NEW YORK – July 10, 2026 (GLOBE NEWSWIRE) – OTC Markets Group Inc. (OTCQX: OTCM), operator of regulated markets for trading 12,000 U.S. and international securities, today announced Tectonic Metals Inc. (TSX-V: TECT; OTCQX: TETOF), a mineral exploration company, has qualified to trade on the OTCQX® Best Market. Tectonic Metals Inc. upgraded to OTCQX from the OTCQB® Venture Market.
Tectonic Metals Inc. begins trading today on OTCQX under the symbol “TETOF.” U.S. investors can find current financial disclosure and Real-Time Level 2 quotes for the company on www.otcmarkets.com.
The OTCQX Market is designed for established, investor-focused U.S. and international companies. To qualify for OTCQX, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws. Graduating to the OTCQX Market marks an important milestone for companies, enabling them to demonstrate their qualifications and build visibility among U.S. investors.
Tony Reda, Co-Founder, President & CEO of Tectonic Metals, commented: “Trading on the OTCQX is a major milestone that furthers our strategy to expand Tectonic’s reach across North American capital markets. The completion of our largest financing to date, which raised more than C$92 million in March 2026, was a key catalyst that supported this transition. With five rigs now turning at our Flat Gold Project in Alaska as part of our largest-ever drill program, we are well positioned to broaden our U.S. investor base and increase market awareness at a pivotal stage in the Company’s growth.”
About Tectonic Metals Inc.
Tectonic Metals Inc. is a mineral exploration company led by an experienced and well-respected technical and financial team with a track record of wealth creation for shareholders. The Company is focused on exploring and developing its flagship Flat Gold Project in southwestern Alaska, covering 99,840 acres of predominantly Native-owned land belonging to Doyon, Ltd., a leading Alaska Native Regional Corporation and one of Tectonic’s largest shareholders. The current focus is on advancing the Chicken Mountain target, one of six multi-kilometre-scale intrusion zones at the Flat Gold Project, where drilling has achieved a 100% success rate across 191 holes to date.
Key members of the Tectonic team were involved in Kaminak Gold Corporation, the company that raised C$165M to fund the acquisition, discovery and advancement of the Coffee Gold Project through to the completion of a bankable feasibility study before selling the multi-million-ounce gold project to Goldcorp Inc. for C$520 million in 2016.
For more information, please visit tectonicmetals.com.
OTC Markets Group Inc. (OTCQX: OTCM) operates regulated markets for trading 12,000 U.S. and international securities. Our data-driven disclosure standards form the foundation of our public markets: OTCQX® Best Market, OTCQB® Venture Market, OTCID® Basic Market and Pink Limited™ Market. Our OTC Link® Alternative Trading Systems (ATSs) provide critical market infrastructure that broker-dealers rely on to facilitate trading. Our innovative model offers companies more efficient access to the U.S. financial markets.
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Selected as one of three late-breakthrough abstracts: clinical trials and innovation in thrombosis, CAD-1005 took center stage before the global thrombosis community at the largest ISTH meeting in more than a decade.
Oral presentation by Principal Investigator Dr. Steven E. McKenzie highlighted CAD-1005 as the first randomized, blinded, placebo-controlled trial for Heparin-Induced Thrombocytopenia (HIT).
Phase 2 data demonstrate an absolute reduction of more than 25% in thrombotic events, supporting the clinical advancement of this Phase 3-ready program.
CAD-1005 targets a life-threatening immune-mediated clotting disorder, with an estimated $2 billion in peak annual revenue and no currently approved root-cause therapies.
PARIS, July 13, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for rare immunothrombotic conditions, announced today that late-breaking clinical data from the Phase 2 study of the first-in-class 12-lipoxygenase (12-LOX) inhibitor CAD-1005 were featured in a highly anticipated late-breaking oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris.
This year’s ISTH Congress marked a historic milestone, bringing together clinicians, researchers, scientists, educators and industry leaders from around the world for five days of scientific discovery, collaboration and innovation in thrombosis, hemostasis and vascular biology. Drawing the largest in-person audience in more than a decade, the event attracted over 6,000 registrants and more than 3,100 abstract submissions. As the premier global gathering for cutting-edge scientific research, the ISTH late-breakthrough program is reserved for high-impact clinical trial results and first disclosures that may define future standards of care and clinical practice.
The oral presentation, titled “12-lipoxygenase inhibition with CAD-1005 (formerly known as VLX-1005) in heparin-induced thrombocytopenia,” was part of the high-profile session on clinical trials and breakthrough innovations. It marks a historic milestone as the first randomized, blinded, placebo-controlled clinical trial in patients with Heparin-Induced Thrombocytopenia (HIT).
“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that is intended to address the root cause of immune-mediated platelet activation in HIT,” said Dr. Steven E. McKenzie. “The data we presented in Paris illustrated how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care. By showing an encouraging reduction in thrombotic events when added to standard anticoagulation, this therapy may offer a highly differentiated and desperately needed option for these high-risk patients. Clinicians from around the world were enthusiastic about this novel approach to a serious unmet medical need.”
Key Phase 2 Highlights Presented:
Addressing the Root Cause: Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation.
Efficacy Signal: Patients treated with CAD-1005 experienced a reduction of more than 25% in new or worsening thrombotic events compared with the placebo arm (50% vs. >75%), despite the study not being sufficiently powered for statistical significance.
Safety Signal: No serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment with CAD-1005 was associated with fewer thromboembolic events without an increase in major bleeding.
Paradigm Shift in Trial Design: The trial established that the traditional platelet count recovery rate is an inadequate surrogate for clinical efficacy, as thrombotic events continued to occur after recovery. This provides critical framework intelligence for Cadrenal’s upcoming pivotal Phase 3 registration trial.
“The selection of the Phase 2 study for a late-breaking presentation at ISTH underscores the scientific integrity and significant commercial potential of CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With our recent financing, we are well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin.”
CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug status from the European Medicines Agency (EMA).
About Heparin-Induced Thrombocytopenia (HIT)
HIT is an immune-mediated, prothrombotic adverse drug reaction in which antibodies against platelet factor 4-heparin complexes activate platelets via FcγRIIA receptors, triggering a cascade that can lead to life-threatening thrombosis. Current management relies on non-heparin anticoagulants, which reduce thrombin generation but do not directly address the underlying antibody-mediated platelet activation; new thrombosis remains a major clinical concern even with appropriate anticoagulant therapy.
About CAD-1005
CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. To view how CAD-1005 works in HIT, click https://vimeo.com/1209382706/7dde06dc08?share=copy&fl=sv&fe=ci
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for 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 in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children <5 years old and is the leading cause of acquired heart disease in developed countries. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).
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 such as targeting 12-lipoxygenase being a novel, highly selective therapeutic approach addressing the root cause of immune-mediated platelet activation in HIT; the data presented in Paris illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care; the therapy offering a highly differentiated and desperately needed option for these high-risk patients; the selection of the Phase 2 study for a late-breaking presentation at ISTH underscoring the scientific integrity and significant commercial potential of CAD-1005; and the Company being well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to enter into a partnership opportunity for CAD-1005 and tecarfarin; the ability to benefit from the commercial potential of CAD-1005; raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; 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.
Ground Based Modular System Recently Demonstrated Mission Effectiveness
SAN DIEGO, July 13, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, today announced that the company has recently received an approximate $100 million sole source prime contract award for the production of a ground-based modular space domain awareness system. Kratos is an industry leader in space domain awareness, directed energy and other relevant national security systems. Work under this new program award will be performed at secure Kratos production and integration facilities.
Mike Johns, Kratos Senior Vice President, said, “Kratos is proud to have developed, tested and demonstrated this true technology-leading space domain awareness system, which will now be entering production. Our entire organization is extremely proud to have the confidence with our customer to move forward with this mission critical national security system. Based on customer feedback, we believe that this program could in the future become one of the most important for our DRSS business.”
Eric Demarco, Kratos’ President and CEO, said, “We believe that across our company, Kratos has the right, relevant products, at the right time, at the right cost points—products which can be rapidly mass produced and fielded now. There is a generational rebuild and recapitalization of the U.S. defense industrial base under way, including for strategic space systems, to deter and defeat our enemies, and Kratos is committed to supporting the Department of War and the success of its mission.”
Due to security related, competitive and other considerations, no additional information will be provided.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, 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 and follow Kratos on LinkedIn and X.
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.
Cumulative sales milestones up to $255 million and modest upfront/near-term development milestones
Royalties equaling 22% of net sales
Ocugen to manufacture and supply OCU400
MALVERN, Pa., July 13, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a license agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive rights to OCU400, Ocugen’s novel modifier gene therapy for Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.
Pursuant to the term sheet, under the license agreement, Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4 million. The Company would be entitled to sales milestone payments up to $255 million, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen’s partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement.
RP is a leading cause of inherited vision loss globally, with notable prevalence across the MENA region, underscoring the significant unmet need OCU400 is positioned to address through this partnership.
“This step forward represents an important milestone in our effort to advance OCU400 regional partnership strategy,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring this one-time potential treatment for life to a region where RP is highly prevalent with a significant unmet medical need where patients are desperately looking for rescue from blindness. This agreement underscores the momentum behind OCU400 and our continued commitment to patients.”
“Bringing innovative gene therapies to patients across the MENA region is a strategic imperative for Roots Pharmaceutical and its strategic partner Al-Dhow International Holding,” said Dr. Islam Zayed, CEO & Co founder of Roots Pharmaceutical. Dr.Zayed emphasized that “ OCU400 built on our legacy of bringing Rare Disease therapies to patients in MENA and enables our combined teams to decrease disease burden in the region. Importantly, Roots is dedicated to bringing OCU400 to patients with Retinitis Pigmentosa and creating a new treatment paradigm. We are excited to partner with the Ocugen team.”
Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 90 days.
Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical development with a topline readout expected in 1Q 2027 and BLA submission to follow.
AboutOcugen,Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
CautionaryNoteonForward-LookingStatements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding the terms of the definitive license and supply agreement with Roots Pharmaceutical, the timing of entering into such definitive agreement or whether such definitive agreement will be executed at all, the anticipated benefits to Ocugen of such definitive agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatoryfilingsandanticipateddevelopmenttimelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthat the definitive license and supply agreement with Roots Pharmaceutical will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that such definitive agreement, if executed, will not lead to the currently anticipated benefits to Ocugen, the risks that preliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subjecttodifferinginterpretationsandassessments,includingbyregulatoryauthorities. Theseand otherrisks anduncertaintiesare more fully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
New agreement, effective January 1, 2027, to add approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.)
On top of two previously announced major commercial payer agreements and Medicaid availability in most states, pharmacy coverage for TONMYA will total approximately 46% of all covered lives in the U.S.
Sales force expansion underway with additional field deployment expected by mid-third quarter 2026
BERKELEY HEIGHTS, N.J., July 13, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage biotechnology company, today announced a major managed Medicare agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets), adding approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.). The new agreement will go into effect on January 1, 2027. On top of two prior commercial coverage agreements with leading group purchasing organizations (GPOs) effective in the second quarter of 2026, and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for TONMYA on January 1, 2027, will total approximately 145 million covered lives (46% of 314 million covered lives). Discussions with other commercial and Medicare payers continue to advance.
Following these coverage milestones and positive trends across the launch’s key performance indicators, Tonix is executing its strategy to incrementally grow the TONMYA sales force and expects to deploy 50 new sales force representatives in the field by mid-third quarter 2026, bringing the full sales force to approximately 150 people.
“Patient access to TONMYA is accelerating with the new Medicare agreement on top of two previously announced commercial coverage wins in the first two full quarters of launch,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Having gained substantial patient access, we are expanding our sales force. We believe we are strongly positioned to address patients’ interest in an alternative fibromyalgia medicine and realize the significant potential of the TONMYA opportunity. TONMYA is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use that could serve as an important treatment option.”
Thomas Englese, MBA, Executive Vice President, Commercial Operations, added, “Our coverage growth reflects the recognition of TONMYA’s value for patients and healthcare prescribers (HCPs). Alongside this progress, we are also seeing positive signals across our launch key metrics, including new prescribers, new patients initiating treatment, total prescriptions, and refill prescriptions. By scaling our field team, we expect to engage more top-target HCPs through increased breadth and frequency. We are simultaneously expanding marketing and medical affairs activities to develop greater understanding of fibromyalgia and TONMYA among patients and HCPs. We remain focused on operational excellence and execution.”
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets)
TONMYA (cyclobenzaprine HCl sublingual tablets) was approved on August 15, 2025, by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, alpha1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Brian Korb (Investors) astr partners (917) 653-5122 [email protected]
Andrea Cohen (Media) Sam Brown Inc. (917) 209-7163 [email protected]
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
BOCA RATON, Fla.–(BUSINESS WIRE)–Jul. 13, 2026– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) announced today that the Company has entered into a five-year support services contract with U.S. Immigration and Customs Enforcement (“ICE”) for the activation of a federal immigration processing center at the 1,188-bed Big Horn Facility (the “Facility”) in Hudson, Colorado. GEO has entered into a lease agreement with the Facility owner.
The support services contract is expected to generate approximately $85 million in annual revenues in the first full year of operations, excluding transportation revenue. GEO’s support services are expected to include the exclusive use of the Facility by ICE, along with security, maintenance, and food services, as well as access to recreational amenities, medical care, and legal counsel.
George C. Zoley, GEO’s Chairman, Chief Executive Officer and Founder, said, “We expect that our company-leased Big Horn Facility in Colorado will play an important role in helping meet the need for increased federal immigration processing center bedspace. We are proud of our 40-year public-private partnership with ICE, and we stand ready to continue to assist the federal government in meeting its immigration enforcement priorities.”
About The GEO Group
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 97 facilities totaling approximately 76,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 20,000 employees.
Use of forward-looking statements
This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission including its Form 10-K, 10-Q and 8-K reports. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Readers are strongly encouraged to read the full cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including those referenced above. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a leading artificial intelligence (“AI”) company offering AI and augmented reality (“AR”)-powered solutions to beauty, fashion, photo and video creative industries, announced today that it has entered into a definitive Agreement and Plan of Merger (the “Merger Agreement”), dated as of July 10, 2026, with ProjectNY, an exempted company with limited liability incorporated under the laws of the Cayman Islands controlled by Ms. Alice H. Chang (“Merger Sub”), pursuant to which, and subject to the terms and conditions thereof, Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as the surviving company (the “Surviving Company”) and becoming a privately held company.
Pursuant to the terms of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each ordinary share of the Company issued and outstanding immediately prior to the Effective Time, other than the Excluded Shares, the Continuing Shares and the Dissenting Shares, each as defined in the Merger Agreement, will be cancelled and cease to exist in exchange for the right to receive US$2.00 in cash per share without interest (the “Per Share Merger Consideration”).
The Per Share Merger Consideration represents a premium of approximately 48.1% to the closing price of the Company’s Class A ordinary shares on March 17, 2026, the last trading day prior to the Company’s announcement on March 18, 2026 of its receipt of the preliminary non-binding going-private proposal, and a premium of approximately 39.6% to the volume-weighted average closing price of the Company’s Class A ordinary shares during the 30 trading days prior to that announcement.
Concurrently with the execution of the Merger Agreement, Merger Sub entered into separate voting and support agreements with Ms. Alice H. Chang and her controlled entities GOLDEN EDGE CO., LTD., DVDonet.com. Inc. and World Speed Company Limited (the “Chairwoman Parties”) as well as CyberLink International Technology Corp. (“CyberLink”). Pursuant to such agreements, Chairwoman Parties and CyberLink will vote all ordinary shares they hold directly or indirectly in favor of the authorization and approval of the Merger Agreement, the plan of merger and the transactions contemplated thereby, including the Merger. Such ordinary shares represent approximately 53.4% of the total issued and outstanding share capital of the Company and approximately 81.2% of the total voting power of the Company as of the date of the Merger Agreement.
The Merger is expected to be funded through available cash of the Company and its subsidiaries. The Continuing Shareholders will not receive cash consideration for their Continuing Shares, which will not be cancelled in the Merger and will remain outstanding and continue to exist as ordinary shares of the Surviving Company at the Effective Time.
The Company’s board of directors (the “Board”), acting upon the unanimous recommendation of the special committee of independent and disinterested directors established by the Board (the “Special Committee”), approved the Merger Agreement, the plan of merger, and the transactions contemplated thereby, including the Merger, and resolved to recommend that the Company’s shareholders vote to approve them. The Special Committee negotiated the terms of the Merger Agreement with the assistance of its own financial and legal advisors.
The Merger, which is currently expected to close during the last quarter of 2026, is subject to customary closing conditions, including the approval of the Merger Agreement, the plan of merger and the transactions contemplated thereby, including the Merger, by the affirmative vote of at least two-thirds of the votes cast by holders of the Company’s ordinary shares present and voting in person or by proxy as a single class at an extraordinary general meeting of the Company’s shareholders.
If completed, the Merger will result in the Company becoming a privately held company, its Class A ordinary shares will no longer be listed on the New York Stock Exchange, and the Company’s Class A ordinary shares and warrants will be deregistered under the U.S. Securities Exchange Act of 1934, as amended.
Advisors
Kroll, LLC is serving as financial advisor to the Special Committee; DLA Piper UK LLP is serving as international legal counsel to the Special Committee.
Sullivan & Cromwell LLP is serving as U.S. legal counsel to Merger Sub, the Chairwoman Parties and CyberLink; and Maples and Calder (Hong Kong) LLP is serving as Cayman Islands legal counsel to Merger Sub and the Chairwoman Parties.
Additional Information About the Merger
The Company will furnish to the U.S. Securities and Exchange Commission (the “SEC”) a current report on Form 6-K regarding the Merger, which will include as an exhibit thereto the Merger Agreement. All parties desiring details regarding the Merger are urged to review these documents, which will be available at the SEC’s website.
In connection with the Merger, the Company will prepare and mail to its shareholders a proxy statement that will include a copy of the Merger Agreement. In addition, in connection with the Merger, the Company and certain other participants in the Merger will prepare and file with the SEC a Schedule 13E-3 transaction statement that will include the Company’s proxy statement (the “Schedule 13E-3”). INVESTORS AND SHAREHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE SCHEDULE 13E-3, THE PROXY STATEMENT AND OTHER MATERIALS FILED WITH OR FURNISHED TO THE SEC WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE MERGER AND RELATED MATTERS. In addition to receiving the proxy statement and Schedule 13E-3 by mail, shareholders will also be able to obtain these documents, as well as other filings containing information about the Company, the Merger and related matters, without charge from the SEC’s website.
This announcement is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell any securities, and it is not a substitute for any proxy statement, Schedule 13E-3 or other materials that may be filed with or furnished to the SEC in connection with the Merger.
About Perfect Corp.
Founded in 2015, Perfect Corp. is a leading AI company offering self-developed AI- and AR-powered solutions dedicated to transforming the world with digital tech innovations that make your virtual world beautiful. On Perfect’s direct consumer business side, Perfect operates a family of YouCam consumer apps and web-editing services for photo, video and camera users, centered on unleashing creativity with AI-driven features for creation, beautification and enhancement. On Perfect’s enterprise business side, Perfect empowers major beauty, skincare, fashion, jewelry, and watch brands and retailers by supplying them with omnichannel shopping experiences through AR product try-ons and AI-powered skin diagnostics. With cutting-edge technologies such as Generative AI, real-time facial and hand 3D AR rendering and cloud solutions, Perfect enables a personalized, enjoyable and engaging shopping journey and helps brands elevate customer engagement, increase conversion rates, and propel sales growth. Throughout this journey, Perfect maintains its unwavering commitment to environmental sustainability and fulfilling social responsibilities. For more information, visit https://ir.perfectcorp.com/.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on beliefs and assumptions and on information currently available to Perfect. In some cases, forward-looking statements can be identified by words such as may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing, target, seek or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Forward-looking statements in this communication include, without limitation, statements regarding the proposed Merger, the expected timing and completion of the Merger, the expected funding of the Merger, the expected treatment of the Company’s ordinary shares, options, warrants, Company Earnout Shares and Continuing Shares, the expected delisting and deregistration of the Company’s Class A ordinary shares and warrants, the expected filing and mailing of transaction materials, the anticipated timing of the shareholders meeting and the expected benefits or effects of the Merger. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include, among others, risks and uncertainties relating to the ability to complete the Merger on the proposed terms or anticipated timeline or at all; the possibility that competing offers or acquisition proposals will be made; the possibility that required shareholder approval, regulatory approvals or other consents may not be obtained; the failure to satisfy other conditions to the completion of the Merger; potential litigation relating to the Merger; the amount of costs, fees, expenses and charges related to the Merger; the effect of the announcement, pendency or completion of the Merger on the Company’s business, results of operations, financial condition, cash flows, prospects, relationships with customers, suppliers and employees, operating results and business generally; and other risks and uncertainties described in the Company’s filings with the SEC. Perfect cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that Perfect presently does not know or that Perfect currently does not believe are material that could also cause actual results to differ from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Except as required by applicable law, Perfect does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Earnings Release Scheduled for Thursday, August 6, 2026 Before the Market Opens
Conference Call Scheduled for Thursday, August 6, 2026 at 1:00 PM (Eastern Time)
BOCA RATON, Fla.–(BUSINESS WIRE)–Jul. 9, 2026– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its second quarter 2026 financial results on Thursday, August 6, 2026 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 1:00 PM (Eastern Time) on Thursday, August 6, 2026.
To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:
In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.
A telephonic replay will also be available through August 13, 2026. The replay numbers are 1-855-669-9658 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 1433186. If you have any questions, please contact GEO at 1-866-301-4436.
GLYFADA, Greece, July 08, 2026 (GLOBE NEWSWIRE) — Seanergy Maritime Holdings Corp. (the “Company” or “Seanergy”) (NASDAQ: SHIP) announced today the pricing of the offering of €100 million of unsecured bonds (the “Bonds”) to investors in Greece. The Bonds will be admitted to trading on the Fixed Income Securities Segment of Euronext Athens Holding S.A. (“Euronext Athens”).
The Bonds mature in July 2031, were issued at par and carry a coupon of 4.90% per annum, payable semi-annually. Settlement is expected on July 10, 2026 and trading is expected to commence on July 13, 2026.
The proceeds are expected to be used to finance part of the cost of newbuilding vessels and/or second-hand vessel acquisitions, as well as for general corporate and working capital purposes. Offering expenses are estimated at approximately €4.4 million.
Stamatis Tsantanis, the Company’s Chairman & Chief Executive Officer, stated:
“We are very pleased with the successful completion of this offering, which represents an important milestone for Seanergy in the Hellenic capital markets.
“We sincerely thank the Hellenic investment community for its strong confidence in our strategy and long-term prospects.
“The Bonds provide meaningful non-dilutive capital, diversifying further our capital structure, while supporting the disciplined execution of our fleet growth strategy.”
The Bonds have not been and will not be registered under the Securities Act of 1933, as amended or the securities laws of any state of the United States, and, subject to certain exceptions, may not be offered or sold within the United States. The offering of Bonds is not directed to, and may not be accessed by, any person located in the United States. This press release does not constitute an offer to sell or the solicitation of an offer to buy the Bonds, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.
AboutSeanergyMaritimeHoldingsCorp.
Seanergy Maritime Holdings Corp. is a prominent pure-play Capesize shipping company publicly listed in the U.S. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company owns or finance leases 19 vessels (2 Newcastlemax and 17 Capesize) with an average age of approximately 15.0 years and an aggregate cargo carrying capacity of approximately 3,463,843 dwt. Upon completion of the sale of the M/V Dukeship and the delivery of the newbuilding vessels, the Company is expected to own or finance lease 24 vessels (3 Newcastlemax and 21 Capesize), with an aggregate cargo carrying capacity of approximately 4,400,390 dwt.
The Company is incorporated in the Republic of the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”.
This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including with respect to the consummation of and use of proceeds of the offering of Bonds. Words such as “may”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s operating or financial results; the Company’s liquidity, including its ability to service its indebtedness; competitive factors in the market in which the Company operates; shipping industry trends, including charter rates, vessel values and factors affecting vessel supply and demand; future, pending or recent acquisitions and dispositions, business strategy, impacts of litigation, areas of possible expansion or contraction, and expected capital spending or operating expenses; risks associated with operations outside the United States; risks arising from trade disputes between the U.S. and China, including the re-imposition of reciprocal port fees; broader market impacts arising from trade disputes or war (or threatened war) or international hostilities, such as between the U.S. and Israel and Iran, the U.S. and Venezuela, China and Taiwan and Russia and Ukraine; risks associated with the length and severity of pandemics; and other factors listed from time to time in the Company’s filings with the SEC, including its most recent annual report on Form 20-F. The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
For further information please contact: Seanergy Investor Relations Tel: +30 213 0181 522 E-mail: [email protected]
Capital Link, Inc. Paul Lampoutis 230 Park Avenue Suite 1540 New York, NY 10169 Tel: (212) 661-7566 E-mail: [email protected]
Anna Wichmann Capital Link Athens Tel: +30 210 6109 800 E-mail: [email protected]
STAFFORD, Texas, July 09, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01 in Europe.
All European and US Sites to Treat Patients with Commercially Manufactured GP2
The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.
The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.
About FLAMINGO-01 Open Label Phase III Data
More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Record Quarterly Sales in Both Segments Drives EPS, Cash Flow and Value Creation Raising Fiscal Year 2027 Guidance
FORT WORTH, Texas, July 8, 2026 /PRNewswire/ — AZZ Inc. (NYSE: AZZ), the leading independent provider of hot-dip galvanizing and coil coating solutions, today announced financial results for the first quarter ended May 31, 2026.
Fiscal Year 2027 First Quarter Overview (as compared to prior fiscal year first quarter(1)):
Total Sales of $448.5 million, up 6.3%
Metal Coatings sales of $210.3 million, up 12.3%
Precoat Metals sales of $238.2 million, up 1.5%
Net Income of $52.0 million, down 69.6%; prior year results were meaningfully impacted by equity in earnings from our minority interest in the AVAIL JV related to the sale of the Electrical Products Group to nVent Electric plc; Adjusted net income of $55.8 million, up 3.6%
GAAP diluted EPS of $1.72 per share, down 69.6% due to equity in earnings from the AVAIL JV as mentioned above; Adjusted diluted EPS of $1.85, up 3.9%
Consolidated Adjusted EBITDA of $99.5 million, or 22.2% of sales, versus prior year of $106.4 million, or 25.2% of sales; prior year Q1 included $7.7 million equity in earnings(2) from AVAIL JV operations
Segment Adjusted EBITDA margin of 30.3% for Metal Coatings and 21.7% for Precoat Metals
Cash flow from operations of $37.1 million
Cash dividend of $0.20 per share to common shareholders paid during the quarter, recently announced 20% increase in dividend to $0.24 per share
Net leverage ratio of 1.4x
(1) Adjusted Net Income, Adjusted EPS, Adjusted EBITDA, and net leverage ratio are non-GAAP financial measures as defined and reconciled in the tables below.
(2) Excludes $165.8 million of the $173.5 million of equity in earnings from the AVAIL JV that is included in prior year Q1 GAAP net income.
Tom Ferguson, President, and Chief Executive Officer of AZZ, commented, “We are off to a great start in the fiscal year as sales grew to $448.5 million, up 6.3% over the prior year quarter. Our sales momentum and disciplined operational execution resulted in Adjusted EBITDA of $99.5 million, or 22.2% of sales, which generated adjusted diluted EPS of $1.85, up 3.9%. Metal Coatings achieved strong, double-digit sales gains on higher volume of galvanized steel. Meanwhile, Precoat Metals reached record first-quarter sales, fueled by a combination of price increases to offset materials and input cost inflation and the ongoing production ramp-up at the Washington, Missouri facility. We are on track to set new sales and profitability records in fiscal year 2027 due to external market visibility as we continue to execute our strategic plans; therefore, we have increased our annual guidance range.”
“We ended the quarter with a strong balance sheet and low net debt leverage of 1.4x, providing meaningful financial flexibility as we progress through the year. In the first quarter, we generated $37.1 million in cash from operations and will remain focused on disciplined management of working capital, capital expenditures, and debt throughout the fiscal year. Driven by a proven strategy and disciplined approach to M&A, we are actively pursuing an expanding pipeline of high-quality acquisition targets that will contribute to long-term shareholder value. Finally, I want to thank our AZZ employees as I am proud to work with such a talented group that incorporates pride and passion in everything they do,” Ferguson concluded.
Segment Performance First Quarter2027Metal Coatings Sales of $210.3 million increased by 12.3% over the first quarter of last year, primarily due to increased volume supported by project spending in several end markets, including construction, industrial, and infrastructure. Segment Adjusted EBITDA of $63.8 million resulted in Adjusted EBITDA margin of 30.3%, a decrease of 260 basis points from the prior year first quarter due to the sale of land in the prior year quarter and share growth in large projects this year.
First Quarter2027 Precoat Metals Sales of $238.2 million increased by 1.5% compared to the first quarter of last year, primarily due to increased sales from the Washington, Missouri facility and the pass-through of higher paint and input costs, partially offset by lower volume due to decreases in construction, infrastructure, HVAC and appliance end markets. Segment EBITDA of $51.8 million resulted in EBITDA margin of 21.7%, an increase of 100 basis points from the prior year first quarter, primarily due to higher sales.
Balance Sheet, Liquidity and Capital Allocation The Company generated operating cash of $37.1 million for the first three months of fiscal year 2027 through improved earnings, coupled with a continued focus on working capital management. At the end of the first quarter, the Company’s net leverage was 1.4x trailing twelve months Adjusted EBITDA. During the first three months of fiscal year 2027, the Company made no debt repayments and returned cash to common shareholders through cash dividend payments totaling $6.0 million. Capital expenditures for the first three months of fiscal year 2027 were $18.7 million, and full fiscal year capital expenditures are expected to be approximately $80 – $100 million.
Financial Outlook — Raising Fiscal Year 2027 Guidance We are raising our fiscal year guidance for the year ending February 28, 2027, which reflects our confidence in the Company’s strategic execution, operational resilience, and market positioning. Fiscal year 2027 guidance reflects our best estimates given expected market conditions for the full year, an annualized effective tax rate of 25% and excludes M&A activity and any federal regulatory changes that may emerge.
PriorFY2027 Guidance(1)
RevisedFY2027 Guidance(1)
Sales
$1.725 – $1.775 billion
$1.80 – $1.85 billion
Adjusted EBITDA
$360 – $400 million
$375 – $415 million
Adjusted Diluted EPS
$6.50 – $7.00
$6.75 – $7.15
(1) FY2027 Guidance Assumptions:
a.
The newly built Washington, Missouri plant is expected to be accretive to earnings in FY2027.
b.
Capital expenditures are expected to be approximately $80 to $100 million, reflecting an increase in growth capital for hot-dip galvanizing capacity expansions and technology improvements for both Metal Coatings and Precoat Metals.
c.
Interest expense is expected to be $35 to $45 million.
d.
The annualized effective tax rate of 25% excludes federal regulatory changes that may emerge.
e.
Debt reduction in the range of $130 to $170 million.
f.
Adjusted Diluted EPS guidance includes adding back amortization related to the Company’s intangible assets, adjustments related to the AVAIL JV and debt financing costs related to the refinancing of the Company’s Revolving Credit Facility.
g.
Excludes all potential M&A activities.
h.
Excludes the potential for equity in income (or loss) and cash distributions from AZZ’s minority interest in its unconsolidated subsidiary.
Conference Call Details AZZ Inc. will conduct a live conference call with Tom Ferguson, Chief Executive Officer, Jason Crawford, Chief Financial Officer, and David Nark, Chief Marketing, Communications, and Investor Relations Officer to discuss financial results for the first quarter of the fiscal year 2027, Thursday, July 9, 2026, at 11:00 A.M. ET. Interested parties can access the conference call by dialing (844) 855-9499 or (412) 317-5497 (international). A webcast of the call will be available on the Company’s Investor Relations page at http://www.azz.com/investor-relations.
A replay of the call will be available at (855) 669-9658 or (412) 317-0088 (international), replay access code: 5406597 through July 16, 2026, or by visiting http://www.azz.com/investor-relations for the next 12 months.
About AZZ Inc. AZZ Inc. is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end-markets in North America. Collectively, our business segments provide sustainable, unmatched metal coating solutions that enhance the longevity and appearance of buildings, products and infrastructure that are essential to everyday life.
Safe Harbor Statement Certain statementsherein about our expectations of future events or results constitute forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by terminology such as “may,” “could,” “should,” “expects,” “plans,” “will,” “might,” “would,” “projects,” “currently,” “intends,” “outlook,” “forecasts,” “targets,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Such forward-looking statements are based on currently available competitive, financial, and economic data and management’s views and assumptions regarding future events. Such forward-looking statements are inherently uncertain, and investors must recognize that actual results may differ from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made and are subject to risks that could cause them to differ materially from actual results. Certain factors could affect the outcome of the matters describedherein. This press release may contain forward-looking statements that involve risks and uncertainties including, but not limited to, changes in customer demand for our manufactured solutions, including demand by the construction; infrastructure; transportation; HVAC & appliance; container; and the metal coatings end markets. We could also experience additional increases, including increases due to inflation, in labor costs, components and raw materials including zinc and natural gas, which are used in our hot-dip galvanizing process and paint used in our coil coating process; supply chain vendor delays; delays in additional acquisition opportunities; an increase in our debt leverage and/or interest rates on our debt, of which a significant portion is tied to variable interest rates; availability of experienced management and employees to implement AZZ’s growth strategy; a downturn in market conditions in any industry relating to the manufactured solutions that we provide; economic volatility, including a prolonged economic downturn or macroeconomic conditions such as inflation or changes in the political stability in the United States or Canada; tariffs, acts of war or terrorism inside the United States or abroad; and other changes in economic and financial conditions. AZZ has provided additional information regarding risks associated with the business, including in Part I, Item 1A. Risk Factors, in AZZ’s Annual Report on Form 10-K for the fiscal year ended February28, 2026, and other filings with the SEC, available for viewing on AZZ’s website at www.azz.com and on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully when evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. These statements are based on information as of the datehereof and AZZ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Company Contact: David Nark, Chief Marketing, Communications, and Investor Relations Officer AZZ Inc. (817) 810-0095 www.azz.com
Investor Contact: Sandy Martin / Phillip Kupper Three Part Advisors (214) 616-2207 or (817) 368-2556 www.threepa.com
90.5% interim disease control rate (DCR) observed with combination therapy
Initial Part C efficacy observations align with previously reported THIO-101 clinical activity despite a more heavily pre-treated patient population
CHICAGO, July 08, 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 positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line (3L) therapy for patients with advanced non-small cell lung cancer (NSCLC).
Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo®) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate.2
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies.”
MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.
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.
SHELTON, CT / ACCESS Newswire / July 8, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, reports that a Coverage Initiating Research Report on the Company by an Independent Analyst has been published, dated as of July 6, 2026.
The report rates the Company with a rating of “Outperform” and has assigned a target price of $6.00, based on the analyst’s estimates. This research report provides a summary of the Company’s current programs, as well as additional longer term programs. The report was written by Mr. Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc. The report and additional coverage of the Company is available at channelchek.com. The report is also available at the Company’s website, nanoviricides.com .
The Company provided publicly available information to the Analyst, and also provided answers to questions of a technical nature, as is typical. All estimates of timelines, financial projections and modeling, etc. were made independently by the Analyst. The Company does not provide guidance on its timelines or revenues, profit or loss projections, nor does it review or have any input into the independent assessments.
The Company has retained Noble Capital as part of its investor outreach program. No part of the Analyst’s compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public appearance and/or research report. All views expressed in this report accurately reflect the Analyst’s personal views about the subject securities or issuers. This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs.
In a separate update, NanoViricides reports that Anil R. Diwan, PhD, the Company’s President and Executive Chairman was interviewed in a “Fireside Chat” by host Mr. Dave Donlin. This video interview was published by StockInvestor Daily under the IPO-Edge program on June 29, 2026 and is available at https://ipo-edge.com/replay-fireside-chat-with-nanoviricides-president-exec-chairman-anil-r-diwan/. The video is also available on the Company’s website (nanoviricides.com). The video provides information on the Company’s technology, how it is differentiated from current approaches, and the current programs.
In this Fireside Chat, Dr. Diwan discussed:
How NanoViricides’ broad-spectrum antiviral drugs like its lead drug NV-387 work alongside vaccines.
NanoViricides advancing a broad-spectrum antiviral approach that will be effective even against variants with its lead drug NV-387; how this differs from current antivirals in treating viral diseases like RSV and FLU.
The company’s Orphan Drug Designation granted by the FDA and its filing for Rare Pediatric Disease Designation for Measles; how the Company benefits from these designations and the upcoming potential funding benefits.
The resurgence of Measles despite having a vaccine in place and how it has caused epidemics in Europe, Canada, Mexico, and Bangladesh, while also making headlines in the U.S. Why this is happening and what this return tell us about current protection against viral diseases that are thought to be eliminated by vaccines.
The resurgence of several viral infections globally, like Monkeypox and Ebola, and the WHO declaring global alerts as diseases come back with new virus variants for which there is no vaccine or treatment, and how NanoViricides can help.
NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.
