with the licensing of a Sigma-1 receptor antagonist for development in neuropathic pain relief. Published studies on the Sigma-1 receptor’s mechanism of action have shown activity in pain and several neurological diseases. We see this as an extension of the company’s product line in neurology, including products for fibromyalgia/pain, acute stress disorder, major depressive disorder, and migraine headache.
TNX-4900 Is Highly Selective For The Sigma-1 Receptor. The new molecule, known as TNX-4900, is a small molecule developed to be highly selective for the Sigma-1 receptor, avoiding the Sigma-2 and other Sigma receptor-family members. It has been tested in multiple models of pain and selected for its efficacy and safety profile. TNX-4900 has also shown ability to cross the blood-brain barrier, with favorable adsorption, distribution, metabolism and elimination (ADME) properties.
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After several challenging years marked by higher interest rates, tighter capital markets, and depressed valuations, signs are emerging that the biotech sector may be on the cusp of a meaningful turnaround. One of the clearest indicators is the renewed pickup in mergers and acquisitions activity across biotech and pharmaceutical companies. Historically, periods of rising M&A have often preceded broader recoveries in biotech equities, particularly among small- and mid-cap names that have been trading at discounted valuations.
Large pharmaceutical companies are once again stepping up as active acquirers. Many face looming patent expirations that threaten billions of dollars in revenue over the next several years, creating urgency to replenish drug pipelines. Rather than relying solely on in-house research and development, big pharma is increasingly turning to acquisitions and strategic partnerships with innovative biotech firms that already have promising assets in development. This dynamic disproportionately benefits smaller biotech companies, which often lack the capital to fully commercialize therapies on their own but possess highly valuable intellectual property.
The macroeconomic backdrop is also becoming more supportive. Expectations around interest rate cuts play a critical role in driving this renewed activity. Biotech companies are capital-intensive by nature, frequently operating for years without meaningful revenue while funding clinical trials and regulatory processes. When interest rates are high, the cost of capital rises, making financing more difficult and suppressing valuations. As rates begin to fall—or even as markets anticipate easing—capital becomes cheaper and more accessible, enabling both buyers and sellers to transact more confidently.
Lower interest rates also have a powerful effect on biotech valuations. Because many biotech companies derive much of their value from future potential cash flows rather than current earnings, they are particularly sensitive to discount rates used in valuation models. When rates decline, the present value of future earnings increases, supporting higher valuations across the sector. This dynamic can help reverse the multiple compression biotech stocks experienced during the tightening cycle.
In addition, rate cuts tend to shift investor behavior toward a more “risk-on” environment. As yields on safer assets like bonds decline, investors are more inclined to seek growth opportunities in sectors such as biotech, where innovation and breakthrough therapies can drive outsized returns. Rising equity prices and improved sentiment, in turn, make biotech companies more attractive acquisition targets, reinforcing the M&A cycle.
For small-cap biotech investors, this combination of increased deal activity and improving macro conditions is particularly significant. M&A announcements often come with substantial acquisition premiums, providing immediate upside for shareholders and helping reprice comparable companies across the sector. Even firms that are not direct acquisition targets can benefit as investors reassess the strategic value of underappreciated pipelines and platforms.
While risks remain and selectivity is still critical, the resurgence of biotech M&A alongside a more favorable interest rate environment suggests that the sector’s prolonged downturn may be nearing its end. If rate cuts materialize and deal momentum continues, biotech—especially at the small-cap level—could be positioned for a sustained recovery rather than just a short-term bounce.
U.S. inflation is expected to remain above the Federal Reserve’s 2% target in November, reinforcing the central bank’s cautious stance as the economic data calendar finally returns to normal following this year’s prolonged government shutdown. The upcoming Consumer Price Index (CPI) report, scheduled for release Thursday morning, will be the final major inflation update published on a disrupted schedule, marking a key moment for markets assessing the trajectory of monetary policy into 2026.
Consensus estimates suggest headline CPI rose 3.1% year over year in November, while core inflation—which excludes food and energy—is also expected to come in at 3.1%. That would represent a modest increase from the 3.0% readings recorded in September, the most recent inflation data available after October’s report was canceled during the shutdown. With no October data to provide a month-to-month comparison, investors will be forced to rely on broader trend signals rather than short-term momentum.
Despite inflation remaining elevated, economists generally view current price pressures as part of a gradual cooling process rather than a renewed acceleration. Demand across the economy has shown signs of moderation, particularly as higher borrowing costs continue to weigh on discretionary spending and business investment. However, progress toward the Fed’s target remains uneven, and several factors continue to complicate the inflation outlook.
One key source of persistence is goods inflation, which analysts say remains sticky due to tariffs and supply chain adjustments. While global logistics have improved compared to prior years, trade policy and cost pressures continue to filter through consumer prices. At the same time, services inflation—long viewed as a more stubborn component—has shown tentative signs of easing, helped in part by softer health insurance costs and slower wage growth in some sectors.
Recent labor market data adds another layer of complexity. The November jobs report, released earlier this week, showed stronger-than-expected job creation alongside an unemployment rate that rose to a four-year high. This combination suggests a labor market that is cooling, but not collapsing—an outcome that supports the Fed’s view that inflation can ease without triggering a sharp economic downturn.
As a result, markets increasingly expect the Federal Reserve to remain on hold at its January meeting. Futures pricing currently implies a relatively low probability of a rate cut in the near term, as policymakers wait for clearer evidence that inflation is moving sustainably toward target. The Fed’s most recent projections point to only one additional rate cut in 2026, following a series of quarter-point reductions late in 2025.
For investors, the message is one of patience rather than panic. Inflation remains above target, but the direction of travel appears constructive. As economic data resumes its regular cadence in the months ahead, policymakers and markets alike will gain a clearer picture of whether pricing pressures are continuing to fade or becoming entrenched once again. Until then, the Fed is likely to err on the side of caution, prioritizing long-term stability over short-term market expectations.
Crude oil prices sank to their lowest levels in nearly four years this week, underscoring how deeply oversupplied the global energy market has become. Both major benchmarks—Brent and West Texas Intermediate (WTI)—fell below key psychological thresholds, with WTI briefly dipping under $55 a barrel and Brent sliding into the high $50s. The move marks a dramatic reversal from the tight energy markets of recent years and signals mounting pressure across the oil industry.
The selloff reflects what many analysts have been warning about for months: supply has simply outpaced demand. Production growth from OPEC+ and non-OPEC producers alike has overwhelmed consumption, even as global demand remains relatively steady. Since the spring, OPEC+ members have steadily unwound earlier production cuts, adding millions of barrels per day back into the market. Saudi Arabia, in particular, has prioritized regaining market share, even at the expense of lower prices.
Outside the cartel, output has also continued to climb. Producers across parts of the Middle East, Africa, and Asia have increased exports, while U.S. inventories are projected to keep building well into 2026. According to international energy agencies, the imbalance could widen further next year, with excess supply potentially approaching four million barrels per day—an extraordinary figure by historical standards.
One of the clearest signs of the glut is happening offshore. Oil tankers holding crude at sea have surpassed one billion barrels, as sellers struggle to find buyers willing to take delivery at current prices. Storage economics are also shifting, with parts of the oil futures curve slipping into contango. This market structure, where future prices trade above spot prices, typically signals oversupply and encourages traders to store oil rather than sell it immediately.
Pressure is spreading beyond crude itself. Refining margins have narrowed as prices for gasoline, diesel, and jet fuel soften alongside oil. Crack spreads—which measure the profitability of turning crude into refined products—have tightened, removing one of the last pillars of support for energy prices earlier this year.
Wall Street remains firmly bearish. Several major banks now expect oil prices to remain under pressure through 2026, with forecasts clustering in the low-to-mid $50 range and downside risks extending even further. Some analysts warn that if producers fail to curb output, prices could fall into the $40s, levels that would strain balance sheets across the exploration and production sector.
Geopolitics adds another layer of complexity. Sanctions on Russian producers could limit some supply, but discounted barrels often find their way to buyers willing to navigate restrictions. Meanwhile, any breakthrough in peace talks between Russia and Ukraine could ultimately bring more oil back onto the global market, worsening the surplus. Tensions involving Venezuela and U.S. policy decisions also remain wild cards, though none appear strong enough to offset the sheer volume of excess supply.
For energy companies, the implications are sobering. Lower prices threaten drilling activity, investment, and employment, particularly in high-cost regions. While central bank rate cuts and a weaker dollar typically support commodities, oil’s current trajectory is being driven less by macro policy and more by fundamentals. For now, the message from the market is clear: until supply comes back into balance, oil prices are likely to stay under pressure.
CULVER CITY, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, unveiled major advancements across its growing digital ecosystem during its 2025 Investor Day at the NASDAQ MarketSite in New York City. Company executives shared new developments in crypto and long-term content expansion for the company’s leading game franchise ARK.
During the event, Snail introduced its upcoming stablecoin initiative, revealing the name, $USDO and the official branding. Product Owner, Matthew Harper, symbolically minted the first official coin live on stage, marking a significant milestone in the company’s strategy to integrate secure, utility focused digital payments across its ecosystem.
Snail also debuted Golden Poop, a commemorative digital meme collectible created to humorously acknowledge gaming culture and industry satire.
The event wrapped with a showcase of the new ARK: Lost Colony teaser trailer, confirming that the DLC will launch on December 18. Snail closed the presentation with a multi-year content roadmap presented by Jeremy Stieglitz, Studio Wildcard Co-founder and Lead Designer for ARK, showcasing the resilient and well-defined ARK pipeline that provides the Company clear visibility and continuous franchise support through 2027.
ARK Roadmap 2026: Survival of the Fittest by Studio Sirens Bob’s True Tales: Tides of Fortune ARK: World Creator ARK: Dragontopia
ARK Roadmap 2027: ARK: Atlantis Bob’s True Tales: Galaxy Wars ARK: Legacy of Santiago Part 1
A replay of the Investor Day will be available on the Company’s Events and Presentation section of its investor relations website here.
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and in certain of our public filings with the SEC and include, but are not limited to statements regarding the Company’s major advancements and new developments in crypto and long-term content expansion. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed by the Company with the SEC on March 26, 2025 and other documents filed by the Company from time to time with the SEC, including the Company’s Forms 10-Q filed with the SEC. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 SNAL@gateway-grp.com
CHICAGO, IL, Dec. 16, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,233,488 shares of common stock at a purchase price of $1.224 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.36 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about December 18, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $1.51 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About 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) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) 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.
BOCA RATON, FL / ACCESS Newswire / December 16, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced that the Company has renewed its carriage agreement with YouTube TV, one of the nation’s leading live streaming television platforms.
As part of the multiyear deal, the Newsmax channel will continue to be available in YouTube TV’s Base Package.
In addition to locking down Newsmax’s distribution on YouTube TV, the Newsmax streaming service, Newsmax+, will be available through YouTube’s Primetime Channels app store beginning in early 2026.
YouTube TV also recently added Newsmax en Espanol, the first and only U.S.-based news channel to use advanced AI technology to dub its content into another language on a live basis. Newsmax en Espanol is available in YouTube TV’s Spanish Plan and Spanish Plus add-on package.
“This agreement keeps Newsmax, the fastest growing cable network in the U.S., on YouTube TV, the fastest growing pay TV platform in the U.S., for years to come,” said Andy Biggers, Newsmax’s Senior Vice President of Distribution.
“YouTube TV have been great partners, and we look forward to continuing to grow together,” Biggers continued.
Newsmax, the fourth highest-rated cable news channel, is carried by every major pay TV operator in the United States, reaching nearly 60 million households with its trusted, independent news coverage.
This milestone places Newsmax’s reach on par with legacy networks such as CNN and Fox News, a remarkable achievement for one of America’s fastest-growing news brands.
About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 22 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
Forward-Looking Statements This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited to the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2024, Newsmax’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.
Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain
Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies
CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small-molecule Sigma-1 receptor (S1R) antagonist with demonstrated analgesic activity in multiple models of neuropathic pain.
“Sigma-1 receptor antagonism has generated considerable scientific interest as a promising class of non-opioid, non-addictive analgesics,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “With our extensive experience studying and developing an FDA approved non-opioid analgesic we are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class.”
Dr. Youyi Peng, co-inventor of TNX-4900, formerly a Senior Bioinformatics Specialist at the Rutgers Cancer Institute of New Jersey and now a consultant to Tonix, added, “We used computer-aided and AI-driven approaches to design this new class of selective Sigma-1 receptor antagonists. TNX-4900 showed robust analgesic efficacy in multiple pain models and an encouraging safety profile, supporting its potential as a new non-opioid approach to treating neuropathic pain.”
TNX-4900 was created from a structure-based drug design program led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University that produced a series of potent and selective triazole-based S1R antagonists. The compound binds the human Sigma-1 receptor with nanomolar affinity (Ki = 7.5 nM), demonstrates > 100-fold selectivity over the Sigma-2 receptor, and exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination (ADME) properties, including oral bioavailability of approximately 28%.
“Our foundational research into TNX-4900 represents an important step toward developing non-opioid solutions for chronic pain. We are pleased to see this innovation progress toward potential clinical application, which could address a critical need for safer pain management options,” said Dr. William Welsh, Distinguished Professor in the Department of Pharmacology at Rutgers Robert Wood Johnson Medical School (RWJMS).
In preclinical models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and chronic dosing without evidence of tolerance or motor impairment. Tonix plans to advance TNX-4900 through expanded pharmacokinetic, formulation, and safety studies to support IND-enabling development.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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.
The November jobs report offered fresh signs that the U.S. labor market is cooling, but not enough to materially alter the Federal Reserve’s near-term policy outlook. While the data points to slower hiring and a higher unemployment rate, policymakers and economists broadly agree that the figures fall short of triggering an immediate shift toward additional rate cuts.
According to the latest report, the U.S. economy added 64,000 jobs in November, a modest rebound after a net loss of 105,000 jobs in October. At the same time, the unemployment rate rose to 4.6%, its highest level in more than four years. Under normal circumstances, a jump of that magnitude might raise alarms at the Fed. This time, however, the context surrounding the data matters just as much as the headline numbers.
Economists caution that recent employment figures may be distorted by technical and temporary factors, including the lingering effects of the government shutdown that spanned October and part of November. The Labor Department itself flagged higher-than-usual uncertainty in the data, citing lower survey response rates, changes in weighting methodology, and the use of a two-month analysis window instead of a single month. These quirks make it harder to draw firm conclusions about the true underlying trend in the labor market.
A significant portion of the weakness also stems from government employment. Federal payrolls declined sharply as deferred resignations tied to earlier buyout programs finally showed up in official counts. Since peaking earlier in the year, federal employment has fallen by more than a quarter-million jobs. While that has pushed the unemployment rate higher, it does not necessarily reflect broader weakness in private-sector hiring.
At the same time, labor force participation rose in November, suggesting that more people are actively looking for work. That dynamic can temporarily lift the unemployment rate even if the economy is not deteriorating rapidly. In other words, the increase in joblessness may be more about shifting labor supply than collapsing demand.
Federal Reserve Chair Jerome Powell has repeatedly emphasized the need for caution when interpreting recent data. He has noted that both labor and inflation metrics may be distorted, not just volatile, and warned against overreacting to any single report. Some Fed watchers believe monthly payroll growth may be overstated and that underlying job creation could be closer to flat or slightly negative—a scenario consistent with a late-cycle slowdown rather than an outright downturn.
For now, the November report reinforces the Fed’s patient stance. Labor market softness appears real, but there is little evidence that the broader economy has stalled. Inflation trends and upcoming employment data, particularly for December and January, will be critical in determining whether policymakers feel confident enough to resume cutting rates.
In short, November’s jobs data neither forces the Fed’s hand nor closes the door on future easing. It keeps policymakers in wait-and-see mode—alert to downside risks, but not yet convinced that the economy requires immediate additional support.
Vancouver, British Columbia–(Newsfile Corp. – December 15, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) announces that its Board of Directors has approved grants of incentive restricted share units (“RSU”) and stock options.
Restricted Share Units
Under the Company’s Restricted Share Unit Plan (the “Plan”), RSUs may be granted to directors, employees, and contractors of the Company. At the discretion of the Company’s Board of Directors, the Plan permits the Company to either redeem RSUs for cash or by issuance of Hemisphere’s common shares.
On December 12, 2025, the Company awarded 930,000 incentive RSUs to directors and officers of Hemisphere, all of which will vest one-third annually over a three-year period and will expire on December 15, 2028.
Stock Options
Additionally, in accordance with the Company’s Stock Option Plan, Hemisphere has granted 48,000 incentive stock options to its investor relations service provider on December 15, 2025 at an exercise price of $2.01 per share which will vest quarterly over 12 months and expire on December 15, 2030.
About Hemisphere Energy Corporation
Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood enhanced oil recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.
For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:
Don Simmons, President & Chief Executive Officer Telephone: (604) 685-9255 Email: info@hemisphereenergy.ca
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 news release.
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 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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Phase 3 Trial Has Treated Its First Patient. MAIA has begun its pivotal Phase 3 trial for THIO in NSCLC (non-small cell Lung Cancer), meeting our expected timeframe. In October, the Phase 2 THIO-101 trial began its Part C and will continue as the Phase 3 is running. These trials are the latest in a series of positive announcements for THIO (ateganosine) clinical development, keeping it on schedule for additional milestones in 2026.
Trial Design Can Lead To First Approval. The Phase 3 THIO-104 is an open-label trial is testing ateganosine in combination with an CPI (immune checkpoint inhibitor) as a third-line treatment in patients who are resistant to CPIs and chemotherapy. Patients who have failed two courses of chemotherapy including CPIs will be randomized into two groups to receive either the ateganosine/CPI combination or standard of care chemotherapy. The primary endpoint is Overall Survival (OS).
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
DSMB Ends Comparator Arm; Trial Proceeds Exclusively With GEO-CM04S1 Following mRNA Vaccine’s Failure to Meet Primary Endpoint
Phase 2 Data Reinforce GEO-CM04S1 as an Important Next-generation Vaccine Candidate for the 40 Million U.S. and 400 Million Global Immunocompromised Patients Underserved by First-generation COVID-19 Vaccines
ATLANTA, GA – December 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced the publication of interim Phase 2 clinical data on its next-generation COVID-19 vaccine in patients with chronic lymphocytic leukemia (CLL).
The Research Letter in the British Journal of Haematology reports that GEO-CM04S1 met the study’s primary immunologic endpoint, generating significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 (Pfizer-BioNTech) in patients with chronic lymphocytic leukemia (CLL) – a population known for poor vaccine responsiveness.
Importantly, following interim analysis, the trial’s Data and Safety Monitoring Board (DSMB) ruled to discontinue the randomized, double-blind comparator arm after the mRNA vaccine failed to meet the predefined primary immunogenicity endpoint. Enrollment is now proceeding exclusively in a single-arm cohort receiving GEO-CM04S1, as previously described in GeoVax’s clinical update at the European Hematology Association (EHA) 2025 Conference.
GEO-CM04S1’s superior performance in enhancing cellular immune response against SARS-CoV-2 in individuals with CLL, a patient population that generally responds sub optimally to vaccines designed to induce humoral (antibody) responses, underscores its potential to fill a protection gap for profoundly immunocompromised patients. More than 40 million adults in the U.S. and 400 million globally have some degree of compromised immunity, many of whom fail to mount meaningful responses to currently authorized COVID-19 vaccines. GEO-CM04S1 is specifically designed to address this gap through its dual-antigen (Spike + Nucleocapsid), MVA-based platform, which promotes robust, durable T-cell responses that are less impacted by immune dysfunction and viral variation.
Phase 2 Study Overview (NCT05672355)
CLL patients previously vaccinated with mRNA vaccines
31 enrolled; 27 evaluable for primary analysis
Primary endpoint: ≥3-fold rise in antigen-specific IFN-γ–secreting T cells at Day 56
40% of GEO-CM04S1 recipients met the primary endpoint vs. 14.3% for BNT162b2
Higher Spike-specific IFN-γ responses at Days 28, 56, and 84
2. Durable activation of Nucleocapsid-specific T cells
~10-fold higher N-specific CD4 T-cell activation vs. BNT162b2
Responses maintained through Day 180
3. Broader immune engagement in spite of CLL-associated humoral defects
GEO-CM04S1 generated sustained N-IgG and a correlation between N-specific antibodies and T-cell activation
mRNA vaccination produced higher early RBD-IgG titers but limited cellular immunity
Kelly T. McKee, MD, MPH, Chief Medical Officer, stated: “These results demonstrate GEO-CM04S1’s ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB’s decision to discontinue the comparator arm further validates the vaccine’s clinical relevance for immunocompromised individuals.”
David Dodd, Chairman & CEO, added: “With more than 40 million immunocompromised Americans, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens our regulatory and partnering strategy as we advance toward potential commercialization.”
Medical and Commercial Significance
The findings published in BJH, combined with the DSMB’s action, reinforce the value of the differentiated profile of GEO-CM04S1 across multiple dimensions:
Critical unmet need: Immunocompromised individuals remain vulnerable and, in many cases, sub optimally protected from the threat of SARS-CoV-2.
Multi-antigen design: GEO-CM04S1’s dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches.
These segments represent a $30B+ annual potential commercial market.
About GEO-CM04S1
GEO-CM04S1 is a dual-antigen MVA-vectored COVID-19 vaccine being evaluated in multiple Phase 2 trials, including a primary vaccination for immunocompromised individuals, and a booster vaccination for CLL patients.
The vaccine has generated robust immune responses in difficult-to-vaccinate populations including CAR-T and stem-cell transplant recipients, who typically fail to respond well to first-generation vaccines.
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.
STAFFORD, Texas, Dec. 15, 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 an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01.
A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient non-HLA-A*02 arm of FLAMINGO-01. This arm does not have a direct placebo comparator arm, thus these two methods were used.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. See the summary of the Phase IIb results below.
The first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years.
In addition to announcing this first analysis of the recurrence rate data in the open label non-HLA-A*02 arm of FLAMINGO-01, the Company previously reported promising observations 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.
The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the 250 patient non-HLA-A*02 data set, all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. Since the 250 non-HLA-A*02 patients do not have a placebo arm for a direct comparison, the following two methods were used, yielding the 80% reduction in recurrence rate observation:
Method 1: The recurrence rate of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for this population in the Katherine study who received TDM1 (Kadcyla), which is about 3.5-4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100. The data suggests an approximately 80% reduction in recurrence rate after the GLSI-100 PIS is completed as compared to the TDM1 arm of the Katherine study at a similar timepoint.
Method 2: The recurrence rate during the first 6 months of vaccination or PIS period when the patient may not be fully protected or protected at all, which covered an exposure period of 100 patient years, was compared to the recurrence rate after the PIS is completed and after peak immunity is believed to be achieved, which covered an exposure period of 132 patient years. The exposure period (patient years) is defined as the cumulative number of years all patients are followed in a period. The data suggests that the peak immunity is lowering the recurrence rate by approximately 80% after the PIS is completed as compared to the recurrence rate during the PIS period.
For the first 6 months of vaccination or PIS, the theoretical maximum patient years would be 250 patients at 0.5 years each or 125 patient years. Thus 100 completed patient years represents 80% of the maximum potential patient years and within 3 to 6 months all vaccinations during this period may be completed.
For the period after the PIS is completed, the theoretical maximum patient years would be 250 patients at 3.5 years of follow-up each or 875 patient years. Thus 132 completed patient years represents 15% of the maximum potential patient years and represents an average of 9 months of follow-up time after the PIS for patients who have completed the PIS.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
CEO Snehal Patel commented, “We are very excited to announce in our 100th press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. We are equally excited to see a positive trend in the recurrence rate in the non-HLA-A*02 arm of FLAMINGO-01, as assessed multiple ways, that is trending similarly to the Phase IIb trial results where HLA-A*02 patients were treated. Despite these being preliminary results that will mature and can change with time, seeing a reduction in expected recurrence rates that is trending towards a low HR of 0.2, which represents an 80% reduction in recurrence rate, is very encouraging and which is why along with the similarly promising safety and immune response data to date, we will seek to continue to treat non-HLA-A*02 patients in a placebo controlled manner in the study. We will continue to analyze the data and may provide updates at any time.”
Previously Published Phase IIb Data
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of 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
