The Company recently announced an exclusive distribution agreement with Innomedica CCB S.A. for its Kinesiology Line, AVERSA products and Mosquito repellent patches
ORLANDO, Fla., March 18, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) today announced that The Costa Rica Ministry of Health has approved the Company’s line of Kinesiology Tapes for import and Sale. Innomedica CCB, the company’s exclusive distribution partner for Costa Rica oversaw and financed the regulatory approval process.
The Company, partnering with Innomedica plans to begin ramping up marketing efforts for these products and its mosquito repellant patch line following this latest approval.
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
Dr. Christian Lunetta to Present “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial”
CAMBRIDGE, Mass., March 18, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that Dr. Christian Lunetta will present new data and insights on the development of PrimeC, the company’s investigational therapy for amyotrophic lateral sclerosis (ALS), at the AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, to be held in Copenhagen, Denmark, on March 19, 2026.
Dr. Lunetta’s presentation, titled “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial,” will take place during the symposium “Mechanisms and Therapeutics in the ALS-FTD Spectrum (SOD-1, TDP-43, C9ORF72 and TMEM106B).”
The presentation will review key clinical and biomarker findings from the Phase 2b PARADIGM trial, which evaluated PrimeC in people living with ALS. The data provide important insights into disease mechanisms and treatment effects that helped inform the design of the company’s global Phase 3 PARAGON trial, currently being advanced to further evaluate PrimeC’s safety and efficacy.
“ALS is one of the most complex neurodegenerative diseases, and advancing therapeutic development requires the integration of rigorous clinical research with deeper biological insight,” said Dr. Christian Lunetta. “The clinical findings emerging from the PARADIGM trial, together with the expanding biomarker analyses, provide an important scientific foundation as we advance toward the PARAGON Phase 3 study. I look forward to sharing these results with the scientific community at AD/PD 2026 and to contributing, together with fellow investigators, to the next stage of clinical development as we work to advance meaningful therapeutic options for people living with ALS.”
“We are deeply appreciative of Dr. Lunetta’s role in presenting these findings and of his contribution as part of the clinical investigator community behind this work,” said Dr. Shiran Zimri, NeuroSense VP of Research and Development and Canada Country Lead. “The timing of this presentation, coming just days after the publication of the PARADIGM results in JAMA Neurology and at such a highly regarded scientific forum, is especially meaningful. It creates a unique moment where robust, peer-reviewed data can immediately be brought into scientific exchange and critical discussion. For us, this is not only about sharing results, but about engaging the field in a deeper understanding of the clinical and biomarker insights from PARADIGM as we advance with urgency toward our global Phase 3 PARAGON study.”
The PARAGON Phase 3 trial is planned as a multinational, randomized, double-blind, placebo-controlled study designed to further evaluate PrimeC’s potential to slow disease progression in people living with ALS.
NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.
About NeuroSense
NeuroSense Therapeutics is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
Tender Offer Made in Connection with Parties’ Pending Business Combination Expected to Close Early in the Second Quarter
HOUSTON and SEATTLE, March 18, 2026 (GLOBE NEWSWIRE) — Saltchuk Resources, Inc. (the “Offeror”) and Great Lakes Dredge & Dock Corporation (NASDAQ:GLDD) (the “Company”) announced that the Offeror has commenced a cash tender offer (the “Tender Offer”) for any and all of the Company’s 5.25% Senior Notes due 2029 (the “Notes”).
In conjunction with the Tender Offer, the Offeror is soliciting (the “Consent Solicitation”) consents (each, a “Consent” and, collectively, the “Consents”) from holders of the Notes (each, a “Holder” and, collectively, the “Holders”) to amend certain provisions (the “Proposed Amendments”) of the indenture, dated as of May 25, 2021 (as supplemented from time to time prior to the date hereof, the “Indenture”), between Computershare Trust Company, N.A., as successor to Wells Fargo Bank, National Association, as trustee (the “Trustee”), the Company and the subsidiary guarantors party thereto, under which the Notes were issued. In order for the Proposed Amendments to be approved with respect to the Notes, Holders of a majority in principal amount of the outstanding Notes must consent to the Proposed Amendments (the “Requisite Consents”). If the Requisite Consents with respect to the Notes are received, the Proposed Amendments would, among other things, eliminate substantially all of the restrictive covenants, eliminate certain events of default and modify certain redemption notice requirements with respect to the Notes.
Holders may not tender their Notes without delivering their Consents pursuant to the Consent Solicitation and may not deliver Consents without tendering their Notes pursuant to the Tender Offer. The terms and conditions of the Tender Offer and Consent Solicitation are described in an Offer to Purchase and Consent Solicitation Statement, dated March 18, 2026 (the “Offer to Purchase and Consent Solicitation Statement”). Capitalized terms used herein, but not otherwise defined, have the meanings ascribed to such terms in the Offer to Purchase and Consent Solicitation Statement.
Upon the terms and subject to the conditions set forth in the Offer to Purchase and Consent Solicitation Statement, the Offeror will pay to each Holder who validly tenders (and does not validly withdraw) their Notes and validly delivers (and does not validly revoke) Consents on or prior to 5:00 P.M., New York City time, on March 31, 2026, unless extended or earlier terminated (such date and time, as the same may be extended, the “Early Tender Deadline”), an amount in cash equal to the Tender Offer Consideration, plus the Early Tender Payment for the Notes (as described in the table below and in the Offer to Purchase and Consent Solicitation Statement) on the Early Settlement Date or Final Settlement Date, as applicable (each of which is defined below and either of which may be referred to herein as a “Settlement Date”), if such Notes are accepted for purchase by the Offeror. Tendered Notes may be withdrawn any time on or prior to 5:00 P.M., New York City time, on March 31, 2026 (such date and time, as the same may be extended, the “Withdrawal Deadline”) but not thereafter. Holders who validly tender their Notes and validly deliver Consents after the Early Tender Deadline but on or prior to the Expiration Time (as defined below) will be entitled to receive the Tender Offer Consideration (as described in the table below and in the Offer to Purchase and Consent Solicitation Statement) but not the Early Tender Payment on the Final Settlement Date, if such Notes are accepted for purchase.
In addition to the Tender Offer Consideration or the Total Consideration (as described in the table below), as applicable, such Holders will also receive accrued and unpaid interest on the Notes that the Offeror accepts for purchase in the Tender Offer up to, but excluding, the applicable Settlement Date (“Accrued Interest”).
The following table summarizes the material pricing terms of the Tender Offer.
The Tender Offer and Consent Solicitation are scheduled to expire at 5:00 P.M., New York City time, on April 15, 2026, unless extended or earlier terminated by the Offeror in its sole discretion (such date and time, as the same may be extended, the “Expiration Time”). If, as anticipated, the Offeror’s pending Equity Offer (as defined below) is consummated prior to the Expiration Time, the Offeror may, in its sole discretion, accept for purchase the Notes that have been validly tendered and not validly withdrawn on or prior to the Early Tender Deadline at or promptly following the consummation of the Equity Offer (the “Early Settlement Date”). If the Offeror elects to schedule an Early Settlement Date, the Offeror will provide a notice of such date by press release or other public announcement. If the Equity Offer is not consummated prior to the Expiration Time, there will be no Early Settlement Date. The Offeror expects to accept for purchase the Notes validly tendered and not validly withdrawn on or prior to the Expiration Time promptly following the Expiration Time (the “Final Settlement Date”), subject to the satisfaction of all conditions to the Tender Offer and Consent Solicitation. In the event that the Equity Offer is not consummated prior to the Expiration Time, the Offeror intends to extend the Expiration Time.
Pending Business Combination and Financing Transactions
The Tender Offer and the Consent Solicitation are being made in connection with, and are expressly conditioned upon the closing of, the acquisition of the Company pursuant to the Agreement and Plan of Merger, dated February 10, 2026 (as it may be amended, supplemented or otherwise modified from time to time, the “Merger Agreement”), by and among the Company, the Offeror, and Huron MergeCo., Inc., a Delaware corporation and wholly owned subsidiary of the Offeror (the “Acquisition Sub”). Pursuant to the terms and conditions of the Merger Agreement, Acquisition Sub commenced a tender offer (the “Equity Offer”) on March 4, 2026 to purchase all of the outstanding shares of common stock, par value $0.0001 per share, of the Company (“Company Common Stock”), for $17.00 per share of Company Common Stock, net to the seller thereof in cash, without interest, subject to any required tax withholdings (subject to the conditions described in the offer to purchase filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 4, 2026, by the Offeror and Acquisition Sub (together with any amendments or supplements thereto, the “Equity Offer to Purchase”). The Merger Agreement also provides that, as soon as practicable on the same business day that Acquisition Sub irrevocably accepts for payment all shares of Company Common Stock that are validly tendered (and not validly withdrawn) pursuant to the Equity Offer, or at another date mutually agreed upon by the Company, the Offeror and Acquisition Sub, upon the terms and subject to the conditions set forth in the Merger Agreement, Acquisition Sub will be merged with and into the Company (the “Merger” and, collectively with the Equity Offer, the “Acquisition Transactions”), with the Company continuing as the surviving corporation and a wholly owned subsidiary of the Offeror.
The Offeror and the Company expect (i) to close the Acquisition Transactions early in the second quarter of 2026, subject to the satisfaction (or, to the extent permitted, waiver) of the conditions set forth in the Merger Agreement, and (ii) the Early Settlement Date to occur on or about the closing date of the Acquisition Transactions, as more fully described in the Offer to Purchase and Consent Solicitation Statement. Assuming the satisfaction or waiver of the conditions to the Equity Offer and the Merger Agreement, the Acquisition Transactions are currently scheduled to close on April 1, 2026. The closing of the Acquisition Transactions is not conditioned on (i) any minimum amount of Notes being tendered, (ii) the receipt of the Requisite Consents or (iii) the closing of the Tender Offer or the Consent Solicitation.
The Offeror intends to finance the cash consideration for the Acquisition Transactions, the refinancing of certain of its existing indebtedness, the discharge of the Notes, and certain related transaction expenses using available cash and either the proceeds of borrowings under the New Credit Agreement (as defined below) or a combination of the Offeror’s existing credit facilities and the proceeds from borrowings under the Bridge Facility (as defined below).
Certain lenders, including an affiliate of the Dealer Manager, have agreed to enter into new senior unsecured credit facilities, which are expected to be provided in the form of either (i) a fully committed, senior unsecured bridge term loan facility (the “Bridge Facility”) or (ii) a new senior unsecured credit agreement (the “New Credit Agreement” and, together with the Bridge Facility, the “New Senior Credit Facilities”) providing for (x) a five-year $1.5 billion revolving credit facility and (y) a five-year $1.25 billion term loan facility.
General Information
The Offeror’s obligation to accept for purchase, and to pay for, Notes validly tendered and not validly withdrawn and to accept accompanying Consents validly delivered and not validly revoked pursuant to the Tender Offer and Consent Solicitation is conditioned upon the following having occurred or having been waived by the Offeror: (1) the consummation of the Equity Offer on the terms and conditions set forth in the Merger Agreement and Equity Offer to Purchase, and (2) the satisfaction of the General Conditions described in the Offer to Purchase and Consent Solicitation Statement. In addition, our obligation to accept Consents that have been validly delivered and not validly revoked pursuant to the Consent Solicitation is further conditioned upon supplemental conditions described in the Offer to Purchase and Consent Solicitation Statement. There can be no assurance that the Tender Offer or the Consent Solicitation will be consummated. The Offeror may amend, extend or terminate the Tender Offer and the Consent Solicitation, in its sole discretion. The Tender Offer is not conditioned on any minimum amount of Notes being tendered or the receipt of the Requisite Consents.
The Offeror intends to fund the Total Consideration and the Tender Offer Consideration (including, in each case, the Accrued Interest), plus all related fees and expenses, using available cash and the borrowings described above under Pending Business Combination and Financing Transactions.
Any Notes not tendered and purchased pursuant to the Tender Offer will remain outstanding. If the Requisite Consents are received with respect to the Notes, and the Proposed Amendments become operative with respect to the Indenture, then the Notes that are not purchased pursuant to the Tender Offer will be subject to the Proposed Amendments as set forth in a supplemental indenture with respect to the Indenture.
To the extent any Notes remain outstanding following the consummation of the Tender Offer and Consent Solicitation, the Offeror intends, but is not obligated, to redeem such remaining Notes at par on or after June 1, 2026 and satisfy and discharge the Company’s obligations under the Indenture pursuant to the terms thereof. Alternatively, the Offeror may cause the Company to leave any such remaining Notes outstanding or effect any of the alternative transactions described in the Offer to Purchase and Consent Solicitation Statement.
BofA Securities has been retained as the Dealer Manager in connection with the Tender Offer and as the Solicitation Agent in connection with the Consent Solicitation. In such capacities, they may contact Holders regarding the Tender Offer and the Consent Solicitation and may request brokers, dealers, banks, trust companies and other nominees or intermediaries to forward the Offer to Purchase and Consent Solicitation Statement and related materials to beneficial owners of Notes. Questions and requests for assistance regarding the terms of the Tender Offer and the Consent Solicitation should be directed to the Dealer Manager at (888) 292-0070 (toll-free) or (980) 388-3646 (collect). Questions regarding the procedures for tendering Notes and delivering Consents relating to the Tender Offer and the Consent Solicitation or requests for additional copies of the Offer to Purchase and Consent Solicitation Statement may be directed to Global Bondholder Services Corporation, the Tender and Information Agent for the Tender Offer, at (212) 430-3774 (for banks and brokers only) or (855) 654-2014 (toll-free) (for all others) or [email protected].
This press release is for informational purposes only. The Tender Offer and the Consent Solicitation are being made solely pursuant to the Offer to Purchase and Consent Solicitation Statement. This press release does not constitute an offer to purchase or the solicitation of an offer to sell any securities. Full details of the terms and conditions of the Tender Offer and the Consent Solicitation are described in the Offer to Purchase and Consent Solicitation Statement, which is being furnished by the Offeror to Holders of the Notes. Holders of the Notes are encouraged to read the Offer to Purchase and Consent Solicitation Statement and the information incorporated therein by reference, as they contain important information regarding the Tender Offer and the Consent Solicitation. The Tender Offer and the Consent Solicitation are not being made to Holders in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. In any jurisdiction in which the securities laws or blue sky laws require the Tender Offer or the Consent Solicitation to be made by a licensed broker or dealer, the Tender Offer and the Consent Solicitation will be deemed to be made on behalf of the Offeror by the Dealer Manager, or one or more registered brokers or dealers that are licensed under the laws of such jurisdiction.
This press release is for information purposes only and does not constitute an offer to buy or the solicitation of an offer to sell any securities. The Offeror’s solicitation and offer to buy shares of Company Common Stock is being made only pursuant to the Equity Offer to Purchase and related materials that the Offeror and Acquisition Sub have filed with the SEC. In connection with the Equity Offer, the Offeror and Acquisition Sub have filed a Tender Offer Statement on Schedule TO with the SEC and the Company has filed a Solicitation/Recommendation Statement on Schedule 14D-9. Before making any investment decision with respect to the Equity Offer, investors and security holders of the Company are urged to read the tender offer materials, the solicitation/recommendation statement and any other relevant documents filed with the SEC. In addition, all of these materials (and all other tender offer documents filed with the SEC) are available at no charge from the SEC through its website at www.sec.gov and upon request to MacKenzie Partners, Inc., the information agent for the Equity Offer, at 7 Penn Plaza, New York, New York 10001, by calling toll free (800) 322-2885. Broadridge Corporate Issuer Solutions, LLC is acting as depositary and paying agent for the Equity Offer.
None of the Offeror, the Company, the Trustee, the Dealer Manager, the Tender and Information Agent, or any of their respective affiliates makes any recommendation as to whether Holders should tender or refrain from tendering their Notes in response to the Tender Offer or delivering Consents pursuant to the Consent Solicitation, and no person or entity has been authorized by any of them to make such a recommendation. Holders must make their own independent decision as to whether to tender Notes and deliver accompanying Consents and, if so, the principal amount of the Notes as to which action is to be taken.
Nothing contained herein shall constitute a notice of redemption of the Notes or an obligation to issue a notice of redemption or satisfy or discharge the Indenture.
About Saltchuk Resources, Inc.
Saltchuk is a privately owned family of diversified freight transportation, marine service, and energy distribution companies, with consolidated annual revenue of approximately $5.5 billion and 8,800 employees. We make multi-generational investments, championing our companies’ individual brands while providing strategic leadership and resources through our Corporate Home. Our companies maintain independent operations guided by shared values: safety comes first, reliability defines our customer relationships, and integrity shapes how we conduct business. We’re committed to each other, to environmental stewardship, and to contributing to our communities, fostering places where anyone would be proud for their children to work. Headquartered in Seattle, additional information is available at www.saltchuk.com.
About Great Lakes Dredge & Dock Corporation
Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States, which is complemented with a long history of performing significant international projects. In addition, Great Lakes is fully engaged in expanding its core business into the offshore energy industry. GLDD employs experienced civil, ocean and mechanical engineering staff in its estimating, production, and project management functions. In its over 136-year history, GLDD has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experience-based performance as they advance through GLDD operations. GLDD’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the GLDD’s culture. GLDD’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.
Forward-looking statements made herein with respect to the Tender Offer and Consent Solicitation and related transactions, including, for example, the timing of the completion of the Tender Offer and Consent Solicitation, Equity Offer and the Merger or the potential benefits of any such transactions, reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, the Company and the Offeror’s actual results may differ materially from its expectations or projections. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “estimate,” “target,” “project,” “contemplate,” “predict,” “potential,” “continue,” “may,” “would,” “could,” “should,” “seeks,” “scheduled to,” or other similar words, or the negative of these terms or other variations of these terms or comparable language.
The following factors, among others, could cause actual plans and results to differ materially from those described in forward-looking statements. Such factors include, but are not limited to, the effect of the announcement of the Acquisition Transactions and the Tender Offer and Consent Solicitation on the Company and the Offeror’s relationships with employees, governmental entities and other business relationships, operating results and business generally; the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement, and the risk that the Merger Agreement may be terminated in circumstances that require the Company to pay a termination fee; the possibility that competing offers will be made; the outcome of any legal proceedings that may be instituted against the Company and the Offeror related to the transactions contemplated by the Merger Agreement, including the Acquisition Transactions; uncertainties as to the timing of the consummation of the Tender Offer and Consent Solicitation and the Acquisition Transactions; uncertainties as to the number of stockholders of the Company who may tender their stock in the Equity Offer and number of Holders who may tender their Notes and deliver accompanying Consents in the Tender Offer and Consent Solicitation; the failure to satisfy other conditions to consummate the Acquisition Transactions on the anticipated timeframe or at all; risks that the Tender Offer and Consent Solicitation and the Acquisition Transactions disrupt current plans and operations and the potential difficulties in employee retention as a result of the proposed transactions; the effects of local and national economic, credit and capital market conditions on the economy in general, and other risks and uncertainties; and those risks and uncertainties discussed from time to time in the reports or other public filings of the Company, the Offeror or the Acquisition Sub with the SEC.
Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its periodic filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025. GLDD’s SEC filings are available publicly on the SEC’s website at www.sec.gov, on GLDD’s website at gldd.com under “Investors—Financials & Filings—SEC filings” or upon request via email to [email protected]. All forward-looking statements contained in this communication are based on information available to the Company and the Offeror as of the date hereof and are made only as of the date of this communication. The Company and the Offeror disclaim any obligation or undertaking to update or revise the forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required under applicable law. These forward-looking statements should not be relied upon as representing the Company and the Offeror’s views as of any date subsequent to the date of this communication. Furthermore, any information about our intentions contained in any of our forward-looking statements reflects our intentions as of the date of such forward-looking statement, and is based upon, among other things, existing regulatory, industry, competitive, economic and market conditions, and our assumptions as of such date. We may change our intentions, strategies or plans (including our plans expressed herein) without notice at any time and for any reason. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of the Company and the Offeror.
Contact:
Eric Birge, Vice President of Investor Relations of the Company, 313-220-3053
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a leading artificial intelligence (“AI”) company offering AI and augmented reality (“AR”) powered solutions to beauty, fashion, photo and video creative industries, today announced that its board of directors (the “Board”) has received a preliminary non-binding proposal letter, dated March 18, 2026 (the “Proposal”), from CyberLink International Technology Corp. (“CyberLink”) and Ms. Alice H. Chang, Chairwoman of the Board and Chief Executive Officer of Perfect, and her controlled entities (collectively, the “Consortium Members”) that proposes a “going-private” transaction for US$1.95 in cash per ordinary share (the “Transaction”).
According to the Proposal, the Consortium Members will establish an acquisition vehicle to implement the Transaction. The Transaction is expected to be financed through equity contributions from the Consortium Members in the form of rollover equity in the Company and available unrestricted cash from the Company. Debt financing may also be arranged as necessary at the discretion of Consortium Members. A copy of the Proposal is attached hereto as Exhibit A.
The Board intends to convene in the near future to review the Proposal and to establish a special committee of independent and disinterested directors for the purpose of evaluating and considering the Proposal. In connection with its review, the special committee, once formed, will be authorized to retain independent legal, financial and other advisors to assist in its evaluation.
The Company cautions its shareholders and others considering trading in its securities that the Board and its relevant committees have not made any decision with respect to the Company’s response to the Proposal. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Transaction or that the Transaction or any other similar transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law.
About Perfect Corp.
Founded in 2015, Perfect Corp. is a leading AI company offering self-developed AI- and AR- powered solutions dedicated to transforming the world with digital tech innovations that make your virtual world beautiful. On Perfect’s direct consumer business side, Perfect operates a family of YouCam consumer apps and web-editing services for photo, video and camera users, centered on unleashing creativity with AI-driven features for creation, beautification and enhancement. On Perfect’s enterprise business side, Perfect empowers major beauty, skincare, fashion, jewelry, and watch brands and retailers by supplying them with omnichannel shopping experiences through AR product try-ons and AI-powered skin diagnostics. With cutting-edge technologies such as Generative AI, real-time facial and hand 3D AR rendering and cloud solutions, Perfect enables personalized, enjoyable, and engaging shopping journey and helps brands elevate customer engagement, increase conversion rates, and propel sales growth. Throughout this journey, Perfect maintains its unwavering commitment to environmental sustainability and fulfilling social responsibilities. For more information, visit https://ir.perfectcorp.com/.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on beliefs and assumptions and on information currently available to Perfect. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including strategies or plans, are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. These statements are based on Perfect’s reasonable expectations and beliefs concerning future events and involve risks and uncertainties that may cause actual results to differ materially from current expectations. These factors are difficult to predict accurately and may be beyond Perfect’s control. Forward-looking statements in this communication or elsewhere speak only as of the date made. New uncertainties and risks arise from time to time, and it is impossible for Perfect to predict these events or how they may affect Perfect. In addition, risks and uncertainties are described in Perfect’s filings with the Securities and Exchange Commission. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Perfect cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that Perfect presently does not know or that Perfect currently does not believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Perfect, its directors, officers or employees or any other person that Perfect will achieve its objectives and plans in any specified time frame, or at all. Except as required by applicable law, Perfect does not have any duty to, and does not intend to, update or revise the forward-looking statements in this communication or elsewhere after the date of this communication. You should, therefore, not rely on these forward-looking statements as representing the views of Perfect as of any date subsequent to the date of this communication.
Exhibit A
March 18, 2026
The Board of Directors Perfect Corp. 14F, No. 98 Minquan Road Xindian District New Taipei City 231 Taiwan
Dear Sirs and Madam:
Ms. Alice H. Chang (“Ms. Chang”), and her controlled entities GOLDEN EDGE CO., LTD., DVDonet.com. Inc. and World Speed Company Limited (collectively, the “Chairwoman Parties”), and CyberLink International Technology Corp. (“CyberLink”, together with Chairwoman Parties, the “Consortium Members”) are pleased to submit this preliminary non-binding proposal to acquire Perfect Corp. (the “Company”) in a going private transaction (the “Acquisition”).
We believe that our proposal provides a very attractive opportunity to the Company’s shareholders. Our proposal represents a premium of 44.4% to the Company’s closing price on March 17, 2026 and a premium of 35.4% and 23.4% to the volume-weighted average closing price during the last 30 and 60 trading days, respectively.
Consortium. The Consortium Members have entered into a consortium agreement dated March 18, 2026, pursuant to which the Consortium Members will form an acquisition company for the purpose of implementing the Acquisition, and the Consortium Members have agreed to work exclusively in pursuing the Acquisition.
Purchase Price. The consideration payable for each Class A ordinary share of the Company will be US$1.95 per ordinary share in cash (in each case other than those ordinary shares held by the Consortium Members that may be rolled over in connection with the Acquisition).
Closing Certainty. We believe that our proposal offers a high degree of closing certainty and are well positioned to negotiate and complete the proposed Acquisition on an expedited basis.
Financing. We intend to finance the Acquisition with equity capital from the Consortium Members in the form of rollover equity in the Company and available unrestricted cash from the Company. Debt financing may also be arranged to the extent necessary or desirable at the sole discretion of the Consortium Members.
Definitive Agreements. We are prepared to promptly negotiate and finalize definitive agreements (the “Definitive Agreements”) providing for the Acquisition and related transactions. These documents will provide for representations, warranties, covenants and conditions that are typical, customary and appropriate for transactions of this type.
Process. We believe that the Acquisition will provide superior value to the Company’s shareholders. We recognize that the Company’s Board of Directors (the “Board”) will evaluate the Acquisition independently before it can make its determination to endorse it, and we expect that the Board will establish a special committee comprised of independent and disinterested directors of the Company (the “Special Committee”).
Given the involvement of the Chairwoman Parties and CyberLink in the Acquisition, we appreciate that the independent members of the Board will proceed to consider the proposed Acquisition, and that each of Ms. Chang and Mr. Jau-Hsiung Huang will recuse herself / himself, as director of the Board, from participating in any Board deliberations and decisions related to the Acquisition. We expect that the Special Committee and its advisors will be exclusively authorized to consider and negotiate with us the proposed Acquisition, including the Definitive Agreements, and that no other members of management or any directors other than the members of the Special Committee will participate in any deliberations and decisions related to the Acquisition unless their involvement is approved by the Special Committee.
Consortium Members in the aggregate beneficially own approximately 53.4% of the total issued and outstanding share capital of the Company (excluding any ordinary shares issuable upon the Consortium Members’ exercise of options or warrants within 60 days), representing 81.2% of the total voting power of the Company, as calculated based on a total number of 101,848,671 issued and outstanding ordinary shares (consisting of 85,059,953 Class A ordinary shares and 16,788,718 Class B ordinary shares) of the Company as of December 31, 2025.
Confidentiality. Each of the Consortium Members will, as required by law, promptly file an amendment to its respective Schedule 13D to disclose this letter and the agreement among the Consortium Members. However, we are sure you will agree with us that it is in all of our interests to ensure that we proceed in a strictly confidential manner, unless otherwise required by law, until we have executed Definitive Agreements or terminated our discussions.
No Binding Commitment. This letter constitutes only a preliminary indication of our interest, and does not constitute any binding commitment with respect to the Acquisition. A binding commitment will result only from the execution of Definitive Agreements, and then will be on terms and conditions provided in such documentation.
In closing, we would like to express our commitment to working together to bring this Acquisition to a successful and timely conclusion. Should you have any questions regarding this proposal, please do not hesitate to contact us. We look forward to hearing from you.
STAFFORD, Texas, March 18, 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 upcoming AACR Meeting 2026.
Two abstracts and two posters were accepted for presentation. The titles and authors of the abstracts are as follows:
Abstract Number: CT138 – Poster Section 52 on April 20, 2026, 2-5pm
Abstract Title: Preliminary delayed-type-hypersensitivity immune response results from open-label arm of on-going Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01
Snehal S. Patel1, Jaye Thompson1, F. Joseph Daugherty1, Francois-Clement Bidard2, William J. Gradishar3, Marcus Schmidt4, Miguel Martin5, Joyce A. O’Shaughnessy6, Hope S. Rugo7, Cesar A. Santa-Maria8, Laura M. Spring9, Mothaffar F. Rimawi10
1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL,4University Medical Center Mainz, Mainz, Germany,5GEICAM, Madrid, Spain,6Sarah Cannon Research Institute, Dallas, TX,7City of Hope Comprehensive Cancer Center, Duarte, CA,8Johns Hopkins University, Baltimore, MD,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX
This will be the first abstract and poster from FLAMINGO-01 with statistically significant immune response data, potentially with subgroup analysis by the most prevalent HLA types. A positive immune response is an indicator that the immune system has been activated against recurring cancer cells, potentially leading to the prevention of metastatic breast cancer and improved long term survival.
Immune responses to GP2 were measured at baseline and over time using delayed-type-hypersensitivity (DTH) skin tests and other methods. The DTH skin test measures the diameter of the skin immune response to GP2 in millimeters, 48-72 hours after intradermal injection of a low concentration of GP2 without GM-CSF.
Abstract Number: CT227 – Poster Section 51 on April 21, 2026, 9am-12pm
Abstract Title: Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01
Jaye Thompson1, Snehal Patel1, Mira Patel1, Anu Tammareddi1, F. Joseph Daugherty1, Mothaffar F. Rimawi2
1Greenwich LifeSciences, Stafford, TX,2Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX
This abstract and poster will continue to update principal investigators at the conference about the study design of FLAMINGO-01.
The Steering Committee authoring abstract CT138 is comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:
Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Hope S. Rugo – Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Professor Emeritus, University of California, San Francisco
Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital
About the AACR Annual Meeting 2026
The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
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 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
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.
BERKELEY HEIGHTS, N.J., March 17, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17–22, 2026, in San Diego, California.
Oral Presentation Details
Title: TFF2 deficiency amplifies IL-1β-driven inflammation and promotes aging-associated gastric tumor progression Abstract #: 6822 Date and Time: April 21, 2026, 2:30–4:30 p.m. PT (5:30-7:30 p.m. ET) Session Category: Tumor Biology Session Title: Aging Micro- and Macro-Environments in Tumor Progression and Therapy Presenters: Shuang Li, MD, PhD, and Timothy C. Wang, MD, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center (Tonix co-authors: Seth Lederman, MD, Chief Executive Officer, and Bruce L. Daugherty, PhD, MBA, Executive Vice President of Research)
Poster Presentation Details
Title: In vitro characterization of fully human antagonistic anti-BTLA monoclonal antibodies Poster #: 6550 Date and Time: April 21, 2026, 2:00-5:00 p.m. PT (5:00-8:00 p.m. ET) Session Category: Clinical Research Session Title: Immune Checkpoint Blockade Location: Poster Section 44, Board 16 Presenter: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix
Title: Pharmacokinetics of TNX-1700 in non-human primates and human FcRn/serum albumin transgenic mice Poster #: 7940 Date and Time: April 22, 2026, 9:00 a.m.–12:00 p.m. PT (12:00-3:00 p.m. ET) Session Category: Clinical Research Session Title: Tumor Microenvironment Modulators Location: Poster Section 49, Board 15 Presenter: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix
About TNX-1700 TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical development for the treatment of gastric and colorectal cancer in combination with PD-1 blockade. TNX-1700, in-licensed from Columbia University, is in the pre-Investigational New Drug (IND) stages of development.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
2025 Was a Transformative Year due to Merger Completed in Q3
OLD GREENWICH, Conn., March 17, 2026 (GLOBE NEWSWIRE) — Star Equity Holdings, Inc. (Nasdaq: STRR and STRRP) (“Star” or the “Company”), a diversified holding company, announced today financial results for the fourth quarter and full year ended December 31, 2025.
2025Fourth Quarter Summary
Revenue of $56.8 million increased 69% from the fourth quarter of 2024.
Gross profit of $24.2 million increased 38% from the fourth quarter of 2024.
Net loss attributable to common shareholders of $2.4 million, or $0.67 loss per diluted share, versus net loss attributable to common shareholders of $0.6 million, or $0.20 loss per diluted share, in the fourth quarter of 2024. Adjusted net loss attributable to common shareholders per diluted share (Non-GAAP measure)* was $0.10 compared to adjusted net income attributable to common shareholders per diluted share of $0.04 in the fourth quarter of 2024.
Adjusted EBITDA (Non-GAAP measure)* increased to $2.2 million, versus adjusted EBITDA of $0.9 million in the fourth quarter of 2024.
2025 Full-Year Summary
Revenue of $172.2 million increased 23% from 2024. Full year 2025 pro forma (“PF”)(1) revenue of $224.7 million increased 7% from 2024.
Gross profit of $79.9 million increased 14% from 2024. PF gross profit of $95.0 million increased 6% from 2024
Net loss attributable to common shareholders of $6.7 million, or 2.08 loss per diluted share, compared to net loss of $4.8 million, or $1.59 loss per diluted share, in 2024. Adjusted net loss attributable to common shareholders per diluted share (Non-GAAP measure)* of $0.20 increased from adjusted net loss attributable to common shareholders per diluted share of $0.49 in the prior year.
Adjusted EBITDA (Non-GAAP measure)* was $4.2 million, versus adjusted EBITDA of $0.9 million in 2024. PF adjusted EBITDA of $12.6 million increased from $4.4 million in 2024.
Total cash including restricted cash was $13.4 million at December 31, 2025.
Jeff Eberwein, Chief Executive Officer at Star, said, “Our fourth quarter and full-year financial results reflect positive momentum and improvement over the prior year quarter, largely attributable to the addition of the Building Solutions and Energy Services divisions which occurred with the merger that closed in August 2025.”
Jake Zabkowicz, Global CEO of Hudson Talent Solutions (“HTS”), noted, “HTS delivered a 4.8% revenue increase in the fourth quarter Full-year revenues remained relatively flat compared to 2024 despite macroeconomic challenges and significant ongoing pressure in the talent market. In 2025, we expanded our service offering with the implementation of agentic AI, positioning us at the forefront of the talent industry’s digital transformation.”
Rick Coleman, COO of Star, added, “Residential and commercial building demand were relatively soft throughout the year, but our Building Solutions segment delivered strong results, including significantly higher sales and profitability. Energy Services division performance was also strong as ADT expanded market share across all core markets with particularly robust growth in mining and geothermal. These results highlight the team’s ability to combine strong execution with innovation across a broad range of end markets and applications.”
Mr. Eberwein concluded, “2025 was a transformational year for Star. The merger that closed in August strengthened our operating and financial position, accelerated our growth strategy, and reinforced our conviction that our stock remains undervalued. To that end, we repurchased more than $2.6 million of stock during 2025 and expect to continue utilizing buybacks to enhance shareholder value.”
* The Company provides non-GAAP measures as a supplement to financial results based on accounting principles generally accepted in the United States (“GAAP”). Adjusted EBITDA, EBITDA, adjusted net income or loss, and adjusted net income or loss per diluted share are defined in the segment tables at the end of this release and a reconciliation of such non-GAAP measures to the most directly comparable GAAP measures is included within such segment tables.
Segment Highlights
Building Solutions
Fourth quarter 2025 Building Solutions revenue was $18.0 million and gross profit was $4.6 million. Fourth quarter Adjusted EBITDA was $1.9 million.
Full year 2025 Building Solutions revenue was $27.6 million and gross profit was $6.3 million. Full year 2025 Adjusted EBITDA was $2.5 million.
Full year 2025 PF Building Solutions revenue was $71.9 million, up from $60.1 million in 2024, and full year 2025 PF gross profit was $18.0 million versus $14.0 million in the prior year. Full year 2025. PF adjusted EBITDA was $7.2 million, up from adjusted EBITDA of $5.3 million a year ago.
Building Solutions backlog as of December 31, 2025 was $9.6 million, and the trailing 12-month book-to-bill ratio was 0.89.
Business Services
Fourth quarter 2025 Business Services revenue was $35.2 million, up from $33.6 million in the prior year quarter, while gross profit was $18.1 million, up from $17.6 million in the prior year quarter. Business Services adjusted EBITDA was $0.9 million, down from $1.5 million in the prior year quarter.
Full year 2025 Business Services revenue was $139.7 million, down from $140.1 million in the prior year, while gross profit was $71.8 million, up from $70.2 million in the prior year. Full year 2025 Business Services adjusted EBITDA was $5.0 million, up from $4.3 million in the prior year.
Regionally, APAC and Americas gross profit for full year 2025 grew 11.7% and 4.4%, respectively. This growth was offset by EMEA, where gross profit declined by (18.7)%.
Energy Services
Fourth quarter 2025 Energy Services revenue was $3.6 million. Fourth quarter 2025 gross profit was $1.6 million, and adjusted EBITDA was $0.9 million.
Full year 2025 Energy Services revenue was $4.9 million. Full year 2025 gross profit was $1.9 million and adjusted EBITDA was $1.0 million.
PF Energy Services revenue for full year 2025 was $13.2 million, up from $10.1 million in 2024, while PF gross profit was $5.5 million, down from $5.7 million in 2024. Full year 2025 PF adjusted EBITDA was $2.9 million, up from $2.1 million in 2024.
(1) PF Building Solutions, Energy Services, and Investments results from Star Operating Companies, Inc. for the full year of 2025 and 2024. PF Building Solutions reflects results from Timber Technologies for the full year in 2024. Timber Technologies was acquired by Star Operating Companies on May 17, 2024. PF Energy Services in 2025 and 2024 reflects Alliance Drilling Tools results, which was acquired by Star Operating Companies on March 3, 2025.
Corporate Costs
The Company’s corporate costs of $1.9 million for the fourth quarter of 2025 excluded $0.3 million of non-recurring expenses. This compares to corporate costs of $0.6 million in the fourth quarter of 2024, which excluded $0.0 million of non-recurring expenses.
The Company’s corporate costs of $4.9 million for full year 2025 excluded $2.5 million of non-recurring expenses. This compares to corporate costs of $3.4 million for full year 2024, which excluded $0.9 million of non-recurring expenses.
Liquidity and Capital Resources
The Company ended the fourth quarter of 2025 with $13.4 million in cash, including $3.1 million in restricted cash. The Company used $3.9 million in cash flow from operations in the fourth quarter of 2025 compared to $2.0 million generated in the fourth quarter of 2024. For full year 2025, the company used $7.3 million in cash flow from operations compared to $2.8 million in cash flow from operations in 2024. Year-end 2025 working capital excluding cash was $22.4 million, representing a temporary build-up that is expected to decline in the first quarter of 2026.
Share Repurchase Program
In the fourth quarter of 2025, the Company repurchased 5,964 shares for approximately $66,000. For the full year 2025, the Company repurchased 280,886 shares for approximately $2.6 million and has repurchased about $10 million of common stock since 2020. As of year-end 2025, the Company has $2.5 million remaining under its $3 million repurchase program authorized in September 2025 and continues to view share repurchases as an attractive use of capital.
NOL Carryforward
As of December 31, 2025, Star had $215 million of usable net operating losses (“NOL”) in the U.S., which the Company considers to be a very valuable asset for its stockholders. In order to protect the value of the NOL for all stockholders, the Company has a rights agreement and charter amendment in place that limit beneficial ownership of Star Equity common stock to 4.99%. Stockholders who wish to own more than 4.99% of Star Equity common stock, or who already own more than 4.99% of Star Equity common stock and wish to buy more, may only acquire additional shares with the Board’s prior written approval.
Preferred Stock Dividends
In Q4 2025, the Company’s board of directors (the “Board”) declared a quarterly cash dividend to holders of the Company’s 10% Series A Cumulative Perpetual Preferred Stock of $0.25 per share, paid on December 10, 2025 to the shareholders of record as of December 1, 2025.
In addition, on February 13, 2026, the Board declared a cash dividend to holders of the Company’s 10% Series A Cumulative Perpetual Preferred Stock of $0.25 per share. The record date for this dividend was March 1, 2026, and the payment date was March 10, 2026.
Conference Call/Webcast
The Company will conduct a conference call tomorrow, March 18, 2026, at 10:00 a.m. ET to discuss this announcement. Individuals wishing to listen can access the webcast on the investor information section of the Company’s web site at www.starequity.com.
If you wish to join the conference call, please use the dial-in information below:
Toll-Free Dial-In Number: 1 (833) 890-6161
International Dial-In Number: 1 (412) 504-9848
The archived call will be available on the investor information section of the Company’s web site at www.starequity.com.
About Star Equity Holdings, Inc.
Star Equity Holdings, Inc. is a diversified holding company that seeks to build long-term shareholder value by acquiring, managing, and growing businesses with strong fundamentals and market opportunities. Its current structure comprises four segments: Building Solutions, Business Services, Energy Services, and Investments. For more information visit www.starequity.com.
On August 22, 2025, the Company completed its previously announced acquisition of Star Operating Companies, Inc. (“Star Operating”, formerly known as Star Equity Holdings, Inc.), pursuant to the Agreement and Plan of Merger, dated as of May 21, 2025 (the “Merger Agreement”), by and among the Company, Star Operating and HSON Merger Sub, Inc., a wholly owned subsidiary of the Company (“Merger Sub”). Upon the terms and subject to the conditions of the Merger Agreement, on August 22, 2025, at the effective time of the merger pursuant to the Merger Agreement (the “Merger”), Merger Sub merged with and into Star Operating, with Star Operating continuing as the surviving corporation of the Merger as a wholly owned subsidiary of the Company. Effective September 5, 2025, the Company changed (i) its name to Star Equity Holdings, Inc. and (ii) its trading symbols on Nasdaq to STRR and STRRP.
Building Solutions The Building Solutions division operates in three niches: (i) modular building manufacturing; (ii) structural wall panel and wood foundation manufacturing, including building supply distribution operations; and (iii) glue-laminated timber (glulam) column, beam, and truss manufacturing.
Business Services The Business Services division provides flexible and scalable recruitment solutions to a global clientele, servicing organizations at all levels, from entry-level positions to the C-suite. The division focuses on mid-market and enterprise organizations worldwide, partnering consultatively with talent acquisition, HR, and procurement leaders to build diverse, high-impact teams and drive business success.
Energy Services The Energy Services division engages in the rental, sale, and repair of downhole tools used in the oil and gas, geothermal, mining, and water-well industries.
Investments The Investments division manages and finances the Company’s real estate assets as well as its investment positions in private and public companies.
Investor Relations: The Equity Group Lena Cati (212) 836-9611 [email protected]
Forward-Looking Statements
This press release contains statements that the Company believes to be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this press release, including statements regarding the Company’s future financial condition, results of operations, business operations and business prospects, are forward-looking statements. Words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “predict,” “believe,” and similar words, expressions, and variations of these words and expressions are intended to identify forward-looking statements. All forward-looking statements are subject to important factors, risks, uncertainties, and assumptions, including industry and economic conditions that could cause actual results to differ materially from those described in the forward-looking statements. Such factors, risks, uncertainties, and assumptions include, but are not limited to, (1) global economic fluctuations, (2) changes in the cost and availability of commodities, materials, and equipment, (3) risks related to providing uninterrupted service to clients, (4) the ability of clients to terminate their relationship with the Company at any time, (5) risks associated with real estate ownership, (6) the Company’s ability to successfully achieve its strategic initiatives, (7) risks related to fluctuations in the Company’s operating results from quarter to quarter, (8) risks related to potential acquisitions or dispositions of businesses by the Company, (9) our profitability and growth being tied to the success of our operating businesses, (10) risks associated with our financial investments in other businesses, (11) our ability to improve existing products and services and develop, introduce, and market new products and services successfully, (12) the loss of or material reduction in our business with any of the Company’s largest customers, (13) competition in the Company’s markets, (14) risks related to potential decreases in demand for products, (15) our ability to maintain costs at an acceptable level, (16) the negative cash flows and operating losses that may recur in the future, (17) risks related to international operations, including foreign currency fluctuations, political events, trade wars, natural disasters or health crises, including the Russia-Ukraine war, and potential conflict in the Middle East, (18) risks relating to how future credit facilities may affect or restrict our operating flexibility, (19) our ability to generate or borrow sufficient cash to make payments on our indebtedness, (20) risks related to indebtedness, (21) risks associated with the Company’s investment strategy, (22) the Company’s dependence on key management personnel, (23) the Company’s ability to attract and retain highly skilled professionals, management, and advisors, (24) the Company’s ability to collect accounts receivable, (25) the Company’s exposure to legal proceedings, investigations and disputes, and limits on related insurance coverage, (26) the Company’s ability to utilize net operating loss carryforwards, (27) the potential for goodwill impairment, (28) volatility of the Company’s stock price, (29) risks related to our historically low trading volume, (30) risks related to securities or industry analysts, (31) the Company’s ability to declare dividends, (32) risks associated with failure to pay dividends on our Series A Preferred Stock, (33) our history of annual net losses, (34) risks related to our international operations, (35) risks related to compliance with federal and state laws, regulations, and other rules, (36) our exposure to employment-related claims, legal liability, and costs from clients, employees, and regulatory authorities, (37) risks related to the imposition of licensing or tax requirements or new regulations, (38) the effect of Anti-takeover provisions in our organizational documents, (39) the effect of the protective amendment contained in our Restated Certificate of Incorporation, (40) the impact of our stockholder rights plan, or “poison pill,” on stockholder decision making, (41) risks related to our scaled disclosure requirements as a smaller reporting company, (42) risks related to evolving ESG and DEI rules and regulations, (43) the Company’s heavy reliance on information systems and the impact of potentially losing or failing to develop technology, (44) the adverse impacts of cybersecurity threats and attacks, and (45) risks related to the use of new and evolving technologies, and (46) those risks set forth in “Risk Factors in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.” The foregoing list should not be construed to be exhaustive. Actual results could differ materially from the forward-looking statements contained in this press release. In view of these uncertainties, you should not place undue reliance on any forward-looking statements, which are based on our current expectations. These forward-looking statements speak only as of the date of this press release. The Company assumes no obligation, and expressly disclaims any obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.
HOUSTON, March 16, 2026 /PRNewswire/ — Summit Midstream Corporation (NYSE: SMC) (“Summit”, “SMC” or the “Company”) announced today its financial and operating results for fourth quarter and full-year 2025, Permian and Rockies segment growth update, and provided full-year 2026 financial guidance.
Highlights
Fourth quarter net loss of $7.3 million, Adjusted EBITDA of $58.5 million, cash flow available for distributions (“Distributable Cash Flow” or “DCF”) of $33.7 million and free cash flow (“FCF”) of $17.0 million
Recently signed three 10+-year firm take-or-pay contracts on Double E that are expected to drive Permian Segment Adjusted EBITDA from $34 million in 2025 to approximately $60 million in 2029
Launched a binding open season on Double E to secure market commitments to support a mainline compression project to increase firm capacity by up to 50% from 1.6 Bcf/d to approximately 2.4 Bcf/d
Refinanced Double E capital structure1 with a new term loan that will fund Double E capital projects (including the mainline compression project) and provide an $85 million one-time distribution to Summit to pay down debt and repay $45 million of arrears on its corporate Series A Preferred Stock
Executed a new 10-year crude oil gathering agreement covering more than 200,000 acres in the Williston
Active customer base with seven rigs running, approximately 90 DUCs and 116 to 126 wells expected in 2026
Provided 2026 full-year financial guidance range of $225 million to $265 million in Adjusted EBITDA and total capital expenditures of $85 million to $105 million, including $35 million attributable to Double E
Management Commentary
Heath Deneke, President, Chief Executive Officer and Chairman, commented, “We are pleased with the commercial and financial progress achieved over the past two quarters, which underscore the strategic value of our infrastructure, embedded growth opportunities, and our continued focus on execution with financial discipline. With the signing of major long-term agreements on the Double E Pipeline and in the Williston Basin, we are building on strong commercial momentum in our Permian and Rockies segments, while maintaining steady operational performance, strengthening our balance sheet and allocating capital prudently. We’re also further advancing Double E’s growth with a new open season to support a mainline compression project that could expand pipeline capacity by 50% by the end of 2028. Additionally, the Double E refinancing underscores Summit’s financial flexibility and ability to execute on important growth initiatives while continuing to maintain focus on reaching long-term corporate leverage targets. The planned repayment of the arrears on the Series A Preferred Stock further simplifies Summit’s balance sheet and is also an important step towards enabling a sustainable return of capital program for our shareholders in the future.
Operationally, despite the earlier oil price headwinds, we maintained an active customer base with seven rigs currently running behind our systems, approximately 90 DUCs and between 116 to 126 wells expected to be turned in line in 2026. Our 2026 outlook reflects sustained activity across our systems and incremental investment in high-return growth projects, which we expect will drive EBITDA growth in 2027 and beyond. Furthermore, given the mid-$60 oil price assumption embedded in our 2026 guidance, we are optimistic that customer activity levels could further increase in the second half of the year if the recent spike in oil prices continues to lift the backend of the forward price curve.”
Double E Commercial Update
Producers Midstream II reached a final investment decision on Train II of its Dude processing plant in Lea County, New Mexico, which was a condition precedent to the commencement of the previously announced 10-year, 100 MMcf/d firm transportation agreement. The new contract is expected to commence service in the fourth quarter of 2026.
Double E Pipeline entered into a new 11-year take-or-pay natural gas firm transportation agreement with a large, investment-grade shipper for 210 MMcf/d of capacity, including 80 MMcf/d expected to commence in the fourth quarter of 2026 and an additional 130 MMcf/d expected to commence in the second half of 2028. These commitments also expand Double E’s downstream connectivity with new delivery points into the Transwestern Central Pool, the Hugh Brinson Pipeline and a planned future connection with the Desert Southwest Pipeline. The new delivery points will significantly broaden Double E Shipper’s access to diverse and growing end use markets in addition to the multiple interconnects with downstream egress pipelines connecting the Waha Hub to Gulf Coast markets.
Double E Pipeline also entered into a new 11+ year natural gas transportation agreement with an undisclosed shipper for 230 MMcf/d of firm capacity, with 100 MMcf/d expected to start in the fourth quarter of 2027, 80 MMcf/d in the fourth quarter of 2028, and an additional 50 MMcfd in the second quarter of 2029. The agreement is contingent upon satisfaction of certain customary conditions precedent and is subject to shipper providing notice of its final investment decision to construct an expansion of its processing facility prior to October 1, 2026.
With the additional contracts, Summit expects its 70% interest in Double E to generate approximately $60 million of Segment Adjusted EBITDA in 2029, representing an approximate 76% increase to the $34 million of Segment Adjusted EBITDA generated in 2025. These projects are expected to cost approximately $50 million, net to Summit’s 70% interest, with approximately $35 million expected in 2026 and the remainder in 2027. These capital requirements are expected to be fully funded with the new term loan at Summit Permian Transmission which is non-recourse to Summit. Further, Double E has launched a binding open season to secure market commitments to support a mainline compression project to expand the pipeline’s capacity from approximately 1.6 Bcf/d to over 2.4 Bcf/d by the end of 2028. The compression expansion remains subject to additional commercial support via incremental long-term take-or-pay agreements and FERC and other regulatory approvals.
Double E Refinancing Transaction
Subsequent to quarter-end, Summit refinanced the Summit Permian Transmission, LLC and Summit Permian Transmission Holdco, LLC capital structure with a new $440 million term loan facility, including a $340 million borrowing at closing, $50 million committed delayed draw facility used to fund the Producers Midstream and other expansion projects, as well as a $50 million uncommitted accordion to fund the expected mainline compression expansion project. Proceeds from the new facility were used to refinance the $112.7 million Summit Permian Transmission term loan, $141.9 million Summit Permian Transmission Holdco’s preferred units2, an $85 million one-time distribution to Summit, and pay other fees and expenses. Summit intends to use the $85 million one-time distribution to pay down approximately $45 million of accrued and unpaid dividends on its Series A Preferred Stock and approximately $40 million of ABL borrowings. Repayment of the accrued and unpaid dividends represents a critical step of Summit’s objective to resume dividend payments on its common stock once Summit achieves its long-term leverage target of 3.5x. In addition, the $40 million ABL repayment reduces Summit’s leverage by approximately 0.2x, aligning with its continued focus on corporate de-levering.
Pro Forma Capitalization
Williston Commercial Update
During the fourth quarter, Summit executed a new 10-year crude gathering agreement with a Bakken producer, anchored by a large Area of Dedication covering more than 200,000 acres across its existing footprint in Divide County, North Dakota. The first new pad — consisting of four 3-mile laterals — is expected to be turned in line in the first quarter of 2026. This agreement meaningfully expands Summit’s dedicated acreage and long-term economic inventory supporting its infrastructure, while positioning the Company to pursue additional development opportunities across northern Williams and southern Divide Counties. With the efficiency gains associated with 3-mile laterals, these areas have become economically attractive in the current oil price environment. As Bakken producers continue expanding activity in the northern and western portions of the basin, Summit expects increasing commercial momentum and growth around its Polar and Divide systems.
Fourth Quarter 2025 Business Highlights
SMC’s average daily natural gas throughput on its wholly owned operated systems decreased 3.4% to 894 MMcf/d, while liquids volumes decreased 8.3% to 66 Mbbl/d, relative to the third quarter of 2025. Double E pipeline transported an average of 861 MMcf/d and contributed $8.7 million in Adjusted EBITDA, net to SMC, for the fourth quarter of 2025.
Natural gas price-driven segments:
Natural gas price-driven segments generated $31.5 million in combined Segment Adjusted EBITDA, a $4.6 million decrease relative to the third quarter and combined capital expenditures of $9.2 million.
Mid-Con Segment Adjusted EBITDA totaled $21.5 million, a decrease of $2.1 million relative to the third quarter of 2025, primarily due to a decrease in volume throughput on the system. Volume throughput on the system decreased by 3.7% primarily due to natural production declines partially offset by six new well connections in the Arkoma. Subsequent to quarter end, six new wells were connected in the Arkoma. There is currently one rig running in the Arkoma, with 21 DUCs behind the system, including 17 DUCs in the Barnett, which are all expected to come online in 2026.
Piceance Segment Adjusted EBITDA totaled $10.0 million, a decrease of $2.5 million relative to the third quarter of 2025, primarily due to realization of previously deferred revenue in the third quarter and a 5.4% decrease in volume throughput. There were no new wells connected to the system during the fourth quarter.
Oil price-driven segments:
Oil price-driven segments generated $36.6 million of combined Segment Adjusted EBITDA, representing a $1.1 million decrease relative to the third quarter of 2025, and had combined capital expenditures of $9.0 million.
Rockies Segment Adjusted EBITDA totaled $27.8 million, a decrease of $1.2 million relative to the third quarter of 2025, primarily driven by a 8.3% decrease in liquids volume throughput, partially offset by a 1.3% increase in natural gas volume throughput, relative to the third quarter of 2025. The decrease in liquids volumes was primarily driven by natural production declines and no new well connections in the Williston Basin during the quarter. Natural gas volume growth was supported by 33 new well connections in the DJ Basin, which are expected to reach peak production in the second quarter of 2026. There are currently six rigs running and approximately 65 DUCs behind the system.
Permian Segment Adjusted EBITDA totaled $8.8 million, an increase of $0.1 million relative to the third quarter of 2025, primarily due to a 20.9% increase in volumes shipped on the Double E Pipeline leading to an increase in proportionate Adjusted EBITDA from our Double E joint venture.
The following table presents average daily throughput by reportable segment for the periods indicated:
The following table presents Adjusted EBITDA by reportable segment for the periods indicated:
Capital Expenditures
Capital expenditures totaled $19.1 million in the fourth quarter of 2025, inclusive of maintenance capital expenditures of $4.0 million. Capital expenditures in the fourth quarter of 2025 were primarily related to pad connections in the Rockies and Mid-Con segments.
2026 Guidance
SMC is releasing guidance for 2026, which is summarized in the table below. These projections are subject to risks and uncertainties as described in the “Forward-Looking Statements” section at the end of this release.
SMC’s guidance range is anchored by recent drilling and completion schedules provided by its customers and is reflective of the current commodity price environment. The Company’s approach to its 2026 guidance is consistent with the framework used for its 2025 guidance range. If SMC’s producer customers hit their production targets and timing of planned well connects, the Company would expect to be near the high end of the 2026 guidance range. The midpoint of the guidance range reflects a conservative, yet appropriate, level of risking to the most recent drill schedules and volume forecasts provided by its customers. The low end of the guidance range reflects additional delays to customer drilling and completion schedules and planned well connects.
SMC expects approximately 116 to 126 well connections in 2026. Of the expected well connections in 2026, approximately 20% are natural gas-oriented wells and approximately 80% are crude oil-oriented wells. Customers are currently running seven rigs behind SMC systems, with approximately 90 DUCs, providing line of sight to the 2026 estimated well connections and associated volume growth.
SMC expects its natural gas gathering system throughput to range from 875 MMcf/d to 920 MMcf/d. Double E existing take-or-pay contracts of 1,115 MMcf/d is expected to increase to 1,285 MMcf/d when the Producers Midstream II and other projects are placed into service, as early as the fourth quarter of 2026. Liquids volumes are expected to range from 65 Mbbl/d to 90 Mbbl/d.
The guidance outlook also reflects a reduction in MVC shortfall payments in the Piceance from $16.9 million in 2025 to approximately $13.0 million in 2026, and excludes approximately $2 million of deferred revenue that benefited 2025 results.
The midpoint of the guidance range assumes strip commodity prices as of February 19, 2026, implying an average 2026 Henry Hub price of approximately $3.40 per MMBtu and WTI of approximately $64 per barrel.
Adjusted EBITDA is expected to range from $225 million to $265 million. SMC’s 2026 capital expenditure guidance of $50 million to $70 million, excluding Double E, includes capital reimbursements related to specific development projects with certain customers. The Company’s full year 2026 growth capex guidance range is primarily related to new pad connections in the Rockies and Mid-Con segments. Included in this range is approximately $15 million to $20 million of maintenance capex. Double E capital expenditures for 2026 are expected to be approximately $35 million, net to SMC, primarily related to a new plant connection and downstream connections associated with the recently announced shipper contracts.
Capital & Liquidity
As of December 31, 2025, SMC had $9.3 million in unrestricted cash on hand and $113 million drawn under its $500 million ABL Revolver with $386 million of borrowing availability, after accounting for $0.8 million of issued, but undrawn letters of credit. As of December 31, 2025, SMC’s gross availability based on the borrowing base calculation in the credit agreement was $810 million, which is $310 million greater than the $500 million of lender commitments to the ABL Revolver. As of December 31, 2025, SMC was in compliance with all financial covenants, including interest coverage of 2.7x relative to a minimum interest coverage covenant of 2.0x and first lien leverage ratio of 0.5x relative to a maximum first lien leverage ratio of 2.5x. As of December 31, 2025, SMC reported a total leverage ratio of approximately 4.1x, excluding the potential earnout liability in connection with the Tall Oak Acquisition.
As of January 2, 2026, the Permian Transmission Credit Facility balance was $112.7 million a reduction of $4.3 million relative to the September 30, 2025 balance of $117.0 million due to scheduled mandatory amortization. Summit Midstream Permian has $3.8 million of cash-on-hand as of January 2, 2026.
Subsequent to quarter-end, Summit Permian Transmission, LLC entered into a new $440 million senior secured term facility, which includes a $50 million committed accordion feature and a $50 million uncommitted accordion feature (the “Term Facility”) maturing in March 2031. Proceeds from the Term Facility were used to refinance Summit Permian Transmission’s existing credit facility, Summit Permian Transmission Holdco’s preferred units, fund an $85 million restricted payment to SMC, provide liquidity to fund SMC’s share of capital expenditures including those associated with the recently announced expansion projects, and pay other fees and expenses.
MVC Shortfall Payments
SMC billed its customers $4.3 million in the fourth quarter of 2025 related to MVC shortfalls. For those customers that do not have MVC shortfall credit banking mechanisms in their gathering agreements, the MVC shortfall payments are accounted for as gathering revenue in the period in which they are earned. In the fourth quarter of 2025, SMC recognized $4.3 million of gathering revenue associated with MVC shortfall payments. SMC had no adjustments to MVC shortfall payments in the fourth quarter of 2025. SMC’s MVC shortfall payment mechanisms contributed $4.3 million of total Adjusted EBITDA in the fourth quarter of 2025.
Quarterly Dividend
The Board of Directors of Summit Midstream Corporation continued to suspend cash dividends payable on the common stock for the period ended December 31, 2025. The quarterly cash dividend on the Series A Preferred Stock, for the period ended March 14, 2026, will be paid to preferred shareholders of record as of the close of business on March 2, 2026.
The Board of Directors approved the full repayment of all previously deferred Series A Preferred Stock dividends, payable on March 27, 2026 to holders of record as of the close of business on March 17, 2026.
Fourth Quarter 2025 Earnings Call Information
SMC will host a conference call at 10:00 a.m. Eastern on March 17, 2026, to discuss its quarterly operating and financial results. The call can be accessed via teleconference at the following link: Q4 2025 Summit Midstream Corporation Earnings Conference Call (https://register-conf.media-server.com/register/BI12ac80a058874aaa998fdc335346beed). Once registration is completed, participants will receive a dial-in number along with a personalized PIN to access the call. While not required, it is recommended that participants join 10 minutes prior to the event start. The conference call, live webcast and archive of the call can be accessed through the Investors section of SMC’s website at www.summitmidstream.com.
Use of Non-GAAP Financial Measures
We report financial results in accordance with U.S. generally accepted accounting principles (“GAAP”). We also present Adjusted EBITDA, Segment Adjusted EBITDA, Distributable Cash Flow, and Free Cash Flow, non-GAAP financial measures.
Adjusted EBITDA
We define Adjusted EBITDA as net income or loss, plus interest expense, income tax expense, depreciation and amortization, our Proportional Adjusted EBITDA for equity method investees, adjustments related to MVC shortfall payments, adjustments related to capital reimbursement activity, unit-based and noncash compensation, impairments, items of income or loss that we characterize as unrepresentative of our ongoing operations and other noncash expenses or losses, income tax benefit, income (loss) from equity method investees and other noncash income or gains. Because Adjusted EBITDA may be defined differently by other entities in our industry, our definition of this non-GAAP financial measure may not be comparable to similarly titled measures of other entities, thereby diminishing its utility.
Management uses Adjusted EBITDA in making financial, operating and planning decisions and in evaluating our financial performance. Furthermore, management believes that Adjusted EBITDA may provide external users of our financial statements, such as investors, commercial banks, research analysts and others, with additional meaningful comparisons between current results and results of prior periods as they are expected to be reflective of our core ongoing business.
Adjusted EBITDA is used as a supplemental financial measure to assess:
the ability of our assets to generate cash sufficient to make future potential cash dividends and support our indebtedness;
the financial performance of our assets without regard to financing methods, capital structure or historical cost basis;
our operating performance and return on capital as compared to those of other entities in the midstream energy sector, without regard to financing or capital structure;
the attractiveness of capital projects and acquisitions and the overall rates of return on alternative investment opportunities; and
the financial performance of our assets without regard to (i) income or loss from equity method investees, (ii) the impact of the timing of MVC shortfall payments under our gathering agreements or (iii) the timing of impairments or other income or expense items that we characterize as unrepresentative of our ongoing operations.
Adjusted EBITDA has limitations as an analytical tool and investors should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. For example:
certain items excluded from Adjusted EBITDA are significant components in understanding and assessing an entity’s financial performance, such as an entity’s cost of capital and tax structure;
Adjusted EBITDA does not reflect our cash expenditures or future requirements for capital expenditures or contractual commitments;
Adjusted EBITDA does not reflect changes in, or cash requirements for, our working capital needs; and
although depreciation and amortization are noncash charges, the assets being depreciated and amortized will often have to be replaced in the future, and Adjusted EBITDA does not reflect any cash requirements for such replacements.
We compensate for the limitations of Adjusted EBITDA as an analytical tool by reviewing the comparable GAAP financial measures, understanding the differences between the financial measures and incorporating these data points into our decision-making process.
We define Segment Adjusted EBITDA as total revenues less total costs and expenses; plus (i) other income excluding interest income, (ii) our proportional adjusted EBITDA for equity method investees, (iii) depreciation and amortization, (iv) adjustments related to MVC shortfall payments, (v) adjustments related to capital reimbursement activity, (vi) stock-based and noncash compensation, (vii) impairments and (viii) other noncash expenses or losses, less other noncash income or gains. We define Proportional Adjusted EBITDA for our equity method investees as the product of (i) total revenues less total expenses, excluding impairments and other noncash income or expense items and (ii) amortization for deferred contract costs; multiplied by our ownership interest during the respective period.
Distributable Cash Flow
We define Distributable Cash Flow as Adjusted EBITDA, as defined above, less cash interest paid, cash paid for taxes, net interest expense accrued and paid on the senior notes, and maintenance capital expenditures.
Free Cash Flow
We define free cash flow as distributable cash flow attributable to common and preferred shareholders less growth capital expenditures, less investments in equity method investees, less dividends to common and preferred shareholders. Free cash flow excludes proceeds from asset sales and cash consideration paid for acquisitions.
We do not provide the GAAP financial measures of net income or loss or net cash provided by operating activities on a forward-looking basis because we are unable to predict, without unreasonable effort, certain components thereof including, but not limited to, (i) income or loss from equity method investees and (ii) asset impairments. These items are inherently uncertain and depend on various factors, many of which are beyond our control. As such, any associated estimate and its impact on our GAAP performance and cash flow measures could vary materially based on a variety of acceptable management assumptions.
About Summit Midstream Corporation
SMC is a value-driven corporation focused on developing, owning and operating midstream energy infrastructure assets that are strategically located in the core producing areas of unconventional resource basins, primarily shale formations, in the continental United States. SMC provides natural gas, crude oil and produced water gathering, processing and transportation services pursuant to primarily long-term, fee-based agreements with customers and counterparties in five unconventional resource basins: (i) the Williston Basin, which includes the Bakken and Three Forks shale formations in North Dakota; (ii) the Denver-Julesburg Basin, which includes the Niobrara and Codell shale formations in Colorado and Wyoming; (iii) the Fort Worth Basin, which includes the Barnett Shale formation in Texas; (iv) the Arkoma Basin, which includes the Woodford and Caney shale formations in Oklahoma; and (v) the Piceance Basin, which includes the Mesaverde formation as well as the Mancos and Niobrara shale formations in Colorado. SMC has an equity method investment in Double E Pipeline, LLC, which provides interstate natural gas transportation service from multiple receipt points in the Delaware Basin to various delivery points in and around the Waha Hub in Texas. SMC is headquartered in Houston, Texas.
Forward-Looking Statements
This press release includes certain statements concerning expectations for the future that are forward-looking within the meaning of the federal securities laws. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements and may contain the words “expect,” “intend,” “plan,” “anticipate,” “estimate,” “believe,” “will be,” “will continue,” “will likely result,” and similar expressions, or future conditional verbs such as “may,” “will,” “should,” “would” and “could.” In addition, any statement concerning future financial performance (including future revenues, earnings or growth rates), payment of dividends on any series of stock, ongoing business strategies and possible actions taken by SMC or its subsidiaries are also forward-looking statements. Forward-looking statements also contain known and unknown risks and uncertainties (many of which are difficult to predict and beyond management’s control) that may cause SMC’s actual results in future periods to differ materially from anticipated or projected results. An extensive list of specific material risks and uncertainties affecting SMC is contained in its 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 16, 2026, as amended and updated from time to time. Any forward-looking statements in this press release are made as of the date of this press release and SMC undertakes no obligation to update or revise any forward-looking statements to reflect new information or events.
CULVER CITY, Calif., March 17, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, will hold a conference call and webcast on Thursday, March 19, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its financial results for the fourth quarter and full year ended December 31, 2025.
Snail, Inc. management will host the conference call and webcast, followed by a question-and-answer period. Participants may listen to the live webcast and replay via the link here or on the Company’s investor relations website at https://investor.snail.com/.
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 [email protected]
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today announced an initiative to expand its reach and complement its existing, telephonic insurance distribution model.
SelectQuote Local will leverage the Company’s industry-leading marketing, technology, customer service, and carrier relationships to offer consumers its senior health and life insurance products through a franchise model offering local sales and support. SelectQuote Local provides consumers the opportunity to meet with local representatives while still offering the Company’s same affordable and simple way to quickly and easily find the type of insurance to meet their unique needs. Franchise owners will have an opportunity to purchase rights to operate their SelectQuote Local franchise in a particular geographic region, providing a compelling business opportunity for them and an exciting new growth opportunity for the Company.
“We see SelectQuote Local as a natural extension of our existing SelectQuote business. With over four decades as a pioneering insurance brokerage, we have optimized our approach to marketing, shopping, selling, and customer service. We’ve helped millions of customers find the best insurance coverage to meet their unique needs. We believe SelectQuote Local creates an opportunity to extend our reach to more consumers, namely those who wish to do business with someone in their local market,” said Bill Grant, SelectQuote’s Chief Operating Officer. “It’s the perfect complement to our existing platform and, given our diversified business model that extends across senior health and healthcare services as well as term life and final expense product offerings, SelectQuote is uniquely positioned to deliver on this market opportunity. No one else can match our breadth of offerings, our capabilities, our experience, or our expertise.”
SelectQuote Chief Financial Officer Ryan Clement added, “From a financial perspective, we think SelectQuote Local provides an exciting and cash efficient opportunity to leverage our proven technology and carrier platform to drive increased scale to our insurance distribution business. We expect the SelectQuote Local model to require a low level of capital investment from the Company and, over time, to create a recurring royalty stream providing compelling cash-on-cash returns for shareholders. In addition, our highly-complementary SelectRx pharmacy and healthcare services business continues to grow more cash generative. We are already projecting meaningful operating cash flow for this fiscal year and expect cash generation to increase in the quarters and years to come. When paired with our recently finalized $415 million credit facility, SelectQuote Local, alongside our growing healthcare services business, provides a path to increasing scale and to accelerating our progress toward de-levering the business.”
This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, changes in reimbursement rates under our contracts with pharmacy benefit managers, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.
About SelectQuote
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), plans to submit a formal NDA in the near future.
Mr. Ping Zhang, Executive Chairman of Gyre, stated, “I am very pleased to see the decision by the Chinese CDE to grant priority review to our NDA for F351. It underscores both the urgency of the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. HBV infection affects tens of millions of patients in China and a significant number of them will develop liver fibrosis and eventually cirrhosis. If approved, F351 could address the need for these patients. We thank the agency for their continued support to advance therapies for liver fibrosis patients in need of treatment and look forward to working closely with CDE to move F351 toward approval.”
About Priority Review Designation by the NMPA in China
Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process.
About Hydronidone (F351)
Hydronidone, also known as F351, is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in HSCs.
The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.
About CHB-Induced Liver Fibrosis
CHB-induced liver fibrosis is the accumulation of scar tissue (collagen) in the liver caused by persistent inflammation from hepatitis B virus. According to the World Health Organization, approximately 254 million people worldwide were living with CHB infection in 2022, with 1.2 million new infections each year, and 1.3 million deaths globally. CHB is the leading aetiology of liver fibrosis and liver cancer globally, with up to 36% of all CHB patients globally developing cirrhosis. CHB prevalence varies across geographies with China and the United States estimated to have among the highest number of CHB cases.
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 NMPA Center for Drug Evaluation 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 indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230. On March 2, 2026 Gyre announced its agreement to acquire Cullgen Inc., a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degraders and degrader antibody conjugate therapies.
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 expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone for the treatment of CHB-associated liver fibrosis and early cirrhosis and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China. 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: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026 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.
STAFFORD, Texas, March 17, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01.
6 Months of Additional Patient Data Since Last Update Shows Recurrence Rate of <1% per Year in Non-HLA-A*02 Patients Treated with GLSI-100, Following Completion of Primary Immunization Series (PIS)
This <1% Annual Recurrence Rate Observed in Non-HLA-A*02 Patients is Statistically Significantly Smaller Than a 4% Annual Recurrence Rate Over a Similar Time Period Observed in the Katherine Study (Kadcyla Treated Arm) Yielding an Approximately 70-80% Reduction in Recurrence Rate as Explained Below
The non-HLA-A*02 arm does not have a direct placebo comparator arm, thus a Kaplan Meier survival analysis is not possible, and the following method was used:
The <1% recurrence rate per year of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for a similar population in the Katherine study who received TDM1 (Kadcyla), which is about 4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100.
As of this data cut, the current recurrence rate of the non-HLA-A*02 patients treated with GLSI-100, following completion of the PIS over an average of 1.2 years of patient exposure, is statistically significantly smaller than a 4% annual recurrence rate over a similar time period observed in the Katherine study (0.7% versus 4% annual recurrence rate over 1.2 patient-years, 83% reduction in recurrence rate, Chi Square, p < 0.005). This preliminary data will continue to be updated and cleaned, so future and final results may vary. Future updates may be presented at upcoming conferences.
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.
Additional information about the non-HLA-A*02 arm follows:
Virtually all of the non-HLA-A*02 patients have completed the primary immunization series, which is the first 6 monthly vaccinations in the study.
Every 6 months approximately 110 patient-years are added to the non-HLA-A*02 patient data base.
Enhertu (T-DXd) treated patients can be enrolled in FLAMINGO-01. In the future, if Enhertu is approved for high risk patients in the adjuvant setting, more Enhertu treated patients could be enrolled in FLAMINGO-01 and may recur at a lower rate than if treated with Kadcyla. The recurrence rate assumptions in the design of FLAMINGO-01 include this possibility as well as other potential improvements in standard of care.
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 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 compared to the recurrence rates comparable to those observed in the Katherine study of Kadcyla shows an approximately 70-80% reduction in recurrence rate.
This non-HLA-A*02 arm 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.
The Journal of the American Medical Association (JAMA Neurology) publication highlights consistent clinical and biomarker findings from NeuroSense PARADIGM Phase 2b trial in ALS, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers
CAMBRIDGE, Mass., March 16, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology.
Earlier today, Mass General Brigham (MGB) and Barrow Neurological Institute (BNI) issued a joint announcement highlighting the publication and the contributions of the investigators involved in the PARADIGM trial. NeuroSense is honored to collaborate with these leading ALS research centers of excellence and their distinguished clinical teams in advancing research for people living with ALS.
PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension.
PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways.
The publication was authored by a distinguished international group of ALS investigators, including Merit Cudkowicz, MD, MSc (Mass General Brigham and Harvard Medical School), Vivian Drory, MD (Tel-Aviv Sourasky Medical Centre), Adriano Chiò, MD, PhD (University of Torino), Christian Lunetta, MD (IRCCS Maugeri), Christen Shoesmith, MD (London Health Sciences Centre), Ruben van Eijk,MD, PhD (UMC Utrecht), Jeffrey Rosenfeld, MD, PhD (Loma Linda University), and Jeremy Shefner, MD, PhD (Barrow Neurological Institute), together with additional collaborators across North America, Europe, and Israel.
Key highlights from the PARADIGM phase 2b study published
Strong safety and tolerability profile: PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events mild to moderate and transient.
Clinically meaningful functional outcomes: Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001).
Reduction in risk of major ALS complications: Early initiation of PrimeC was associated with a 64% relative reduction in risk of ALS-related complications (p=0.02), including respiratory failure, hospitalization, or death.
Biological evidence supporting disease modification: PrimeC treatment was associated with significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting its biological activity and reinforcing the potential for disease-modifying effects.
Supports advancement to Phase 3: These findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS.
“ALS is one of the most serious neurological diseases, and there is an urgent need for therapies that can meaningfully alter its course,” said Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School. “What is particularly noteworthy about the PARADIGM results is the consistency of the findings across clinical outcomes and disease-relevant biomarkers, in addition to good safety. These results provide a strong scientific rationale for continuing the clinical development of PrimeC and support its evaluation in a larger confirmatory Phase 3 trial.”
“What stands out about the PARADIGM study is the multiple clinical endpoints suggest the same level of clinical benefit and that multiple biomarkers are consistent with clinical endpoints,” said Jeremy M. Shefner, MD, PhD, Professor of Neurology at the Barrow Neurological Institute and corresponding author of the publication. “Together, these findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 trial designed to validate its impact for patients.”
“The publication of the PARADIGM results in the prestigious JAMA Neurology represents an important milestone for NeuroSense and for people living with ALS,” said Ferenc Tracik, MD, Chief Medical Officer of NeuroSense Therapeutics. “This article integrates PrimeC’s safety, clinical, and biomarker data over 18 months. The consistent findings of slower functional decline, reduced risk of ALS-related complications, and modulation of iron-regulatory and microRNA biomarkers strengthen confidence in PrimeC’s potential as a disease-modifying therapy. These findings directly informed the design of our Phase 3 trial, which has received FDA clearance to proceed.”
PARADIGM Study Overview
PARADIGM was a multinational Phase 2b randomized, double-blind, placebo-controlled clinical trial conducted at leading ALS referral centers in Italy, Canada, and Israel.
The study enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo for six months. The double-blind phase was followed by a 12-month open-label extension, during which all participants received PrimeC while maintaining blinding to original treatment assignment.
Even though the trial was not powered to demonstrate definitive efficacy, participants who received PrimeC from the outset maintained a clinically meaningful 7.92-point functional advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007), with the largest improvement observed in the bulbar domain (p=0.001), a key determinant of speech, swallowing, and quality of life in ALS.
In addition, ALS complication-free survival demonstrated a 64% relative risk reduction favoring early treatment (p=0.02), suggesting potential long-term clinical benefit.
Biomarker Findings
The trial also demonstrated biological activity consistent with PrimeC’s proposed multi-pathway mechanism.
Markers of iron metabolism, which are frequently dysregulated in ALS, showed favorable significant changes, including preservation of transferrin levels and stabilization of ferritin.
In parallel, plasma microRNA analysis revealed statistically significant downregulation of ALS-associated microRNAs miR-199a-3p, miR-199a-5p, miR-181a-5p, and miR-181b-5p, which have been linked to disease severity and prognosis.
Together, these findings provide biological evidence that PrimeC engages disease-relevant pathways and support its continued development as a potential disease-modifying therapy.
About PrimeC
PrimeC is an investigational fixed-dose oral combination therapy composed of celecoxib and ciprofloxacin in a synchronized extended-release formulation. The therapy is designed to simultaneously target multiple biological mechanisms implicated in ALS progression, including neuroinflammation, iron dysregulation, and microRNA dysregulation.
The therapeutic rationale for PrimeC is supported by preclinical evidence across ALS disease models and human induced pluripotent stem cell–derived motor neuron systems and has now been evaluated in a randomized Phase 2b clinical trial.
About NeuroSense Therapeutics
NeuroSense Therapeutics is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for people living with ALS and other neurodegenerative diseases. The company’s lead program, PrimeC, is designed to simultaneously target multiple biological pathways implicated in ALS progression.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
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