Author: [email protected]

Release – MAIA Biotechnology Reports Overall Survival Exceeding Two Years for Eight Patients in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by [email protected]

Research News and Market Data on MAIA

March 31, 2026 9:15am EDTDownload as PDF

Potential breakthrough therapeutic targets $50B+ global immunotherapy market1

CHICAGO, March 31, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a poster presented on March 27, 2026, at the European Lung Cancer Congress 2026 (ELCC), a premier thoracic oncology forum held March 25-28, 2026, in Copenhagen, Denmark.

MAIA reports overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of its ongoing Phase 2 THIO-101 clinical trial in non-small cell lung cancer (NSCLC). The patients did not receive subsequent lines of therapy.

The eight patients featured in the poster include:

  • 1 patient in third-line (3L) therapy with survival of 33 months. Expected survival in this heavily pre-treated population is 5.8 months.2
  • 4 patients in 2L therapy with survival over 30 months. Documented OS for standard of care treatment (chemotherapy or checkpoint inhibitors alone) in second-line (2L) therapy is 10.5 months.3
  • All patients have failed previous treatment (prior to THIO-101) with a checkpoint inhibitor (CPI) alone.
  • All patients completed 29-34 cycles of therapy, except for 1 patient who completed 2 cycles of therapy with survival follow-up of 725 off therapy.
  • 5 of the 8 patients have survival follow-up ongoing.

“It’s very encouraging to see such outstanding survival from these patients extending beyond our 24-month trial protocol and without any subsequent treatment. OS surpassing two-years bodes well as we continue to monitor patients in our ongoing Phase 3 pivotal trial and in THIO-101 Part C,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “These results illuminate ateganosine’s valuable role in targeting telomeres to eliminate NSCLC tumor cells and support this treatment—ateganosine sequenced by a CPI—as a potential breakthrough therapeutic option for NSCLC.”

THIO-101 treated 79 patients in Parts A and B of the trial. The Part C expansion is currently enrolling up to 48 participants in Asia and Europe. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population.

MAIA’s ELCC poster is available on MAIA’s website at maiabiotech.com/publications. 

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

1 Immune Checkpoint Inhibitors Market Analysis by Mordor Intelligence, July 2025
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549
3 https://clinicaltrials.gov/study/NCT01168973?tab=results

Primary Logo

Source: MAIA Biotechnology, Inc.

Released March 31, 2026

Release – Cadrenal Therapeutics Reports Fourth Quarter 2025 Financial Results; Provides Corporate Update on CAD-1005 Program for HIT Following End-of-Phase 2 FDA Meeting

Posted on by [email protected]

Research News and Market Data on CVKD

Encouraging Phase 2 HIT data and recent FDA feedback support continued advancement of CAD-1005 as Cadrenal’s near-term development priority; broader 12-LOX platform remains a longer-term opportunity

PONTE VEDRA, Fla., March 31, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update highlighting recent progress across its CAD-1005 program for HIT and broader 12-LOX inhibitor platform. The update reflects continued progress for CAD-1005, Cadrenal’s first-in-class 12-LOX inhibitor for suspected heparin-induced thrombocytopenia (HIT), including completion of its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) on March 26, 2026, to align on the proposed Phase 3 pivotal trial of CAD-1005 in patients with HIT.

Recent Highlights

  • Reported encouraging results from a randomized, blinded, placebo-controlled Phase 2 study of CAD-1005 in HIT, with fewer new or worsening thrombotic events observed in patients treated with CAD-1005 on a background of standard anticoagulant therapy.
  • Observed a greater than 25% absolute reduction in thrombotic events in the CAD-1005 treatment arm versus placebo, while also gaining important insight that platelet count recovery may not be an appropriate surrogate endpoint for clinical efficacy in HIT.
  • On March 26, 2026, the Company completed its End-of-Phase 2 meeting with the FDA and clarified a potential registrational path for its planned Phase 3 pivotal trial.
  • Incorporation of FDA feedback into Phase 3 protocol is currently underway.
  • Continued to position CAD-1005 as the only selective 12-LOX inhibitor currently in clinical development, supported by Orphan Drug and Fast Track designations from the FDA and orphan drug status from the European Medicines Agency.
  • While HIT remains the Company’s near-term development priority, it continues to see additional scientific support for 12-LOX inhibition beyond HIT, including research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling.

“CAD-1005 continues to reinforce our conviction that selective 12-LOX inhibition may offer a differentiated approach for patients with HIT, a life-threatening, immune-mediated prothrombotic disorder, and a serious condition with substantial unmet need,” commented Quang X. Pham, Chairman & CEO. “Despite modern care, mortality remains high (up to 18-20% in some groups), with many survivors facing limb amputations. The encouraging Phase 2 results, including the reduction in thrombotic events observed on top of standard anticoagulant therapy, further strengthen our confidence in the program and in the decision to make CAD-1005 our lead development priority.”

“The recent End-of-Phase 2 meeting with the FDA is an important milestone in clarifying the regulatory path forward for CAD-1005. As we incorporate FDA feedback and prepare for the next stage of development, we remain focused on advancing CAD-1005 as our lead priority in HIT. At the same time, we continue to evaluate longer-term opportunities across our broader 12-LOX platform and other pipeline assets to support future value creation.”

Fourth Quarter 2025 Financial Highlights
Research and development expenses for the quarter ended December 31, 2025, were $0.7 million compared to $1.5 million for the same period in 2024. General and administrative expenses for the quarter ended December 31, 2025, were $2.4 million compared to $2.7 million for the same period in 2024. Cadrenal reported a net loss of $3.0 million for the quarter ending December 31, 2025, compared to $4.2 million for the same period in 2024.

On December 31, 2025, Cadrenal had cash and cash equivalents of $4.0 million. The Company is evaluating financing and strategic alternatives to support its planned clinical development activities. The Company had approximately 2.3 million shares of common stock outstanding as of December 31, 2025.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also under development for chronic indications.

The Company’s broader pipeline features tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation, including for patients with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the continued progress for CAD-1005 for suspected heparin-induced thrombocytopenia; a potential registrational path for the Company’s planned Phase 3 pivotal trial; additional scientific support for 12-LOX inhibition beyond HIT; research in obesity and type 2 diabetes showing potential improvements in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling; selective 12-LOX inhibition offering a differentiated approach for patients with HIT, a serious condition with substantial unmet need; continuing to evaluate longer-term opportunities across the Company’s broader 12-LOX platform and other pipeline assets to support future value creation; the Company’s clinical development plans and timing, regulatory pathway and potential registration strategy for CAD-1005; the design and initiation of its planned Phase 3 trial, the potential therapeutic and commercial opportunity for CAD-1005 and the Company’s broader pipeline, and the Company’s capital requirements and potential financing or strategic alternatives. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue progress CAD-1005; the ability to successfully plan a registrational path for the Company’s planned Phase 3 pivotal trial; the ability for 12-LOX inhibition to provide improvements in obesity and type 2 diabetes in glycemic control, pancreatic beta-cell preservation, and inflammatory signaling and support future value creation; the Company’s ability to raise sufficient funding to commence and complete its planned Phase 3 trial, and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
[email protected]

View full release here.

Release – First Phosphate Completes Infill Drill Program

Posted on by [email protected]

Research News and Market Data on FRSPF

March 31, 2026 7:15 AM EDT | Source: First Phosphate Corp.

Saguenay-Lac-Saint-Jean, Quebec–(Newsfile Corp. – March 31, 2026) – First Phosphate Corp. (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) (“First Phosphate” or the “Company“) is pleased to announce the completion of its infill drill program launched on October 21, 2025 at its Bégin-Lamarche property in Saguenay-Lac-St-Jean, Quebec.

The drilling campaign has confirmed extensive, continuous mineralization across the existing horizon of the initial resource estimate. The drill program has also discovered two new phosphate intersects located in the Northern Zone and in the Southern Zone on the eastern side of the existing mineralized zone. An additional 10,000 meters of targeted drilling was added to the initial drill program of 30,000 meters to solidify an understanding of these new intersects as well as to test additional mineralization located at depth in various areas across the Northern and Southern Zones.

The Company is currently processing the full set of drill results from its original and expanded drill campaign which totalled about 40,000 m with the goal of upgrading the geological model for the Bégin-Lamarche property in the coming weeks.

“We were able to discover, drill and create a significant geological model for the Bégin-Lamarche property all within about 3.5 years,” commented Gilles Laverdiere, Chief Geologist of First Phosphate. “Such rapid progression from initial discovery reflects the exceptional continuity of the phosphate mineralization and the efficiency of our exploration approach.”

The Company also announces that Gilles Laverdiere will be retiring as Chief Geologist following 48 years of dedicated service to the mining industry. Existing team member, Steeve Lavoie, PGeo., will assume the role of Chief Geologist. Steeve has over 20 years of experience in the mineral exploration industry, having worked most recently with Agnico Eagle Mines prior to joining First Phosphate in November 2025.

“I’d like to thank Gilles Laverdière for his dedication to First Phosphate and the Bégin-Lamarche project since its early discovery and for building our strong exploration foundation,” says First Phosphate CEO, John Passalacqua. “Most importantly, we would like to thank Gilles for delaying his retirement until he could see through Bégin-Lamarche to its resource definition and geological modelling. Gilles is a man of remarkable dedication and a true role model for the industry.”

The Company also announces today a grant of 300,000 incentive stock options (the “Options”) to Steeve Lavoie in accordance with the terms of the Company’s Omnibus Equity Incentive Plan. Each Option has an exercise price of $0.98 and expires on December 29, 2028 with 25% vesting every 6 months for two years following the date of grant. All securities issued in accordance with the Option grant are subject to a hold period of four months plus one day.



First Phosphate Bégin-Lamarche Project 2023-2026 Drill Holes

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/8917/290491_6794497ce49b893a_001full.jpg

Qualified Persons

The scientific and technical information relating to First Phosphate contained in this press release has been reviewed and approved by Gilles Laverdière, P.Geo., Chief Geologist of First Phosphate and Steeve Lavoie, P,Geo., Geology Manager of First Phosphate who are qualified persons within the meaning of National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”).

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, please contact:

Bennett Kurtz
CFO, CAO
[email protected]
Tel : +1 (416) 200-0657
Investor Relations: [email protected]
Media Relations: [email protected]
Website: www.FirstPhosphate.com

Follow First Phosphate:

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

Forward-Looking Information and Cautionary Statement

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

info

Source: First Phosphate Corp.

Release – Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Outlines Planned Adaptive Phase 2 Field Study of TNX-4800 for the Prevention of Lyme Disease, at the World Vaccine Congress Washington 2026

Posted on by [email protected]

Research News and Market Data on TNXP

March 31, 2026 7:00am EDTDownload as PDF

TNX-4800 is a long-acting anti-Borrelia burgdorferi OspA human monoclonal antibody in development as a single-dose Lyme prophylactic
 
Phase 1 study of TNX-4800 demonstrated safety, tolerability, and pharmacokinetics supportive of approximately four months protection
 
Company expects to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA clearance
 

BERKELEY HEIGHTS, N.J., March 31, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced Phase 1 data of TNX-4800 (formerly known as mAb 2217LS)1,2 was presented by Mark S. Klempner, MD, professor of medicine at UMass Chan Medical School, an inventor of TNX-4800 and principal investigator of the study, on March 30, 2026, at the World Vaccine Congress Washington 2026. Tonix also announced its planned strategy for an adaptive Phase 2 field study expected to initiate in the first half of 2027, pending FDA clearance.

TNX-4800 is a long-acting borreliacidal (or bactericidal), human monoclonal antibody (mAb) with an engineered crystallizable fragment (Fc) domain for an extended half-life that targets the outer surface protein A (OspA) of Borrelia burgdorferi, which causes 99.9% of Lyme disease cases in the U.S.3,4 Tonix is developing TNX-4800, which the Company in-licensed from UMass Chan Medical School in 2025, as a prophylactic that is administered in a single subcutaneous (SC) dose expected to provide approximately four months protection to people in endemic areas during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

“TNX-4800 is expected to provide a preventative option to the 87 million5 people in the United States who are at high risk of contracting the disease because they live, work, or vacation in a tick-endemic area,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “As a monoclonal antibody, we believe TNX-4800 offers significant advantages over vaccines in development. Lyme disease vaccines that elicit antibodies to OspA currently in development take more than six months to offer protection and require complex immunization schedules. A previously approved anti-OspA vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization schedule.”

Dr. Lederman continued, “TNX-4800, targeting Borrelia burgdorferi, the serotype that causes 99.9% of Lyme disease in the U.S., is a single dose subcutaneous administration that potentially offers immunity within two days for a duration of approximately four months. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease. We believe the Phase 1 pharmacokinetic (PK) data support our plan to conduct an adaptive field study in the first half of 2027, pending FDA clearance, in which protection at four months is the primary endpoint, and protection at six months is a key secondary endpoint.”

Phase 1 Results

“Our study demonstrated potentially protective blood levels of TNX-4800 at two days, with protective blood levels sustained for at least four months due to its extended half-life design,” said Dr. Klempner. “Additionally, with its differentiated mechanism of action, TNX-4800 has the potential to provide passive immunity by directly supplying neutralizing antibodies, bypassing the need for a vaccine to induce a patient’s immune system to generate its own antibodies, which can be associated with other issues. We look forward to further clinical investigation of TNX-4800 as we strive to overcome this major public health challenge.”

The primary objective of the Phase 1 study was to evaluate the safety and tolerability of a SC injection of TNX-4800 when administered to healthy male and female subjects ages 19-65 years old. The secondary objective was to evaluate the PK of a SC dose of TNX-4800 when administered to healthy subjects. 44 subjects were enrolled, with 41 subjects completing the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg.

Results showed no significant clinical or laboratory safety signals, with most adverse events mild or moderate. Peak serum concentration (Cmax) increased by ~25-fold for a 20-times increase in dose. Serum TNX-4800 was measurable at earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 levels remained quantifiable for >200 days in 80% of subjects at the lowest dose, and for up to 350 days in the majority of subjects at higher doses (i.e., ≥ 1.5 mg/kg). The mean half-life ranged from 62-69 days across TNX-4800 cohorts. Serum concentrations were quantifiable for up to 12 months in most subjects.

  • Mean exposure for the 10 mg/kg cohort had <17% of the highest exposures in a nonclinical toxicology study.
  • The maximum half-life ranged from 81-104 days, with the 10mg/kg cohort at 97 days and 5mg/kg cohort at 87 days.
  • In the 5mg/kg dose cohort, mean serum TNX-4800 concentration was approximately 10 μg/ml at four months, which was approximately twice the minimum effective concentration, or MEC, calculated from in vitro bactericidal activity, and approximately the MEC from in vitro tick-feeding experiments. These data support Tonix’s planned evaluation of protection at four months as the proposed primary endpoint.

Adaptive Phase 2 Field Study Plans

Pending FDA clearance, the Company plans to initiate an adaptive field study in the first half of 2027. TNX-4800 will be studied in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a single SC dose of TNX-4800, 350 mg, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 4 following administration). Based on the Phase 1 PK data, a fixed dose of 350 mg was selected for the Phase 2 field study, which is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. Participants will include adolescents and adults 16 to 65 years of age in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease at four months (comparison of TNX-4800 group and placebo group). A key secondary endpoint will be the prevention of Lyme disease at six months (comparison of TNX-4800 and placebo).

The Company expects to have GMP investigational product available for clinical testing in early 2027. Additionally, if necessary and pending FDA clearance, the Company plans to initiate a controlled human infection model (CHIM) study in 2028.

A copy of Dr. Klempner’s World Vaccine Congress Washington 2026 presentation is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations. The Company’s TNX-4800 specific presentation can be found under the Presentations tab on the Investors section of the Tonix website at https://ir.tonixpharma.com/presentations.

About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a long-acting borreliacidal (or bactericidal), human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 was 95% effective at preventing infection of non-human primates after six days of exposure to ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. A single administration is designed to potentially provide immunity against Lyme disease within two days and maintain protective antibody levels for approximately four months, without relying on the recipient’s immune system to generate antibodies. TNX-4800 also avoids the multidose priming schedules required for OspA vaccines in development7 and the FDA-approved vaccine that was withdrawn from the market.8 

About the TNX-4800 Phase 1 Study
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single SC administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25 times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 17% of the highest exposures in a rat toxicology study. Anti-drug antibodies were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

About Lyme Disease 
In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat range for ticks.9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.10

Citations
1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.
2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.
3Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.
4Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.
5Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.
6 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8.
7Comstedt P, et al. Vaccine. 2015 33(44):5982-8.
8Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8.
9Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773.
10National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.

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. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults 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 investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), 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 TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready 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 registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

About UMass Chan Medical School
UMass Chan Medical School, one of five campuses of the University of Massachusetts system, comprises the T.H. Chan School of Medicine, the Morningside Graduate School of Biomedical Sciences, the Tan Chingfen Graduate School of Nursing, ForHealth Consulting at UMass Chan Medical School, MassBiologics, and a thriving Nobel-Prize-winning biomedical research enterprise. UMass Chan is advancing together to improve the health and wellness of our diverse communities throughout Massachusetts and across the world by leading and innovating in education, research, health care delivery and public service. It is ranked among the best medical schools in the nation for primary care education and biomedical research by U.S. News & World Report. Learn more at www.umassmed.edu.

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]

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released March 31, 2026

Release – MustGrow to Close NexusBioAg Canadian Distribution Arm to Focus on TerraSante™ Sales Growth in U.S.

Posted on by [email protected]

Research News and Market Data on MGROF

SASKATOON, Saskatchewan, Canada, March 31, 2026 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), announces it is to close its wholly-owned Canadian marketing and distribution business NexusBioAg effective April 15, 2026.  NexusBioAg had been re-selling and distributing third party products to Canadian farmers, a lower-margin and price-competitive business. Remaining inventory will be sold in subsequent months through existing distribution channels. MustGrow will focus its capital and resources on scaling inventory to meet accelerating demand for its mustard-derived organic biofertility product TerraSante™ in the U.S.

TerraSante™ Sales Growth

In 2025, sales demand from large U.S. commercial farmers outstripped MustGrow’s inventory production.  MustGrow’s decision to focus on its proprietary TerraSante™ product in the U.S. requires more focused capital and resources to scale inventory to meet the accelerating demand MustGrow experienced in 2025, and continues to see in 2026.

In January 2026, MustGrow closed a $2 million equity financing, and the proceeds are, in part, being used to build TerraSante™ inventory to meet growing demand for the product.  A $2 million credit facility via CIBC and guaranteed by Canada’s Export Development Canada (EDC) has also strengthened MustGrow’s ability to produce inventory.  MustGrow utilizes multiple international third-party manufacturers to produce TerraSante™, allowing MustGrow to ramp-up production to meet sales demand, while eliminating the need to build an expensive production plant.

Additionally, MustGrow is assessing multiple global partnership opportunities to expand TerraSante™ internationally.

TerraSante™ for Soil and Ecological Health

MustGrow’s mustard-derived TerraSante™ organic biofertilizer is a wettable powder containing nutritious plant proteins and carbohydrates that feed the soil and soil microbes.  TerraSante™ is currently registered and approved for sale in California, Florida, Arizona, Idaho, Oregon, and Washington State, under Organic OMRI Listed® certification and California’s Organic Input Material (OIM) Program.

MustGrow’s biofertility program focuses on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.  Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being applied with the intention to improve the health of the soil and soil microbiome, and have a positive impact on root and plant health.

TerraSante™ contains nutritious plant proteins and carbohydrates that feed the soil and soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health.  These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress.  TerraSante™ has the potential to improve crop nutrient uptake and, hence, overall crop performance.  There are no artificial additives or preservatives used during its manufacturing.

To learn more about TerraSante™, visit TerraSante™ – MustGrow.

About MustGrow

MustGrow Biologics Corp. is a provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s technology is centered on harnessing the natural defense mechanisms and organic compounds found in mustard seed and formulating them into organic biofertility, biostimulant, and biocontrol products. These solutions are designed to protect soil health and the soil microbiome, support plant health, and contribute to global food security through more sustainable agricultural practices.  In the United States, MustGrow’s flagship biofertility product, TerraSante™, is registered, organically certified, and commercially sold in key agricultural states, including California. Outside of North America, MustGrow is focused on collaborating with leading global agriculture companies, such as Bayer AG in Europe, the Middle East, and Africa, to commercialize its wholly owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio, which includes approximately 110 issued and pending patents. MustGrow is publicly traded on the TSX Venture Exchange under the symbol MGRO and has approximately 62.9 million common shares issued and outstanding, and approximately 77.1 million shares on a fully diluted basis.

For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson Director & CEO
Phone: +1-306-668-2652
[email protected]

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Forward-looking statements in this news release, including statements about: the impact and significance of performance data and field testing, the timing of the closing of NexusBioAg, if at all, the future demand for the Company’s products and the use of proceeds from past financings, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2026 MustGrow Biologics Corp. All rights reserved.

Release – SEGG Media Aligns Leadership to Drive Revenue Execution and Growth

Posted on by [email protected]

Research News and Market Data on SEGG

March 30, 2026

PDF Version

FORT WORTH, Texas, March 30, 2026 (GLOBE NEWSWIRE) — Sports Entertainment Gaming Global Corporation (NASDAQ: SEGG, LTRYW) (the “Company” or “SEGG Media”), the global sports, entertainment, and gaming group, today announced the appointments of Veloce executives Daniel Bailey as Chief Commercial Officer and Jack Clarke as Chief Strategy Officer, further strengthening our leadership team as SEGG Media moves forward in its strategic growth phase.

After completing the Veloce acquisition and materially increasing the Company’s revenue, these appointments have been made to further support SEGG Media’s 90-day plan focused on execution, integrating operations and teams, and monetizing new assets.

Operators with Proven Track Records

Daniel Bailey, Chief Commercial Officer, brings over a decade of experience in motorsport and global sports commercial strategy, having delivered $53+ million in commercial partnerships and revenue.

Mr. Bailey played a key role in scaling Veloce Media Group, including structuring the acquisition of Quadrant and securing a series of multi-million-pound funding rounds. His experience includes partnerships with global blue-chip brands and rights holders including Formula 1, VISA, Ferrari, McLaren, Mercedes, E.ON, Tencent, Sotheby’s, and Deutsche Bank.

Previously, Mr. Bailey led commercial efforts at IMG Motorsports and co-founded MPA Creative, an award-winning PR, marketing, and events agency, where he remains an active Director. MPA was named 2026 Boutique Agency of the Year at the Race Media Awards.

As Chief Commercial Officer, Mr. Bailey will lead SEGG Media’s global monetization strategy, focused on revenue growth, partnerships, and value creation across the Company’s digital ecosystem.

Jack Clarke, Chief Strategy Officer, combines elite sporting experience with high-growth media entrepreneurship. A former professional racing driver with wins and podiums in FIA Formula 2, he transitioned into business in 2015.

After roles in a sports technology investment fund and IMG, Mr. Clarke co-founded Veloce Media Group, helping build one of the fastest-growing digital motorsport and gaming media platforms globally. He played a key role in scaling Veloce’s esports operations and growing its media network to over 600 million monthly views – shaping commercial and strategic direction from inception, and driving innovation across content, partnerships, and revenue models.

As Chief Strategy Officer, Mr. Clarke will focus on enterprise strategy, capital discipline, and integration execution to ensure acquisitions translate into scalable revenue and long-term shareholder value.

Marc Bircham, Chairman of SEGG Media, commented: “We are aligning leadership for execution to deliver the results expected of us by our shareholders. Dan and Jack are operators who have built, scaled, and monetized platforms globally.”

Robert Stubblefield, Chief Financial Officer and Interim President and CEO, added: “Dan and Jack bring a rare combination of strategic discipline and commercial firepower. Their experience in scaling Veloce and delivering real revenue growth directly aligns with our priorities. We believe this significantly strengthens our ability to execute and deliver value that is not yet reflected in the market.”

Positioned for Near-Term Revenue Expansion

SEGG Media’s current initiatives are expected to:

  • Expand revenue through maximizing the potential of high-growth digital and media assets
  • Accelerate monetization for Sports.com, Concerts.com, and TicketStub.com
  • Unlock operating efficiencies through integration and scale
  • Improve financial visibility as execution milestones for revenue growth are achieved

Disciplined Strategy, High-Impact Execution

SEGG Media continues to prioritize fiscal and operating discipline and high-return initiatives, focusing on:

  • Near-term revenue generation
  • Minimizing shareholder dilution
  • Clear, measurable achievement that results in creating shareholder value

About SEGG Media Corporation

Sports Entertainment Gaming Global Corporation (Nasdaq: SEGG, LTRYW) is a global sports, entertainment, and gaming group operating a portfolio of digital and experiential assets including Sports.com, Concerts.com, TicketStub.com, Lottery.com, and Veloce Media Group. Through its expanding ecosystem of media, live experiences, gaming platforms, and creator-led content, the Company connects global audiences to the sports, events, and interactive entertainment they love. Focused on disciplined execution, ethical gaming, and scalable revenue generation, SEGG Media is building an integrated platform designed to drive sustainable growth and long-term shareholder value.

Important Notice Regarding Forward-Looking Statements 

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this press release, regarding the Company’s strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. When used in this Form 8-K, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” “initiatives,” “continue,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. The forward-looking statements speak only as of the date of this press release or as of the date they are made. The Company cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of the Company. In addition, the Company cautions you that the forward-looking statements contained in this press release are subject to risks and uncertainties, including but not limited to, any future findings from ongoing review of the Company’s internal accounting controls, additional examination of the preliminary conclusions of such review, the Company’s ability to secure additional capital resources, the Company’s ability to continue as a going concern, the Company’s ability to respond in a timely and satisfactory matter to the inquiries by Nasdaq, the Company’s ability to regain compliance with the Bid Price Requirement, the Company’s ability to regain compliance with Nasdaq Listing Rules, the Company’s ability to become current with its SEC reports, and those additional risks and uncertainties discussed under the heading “Risk Factors” in the Form 10-K/A filed by the Company with the SEC on April 22, 2025, and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that the Company has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Should one or more of the risks or uncertainties described in this press release materialize or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. Except as otherwise required by applicable law, the Company disclaims any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date of this press release.

This press release was published by a CLEAR® Verified individual.

For additional information, visit www.seggmedia.com or contact media relations at [email protected].

Release – Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update

Posted on by [email protected]

Research News and Market Data on UNCY

March 30, 2026 7:05am EDT Download as PDF

  • Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026
  • Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26
  • As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027

LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2025, and provided a business update.

“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.”

Key Highlights & Upcoming Milestones

  • In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission. The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product (Drug Product).
  • As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing to strengthen its commercial infrastructure and advance market readiness initiatives.

Financial Results for the Year Ended December 31, 2025

Research and Development (R&D) expenses were $9.1 million for the year ended December 31, 2025, compared to $20.0 million for the same period in 2024. The decrease in research and development expenses was primarily due to a decrease in drug development as well as clinical trial costs.

General and Administrative (G&A) expenses were $20.4 million for the year ended December 31, 2025, compared to $12.1 million for the same period in 2024. The increase was primarily due to an increase in consulting, professional services, and commercial launch preparation costs.

Other income was $3.0 million for the year ended December 31, 2025 compared to Other expense of $4.6 million in the same period in 2024 due primarily to a decrease in the fair value of the Company’s warrant liability.

Net loss attributable to common stockholders for the year ended December 31, 2025 was $26.6 million, or $1.67 per share of common stock, compared to a net loss attributable to common stockholders of $37.8 million, or $5.65 per share of common stock for the same period in 2024. The decreased net loss for the year ended December 31, 2025, was attributable primarily to the decrease in drug development and clinical trial costs.

As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million. The Company believes that it has sufficient resources to fund planned operations into 2027.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:

Layne Litsinger
Real Chemistry
[email protected]

SOURCE: Unicycive Therapeutics, Inc.

View full release here.

Release – NN Announces Acquisition to Further Growth in Electric Grid and Data Center

Posted on by [email protected]

Research News and Market Data on NNBR

PDF Version

CHARLOTTE, N.C., March 27, 2026 (GLOBE NEWSWIRE) — NN, Inc. (“NN” or the “Company”) (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies with six sigma quality today announced that it has acquired the large-scale automated plating operations from a leading global provider of electrical infrastructure solutions. This seller is an existing customer which is moving from in-house manufacturing to outsourced operations with this decision.

The equipment acquisition will enable NN to significantly expand its processing capabilities in silver-plated busbars and terminals among other capabilities, which are ideal electrical components for electric grid and data center equipment. This further enables NN to broaden its market aperture on growth in this area, its second largest end market.

The plating line being acquired is substantially larger and more automated than NN’s current capabilities, featuring large plating baths designed for high-volume, low-cost production. The automated plating line will enable NN to process larger parts representing a transformative expansion of its product offering in terms of size, volume, and type of plated metal products that NN will be able to deliver to its electrical customers.

NN expects this new capability to be operational at an existing facility in the fall of 2026. Financially, the new business won from this line will be inclusive to the Company’s prior guidance of $70 million to $80 million of new business wins in 2026. The capex associated with this project is inclusive to the company’s capex guidance of $20 million to $22 million in 2026. The Company is funding this strategic addition from operating cash flow.

The key end markets that will be targeted with this new capability are electric grid equipment and data center equipment. The Company is initially focused on switchgear assemblies used in emergency power generation for the grid, hospitals, and data centers.

Harold Bevis, President and Chief Executive Officer of NN, Inc., commented, “This equipment acquisition is another stepping stone for NN’s strategic pivot into certain high-value verticals that fit its operational footprint. We are adding capabilities that open up the aperture for growth in the target markets of electric grid and data center. Our plating business is known in the industry as GMF and is one of the highest gross margin plants in the NN portfolio. This is accretive business for NN. The return on investment is consistent with the ROIs that we target for new business.”

Bevis continued, “This is precisely the type of high-value, capital-efficient growth opportunity that we are focused on securing as we execute our sales growth plan. GMF has a strong reputation for quality, on-time delivery, and deep expertise in the science of electroplating. This business is key to growth in electronics, defense, electric grid, and data center. This equipment is a logical addition to our capabilities and will unlock our prospecting into larger parts, higher volume parts, bigger programs, and more customers. The equipment was acquired from a long-term NN customer, that intends to repurpose its reclaimed floor space as data center and grid infrastructure markets take off, so this is a win-win for all parties.”

“This acquisition is consistent with NN’s broader strategic transformation plan, which has already delivered three consecutive years of improved adjusted EBITDA. The Company has exited dilutive, lower-value business and is actively replacing that rationalized volume with higher-margin, accretive new growth through engineering-led new products and new program wins. NN has secured more than $200 million of new awards from its technology-based new business development program, and NN expects to launch approximately 100 awarded programs during 2026. Launched in mid-2023 under new management, the new business program is focused on leveraging the Company’s technology and operational footprint strengths into new areas. The Company is guiding to a fourth consecutive year of improved adjusted EBITDA and a materially higher amount of operating cash flow.”

Bevis continued, “NN has a couple of other small acquisitions that we are focused upon and have been working on for about a year. They are also focused on non-automotive, high-value capability expansion and profitable growth. Over the last two years most of our operating cash flow was consumed by four plant closures and severing about 800 people, which was tough and brutal for those impacted but necessary for NN’s transition.

We have turned the page onto a new chapter and have a balanced approach to our revenue growth and repositioning. We are pursuing a few target markets that require safety critical features on linchpin metal parts and assemblies. We are extremely committed to a common engineering and manufacturing platform that can deliver value-added metal part solutions in several safety-critical end markets that offer high margins due to delivering high value. These include:

  • High-value auto parts – our #1 end market
  • Electric grid and data center parts – our #2 market, on a plan to become our #1 market
  • Defense, weapons, and electronic parts
  • Medical equipment parts

Bevis concluded, “We are intentionally pricing higher on low-value, low-margin business like commodity auto. Where we can, we are repurposing existing equipment, but when we must buy new equipment, we are doing so. We do not keep these kinds of records but 2026 will probably be the most amount of new equipment installed in our company. And it is all pre-loaded with new awards. The key enablers in our success are our engineering skills and our trade secrets regarding making metals deliver exceptional functionality at scale. This is code for world-class six sigma quality processes designed around error-proof, fail-proof design-for-manufacturability. We do this through our own knowledge, co-development with our customers, and emerging AI assistance. 2026 is shaping up to be a fun year focused upon engineering-driven revenue growth.”

ABOUT GMF

GMF has supported high-reliability programs across defense, aerospace, medical, and industrial markets for more than 50 years. The division provides manual rack, barrel, and vibratory plating, stainless steel electropolishing, and a broad range of precious and non-precious metal finishes that meet stringent military and commercial specifications. GMF holds NADCAP accreditation, ISO 13485:2016, and ISO 9001:2015 certifications, and processes millions of parts annually across more than 50,000 square feet of production space. The division is noted for its reputation in high-quality production, on-time delivery, and a 50% hit rate on quoted new business, which is well above industry averages. For more information, please visit www.genmetal.com.

ABOUT NN

NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and China. For more information about the Company and its products, please visit www.nninc.com.

Forward-Looking Statements

This press release contains express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding NN’s pursuit of new end markets, NN’s competitive position in the data center market, the success of NN’s investments to meet the requirements of awarded business, and expected new business wins for 2026 and other statements that are not historical facts. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “growth,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project”, “trajectory” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; material changes in the costs and availability of raw materials; the level of our indebtedness; our ability to secure, maintain or enforce patents or other appropriate protections for our intellectual property; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Investor Relations: 
Joseph Caminiti or Abe Plimpton
[email protected]  
312-445-2870 

Primary Logo

Source: NN, Inc.

Release – SKYX Reports Another Record Quarter with Revenue of $25 Million in Q-4 Demonstrating 8 Consecutive Quarters of Year Over Year Growth with Annual Record Revenue of $92 Million in 2025 Compared to $86 Million in 2024 as it Continues to Grow its Market Penetration

Posted on by [email protected]

Research News and Market Data on SKYX

March 26, 2026 16:05 ET  | Source: SKYX Platforms Corp.

Gross Profit Increased to $28 Million in 2025 Compared to $25 Million in 2024, Representing a $3 Million (13%) Increase in Gross Profit

Operating Cash Used in 2025 Amounted to $13 Million Compared to $18 Million in 2024, Representing a $5 Million (27%) Reduction in Cash Used in Operating Activities

SKYX Raised $29 Million in Q1 2026 Investments from Fundamental Institutions

SKYX Announced Collaboration with NVIDIA AI Ecosystem Connect Program, Expecting to Grow Its Collaboration with NVIDIA into Future Smart Home Projects

SKYX Announced Launch of Its Advanced SKYFAN and Turbo Heater on Its E-Commerce Platform with 60 Websites, 1stoplighting.com, and U.S. Leading Retailers Including Home Depot, Target, Lowe’s, and Walmart

Based on the Growing Sales of Its Patented Turbo Heater Fan, SKYX Is Expanding the Category of the “All-Season Ceiling Fan” — Heat in Winter and Cool in Summer — to Provide Additional Products in New Designs and Larger Sizes

Company Expects to Continue Its Growth in 2026 to Advance Its Path to Cash-Flow Positive

SKYX Anticipates Securing Significant Business Opportunities in the Hotel and Builder Segments in the First Half of 2026

SKYX’s Enhanced Safety Code Standardization Team Continues Its Progress Toward Its Goal of a Safety-Mandated Standardization in Homes/Buildings of Its Life-Saving Ceiling Outlet/Receptacle Technology

SKYX Is Expected to Supply Its Advanced Smart Home Technologies to Upcoming and Future Key Projects in the U.S. and Globally, Including New York, North Carolina, Austin, San Antonio, South Florida (Including Miami’s New $4 Billion Smart City), Saudi Arabia, and Egypt

SKYX Is Expected to Deploy Over 1 Million Units of Its Advanced Smart Home Plug-and-Play Technologies During These Projects

SKYX Continues to Grow Its Market Penetration and Expects to Deploy Over 100,000 of Its Products into Homes/Units by the End of 2026 Through Retail and Pro Segments

SKYX’s Technology Expansion Provides Additional Opportunities for Future Recurring Revenues Through Interchangeability, Upgrades, AI Services, Monitoring, Subscriptions, and More

SKYX Will Be Launching a New AI-Driven Software in 2026 for Its E-Commerce Platform of 60 Websites, Which Is Expected to Increase Conversion Rates and Sales Up to 30%

MIAMI, March 26, 2026 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), an award winning, highly disruptive advanced and smart home platform technology company with over 100 U.S. and Global pending and issued patents and a portfolio of 60 lighting and home décor websites, with a mission to make homes and buildings become advanced-safe-smart instantly as the new standard, today reported its financial and operational results for the Fourth Quarter and Fiscal Year ended December 31, 2025.

Fourth Quarter 2025 and Subsequent Highlights:

  • SKYX reports record sales $92.0 million in 2025 compared with $86 million in 2024.
  • Generated a record $25 million in revenue in Q-4 2025 compared to $24 million in Q-4 2024.
  • Gross profit in 2025 increased to $28 million, from $25 million, representing a 13% increase.
  • SKYX is armed with cash, cash equivalents and restricted cash of $10 million as of December 31, 2025, together with $29 million the Company subsequently raised in January 2026 (from one fundamental investors in straight equity with no warrants), as compared to $16 million as of September 30, 2025.
  • Management expects significant growth in 2026 to advance its path to becoming cash-flow positive.
  • SKYX’s e-commerce sales are converted into cash rapidly, advancing it cash position often referred to as the “Dell Working Capital Model”, lowering its cost of capital.
  • In light of its strengthened balance sheet following recent capital raises, management believes the Company is well capitalized to execute its growth initiatives while progressing toward sustained cash-flow generation and profitability.
  • SKYX has successfully demonstrated its technology during a Marriott Hotel renovation and expects to grow its hotel segment during 2026.
  • Marriott Hotel chain owner, The Shaner Group, led a $16.5 million investment round. The Shaner Group is an owner and developer of more than 70 hotels worldwide.
  • Company is expecting to secure additional significant business opportunities in 2026.
  • SKYX continues its growth and expects to deploy over 100,000 of its products into homes/units during 2026 through retail and pro segments.
  • SKYX announced the launch of its patented advanced SKYFAN and Turbo Heater to the leading U.S. retailer Home Depot, including a new SkyPlug branding page on HomeDepot.com.
  • SKYX recently announced the launch of its Turbo Heater fan at leading U.S. retailers Target, Walmart, and Lowe’s, and on its e-commerce platform across 60 websites.
  • SKYX anticipates securing additional significant business opportunities on several fronts during 2026.
  • SKYX is expected to supply its advanced smart home technologies to upcoming and future key projects in the U.S. and globally, including projects in Pittsford, New York; North Carolina; Austin, Texas; San Antonio, Texas; South Florida including the new $4 billion smart city in Miami, Florida; Saudi Arabia; and Egypt, among others.
  • SKYX is expected to deploy over 1 million units of its advanced smart home plug-and-play technologies during these projects.

Technology Roadmap

  • SKYX announced a collaboration with the NVIDIA AI Ecosystem Connect Program. SKYX expects to grow its collaboration with NVIDIA through its existing and future smart home projects.
  • SKYX will be launching a new AI driven software for its e-commerce platform of 60 websites, expected to increase its conversion rate and sales up to 30%.
  • The Company secured U.S. and global strategic manufacturing partnerships with premier manufacturers including in the U.S., Vietnam, Taiwan, China, and Cambodia.
  • SKYX’s technologies expansion provides additional opportunities for future recurring revenues through interchangeability, upgrades, AI services, monitoring, subscriptions, and more.

Financing Highlights

  • We extended and converted $13.5 million in notes coming due with maturity out to 5 years until 2030.
  • We raised $29 million in equity during January 2026.

Safety Standardization Mandatory Code / Insurance Specification and Recommendation 

  • SKYX’s Safety Code Standardization Team is receiving support from a new significant prominent leader with its government safety agency’s process for a safety mandatory standardization of its electrical ceiling outlet/receptacle technology.
  • SKYX’s code team is led by industry veterans Mark Earley, former head of the National Electrical Code (NEC), and Eric Jacobson, former President and CEO of the American Lighting Association (ALA). The Company’s safety Code Standardization team believes it will garner assistance from additional safety organizations with its code mandatory safety standardization efforts based on the product’s significant safety aspects. Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries. Both strongly believe that, considering the Company’s standardization progress including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturers Association) and being voted into 10 segments in the NEC Code Book, it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings.
  • With respect to insurance companies, the Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder fall injuries, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe advanced plug & play products it will start being recommended by insurance companies.

2025 Financial Results

Revenue in 2025 increased to a record $92.0 million, including record sales of $25 million in the fourth quarter, including e-commerce sales, smart home products and advanced plug & play products. Gross profit in 2025 increased to $28 million, or 30% of revenue from $25 million, or 29% of revenue in 2024. We are armed with cash, cash equivalents and restricted cash of $10 million as of December 31, 2025, in addition to $29 million we raised in January 2026, as compared to $16 million as of September 30, 2025. Cash used in operating activities for 2025 amounted to $13 million, as compared to $18 million in 2024. Net loss per share decreased by $0.04 to $0.32 per share in 2025 compared to $0.36 in 2024. Adjusted EBITDA loss per share, a non-GAAP measure, decreased to $0.10 per share in 2025, as compared to $0.13 per share, in 2024.

The Company’s annual report on Form 10-K will be filed with the SEC and will be made available on the Company’s investor relations website: https://ir.skyplug.com/sec-filings/.

Management Commentary

Our year ended December 31, 2025, was highlighted by our four quarters of consecutive growth including sales and rollout of our advanced ceiling smart and standard plug & play platform products on many leading U.S. and Canadian websites. We believe we are accelerating sales momentum while driving toward a stronger gross margin profile, supported in part by contributions from the Turbo Heater Fan, and continuing to actively manage SKYX’s cash burn. Our e-commerce platform with 60 websites is expected to continue providing additional cash flow to the Company. Management anticipates that in 2026 the Company will continue to advance its path towards cash flow positive.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://www.skyx.com/ or follow us on LinkedIn.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s ability to achieve positive cash flows; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws. 

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense, amortization expense, and impairment charges associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
[email protected]

Dial-In Information:

SKYX Participating Members will Include:

SKYX Platforms – Q4 2025 and 2025 Full Year Corporate Update Call
Date: March 26, 2026
Time: 4:30 p.m. Eastern Time
U.S./Canada Dial-in: 1-412-317-5180
International Dial-in: 1-844-825-9789 

Call me™ link for instant telephone access to the event: https://callme.viavid.com/?$Y2FsbG1lPXRydWUmcGFzc2NvZGU9JmluZm89Y29tcGFueSZyPXRydWUmYj0xNg==

Call me™ Passcode: 8524520
Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1757430&tp_key=97c42ef65d
Please dial in at least 10 minutes before the start of the call to ensure timely participation.

Release – Newsmax Announces Fourth Quarter and Fiscal Year 2025 Financial Results

Posted on by [email protected]

Research News and Market Data on NMAX

March 26, 2026

Company Reports Record Full-Year Revenues of $189.3 million, a 10.7% Year-Over-Year Increase, Outpacing Election-Year Comparison

Broadcast Revenues Increase to $153.3 million, a 17.3% Increase Year-Over-Year

Newsmax Remains the Fourth Highest-Rated Cable News Channel, Reaching More Than 58 Million Total Viewers

Company Projects Accelerated Revenue Growth in 2026

BOCA RATON, FL / ACCESS Newswire / March 26, 2026 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced its financial results for the fourth quarter and full-year ended December 31, 2025.

2025 Business and Operational Highlights

  • Delivered record full-year 2025 revenues of $189.3 million, representing a 10.7% year-over-year increase and achieving results at the high end of the Company’s full-year guidance range, despite a challenging post-election year comparison.
  • Expanded domestic distribution through new and renewed multi-year carriage agreements, including a multi-year renewal with YouTube TV, maintaining Newsmax’s placement in the platform’s base package and extending Newsmax+ availability through YouTube Prime-time Channels beginning in 2026.
  • Advanced the Company’s international expansion strategy through new multi-year distribution agreements across Europe and the Middle East, including launches in France, Israel and Cyprus, and a brand license agreement to launch Newsmax Ukraine, extending the Company’s reach to more than 100 countries worldwide.
  • Continued to scale the Company’s streaming and digital platforms through the expansion of Newsmax2 across major FAST and connected TV platforms and ongoing investment in exclusive content for the Newsmax+ subscription service.
  • Maintained Newsmax’s position as the fourth highest-rated cable news channel in the United States while expanding total audience reach across cable, streaming, digital and social media platforms, reaching more than 58 million total viewers in 2025 and finishing #6 among all cable channels in total day ratings, according to Nielsen.

Management Commentary

“Fiscal year 2025 was a defining year for Newsmax,” said Christopher Ruddy, Chief Executive Officer of Newsmax. “In our first year as a public company, we delivered double digit revenue growth and expanded our audience reach across cable, FAST and digital platforms, even in a non-election year when industry-wide viewership and advertising demand typically normalize. We broadened both our domestic and international distribution footprint, extending Newsmax to new platforms and markets around the world, while reinforcing our position as the fourth highest-rated cable news network. These achievements underscore the strength of our multi-platform model and diversified revenue streams that benefit from the continued demand for independent, values-driven journalism, which resonates with audiences across all of our platforms.”

Ruddy continued, “Looking ahead, with key milestones completed and the costs of becoming a public company largely absorbed, we are well positioned to accelerate our growth trajectory with strategic investment initiatives across content, distribution and technology. As we enter 2026 , we believe Newsmax is entering this next chapter from a position of strength, supported by a solid financial foundation, expanding distribution and a clear focus on sustainable, long-term growth for our shareholders.”

Financial Results:

Revenue by Segment by Component Summary Table (unaudited):

Fourth Quarter 2025 Financial Highlights:

  • Newsmax reported total quarterly revenues of $52.2 million for the three-month period ended December 31, 2025, representing a 9.6% year-over-year increase.
  • Total broadcasting revenues grew 12.6% year-over year to $42.5 million for the fourth quarter of 2025, underscoring continued growth even in a non-election year. This was driven by affiliate fee revenue growth, higher ratings and pricing for broadcasting ad revenue, and licensing growth.
  • Newsmax reported a quarterly Net Loss of $(3.0) million as compared to a net loss of $(6.9) million reported in same quarter in the prior year, primarily driven by higher strategic investments in headcount, programming and production capabilities to support the ongoing expansion and enhancement of our content offering, stock-based compensation costs, offset by higher broadcasting advertising, affiliate fees, book sales and licensing revenue.
  • Quarterly adjusted EBITDA was $(1.3) million, a decrease of $(3.8) million from the amount reported in the same quarter last year, primarily due to higher production and programming expense, increased personnel, increase legal, consulting and public company costs. (See reconciliation of net loss to adjusted EBITDA below).
  • The Company ended the quarter with $131.3 million in cash and short-term investments. cash and cash equivalents were $20.4 million and short-term investments were $110.9 million.

Fiscal Year 2025 Financial Highlights:

  • Newsmax reported total revenues of $189.3 million for the year ended December 31, 2025, representing a 10.7% year-over-year increase.
    • Total broadcasting revenues increased 17.3% year-over-year to $153.3 million, driven by an increase in advertising revenue due to higher ratings and pricing, timing of new affiliate contractual relationships and growth of subscription revenue from Newsmax+.
  • Newsmax reported a net loss of $(99.5) million for full year 2025, largely driven by approximately $79 million in legal settlement expenses, along with stock-based compensation costs, non-cash derivative and warrant liability adjustment and higher production and programming investments, partially offset by higher Broadcasting advertising revenues, affiliate fees and licensing fees.
  • Full-year adjusted EBITDA was $(6.5) million, reflecting continued strategic investments in content, talent, technology and public company infrastructure. (See reconciliation of net loss to adjusted EBITDA below).

Fiscal Year 2026 Outlook

The Company is issuing full-year 2026 guidance as follows:

  • Full-year revenue of $212 million to $216 million, representing 13% year-over-year growth at the midpoint of the range.

“Our full-year 2025 results reflect disciplined execution across the business, with revenue performance at the high end of our guidance range despite a challenging post-election comparison,” commented Darryle Burnham, Chief Financial Officer of Newsmax. “We ended the year with a strong balance sheet and increased financial flexibility following our transition to a public company, and as we look ahead, we are confident in our financial outlook and are focused on prudent investment in content, technology and distribution initiatives that support sustainable, long-term shareholder value.”

About Newsmax

Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 24 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”

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

Investor Contacts

Newsmax Investor Relations
[email protected]

Forward-Looking Statements

This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited changes in domestic and global general economic and macro-economic conditions and the volatility of the price of Common Stock that may result from, among other things, comments by securities analysts or other third parties, including blogs, articles, message boards and social and other media, large shareholders exiting their position in our Common Stock, any negative public perception of us, sales of shares previously registered for resale, or other uncertainties and the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2025 and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.

USE AND DEFINITION OF NON-GAAP FINANCIAL MEASURES

This press release contains a financial measure that has not been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”). This financial measure is Adjusted EBITDA.

Non-GAAP financial measures are used to supplement the financial information presented on a U.S. GAAP basis and should not be considered in isolation or as a substitute for the relevant U.S. GAAP measures and should be read in conjunction with information presented on a U.S. GAAP basis. Because not all companies use identical calculations, our presentation of Non-GAAP measures may not be comparable to other similarly titled measures of other companies.

Adjusted EBITDA1 is defined as revenues less cost of revenues and general and administrative expenses and does not include depreciation and amortization, interest expense, net, impairment charges, unrealized gains (losses) on marketable securities, other corporate matters (consisting primarily of certain litigation expenses, and related fees, for specific legal proceedings that the Company has determined are infrequent and unusual in terms of their magnitude), other, net, and income tax expense.

You are encouraged to evaluate each adjustment used in calculating our non-GAAP financial measure and the reasons we consider our non-GAAP financial measure appropriate for supplemental analysis. In evaluating our non-GAAP financial measure, you should be aware that in the future we may incur expenses similar to the adjustments in our presentation. Our non-GAAP financial measure has limitations as an analytical tool, and you should not consider this measure in isolation or as a substitute for analysis of our results as reported under GAAP. Our presentation of our non-GAAP financial measure should not be construed as an inference that our future results will be unaffected by unusual or non-recurring items. Our non-GAAP financial measure may not be comparable to other companies. Please see a historical reconciliation of this measure to the most comparable GAAP measure presented in our consolidated financial statements below.

_________________

1 The Company compensates for limitations of the adjusted EBITDA measure by prominently disclosing GAAP net income (loss), which the Company believes is the most directly comparable GAAP measure, and providing investors with a reconciliation from GAAP net loss to adjusted EBITDA on page 11.

View full release here.

Release – Kratos Awarded $49 Million NSWC PHD Contract for Oriole™ Rocket Motor and Thrust Vector Control Systems to Support Navy Missile and Test Programs

Posted on by [email protected]

Research News and Market Data on KTOS

March 26, 2026

PDF Version

SAN DIEGO, March 26, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology, products, system and software company in defense, national security, and global markets, announced today that it has been selected by the Naval Surface Warfare Center, Port Hueneme Division (NSWC PHD) for production and delivery of up to 36 Oriole™ solid rocket motors and three Thrust Vector Control (TVC) nozzle kits. The contract includes a funded base award for Oriole with options that, if fully exercised, bring the total contract value for solid rockets to $39,077,237. An option for 3 Oriole TVC production kits, valued at $10,136,009, is also included in the award.

The Oriole rocket system is an affordable, mission-relevant flight test solution, supporting the Navy’s critical suborbital target and experimental hypersonic test requirements with rapid delivery and fielding. Kratos’ proven capability and flawless track record delivering Oriole rocket systems and vehicle hardware components enables customers to maintain robust test and evaluation schedules in support of emerging national security requirements.

“Kratos continues to provide the Department of War with proven, affordable, and rapid turn-key launch vehicle solutions,” said Dave Carter, President of Kratos Defense & Rocket Support Services. “Our Oriole rocket motor and TVC kit systems deliver critical capability to our Navy and DoW customers, supporting operational needs and test objectives on accelerated timelines.”

This award continues Kratos’ long-standing partnership with NSWC PHD in support of ballistic missile defense, hypersonic research, and other test programs. With repeated program successes and regular technology refreshes, Kratos continues to reinforce its industry leading position in the design, production, and sustainment of mission-critical solutions for national security applications.

“Kratos is honored to support our Navy and defense customers with real, existing, mission-relevant products and systems, rapidly fielded to address today’s most pressing challenges,” said Eric DeMarco, President and CEO of Kratos Defense & Security Solutions. “Our approach—making internal investments to deliver affordable, first-to-market national security hardware—remains central to our growth and our commitment to our customers’ evolving needs.”

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

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Cantrell
[email protected]

Investor Information:
877-934-4687
[email protected]
Source: Kratos Defense & Security Solutions, Inc.

Primary Logo

Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) to Assess Potential for Treating Migraine and Craniofacial Pain

Posted on by [email protected]

Research News and Market Data on TNXP

March 26, 2026 7:00am EDT Download as PDF

Intranasal oxytocin blocks the release of calcitonin gene-related peptide (CGRP) in animal models and is the core technology of TNX-1900 for craniofacial pain conditions, including migraine and trigeminal neuralgia

TNX-1900 will be studied in the trigeminal neurovascular reactivity model, by measuring the forehead skin blood flow response to capsaicin and electrical stimulation by Laser Speckle Contrast Imaging (LSCI)

Oxytocin treatment affects a pathway distinct from the recently available CGRP migraine treatment drug class

BERKELEY HEIGHTS, N.J., March 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced that the first participant has been dosed in a Phase 1 investigator-initiated study to evaluate the effect of TNX-1900 (intranasal potentiated oxytocin) on trigeminal nerve-mediated vasodilation of the forehead using capsaicin as well as electrical stimulation, a model for trigeminal neurovascular reactivity, in healthy female human volunteers. Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, is serving as principal investigator and sponsor for the study in a collaborative research agreement with Tonix.

In animal studies, intranasal oxytocin has been shown to bind to oxytocin receptors in the trigeminal ganglion, blocking the release of calcitonin gene-related peptide (CGRP), a potent vasodilator critically involved in the pathogenesis of migraine.1 Dr. Maassen van den Brink has previously found a CGRP inhibitor and a triptan to inhibit the forehead dermal blood flow response to capsaicin in migraineurs and healthy volunteers, respectively.2,3

“We are excited to collaborate with Professor Maassen van den Brink on this proof-of-concept study investigating the potential for TNX-1900 for treating migraine, craniofacial pain, and other related conditions,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “While there are several CGRP inhibitors approved for the treatment of migraine, TNX-1900’s oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non-opioid treatment for migraine and other craniofacial pain conditions.”

As part of the preliminary work in support of this study, Dr. Maassen van den Brink’s team recently validated a newer detection method for dermal blood flow known as Laser Speckle Contrast Imaging (LSCI) in the trigeminal neurovascular reactivity model.4

“We are excited to be using LSCI in this study of TNX-1900, which adds to our established model by providing real-time and higher resolution dermal blood flow measurements, compared to Laser Doppler Perfusion Imaging used in earlier studies,” said Dr. Maassen van den Brink. “Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes.”

About Migraine

Migraine is a neurovascular condition that typically manifests in a throbbing moderate to severe headache which lasts at least four hours, often on one side of the head and aggravated by routine physical activity. It can also be accompanied by nausea, vomiting, visual disturbances, and sensitivity to bright light and loud noises.5 Epidemiological studies indicate that globally, approximately 1.2 billion individuals suffer from migraines annually.6 In the U.S., approximately 39 million Americans suffer from migraines, and among these individuals, approximately four million experience chronic migraines (15 or more headache days per month, at least eight of which are migraines).6

About TNX-1900

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation of oxytocin in development as a candidate for the treatment of migraine and craniofacial pain. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system7 resulting in binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site of CGRP release.1 Blocking CGRP release is a distinct mechanism compared with CGRP receptor antagonist and anti-CGRP antibody drugs, which block the binding of CGRP to its receptor, or bind to the peptide CGRP. The addition of magnesium to the oxytocin formulation in TNX-1900 enhances oxytocin receptor binding8 as well as having an inhibitory effect on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models.9 Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children.10 Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects, which could potentially occur with systemic CGRP receptor antagonists and anti-CGRP (receptor) antibodies.11 For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. This mechanism is being investigated in a Phase 1 study to evaluate the effect of TNX-1900 on trigeminal nerve-mediated vasodilation of the forehead model for craniofacial pain. In addition, daily dosing is more rapidly reversible, in contrast to monthly or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to craniofacial pain conditions, TNX-1900 is being developed for treatment of binge eating disorder, adolescent obesity, bone health in pediatric autism and arginine-vasopressin deficiency. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Citations

1Tzabazis A, et al. Oxytocin receptor: Expression in the trigeminal nociceptive system and potential role in the treatment of headache disorders. Cephalalgia. 2016. 36(10):943-50.
2de Vries Lentsch S, et al. CGRP-mediated trigeminovascular reactivity in migraine patients treated with erenumab. J Neurol Neurosurg Psychiatry. 2022 Aug;93(8):911-912.
3Ibrahimi K, et al. A human trigeminovascular biomarker for antimigraine drugs: A randomized double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia. 2017 Jan;37(1):94-98.
4van Lohuizen et al. 2025. Trigeminovascular activity using a forehead dermal blood flow model: preliminary results of a validation study. J Headache and Pain 26 (Suppl 2): 138.
5The International Classification of Headache Disorders, 3rd Edition. Cephalalgia. 2018. 38(1):1-211.
6Burch et al. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin 37 (2019):631–649.
7Yeomans DC, et al. Nasal oxytocin for the treatment of psychiatric disorders and pain: achieving meaningful brain concentrations. Transl Psychiatry. 2021. 11(1):388.
8Antoni FA and Chadio SE. Essential role of magnesium in oxytocin-receptor affinity and ligand specificity. Biochem J. 1989. 257(2):611-4.
9Cai Q, et al. Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Psychiatry Clin Neurosci. 2018. 72(3):140-151.
10Yeomans, DC et al. 2017. US patent US2017368095.
11MaassenVanDenBrink A, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016. 37(9):779-788.

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. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults 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 investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), 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 long-acting human 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 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 forth 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]

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Release – Comstock Inc. Announces 2026 Annual Meeting

Posted on by [email protected]

Research News and Market Data on LODE


Virginia City, Nevada, March 26, 2026 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) is pleased to announce that its 2026 Annual Meeting of Shareholders has been scheduled for Thursday, May 28, 2026, starting at 9:00 a.m. Pacific Daylight Time in Reno, Nevada, at the Peppermill Hotel. The meeting will feature Comstock Metals, strategic investments, and clean energy systems.

The 2026 Annual Meeting schedule for May 28, 2026, is as follows: 

8:00 am to 9:00 am PDT – Continental Breakfast 
9:00 am to 11:30 am PDT – 2026 Annual Shareholders Meeting, Company Presentations, Q & A 
12:00 pm to 1:00 pm PDT – Lunch and Conversations with Company Management and Directors

The record date for the Annual Meeting is March 31, 2026.  Only shareholders of record at the close of business on March 31, 2026, may vote at the meeting.  The Company’s proxy statement will be sent to shareholders of record and will describe all matters to be voted on. Shareholders are invited to register for the 2026 Annual Meeting: Register to Attend. 

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics.

To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.com, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
Judd B. Merrill, Chief Financial Officer
Tel (775) 413-6222
[email protected]

For media inquiries:
Zach Spencer, Director of External Relations
Tel (775) 847-7573
[email protected]

Forward-Looking Statements 

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “forecast,” “seek,” “target,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: expectations regarding the completion of the proposed securities offering, future market conditions; future explorations or acquisitions, divestitures, spin-offs or similar distribution transactions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: sales of, and demand for, our products, services, and/or properties; industry market conditions, including the volatility and uncertainty of commodity prices; the speculative nature, costs, regulatory requirements, and hazards of natural waste resource identification, exploration, development, availability, recycling, extraction, processing, and refining activities, including operational or technical difficulties, and risks of diminishing quantities or insufficiency of grades of qualified resources;; changes in our planning, exploration, research and development, production, and operating activities; research and development, exploration, production, operating, and other variable and fixed costs; throughput rates, margins, earnings, debt levels, contingencies, taxes, capital expenditures, net cash flows, and growth; restructuring activities, including the nature and timing of restructuring charges and the impact thereof; employment and contributions of personnel, including our reliance on key management personnel; the costs and risks associated with developing new technologies; our ability to commercialize existing and new technologies; the impact of new, emerging, and competing technologies on our business; the possibility of one or more of the markets in which we compete being impacted by political, legal, and regulatory changes, or other external factors over which we have little or no control; the effects of mergers, consolidations, and unexpected announcements or developments from others; the impact of laws and regulations, including permitting and remediation requirements and costs; changes in or elimination of laws, regulations, tariffs, trade, or other controls or enforcement practices, including the potential that we may not be able to comply with applicable regulations; changes in generally accepted accounting principles; adverse effects of climate changes, natural disasters, and health epidemics, such as the COVID-19 outbreak; global economic and market uncertainties, changes in monetary or fiscal policies or regulations, the impact of terrorism and geopolitical events, volatility in commodity and/or other market prices, and interruptions in delivery of critical supplies, equipment and/or raw materials; assertion of claims, lawsuits, and proceedings against us; potential inability to satisfy debt and lease obligations, including because of limitations and restrictions contained in the instruments and agreements governing our indebtedness; our ability to raise additional capital and secure additional financing; interruptions in our production capabilities due to equipment failures or capital constraints; potential dilution from stock issuances, recapitalization, and balance sheet restructuring activities; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to maintain the listing of our securities on any securities exchange or market; and our ability to implement additional financial and management controls, reporting systems and procedures and comply with Section 404 of the Sarbanes-Oxley Act, as amended. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.