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Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

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May 27, 2026 7:00am EDT

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results show that these design objectives were achieved in TNX-1500.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety, tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile, suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose.

TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts

Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts

Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

The Russell Reconstitution 2026 Preliminary List

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The preliminary list of stocks to be included in the Russell Reconstitution, and also which Russell Index, is a significant day for many stock investors and the impacted companies as well. This year, it occurred on Friday, May 22. The list, although preliminary and subject to refinements each Friday through June, includes the stocks believed to meet the requirements based on valuations taken on April 30. This is the first official filing from the popular index provider, and it gives the investor public an early look at what to expect when the indexes are reconstituted. The reconstitution can be expected to impact prices as index fund managers readjust their holdings. The event also, for many, redefines the market-cap levels that are considered small-cap, mid-cap, and large-cap. This year carries an added dimension: for the first time since 1989, FTSE Russell has moved to a semi-annual reconstitution schedule. That means the June event will be followed by a second reconstitution in December.

Background

The Russell Reconstitution reconfigures the membership of the Russell indexes by defining the top 3,000 stocks based on market cap (Russell 3000), then the top 1,000 stocks (Russell 1000), and reclassifying the remaining 2,000 stocks to form the Russell 2000 Small Cap Index. These serve as a benchmark for many institutional investors, as the indexes reflect the performance of the U.S. equity market across different market-cap classifications. An estimated $11 trillion in assets are benchmarked to the Russell Indexes, which makes the annual reconstitution process one of the most consequential events in the equity markets each year. By adding, removing, and reweighting stocks, the reconstitution process ensures the indexes accurately represent the market.

The Preliminary List, published after the market closed on May 22, 2026, is a critical step in the market cap reclassification process. It gives market participants an initial look at potential additions and deletions from the indexes. Stocks on this preliminary roster often experience increased attention from investors, since the list signals where buying or selling pressure could build once the final reconstitution is completed.

The June 2026 reconstitution reflects a U.S. equity market with continued strength among mega-cap leaders and improving breadth in small-cap segments. Technology and Industrials led movement into the Russell 1000, while companies across several industries replenished the Russell 2000, reinforcing its role as a pipeline for emerging companies.

The newly reconstituted indexes become live after the market close on June 26, 2026.

Implications for Investors

The release of the Russell Preliminary List on May 22 could provide opportunities for investors, including:

Enhanced Market Visibility. Companies listed on the Preliminary List may experience increased trading volumes and heightened market attention, or even scrutiny, as investors evaluate their potential inclusion in the Russell indexes.

Potential Price Movements. Stocks slated for addition or deletion from the indexes can experience price volatility as market participants adjust their positions ahead of the anticipated reconstitution changes.

Portfolio Adjustments. Active managers who track the Russell indexes may need to realign their portfolios to reflect the new index constituents, which can trigger buying or selling activity in affected stocks.

Semi-Annual Impact. The move to a twice-yearly reconstitution schedule in 2026 means these dynamics will now play out two times per year. Investors and IR teams should start preparing for a December reconstitution cycle as well, with a second rank day expected in the fall.

Investor Considerations

Stock market participants should keep the following in mind when analyzing the Preliminary List and its potential impact:

Upcoming Update Dates. Following the May 22 preliminary release, updated lists will be posted after 6 PM ET on May 29, June 5, June 12, and June 18. The reconstitution becomes final after the close of U.S. equity markets on June 26, 2026. Watching these updates is the best way to track actual index membership changes as they develop.

Final Reconstitution. The Preliminary List is subject to changes before the final reconstitution. Updates may occur due to faulty data or significant corporate changes, such as a merger, that took place after the April 30 market cap snapshot.

Fundamental Analysis. The fundamentals and financial health of the companies should always be among the most important factors for non-index investors to consider. Historically, potential additions have often presented attractive investment opportunities, while potential deletions may result in a stock receiving less attention from the broader market.

Take Away

The Preliminary List released on May 22, 2026, is an important early step in the Russell Reconstitution process. This year it also marks a structural change in how the reconstitution works, with the shift to semi-annual rebalancing adding a new layer of relevance for investors and companies alike. The stocks listed may experience increased market visibility and price movement in the weeks ahead, but the list remains subject to changes through June 18. The final reconstitution takes effect after market close on June 26. As always, thorough fundamental analysis, including earnings, growth potential, and liquidity, should guide investment decisions. For more information to evaluate small-cap names, look to Channelchek as a source of data on over 6,000 small-cap companies

GeoVax Labs (GOVX) – Development To Focus On Best Opportunities In Infectious Disease and Oncology

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Wednesday, May 27, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Resources To Focus On Current Market Needs. GeoVax has reviewed its pipeline products in infectious disease and oncology programs. Preparations will continue for the Phase 3 immunobridging trial in Mpox, expected to begin later this year.  A Phase 2 for Gedeptin is planned for FY2027. Development of CM-04S1 has been terminated, as the diminished need for a vaccine to protect immunocompromised patients from COVID-19 no longer justifies its continuation.

GEO-MVA and Infectious Diseases Remain A Priority. As discussed in our Research Note on May 19, 2026, GeoVax is preparing for a Phase 3 immunobridging trial in Mpox that could meet EMA requirements for accelerated approval. The trial is expected to begin in 2H26 with a planned enrollment of about 500 participants. The preclinical pipeline includes products for other infectious viruses that could be developed if grant or other funding were available.


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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. 

Cocrystal Pharma (COCP) – Technology Platform Has Novel Therapeutics Against Hantavirus, Bunyavirus, and Influenza

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Wednesday, May 27, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Proprietary Technology Has Produced A Large Library Of Novel Antivirals. Cocrystal has developed a library of antivirals based on its proprietary technology. While clinical development has prioritized products with clear medical needs and regulatory pathways to approval, it continues to research new compounds that can be moved into development as public health needs change. After the recent outbreaks of hantavirus, Ebola, and several previously lesser-known viruses, the company tested some of these compounds and found them to be effective.

Cocrystal’s Proprietary Technology Acts Early In The Viral Lifecycle. Cocrystal drugs target enzymes essential to the viral life cycle and reproductive process. These enzymes are highly conserved across viral families and rarely mutate, allowing compounds to show broad efficacy against multiple strains. This differs from vaccines that train the immune system to recognize and kill a virus. Vaccines often target surface proteins that can mutate, rendering the vaccine ineffective.


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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. 

Nicola Mining Inc. (NICM)(NIM:CA) – Visible Production and Cash Flow Growth Coupled with Significant Discovery Potential

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Wednesday, May 27, 2026

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Unique within the junior mining space. Nicola Mining (NASDAQ: NICM, TSX.V: NIM) combines near-term cash flow generation with significant exploration upside across a portfolio of gold, silver, and copper assets in British Columbia. A key strategic asset is the fully permitted Merritt Mill, the only facility in British Columbia allowed to process third-party gold and silver ore, with expansion plans underway to increase throughput capacity. Nicola seeks to leverage its mill by providing milling services under profit-sharing agreements to third parties and consolidating small high-grade gold and silver projects in British Columbia, while advancing its New Craigmont Copper, Treasure Mountain Silver, and Dominion Creek Gold projects.

Advancing multiple avenues of growth. Nicola’s flagship New Craigmont Copper Project is a significant value driver, with ongoing drilling targeting a potential large-scale porphyry copper system adjacent to the Highland Valley Copper Mine. Nicola is also advancing the high-grade Treasure Mountain Silver Project and the Dominion Creek Gold Project, both of which are expected to see increased exploration and development activity later this year.


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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. 

First Phosphate Corp. (FRSPF) – A Major Expansion and Upgrading of Mineral Resources

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Wednesday, May 27, 2026

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A Major Expansion and Upgrading of Mineral Resources. First Phosphate released the results of its updated Mineral Resource Estimate (MRE) for the Begin-Lamarche project in Saguenay-Lac-Saint Jean, Quebec, Canada. The updated MRE reflects the success of the company’s 2025 to 2026 drilling campaign, resulting in a 378% increase in indicated resources compared to the previous estimate completed two years ago. The significant upgrade is important because it advances a significant portion of the resource into the indicated and measured categories, which are required to move the project toward a feasibility study targeted for December 2026.

Longer Potential Mine Life. The ability to upgrade existing resources and classify newly discovered extensions directly into the indicated category demonstrates the strong continuity, consistency, and quality of the deposit. The increased tonnage is also expected to support a longer potential mine life, while the deposit remains open at depth, providing additional exploration upside and long-term growth potential.


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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. 

Stratasys Acquires MarkForged for $42.5 Million in All-Cash Deal Targeting Defense and Aerospace 3D Printing Growth

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Stratasys Ltd. (Nasdaq: SSYS), a Minnesota and Israel-based leader in additive manufacturing solutions, announced Wednesday it has entered into a definitive agreement to acquire MarkForged, Inc. in an all-cash transaction valued at $42.5 million, subject to customary adjustments. MarkForged is currently a wholly owned subsidiary of Nano Dimension (Nasdaq: NNDM), which will retain MarkForged’s Metal Binder Jetting product line as part of the deal structure. The transaction is expected to close in the second half of 2026, subject to regulatory approvals and customary closing conditions.

At $42.5 million for a business that generated approximately $70 million in revenue in 2025, the transaction reflects an implied revenue multiple of roughly 0.6 times trailing sales. Stratasys expects the deal to be accretive to gross margins and generate positive adjusted EBITDA contribution within the first year following close, though actual results may differ from these forward-looking projections.

What Stratasys Is Acquiring

MarkForged built its core technology around Continuous Carbon Fiber Fused Filament Fabrication, a manufacturing approach that enables production of parts that are lighter and stronger than traditional alternatives. Its integrated platform, the Digital Forge, combines 3D printing hardware, proprietary high-performance materials, and a software ecosystem that includes simulation, part management, and automated print optimization designed with security and compliance requirements in mind.

The acquisition adds a broad portfolio of high-performance polymer and metal filaments to Stratasys’ existing materials capabilities, expanding the combined company’s addressable market across aerospace, defense, automotive, and industrial production verticals. MarkForged’s partner and reseller network is also expected to generate cross-selling opportunities across both companies’ existing customer bases.

The Industry Context

The additive manufacturing sector has been undergoing consolidation as demand for production-grade 3D printing grows in defense and aerospace applications. Government agencies including the Air Force Research Laboratory, DARPA, and the Space Force have expanded procurement of components produced through additive manufacturing for tooling, fixtures, ground support equipment, and select production parts.

Supply chain resilience has emerged as a structural driver of this demand. The ability to produce certified, production-ready components digitally on demand reduces dependence on traditional global supply chains, a priority that has gained urgency across both commercial and defense manufacturing environments since 2020. Stratasys positions this acquisition as a response to that demand shift, strengthening its capabilities in sectors where performance, reliability, and manufacturing agility are operational requirements.

Key Risks to Monitor

As with any acquisition, execution risk exists. The successful integration of MarkForged’s operations, technology, and personnel into Stratasys is not guaranteed. Stratasys is itself a small cap company operating in a competitive and evolving technology sector. The additive manufacturing market continues to face headwinds including longer-than-anticipated enterprise adoption cycles, pricing pressure from emerging competitors, and macroeconomic factors that can compress capital equipment budgets at customer organizations. The projected synergies and EBITDA accretion within the first year are forward-looking estimates and may not materialize as projected.

Stratasys has indicated it will update its financial guidance following the closing of the transaction.

The Russell 2000 Is Leading Again. Is This Time Different?

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Small caps are back in front. The Russell 2000 climbed 1.70% Tuesday, outpacing the Nasdaq’s 1.16% gain, the S&P 500’s 0.73% advance, and the Dow’s modest 0.17% move, as markets returned from the Memorial Day holiday weekend and immediately pushed toward record territory. The outperformance did not happen in a vacuum. It happened despite fresh escalations in both the Iran conflict and the war in Ukraine, two headlines that would have rattled markets badly just a few months ago.

The fact that investors are actively choosing to ignore those risks and rotate into the smallest, most domestically exposed names in the market says something worth paying attention to.

Going into Memorial Day, the narrative around small caps had been running dark. The Russell 2000 spent three consecutive weeks underperforming large cap indices as Treasury yields hit 19-year highs, traders priced in a near 50% probability of Fed rate hikes by year-end, and consumer sentiment fell to an all-time record low. Small caps carry disproportionately more variable-rate debt and have less balance sheet flexibility to absorb a prolonged higher-rate environment, which meant they bore the brunt of that anxiety more than any other segment of the market.

Tuesday’s session is the first indication that the selling pressure may have been overdone.

To understand why today matters, the short-term volatility needs to be placed inside the larger story building all year. The Russell 2000 entered 2026 trading at a 31% discount to the S&P 500 on a forward price-to-earnings basis, a valuation gap that had reached its widest level in over 25 years. In January, the index staged a historic 15-session winning streak against the S&P 500, the longest period of small cap dominance since May 1996, as institutional capital began rotating out of overextended large cap technology and into domestic-focused companies.

That rotation stalled in March and April as the Iran conflict sent oil surging, Treasury yields spiked, and rate cut expectations evaporated. But the fundamental case never went away. Russell 2000 companies generate approximately 80% of their revenue domestically, making them direct beneficiaries of the onshoring trend and fiscal provisions in the One Big Beautiful Bill Act. Consensus earnings growth estimates for the Russell 2000 sit at 44.9% year over year for Q1, the highest forward bar since mid-2025. The fundamentals have not deteriorated. The sentiment did.

Whether today represents the start of a sustained rotation or a post-holiday bounce will be answered in the sessions ahead. If the 30-year yield retreats from its 5.12% recent peak and rate hike probabilities fade, the conditions for a durable small cap rally fall into place. If yields hold and Fed Chair Kevin Warsh signals a hawkish June, today’s move fades just as quickly.

The underlying case remains intact. The Russell 2000 does not need perfection to move higher. It needs the rate picture to stop getting worse. Today, at least, that is exactly what the market decided to believe.

Release – First Phosphate Reports Updated Mineral Resource Estimate for Bégin-Lamarche Phosphate Deposit

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Saguenay, Quebec–(Newsfile Corp. – May 26, 2026) – First Phosphate Corp (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) (“First Phosphate” or the “Company”)  is pleased to announce the results of its updated Mineral Resource Estimate (“MRE”) for its Bégin-Lamarche project in Saguenay-Lac-Saint-Jean, Québec, Canada. The updated MRE includes results from the 2025-2026 drilling program described in the Company’s press release dated April 27, 2026.

  • The updated MRE includes a 378% increase in Indicated Mineral Resources over the Company’s Initial MRE dated September 9, 2024.
  • Measured pit-constrained Mineral Resource: 6.2 Mt @ 7.70% P2O5 (phosphate).
  • Indicated pit-constrained Mineral Resource: 198.5 Mt @ 6.00% P2O5.
  • Inferred pit-constrained Mineral Resource: 89.5 Mt @ 6.16% P2O5.
  • The Deposit remains open at depth.
  • Metallurgical test work indicates an anticipated apatite concentrate grade of 40.4% P2O5 at an 88% process recovery rate, with very low levels of potentially deleterious elements, and has been qualified for production of battery-grade phosphoric acid for lithium iron phosphate (“LFP”) battery with a conversion ratio of 91.1%.
  • The Deposit is located next to existing road and hydroelectric infrastructure and at only 70 km driving distance from the deep-sea Port of Saguenay.
  • The Deposit benefits from definitive, long-term, partially prepaid offtake from an existing, creditworthy partner.
  • Apatite (phosphorus, phosphate) is listed on the critical minerals lists of Québec, Canada, the United States and the European Union.

“We are pleased with the results of our 2025-2026 drilling exploration program and the quantity and quality upgrade provided to our Mineral Resources,” says First Phosphate CEO, John Passalacqua. “We are now able to continue to move the project forward with great confidence in our Mineral Resources.”

The updated MRE, with an effective date of May 1, 2026, was carried out by Mr. Antoine Yassa, P.Geo., of P&E Mining Consultants Inc., who is an Independent Qualified Person within the meaning of Canadian Securities Administrators’ National Instrument 43-101: Standards of Disclosure for Mineral Projects (“NI 43-101”).

The Bégin-Lamarche Phosphate Deposit contains a significant phosphate Mineral Resource that is associated with well-defined oxide-apatite peridotite (OAP) intrusions within the large Lac-Saint-Jean anorthosite suite (LSJAS). The LSJAS is the largest phosphate-mineralized anorthosite worldwide. The phosphate Deposit is comprised of four mineralized zones which are continuous, only separated by faults within the Deposit and extend over a length of 2,750 m (Figure 1). The Mountain Zone is a single phosphate-bearing mass having a diameter of up to 200 m and a length of 250 m. The Northern zone is comprised of four phosphate layers ranging from 30 m to 200 m in thickness and a length of 625 m. The Central Zone bears eight phosphate layers, one of them having up to 50 m in thickness and extending to 900 m. The Southern Zone bears three phosphate layers, one of them having up to 125 m in thickness and extending to 725 m.

Figure 1 – The Bégin-Lamarche Deposit Updated Optimized Pit Shell

Cannot view this video? Visit:
https://www.youtube.com/watch?v=d3kPMqd6rUU

The Bégin-Lamarche Deposit mineralized wireframes boundaries were determined from lithology, structure, and grade boundary interpretation based on visual inspection of drill hole cross-sections. Four mineralized wireframe zones were developed and referred to as the Mountain, Northern, Central and Southern Zones. The mineralized wireframes were constructed on 50 m spaced vertical cross-sections, with on-screen digitized polylines on drill hole cross-sections in GEMS™. The mineralized wireframe outlines were influenced by the selection of mineralized material above 2.5% P2O5 that demonstrated a lithological and structural zonal continuity along strike and down dip. In some cases, mineralization <2.5% P2O5 was included for the purpose of maintaining mineralized zone continuity. The minimum constrained width for mineralized wireframe interpretation was 3 m of drill core length.

The Bégin-Lamarche Mineral Resource Estimate is based on 276 drill holes totalling 68,345 m. The database contained 20,682 analyses for percentage of P2O5. The Mineral Resource Estimate is presented in Table 1.

 Table 1
Pit-Constrained Mineral Resource Estimate(1-4) at 2.5% P2O5 Cut-Off
ClassificationZoneTonnes (M)P2O5 (%)P2O5 (Mt)
MeasuredMountain6.27.700.47
Total6.27.70.47
IndicatedMountain5.38.450.45
Northern78.36.695.24
Central71.05.503.91
Southern43.95.262.31
Total198.56.0011.91
Measured & IndicatedMountain11.58.040.92
Northern78.36.695.24
Central71.05.503.91
Southern43.95.262.31
Total204.76.0512.38
InferredMountain0.59.090.04
Northern30.77.332.25
Central31.85.671.80
Southern26.55.321.41
Total89.56.165.50

 
Note: P2O5 = phosphorus pentoxide.

1. Mineral Resources, which are not Mineral Reserves, do not have demonstrated economic viability.

2. The estimate of Mineral Resources may be materially affected by environmental, permitting, legal, title, taxation, socio-political, marketing, or other relevant issues.

3. The Inferred Mineral Resource in this estimate has a lower level of confidence than that applied to an Indicated Mineral Resource and must not be converted to a Mineral Reserve. The Company expects that the majority of the Inferred Mineral Resource may be upgraded to an Indicated Mineral Resource with continued exploration.

4. The Mineral Resources in this press release were estimated using the Canadian Institute of Mining, Metallurgy and Petroleum (CIM), CIM Standards on Mineral Resources and Reserves, Definitions (2014) and Best Practices Guidelines (2019) prepared by the CIM Standing Committee on Reserve Definitions and adopted by the CIM Council.
 

The Bégin-Lamarche Mineral Resource Estimate was derived from applying a 2.5% P2O5 cut-off value to the pit-constrained block model and reporting the resulting tonnes and grades for potentially mineable areas. The following parameters were used to calculate the cut-off value that determines the open pit potentially economic portion of the constrained mineralization (Table 2).

The P2O5 cut-off value is calculated with parameters below:

  • US$:C$ Exchange Rate: $0.72
  • P2O5 Price (32%): US$225/t (approx five-year trailing average)
  • P2O5 Price (40%): US$280/t
  • P2O5 Process Recovery: 88%
  • Processing & Conc Transport Cost: C$20/t
  • G&A: $1.50/t
  • Mining Cost: C$2.75/t (mineralized material and waste)
  • Pit Slopes: 45°

Accordingly, the P2O5 cut-off of potential open pit mining is calculated to be = 2.5%.

The optimized pit-constrained Mineral Resource Estimate is moderately sensitive to the selection of reporting P2O5 cut-off values, as demonstrated in Table 2.

Table 2
Pit-Constrained Mineral Resource Estimate Sensitivity to P2O5 Cut-Off
ClassCut-offTonnesP2O5P2O5
P2O5 %(M)(%)(Mt)
Measured5.04.98.670.4
4.55.28.430.4
4.05.58.220.5
3.55.88.020.5
3.06.07.840.5
2.56.27.700.5
2.06.37.570.5
Indicated5.0119.07.418.8
4.5138.07.059.7
4.0156.86.7110.5
3.5172.96.4411.1
3.0186.76.2011.6
2.5198.56.0011.9
2.0207.65.8312.1
Inferred5.055.57.494.2
4.565.07.094.6
4.073.66.755.0
3.580.96.495.2
3.086.06.295.4
2.589.56.165.5
2.092.06.055.6

Metallurgical Testwork has been successfully conducted by SGS at their Québec City facility with additional support by SGS Lakefield Ontario. Recent test results have confirmed that an apatite concentrate can be obtained analyzing 40.4% P2O5 and at 88% recovery.

First Phosphate’s Bégin-Lamarche Deposit is located approximately 50 km driving distance north of the City of Saguenay, Québec’s sixth-largest city, which hosts daily flights to Montréal, a skilled industrial workforce, strong local infrastructure, and which is 30 km driving distance from the deep-sea Port of Saguenay.

The geological and drilling work was planned, carried out and supervised by Laurentia Exploration Inc. The drill core was logged at Lamarche near the Deposit and at Laurentia Exploration’s offices. The drill core was sawed and sampled at Laurentia Exploration’s offices in Jonquière.

Qualified Persons

The scientific and technical disclosure for First Phosphate included in this News Release have been reviewed and approved by Steeve Lavoie, P.Geo. Mr. Lavoie is Chief Geologist of the Company and a Qualified Person under National Instrument 43-101 Standards of Disclosure of Mineral Projects (“NI 43-101”).

The Qualified Person independent of the issuer, responsible for estimating the Mineral Resources of the Begin-Lamarche Property, within the meaning of NI 43-101, is Mr. Antoine Yassa, P.Geo., of the firm P&E Mining Consultants Inc. Mr. Yassa has read and approved the scientific and technical information in this press release for accuracy and compliance with NI 43-101.

P&E Mining Consultants Inc., an associate group of 20 geological and mine engineering professionals established in 2004, provides geological and mine engineering consulting reports, Mineral Resource and Mineral Reserve Estimates, NI 43-101 Technical Reports, Preliminary Economic Assessments, Pre-Feasibility and Feasibility Studies.

Laurentia Exploration inc. is a firm of consulting geologists based in Jonquière, Saguenay Lac-St-Jean. It has 80 employees, mainly geology professionals who are members in good standing of a professional order. The firm was founded in 2017 and carries out projects throughout Québec and Ontario.

About First Phosphate Corp.

First Phosphate (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) is a mineral exploration and development and clean technology company dedicated to building and reshoring a vertically integrated mine-to-market supply chain for the production of LFP batteries in North America. Target markets include energy storage, data centers, robotics, mobility, and national security.

First Phosphate’s flagship Bégin-Lamarche property, located in Saguenay-Lac-Saint-Jean, Québec, Canada, represents a rare North American igneous phosphate resource producing high-purity phosphate characterized by very low levels of impurities.

For additional information

Steeve Lavoie
Chief Geologist
Tel: +1 (418) 815-5416

Investor Relations: https://firstphosphate.com/investors
General Inquiries: https://firstphosphate.com/contact
Website: www.FirstPhosphate.com
X : https://x.com/FirstPhosphate
LinkedIn : https://www.linkedin.com/company/first-phosphate

Forward-Looking Information and Cautionary StatementThis news release contains certain statements and information that may be considered “forward-looking statements” and “forward looking information” within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking statements and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved” and other similar expressions. In addition, statements in this news release that are not historical facts are forward looking statements, including, among other things: the Company’s planned exploration and production activities; the properties and composition of any extracted phosphate; and the calculation of mineral resources at the project and the possibility of eventual economic extraction of minerals from the project. 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: that engineering and construction timetables and capital costs for the Company’s, exploration, development and expansion projects are correctly estimated and not affected by unforeseen circumstances; the ability to obtain financing for its proposed operations on acceptable terms; no material deterioration in general business and economic conditions; no material delays in obtaining permits and other approvals; no significant disruptions affecting the activities of the Company or its ability to access required project equipment and services, and operating supplies in sufficient quantities and on a timely basis; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the ability to complete the exploration and development programs consistent with the Company’s expectations; commodity price expectations including assumptions for P2O5; the Company’s relationship with local municipalities and First Nations 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

Release – Tonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at The Professional Society for Health Economics and Outcomes Research (ISPOR) 2026 Annual Meeting

Posted on by [email protected]

May 26, 2026 7:00am EDTDownload as PDF

Real-world analysis of three years of closed claims data from Symphony Health focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia

Data underscore high comorbidity burden, multimodal treatment approach, and extensive healthcare resource utilization (HCRU) among patients with fibromyalgia

Tonix commercially launched TONMYA® in November 2025, the first new fibromyalgia drug for adults in the U.S. approved in over 15 years

BERKELEY HEIGHTS, N.J., May 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data from a real-world claims analysis characterizing U.S. adults with fibromyalgia in a poster at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, held May 17-20, 2026, in Philadelphia, Pennsylvania.

“Fibromyalgia is a chronic pain disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbance, cognitive dysfunction, and somatic symptoms, leading to substantial management challenges,”1-4 said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “More than 10 million adults in the U.S. suffer from fibromyalgia. In response to fibromyalgia’s complex and persistent symptoms, and extensive comorbidities, fibromyalgia patients face rotating treatment approaches, and high HCRU. These findings highlight the need for comprehensive disease management and more effective therapeutic interventions to reduce the clinical and economic burden of fibromyalgia. Tonix is focused on the commercial launch of TONMYA, a first-in-class, first-line, non-opioid analgesic medicine designed for daily bedtime administration and long-term use.”

Data presented at ISPOR 2026 represent a retrospective, multi-year, multi-cohort study using the Symphony Health closed claims database, encompassing administrative medical and pharmacy claims collected between April 2021 and April 2024. The study’s objective was to evaluate real-world characteristics, including demographics, comorbidities, and HCRU among adults diagnosed with fibromyalgia (ICD-10-CM diagnosis code M79.7). The Year 3 cohort (April 2023 to March 2024) included 261,776 adult patients, with a median age of 53 years. Most patients were female (92.1%). Patients were White non-Hispanic (49.6%), Hispanic (22.4%), Other (19.6%), and Black (8.3%).

Comorbidity burden was high, with 93.2% of patients having at least one fibromyalgia-related comorbidity, most commonly anxiety/depression (63.9%), dorsalgia/back pain (56.5%), hypertensive diseases (51.4%), and joint pain (48.4%). Among the 90.3% of patients with at least one co-existing condition (or comorbidity), 36.2% had four or more, and subgroups including Black/Brown women, women on opioids, women with gut health issues, and older women with sleep issues all carried higher rates of comorbidity than the overall cohort. Among insured patients (n=92,157), HCRU was extensive, and inpatient services represented the largest component of healthcare costs at $29,896 per patient annually, followed by pharmacy ($9,453) and outpatient ($6,196) costs, demonstrating the large burden on commercial and public healthcare programs. Antidepressants were the most frequently used medication class (48.2%), followed by NSAID analgesics (43.4%), anticonvulsants (41.6%), gastric acid secretion reducers (41.5%), skeletal muscle relaxants (40.7%), and opioid analgesics (39.4%). The medication use reflects reliance on multimodal pharmacologic strategies to manage fibromyalgia-related symptoms in routine clinical practice.

A copy of the Company’s poster presentation, “Characterizing Patients with Fibromyalgia: A U.S. Real-World Claims Analysis,” is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations/.

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.

Citations

1. Bilge U, et al. Cardiovasc Dis. 2018;155:30–5.
2. Choy EH, Mease PJ. Rheum Dis Clin North Am. 2009;35(2):329–37.
3. Rivera FA, et al. Front Med (Lausanne). 2023;10:1301944.
4. Winslow BT, et al. Am Fam Physician. 2023;107(2):137–44.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

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.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released May 26, 2026

Micron Surges 12% as the Market Begins to Reprice What AI Means for Memory Chips

Posted on by [email protected]

Micron Technology (Nasdaq: MU) surged more than 12% Tuesday to trade near $850, extending what has already been one of the most remarkable runs in the semiconductor sector over the past twelve months. The catalyst was a Wall Street price target revision that set a new high-water mark for analyst expectations on the stock — but the move reflects something larger than a single upgrade. It reflects a growing conviction that artificial intelligence has fundamentally and permanently changed how memory markets work.

The numbers behind that conviction are not abstract. Micron’s most recent quarter posted revenue of $13.64 billion, up 57% year over year, with non-GAAP earnings per share of $4.78 and well above the $3.94 consensus estimate. Its Cloud Memory Business Unit nearly doubled to $5.28 billion in a single quarter at 66% gross margins. Forward guidance calls for $18.7 billion in revenue next quarter with non-GAAP EPS of $8.42. These are numbers that reflect the hyperscaler AI buildout running directly through Micron’s high-bandwidth memory franchise at full speed.

Why This Cycle Feels Different

Memory semiconductors have historically been among the most volatile in the chip sector — prone to sharp boom-bust swings driven by oversupply, inventory corrections, and demand unpredictability. Those cycles made memory stocks notoriously difficult to value and kept multiples compressed even during periods of strong earnings. What’s changing now is the nature of demand itself.

AI data centers consume high-bandwidth memory at a scale and consistency that prior computing architectures never required. Unlike consumer electronics demand which is seasonal, discretionary, and cyclical, hyperscaler AI infrastructure spending is driven by multi-year capital commitments from companies like Amazon, Microsoft, Google, and Meta that are building capacity they believe they will need for decades. That shift is beginning to generate long-term supply agreements that lock in pricing and demand visibility, smoothing the earnings volatility that historically made memory stocks difficult to hold through a full cycle.

If that structural change holds, the entire framework for valuing memory companies changes with it, and Micron, as the dominant US-based producer, is the most direct expression of that thesis.

The Domestic Manufacturing Milestone

Layered underneath Tuesday’s move is a separate development that adds industrial and political weight to the story. On Friday, Micron’s Manassas, Virginia facility began producing 1-alpha DRAM, the most advanced memory chip ever manufactured on US soil. The milestone arrives as Washington continues to prioritize domestic semiconductor production under the CHIPS Act framework, and as AI supply chains face increasing scrutiny around geographic concentration. Micron now holds onshore capacity, active government support, and an accelerating demand environment simultaneously, a combination that rarely aligns this cleanly.

MU stock has now run approximately eightfold over the past year, outperforming the S&P 500, the VanEck Semiconductor ETF, and the iShares Semiconductor ETF by a wide margin.

The Broader Semiconductor Read

For investors tracking smaller names in the semiconductor space, the Micron move carries a direct implication. If AI has structurally improved the durability and predictability of memory market earnings, the same logic begins to apply to smaller companies serving adjacent segments, specialty DRAM providers, DDR5 component manufacturers, advanced packaging companies, and AI-optimized storage technology players. AMD climbed more than 5% Tuesday on the same AI semiconductor sentiment wave, confirming this is a sector rerating rather than a single-stock event.

The memory supercycle has a new price tag. The market is just beginning to figure out what that means for everything downstream.

Conduent (CNDT) – Operational Reset Advances

Posted on by [email protected]


Tuesday, May 26, 2026

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.

Sale viewed favorably. The sale of the Public Transit business is expected to significantly narrow Conduent’s global operating footprint and streamline operations, while also exiting a capital-intensive business that required ongoing investments in hardware, infrastructure, and implementation. We believe the transaction should improve operational focus and support management’s strategy to prioritize higher-margin, technology-enabled service offerings.

Estimate revisions affect revenue, not adj. EBITDA. Despite likely downward revisions to revenue guidance following the divestiture, we do not anticipate a meaningful change to EBITDA guidance and believe the transaction improves overall business quality by increasing focus on higher-margin, technology-enabled service offerings. We have adjusted our 2026 and 2027 revenue expectations in light of the prospective sale. 


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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. 

Euroseas (ESEA) – First Quarter 2026 Review and Outlook

Posted on by [email protected]


Tuesday, May 26, 2026

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First quarter financial results. Euroseas Ltd. reported solid first-quarter 2026 financial performance supported by elevated charter rates, full fleet utilization, and disciplined cost management. Although net revenues declined slightly to $55.8 million from $56.3 million in the prior year period due to a smaller average fleet size, adjusted EBITDA increased to $40.9 million from $37.1 million, and adjusted earnings per share rose to $4.70 from $3.76. The Company also maintained a strong balance sheet with substantial liquidity, moderate leverage, and approximately $650 million in contracted revenue backlog, providing significant visibility into future cash flow generation.

Outlook remains favorable. In our view, the outlook for the feeder and intermediate containership segments remains favorable through the remainder of 2026 based on constrained vessel supply, high fleet utilization, and ongoing supply chain disruptions. However, growing macro and geopolitical risks, including slowing global growth, evolving trade policies, and Middle East tensions, could temper containerized trade growth in 2027. Euroseas’ strong charter coverage of 92.4% in 2026, 75.9% in 2027, and 43.1% in 2028 is expected to insulate the company from any volatility in the market.


Get the Full Report

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 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.