2025 Year-End Wrap: Small-Cap Investors Eye Mining, Biotech, and Tech for 2026 Opportunities

As 2025 comes to a close, the investment landscape has offered a year of contrasts. Mega-cap tech stocks dominated headlines, driven by artificial intelligence and cloud computing, while the small-cap sector faced a challenging environment, weighed down by elevated interest rates, cautious credit markets, and selective investor demand. Yet for those focused on quality small-cap companies, the year also laid the groundwork for potential gains in 2026, particularly in mining, biotech, and technology sectors.

The Russell 2000, a key small-cap benchmark, lagged behind the broader S&P 500 in 2025. Despite underperformance, this divergence has created opportunity. Valuation gaps between small caps and large caps widened, offering investors attractive entry points in companies with strong fundamentals. Small-cap stocks with solid balance sheets and consistent cash flow outperformed peers reliant on speculative growth or cheap capital.

Certain sectors stood out for resilience and growth. Mining and natural resources small caps benefited from ongoing global demand for metals and energy transition materials. Lithium, copper, and critical minerals companies were particularly well-positioned as governments and private companies accelerated clean energy initiatives. These companies not only captured investor interest but also provided a hedge against inflation and volatility in broader equity markets.

The biotech sector saw selective strength as well. Smaller firms focused on innovative therapies, AI-assisted drug discovery, and niche medical devices attracted attention despite macroeconomic headwinds. With continued demand for breakthroughs in personalized medicine, gene therapy, and diagnostic technology, biotech small caps offered a combination of growth potential and sector tailwinds. Investors increasingly favored companies demonstrating revenue traction or near-term product catalysts over speculative pipeline stories.

Technology-focused small caps, including niche AI, cybersecurity, and software-as-a-service providers, also experienced renewed interest. While mega-cap tech firms dominated headlines, small-cap innovators positioned in AI infrastructure, enterprise solutions, and specialized tech services saw capital flow in. These companies benefited from both secular growth trends and attractive valuations relative to large peers, making them a compelling segment for investors looking to balance growth with risk management.

Looking ahead to 2026, the outlook for small-cap equities appears cautiously optimistic. Analysts expect stabilization in interest rates, improving liquidity conditions, and renewed investor rotation from high-valuation mega caps into undervalued small caps. Investors are likely to focus on quality, balance sheet strength, and exposure to durable economic trends, particularly in mining, biotech, and technology. These sectors are well-positioned to capture structural tailwinds, whether from AI adoption, healthcare innovation, or energy transition.

While selectivity will be critical, the combination of lower valuations, sector-specific growth opportunities, and improving market sentiment provides a favorable backdrop for small-cap investors. Those disciplined in stock selection and sector focus may find meaningful upside potential as the market moves into 2026.

In summary, 2025 highlighted the challenges of small-cap investing but also underscored key opportunities. Mining, biotech, and technology sectors emerged as standout areas, offering both resilience and growth potential. As investors enter 2026, the small-cap space remains a fertile ground for disciplined, research-driven investment strategies.

Meta Acquires AI Startup Manus to Accelerate Next Phase of Artificial Intelligence Strategy

Meta is continuing its aggressive expansion into artificial intelligence with the acquisition of Manus, a fast-growing AI startup, signaling the company’s intent to strengthen its position in an increasingly competitive AI landscape. The Facebook and Instagram parent company confirmed the deal this week, though it did not disclose financial terms. Multiple reports estimate the transaction value at more than $2 billion.

Manus, now headquartered in Singapore, gained industry attention earlier this year after launching a general-purpose AI agent designed to assist users with research, coding, and productivity-driven tasks. The platform operates on a subscription model and has experienced rapid adoption across both individual users and businesses. Within just eight months of launch, Manus surpassed $100 million in annual recurring revenue, highlighting strong market demand for its AI capabilities.

Meta described the acquisition as a strategic fit for its broader AI ambitions. The company plans to scale Manus’ technology across its ecosystem, including integration into Meta AI for both consumer and enterprise use cases. Importantly, Meta indicated that Manus will continue operating its existing services independently, allowing current users to retain access through the startup’s app and website.

Leadership at Manus emphasized continuity following the acquisition. The company views the partnership as an opportunity to grow on a more stable foundation while preserving its operational autonomy and product direction. This approach reflects Meta’s recent strategy of acquiring specialized AI teams while allowing them to maintain their core innovation culture.

The deal also carries geopolitical implications. Manus previously received backing from several Chinese-linked investors and originated from a company founded in China before relocating to Singapore. Meta confirmed that, following the acquisition, there will be no remaining Chinese ownership interests in Manus. The startup will also discontinue operations in China while continuing to expand from its Singapore base, where the majority of its workforce is located.

Meta’s move comes as CEO Mark Zuckerberg intensifies efforts to position the company at the forefront of artificial intelligence development. Facing stiff competition from rivals such as Google and OpenAI, Meta has made AI a central pillar of its long-term growth strategy. Earlier this year, the company made a multibillion-dollar investment in AI data firm Scale and recruited its CEO to help lead advanced AI research initiatives.

By bringing Manus under its umbrella, Meta gains a commercially proven AI platform and a rapidly scaling technology team. The acquisition reinforces Meta’s commitment to embedding AI across its products while accelerating innovation in intelligent agents that could reshape how users interact with digital platforms in the years ahead.

Snail (SNAL) – Investor Day Highlights


Tuesday, December 30, 2025

Snail 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.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , 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.

Investor Day. At the company’s 2025 Investor Day on December 16th in New York, management provided a strategic update on its product release roadmap and highlighted early progress in the development of its digital asset strategy. Notably, the company symbolically minted its first stablecoin known as USDO during the presentation. A replay of the presentation can be viewed here.

Digital strategy. The company aims to utilize the USDO token to integrate a digital payment system across its gaming platforms and create a rewards ecosystem. Importantly, this positions Snail to be an early mover in utilizing stablecoins in gaming, leveraging its sizeable user base of roughly 91 million ARK gamers.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Newsmax (NMAX) – Expands Global Reach


Tuesday, December 30, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , 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.

Executing key growth driver. Newsmax Broadcasting is executing a focused international expansion strategy aimed at extending its U.S. news brand to global audiences through capital-efficient distribution and licensing agreements. By prioritizing multi-year carriage partnerships and selective localization, the company has expanded availability to more than 100 countries across five continents, positioning international markets as a growing driver of long-term reach and revenue diversification.

Recent distribution agreement. Newsmax secured new multi-year distribution agreements across Europe and the Eastern Mediterranean. The channel launched on Free TV in France, reaching approximately 3.5 million households, on HOT in Israel to more than 200,000 subscribers, and on Primetel in Cyprus. These partnerships deepen Newsmax’s presence in strategically important markets and increase access to U.S. and global news content for international audiences.


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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. 

Why Elevated U.S. Tariffs Are Becoming a Long-Term Reality — and What It Means for Small-Cap Stocks

U.S. tariff policy has undergone a dramatic transformation in 2025, reshaping the economic backdrop that investors will carry into the new year. Average tariff rates that once hovered near historic lows have surged above 15%, marking one of the sharpest shifts toward protectionism in decades. As 2026 approaches, market analysts widely expect these levels to remain largely intact, creating a new operating environment for companies—especially small-cap firms that are more sensitive to input costs and domestic demand.

Policy expectations across Wall Street suggest that the current tariff framework is no longer temporary. Multiple economic models now assume an average tariff rate near 15% through at least the first half of 2026. While limited exemptions may be granted on select goods, few observers see a broad rollback on the horizon. The implication is that businesses, investors, and consumers must adjust to tariffs as a structural feature of the U.S. economy rather than a short-term negotiating tactic.

Legal challenges to the administration’s authority to impose sweeping tariffs could introduce volatility, but most experts believe these efforts will not materially change the outcome. Even if courts restrict certain tariff powers, alternative statutory tools remain available to maintain similar rate levels. For markets, this means that any legal disruption is likely to be brief and tactical, not transformational.

Political incentives further reinforce the durability of current tariff policy. Trade protection has become a cornerstone of the administration’s broader economic agenda, tied to reshoring manufacturing, strengthening supply chains, and generating government revenue. Tariff collections in 2025 have already reached historically high levels, strengthening the case for maintaining the policy despite concerns over rising costs.

For small-cap companies, the persistence of elevated tariffs presents a mixed picture. On one hand, firms that rely heavily on imported inputs face margin pressure as higher costs work their way through supply chains. Many companies were able to temporarily cushion the impact by building inventory ahead of tariff increases, but those buffers are now thinning. As restocking occurs at higher tariff rates, pricing decisions will become more difficult—particularly for smaller businesses with limited pricing power.

On the other hand, small-cap stocks with domestic production, localized supply chains, or exposure to U.S. manufacturing could benefit from a more protected competitive landscape. Tariffs may reduce foreign competition in certain sectors, allowing domestic players to capture market share or stabilize pricing. For investors focused on small caps, this dynamic makes sector selection increasingly important.

Looking ahead, 2026 is shaping up to be the year when the economic consequences of tariffs become more visible. While some easing could occur around politically sensitive consumer goods, analysts do not expect a meaningful decline in overall rates. Instead, the emphasis is likely to shift toward managing the downstream effects on inflation, corporate earnings, and consumer spending.

For small-cap investors, clarity may be the most valuable takeaway. With tariff policy appearing set for the foreseeable future, markets can move past speculation and focus on fundamentals. Companies that adapt efficiently—by reshoring production, renegotiating supplier contracts, or passing through costs strategically—may emerge stronger. In a higher-tariff world, resilience and adaptability could become defining traits of the next generation of small-cap winners.

Release Nicola Mining Announces Strategic Investment from Ocean Partners

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December 29, 2025 9:00 AM EST | Source: Nicola Mining Inc.

Vancouver, British Columbia–(Newsfile Corp. – December 29, 2025) – Nicola Mining Inc. (TSXV: NIM) (the “Company” or “Nicola Mining“) is pleased to announce an additional investment from Ocean Partners UK Limited[1] (“Ocean Partners“), which has agreed to participate in a strategic non-brokered private investment of $1,000,000 to strengthen the Company’s balance sheet as it prepares to uplist onto NASDAQ in Q1 of 2026.

The Company will issue 1,111,112 units (each a “Unit“) at a price of $0.90 per Unit for gross proceeds of up to $1,000,000 (the “Offering“).

Each Unit will consist of one common share of the Company (each, a “Share“) and one transferable common share purchase warrant (each, a “Warrant“). Each Warrant will entitle the holder to purchase one additional Share at a price of $1.10 per Share for a period of three years following the closing of the Offering (the “Closing“). The expiry of the Warrants may be accelerated if the closing price of the Company’s common shares on the TSX Venture Exchange (the “Exchange”) is $1.70 or greater for a minimum of ten consecutive trading days, provided that a notice of acceleration is issued in accordance with the terms of the Warrants.

All securities issued in connection with the Offering will be subject to a statutory holding period expiring four months and one day after closing of the Offering. Completion of the Offering is subject to the approval of the Exchange. Any participation by insiders in the Offering will constitute a related party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) but is expected to be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101.

The aggregate gross proceeds from the sale of the Offering will be used for general working capital.

None of the securities sold in connection with the Offering will be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Strategic Advisor – Mr. Rahim Kassim-Lakha of Blue Sail Capital

Nicola is also pleased to announce the appointment of Rahim Kassim-Lakha, founder and CEO of Blue Sail Capital, as Strategic Advisor. With nearly 30 years of investing in global i capital markets and M&A experience, Mr. Kassim-Lakha has a proven track record in raising capital and structuring transactions. He has held senior roles at Fidelity Capital and U.S. Global Investors, where he managed over US$1 billion across three award-winning funds. As Strategic Advisor he will provide guidance on capital markets strategy and corporate development opportunities as Nicola advances its projects.

About Nicola Mining

Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.

The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which is a fully-permitted high grade silver mine and includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.

On behalf of the Board of Directors

Peter Espig

Peter Espig
CEO & Director

For additional information

Contact: Peter Espig
Phone: (778) 385-1213
Email: info@nicolamining.com
URL: www.nicolamining.com

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.


[1] Ocean Partners operates in several countries throughout the world. Ocean Partners maintains a strong global network of relationships and contacts in the base metal mining and smelting sector.

info

Source: Nicola Mining Inc.

Release – Nutriband Inc. Signs Agreement to Sell Majority Stake of Subsidiary Pocono Pharmaceutical for $5M USD to EarthVision Bio

Research News and Market Data on NTRB

Earthvision Bio, is currently developing and commercializing its line of sustainable products developed by Dr. Gordon Moore, the founder of Intel, and Dr. Hans Franke, ex-chairman for Chevron Europe

Nutriband Inc. Shareholders will retain 10% of the shareholding in Earth Vision Bio following the acquisition

The expected closing date for the transaction is Dec 31, 2025.

Orlando, Fla. – Dec 29, 2025 – Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW), today announced that it has signed an agreement to sell a 90% interest in its subsidiary Pocono Pharmaceutical for $5M USD to EarthVision Bio.

Earthvision Bio has developed and are commercializing a new category of sustainable products created by Dr. Gordon Moore, the founder of Intel (NASDAQ: INTC), and Dr. Hans Franke, who was board chairman for Chevron Europe. The Company has developed a sustainable way to replace plastic, molded fiber, wood, and paper products with Earth-friendly alternatives.

Nutriband Inc. Shareholders will retain 10% of the shareholding in Earth Vision Bio following the acquisition.

Nutriband inc. will use the proceeds from the sale of Pocono Pharma towards its continued development of AVERSA Fentanyl which has the potential to be the world’s first and only abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach annual US sales of $80 million to $200 million.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from

 

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Release – Cadrenal Is Rebuilding the Parts of Anticoagulation Everyone Else Gave Up On

Research News and Market Data on CVKD

PONTE VEDRA, FL / ACCESS Newswire / December 29, 2025 / Every industry has its forgotten corners. In anticoagulation, those corners turned into entire neighborhoods. For years, the field centered itself around convenience drugs built for broad populations and clean commercial lines. Warfarin stayed because it always had. DOACs (direct oral anticoagulants) rose in use because they were easier to manage. The patients who were harder to serve, the ones with unstable renal function or dangerous immune responses, got pushed to the edges of the conversation.

Cadrenal Therapeutics (NASDAQ:CVKD) did not follow the herd. It walked straight into the clinical territory everyone else avoided. Not because it was simple. Not because it was fashionable. But because improving outcomes for the most fragile patients is where real therapeutic change begins. The future of anticoagulation will not be won by a slightly more polished version of what already exists. It will be won by companies willing to rebuild the pieces that Big Pharma stopped trying to fix.

That is where Cadrenal stands today. The company is not chasing the old model. It is reconstructing the parts of anticoagulation where the stakes are the highest and the options are the weakest. It is doing it with intention, with discipline, and with a portfolio engineered to solve the hardest problems first. That is how you build something lasting in a field that has not changed meaningfully in decades.

Tecarfarin Sets the Foundation for a Different Kind of Platform

Cadrenal’s Phase 3-ready lead asset, tecarfarin, makes the company’s strategy instantly clear. The drug is designed to serve patients who fall outside the tolerances of traditional anticoagulation. End-stage kidney disease. Dialysis transitions. Complex cardiac burdens that magnify every downside of existing drugs. These are not the easy cases. They are the cases where outcomes hinge on control, predictability, and the ability to adjust therapy without destabilizing the entire system.

Tecarfarin was built precisely for that environment. It is engineered to offer stability where warfarin wobbles. It maintains therapeutic levels without the wild swings that plague standard vitamin K antagonists. It avoids the renal clearance issues that make DOACs dangerous for kidney-impaired patients. And it retains reversibility, one of the most clinically valuable yet commercially underappreciated traits in anticoagulation.

This is not a niche convenience drug. It is the cornerstone of a platform built for patients who cannot rely on yesterday’s tools. Tecarfarin is what happens when a company decides to re-engineer the roots of a category rather than dress up the branches.

The eXIthera XIa Acquisition Expanded Cadrenal From Chronic to Acute Care

The company’s next major move signaled its intent to play across the full spectrum of anticoagulation. Cadrenal acquired a Factor XIa inhibitor portfolio from eXIthera, giving it a second mechanistic approach that fits squarely into acute hospital care. Factor XIa is one of the most promising targets in modern hematology because it reduces clot formation without triggering the same bleeding penalties clinicians struggle with today.

This acquisition expanded Cadrenal’s relevance beyond chronic conditions and into the point-of-care environment, where hospitals need safer and more predictable anticoagulation. A single admission involving a bleeding complication or a clot formation event can cost tens of thousands of dollars and derail treatment plans. Hospitals know this. Physicians know this. Cadrenal clearly knows it too.

By integrating Factor XIa into its strategy, the company now spans both sides of the anticoagulation lifecycle. Tecarfarin stabilizes long-term risk. Factor XIa manages acute risk. Very few small companies get that kind of mechanistic breadth. Cadrenal built it in a single step.

VLX-1005 Pushed Cadrenal Into High-Stakes Immune-Mediated Territory

Then Cadrenal raised the stakes again. The company acquired VLX-1005, a first-in-class 12-LOX inhibitor in Phase 2 development for heparin-induced thrombocytopenia. HIT is one of the most dangerous complications in hospital medicine. It turns a routine anticoagulant like heparin into a trigger for catastrophic clotting and platelet collapse. Doctors do not get much time to react once HIT is in motion.

VLX-1005 comes with Orphan Drug and Fast Track designations, which immediately elevate its strategic value. This program moves Cadrenal into an area where treatment options are scarce, the stakes are immediate, and even incremental improvements matter. It also proves that the company is building a portfolio, not a single drug story.

With VLX-1005 in the mix, Cadrenal now sits on three distinct scientific pillars. Vitamin K antagonism with tecarfarin. Factor XIa inhibition for acute care. 12-LOX inhibition for immune-mediated thrombosis. This is not an accidental collection of assets. It is a purpose-built response to the biggest failures of today’s anticoagulation toolkit.

A Pipeline Built for the Problems That Actually Matter

Cadrenal is rebuilding the parts of anticoagulation that the rest of the industry quietly accepted as unsolvable. It focuses on the patients who create the most clinical and economic strain. It is expanding across chronic, acute, and immune-mediated conditions without drifting away from its central theme.

The company does not look like a microcap when you study the configuration of its pipeline. It looks like a specialty anticoagulation house in its early chapters. Investors will eventually catch up, but the company is not waiting for them. The work is already underway. The blueprint is already visible. And the parts of anticoagulation that everyone else has given up on are finally being rebuilt.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Accuracy & Disclosure Statement: Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, extended to December 31, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.

At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM may hold shares of Cadrenal Therapeutics and may sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.

Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.

Contact information for this release: info@hawkpointmedia.com

SOURCE: Cadrenal Therapeutics

Release – Kratos Receives Approximately $30 Million in Air Defense and C5ISR System National-Security-Related Hardware Production Contracts

Research News and Market Data on KTOS

December 29, 2025

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SAN DIEGO, Dec. 29, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, announced today that it has recently received approximately $30 million in Air Defense and C5ISR system national-security-related, military-grade custom hardware production contracts. Kratos is an industry leader in the development, engineering, design, and large-scale production of military-grade hardware and integrated systems for missile, radar, counter-UAS, hypersonic, directed energy, satellite communication, and other complex systems. Work performed under the recent contract awards will be performed in secure Kratos manufacturing facilities.

Tom Mills, President of Kratos’ C5ISR Division, said, “Our entire team is honored to have our customers’ confidence in our ability to engage early in the systems’ design phase to collaborate with our customers on system-level engineering and design, provide highly engineered custom systems and solutions, large-scale manufacturing, at an affordable cost, for these urgent, relevant, and mission critical systems. Kratos is the recognized industry leader in delivering military-grade hardware and systems in direct support of America’s National Security requirements.”

Eric DeMarco, President and CEO of Kratos, said, “Delivering relevant, military-grade hardware on time, on schedule, and that works every time is hard, and Kratos’ demonstrated capability to continuously do so is a differentiator for our Company to our customers and partners. Kratos is currently in high volume, mass production on multiple hypersonic, counter-UAS, missile, radar and other systems, and we are proud to be the clear industry leader in our mil-spec hardware areas of expertise.”

Due to competitive, security related and other considerations, no additional information will be provided.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Cantrell
claire.cantrell@kratosdefense.com

Investor Information:
877-934-4687
investor@kratosdefense.com

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Source: Kratos Defense & Security Solutions, Inc.

Release – Newsmax Expands in Europe, Mid-East with Major Distribution Deals

Research News and Market Data on NMAX

December 29, 2025

Carriage Deals With Free TV France, HOT Israel and Primetel Cyprus, Along With a Partnership in Ukraine, Extend Newsmax’s Reach Across Europe and the Mid-East

BOCA RATON, FLORIDA / ACCESS Newswire / December 29, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) through its subsidiary Newsmax Broadcasting, today announced a series of multi-year distribution agreements with major TV distributors across Europe and the eastern Mediterranean. These partnerships with Free TV in France, HOT in Israel and Primetel in Cyprus will make the Newsmax channel available to millions of new households and demonstrates the Company’s commitment to delivering independent U.S.-based news to international audiences.

In addition, Newsmax has entered into a brand license agreement to launch early next year a local channel, “Newsmax Ukraine”, available in the Ukrainian language.

New carriage and brand license agreements

  • Free TV (France) – Free TV, one of France’s leading telecommunications providers, has launched Newsmax on channel 351, reaching approximately 3.5 million households. This partnership strengthens Newsmax’s presence in Western Europe and offers French viewers 24/7 access to both U.S. and global news.
  • HOT (Israel) – Newsmax is now available in English on channel 204 through HOT Israel, a major telecommunications and pay TV operator. The launch reaches more than 200,000 subscribers and expands Newsmax’s footprint in a key U.S.-ally market, providing Israeli audiences with access to breaking news, political analysis and cultural coverage.
  • Primetel (Cyprus) – Newsmax has debuted on channel 241 via Primetel, a leading IPTV and telecom provider in Cyprus. Primetel subscribers can access Newsmax’s live news, interviews and talk programming, further strengthening Newsmax’s presence in the eastern Mediterranean region.
  • Newsmax Ukraine – Newsmax has signed a brand license agreement for the launch of Newsmax Ukraine, a localized news channel expected to go live in the first half of 2026. The channel will operate under the Newsmax brand and editorial framework, marking an important step in the Company’s Eastern European growth strategy and its commitment to expanding access to international news in the region.

Newsmax is now available in more than 100 countries across five continents. According to Nielsen, Newsmax is the fourth highest-rated cable news network in the United States, reaching over 40 million Americans through its television channel, streaming services and digital platforms.

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.”

For more information, please visit Investor Relations | Newsmax Inc.

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.

Investor Contacts
Newsmax Investor Relations
ir@newsmax.com

SOURCE: Newsmax Inc.

View the original press release on ACCESS Newswire

Release – Tonix Pharmaceuticals Announces Pricing of $20.0 Million Registered Direct Offering

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December 29, 2025 7:57am EST Download as PDF

CHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial stage biotechnology company, today announced it has entered into a securities purchase agreement with Point72 for the purchase and sale of 615,025 shares of its common stock at an offering price of $16.26 per share and, in lieu of shares of common stock, pre-funded warrants to purchase up to an aggregate of 615,025 shares of common stock at a purchase price of $16.259 per pre-funded warrant, which equals the offering price per share of the common stock less the $0.001 per share exercise price of each pre-funded warrant. The closing of the offering is expected to take place on or about December 30, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds of the offering will be approximately $20.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the commercialization of its marketed products, the development of its product pipeline, and general working capital and corporate purposes.

TD Cowen is acting as sole placement agent for the offering. A.G.P./Alliance Global Partners is acting as a financial advisor.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-287965) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com.

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 registration or qualification under the securities laws of any such state or other jurisdiction.

Tonix Pharmaceuticals Holding Corp.*
Tonix 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.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.

Other serotonergic drugs: Serotonin syndrome has been reported.

CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

Tramadol: Seizure risk may be enhanced.

Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Source: Tonix Pharmaceuticals Holding Corp.

Released December 29, 2025

Release – Tonix Pharmaceuticals Announces Program Updates on Phase 2/3-Ready Long-Acting Monoclonal Antibody (mAb) Designed for Seasonal Prevention of Lyme Disease (TNX-4800)

Research News and Market Data on TNXP

December 29, 2025 7:45am EST Download as PDF

Exploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive field study

Expect to have investigational product of TNX-4800 (anti-Borrelia OspA mAb) available for clinical trials in early 2027

Approximately 70 million people that live, work or vacation in areas of the U.S. in which Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis

CHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial stage biotechnology company, today announced program updates on TNX-4800 (formerly known as mAb 2217LS)1,2, which is a long-acting human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans. TNX-4800 is being developed for annual seasonal use, as one subcutaneous administration in the spring to protect against Lyme disease through fall, or the entire tick season in the U.S. There are no currently marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

“We plan to meet with the FDA in 2026 to explore Phase 2/3 development options,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe a controlled human infection model (CHIM)3-5 study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval. We are on a path to have investigational product produced under Good Manufacturing Practices (GMP) available for testing early in 2027. We believe TNX-4800’s long-acting mAb prophylaxis could play an important role for preventing Lyme for millions of people who live, work, and vacation in regions endemic for Lyme disease. TNX-4800 provides near-immediate immunity to the bacteria that cause Lyme disease after a single administration, which is very different from Lyme disease vaccine programs currently in development. Prophylaxis with TNX-4800 may also avoid the limitations of vaccine products designed to actively immunize against Lyme, including suboptimal immune responses from age, immunocompetence, and other reasons.”

About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a fully human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. By binding OspA when TNX-4800 containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. Published work in non-human primates showed that TNX-4800 was 95% effective in preventing infection after 6 days of exposure to ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its crystallizable fragment (Fc) domain which served to prolong the serum half-life. A single administration in the Spring is designed to provide immunity within two days and maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of the major Borrelia genospecies from ticks to animals. TNX-4800 also sidesteps the multidose schedules required for OspA vaccines in development6 and FDA-approved vaccines that have been withdrawn from the market due to concerns about increased risk of autoimmunity.7 Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA) to the FDA.

About TNX-4800 Pharmacokinetics
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, pharmacokinetics (PK), and immunogenicity of TNX-4800 in healthy adults. Forty-four subjects were randomized and 41 completed the study. Subjects received a single subcutaneous (SC) administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25-times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62–69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 20% of the highest exposures in a rat toxicology study. Anti-drug antibodies (ADA) were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

About Lyme Disease 
In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year.8 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed, and even with treatment, up to 20% of cases may progress to a Post-Treatment Lyme Disease Syndrome (PTLDS) called “Chronic Lyme” or “Long Lyme”. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue and other symptoms.9

About Borrelia Burgdorferi
In infected deer ticks, Borrelia’s OspA lipoprotein binds to tick-gut receptor TROSPA and helps it adhere to the midgut lining. During a tick bite blood meal, Borrelia downregulates OspA, upregulates OspC, and activates motility genes. Borrelia undergoes a metamorphic-like transformation, becoming highly flagellated and mobile, which facilitates migration to the tick salivary glands and invasion of human host tissues. During a tick bite of an animal pre-treated with TNX-4800, the tick ingests host blood containing TNX-4800, which kills and blocks the metamorphic-like transformation of Borrelia in the tick’s midgut preventing transmission of the bacteria. Lyme-causing Borrelia-exposed or -infected individuals, rarely make antibodies against OspA which allows for people to be reinfected despite having immunity to OspC. Consequently, we expect that protection against Borrelia would require annual prophylaxis with TNX-4800.

About Monoclonal Antibody Prophylaxis
Two long-acting monoclonal antibody products10,11 have won FDA approval for prophylaxis against respiratory syncytial virus (RSV). AstraZeneca (in partnership with Sanofi) markets Beyfortus™ (nirsevimab) and Merck markets Enflonsia™ (clesrovimab).

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.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Citations

1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.

2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.

3Cavaleri M, et al.. Biologicals. 2024. 85:101745.

4Abo YN, et al.. Lancet Infect Dis. 2023. 23(12):e533-e546.

5Ramanathan R, et al.. Vaccine. 2019 Jul 18;37(31):4256-4261.

6Comstedt P, et al. Vaccine. 2015 33(44):5982-8.

7Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn over concerns about an increased risk of autoimmune arthritis triggered by molecular mimicry, particularly in HLADRB1*0401 (“DR4+”) individuals. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. doi: 10.1017/S0950268806007096. Epub 2006 Aug 8. PMID: 16893489; PMCID: PMC2870557.

8Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. doi: 10.1093/cid/ciz872. PMID: 31620776; PMCID: PMC7155782.

9National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.

10May 29, 2025. Sanofi Press Release. “Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs.” https://bit.ly/40DeJGf

11June 9, 2025. Merck Press Release. “U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season” https://bit.ly/4kkXDE8.

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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 
 

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.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released December 29, 2025

Release – First Phosphate Common Shares Added to the CSE25 Index

Research News and Market Data on FRSPF

December 29, 2025 7:11 AM EST | Source: First Phosphate Corp.

Saguenay, Quebec–(Newsfile Corp. – December 29, 2025) – First Phosphate Corp. (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) (“First Phosphate” or the “Company“) is pleased to announce that, effective December 19, 2025, its common shares have been added to the CSE25 Index as part of the Canadian Securities Exchange’s (“CSE”) quarterly index rebalancing.

The CSE 25 Index is comprised of the 25 leading companies listed on the CSE, selected based on market capitalization and liquidity criteria. Inclusion in the index increases visibility among institutional and retail investors and results in broader exposure through index-linked investment products and mandates.

“Inclusion in the CSE25 reflects the growing recognition of First Phosphate’s strategic positioning within the North American critical minerals and energy transition ecosystem,” said John Passalacqua, CEO of First Phosphate. “As lithium iron phosphate (“LFP”) batteries are now the dominant chemistry for grid-scale energy storage, data centers and mobility applications, investors are increasingly focused on secure, domestic sources of high-purity phosphate and our differentiated, vertically integrated platform to serve that demand.”

First Phosphate is advancing a rare, high-purity igneous phosphate resource in Saguenay-Lac-Saint-Jean, Quebec, with the objective of supplying high purity phosphate-based downstream materials required for LFP batteries. The Company’s mine-to-market strategy is focused on onshoring critical battery materials, reducing supply chain risk, and supporting North American energy security.

First Phosphate has recently produced commercial-grade LFP 18650 battery cells using North American critical minerals: https://firstphosphate.com/north-american-lfp-battery-cells

The high-purity phosphoric acid and iron powder for these LFP 18650 battery cells was produced using rare igneous anorthosite rock extracted from the Company’s Bégin-Lamarche property in Saguenay-Lac-Saint-Jean, Quebec.



To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/8917/279099_3516aef334ac8b75_001full.jpg

About First Phosphate Corp.

First Phosphate (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) is a mineral exploration, development and cleantech company dedicated to building and onshoring a vertically integrated mine-to-market lithium iron phosphate (LFP) battery supply chain for North America. Target markets include energy storage, data centers, robotics, mobility and national security. First Phosphate’s flagship Bégin-Lamarche Property in Saguenay-Lac-Saint-Jean, Quebec, Canada is a North American rare igneous phosphate resource yielding high-purity phosphate with minimal impurities.

Media & Investor Contact:

Bennett Kurtz
Chief Financial Officer
bennett@firstphosphate.com
Tel: +1 (416) 200-0657

Investor Relations: investor@firstphosphate.com
Media Relations: media@firstphosphate.com
Website: www.FirstPhosphate.com

Follow First Phosphate:

X: https://x.com/FirstPhosphate
LinkedIn: https://www.linkedin.com/company/first-phosphate

-30-

Forward-Looking Information and Cautionary Statements

This release includes certain statements that may be deemed “forward-looking information”. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. In particular, this press release contains forward-looking information relating to, among other things: increased visibility among institutional and retail investors and broader exposure through index-linked investment products and mandates resulting from inclusion in the CSE25 index; supplying high purity phosphate-based downstream materials required for LFP batteries; the Company’s plans for onshoring critical battery materials, reducing supply chain risk, and supporting North American energy security; and the Company’s plans for building and onshoring a vertically integrated mine-to-market LFP battery supply chain for North America. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include development and exploration successes, continued availability of capital and financing, and general economic, market or business conditions. These statements are based on a number of assumptions including, among other things, assumptions regarding general business and economic conditions; there being no significant disruptions affecting the activities of the Company or inability to access required project inputs; permitting and development of the projects being consistent with the Company’s expectations; the accuracy of the current mineral resource estimates for the Company and results of metallurgical testing; certain price assumptions for P2O5 and Fe2O3; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the Company’s relationship with First Nations and other Indigenous parties remaining consistent with the Company’s expectations; the Company’s relationship with other third party partners and suppliers remaining consistent with the Company’s expectations; and government relations and actions being consistent with Company expectations. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. The Company does not assume any obligation to update or revise its forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law. All forward-looking information contained in this release is qualified by these cautionary statements.

info

Source: First Phosphate Corp.