NEW YORK, September 29, 2025 (PRNewswire) — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”) today announced a proposed registered underwritten public offering (the “Offering”) by the Company of $100,000,000 aggregate principal amount of its convertible senior notes due 2030 (the “Notes”), subject to market and other conditions. The Company also intends to grant the underwriters in the Offering a 30-day option to purchase up to an additional $15,000,000 aggregate principal amount of Notes on the same terms and conditions, solely to cover over-allotments.
The Notes will be senior, unsecured obligations of the Company. The Notes will mature on October 1, 2030, unless earlier converted, redeemed or repurchased. Holders may convert their Notes at their option prior to the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, the Company will pay or deliver to such converting holders, as the case may be, cash, ordinary shares, par value $0.01 per share, of the Company (the “ordinary shares”) or a combination of cash and ordinary shares, at its election. The interest rate, initial conversion rate and certain other terms of the Notes will be determined at the time of pricing of the Notes.
The net proceeds from the Offering will primarily be used to purchase Ethereum and may be used by the Company for general corporate purposes, including potential investments, acquisitions and other business opportunities relating to digital assets.
Barclays, Cantor and B. Riley Securities are acting as joint lead book-running managers for the Offering.
The Offering will be made pursuant to an effective shelf registration statement on Form S-3, as amended, filed with the Securities and Exchange Commission (the “SEC”), which was declared effective by the SEC on June 20, 2025. The preliminary prospectus supplement and the accompanying prospectus related to the Offering have been filed with the SEC and will be available on the SEC’s website at www.sec.gov. Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus and other documents the Company has filed with the SEC for more complete information about Bit Digital and the Offering.
Copies of the preliminary prospectus supplement and the accompanying prospectus related to the Offering may also be obtained from: Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-888-603-5847, or by email at barclaysprospectus@broadridge.com, Cantor Fitzgerald & Co., Attention: Equity-Linked Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, by email at elcm@cantor.com or B. Riley Securities, 1300 17th Street North, Suite 1300, Arlington, VA 22209, Attention: Prospectus Department, by telephone at (703) 312-9580 or by email at prospectuses@brileysecurities.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.
This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any securities, nor shall there be a sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The Offering will be made only by means of the prospectus supplement and the accompanying prospectus. This press release contains information about the pending Offering, and there can be no assurance that the Offering will be completed.
About Bit Digital Bit Digital is a publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies. The Company began accumulating and staking ETH in 2022 and now operates one of the largest institutional Ethereum staking infrastructures globally. Bit Digital’s platform includes advanced validator operations, institutional-grade custody, active protocol governance, and yield optimization. Through strategic partnerships across the Ethereum ecosystem, Bit Digital aims to deliver exposure to secure, scalable, and compliant access to onchain yield.
Forward Looking Statements This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies, including statements about Bit Digital, Inc.’s ability to consummate the pending offering and the terms of such offering. All statements, other than statements of historical fact, included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “intends,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report) and any subsequently filed quarterly reports on Form 10-Q and any Current Reports on Form 8-K. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CHICAGO, IL, Sept. 29, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,733,766 shares of common stock at a purchase price of $1.30 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.57 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 1, 2025, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $2.25 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.
The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
PDF VersionManaged Complex Ground Integration Program of Critical Systems with Diverse Partners
SAN DIEGO, Sept. 29, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, has successfully completed the Preliminary Design Review (PDR) for the Space Development Agency’s Advanced Fire Control Ground Integration (AFCGI) system. Kratos’ successful completion of the PDR with zero liens allows the program to advance on an accelerated timeline, aligning with projected launch milestones.
As previously announced, in 2024 Kratos secured a $116.7 million prime contract for the AFCGI program. AFCGI integrates advanced software, resilient ground systems and secure networks into a unified architecture for real-time fire control. It is a complex capability providing the warfighter with immediate, mission-relevant advantages. Achieving zero liens signifies that all design challenges, risks and outstanding items identified during the review for this program were thoroughly addressed and resolved, ensuring no lingering issues remain that could impede the project’s progress. Kratos completed the PDR in April of 2025, only five months from the award date.
Greg Caicedo, Senior Vice President of Kratos Space, said, “Kratos is leading this strategic and complex program with our industry partners to meet SDA’s demand for speed. An advanced software-enabled approach delivered on aggressive timelines enables rapid adaptation and readiness far beyond what legacy hardware-centric systems can achieve.”
Kratos, along with its diverse team, will deliver and manage ground segment resources, operate a government-owned, contractor-operated (GOCO) demonstration center and run a secure cloud environment for mission software and partner system integration. Kratos will also provide program management, engineering, integration, testing and operations for the entire ground structure. Through its OpenSpace® platform, Kratos is integrating virtualized ground functions with advanced orchestration and automation, allowing software-defined scalability to support the complex demands of the program.
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.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
BRENTWOOD, Tenn., Sept. 29, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has been awarded two new contracts with U.S. Immigration and Customs Enforcement (“ICE”) to utilize 3,593 beds at two facilities we own in core enforcement areas of the United States. Once fully activated, we expect to generate total annual revenue at the two facilities combined of nearly $200 million.
California City Immigration Processing Center – 2,560 beds
New contract with ICE to utilize our 2,560-bed California City Immigration Processing Center. We have been preparing to accept detainees at this facility since April 1, 2025, when we entered into a six-month Letter Contract with ICE to resume operations at the facility while we worked to negotiate and execute a longer-term contract.
We began receiving detainees at the facility on August 27, 2025 under terms of the Letter Contract. Transitioning from a Letter Contract to the definitive contract effective September 1, 2025 will result in variability in revenue and cash flow as we continue to successfully hire staff and receive additional detainees during the activation period. We currently expect the activation to be complete in the first quarter of 2026, achieving a normalized run-rate in the second quarter of 2026. Total annual revenue once the activation is complete is expected to be approximately $130 million. The new contract expires in August 2027.
Midwest Regional Reception Center – 1,033 beds
New contract with ICE at our 1,033-bed Midwest Regional Reception Center in Leavenworth, Kansas. We entered into a six-month Letter Contract with ICE on March 7, 2025 to begin activation efforts at the facility while we worked to negotiate and execute a longer-term contract. Although we have been successful in hiring staff and have prepared the facility to accept detainees during this term, the intake process has been delayed by legal challenges.
The new contract commenced on September 7, 2025, and is for a term of 24 months. The agreement provides for a fixed monthly payment plus an incremental per diem payment based on detainee populations, both of which commence once the temporary injunction currently prohibiting the intake of detainees is no longer enforceable. Total annual revenue once the facility is fully activated is expected to be approximately $60 million. However, we cannot predict if or when the legal challenges will be successfully resolved.
Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “We are pleased to announce the finalization of contracts for these two facilities, both of which were idle at the beginning of the year. The geographic locations of each of these facilities will enhance our ability to support our government partner in its effort to enforce immigration laws in areas of need across the United States. Looking forward, we anticipate additional contracting activity that will help satisfy ICE’s growing needs.”
Patrick D. Swindle, CoreCivic’s President and Chief Operating Officer, added, “Once fully activated, these two facilities are expected to generate combined annual revenue of nearly $200 million. While the intake process has been delayed at the Midwest Regional Reception Center, we will offer newly hired employees opportunities to be redeployed at our other activations until the legal challenges are resolved. Our team continues to work hard on activating our idle facilities, which helps lay the foundation for continued earnings growth into 2026 and beyond.”
About CoreCivic
CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest operators of such facilities in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
This press release includes statements as to our beliefs and expectations of the outcome of future events that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.
CERRITOS, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, is pleased to announce a new partnership with Protocol Behavioral Health, a leading provider of evidence-based mental health care for cancer patients. This collaboration underscores TOI’s commitment to delivering whole-person care by integrating behavioral health services directly into the cancer care journey.
Research shows that approximately 30% of cancer patients experience significant depression or anxiety, and oncologists widely agree that behavioral health support can benefit nearly every patient. Through this partnership, TOI patients will gain timely access to mental health services that are tailored specifically to the emotional and psychological challenges of cancer, with no waitlists and full integration into the patient’s care team, and the added benefit of services offered in multiple languages to support our diverse patient population.
“Anxiety and depression can greatly threaten a patient’s outcome by affecting their ability to complete treatment in the recommended time,” said Yale Podnos, MD, Chief Medical Officer at The Oncology Institute. “By embedding behavioral health services directly into our care model, we’re closing a critical gap in oncology and ensuring our patients have access to the support they need, exactly when they need it.”
Key Benefits of the Partnership:
Integrated Care Delivery: Protocol clinicians collaborate with TOI providers using the Collaborative Care Model (CoCM), an evidence-based framework proven to improve outcomes through team-based care.
Improved Access: Patients receive behavioral health support without delays, removing a major barrier to care in traditional mental health systems.
Specialized Expertise: Protocol’s behavioral health care managers and psychiatric providers are trained specifically to support oncology patients through diagnosis, treatment, survivorship, and beyond.
Improved Patient Outcomes: Studies link integrated behavioral health care to better treatment adherence, quality of life, and patient satisfaction.
“We founded Protocol to meet a clear need in oncology,” said Cara Bohon, PhD, Chief Clinical Officer of Protocol Behavioral Health. “Through this partnership, we’re ensuring that mental health care is not a luxury or an afterthought; it’s a core part of the patient’s treatment plan from day one.”
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Protocol Behavioral Health provides timely, evidence-based mental health care tailored to the unique needs of cancer patients. Using the Collaborative Care Model, Protocol integrates behavioral health managers and psychiatric providers directly into oncology care teams. This model ensures seamless coordination, personalized support, and better outcomes for patients experiencing depression, anxiety, and other behavioral health challenges.
NORWOOD, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its third quarter 2025 financial results on November 5, 2025 after the markets close. Management will host a conference call on November 6, 2025 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q325 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND
TNX-2900 granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, providing the potential for a Priority Review Voucher upon approval
Magnesium-potentiated intranasal oxytocin formulation designed to reduce dose-related inconsistencies in receptor activity
CHATHAM, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated commercial-stage biotechnology company with innovative marketed products and a pipeline of development candidates, today announced plans to progress its TNX-2900 program for the treatment of Prader-Willi syndrome (PWS) into a Phase 2 clinical trial. TNX-2900 is a proprietary magnesium-potentiated intranasal oxytocin formulation designed to improve receptor binding and decrease dose-related inconsistencies in receptor activity. The program has received both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA), which would make Tonix eligible for a transferable Priority Review Voucher, upon approval. The FDA has cleared the Investigational New Drug (IND) application for TNX-2900 to progress into Phase 2 development.
“We are pleased to advance TNX-2900 into a Phase 2 trial for PWS, a condition with unmet needs for new medicines with activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Families caring for children with PWS face significant challenges and burdens. Among them is hyperphagia which drives persistent food-seeking behaviors that require constant supervision and often result in obesity and serious medical complications. With an average life expectancy of less than 30 years, treatment of PWS remains an urgent and unmet need. By addressing limitations of traditional oxytocin delivery, we believe TNX-2900 has the potential to become an FDA-approved therapy targeting the oxytocin receptor in PWS and provide meaningful benefit for patients and families living with this rare disorder.”
Tonix plans to conduct a Phase 2 randomized, double-blind, placebo-controlled, parallel-design study to evaluate the safety, tolerability, and efficacy of TNX-2900 in male and female participants with PWS, ages 8 to 17.5 years. Eligible participants will be randomized to receive 12-weeks of treatment with TNX-2900 at one of three dose levels, or placebo, in a 1:1:1:1 ratio. The primary efficacy endpoint will be the change from baseline in the validated Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a widely used measure of hyperphagia severity in PWS. Secondary objectives will include assessments of behavior, caregiver burden, and quality of life measures, as well as safety and tolerability outcomes.
Prader-Willi syndrome (PWS) is a rare genetic disorder and the leading cause of life-threatening childhood obesity, affecting about 1 in 10,000 to 1 in 30,000 births. Infants often present with poor muscle tone and feeding difficulties, while children and adolescents develop hyperphagia, behavioral challenges, and severe obesity and metabolic disease. Current interventions are difficult to sustain and often inadequate.
Research suggests PWS is associated with a functional deficiency of oxytocin, a neuropeptide that regulates satiety and feeding behaviors through the oxytocin receptor. Oxytocin treatment addresses several key features of PWS expressed in the MAGEL2 (MAGE-like 2) knock-out mouse.1 Intranasal oxytocin therapy has shown benefits in infants with PWS.2 Carbetocin has a different spectrum of activity on oxytocin and vasopressin receptors than oxytocin and carbetocin has not been tested to our knowledge in the MAGEL2 knock-out mouse.3 Oxytocin has dose-related inconsistencies in receptor activity that have been described as “high-dose suppression” or an “inverted “U” dose response.4 TNX-2900 is formulated with magnesium to further enhance oxytocin receptor binding and signaling, with the goal of providing more consistent and selective receptor activation while minimizing off-target vasopressin effects. In vitro and in vivo in animals Mg++– containing formulations reduce these inconsistencies.4
About Prader-Willi Syndrome (PWS)
PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes, specifically related to the MAGE (melanoma antigen) gene family on the Prader–Willi critical region (15q11–q13) on the paternally acquired chromosome. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.5 Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in correcting behavioral characteristics of the MAGEL2 knock-out mouse model for PWS and autism. 1,6,7 Six clinical trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four clinical studies showed evidence for improvement in PWS-related behaviors/symptoms/2,810 Three of these clinical studies reported evidence for improvement in hyperphagia8-10 and one showed an improvement in sucking in infants.2
Schaller F, et al. Hum Mol Genet. 2010. 19:4895-4905.
Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
Meyerowitz JG, et al. Nat Struct Mol Biol. 2022 29(3):274-281.
Bharadwaj VN, et al. Pharmaceutics. 2022 14(5):1105.
Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
Meziane H, et al. Biol Psychiatry. 2015. 78: 85-94.
Kuppens RJ, et al. Clin Endocrinol. 2016. 85:979-987.
Miller JL et al. Am J Med Genet A. 2017. 173:1243-1250.
Damen L, et al. Clin Endocrinol. 2020. 94:774-785.
About TNX-2900 and Tonix’s Potentiated Oxytocin Platform
TNX-2900 is based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulation intended for use by children and adolescents. This formulation is believed to enhance the potency of oxytocin as well as increase specificity for oxytocin receptors relative to vasopressin receptors, potentially reducing unwanted side effects from activating vasopressin receptors. In collaboration with academic investigators, Tonix is also testing a different intranasal formulation, designated TNX-1900 for adolescent obesity, binge eating disorder, bone health in autism, and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish. It was initially approved by the U.S. Food and Drug Administration as Pitocin®, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon® (oxytocin nasal 40 international units/ml).
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a commercial-stage, fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology and infectious diseases. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SASKATOON, Saskatchewan, Canada, September 26, 2025 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”) today announced that the board of directors of the Company authorized and approved the grant of a total of1,660,315 deferred share units (“DSUs”) and restricted share units (“RSUs”) to certain directors, officers, and consultants of the Company, effective September 25, 2025. This grants of DSUs and RSUs are made pursuant to the Company’s Omnibus Equity Incentive Plan (the “Plan”).
The DSUs will vest when the holder ceases to be a director, officer or employee of the Company or any of its affiliates, as applicable. On settlement, each DSU will entitle the holder to recive to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company.
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About MustGrow
MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 109 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 69.1 million shares fully diluted. For further details, please visit www.mustgrow.ca.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
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.
CULVER CITY, Calif., Sept. 26, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, announced its participation in this year’s Steam Autumn Sale, starting from September 29, 2025 through October 6, 2025. By featuring flagship titles, early access projects, and indie publishing partnerships, Snail aims to leverage this event as an opportunity to showcase portfolio depth, increase visibility, and potentially broaden its player base across multiple market segments.
Featured Discounts and Content Highlights:
ARK: Survival Ascended – 50% Off – Jump into the ultimate dinosaur survival adventure at 50% off and experience ARK like never before.
Bellwright – 20% Off – With over 1 million Steam wishlists, Bellwright remains in early access and may benefit from the visibility generated through seasonal events during its path to 1.0.
West Hunt – 50% Off – A social deduction party game that has developed its audience through visibility among multiplayer and streaming communities.
Survivor Mercs – 38% Off – An early access roguelite extraction shooter, where Snail anticipates that additional exposure during the sale may support community growth in advance of its 1.0 release.
Robots at Midnight – 30% Off – Designed as an accessible entry point into soulslike gameplay, the title combines immersive exploration, fast-paced combat, and a striking retro-futuristic setting.
Zombie Rollerz: The Last Ship – 19% Off – Stands out in the crowded roguelite and bullet heaven space by fusing tower defense strategy with bullet-dodging chaos, bringing a fresh twist to genre conventions through hybrid innovation.
Snail views seasonal promotions as a key element of its broader publishing strategy. During the recent Annual Steam Publisher Sale Event in June, significant discounts on many of its titles helped drive in-game engagement and sustained momentum throughout the month. Following the sale, ARK: Survival Evolved experienced a notable resurgence in both player engagement and sales, with over 3.8x total units sold, average daily sales increasing by 3,022% compared to prior months in 2025 and concurrent players peaking at 65,885 during the recent Steam Publisher Sale. These seasonal promotional events are designed to lower barriers to entry, making it easier for new players to explore established franchises while also drawing attention to early access projects still in active development. By participating in the Steam Autumn Sale, the Company aims to continue driving engagement for its established games while increasing exposure for indie and up-and-coming titles. This multifaceted approach has the potential to both diversify Snail’s player base and strengthen long-term engagement across its portfolio.
For creators interested in collaborative opportunities please reach out to creatordirect@noiz.gg
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and in our public filings with the SEC and include, but are not limited to, statements regarding the possibility that these seasonal promotions will reduce barriers to entry and our multifaceted approach has the potential to both diversify Snail’s player base and strengthen long-term engagement across out portfolio. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed by the Company with the SEC on March 26, 2025 and other documents filed by the Company from time to time with the SEC, including the Company’s Forms 10-Q filed with the SEC. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 SNAL@gateway-grp.com
Kratos Latest Weapons-Configured Valkyrie will be On-Site
Kratos MAKO Tactical Jet Drone, the First CCA to Demonstrate Manned-Unmanned Teaming in 2015, also to be Displayed
SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets and an industry-leading provider of high-performance, jet-powered unmanned aerial systems, will display tactical and target unmanned jet drones, including the latest weapons-configured Valkyrie, at the upcoming Marine Corps Air Station Miramar Air Show September 26-28. Kratos’ tactical family of unmanned jet drones is designed for a range of military operations, including strike, ISR (intelligence, surveillance, and reconnaissance), RF (radio frequency), and communications. This lineup features the latest advancements, including the XQ-58 Valkyrie, UTAP-22 Mako, Tactical Firejet, and BQM-177 target system.
The Miramar Air Show invites both domestic and international visitors to explore full-scale Kratos tactical and target aircraft systems on display. These innovative systems exemplify the future of uncrewed air technology, providing proven and affordable solutions for mass production, deployment, and military engagement. Kratos’ unique approach aligns seamlessly with the Department of Defense’s latest technology initiatives and affordability strategies, enabling systems that can operate effectively from even the most remote locations worldwide.
The XQ-58 Valkyrie is a Collaborative Combat Aircraft (CCA)/ Autonomous Collaborative Platform (ACP) designed to operate with Joint and Allied Forces. Flying since 2019, the XQ-58 continues to pioneer tactical unmanned aerial system (UAS) technology and collaborative manned-unmanned capability.
Steve Fendley, President of Kratos Unmanned Systems Division, said, “We are proud to showcase our latest drone technologies at Miramar, offering attendees a unique opportunity to see these systems in person. Kratos is a recognized leader in unmanned systems, delivering affordable, high-performance aerial platforms like the XQ-58 Valkyrie that support a wide range of national security missions with speed, agility, and innovation. The Miramar Air Show is the ideal venue to highlight Kratos’ game changing systems that represent the future.”
Eric DeMarco, President and CEO of Kratos, said, “We are once again honored to be able to display Kratos’ affordable, leading technology hardware and systems at the Miramar Air Show with our partner, the United States Marine Corps. The Marines are a demonstrated-technology innovation leader, including Kratos’ UTAP 22 Mako, a CCA that began flying manned-unmanned teaming with USMC Harrier manned jet fighters in 2015, through today with Kratos’ Valkyrie flying with USMC F-35s. Kratos will continue to work closely with the Marines, including with certain of our most recent Drone related systems and capabilities.”
Kratos’ Tactical Firejet is designed to affordably meet requirements for fast ingress and egress of tactically denied battle spaces with the ability to deliver significant payloads over long ranges at high speed.
Located in Hangar Three, visitors to Kratos’ display can also learn more about the Spartan Line of turbojet engines, showcasing unique capabilities for expendable engine applications, such as unmanned aerial systems and tactical missiles. Additionally, Kratos’ display will feature Elroy Air’s Chaparral, a hybrid-electric autonomous vertical takeoff-and-landing (VTOL) cargo drone, of which Kratos was recently announced as Elroy Air’s exclusive U.S. manufacturing partner.
Elroy Air’s Chaparral, of which Kratos is the exclusive U.S. manufacturer, is a hybrid-electric Vertical Take-Off and Landing cargo drone designed to autonomously transport 300 pounds of cargo over distances of 300 miles. Engineered for quick turnaround, efficiency, and safety, the Chaparral enables secure, uncrewed cargo delivery at a fraction of the capital and operational cost of piloted helicopters while eliminating risk to personnel in contested or high-risk logistics environments.
The Kratos Mako is a high-speed, highly maneuverable unmanned aerial system (UAS) with open mission-system flexibility and ample payload capacity to make it an affordable and highly effective solution.
Miramar Air Show attendees will have the opportunity to engage with various static displays of advanced aircraft, providing insights into the latest innovations in aviation technology. Held at Marine Corps Air Station Miramar in San Diego, California, the show also features aerial performances and dynamic flight demonstrations with cutting-edge aircraft.
With advanced aerodynamic design, the BQM-177 is a formidable high-performance target for live-fire training scenarios, including sub-sonic, sea-skimming anti-ship cruise missile accurate threat emulation.
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.
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. Such statements relate to a variety of matters including, without limitation, Kratos’ expectations regarding the use of the proceeds from the public offering, the pipeline for opportunities, and Kratos’ success with respect to such opportunities, as well as other statements that are not purely statements of historical fact. 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 including, but not limited to: risks and uncertainties related to market conditions as well as general economic factors. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
THIO-101 Phase 2 trial to enroll patients in the U.S. as part of the expansion of the study in third-line treatment for advanced non-small cell lung cancer (NSCLC)
CHICAGO, Sept. 24, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, announced today that the National Institutes of Health (NIH) has awarded a $2.3 million grant for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC).
The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy. The NIH grant allocations will be distributed over three years from 2025-2027.
“We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial. It’s a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market,” said CEO Vlad Vitoc, M.D. “With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately.”
“The NIH grant is a tremendous achievement and a testament to the dedication, collaboration, and hard work of everyone involved in the clinical development of ateganosine,” added Victor Zaporojan, M.D., MAIA’s senior medical director. “Ateganosine represents a potential solution for the significant unmet clinical need in third-line NSCLC, where no established standard of care exists and where the overall survival outcomes observed with ateganosine have not been achieved by other therapies. By enrolling patients in the United States, our trial will gain access to a substantially larger patient pool across multiple continents, further strengthening the impact and relevance of our study.”
In Parts A and B of THIO-101, median overall survival (OS) for the 22 patients in third-line treatment was 17.8 months as of June 30, 2025, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months. The first patient in the expansion of the trial was dosed in July 2025 in Taiwan.
Research referenced in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA309843. The content is solely the responsibility of MAIA and does not necessarily represent the official views of the National Institutes of Health.
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.
GEK800 Small Engine Designed to Power the Next Generation of Affordable Unmanned Aerial Systems and CCA-type Aircraft
AFRL, GE Aerospace, Kratos Defense, and Purdue Zucrow Labs Collaborating on Extremely Tight Testing Timeline
SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets, and GE Aerospace (NYSE: GE) announced that they have started altitude testing on its GEK800 small engine designed to power the next generation of affordable unmanned aerial systems and CCA-type aircraft. The testing began today at an altitude test facility at Purdue University’s Maurice J. Zucrow Laboratories.
“Altitude testing is the next milestone in demonstrating our commitment to delivering high-performance, affordable, jet engines to support our defense customers,” said Stacey Rock, President of Kratos Turbine Technologies. “Our team is uniquely positioned to bring these advanced designs into high-rate production to support the rising demand for propulsion systems for cruise missiles and CCA-type aircraft. The GEK800 has been designed and engineered up front, from conception, to be manufactured in large quantities at a low cost.”
“The GEK800 engine has performed well and exceeded our expectations in its ground testing to date,” said Mark Rettig, Vice President of Edison Works Advanced Programs at GE Aerospace. “During altitude testing, we will collect data on the engine’s performance in a range of altitudes to assess its operability in simulated real-world conditions.”
“We are thrilled that the propulsion test infrastructure of our new lab created the opportunity to test the new GEK800 engine,” said Scott Meyer, Managing Director of Zucrow Laboratories. “The cooperation and comradery between the GE and Kratos teams, and our students and staff at Zucrow Labs, has been amazingly productive and a pleasure to be a part of. We are excited to have a role in the development of this critical new capability for our nation.”
The GEK800 is an 800-lb jet engine that could potentially power unmanned aerial systems (UAS), collaborative combat aircraft (CCAs), and missiles. Initially developed and ground tested by Kratos over the course of a decade, Kratos and GE Aerospace began working together in 2023 to complete additional development efforts and testing on the engine and have completed more than 50 engine starts in ground testing at Kratos and GE Aerospace testing facilities.
The altitude testing will focus on an altitude window between 5,000-35,000 feet and is anticipated to be complete by the end of the year. GE Aerospace, Kratos, and Purdue University have been collaborating for the last few months on the engine testing, which will be the first engine to test at newly expanded ZL9 test facility at Zucrow Labs.
“The collaboration between AFRL, GE Aerospace, Kratos Defense, and Purdue Zucrow Labs on an extremely tight timeline is outstanding. While demonstrating engine technology is clearly significant, the successful development of rapid and affordable altitude test capability is a crucial element in delivering on our nation’s defense readiness,” said Chris Rawlings, Vice President, of Kratos Turbine Technologies Defense Programs.
In June, Kratos and GE Aerospace announced the signing of a formal teaming agreement to advance propulsion technologies for the next generation of affordable unmanned aerial systems and CCA-type aircraft. This collaboration strengthens the companies’ ongoing partnership and builds on last year’s Memorandum of Understanding (MOU) to advance the development and production of small, cost-effective engines for unmanned platforms. The new teaming agreement expands on that MOU and provides the framework for the two companies to develop, manufacture, test, and field the GEK800 engine.
Kratos brings more than 25 years of experience developing and producing small, affordable engines for UAS, drones, and missile platforms. GE Aerospace adds a century of expertise in propulsion technology and the ability to scale advanced designs into high-rate production —helping bridge the gap from prototype to deployment.
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.
About GE Aerospace GE Aerospace is a global aerospace propulsion, services, and systems leader with an installed base of approximately 49,000 commercial and 29,000 military aircraft engines. With a global team of approximately 53,000 employees building on more than a century of innovation and learning, GE Aerospace is committed to inventing the future of flight, lifting people up, and bringing them home safely. Learn more about how GE Aerospace and its partners are defining flight for today, tomorrow, and the future at www.geaerospace.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets, today announced that Elroy Air, a leading developer of autonomous aerial cargo systems for middle-mile logistics and military resupply, has selected Kratos as Elroy Air’s exclusive U.S. manufacturing partner for the Chaparral in a new five-year strategic manufacturing agreement to accelerate expected high-volume production of the Chaparral hybrid-electric autonomous vertical takeoff-and-landing (VTOL) cargo drone.
Elroy Air’s Chaparral, shown here in flight, to be manufactured by Kratos
“Kratos is an established and trusted producer of military UAS and is unique in their manufacturing focus on affordability. Kratos has produced and delivered thousands of uncrewed aircraft, with a well-established and reliable supply chain for these systems. Their expanded production capabilities make them the ideal partner to bring Chaparral to market at scale,” said Elroy Air CEO Andrew Clare. “This partnership accelerates our ability to deliver Chaparral systems to the many customers waiting for them, across both defense and commercial markets.”
Kratos, a proven leader in the development and production of affordable, jet-powered composite unmanned aircraft for the U.S. Department of Defense, recently expanded its manufacturing capacity to support next-generation drone production. This new partnership leverages Kratos’ deep expertise and scaled infrastructure to put the Chaparral into high-volume production.
Eric DeMarco, President and CEO of Kratos, said, “Kratos is the recognized industry leader for rapid development, production, and delivery of affordable, leading technology unmanned aerial drone systems, which is a perfect fit with Elroy Air’s UAV roadmap, incredibly large forecasted addressable market and related future high volume production plans, including for the U.S. military. Kratos provides Elroy Air an immediate and unique competitive, customer differentiating, value-multiplier advantage, with Kratos’ up and running manufacturing facilities, qualified and executing supply chain and relevant past performance qualifications. Kratos’ partnership with Elroy Air is a recent example of Kratos delivering relevant products, not promises, power points and renditions, with expected tangible value creation for our stakeholders.”
“We are thrilled to partner with Elroy Air to produce their industry-leading drone for the dual-use market,” said Steve Fendley, President of Kratos Unmanned Systems Division. “Elroy Air’s market opportunity for Chaparral is already large and continuing to grow. With this growth, Kratos is ideally suited to transition the system to production. The Kratos team is the best in the world at establishing UAS production lines and optimizing affordability.”
Chaparral is designed to autonomously transport up to 300 pounds of cargo over 300 miles, affordably bridging critical logistics gaps for military resupply, disaster relief, and commercial express delivery. The vehicle’s unique hybrid-electric powertrain enables rapid refueling, extra power for recharging batteries and powering payloads in cruise flight, and longer-range cargo transport than similar-sized battery-electric aircraft.
Kratos will perform initial production of Chaparral at their Sacramento, California aircraft production facility and over time, transition to high-rate production at Kratos’ facilities in Oklahoma City. These efforts are expected to bring aerospace jobs to both regions and expand the current supply chain infrastructure that includes many other states across our nation. The first production Chaparral aircraft are planned to be built in 2026.
“Kratos’ proven ability to produce large, composite drones in high volumes makes them the perfect partner to help us scale production of the Chaparral,” said Dave Merrill, Elroy Air’s Founder and Executive Chairman. “Our customers are eager to expand their operations with our systems, and Kratos’ deep production expertise and track record will enable us to deliver robust, world-class Chaparral vehicles in high volumes.”
Kratos and Elroy Air will have their unmanned aircraft systems on display together at the upcoming Miramar Air Show held September 26-28 at the Marine Corps Air Station Miramar in San Diego, California.
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 http://www.kratosdefense.com.
About Elroy Air Elroy Air is developing industry-first autonomous aircraft systems and cutting-edge software to revolutionize express shipping. Deploying innovative hybrid-electric and autonomous vehicle technologies, their vertical-takeoff-and-landing (VTOL) aircraft transcend traditional airport limitations, unlocking new frontiers in commercial air cargo, humanitarian aid, and military logistics. From agile, low-risk resupply for troops, to dynamic disaster response and firefighting support, to warehouse-to-warehouse express parcel transport, Elroy Air’s technology reshapes logistics possibilities. With facilities in Byron California, Elroy Air is backed by premier venture capital firms including Diamondstream Partners, Catapult Ventures, Marlinspike Partners, Snowpoint Ventures, and Shield Capital. Strategic investment from industry giants like Lockheed Martin Ventures and support from visionary angel investors including early Uber executives drive the company’s mission to provide same-day shipping to every person on the planet. For more information, visit elroyair.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
