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Release – Power Metallic Intercepts Lion Style Sulphides (Lion East and Lion West) Following Recently Recognized High Grade Structural Trends

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Research News and Market Data on PNPNF

Mar 03, 2026, 09:00 ET

TORONTO, March 3, 2026 /CNW/ – Power Metallic Mines Inc. (the “Company” or “Power Metallic”) (TSXV: PNPN) (OTCBB: PNPNF) (Frankfurt: IVV1) is pleased to provide an exploration update of recent drilling and results of regional exploration from its fall drill program

Lion East and Lion West Target Areas

Figure 1 Lion long section with Lion East and Lion West holes illustrated (drill hole intersections in Lion Zone not shown for clarity). (CNW Group/Power Metallic Mines Inc.)
Figure 1 Lion long section with Lion East and Lion West holes illustrated (drill hole intersections in Lion Zone not shown for clarity). (CNW Group/Power Metallic Mines Inc.)
Figure 2 Mineralization intersected in PML-26-054 east of the Lion deposit along a shallow east plunging high grade trend (CNW Group/Power Metallic Mines Inc.)
Figure 2 Mineralization intersected in PML-26-054 east of the Lion deposit along a shallow east plunging high grade trend (CNW Group/Power Metallic Mines Inc.)
Figure 3 Mineralization intersected in PML-26-067 west of the Lion deposit along shallow east plunging high grade trend (CNW Group/Power Metallic Mines Inc.)
Figure 3 Mineralization intersected in PML-26-067 west of the Lion deposit along shallow east plunging high grade trend (CNW Group/Power Metallic Mines Inc.)
Figure 4 – Location of PMX exploration holes with areas of interest tested in the summer-fall of 2025. (CNW Group/Power Metallic Mines Inc.)
Figure 4 – Location of PMX exploration holes with areas of interest tested in the summer-fall of 2025. (CNW Group/Power Metallic Mines Inc.)

Structural analysis of mineralization orientation from Lion Zone drill core, while confirming the dominant steep westerly plunge of the Lion Zone, also identified a shallow easterly plunge that appears to control the highest-grade zones within the Lion Zone (Figure 1). Currently four (4) easterly trending structures have been identified.

Recent drilling targeted the shallowest of these trends to determine if this mineralization trend had validity and would extend beyond the known boundaries of the Lion Zone. The first hole in this program, PML-26-054 has intersected 5m of Lion style mineralization with visible copper in narrow massive lenses (Figure 2) and disseminated and stringer style chalcopyrite.

With the confirmation of the easterly plunging trend extending high grade mineralization to the east, hole PML-26-067 was drilled on the western edge of Lion along the same structural trend in an area previously believed to be low grade, and at a vertical depth of approximately 50m this hole intersected 1m of massive copper sulphides (Figure 3) and 3.3 meters of disseminated copper mineralization. Follow-up holes are currently being drilled to establish the size of these two extensions to Lion.

Of significance, the easterly trending structure currently being tested has a trend that aligns with mineralization intersected 350 meters east of Lion in hole PML-25-021 (see news release November 4, 2025), adding further support to the structural trend. This opens the potential of hundreds of meters of strike along the trend plunge direction of this shallowest trend line.

Finally, a three additional easterly plunging trends below the shallowest one currently being tested have yet to be tested by any drilling and all have the potential to add additional zones of mineralization in both the Lion East and the Lion West areas. “The verification of this plunge trend, while expanding the Lion target area, also is acting as a vector direction towards a potential large Ni-Cu deposit that is the source for the mobilized copper mineralization, giving the geologists a new focus for this long-term exploration target”, states Joe Campbell, VP of Exploration for Power Metallic.

The Lion West target area also is actively being drilled following the magnetic high that defines the UM zone between Lion and Nisk. The first hole drilled on this target (PML-25-040) collared in the UM, so was in front of the Lion Zone stratigraphy. This established that there is an offset from the edge of the Lion Zone shifting geology to the north. Despite missing the Lion stratigraphy, below the UM the hole hit mineralization over 0.31m consisting of massive nickeliferous sulphides (2.42% Ni, 1.83 g/t Pd, 0.11% Cu) within a tonalite dyke. This mineralization is like the ‘rafted’ rip-up blocks seen at the Tiger deposit and indicate that a Ni-Pd-Cu deposit exists somewhere below the rafted block. Power Metallic has subsequently moved the drill collar further north to intersect the Lion stratigraphy structurally above the UM, and that hole is currently being drilled.

Summer-Fall Regional Drilling (PMX holes) – New Gold Zone in Hinge Area

The summer-fall 2025 regional exploration program targeted EM anomalies identified in the summer airborne survey, supplemented by surface mapping to identify favourable rock types for Ni-Cu mineralization. The EM survey produced more than 100 conductors. The initial drilling tested a variety of target areas to ascertain their prospectivity for Nisk and Lion style mineralization.

The Power Metallic properties now cover over 330 km2, and to date only 16 holes have been drilled within an area approximately 40km x 10 km in size. Each area drilled is separated by several kilometers, and individual holes are generally hundreds of meters apart, so this initial program should be treated as a first reconnaissance of the regional property.

Five target areas were tested based on EM anomalies, structural complexity, and proximity to potential ultra-mafic source rocks for Ni-Cu mineralization (Figure 4). All holes intersected sufficient semi-massive to massive sulphides to explain the EM conductors. In summary:

Zone 1 – Hinge/Hydro Lands – PMX-25-001, 002, 015, 016

This area produced the best indications of potential Ni-Cu mineralization, and possible mobilized polymetallic (Lion Style). Mineralization is dominantly pyrrhotite within or proximal to high magnesium basalts (komatiitic) and gabbros, with local pyroxenite. Of significance, all holes intersected highly anomalous arsenic and tungsten in, or proximal to, the high magnesium rocks. Both these minerals are considered pathfinders to mineralization in the Sudbury camp. Local indications of polymetallic mineralization include Pd (up to 0.10 g/t), Pt (0.11 g/t) in hole PMX-25-015, and Au (0.36 g/t) in hole PMX-25-001 in the high Mg rocks.

The four holes test an area of more than 2 km of strike along the prospective EM targets, and drill holes are hundreds of meters apart. The consistency of the alteration (As, W) and the rock types is encouraging, but the spacing of the holes is too large to provide any detailed modelling. Currently this area is being tested with follow-up drilling.

Also, of significance in this area hole PMX-25-016, the last hole in the regional program intersected a broadly anomalous gold zone in a recognizable felsic-intermediate volcanic unit (33 meters of low anomalous gold), and contained within this zone is a high-grade intersection of 34.6 g/t Au over 1.50m from 273.5m to 275.0m. This intersection contains a foliation parallel stringer of visible gold. This unit has been identified in surface mapping over several kilometers and was also intersected in hole PMX-25-15 approximately 500m to the east of PMX-25-16. Relogging and resampling of this unit in both holes was incomplete and is being carried out now. Finally, the deep hole (PML-25-021X) targeting the Elephant BHEM plate also intersected this unit approximately 600m below PMX-25-016 with possible indications of mineralization. Assays are pending from this hole.

Zone 2 – Nisk Far West – PMX-25-003

This target was an isolated EM conductor located approximately 10km west of the Nisk deposit. It failed to intersect prospective rock types or anomalous mineralization.

Zone 3 – South Basin Margin West – PMX-25-004, 005, 006, 007, 008, 010

This target tested EM anomalies with complex structures and surface mapping support for hosting UM intrusions along the southern margin of the sedimentary-volcanic basin. The 6 holes were broadly scattered across approximately 5km of strike. All holes hit significant zones of sulphides. The anomalous mineralization consisted largely of Zn, Ag, Pd, Cu, indicative of a VMS deposit style signature. Although this is not Power Metallic’s primary target type, the mineralization observed will require follow-up. There were UM rocks intersected (11m in hole PMX-25-008 as example) but they contained no significant Ni-Cu-PGE anomalism.

Zone 4 – Center Basin Tonalite – PMX-25-009, 011

Like Zone 3, the sulphide mineralization in these two holes appears to support a VMS style mineralization. There were no significant zones of UM rocks in these two holes. 

Zone 5 – South Basin Margin East – PMX-25-012, 013, 014

Like Zone 3 these three holes covered approximately 5km of strike along the southern boundary of the basin. Indications from the sulphides intersected suggest a VMS style with anomalous Zn, Cu, Ag.

Elephant and Tiger Deep BHEM Targets

Drilling of the Elephant BHEM target (extension of hole PML-25-021) intersected pyrrhotite mineralization that did not appear to be Ni-Cu affinity. Follow-up BHEM has not established a strong off-hole conductor. The contact zone stratigraphy associated with the Lion deposit and the UM intrusion has been identified, but this contact did not contain UM. BHEM is currently being reassessed to develop new target vectors, and assay results on the contact zone are pending.

The first hole at Tiger Deep was collared to drill between two BHEM generated conductor plates to refine the target area. While no visual mineralization was intercepted, the geology was encouraging, and follow-up drilling is now targeting a refined BHEM plate. Assay results on the initial hole are pending.

Qualified Person

Joseph Campbell, P. Geo, VP Exploration at Power Metallic, is the qualified person who has reviewed and approved the technical disclosure contained in this news release.

About Power Metallic Mines Inc.

Power Metallic is a Canadian exploration company focused on advancing the Nisk Project Area (Nisk–Lion–Tiger)–a high–grade Copper–PGE, Nickel, gold and silver system–toward Canada’s next polymetallic mine.

 On 1 February 2021, Power Metallic (then Chilean Metals) secured an option to earn up to 80% of the Nisk project from Critical Elements Lithium Corp. (TSX–V: CRE). In June 2025 the Company purchased 313 adjoining claims (~167 km²) from Li–FT Power. As of Dec 31 2025, the Company has added additional land vis its staking efforts and the Company now controls ~330 km² and roughly 50 km of prospective basin margins.

Power Metallic is expanding mineralization at the Nisk and Lion discovery zones, evaluating the Tiger target, and exploring the enlarged land package through successive drill programs.

Beyond the Nisk Project Area, Power Metallic indirectly has an interest in significant land packages in British Columbia and Chile, by its 50% share ownership position in Chilean Metals Inc., which were spun out from Power Metallic via a plan of arrangement on February 3, 2025.

It also owns 100% of Power Metallic Arabia which owns 100% interest in the Jabul Baudan exploration license in The Kingdon of Saudi Arabia’s Jabal Said Belt. The property encompasses over 200 square kilometres in an area recognized for its high prospectivity for copper gold and zinc mineralization. The region is known for its massive volcanic sulfide (VMS) deposits, including the world-class Jabal Sayid mine and the promising Umm and Damad deposit.

For further information, readers are encouraged to contact:
Power Metallic Mines Inc.
The Canadian Venture Building
82 Richmond St East, Suite 202
Toronto, ON

Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

QAQC and Sampling

GeoVector Management Inc (“GeoVector”) is the Consulting company retained to perform the actual drilling program, which includes core logging and sampling of the drill core.

 All core in this news release is NQ sized core. Drill core is re-fitted and measured. Geotech on core includes photographs (wet & dry), rock quality index, magnetic susceptibility, conductivity, and recovery estimates. Core is logged for lithology, mineralogy, and structural features, and sample intervals are delineated and tagged.

 Sampled core is mechanically sawn, and half-core is retained for future reference. GeoVector’s QAQC program includes regular insertion of CRM standards, duplicates, and blanks into the sample stream with a stringent review of all results. QAQC and data validation was performed, and no material errors were observed.

All samples were submitted to and analyzed at Activation Laboratories Ltd (“Actlabs”), a commercial laboratory independent of Power Metallic with no interest in the Project. Actlabs is an ISO 9001 and 17025 certified and accredited laboratories. Samples submitted through Actlabs are run through standard preparation methods and analysed using RX-1 (Dry, crush (< 7 kg) up to 80% passing 2 mm, riffle split (250 g) and pulverize (mild steel) to 95% passing 105 μm) preparation methods, and using 1F2 (ICP-OES) and 1C-OES – 4-Acid near total digestion + Gold-Platinum-Palladium analysis and 8-Peroxide ICP-OES, for regular and over detection limit analysis. Pegmatite samples are analyzed using UT7 – Li up to 5%, Rb up to 2% method. Actlabs also undertake their own internal coarse and pulp duplicate analysis to ensure proper sample preparation and equipment calibration.

Cautionary Note Regarding Forward-Looking Statements

This message contains certain statements that may be deemed “forward-looking statements” concerning the Company within the meaning of applicable securities laws. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” “indicates,” “opportunity,” “possible” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, are subject to risks and uncertainties, and actual results or realities may differ materially from those in the forward-looking statements. Such material risks and uncertainties include, but are not limited to, among others; the timing for various drilling plans; the ability to raise sufficient capital to fund its obligations under its property agreements going forward and conduct drilling and exploration; to maintain its mineral tenures and concessions in good standing; to explore and develop its projects; changes in economic conditions or financial markets; the inherent hazards associates with mineral exploration and mining operations; future prices of nickel and other metals; changes in general economic conditions; accuracy of mineral resource and reserve estimates; the potential for new discoveries; the ability of the Company to obtain the necessary permits and consents required to explore, drill and develop the projects and if accepted, to obtain such licenses and approvals in a timely fashion relative to the Company’s plans and business objectives for the applicable project; the general ability of the Company to monetize its mineral resources; and changes in environmental and other laws or regulations that could have an impact on the Company’s operations, compliance with environmental laws and regulations, dependence on key management personnel and general competition in the mining industry.

SOURCE Power Metallic Mines Inc.

For further information on Power Metallic Mines Inc., please contact: Duncan Roy, VP Investor Relations, 416-580-3862, [email protected]

Release – MAIA Biotechnology Announces Pricing of $30 Million Underwritten Public Offering of Common Stock

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Research News and Market Data on MAIA

March 02, 2026 10:45pm ESTDownload as PDF

Financing included participation by healthcare-dedicated investors alongside
existing shareholders

CHICAGO, IL, March 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 3,000,000 shares of common stock at the public offering price per share, less the underwriting discounts to cover over-allotments, if any. The offering is expected to close on March 4, 2026, subject to satisfaction of customary closing conditions.

The offering was structured as a straightforward common stock only investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Konik Capital Partners, LLC, a division of T.R. Winston & Company is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above are being offered and sold pursuant to a “shelf” registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 15, 2023, and declared effective on August 23, 2023.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement.. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About MAIA Biotechnology

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. 

Cautionary Note Regarding Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended). 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, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) the closing of our underwritten public offering of common stock, 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. A detailed discussion of these uncertainties and risks that affect our business is contained in our SEC filings, including our reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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

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Source: MAIA Biotechnology, Inc.

Released March 2, 2026

Release – Kratos Receives $7 Million Order for Counter-UAS Systems

Posted on by [email protected]

Research News and Market Data on KTOS

March 3, 2026

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Recent Award is Related to Long-term Counter-UAS Production Contract

SAN DIEGO, March 03, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, today announced that it has recently received an approximate $7 million Production Contract Award for a Counter-UAS System designed to detect, track and classify threats, including low-profile unmanned aerial systems, cruise missiles, and other aerial systems. Kratos is an industry leading provider of military-grade hardware for air defense, missile, radar, hypersonic, strategic, directed energy and other systems. Work under this program award will be performed in a secure Kratos manufacturing facility. Due to security related and other considerations, no additional information will be provided.

Eric DeMarco, Kratos President and CEO, said, “Manufacturing military-grade hardware in large scale production runs, that must work every time, is hard and a clear differentiator of Kratos to our partners and customers. Drones, missiles, loitering munitions and other aerial threats are rapidly proliferating globally by our adversaries, and Kratos is proud to manufacture the systems to defend and protect our warfighters.”

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, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

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

Press Contact:
Claire Cantrell
[email protected]

Investor Information:
877-934-4687
[email protected]

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Source: Kratos Defense & Security Solutions, Inc.

Release – Tonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select Market

Posted on by [email protected]

Research News and Market Data on TNXP

March 03, 2026 6:00am EST Download as PDF

BERKELEY HEIGHTS, N.J., March 03, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market is expected to commence at the open of market on March 3, 2026, under the Company’s existing ticker symbol “TNXP.”

The uplisting to the Nasdaq Global Select Market reflects the Company’s compliance with the Nasdaq Global Select Market’s higher financial and corporate governance standards. The transition to this higher tier of the Nasdaq market may enhance the Company’s visibility among institutional investors, improve liquidity and broaden market recognition.

“Uplisting to the Nasdaq Global Select Market is an important milestone for Tonix,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We look forward to leveraging this enhanced platform to drive growth and create value for our shareholders. We’re grateful for the support that has brought us here and excited about what’s ahead.”

The Nasdaq Global Select Market is the highest of the three Nasdaq market tiers and is designed for companies that meet higher financial, liquidity and corporate governance requirements than those of the Nasdaq Capital Market and the Nasdaq Global Market. The Company believes that trading on this tier will further enhance its reputation with customers, partners and investors. Companies at this level may experience increased trading volumes and greater access to institutional investors. Meeting the Global Select Market’s higher financial and corporate governance standards may also signal to the market that a company has achieved financial and operational growth.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.

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

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

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

Media Contacts
Ray Jordan 
Putnam Insights 
[email protected] 

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Source: Tonix Pharmaceuticals Holding Corp.

Released March 3, 2026

Release – Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

Posted on by [email protected]

Research News and Market Data on GLSI

 Download as PDFMarch 03, 2026 6:00am EST

STAFFORD, Texas, March 03, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on the increased patient screen rate in FLAMINGO-01.

FLAMINGO-01 Annual Patient Screen Rate Increases to Over 800 Patients per Year

Over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.

CEO Snehal Patel commented, “While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

  • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
  • The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

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Source: Greenwich LifeSciences, Inc.

Released March 3, 2026

Release – MAIA Biotechnology Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants

Posted on by [email protected]

Research News and Market Data on MAIA

March 02, 2026 5:00pm EST Download as PDF

CHICAGO, IL, March 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in this offering are being offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase additional shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Konik Capital Partners LLC, a division of T.R. Winston & Company, is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above are being offered and sold pursuant to a “shelf” registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 15, 2023, and declared effective on August 23, 2023. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering has been or will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference into such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About MAIA Biotechnology

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.

Cautionary Note Regarding Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended). 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, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) our proposed public offering of common stock and/or pre-funded warrants, 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. A detailed discussion of these uncertainties and risks that affect our business is contained in our SEC filings, including our reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

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

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Source: MAIA Biotechnology, Inc.

Released March 2, 2026

Release – MariMed Extends Series B Preferred Stock Obligation Through 2031, Strengthening Capital Structure

Posted on by [email protected]

Research News and Market Data on MRMD

March 02, 2026 4:15pm ESTDownload as PDF

NORWOOD, Mass., March 02, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or “the Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today that it has entered into a Restructuring and Exchange Agreement (the “Agreement”) with the holders (the “Holders”) of its $14.725 million Series B Convertible Preferred Stock (the “Series B Obligation”). The restructuring extends the maturity of the Company’s obligations on favorable market terms.

The Agreement eliminates the Company’s February 28, 2026 mandatory conversion date obligation and replaces it with a combination of long-dated instruments. As a result, the transaction extends the weighted average maturity of the obligation 4.6 years, significantly reducing near-term refinancing risk and enhancing the Company’s liquidity profile.

Under the Agreement, the Company issued:

  • a $2 million promissory note maturing in March 2028, bearing interest at 8 percent with a two-year term;
  • a $6 million promissory note maturing in March 2031, bearing interest at 10 percent with a five-year term; and
  • $6.725 million of Series B Convertible Preferred Shares, valued at $0.25 per share, which are subject to mandatory conversion in February 2031, unless converted earlier pursuant to its terms.

Additional details of the restructuring are available in a Form 8-K filed by the Company earlier today that is accessible on MariMed’s Investor Relations website at ir.marimedinc.com.

“We are pleased to successfully complete the restructuring, which meaningfully extends the maturity profile of the obligation and enhances our financial flexibility,” said MariMed CEO Jon Levine. “By eliminating this 2026 obligation, we have strengthened our balance sheet and positioned the Company to focus on executing our growth initiatives. The obligation as restructured includes both unsecured debt at favorable market rates and an equity component with a conversion feature at a significant premium to current market. We thank the Holders for their cooperative and collaborative approach to the restructuring and sharing the vision of MariMed’s future.”

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Company Contact:
Howard Schacter
Chief Communications Officer
Email: [email protected]
Phone: (781) 277-0007

Primary Logo

Source: MariMed Inc.

Released March 2, 2026

Release – First Phosphate Receives Conditional Approval for up to $16.7 Million Non-Repayable Contribution from the Government of Canada

Posted on by [email protected]

Research News and Market Data on FRSPF

March 02, 2026 2:03 PM EST | Source: First Phosphate Corp.

Saguenay, Québec–(Newsfile Corp. – March 2, 2026) – First Phosphate Corp. (CSE: PHOS) (OTCQX: FRSPF) (OTCQX ADR: FPHOY) (FSE: KD0) (“First Phosphate” or the “Company“) has been conditionally approved for a non-repayable contribution agreement for up to C$16.7 million with the Government of Canada through Natural Resources Canada (“NRCan”) under the Global Partnerships Initiative (“GPI”).

This contribution funded by the Government of Canada will be deployed to assess the technical and engineering parameters – including processing circuits and equipment – needed to validate the ability to produce a phosphate concentrate that meets the quality requirements of the lithium iron phosphate (“LFP”) battery market. The work will be conducted based on the parameters established under the contract between First Phosphate and its definitive offtaker.

“Canada and our partners are putting real capital behind the secure and resilient critical mineral supply chains that our economies and defence industries rely on,” said The Honourable Tim Hodgson, Minister of Energy and Natural Resources. “By supporting companies like First Phosphate, we are helping deliver the minerals the world needs and the prosperity and security Canadians deserve.”

“This financial support of the Government of Canada represents an important lever for the continuation of our development work,” stated Armand MacKenzie, President of First Phosphate. “This contribution enables us to carry out detailed work aimed at validating LFP application requirements and the expectations of our offtakers and international partners.”

The development work will help strengthen Canada’s strategic positioning within the LFP battery value chain through the development of domestic capacity to process apatite (phosphate concentrate) into high-purity phosphoric acid (“PPA”) for battery applications.

The project will develop a scalable Canadian process for the production of battery-grade phosphate concentrate, reducing dependence on foreign supply chains.

The activities will contribute to significant economic benefits, including the creation of skilled jobs and the potential establishment of a Canadian phosphoric acid facility supported by local commercial production of phosphate concentrate.

The financial contribution is granted for the completion of a study of the Company’s integrated phosphate concentrate project in Saguenay-Lac-Saint-Jean and covers eligible activities planned through 2028, in accordance with the terms of the agreement. It forms part of an initiative to support industrial collaboration and the integration of Canadian projects into international supply chains for battery materials.



To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/8917/285984_19c5995ee4b229ba_001full.jpg

Qualified Person

The scientific and technical disclosure for First Phosphate included in this news release has been reviewed and approved by Gilles Laverdière, P.Geo. Mr. Laverdière is Chief Geologist of First Phosphate and a Qualified Person under National Instrument 43-101 – Standards of Disclosure of Mineral Projects (“NI 43-101”).

About Natural Resources Canada

Natural Resources Canada (“NRCan”) is the federal department responsible for developing policies and programs to ensure the sustainable and responsible development of Canada’s natural resources. Through its initiatives and funding programs, including the International Partnerships Program, NRCan supports projects that contribute to strengthening supply chains, industrial innovation, and Canada’s competitiveness in the critical and strategic minerals sectors.

About First Phosphate Corp

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

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

For further information, please contact:

Armand MacKenzie
President
[email protected]
Tel: +1 (514) 618-5289

Investor Relations: [email protected]
Media Relations: [email protected]
Website: www.FirstPhosphate.com

Follow First Phosphate:

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

– 30 –

Forward-Looking Information and Cautionary Statements

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

info

Source: First Phosphate Corp.

Release – InPlay Oil Corp. Confirms Monthly Dividend for March 2026

Posted on by [email protected]
InPlay Oil logo (CNW Group/InPlay Oil Corp.)

Research News and Market Data on IPOOF

Mar 02, 2026, 07:30 ET

CALGARY, AB, Feb. 26, 2026 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.09 per common share payable on March 31, 2026, to shareholders of record at the close of business on March 16, 2026. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.

About InPlay Oil Corp.
InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

SOURCE InPlay Oil Corp.

For further information please contact: 

Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp.

Telephone: (587) 955-0632

| www.inplayoil.com|

|Darren Dittmer, Chief Financial Officer, InPlay Oil Corp.

Telephone: (587) 955-0634

Release – Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline

Posted on by [email protected]

Research News and Market Data on GYRE

March 2, 2026

PDF Version

  • Acquisition will create a U.S.- and China-based fully integrated biopharmaceutical company with revenue-producing commercial assets and a robust pipeline of degraders, targeting inflammatory diseases and cancers.
  • Access to degrader-antibody conjugates (DACs) platform technology for future discovery engine.
  • Strengthened leadership team designed to support future global growth.
  • Transaction is anticipated to close early in the second quarter of 2026.
  • An updated corporate presentation has been posted to the Gyre and Cullgen websites.

SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, today announced its agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim Chief Executive Officer and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current Chief Executive Officer of Cullgen, Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.

Dr. Luo, the expected President and Chief Executive Officer of Gyre, commented, “We are thrilled about the synergistic coalescing of our companies. Cullgen brings strong drug discovery capabilities and a solid preclinical and clinical pipeline to complement Gyre’s existing and highly efficient China-based manufacturing capabilities and sales team. Gyre is already a commercial-stage company with ETUARY® on the market in China for the treatment of lung fibrosis and a second product for liver fibrosis, Hydronidone (F351), nearing New Drug Application (NDA), submission in China. Gyre is also exploring the expansion of F351’s development in ex-China territories. Following the acquisition, we will have a fully integrated biopharmaceutical company that will be capable of leveraging emerging drug discovery capabilities in China and strong clinical development in the United States to address unmet medical needs worldwide. I am excited for the potential of TPDs and DACs to drive this Company’s future growth globally.”

Mr. Zhang, Chairman of Gyre, commented, “Recently, Gyre, through its majority owned subsidiary, Gyre Pharmaceuticals, had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals’ first-in-class anti-liver fibrosis candidate, Hydronidone, subject to formal approval. As a result, Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China. The addition of Cullgen’s TPD/DAC platform and pipeline is expected to enhance our long-term growth prospects. We are excited to have Cullgen colleagues join our team in both the United States and China.”

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States.

Prior to entering into this transaction, Cullgen’s proposed merger with Pulmatrix was terminated.

Updated Corporate Presentation

In connection with this announcement, a new presentation has been posted on each company’s respective website. Visit http://www.cullgen.com or http://www.gyretx.com.

About Cullgen Inc.

Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and DAC therapies designed to improve the lives of patients suffering from critical conditions such as pain, cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.

Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (TRK) degrader that previously completed a Phase 1 trial for the treatment of acute post-operative pain and Cullgen released positive top-line results from the study in late 2025. Cullgen recently submitted an IND for the molecule, and pending FDA allowance, expects to initiate a Phase 2 trial in acute pain in bunionectomy patients in the United States. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs including next-generation degrader-antibody conjugates.

For more information, please visit www.cullgen.com.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Advisory and Legal Counsel

Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors, and Gyre’s legal counsel is Gibson, Dunn & Crutcher LLP.

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Cullgen.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the structure, timing and completion of the proposed acquisition; the anticipated timing of closing; the expected executive officers and directors of the combined entity; the future operations of the combined entity; the nature, strategy and focus of the combined entity; the development and commercial potential and potential benefits of any product candidates of the combined entity; and anticipated clinical drug development activities and related timelines, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China and the anticipated timing of Cullgen’s Phase 2 trial of its TRK degrader in acute pain. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the risk that the conditions to the closing of the acquisition are not satisfied; uncertainties as to the timing of the consummation of the acquisition and the ability of each of Gyre and Cullgen to consummate the acquisition; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the acquisition; unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025, and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACTS:

Gyre Therapeutics, Inc. 
Ping Zhang, interim CEO and executive chairman
[email protected]

Cullgen Inc. 
Thomas Eastling, CFO
[email protected]

Investors
Chuck Padala
Managing Director, LifeSci Advisors
[email protected]

Release – Cadrenal Therapeutics Highlights Recent 12-LOX Inhibitor Platform Expansion

Posted on by [email protected]

Research News and Market Data on CVKD

Encouraging data for CAD-1005 in Phase 2 HIT Study

EOP2 scheduled for Q1 for top-priority indication

Additional acute and chronic opportunities for 12-LOX inhibition beyond HIT

PONTE VEDRA, Fla., March 02, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing therapies for life-threatening immune and thrombotic disorders, today provided additional perspectives on development opportunities following its recent pipeline expansion with the addition of 12-LOX inhibitors.

As previously announced, Cadrenal recently acquired a portfolio of selective 12-LOX inhibitors, including oral candidates. Encouraging recent data from a blinded, placebo-controlled Phase 2 study of CAD-1005, a parenteral 12-LOX inhibitor, in heparin-induced thrombocytopenia (HIT) demonstrated a reduction in thrombotic events on a background of standard anticoagulants, with an End-of-Phase 2 (EOP-2) meeting scheduled for later this month.

While HIT remains Cadrenal’s near-term regulatory priority with CAD-1005, an ever-growing body of scientific research supports the central role that 12-LOX also plays in inflammatory signaling across multiple high-impact disease areas. Published studies have highlighted its role in atherosclerosis and vascular inflammation, microvascular thrombosis, ischemia-reperfusion injury, and immune-mediated metabolic conditions, including beta-cell stress pathways associated with type 1 diabetes and obesity.

Collectively, these therapeutic areas represent multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes. Cadrenal’s new 12-LOX inhibitor portfolio is a differentiated platform approach across a range of thrombotic and inflammatory conditions, with both acute and chronic potential applications.

“We are very excited to have the only selective 12-LOX inhibitor currently in clinical-stage development and continue to move forward with HIT as our lead indication and regulatory priority,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We also appreciate that 12-LOX inhibition represents an entirely new – and exciting – therapeutic approach and are optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas.”

About 12-LOX

Lipoxygenases are a family of enzymes involved in lipid metabolism that stimulate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic action of 12-LOX ultimately leads to the formation of 12-HETE, a lipid molecule that easily crosses cell membranes. Intracellularly, 12-HETE promotes oxidative stress, while extracellularly, 12-HETE modulates a variety of signaling pathways to regulate inflammatory activity and elicit pro-inflammatory effects. In human blood, 12-LOX is found primarily in platelets and leukocytes; it is also found within the pancreas of diabetics and in certain cancer cells. In HIT, 12-LOX is a critical link in platelet activation via the IgG receptor. Early attempts to develop 12-LOX inhibitors failed because they were not 12-LOX specific. CAD-1005 is the first successful selective 12-LOX inhibitor and the only one to advance to clinical-stage development.

About CAD-1005

CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency.

About Cadrenal Therapeutics, Inc.

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

The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for patients with end-stage kidney diseases and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor designed for use in acute hospital settings.

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

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include Cadrenal’s development opportunities following its acquisition of a 12-LOX inhibitor portfolio; the EOP-2 meeting being scheduled with the FDA for later this month; HIT remaining Cadrenal’s near-term regulatory priority with CAD-1005; the therapeutic areas for Cadrenal’s 12-LOX inhibitor portfolio representing multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes; and being optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; Cadrenal’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities; regulatory limitations relating to Cadrenal’s ability to promote or commercialize its product candidates for specific indications; acceptance of Cadrenal’s product candidates in the marketplace and the successful development, marketing or sale of its products; Cadrenal’s ability to maintain its license agreements; Cadrenal’s ability to retain its key employees or maintain its Nasdaq listing and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:

Matthew Szot, CFO

[email protected]

Investors:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

[email protected]

Release – Bitcoin Depot Expands Product Portfolio with Acquisition of Social Betting Platform, Kutt

Posted on by [email protected]

Research News and Market Data on BTM

March 02, 2026 8:00 AM ESTDownload as PDF

Company Enters Peer-to-Peer Social Betting Market as Part of Broader Product Diversification Strategy

ATLANTA, March 02, 2026 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced that it has acquired Kutt, a peer-to-peer (“P2P”) social betting platform that enables users to wager directly against each other on both private and publicly verifiable events.

The acquisition marks Bitcoin Depot’s first entry into the P2P social betting market and reflects the Company’s broader strategy to diversify its product offerings beyond its core Bitcoin ATM business. Kutt’s platform is positioned within one of the fastest-growing segments of consumer fintech, as Americans wagered over $165 billion through U.S. sportsbooks in 2025, reflecting the continued expansion and normalization of legal, digital sports betting nationwide.

Founded in 2022, Kutt lets users set the terms of their bets across a range of markets, including sports, entertainment, and even user-generated events. Kutt provides a consumer-friendly platform for users to engage directly with one another in a social, gamified, and community-driven environment. Kutt is currently available in most U.S. states.

Traditional sportsbooks limit bettors to the markets, odds, and lines they choose to offer. Kutt removes the house from the equation, putting control in the user’s hands. Bettors agree on the terms of their wagers, making the experience more flexible and personalized. Through its many social features, Kutt offers friends, fans, and strangers an easy way to meaningfully connect with each other.

While Bitcoin Depot remains committed to serving its BTM customers and its crypto ATM network, the Company is increasingly investing in new digital product lines as it seeks to expand into adjacent fintech categories.

“The Kutt team has built a strong product with significant potential for growth,” said Scott Buchanan, CEO of Bitcoin Depot. “As we continue to grow beyond our core Bitcoin ATM business, we see a meaningful opportunity to support Kutt’s next phase through product innovation and expanded marketing reach.”

“Kutt has always been about bringing people together through friendly competition and making social betting simple and fun,” said Sim Harmon, founder and CEO of Kutt. “Becoming part of Bitcoin Depot gives us the opportunity to grow faster, reach new audiences, and build even better experiences for our community. We are grateful to everyone who has been part of our journey so far and excited to take this next step together.”

Kutt will continue to operate under its existing brand, with its leadership team remaining in place following the acquisition.

Since becoming the first U.S. Bitcoin ATM operator to go public in July 2023, Bitcoin Depot has demonstrated its ability to expand domestically and internationally while maintaining a focus on compliance, access, and customer experience.

For more information, visit https://bitcoindepot.com.

About Bitcoin Depot 
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 47 states and at thousands of name-brand retail locations in 31 states through its BDCheckout product. The Company has the largest market share in North America and operates over 9,000 kiosk locations globally as of August 2025. Learn more at www.bitcoindepot.com.

Cautionary Note Regarding Forward-Looking Statements
This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Agreement. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

Contacts: 

Investors & Media
Gateway Group, Inc. 
949-574-3860  
[email protected] 

Primary Logo

Source: Bitcoin Depot Inc.

Released March 2, 2026

Release – Ocugen Announces Phase 3 liMeliGhT Enrollment Completion for OCU400, a Novel Modifier Gene Therapy for Broad Retinitis Pigmentosa

Posted on by [email protected]

Research News and Market Data on OCGN

March 2, 2026

PDF Version

  • Enrollment for liMeliGhT, the first and largest gene therapy registrational trial for broad retinitis pigmentosa (RP) patients, was completed, reflecting strong interest from investigators and patients
  • Topline Phase 3 data expected in 1Q 2027, advancing OCU400 towards potential approval in 2027 as a treatment option for early- to late-stage RP
  • Positive long-term, 3-year Phase 1/2 durable, safety and tolerability data for OCU400 demonstrates sustained clinically meaningful, approximately 2-line LLVA gain, reinforcing durable gene-agnostic benefit

MALVERN, Pa., March 02, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that enrollment is now complete for the OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP). As a one-year clinical trial, topline data will be available in the first quarter of 2027. These data are anticipated to support the Biologics License Application (BLA) filing for OCU400 and potential approval in 2027. The European Medicines Agency (EMA) has also provided acceptability of the U.S.-based trial for submission of a Marketing Authorization Application (MAA).

“With enrollment complete for OCU400, we enter into a very significant time as a Company,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This milestone brings us even closer to potentially delivering our first novel modifier gene therapy candidate to market and providing a one-time treatment for life to hundreds of thousands of RP patients across the globe with unmet medical need.”

The liMeliGhT clinical trial enrolled 140 patients who were randomized 2:1 into the treatment group (2.5×10 vg per eye 250 µL) and untreated control group across mutations (RHO and gene-agnostic arms). The target population included patients with early- to late-stage disease among a broad RP population, including pediatrics (3+ years). The primary endpoint is 12-month change in visual function assessed by LDNA (luminance dependent navigation assessment) with improvement in Lux Level from baseline to 12 months. LDNA is a more sensitive and specific mobility test, proprietary to Ocugen.

“The Phase 3 liMeliGhT clinical trial includes representation of a wide range of gene mutations associated with early to advanced stages of RP and we believe the patient response will support the gene-agnostic mechanism of action of our novel modifier gene therapy platform,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “I want to thank the investigators and clinical research teams for their tireless recruitment efforts and coordination among the trial sites to achieve the enrollment milestone. This dedication has the potential to shift the treatment paradigm for RP by targeting multiple genetic mutations with a single therapeutic approach.”

The OCU400 Phase 3 liMeliGhT clinical trial is the only broad RP gene-agnostic trial and the largest known Phase 3 orphan gene therapy trial.

“It is critical to work towards FDA-approved treatment options that address the significant gap that remains for the approximately 98% of people living with RP who are not candidates for the approved gene therapy for RP,” said Victor H. Gonzalez, Valley Retina Institute, McAllen, Texas, Faculty at University of Texas Rio Grande Valley and the Primary Investigator for the liMeliGhT clinical trial. “I am enthusiastic about the possibility of offering my patients with RP a safe, effective and durable treatment option that could potentially stabilize vision loss or improve vision.”

Positive long-term, 3-year Phase 1/2 data for OCU400 was recently assessed in evaluable subjects and builds on prior 2-year results showing consistent clinically meaningful, approximately 2-line LLVA gain across mutations. OCU400 maintained a favorable durability, safety and tolerability profile with no new treatment-related serious adverse events or adverse events of interest emerged. Additional data include:

  • Visual function benefits were consistently observed over 3 years, with 88% (7/8) of evaluable treated subjects showing improvement or preservation versus untreated fellow eyes
  • Approximately 2-line gain (N=8) observed across multiple mutation types in treated eyes compared to untreated eyes at 3 years

Enrollment completion in the OCU400 Phase 3 clinical trial combined with positive 3-year data from the Phase 1/2 study are important accomplishments in the Company’s plan to begin bringing this potential gene therapy to patients in 2027. Ocugen remains on track to file the rolling BLA in the third quarter of 2026.

About OCU400
OCU400 is the Company’s modifier gene therapy candidate based on a nuclear hormone receptor gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 is designed to reset this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.

About RP
RP is a group of rare genetic disorders that cause a breakdown in the cells of the retina, leading to vision loss and blindness. RP is associated with mutations in more than 100 genes.

There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retinal degeneration. Therefore, the development of gene-specific replacement therapy will not address all forms of RP, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting the broader RP disease in a gene-agnostic manner offer additional hope for patients.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “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, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]