Michael Burry has built a career on being early — and loudly wrong before being right. The founder of Scion Asset Management, immortalized for his prescient bet against the U.S. housing market ahead of the 2008 financial crisis, turned his sights on Palantir Technologies (PLTR) this week with a pointed post on X that sent the stock tumbling roughly 7% before he quietly deleted it.
The claim was simple and blunt, as Burry tends to be: Anthropic, the AI startup behind the Claude platform, is “eating Palantir’s lunch.”
Whether he’s right is a separate question. What’s not debatable is that the market paid attention.
What Burry Actually Said
Burry’s thesis centered on Anthropic’s explosive revenue growth — from $9 billion to $30 billion in annual recurring revenue (ARR) in a matter of months — as evidence that enterprise customers are gravitating toward AI solutions that are “easier, cheaper, and more intuitive.” His argument frames Palantir less as a high-growth technology company and more as a labor-intensive consulting business, pointing to the company’s reliance on Forward Deployed Engineers (FDEs) — Palantir staff embedded inside client organizations for months at a time to implement and maintain its platforms.
That model, Burry argued, is structurally vulnerable as direct AI integrations become more accessible. “It took $PLTR 20 years to get to $5 billion,” he noted, while Anthropic is scaling at a pace that suggests the market may be ready to reward the brains of the AI revolution over the operating systems built around it.
This isn’t a new position for Burry. He disclosed a significant short position in Palantir via long-dated put options as far back as September 2025.
The Bull Case: Palantir’s Moat is Real
Not everyone on Wall Street is ready to write Palantir’s eulogy. Wedbush analyst Dan Ives maintains an Outperform rating with a $230 price target, arguing that Palantir occupies a uniquely defensible position at the intersection of AI and federal government infrastructure. The argument: you cannot run sophisticated AI on sensitive government data without the kind of secure, structured, and compliant data architecture that Palantir provides.
That argument gained added texture this year when the Trump administration banned Anthropic from Pentagon systems following a dispute over AI safety guardrails. Palantir was reportedly ordered to remove Claude from its Maven Smart System and rebuild parts of the platform. That incident, while disruptive in the short-term, arguably underscores the stickiness of Palantir’s enterprise relationships — and the risk that pure AI model providers face in regulated environments where trust, compliance, and security clearances matter as much as raw capability.
Palantir has also posted ten consecutive quarters of accelerating revenue growth, a track record that speaks for itself regardless of how the competitive landscape evolves.
The Bear Case: Valuation Leaves Little Room for Error
Where the bull case gets complicated is on valuation. Morgan Stanley analyst Sanjit Singh, while acknowledging Palantir’s standing as a “clear winner through the first stage of the AI cycle,” has flagged that the stock currently trades at roughly 38 times 2027 sales. At that multiple, even strong execution may not be enough to drive meaningful upside. The bar is simply very high.
Burry’s consulting-business critique also has some factual grounding. Palantir’s 10-K does categorize its FDE deployments under professional services — a labor-driven revenue model that is inherently harder to scale than a software subscription or API-based product. As Anthropic and similar companies lower the barrier to deploying enterprise AI, the question of whether Palantir’s hands-on model remains a differentiator or becomes a liability is a fair one to ask.
The Bigger Picture
What this week’s episode illustrates isn’t necessarily that Burry is right or wrong about Palantir specifically. It’s that the AI investment landscape is entering a more complex phase — one where the market is beginning to draw distinctions between infrastructure plays, model providers, and application layers, and debating which of those tiers captures the most durable value.
Anthropic’s valuation recently reached $380 billion, a figure that reflects investor conviction that the model layer is where the leverage lives. Palantir’s case rests on the idea that data infrastructure and operational trust — particularly in government — represent a moat that model providers cannot easily replicate.
Both arguments have merit. The risk for investors is that at current valuations, both stocks demand a level of confidence in the future that leaves little margin for disappointment.
As always, one social media post — even a deleted one — is not a thesis. But when Michael Burry posts, it’s worth understanding exactly what he’s saying and why the market reacted the way it did.
Net loss on a GAAP basis was $2.8 million for the current quarter compared with a net loss of $7.1 million for the prior year quarter, each period inclusive of various non-cash charges, representing a $4.3 million improvement year-over-year.
Net loss on a non-GAAP basis was $1.6 million for the current and prior year quarters.
Current quarter Adjusted EBITDA was negative $0.61 million, compared with Adjusted EBITDA of negative $0.79 million for the prior year quarter, representing a 24% improvement.
Full year Adjusted EBITDA for 2025 was negative $2.3 million, compared with Adjusted EBITDA of negative $3.5 million for the prior year, representing a 35% improvement.
NEW YORK, April 07, 2026 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, today announced its financial results for the quarter and year ended December 31, 2025.
Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel commented I am pleased with the progress we are making with our legacy brands and all of our new influencer led brands. These new influencer led brands will be launching throughout 2026.” He further commented, “the Company is on track to return to profitability, and we expect to achieve our goal of total brand portfolio reach of 100 million social media followers across our brands”.
Fourth Quarter 2025 Financial Results
Total revenue for the fourth quarter of 2025 was $1.2 million, flat from the prior year quarter.
Direct operating costs and expenses decreased approximately $0.6 million (-22%) from the prior year quarter to $2.2 million in the current quarter. This decrease reflects the various cost reduction actions previously taken by management to restructure and transform the Company’s business model. Currently, the Company has reduced its direct operating expenses to an expected run rate of less than $9 million per annum.
During the prior year quarter, the Company recognized a $3.9 million non-cash impairment charge attributable to the investment in the Isaac Mizrahi brand, whereby there was no similar charge in the current year quarter.
Net loss attributable to Xcel Brands stockholders for the quarter was approximately $2.8 million, or $(0.55) per share, compared with a net loss of $7.1 million, or $(3.00) per share, for the prior year quarter.
After adjusting certain cash and non-cash items, results on a non-GAAP basis were a net loss of approximately $1.6 million, or $(0.32) per share for the current quarter and a net loss of approximately $1.6 million, or $(0.69) per share, for the prior year quarter. Adjusted EBITDA was negative $0.61 million for the current quarter and negative $0.79 million in the prior year quarter, representing a year-over-year improvement of 24%.
Full year 2025 Financial Results
Total revenue for the current year was $4.9 million, representing a decrease of approximately $3.3 million (42%) from the prior year. This decrease was primarily driven by a decline in net licensing revenue as a result of the June 30, 2024, divestiture of the Lori Goldstein brand, and to a lesser extent by the $0.35 million impact of the prior year sell-off of certain residual jewelry inventory and all remaining Longaberger inventory. However, management anticipates that the upcoming launches of new brands will drive revenue growth in 2026 and beyond.
Direct operating costs and expenses decreased approximately $4.2 million (-33%) from the prior year to $8.6 million in the current year. This decrease primarily reflects the various cost reductions previously taken by management to restructure and transform the Company’s business model, and to a lesser extent the impact of the divestiture of the Lori Goldstein brand in 2024.
During the current year, the Company recognized a $6.0 million non-cash loss to write the value of its investment in the Isaac Mizrahi brand down to zero, as well as a $1.9 million loss on early extinguishment of debt, related to the refinancing of its term loan debt.
Net loss attributable to Xcel Brands stockholders for the current year was approximately $17.5 million, or $(5.08) per share, compared with a net loss of $22.4 million, or $(9.84) per share, for the prior year. The prior year period results notably included a $11.8 million loss from equity method investments, predominantly attributable to the Isaac Mizrahi brand.
After adjusting for certain cash and non-cash items, results on a non-GAAP basis were a net loss of approximately $5.2 million, or $(1.52) per share for the current year and a net loss of approximately $5.1 million, or $(2.23) per share, for the prior year. Adjusted EBITDA was negative $2.3 million for the current year and negative $3.5 million in the prior year, representing a year-over-year improvement of 35%.
Balance Sheet
The Company’s balance sheet at December 31, 2025, reflected stockholders’ equity of approximately $15.8 million and unrestricted cash and cash equivalents of approximately $1.2 million. The Company’s balance sheet at December 31, 2025 also reflected $12.7 million of term loan debt, of which $3.3 million is payable in the next 12 months, whereby $1.0 million of restricted cash becomes unrestricted, and the majority of the interest expense is deferred until 2027.
Conference Call and Webcast
The Company will host a conference call with members of the executive management team to discuss these results with additional comments and details at 5:00 p.m. Eastern Time on April 7, 2026. A webcast of the conference call will be available live on the Investor Relations section of Xcel’s website at www.xcelbrands.com. Interested parties unable to access the conference call via the webcast may dial 800-715-9871 or 646-307-1963 and use the conference ID 4508248. A replay of the webcast will be available on Xcel’s website.www.xcelbrands.com
About Xcel Brands
Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands TowerHill by Christie Brinkley, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford and Off/Duty by Coco Rocha brand and also holds noncontrolling interests or long-term license agreement in MesaMia by Jenny Martinez. Xcel also owns and manages the Longaberger by Shannon Doherty brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customer’s shop. The company’s previously owned and current brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, and has over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 46 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “ongoing,” “could,” “estimates,” “expects,” “intends,” “may,” “appears,” “suggests,” “future,” “likely,” “goal,” “plans,” “potential,” “projects,” “predicts,” “seeks,” “should,” “would,” “guidance,” “confident” or “will” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding our anticipated revenue, expenses, profitability, strategic plans and capital needs. These statements are based on information available to us on the date hereof and our current expectations, estimates and projections and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors, including, without limitation, the risks discussed in the “Risk Factors” section and elsewhere in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, which may cause our or our industry’s actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.
For further information please contact: Seth Burroughs Xcel Brands [email protected]
Non-GAAP net income and non-GAAP diluted EPS are non-GAAP unaudited terms. We define non-GAAP net income as net income (loss) attributable to Xcel Brands, Inc. stockholders, exclusive of amortization of trademarks, income (loss) from equity method investments, stock-based compensation and cost of licensee warrants, loss on early extinguishment of debt (if any), gains on sales of assets and investments (if any), asset impairment charges (if any), and income taxes (if any). Non-GAAP net income (loss) and non-GAAP diluted EPS measures do not include the tax effect of the aforementioned adjusting items, due to the nature of these items and the Company’s tax strategy.
Adjusted EBITDA is a non-GAAP unaudited measure, which we define as net income (loss) attributable to Xcel Brands, Inc. stockholders before interest and finance expenses (including loss on extinguishment of debt, if any), accretion of lease liability for exited leases, income taxes, other state and local franchise taxes, depreciation and amortization, income (loss) from equity method investments, asset impairment charges, stock-based compensation and cost of licensee warrants, gains on sales of assets and investments, and costs associated with restructuring of operations. Costs associated with restructuring of operations include operating losses generated by certain of our businesses that have been restructured or discontinued (i.e., wholesale apparel and fine jewelry), as well as non-cash charges associated with the restructuring of certain contractual arrangements.
Management uses non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA as measures of operating performance to assist in comparing performance from period to period on a consistent basis and to identify business trends relating to our results of operations. Management believes non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA are also useful because these measures adjust for certain costs and other events that management believes are not representative of our core business operating results, and thus these non-GAAP measures provide supplemental information to assist investors in evaluating our financial results.
Non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA should not be considered in isolation or as alternatives to net income, earnings per share, or any other measure of financial performance calculated and presented in accordance with GAAP. Given that non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA are financial measures not deemed to be in accordance with GAAP and are susceptible to varying calculations, our non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA may not be comparable to similarly titled measures of other companies, including companies in our industry, because other companies may calculate these measures in a different manner than we do. In evaluating non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA, you should be aware that in the future we may or may not incur expenses similar to some of the adjustments in this document. Our presentation of non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA does not imply that our future results will be unaffected by these expenses or any unusual or non-recurring items. When evaluating our performance, you should consider non-GAAP net income, non-GAAP diluted EPS, and Adjusted EBITDA alongside other financial performance measures, including our net income and other GAAP results, and not rely on any single financial measure.
STAFFORD, Texas, April 07, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on new patent claims based on FLAMINGO-01 statistically significant open label immune response and recurrence rate data.
Statistically significant immune response and recurrence rate data is the basis for new claims recently filed that GLSI-100 clinically benefits non-HLA-A*02 patients, which the Company believes increases the market for GLSI-100 by an additional 100% to 88,000 new patients per year in the US and Europe.
The claims also show a favorable comparison to the blinded HLA-A*02 arms of FLAMINGO-01, without any unblinding.
The invention is solely owned by the Company. If the patent claims are granted, following successful patent prosecution, the patent could provide patent protection through 2045.
The Company plans to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of a patient’s T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response changes over time.
CEO Snehal Patel commented, “We believe that these patent claims, based on statistically significant data, support the enrollment of patients independent of HLA type. In the US, we have already started to enroll both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA’s recent review of such protocol changes. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together with the potential to double the market for GP2 to up to $10 billion in revenue per year.”
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Follows prior patent grants in the U.S. and Australia
Further strengthens NeuroSense’s global intellectual property portfolio
CAMBRIDGE, Mass., April 6, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Brazilian Patent and Trademark Office (INPI) has granted Brazilian Patent No. BR 112024007727-6, entitled “Compositions Comprising Ciprofloxacin and Celecoxib.”
The granted Brazilian patent, following prior approval of the corresponding U.S. patent (12,097,185) and Australian patent (2022370513), provides protection for NeuroSense’s proprietary PrimeC composition in Brazil and extends patent coverage through October 2042, further strengthening the Company’s global intellectual property estate and supporting the long-term development and potential commercialization of PrimeC in ALS, Alzheimer’s disease and additional neurodegenerative indications.
“This patent grant further reinforces the strength and durability of our intellectual property strategy around PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Securing composition-of-matter protection in Brazil is another important step in expanding our global IP footprint as we advance PrimeC toward pivotal development and potential commercialization.”
PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib in a synchronized, extended-release formulation specifically targeted to deliver both agents in a coordinated manner – a key differentiator versus simple co-administration. The formulation is designed to enable consistent exposure across multiple disease pathways implicated in ALS, including neuroinflammation, iron dysregulation, and miRNA dysregulation, supporting a multi-target disease-modifying approach.
We are preparing for initiation of a Phase 3 pivotal clinical trial for PrimeC in ALS (PARAGON), following positive Phase 2b PARADIGM results and clearance from the FDA.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
About Alzheimer’s Disease Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding PrimeC pivotal trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that we do not complete in a timely fashion the PrimeC pivotal trial, and that the single pivotal trial will not be sufficient to support a New Drug Application submission; uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
The American consumer is starting to crack, and the timing could not be worse for small-cap companies heading into earnings season.
The University of Michigan’s Index of Consumer Sentiment closed March at a final reading of 53.3 — below the 54 economists had forecast, down 5.8% from February, and the lowest reading since December. The drop was broad-based, cutting across all age groups and political affiliations, and it arrived just as small-cap stocks were already absorbing a brutal month of rising yields, a stalled rate-cut timeline, and a commodity shock with no clear end in sight.
The culprits are familiar by now: surging gas prices and stock market volatility tied directly to the Iran conflict. With the Strait of Hormuz still largely blocked and Brent crude trading above $110 per barrel, gas prices have risen more than $1 on average over the past month alone, according to AAA. That kind of increase hits consumers immediately and visibly — every fill-up is a reminder that something is wrong — and it has a well-documented drag on discretionary spending.
For small-cap companies, weakening consumer sentiment is not an abstract concern. These businesses — regional retailers, restaurant operators, consumer services companies, domestic manufacturers — are more directly exposed to shifts in consumer behavior than their large-cap counterparts, and they have fewer tools to manage the fallout. They can’t absorb margin compression as long, can’t hedge as efficiently, and don’t have the brand loyalty or pricing power that insulates household names from demand slowdowns.
The inflation expectations embedded in Friday’s data make the picture more complicated. Year-ahead inflation forecasts jumped to 3.8% from 3.4% in February — the largest single-month increase since April 2025, when sweeping global tariffs rattled markets. Long-term inflation expectations came in at 3.2%, still well above the pre-pandemic baseline. When consumers believe inflation is sticky, they pull back on big-ticket discretionary purchases and shift spending toward necessities. That behavioral shift flows directly into the revenue lines of the small-cap consumer sector.
There’s another dimension here that matters specifically to small-cap investors. Middle- and higher-income households reported some of the sharpest drops in sentiment this month, driven in part by stock market losses. With equity exposure now accounting for nearly 40% of household net worth — more than double its share during the oil shocks of the 1990s — market volatility has a faster and deeper psychological impact on consumer behavior than it did in previous energy crises. When portfolios fall, confidence follows, and discretionary spending follows confidence.
The S&P 500 is down 6.5% over the past month. The Dow is off 6.8%. The Russell 2000 has been even harder hit, entering correction territory earlier this month as the combination of higher-for-longer rates, a debt maturity wall, and energy-driven inflation converged at the worst possible time.
Consumer sentiment had been gradually recovering before March’s reversal, which means this isn’t a continuation of a trend — it’s a break in one. Whether it stabilizes or deteriorates further depends almost entirely on how long the Iran conflict persists and whether gas prices begin to pull back. Until there’s clarity on the Strait of Hormuz, small-cap consumer-facing companies should be approached with caution heading into Q1 earnings.
The data is speaking. The question is whether the market is listening.
For decades, the playbook has been simple: when war breaks out, buy gold. But the ongoing U.S.-Israeli conflict with Iran is rewriting that script in real time, and investors are scrambling to make sense of a metal that is behaving more like a speculative trade than the world’s oldest store of value.
Gold has dropped nearly 10% this week, putting it on track for its worst weekly performance in 43 years, with the metal’s total decline since the war began now sitting at approximately 13%. On Friday, gold was trading around $4,570 per troy ounce — erasing two months of gains in a matter of days.
The Rate Problem Nobody Saw Coming
The paradox at the heart of gold’s collapse is this: the same war that should theoretically be sending investors rushing into safe-haven assets is also the reason central banks are slamming the door on interest rate cuts.
The Federal Reserve held rates steady and cited uncertain impacts from the conflict, while the Bank of Japan kept rates unchanged, noting that inflation risks are now tilted to the upside. Central banks across Europe — including the U.K. and the eurozone — followed suit. Market expectations for Fed rate cuts have shifted dramatically, with traders now pricing in no cuts until as late as June 2027 — a full twelve months later than pre-war projections. That matters enormously for gold, which pays no yield. When bonds and other interest-bearing assets become more attractive, gold loses its competitive edge almost immediately.
The Dollar Is Doing Gold No Favors Either
The U.S. dollar has rebounded approximately 2.2% since the Iran war began, halting a months-long slide. Because gold is priced in dollars, a stronger greenback makes the metal relatively more expensive for international buyers, dampening global demand.
Oil prices have remained above $100 per barrel following attacks on major energy infrastructure, including one of the world’s largest natural gas fields shared by Iran and Qatar, with the conflict showing no signs of resolution. Energy-driven inflation is now feeding directly into the rate calculus that is punishing gold.
From Safe Haven to Meme Trade — and Back?
Part of what’s happening is a hangover from an extraordinary run. Gold surged 66% in 2025, its best annual performance since 1979, before hitting $5,000 per troy ounce for the first time in January 2026. Retail investors piled in chasing momentum, and when that momentum began to reverse, the selling accelerated. Some analysts have raised the possibility that central banks, which were previously aggressive buyers, may now be turning into net sellers — an additional headwind few had anticipated.
The longer-term bull case hasn’t disappeared. J.P. Morgan maintains a 2026 year-end target of $6,300 per ounce, while Deutsche Bank holds firm at $6,000 — though both forecasts were set before the Iran escalation.
For long-term holders, the fundamental case remains intact. Real interest rates, global monetary policy, and persistent geopolitical uncertainty have historically been the primary drivers of sustained gold bull markets, and none of those underlying forces have been resolved.
The question isn’t whether gold’s story is over. The question is whether the market has finally priced in a world where geopolitical chaos and monetary tightening can coexist — and where gold, at least temporarily, is caught in the crossfire.
President Trump issued a 60-day waiver of the Jones Act on Wednesday in a bid to cool surging domestic energy prices as the Iran conflict continues to hammer global oil markets. The move, confirmed by White House press secretary Karoline Leavitt, opens U.S. ports to foreign-flagged vessels for the next two months — covering crude oil, refined products like gasoline and diesel, natural gas, coal, fertilizer, and other energy-derived commodities.
The decision comes as Brent crude crossed $109 per barrel Wednesday morning — up more than 7% on the day — while WTI traded above $97. Gas prices at the pump have climbed to a national average of $3.84 per gallon, up sharply from $2.92 just one month ago, according to AAA data. Diesel has already crossed $5 per gallon nationally. The administration is clearly feeling political pressure to act ahead of the midterm cycle, and the Jones Act waiver is the most tangible move it has made so far.
What the Jones Act Actually Does
The Jones Act — formally the Merchant Marine Act of 1920 — requires that any cargo transported between U.S. ports be carried by vessels that are U.S.-built, U.S.-owned, U.S.-flagged, and U.S.-crewed. The law was designed to protect the domestic shipping industry after World War I, but has long been criticized by economists as an inflationary form of protectionism that raises the cost of moving goods within the country. With fewer than 100 Jones Act-compliant vessels in existence, the waiver immediately opens the door to a much larger pool of international tankers to move fuel between domestic ports.
The Practical Impact — And Its Limits
In theory, the waiver should have its biggest effect on refined product shipments from Gulf Coast refinery complexes to the more isolated East Coast — a corridor that has historically been a bottleneck during supply disruptions. Cheaper, more accessible shipping capacity means fuel can theoretically move faster and at lower cost to the regions that need it most.
But experts are already tempering expectations. The core problem isn’t moving fuel — it’s refining it. Most U.S. refineries are configured to process heavier Middle Eastern crude grades, while domestic shale production yields lighter oil. That structural mismatch means the U.S. still cannot fully self-supply even with more flexible shipping rules. The waiver makes domestic logistics more efficient, but it does not solve the underlying supply equation.
The Broader Policy Picture
The Jones Act move is reportedly just one item on a broader White House menu of potential energy interventions being considered, including possible Treasury-led action in energy futures markets and export bans on crude and refined products. Any of those measures — if enacted — would carry significant market implications across the energy sector.
For small and microcap investors, the read-through is layered. Domestic shippers and Jones Act operators could see near-term pricing pressure as foreign competition enters the market. Refiners with Gulf Coast exposure and East Coast distribution capability may benefit from improved logistics economics. And any company with meaningful fuel cost exposure — from regional truckers to agricultural operators to industrial manufacturers — should be watching this space closely as the administration continues to improvise policy responses to a crisis with no clear end date.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Double E Pipeline growth. Summit recently signed two new long-term take-or-pay agreements totaling 540 MMcf/d of incremental firm capacity on the Double E Pipeline, an 11-year, 210 MMcf/d contract with a large investment-grade shipper and an 11-year, 230 MMcf/d agreement with an undisclosed shipper, alongside the previously announced 100 MMcf/d Producers Midstream II commitment, which received an affirmative FID during the quarter. These contracts are expected to grow the Permian Segment Adj. EBITDA from ~$34 million in 2025 to ~$60 million by 2029.
2026 guidance. Summit expects full-year 2026 Adj. EBITDA of $225 million to $265 million, with total capital expenditures of $85 million to $105 million, including approximately $35 million attributable to Double E. The outlook assumes WTI at approximately $64 per barrel and Henry Hub at approximately $3.40 per MMBtu, both materially below current strip prices, suggesting meaningful upside if the commodity environment is sustained. The company expects 116 to 126 well connections supported by seven active rigs and approximately 90 DUCs.
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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.
TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200
Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance
Completed $20.0 million registered direct offering with Point72 on December 29, 2025
Approximately $207.6 million in cash and cash equivalents as of December 31, 2025
BERKELEY HEIGHTS, N.J., March 12, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent operational highlights.
“2025 was transformational for Tonix as we achieved FDA approval and began the U.S. commercial launch of TONMYA, our first fully in-house developed product and the first new medicine approved for fibromyalgia in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for long-term, once-daily bedtime dosing. We believe TONMYA now provides an alternative medicine for the approximately 10 million adults in the U.S. who suffer from fibromyalgia. We have the capabilities to engage healthcare providers and patients, having launched the product and an approximately 90-member salesforce. Early prescription trends reflect favorable prescriber uptake and repeat utilization consistent with our internal launch expectations. Our experienced commercial team is committed to growing awareness and adoption, facilitating patient access, and obtaining payer coverage as we strive to improve the fibromyalgia journey for patients and healthcare providers.”
Dr. Lederman continued, “We also meaningfully advanced our robust clinical pipeline in 2025. Tonix in-licensed TNX-4800, a long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, for which there are no FDA-approved vaccines or prophylactics. This program, developed by researchers at UMass Chan Medical School, anchors our clinical-stage infectious disease pipeline, and we plan to discuss Phase 2/3 development with the FDA this year. An additional highlight includes FDA clearance of the Investigational New Drug application (IND) for HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in major depressive disorder, which is expected to initiate enrollment in mid-2026. Looking ahead, our priorities are clear. We are driven to continue our momentum in 2026 as we focus on the successful commercialization of TONMYA, pipeline progress, and sustainable long-term value for patients and shareholders.”
Commercial Updates
TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults
In August 2025, the U.S. FDA approved TONMYA for the treatment of fibromyalgia in adults, making it the first new prescription medicine approved for this indication in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical trials of nearly 1,000 patients that demonstrated statistically significant reduction in daily pain scores compared to placebo.
On November 17, 2025, TONMYA became commercially available at pharmacies by prescription in the U.S. Approximately 90 sales representatives were deployed in the field in advance of the launch. Early prescription trends reflect favorable adoption rates by prescribers and patients, with prescription volumes increasing each full month post launch. Launch metrics for the period November 17, 2025–February 27, 2026 (launch-to-date), are as follows:
More than 1,500 healthcare providers have prescribed TONMYA to patients.
Approximately 2,500 patients have initiated treatment with TONMYA.
Cumulative prescriptions totaled approximately 4,200. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
The Company has contracted with existing wholesalers and specialty pharmacies for distribution and with companies to assist with prescription fulfillment and patient access. Tonix also has a robust patient access program and support services in place, including TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization.
The Company is prioritizing expanding payer engagement and establishing contracts with commercial payers, while also progressing discussions with Medicare and Medicaid.
Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease, which has no FDA-approved vaccines or prophylactics
In December 2025, Tonix announced plans to meet with the FDA in 2026 to explore Phase 2/3 development options, including a Phase 2 field study and a Phase 2 controlled human infection model (CHIM) study, which is also called a human challenge study. The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, the field study is expected to initiate enrollment in 2027 and the CHIM study in 2028.
Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in development for major depressive disorder (MDD)
In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026.
Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms. TNX-102 SL treatment has been associated with a low incidence of side effects common with traditional antidepressants, including weight gain, blood pressure changes, sexual dysfunction, and cognitive issues.
TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of PTSD
The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial is being conducted by the University of North Carolina under an investigator-initiated IND application. The OASIS trial examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026.
Immunology Pipeline TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody): third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders
In November 2025, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated clinical trial of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026 pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients.
In October 2025, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and pharmacokinetic and pharmacodynamic results and outlining next steps toward Phase 2 evaluation in allogenic kidney transplantation.
Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval
In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027.
Financial: Recent Highlights
Tonix had approximately $207.6 million of cash and cash equivalents as of December 31, 2025, compared to approximately $98.8 million as of December 31, 2024. Net cash used in operations was approximately $99.8 million for the full year ended December 31, 2025, compared to $60.9 million for the same period in 2024. Cash paid for capital expenditures for the full year ended December 31, 2025, were approximately $3.4 million compared to $0.1 million for the same period in 2024.
In December 2025, Tonix completed a $20.0 million registered direct offering with Point72 Asset Management. The net proceeds are being used to fund commercialization of marketed products, pipeline development, and general working capital. TD Cowen acted as sole placement agent for the offering. A.G.P./Alliance Global Partners acted as a financial advisor.
Subsequent to year-end, the Company has raised $8.6 million proceeds using its at-the-market (ATM) facility.
The Company believes that its cash resources at December 31, 2025, will meet its planned operating and capital expenditure requirements into the first quarter of 2027.
As of March 11, 2026, the Company had 13,405,401 shares of common stock outstanding.
Full Year 2025 Financial Results
Net product revenue for the full year 2025 was approximately $13.1 million, compared to $10.1 million in 2024. Net revenue from sales of Zembrace®, SymTouch®, and Tosymra® for the full year 2025 was approximately $11.7 million, compared to $10.1 million in 2024. Net revenue from sales of TONMYA for the period from launch on November 17, 2025, to December 31, 2025, was approximately $1.4 million. Cost of sales for the full year 2025 was approximately $6.6 million, compared to $7.8 million in 2024.
Research and development expenses for the full year 2025 were approximately $44.5 million, compared to $40.0 million in 2024. This increase is predominately due to pipeline prioritization period over period, and increased headcount.
Selling, general, and administrative expenses for the full year 2025 were $87.7 million, compared to $40.1 million in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA as well as increased headcount.
Net loss available to common stockholders was approximately $124.0 million, or $14.57 per basic and diluted share, for the full year 2025, compared to net loss available to common stockholders of $130.0 million, or $176.60 per basic and diluted share, in 2024. The basic and diluted weighted average common shares outstanding for the full year 2025 was 8,511,318 compared to 736,339 shares for 2024.
Fourth Quarter 2025 Financial Results
Net product revenue for the fourth quarter 2025 was approximately $5.4 million, compared to $2.6 million for the same period in 2024, and consisted of combined net sales of TONMYA™, Zembrace® SymTouch®, and Tosymra®. Cost of sales for the fourth quarter 2025 was approximately $1.1 million, compared to $1.2 million for the same period in 2024.
Research and development expenses for the fourth quarter 2025 were approximately $16.9 million, compared to $8.3 million for the same period in 2024. This increase is predominately due to pipeline prioritization period over period and increased headcount.
Selling, general, and administrative expenses for the fourth quarter 2025 were $35.7 million, compared to $15.6 million for the same period in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA and increased headcount.
Net loss available to common stockholders was $46.9 million, or $3.98 per basic and diluted share, for the fourth quarter 2025, compared to net loss available to common stockholders of $22.1 million, or $9.77 per basic and diluted share, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the fourth quarter 2025 was 11,798,945 compared to 2,263,535 shares for the same period in 2024.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYATM (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the Company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Fourth quarter and FY2025 financial results. Summit will report operating and financial results after the market close on Monday, March 16. Management will host a teleconference at 10 am ET on Tuesday, March 17. We anticipate management will provide its outlook and corporate guidance for 2026.
Noble estimates. We forecasted fourth quarter and FY2025 EBITDA of $62.5 million and $246.6 million, respectively, and net losses of $0.4 million, or $(0.00) per share, and $11.5 million, or $(0.95) per share. Our fourth quarter and full year revenue estimates are $146.7 million and $566.5 million, respectively. Recall management previously communicated that it expected adjusted EBITDA to be at the low end of its $245 million to $280 million 2025 guidance range. For 2026, we are projecting revenue, EBITDA, net income and EPS of $591.3 million, $265.7 million, $12.7 million, and $1.03, respectively.
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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.
In the most significant emergency energy intervention since the IEA was founded in 1974, the world’s wealthiest nations just deployed their biggest weapon against soaring oil prices — and crude kept climbing anyway. For investors tracking energy markets and small cap stocks in 2026, the implications are impossible to ignore.
On Wednesday, the International Energy Agency announced that all 32 of its member countries unanimously agreed to release 400 million barrels of oil from emergency reserves, the largest coordinated strategic petroleum reserve release in history. The move more than doubles the 182 million barrels deployed in 2022 following Russia’s invasion of Ukraine. The United States committed 172 million barrels from its Strategic Petroleum Reserve alone. Oil prices briefly dipped — then climbed straight back above $90 a barrel before the day was out.
Why the IEA’s Record Oil Reserve Release Failed to Move Markets
The math exposes the problem quickly. Macquarie analysts estimated the 400 million barrel release equates to roughly four days of global oil production and about 16 days of the volume that normally transits through the Strait of Hormuz. As the analysts noted — if that doesn’t sound like much, it isn’t.
Export volumes through the Strait of Hormuz are currently at less than 10% of pre-conflict levels, as shippers continue to avoid the waterway amid active threats and confirmed vessel attacks. The reserve release addresses the symptom. The Strait of Hormuz closure is the disease — and no amount of barrels from emergency stockpiles fixes a shipping lane that remains effectively shut.
There is also a delivery gap that markets priced in immediately. Once a presidential order is issued to deploy oil from the U.S. Strategic Petroleum Reserve, deliveries typically don’t begin for about 13 days, with additional shipping time before volumes reach end consumers. The supply disruption is happening in real time. The relief is weeks away at best. JPMorgan Chase analysts noted that policy measures may have limited impact on oil prices unless safe passage through the Strait of Hormuz is assured.
How the Iran War Oil Price Surge Is Reshaping the Fed’s Path in 2026
This morning’s February CPI report came in at 2.4% year-over-year, with core inflation cooling to 0.2% month-over-month — the softest monthly reading since last summer. Under normal conditions, that data would be a clear runway for continued Federal Reserve rate cuts in 2026. The Iran war has changed those conditions entirely.
February CPI captures none of the oil shock that began when the conflict escalated on February 28. The real inflation print — the one that reflects $87-plus crude flowing into gasoline, airfares, and freight costs — hasn’t landed yet. Futures markets now imply only one full rate cut in 2026 and roughly a 50% probability of a second, a dramatic collapse from the three or four cuts investors were pricing in just weeks ago. The Iran war oil price surge is doing what no economic data had managed to do — it is freezing the Fed.
What Rising Oil Prices Mean for Small Cap and Microcap Stocks
Energy is the only sector trading higher today, and that creates a direct opportunity set in the small and microcap universe. Domestic energy producers, oilfield services companies, and energy infrastructure plays are clear beneficiaries of sustained high crude prices and the global push to source supply outside the Middle East. These are precisely the kinds of under-the-radar names that populate the small cap space and rarely attract attention until a macro event forces investors to find them.
The rate picture is the countervailing risk. The small cap rotation thesis that pushed the Russell 2000 to nearly 9% year-to-date gains was built on continued Fed easing. A prolonged Iran war, sustained crude oil prices above $90, and a Fed on pause separates quality small cap companies from the leveraged names that were simply riding the rate-cut trade.
The IEA’s record oil reserve release in 2026 is not evidence that the crisis is under control. It is evidence of how severe the disruption actually is. When the largest emergency intervention in energy market history fails to bring prices down, the market is sending a signal — and the investors who act on it early are the ones who tend to come out ahead.
Cintas Corporation (Nasdaq: CTAS) announced an agreement to acquire UniFirst Corporation (NYSE: UNF) in a transaction valued at approximately $5.5 billion, marking one of the largest consolidations in the North American uniform and workplace services industry.
The deal brings together two family-founded companies with long histories serving businesses with uniform rental programs, facility services, and workplace safety products. For investors, the transaction highlights a broader trend toward scale and operational efficiency in a fragmented but highly competitive service sector.
Under the terms of the agreement, UniFirst shareholders will receive $155 in cash and 0.7720 shares of Cintas stock for each share held. Based on Cintas’ closing price of $200.77 on March 9, 2026, the consideration represents a combined value of $310 per share for UniFirst. The transaction carries an implied enterprise value of roughly $5.5 billion.
Once combined, the companies will serve approximately 1.5 million business customers across North America, providing uniforms, facility services products, and safety programs to a wide range of industries.
The uniform rental and facility services market has grown increasingly competitive as companies seek larger service footprints and more efficient logistics networks. The combination of Cintas and UniFirst is expected to expand route density, improve processing capacity, and enhance supply chain efficiency.
Cintas management said integrating UniFirst’s service infrastructure and route networks could strengthen the company’s ability to compete with both traditional uniform service providers and alternative procurement models, including direct-purchase programs and hybrid service models.
Operational integration also extends to technology investments, including systems that support route management, inventory tracking, and service delivery optimization.
For investors, these types of scale-driven efficiencies are often central to consolidation strategies in service-heavy industries where route density and logistics can significantly influence operating margins.
Cintas expects to generate approximately $375 million in operating cost synergies within four years following the closing of the transaction. These savings are projected to come from material sourcing efficiencies, production and service cost improvements, and reductions in selling, general, and administrative expenses.
The company also expects the transaction to become accretive to earnings per share by the end of the second full fiscal year after closing.
At closing, Cintas anticipates maintaining a net leverage ratio of roughly 1.5x debt to EBITDA, reflecting a balance between acquisition financing and balance sheet flexibility.
The cash portion of the purchase price will be funded through a combination of cash on hand, committed credit lines, and other financing sources. Morgan Stanley Senior Funding, KeyBank, and Wells Fargo have provided fully committed bridge financing for the transaction.
The boards of directors of both companies have unanimously approved the transaction. Entities affiliated with the Croatti family—founders of UniFirst—control roughly two-thirds of the company’s voting power and have entered into a voting support agreement in favor of the deal.
Members of the Croatti family also plan to retain an ownership position in the combined company, aligning them with the long-term performance of the merged entity.
The transaction is expected to close in the second half of 2026, subject to regulatory approvals and approval from UniFirst shareholders.
Cintas recently reported preliminary fiscal third-quarter revenue of $2.84 billion for the period ending February 28, 2026, representing an 8.9% year-over-year increase and 8.2% organic growth.
UniFirst is scheduled to report its fiscal second-quarter 2026 results on April 1.
If completed as expected, the acquisition would further solidify Cintas’ position as one of the largest providers of uniform rental and facility services in North America, while continuing a broader trend of consolidation across business services sectors where scale, logistics, and customer relationships play critical roles.
Welcome to a multi-part article series authored by leading cross-border M&A professionals from CBIZ, Greenberg Traurig LLP, Noble Capital Markets, and Pathfinder Advisors LLC. This series provides a comprehensive guide for middle-market and larger European companies and investors seeking strategic acquisitions in the U.S. across the manufacturing, distribution, logistics, business services, and retail sectors. It will illuminate the compelling market dynamics, operational advantages, and strategic imperatives driving these transatlantic deals now, while also offering practical insights on navigating the complexities of U.S. market entry, robust financial and operational due diligence, talent integration, and regulatory considerations. The series aims to equip company owners, corporate development executives, family offices, and private equity professionals with the knowledge to unlock significant value and establish a resilient U.S. presence.
In an era defined by rapid economic shifts and evolving global dynamics, European enterprises may now have unprecedented opportunities to look across the Atlantic for strategic growth opportunities. The U.S. market, with its vast scale and inherent resilience, could present a compelling landscape for inbound M&A.
This first article in our series explores why the current climate favors European acquirers and how strategic U.S. acquisitions could unlock significant value and establish a robust, resilient long-term presence.
The webinar below is for company owners, corporate development executives, family offices and private equity professionals considering U.S. acquisitions of expansion.
This article delves into the specific operational and technological advantages awaiting European acquirers in U.S. manufacturing, distribution, and logistics. Acquiring existing U.S. assets in these sectors provides a potent pathway to not only immediate market entry but also the creation of a more resilient, efficient, and technologically advanced global enterprise.
As European manufacturing and logistics firms solidify their North American foundations, a parallel wave of strategic acquisition is transforming the U.S. service and retail landscape. For the European acquirer, the U.S. “Service Economy” represents more than just a massive consumer base; it is a gateway to specialized talent pools, cutting-edge digital platforms, and a resilient commercial ecosystem that can de-risk a global portfolio.
Navigating this transition from “Industrial Footprint” to “Commercial Dominance” requires a nuanced understanding of the U.S. consumer and the specialized expertise that defines American business services.
Additional article in this series will be published periodically. Please follow Noble Capital Markets on LinkedIn to be among the first to know when those are available.
