CHICAGO, June 01, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, delivered a poster presentation on May 31, 2026, featuring the methodology and study design for its pivotal Phase 3 clinical trial (THIO-104) at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO 2026), being held May 29 – June 2, 2026, in MAIA’s home city of Chicago, Illinois. THIO-104 evaluates the efficacy of MAIA’s telomere targeting agent, ateganosine, administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients resistant to CPIs and chemotherapy. MAIA reported the first patient dosed in THIO-104 in December 2025, and screening and enrollment is underway in Europe and Asia.
“We’re pleased to be back at ASCO, where many of the world’s leading oncology experts gather to discuss the latest advances shaping the future of cancer treatment,” said MAIA CEO Vlad Vitoc, M.D. “The level of engagement and enthusiasm surrounding our clinical programs is very encouraging, particularly as investigators continue enrolling patients in both our pivotal Phase 3 THIO-104 trial and Phase 2 THIO-101 trial expansion.”
MAIA’s ASCO 2060 poster, titled “A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress,” was presented by Tomasz Jankowski, M.D., Phase 2 THIO-101 lead investigator for Poland, enrollment advisor for the pivotal Phase 3 THIO-104 clinical trial and co-author of several MAIA scientific presentations. The poster is attached to this press release and is also available on the Publications page of MAIA’s website maiabiotech.com.
“Investigators are increasingly focused on therapies that can potentially overcome resistance mechanisms and improve outcomes for patients with advanced NSCLC,” said Dr. Jankowski.
“Ateganosine has generated meaningful interest within the oncology community and may offer a promising new therapeutic option for patients who currently face very limited treatment choices.”
The ASCO Annual Meeting is the world’s largest cancer research meeting, with nearly 45,000 attendees and 166 countries represented in 2025.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About THIO-104 Phase 3 Clinical Trial
THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
HOUSTON, June 1, 2026 /PRNewswire/ — Summit Midstream Corporation (NYSE: SMC) (“Summit,” “SMC” or the “Company”) today announced that its Board of Directors has authorized the Company’s inaugural stock repurchase program to repurchase up to $35 million of the Company’s outstanding common stock.
Heath Deneke, President, Chief Executive Officer and Chairman, commented, “The authorization of our inaugural share repurchase program reflects the Board’s confidence in Summit’s financial strength and the significant progress we have made over the past year in simplifying our balance sheet and strengthening our platform. Having repaid all arrears on our Series A Preferred Stock and supported by our improving free cash flow profile and financial flexibility, we are now in a position to utilize a common stock buyback program as a tool to ensure liquidity and support the secondary market of the shares. We believe our common stock represents an attractive opportunity at current levels, and we intend to be opportunistic in executing any repurchases.”
Under the program, repurchases of shares of the Company’s common stock may be made from time to time in the open market, through privately negotiated transactions, block purchases, or otherwise, including through a Rule 10b5-1 trading plan, in compliance with applicable federal and state securities laws, including Rule 10b-18 under the Securities Exchange Act of 1934, as amended. The timing and amount of any repurchases will be determined by management at its discretion based on a variety of factors, including business and market conditions, the trading price of the Company’s common stock, compliance with debt covenants, and certain other considerations. The program does not obligate the Company to repurchase any specific number of shares, has no fixed expiration date, and may be suspended or discontinued at any time.
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), repurchases of the Company’s common stock, 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 U.S. Securities and Exchange Commission 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.
STAFFORD, Texas, June 01, 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 presents the published abstract and poster from the ASCO Annual Meeting 2026.
The abstract is shown below and the poster being presented today can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
This is the second abstract and poster presented jointly with the Steering Committee of FLAMINGO-01 with statistically significant injection site reaction (ISR) immune response data, with subgroup analysis by the most prevalent HLA types.
In the non-HLA-A*02 open label arm where all patients (n=247) were treated with GLSI-100, immune responses to GP2 were measured at baseline and over time using skin tests (DTH) and ISRs.
An ISR reaction, erythema (redness) or induration (white hard bump), was used to assess in vivo immune responses in patients. The diameter of the reaction was assessed 48-72 hours after injection but is not reported here.
In this preliminary data analysis, there was a significant increase in percentage of patients experiencing an ISR reaction (for both erythema and induration) in vaccination 4, vaccination 5 or vaccination 6 compared to the baseline vaccination. There were 208 patients with both baseline vaccination and vaccination 4, 5 or 6 assessments.
Erythema: There was a significant increase in the percentage of patients experiencing erythema ISRs after the 4th, 5th or 6th vaccination compared to the ISRs from the 1st vaccination. In this preliminary analysis, the frequency of ISRs increased significantly from 20.2% of the patients experiencing an ISR after the first vaccination to 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination (McNemar p < 0.001), representing an increase of 2.7x or 174%.
Induration: There was a significant increase in the percentage of patients experiencing induration ISRs after the 4th, 5th or 6th vaccination compared to the ISRs from the 1st vaccination. In this preliminary analysis, the frequency of ISRs increased significantly from 14.9% of the patients experiencing an ISR after the first vaccination to 34.6% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination (McNemar p < 0.001), representing an increase of 2.3x or 132%.
As reported in Table 1, each HLA-A type exhibited more frequent immune reactivity with increased GLSI-100 vaccinations with frequency increasing by 60% to 280% over the frequency after the first vaccination. These results are consistent with the GP2 DTH results presented at AACR.
Mechanism of Action: 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. The Company previously announced that in the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the Primary Immunization Series (PIS) is completed shows an approximately 70-80% reduction in recurrence rate. Thus, the immune response data is supporting the mechanism of action that reduces recurrences and prevents metastatic breast cancer.
This statistically significant non-HLA-A*02 open label arm immune response data for both DTH and ISRs is trending similarly to the immune response data in the HLA-A*02 patients in the Phase IIb study and the HLA-A*02 arms of FLAMINGO-01. The study is ongoing and data collection and cleaning continue, while some patients may still be in their PIS vaccination phase, so final results may vary.
The immune response abstract and poster conclusion: The statistically significant increase in the incidence of ISR reactions over time found in this preliminary analysis of GLSI-100 treated non-HLA-A*02 patients shows that GLSI-100 treatment should not be limited to HLA-A*02 patients. Patients treated with GLSI-100 were increasingly able to mount an immune response to GP2 as evidenced in this preliminary data. Future investigations may explore the use of immune responses to assess correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.
CEO Snehal Patel commented, “The DTH immune response data presented at AACR and the ISR immune response data presented today together further support the mechanism of action and the combination of HLA-A*02 and non-HLA-A*02 patients in the same randomized arms, potentially improving the chances of success at the interim analysis and more than doubling the market potential for GLSI-100. This combination of patients, independent of HLA type, has already started in the US and may soon start in Europe. In addition to ASCO, the Company previously attended AACR and ESMO Breast and plans to attend BIO partnering and investor conferences in the coming months, while presenting additional FLAMINGO-01 data at any time.”
The abstract from today’s immune response data and the members of the Steering Committee follow:
Abstract Number: LBA538 – Poster Section 23 on June 1, 2026, 1:30 – 4:30pm CT
Abstract Title: Preliminary injection site reaction 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, Miguel Martin4, Joyce A. O’Shaughnessy5, Hope S. Rugo6, Cesar A. Santa-Maria7, Marcus Schmidt8, Laura M. Spring9, and Mothaffar F. Rimawi10
1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL, 4GEICAM, Madrid, Spain,5Sarah Cannon Research Institute, Dallas, TX,6City of Hope Comprehensive Cancer Center, Duarte, CA,7Johns Hopkins University, Baltimore, MD,8University Medical Center Mainz, Mainz, Germany,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX
Background: This Phase III trial is a prospective, randomized, double-blinded, multi-center study (NCT05232916) in HLA-A*02 patients at approximately 140 sites in the US and Europe. A third non-randomized arm of approximately 250 non-HLA-A*02 patients is now fully enrolled and preliminary immune response data is presented below. GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100.
Methods: After standard of care neoadjuvant and adjuvant therapy, 6 intradermal injections of GLSI-100 will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up. Immune responses to GP2 were measured over time using delayed-type-hypersensitivity (DTH) skin tests and injection site reactions (ISRs). The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA, 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy, 3) Exclude Stage IV, and 4) Completed at least 90% of planned adjuvant trastuzumab-based therapy.
Results: All patients (n=247) were vaccinated with GLSI-100. Injection site reactions, erythema (redness) was assessed at various time points and represent an in vivo immune response in patients. The ISR orthogonal mean was measured 48-72 hours following vaccination with GLSI-100. For GP2 treated patients, there was a significant increase in the percentage of patients experiencing ISRs in the 4th, 5th or 6th vaccination compared to the ISRs from the 1st vaccination. In this preliminary analysis, the frequency of ISRs increased significantly from 20.2% of the patients experiencing an ISR after the first vaccination to 55.3% of the patients experiencing an ISR after the 4th, 5th or 6th vaccination (McNemar p < 0.001). The study is ongoing and data collection and cleaning continue so final results may vary.
Conclusions: Preliminary injection site reaction data comparing vaccination over time in GLSI-100 treated non-HLA-A*02 patients showed a significant increase in immune response. Future studies may explore the use of immune responses to assess: correlation of DTH to ISRs, immunogenicity of GLSI-100 by specific HLA type, timing of boosters to sustain immunity, clinical site performance, and the discontinuation of treatment for non-responders.
The Steering Committee authoring abstract LBA538 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 2026 ASCO Annual Meeting
ASCO is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: https://conferences.asco.org/am/attend.
About FLAMINGO-01 Open Label Phase III Data
More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) posters can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 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.
Real-world analysis of three years of closed claims data from Symphony Health, focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia
Data demonstrate a substantial and persistent health burden associated with prescribed opioid use among adults with fibromyalgia
Tonix commercially launched TONMYA® in November 2025, the first new fibromyalgia drug for adults in the U.S. in over 15 years approved by the U.S. Food and Drug Administration (FDA)
BERKELEY HEIGHTS, N.J., May 28, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial-stage biotechnology company, presented data from a real-world claims analysis of opioid use in U.S. adults with fibromyalgia at the 2026 ASCP Annual Meeting, held May 26-29, 2026, in Miami Beach, Florida.
“Opioids remain widely prescribed for fibromyalgia despite long-standing guidelines that discourage their use due to lack of efficacy, a growing concern that they worsen fibromyalgia symptoms and the risk of dependence,1-6” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The discrepancy between real-world practice and evidence-based recommendations reveals a gap in knowledge and an urgent need to educate health care prescribers about the nature of fibromyalgia and the availability of non-opioid, FDA-approved medicines. Tonix is currently executing on the launch of TONMYA® (cyclobenzaprine HCl sublingual tablets), a first-in-class, first-line, non-opioid analgesic medicine FDA approved for daily bedtime administration and long-term use in adults with fibromyalgia.”
Data presented at ASCP 2026 represent a retrospective cohort study using the Symphony Health closed claims database, encompassing administrative medical and pharmacy claims collected between April 2021 and April 2024, to evaluate opioid and benzodiazepine use among adults diagnosed with fibromyalgia (ICD-10-CM diagnosis code M79.7). The study’s objective was to quantify opioid and benzodiazepine use in patients diagnosed with fibromyalgia and characterize patients by age, insurance coverage, and polypharmacy. The Year 3 cohort (April 2023 to March 2024) included 261,776 adult patients, with a mean age of 52.3 years. The cohort was predominantly female (92.1%).
Among patients with Commercial or Medicare Advantage insurance, 40.2% of patients were prescribed at least one opioid, with most claims for tramadol (13.7%), followed by oxycodone (13.1%). Among Medicaid patients, 38.8% were prescribed at least one opioid, with most claims for oxycodone (15.7%), followed by tramadol (11.1%). The Medication Possession Ratio (MPR) for opioid use was similar for Commercial or Medicare Advantage patients (0.39) and Medicaid patients (0.40). Opioid use showed the highest prevalence in older age groups: 61-65 years (43.1%), 66-70 years (39.2%), 71-75 years (38.5%), and >75 years (34.4%), and was lower, but still common for younger adults 18-25 years (20.9%). Concomitant opioid and benzodiazepine use was similar in patients covered under Medicare Advantage or Commercial insurance (19.1%) and Medicaid patients (20.4%).
A copy of the Company’s poster presentation, “Opioid Use in Patients with Fibromyalgia: A Retrospective Claims Analysis,” is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations/.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly in women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets)
TONMYA (cyclobenzaprine HCl sublingual tablets) is a sublingual tablet formulation of cyclobenzaprine hydrochloride that was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034.
Citations
1Winslow BT, et al. Am Fam Physician. 2023;107(2):137–44. 2Macfarlane GJ, et al. Annals of the Rheumatic Diseases. 2017;76(2):318. 3Martucci KT, et al. Sci Rep. 2019;9(1):9633. 4Turner JA, et al. Pain. 2016;157(10):2208–2216. 5Fitzcharles MA, et al. J Rheumatol. 2013;40(8):1388–1393. 6American College of Rheumatology. Fibromyalgia. 2024. Available from: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Fibromyalgia.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM), a global leader in the design and manufacture of mission critical fluid, power, heat transfer, vacuum and advanced mixing technologies for the Defense, Energy & Process, and Space industries, announced that it will release its fourth quarter and fiscal year 2026 financial results before financial markets open on Monday, June 8, 2026.
The Company will host a conference call and webcast to review its financial and operating results, strategy, and outlook. A question-and-answer session will follow.
Fourth Quarter Fiscal Year 2026 Financial Results Conference Call
Monday, June 8, 2026 11:00 a.m. Eastern Time Phone: (201) 689-8560 Internet webcast link and accompanying slide presentation: ir.grahamcorp.com
A telephonic replay will be available from 3:00 p.m. ET on the day of the teleconference through Monday, June 15, 2026. To listen to the archived call, dial (412) 317-6671 and enter conference ID number 13760742 or access the webcast replay via the Company’s website at ir.grahamcorp.com, where a transcript will also be posted once available.
ABOUT GRAHAM CORPORATION Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer, vacuum, and advanced mixing technologies for the Defense, Energy & Process, and Space industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise, proprietary technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.
Novel, potent pan-viral inhibitors targeting the viral replication complex are under development for the treatment of hantavirus, bunyavirus and influenza
Hantavirus and bunyavirus infections represent significant unmet medical needs, contribute to ongoing global outbreaks and have no approved treatments or vaccines
BOTHELL, Wash., May 26, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its novel direct-acting antivirals demonstrate pan-viral activity against multiple viruses, including hantavirus, bunyavirus and influenza. These antiviral molecules target a highly conserved region of the viral replication enzyme, specifically the L-protein of Andes hantavirus, which is essential for viral replication and transcription. In vitro potency data show superior activity (IC50 <50 nM) against hantaan virus, which is closely related to the Andes hantavirus strain associated with recent outbreaks.
“We are thoughtfully leveraging our expertise in viral replication enzymes and structure-based drug discovery to develop the next generation of pan-viral replication inhibitors. Our first pan-viral protease inhibitor, CDI-988, recently advanced to a Phase 1b norovirus challenge study in the United States. Our research efforts have expanded to novel pan-viral replication inhibitors with the goal of developing a novel pan-viral lead molecule for multiple viral diseases caused by hantaviruses, bunyaviruses and influenza viruses,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “We are encouraged by our initial in vitro potency data against hantavirus and plan to evaluate in vitro antiviral activity against the Andes hantavirus replication enzyme. We look forward to exploring collaborations and partnerships to address these urgent unmet needs.”
The Andes hantavirus was recently responsible for a deadly outbreak on a cruise ship, infecting up to 11 passengers and crew, resulting in three deaths. Hantaviruses are primarily transmitted by rodents, although human-to-human transmission can occur through prolonged close contact. Andes hantavirus, a member of the genus Hantavirus, is endemic in Argentina and Chile and causes hantavirus cardiopulmonary syndrome (HCPS), which is associated with a case fatality rate of up to 50%. Currently, there are no approved antivirals or vaccines for Andes hantavirus or other hantaviruses.
About Cocrystal Pharma’s Structure-Based Drug Discovery Platform
Cocrystal is leveraging its structure‑based drug discovery platform technology to design next‑generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off‑target effects, offering potentially safer, broad‑spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.
The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s research and development of pan-viral replication inhibitors and exploration of collaborations and partnerships with respect thereto. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, risks arising from the research into a related virus was not done in animals and was necessarily early stage, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Investor Contact: Alliance Advisors IR Bruce Voss [email protected] 310-691-7104
Company Aligns Resources with Programs Demonstrating Strong Clinical, Regulatory, and Market Momentum
ATLANTA, GA — May 26, 2026 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines, today announced a strategic prioritization of its development portfolio to concentrate resources on its lead programs, GEO-MVA and Gedeptin®, reflecting increasing clinical, regulatory, and market alignment across these programs. As part of this decision, the Company has elected to discontinue active development activities related to its GEO-CM04S1 COVID-19 vaccine candidate. This decision was not related to any safety concerns with the vaccine but reflects the continued evolution and contraction of the global COVID-19 vaccine market, and GeoVax’s focus on programs with clearer regulatory pathways, stronger demand visibility, and more immediate commercialization potential. GeoVax emphasized that portfolio prioritization is a standard and essential practice within the biotechnology industry, enabling companies to align resources with the highest-value opportunities as market conditions and scientific landscapes evolve.
“GeoVax is at an important inflection point, and this decision reflects a deliberate and disciplined focus on the programs we believe can deliver the greatest near-term and long-term value,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “As GEO-MVA advances toward clinical validation and potential commercialization, and as Gedeptin gains relevance within emerging immuno-oncology treatment paradigms, we are aligning our resources to support focused execution against these high-potential opportunities.”
GEO-MVA: Expedited Pathway and Near-Term Commercial Opportunity
GEO-MVA, GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox, is advancing under an expedited regulatory pathway supported by European Medicines Agency (EMA) scientific advice. This approach enables potential approval based on a single pivotal immunobridging study demonstrating non-inferiority to an approved MVA vaccine – significantly accelerating development timelines and reducing clinical risk.
The program has clinical-grade material manufactured and released in preparation for the planned Phase 3 immunobridging study. Following successful completion, GEO-MVA is expected to advance toward regulatory submission and potential commercialization within a streamlined timeframe, including potential Emergency Use Licensing.
GeoVax has initiated outreach with global procurement and preparedness stakeholders – including government agencies, international organizations, and biodefense programs – supporting potential vaccine supply agreements aligned with national stockpiling and outbreak response needs. These activities position GEO-MVA to serve as a critical additional supplier of MVA-vaccine supporting supply-chain resilience and biodefense preparedness.
Gedeptin®: Aligned with Emerging Immuno-Oncology Treatment Paradigm
Gedeptin®, GeoVax’s gene-directed enzyme prodrug therapy (GDEPT) platform, is being advanced in alignment with a rapidly evolving oncology landscape, highlighted by the landmark KEYNOTE-689 Phase 3 trial demonstrating improved event-free survival with neoadjuvant checkpoint inhibitor therapy in resectable head and neck cancers.
GeoVax’s planned Phase 2 study (AdPNP-203) will evaluate Gedeptin in combination with pembrolizumab and fludarabine in a neoadjuvant setting, with the objective of enhancing tumor immune visibility and improving clinical outcomes.
Gedeptin’s tumor-targeting mechanism is designed to significantly damage or destroy treated lesions through the localized, in situ generation of a potent chemotherapeutic agent. In addition, Gedeptin appears to sensitize tumors to checkpoint inhibitors, likely through the exposure and release of neoantigens from treated lesions, thereby enhancing responses in both treated and untreated lesions. This mechanism may expand response rates and improve durability of outcomes in patients who derive limited benefit from checkpoint inhibition alone. These developments underscore the growing relevance of Gedeptin within this evolving treatment paradigm and support GeoVax’s decision to prioritize its advancement within the Company’s portfolio.
“This is a strategic step forward for GeoVax,” Dodd added. “By concentrating our efforts on GEO-MVA and maintaining our oncology innovation with Gedeptin, we believe we are positioning the Company for a more focused, execution-driven path toward late-stage development, commercialization and long-term value creation”.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Transaction Expected to Close Before the End of 2026
Conduent Continues to Fortify Its Balance Sheet
Conduent Retains Ownership of Tolling Business Segment
Conduent Incorporated (Nasdaq: CNDT), a global technology‑driven business solutions and services provider, today announced that it has entered into a definitive agreement to sell its Public Transit business, an operating unit of Conduent Transportation, to Modaxo, a global technology organization focused on moving the world’s people. The Public Transit business consists of Transit Fare Management and Fleet Management Solutions businesses.
The sale has a purchase price of $164 million. The companies expect the transaction to close before the end of 2026, subject to customary conditions and regulatory approvals.
“This transaction advances our strategy to simplify the portfolio, sharpen focus on our core businesses, and strengthen our financial foundation. Consistent with the disciplined execution outlined in Q1, it further positions Conduent to deliver sustainable, long-term value for our shareholders, clients, and employees,” said Harsha V. Agadi, Conduent President and Chief Executive Officer. “Modaxo’s technology focus makes it a strong strategic fit for the Public Transit business and those it serves. We remain committed to delivering outstanding quality and performance for our Transportation clients as we prepare for closing and ensure a seamless transition for clients and employees.”
With global operations, the Public Transit business offers fare collection systems, fleet management systems, payment and revenue management platforms, and other hardware‑enabled mobility systems.
Conduent Transportation’s remaining Tolling business provides mission‑critical technology that enables all‑electronic tolling, roadside, and back‑office processing, image review, violation enforcement and analytics. It supports more than 14 million tolling transactions per day.
Additional details of the transaction are outlined in Conduent’s 8-K filed with the U.S. Securities and Exchange Commission (SEC) today.
About Conduent Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 48,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $80 billion in government payments annually, enabling approximately 2.0 billion customer service interactions annually, empowering millions of employees through HR services every year and processing over 14 million tolling transactions every day. Learn more at www.conduent.com.
About Modaxo Modaxo is a global technology organization passionate about moving the world’s people. Working both together and independently, our collective of businesses is committed to delivering software and technology solutions that help connect people with the places they need to go for work, family, and everyday life. Learn more at Modaxo.com.
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
Forward-Looking Statements This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “plan,” “intend,” “will,” “aim,” “should,” “could,” “forecast,” “target,” “may,” “continue to,” “endeavor,” “if,” “growing,” “projected,” “potential,” “likely,” “see,” “ahead,” “further,” “going forward,” “on the horizon,” and similar expressions (including the negative and plural forms of such words and phrases), as they relate to us, are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact included in this press release are forward-looking statements, including, but not limited to, all statements regarding the sale of Conduent’s Public Transit business, including that such transaction will be consummated and the timing of such consummation, expectations regarding our strategy to simplify our portfolio, sharpen our focus, strengthen our financial foundation, and drive value for our shareholders, clients and employees. These statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions, many of which are outside of our control, that could cause actual results to differ materially from those expected or implied by such forward-looking statements contained in this press release, any exhibits to this press release and other public statements we make. Important factors and uncertainties that could cause actual results to differ materially from those in our forward-looking statements include, but are not limited to: Conduent’s ability to realize the benefits anticipated from the sale of its Public Transit business, including as a result of a delay or failure to obtain certain required regulatory approvals or the failure of any other condition to the closing of the transaction such that the closing of the transaction is delayed or does not occur; unexpected costs, liabilities or delays in connection with the proposed transaction; the significant transaction costs associated with the proposed transaction; negative effects of the announcement, pendency or consummation of the transaction on the market price of our common stock or operating results, including as a result of changes in key customer, supplier, employee or other business relationships; the risk of litigation or regulatory actions; our inability to retain and hire key personnel; the risk that certain contractual restrictions contained in the definitive transaction agreement during the pendency of the proposed transaction could adversely affect our ability to pursue business opportunities or strategic transactions; and other factors that are set forth in the “Risk Factors” and other sections of our Annual Report on Form 10-K, as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with or furnished to the Securities and Exchange Commission. Any forward-looking statements made by us in this press release speak only as of the date on which they are made. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether because of new information, subsequent events or otherwise, except as required by law.
Updated Phase 2 CRDF-004 data to be presented during ASCO 2026 rapid oral session on June 2, 2026; investor webcast scheduled for June 3, 2026 at 8:30 am ET to review the data
SAN DIEGO, Calif., May 21, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that it will host an investor webcast featuring members of management on June 3, 2026 at 8:30 am ET to review updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care regimens (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
The updated CRDF-004 data will first be presented during a rapid oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026 at 8:00 am CT/9:00 am ET and will build on the CRDF-004 data previously presented in January 2026. More details about the oral presentation are available on the Company’s website here and the full abstract is now available on the ASCO website.
Investor Webcast Details The investor webcast will take place on June 3 at 8:30 am ET. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website.
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.
Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
ATHENS, Greece, May 20, 2026 (GLOBE NEWSWIRE) — EuroDry Ltd. (NASDAQ: EDRY, the “Company” or “EuroDry”), an owner and operator of drybulk vessels and provider of seaborne transportation for drybulk cargoes, announced today its results for the three-month period ended March 31, 2026.
First Quarter 2026 Highlights:
Total net revenues of $12.8 million.
Net income attributable to controlling shareholders, of $0.26 million or $0.09 earnings per share attributable to controlling shareholders basic and diluted.
Adjusted net income1 attributable to controlling shareholders for the quarter of $0.33 million or $0.12 earnings per share attributable to controlling shareholders basic and diluted, which represents the net income attributable to controlling shareholders excluding the unrealized loss on derivatives.
Adjusted EBITDA1 was $4.9 million.
An average of 11.0 vessels were owned and operated during the first quarter of 2026 earning an average time charter equivalent rate of $14,416 per day. Refer to a subsequent section of the Press Release for the definition and method of calculation of the time charter equivalent rate.
To date, about $5.6 million has been used to repurchase 349,330 shares of the Company, under our share repurchase plan of up to $10 million, announced in August 2022. The Board approved the continuation of the share repurchase plan for a further year in August 2025 and will review it again after a period of twelve months.
____________________________ 1Adjusted EBITDA, Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders are not recognized measurements under US GAAP (GAAP) and should not be used in isolation or as a substitute for EuroDry’s financial results presented in accordance with GAAP. Refer to a subsequent section of the Press Release for the definitions and reconciliation of these measurements to the most directly comparable financial measures calculated and presented in accordance with GAAP.
Recent developments
The Company has signed two contracts with Hengli Shipbuilding (Dalian) for the construction of two 82,000 DWT Kamsarmax bulk carriers. Both vessels are eco and are built to EEDI phase 3 design standard; they are scheduled to be delivered during the first and second quarters of 2028. The total consideration for the two newbuilding contracts is approximately $74.0 million and will be financed with a combination of debt and equity. The contracts are conditional upon receiving a refund guarantee from a bank acceptable to the Company.
Aristides Pittas, Chairman and CEO of EuroDry commented: “During the first quarter of 2026, a seasonally slow quarter, the drybulk market gave up very little ground as compared to the last quarter of last year. Additionally in April and May 2026, the market has firmed across the board with one-year time charter rates and trip earnings flirting and reaching $20,000 per day for both Ultramaxes and Kamsarmaxes.
“Our profitability during the first quarter fully reflected the market conditions with our earnings dropping compared to the fourth quarter in consequence of the easing of market rates during the quarter. But as the market has increased during the last month and a half, so has our profitability, a development that we expect to be reflected in next quarter’s results.
“Whilst the global fleet is aging and the need to provide the market with newer and more efficient vessels is becoming apparent, we see that prices of modern secondhand vessels have significantly increased. Under the circumstances we believe that newbuilding orders which can be placed at prices below modern secondhand ship prices present a better opportunity. We have therefore decided to expand our newbuilding program to include two Kamsarmax vessels to complement the two Ultramaxes we had ordered earlier. After the delivery of all four vessels between Q2 2027 and Q2 2028, our fleet will consist almost entirely of modern eco vessels. As, I believe, we have demonstrated over the past eight years as an independent public company, we invest in a disciplined manner with the sole focus on identifying accretive opportunities for our shareholders and we intend to continue with the same philosophy.”
Tasos Aslidis, Chief Financial Officer of EuroDry commented: “Our net revenues for the first quarter of 2026 were higher by 38.9% as compared to the first quarter of 2025. This is primarily driven by the increase of 101.1% in average time charter equivalent rates our vessels earned during the current quarter as compared to the first quarter of 2025, partly offset by the decreased average number of vessels owned and operated in the current period compared to the same period of 2025.”
“Vessel operating expenses were $5.5 million for the first quarter of 2026 as compared to $6.6 million for the same period of 2025. The decrease is mainly attributable to the decreased average number of vessels owned and operated in the first quarter of 2026 compared to the corresponding period in 2025.“
“Adjusted EBITDA during the first quarter of 2026 was $4.9 million compared to $(1.0) million achieved for the first quarter of last year. As of March 31, 2026, our outstanding debt (excluding the unamortized loan fees) was $100.9 million versus restricted and unrestricted cash of approximately $24.9 million.”
First Quarter 2026 Results: For the first quarter of 2026, the Company reported total net revenues of $12.8 million representing a 38.9% increase over total net revenues of $9.2 million during the first quarter of 2025, which was the result of the increased time charter rates our vessels earned during the first quarter of 2026, partly offset by the decreased average number of vessels owned and operated during the first quarter of 2026, compared to the same period of 2025. On average, 11.0 vessels were owned and operated during the first quarter of 2026 earning an average time charter equivalent rate of $14,416 per day compared to 12.8 vessels in the same period of 2025 earning on average $7,167 per day.
For the first quarter of 2026, a gain on bunkers resulted in positive voyage expenses of $0.3 million compared to voyage expenses of $1.7 million in the first quarter of 2025 that mainly related to vessels repositioning between charters and expenses during operational off-hire time.
Vessel operating expenses decreased to $5.5 million for the first quarter of 2026 from $6.6 million in the same period of 2025. The decrease is mainly attributable to the decreased average number of vessels owned and operated in the first quarter of 2026 compared to the corresponding period in 2025.
In the first quarter of 2026, one of our vessels completed its special survey with drydock for a total cost of $0.7 million. In the first quarter of 2025 one of our vessels completed its intermediate survey in water, for a total cost of $0.1 million.
Depreciation expense for the first quarter of 2026 was $2.9 million compared to $3.2 million for the same period of 2025 as a result of the lower number of vessels owned and operated in the first quarter of 2026.
Related party management fees for the period were $1.1 million remaining at the same level compared to the same period of 2025. This was the result of the decreased number of vessels owned and operated in the first quarter of 2026, offset by the adjustment for inflation in the daily vessel management fee, effective from January 1, 2026, increasing it from 850 Euros to 875 Euros, as well as by the unfavorable movement of the euro/dollar exchange rate during the period.
General and administrative expenses were $0.9 million for the first quarter of 2026, slightly increased compared to the same period of last year.
On January 29, 2025, the Company signed an agreement to sell M/V Tasos, a 75,100 dwt drybulk vessel, built in 2000, for demolition, for approximately $5 million. The vessel was delivered to its buyers, an unaffiliated third party, on March 17, 2025, resulting in a gain on sale of $2.1 million. No case of vessel sale exists within the first quarter of 2026.
Interest and other financing costs for the first quarter of 2026 decreased to $1.5 million as compared to $1.8 million for the same period of 2025. Interest expense during the first quarter of 2026 was lower mainly due to the decreased benchmark rates of our loans and the decreased average debt during the first quarter of 2026, as compared to the same period of last year.
For the three months ended March 31, 2026, the Company recognized a $0.07 million unrealized loss and a $0.09 million realized loss on forward freight agreement contracts. For the three months ended March 31, 2025, the Company recognized a $0.13 million unrealized loss and a $0.04 million realized gain on one interest rate swap.
The Company reported a net income for the period of $0.4 million and a net income attributable to controlling shareholders of $0.3 million, as compared to a net loss of $4.0 million and a net loss attributable to controlling shareholders of $3.7 million for the same period of 2025. The net income attributable to the non-controlling interest of $0.2 million in the first quarter of 2026 represents the income attributable to the 39% ownership of the entities owning the M/V Christos K and M/V Maria represented by NRP Project Finance AS (“NRP investors”) (the “Partnership”).
Adjusted EBITDA for the first quarter of 2026 was $4.9 million compared to $(1.0) million achieved during the first quarter of 2025.
Basic and diluted earnings per share attributable to controlling shareholders for the first quarter of 2026 were $0.09, calculated on 2,796,647 and 2,828,521 basic and diluted weighted average number of shares outstanding, respectively, compared to a basic and diluted loss per share attributable to controlling shareholders of $1.35 for the first quarter of 2025, calculated on 2,737,297 basic and diluted weighted average number of shares outstanding.
Excluding the effect on the net (loss) / income attributable to controlling shareholders for the quarter of the unrealized loss on derivatives and the net gain on sale of vessel (if any), the adjusted earnings attributable to controlling shareholders for the quarter ended March 31, 2026 would have been $0.12 per share basic and diluted, compared to an adjusted loss of $2.07 per share, basic and diluted, attributable to controlling shareholders for the quarter ended March 31, 2025. Usually, security analysts do not include the above item in their published estimates of earnings per share.
Fleet Profile:
The EuroDry Ltd. fleet profile is as follows:
Note: (*) TC denotes time charter. Charter duration indicates the earliest redelivery date. (**) The entity owning the vessel is 61% owned by EuroDry and 39% by NRP Investors. (***) The average Baltic Supramax S10TC Index is an index based on ten Supramax time charter routes. (****) Gross Ballast Bonus (GBB), refers to the payments made by the charterer which serve as compensation for the ballast trip of the vessel from the last port of discharge to the delivery port.
Summary Fleet Data:
(1) Average number of vessels is the number of vessels that constituted the Company’s fleet for the relevant period, as measured by the sum of the number of calendar days each vessel was a part of the Company’s fleet during the period divided by the number of calendar days in that period.
(2) Calendar days. We define calendar days as the total number of days in a period during which each vessel in our fleet was owned by us including off-hire days associated with major repairs, drydockings or special or intermediate surveys or days of vessels in lay-up. Calendar days are an indicator of the size of our fleet over a period and affect both the amount of revenues and the amount of expenses that we record during that period.
(3) The scheduled off-hire days including vessels laid-up are days associated with scheduled repairs, drydockings or special or intermediate surveys or days of vessels in lay-up.
(4) Available days. We define available days as the total number of Calendar days in a period net of scheduled off-hire days incl. laid up. We use available days to measure the number of days in a period during which vessels were available to generate revenues.
(5) Commercial off-hire days. We define commercial off-hire days as days a vessel is idle without employment.
(6) Operational off-hire days. We define operational off-hire days as days associated with unscheduled repairs or other off-hire time related to the operation of the vessels.
(7) Voyage days. We define voyage days as the total number of days in a period during which each vessel in our fleet was in our possession net of commercial and operational off-hire days but including days our vessels were sailing for repositioning. We use voyage days to measure the number of days in a period during which vessels actually generate revenues or are sailing for repositioning purposes.
(8) Fleet utilization. We calculate fleet utilization by dividing the number of our voyage days during a period by the number of our available days during that period. We use fleet utilization to measure a company’s efficiency in finding suitable employment for its vessels and minimizing the amount of days that its vessels are off-hire for reasons such as unscheduled repairs or days waiting to find employment.
(9) Fleet utilization, commercial. We calculate commercial fleet utilization by dividing our available days net of commercial off-hire days during a period by our available days during that period.
(10) Fleet utilization, operational. We calculate operational fleet utilization by dividing our available days net of operational off-hire days during a period by our available days during that period.
(11) Average time charter equivalent rate, or average TCE, is a measure of the average daily net revenue performance of our vessels. Our method of calculating average TCE is determined by dividing time charter revenue and voyage charter revenue, if any, net of voyage expenses by voyage days for the relevant time period. Voyage expenses primarily consist of port, canal and fuel costs that are unique to a particular voyage, which would otherwise be paid by the charterer under a time charter contract or are related to repositioning the vessel for the next charter. Average TCE provides additional meaningful information in conjunction with time charter revenue and voyage charter revenue, if any, the most directly comparable GAAP measure, because it assists our management in making decisions regarding the deployment and use of our vessels and because we believe that it provides useful information to investors regarding our financial performance. Average TCE is a standard shipping industry performance measure used primarily to compare period-to-period changes in a shipping company’s performance despite changes in the mix of charter types (i.e., spot voyage charters, time charters, pool agreements and bareboat charters) under which the vessels may be employed between the periods. Our definition of average TCE may not be comparable to that used by other companies in the shipping industry.
(12) We calculate daily vessel operating expenses, which include crew costs, provisions, deck and engine stores, lubricating oil, insurance, maintenance and repairs and related party management fees by dividing vessel operating expenses and related party management fees by fleet calendar days for the relevant time period. Drydocking expenses are reported separately.
(13) Daily general and administrative expense is calculated by us by dividing general and administrative expenses by fleet calendar days for the relevant time period.
(14) Total vessel operating expenses, or TVOE, is a measure of our total expenses associated with operating our vessels. We compute TVOE as the sum of vessel operating expenses, related party management fees and general and administrative expenses; drydocking expenses are not included. Daily TVOE is calculated by dividing TVOE by fleet calendar days for the relevant time period.
(15) Daily drydocking expenses is calculated by us by dividing drydocking expenses by the fleet calendar days for the relevant period. Drydocking expenses include expenses during drydockings that would have been capitalized and amortized under the deferral method. Drydocking expenses could vary substantially from period to period depending on how many vessels underwent drydocking during the period. The Company expenses drydocking expenses as incurred.
Conference Call and Webcast: Today, May 20, 2026 at 9:00 a.m. Eastern Time, the Company’s management will host a conference call and webcast to discuss the results.
ConferenceCalldetails: Participants should dial into the call 10 minutes before the scheduled time using the following numbers: 877 405 1226 (US Toll-Free Dial In) or +1 201 689 7823 (US and Standard International Dial In). Please quote “EuroDry” to the operator and/or conference ID 13760747. Click here for additional participant International Toll -Free access numbers.
Alternatively, participants can register for the call using the call me option for a faster connection to join the conference call. You can enter your phone number and let the system call you right away. Click here for the call me option.
AudioWebcast-SlidesPresentation: There will be a live and then archived webcast of the conference call and accompanying slides, available on the Company’s website. To listen to the archived audio file, visit our website http://www.eurodry.gr and click on Company Presentations under our Investor Relations page. Participants to the live webcast should register on the website approximately 10 minutes prior to the start of the webcast.
The slide presentation for the first quarter ended March 31, 2026, will also be available in PDF format 10 minutes prior to the conference call and webcast, accessible on the company’s website (www.eurodry.gr) on the webcast page. Participants to the webcast can download the PDF presentation.
EuroDry Ltd. Unaudited Consolidated Condensed Statements of Operations (All amounts expressed in U.S. Dollars – except number of shares)
EuroDry Ltd. Unaudited Consolidated Condensed Statements of Operations (All amounts expressed in U.S. Dollars – except number of shares)
EuroDry Ltd. Unaudited Consolidated Condensed Statements of Cash Flows (All amounts expressed in U.S. Dollars)
EuroDry Ltd. Reconciliation of Net (loss) / income to Adjusted EBITDA (All amounts expressed in U.S. Dollars)
Adjusted EBITDA Reconciliation: EuroDry Ltd. considers Adjusted EBITDA to represent net (loss) / income before interest and other financing costs, income taxes, vessel depreciation, unrealized loss on Forward Freight Agreements (“FFAs”), loss on interest rate swap derivative and net gain on sale of vessel. Adjusted EBITDA does not represent and should not be considered as an alternative to net loss, as determined by United States generally accepted accounting principles, or GAAP. Adjusted EBITDA is included herein because it is a basis upon which the Company assesses its financial performance because the Company believes that this non-GAAP financial measure assists our management and investors by increasing the comparability of our performance from period to period by excluding the potentially disparate effects between periods of, financial costs, unrealized loss on FFAs, loss on interest rate swap derivative, vessel depreciation and net gain on sale of vessel. The Company’s definition of Adjusted EBITDA may not be the same as that used by other companies in the shipping or other industries.
EuroDry Ltd. Reconciliation of Net (loss) / income attributable to controlling shareholders to Adjusted net (loss) / income attributable to controlling shareholders (All amounts expressed in U.S. Dollars – except share data and number of shares)
Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders Reconciliation:
EuroDry Ltd. considers Adjusted net (loss) / income attributable to controlling shareholders, to represent net (loss) / income before unrealized loss on derivatives, which includes FFAs and interest rate swaps, and net gain on sale of vessel. Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders is included herein because we believe they assist our management and investors by increasing the comparability of the Company’s fundamental performance from period to period by excluding the potentially disparate effects between periods of the abovementioned items, which may significantly affect results of operations between periods.
Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders do not represent and should not be considered as an alternative to net (loss) / income attributable to controlling shareholders or (loss) / earnings per share attributable to controlling shareholders, as determined by GAAP. The Company’s definition of Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders may not be the same as that used by other companies in the shipping or other industries. Adjusted net (loss) / income attributable to controlling shareholders and Adjusted (loss) / earnings per share attributable to controlling shareholders are not adjusted for all non-cash income and expense items that are reflected in our statement of cash flows.
About EuroDry Ltd. EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd into a separate listed public company. EuroDry was spun-off from Euroseas Ltd on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY.
EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day-to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters.
The Company has a fleet of 11 vessels, including 3 Panamax drybulk carriers, 5 Ultramax drybulk carriers, 2 Kamsarmax drybulk carriers and 1 Supramax drybulk carrier. EuroDry’s 12 drybulk carriers have a total cargo capacity of 766,420 dwt. After the delivery of two Ultramax vessels in 2027 and the delivery of the two Kamsarmax vessels in 2028, the Company’s fleet will consist of 15 vessels with a total carrying capacity of 1,050,420 dwt.
Forward Looking Statement This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events and the Company’s growth strategy and measures to implement such strategy; including expected vessel acquisitions and entering into further time charters. Words such as “expects,” “intends,” “plans,” “believes,” “anticipates,” “hopes,” “estimates,” and variations of such words and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to changes in the demand for dry bulk vessels, competitive factors in the market in which the Company operates; risks associated with operations outside the United States; and other factors listed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
The New Licensing Agreement Expands SKYX’s Go-To-Market Channels as It Continues to Grow Its Market Penetration with Builders, Hotels, and Retail Segments
Eurofase Operates Globally with a Manufacturing and Distribution Network Spanning U.S., Canada, Europe, and Asia with Advanced Lighting Applications for Buildings, Hotels, Residential and Commercial Segments
SKYX’s Technologies Expansion Provides Additional Opportunities for Future Recurring Revenues through Interchangeability, Upgrades, AI Services, Monitoring, Subscriptions, Among Others
MIAMI, May 20, 2026 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), an award winning highly disruptive advanced smart home and AI platform technology company with over 100 U.S. and global pending and issued patents and a portfolio of 60 lighting and home décor websites, with a mission to make homes and buildings become advanced-safe-smart instantly as the new standard, today announced it signed a licensing agreement with U.S, Canada, and global leading lighting company Eurofase.
This licensing agreement further validates SKYX’s vast U.S. and global B2B go-to-market opportunities including builder, hotel, and residential segments. SKYX technologies reduce up to 90% of time and cost of hotel and building renovations and new build installations. SKYX will work together with Eurofase on their vast builder, hotel, residential and commercial segments.
For over 30 years Eurofase has set the benchmark for luxury lighting and architectural systems as well as advanced heating solutions. Eurofase operates globally with a manufacturing and distribution network spanning the U.S., Canada, Europe, and Asia. Eurofase’s commitment to exceptional design and craftsmanship transforms spaces and inspires limitless design possibilities for buildings, hotels, residential and commercial applications.
Eurofase is known as a trusted partner to contractors, architects, and designers offering a diverse range of high-quality, innovative lighting and heating products tailored for commercial, residential and hospitality applications.
Zack Sharon, Senior Vice President of Sales & Product Management of Eurofase Lighting, said; “We are very excited to license SKYX’s disruptive and cutting-edge technologies for buildings, hotels, and homes. We intend to introduce SKYX technologies to our vast range of B2B customers comprising our builder and hotel segments, as well as during our upcoming trade shows including the June 9/10, 2026, Hotel and Cruise Ship Expo in Miami. The cutting-edge and significant time and cost saving aspects provided by SKYX’s technologies are key elements in enhancing safety and advancing hotel and building standards and will assist Eurofase gain even a stronger footprint within our hospitality segment.”
Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said; “We are excited to sign a licensing agreement with U.S., Canada and global leading lighting company Eurofase. This licensing agreement fits well with our strategy to expand our go to market channels in the U.S. and globally. We look forward to working together with Eurofase on their vast builder, hotel, residential and commercial segments.”
For more information about Eurofase click here: www.eurofase.com
For more information about SKYX click here: www.skyx.com
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced, safe smart home and AI platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://www.skyx.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s ability to achieve positive cash flows; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
Company Highlights Potential Role of MVA-Based Vaccine Technologies in Addressing Emerging Hemorrhagic Fever Threats, Including Ebola and Marburg Viruses
ATLANTA, GA – May 20, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today commented on the rapidly evolving Bundibugyo Ebola virus (BDBV) outbreak in Central Africa and the broader implications for global infectious disease preparedness and biodefense infrastructure.
The recent declaration by the World Health Organization (WHO) of a Public Health Emergency of International Concern (PHEIC) related to the outbreak has intensified concerns regarding global readiness for emerging viral threats, particularly less common Ebola species for which no broadly licensed vaccines currently exist.
GeoVax noted that its MVA-based hemorrhagic fever vaccine development programs have previously demonstrated encouraging preclinical protection signals across multiple filovirus targets, including Ebola and Marburg viruses. Key findings from previously completed studies include:
MVA-EBOV (Zaire Ebola): Demonstrated single-dose protection against lethal Zaire Ebola virus challenge in non-human primates, supporting the potential of MVA-based rapid-response filovirus vaccines.
MVA-SUDV (Sudan Ebola): Demonstrated protective efficacy in multiple preclinical challenge models, including single-dose protection in guinea pigs and survival benefit in non-human primates.
MVA-MARV (Marburg): Demonstrated significant survival protection in rigorous non-human primate challenge studies, supporting further development of MVA-based Marburg vaccine strategies.
“These outbreaks collectively reinforce a growing reality: preparedness against one viral strain does not necessarily ensure preparedness against the next,” said David A. Dodd. “The world is entering an era of continuous infectious disease emergence and re-emergence, where scalable vaccine platforms, diversified manufacturing capabilities, and flexible biodefense infrastructure will become increasingly important.”
Unlike prior Ebola outbreaks involving the Zaire ebolavirus species, the current outbreak involves the Bundibugyo species, which presently lacks a specifically approved vaccine for broad deployment. Public health experts have increasingly noted that the outbreak exposes limitations in existing strain-specific preparedness strategies and reinforces the importance of adaptable vaccine technologies capable of addressing multiple high-consequence pathogens.
The Company believes that MVA-based vaccine platforms may offer several important strategic advantages in responding to emerging infectious disease threats, including:
established safety and tolerability profiles,
flexibility for incorporation of multiple antigens,
potential applicability across multiple viral families,
suitability for rapid adaptation, and
the potential for development of multivalent single-dose vaccine approaches targeting multiple hemorrhagic fever pathogens simultaneously.
“Outbreaks involving Ebola, mpox, Marburg, hantavirus, and other emerging pathogens collectively reinforce the growing need for platform technologies capable of supporting rapid response against evolving threats,” added Mr. Dodd. “The lessons emerging from the current outbreak extend beyond Ebola itself and increasingly point toward the need for resilient, scalable, geographically distributed vaccine manufacturing capacity and second-source biodefense preparedness.”
GeoVax is currently advancing GEO-MVA, its MVA-based vaccine candidate targeting mpox and smallpox, designed to support growing global demand for orthopox preparedness while contributing to the development of domestic U.S.-based MVA manufacturing capability. The pivotal Phase 3 immunobridging study of GEO-MVA, in support of an expedited regulatory path provided by the European Medicines Agency (EMA), is scheduled to initiate in Q4 2026, with data results anticipated within approximately three months following trial initiation.
The Company believes the broader strategic relevance of MVA-based technologies continues to expand as governments and public health organizations increasingly prioritize:
supply-chain resilience,
domestic manufacturing,
flexible vaccine platforms, and
preparedness against multiple emerging infectious disease threats.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
GDEV announces results for the first quarter of 2026
May 19, 2026 – Limassol, Cyprus – GDEV Inc. (NASDAQ: GDEV), an international gaming and entertainment company (“GDEV” or the “Company”) released its unaudited financial and operational results for the three-month period ended March 31, 2026.
First quarter 2026 financial highlights:
Revenue of $99 million increased by 2% year-over-year.
Selling and marketing expenses of $37 million decreased by 13% year-over-year.
Profit for the period, net of tax, of $17 million in Q1 2026 increased vs. $14 million in Q1 2025.
Adjusted EBITDA1 of $18 million in Q1 2026 increased vs. $16 million in Q1 2025.
First quarter of 2026 financial performance in comparison
First quarter 2026 financial performance
In the first quarter of 2026, our revenue increased by $2 million (or 2%) year-over-year and amounted to $99 million. The increase was primarily driven by an increase in in-app purchases made by players.
Platform commissions remained stable at $20 million in the first quarter of 2026 vs. 2025.
Game operation costs remained stable at $14 million in the first quarter of 2026 vs. 2025.
Selling and marketing expenses in the first quarter of 2026 decreased by $5 million vs. the same period in 2025, amounting to $37 million. This decrease is driven by our continued focus on improving the efficiency of user acquisition activities. The decrease reflects a more selective approach to performance marketing, prioritizing channels that attract players with higher long-term value over broad-scale campaigns aimed at short-term growth.
General and administrative expenses increased by $2 million in the first quarter of 2026 vs. the same period of prior year and amounted to $10 million primarily due to increase in legal expenses.
As a result of the factors above, together with the effect of the net foreign exchange loss in the first quarter of 2026 in the amount of $1 million vs. the net foreign exchange gain in the amount of $1 million in the same period of prior year, we recorded a profit for the period, net of tax, of $17 million in the first quarter of 2026 compared with $14 million in the same period of 2025. Adjusted EBITDA in the first quarter of 2026 amounted to $18 million, an increase of $2 million compared with the same period in 2025 driven primarily by the same factors as those affecting the profit.
Cash flows generated from operating activities were positive $4 million in the first quarter of 2026 compared with positive $6 million in the same period in 2025.
1 For more information, see section titled “Presentation of Non-IFRS Financial Measures” on the last two pages of this report, including the reconciliation of the profit for the period, net of tax to the Adjusted EBITDA.
First quarter 2026 operational performance comparison
Bookings increased in the first quarter of 2026 to reach $83 million compared with $81 million in the same period in 2025. The increase was primarily due to an increase in ABPPU of 8% partially offset by a decrease in MPU of 5% in the first quarter of 2026 as compared with the same period of prior year.
The share of advertisement sales as a percentage of total bookings remained relatively stable at 5.8% in the first quarter of 2026 vs. 5.9% in the respective period in 2025.
In the first quarter of 2026 we recorded an increase in share of mobile to reach 64% vs. 59% in the same period in 2025 and a corresponding decrease in share of PC which was fell to 36% vs. 41% in the same period in 2025.
Our split of bookings by geography in the first quarter of 2026 vs. the same period in 2025 saw a decrease in the share of bookings derived from the US and Asia and an increase in bookings derived from Europe and Other.
Note:
Due to rounding, the numbers presented throughout this release may not precisely add up to the totals. The period-over-period percentage changes are based on the actual numbers and may therefore differ from the percentage changes if those were to be calculated based on the rounded numbers.
About GDEV
GDEV is a gaming and entertainment holding company, focused on development and growth of its franchise portfolio across various genres and platforms. With a diverse range of subsidiaries including Nexters and Cubic Games, among others, GDEV strives to create games that will inspire and engage millions of players for years to come. Its franchises, such as Hero Wars, Island Hoppers, Pixel Gun 3D and others have accumulated over 550 million installs and $2.5 billion of bookings worldwide. For more information, please visit www.gdev.inc
Contacts:
Investor Relations
Roman Safiyulin | Chief Corporate Development Officer [email protected]
Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Such statements are based on current expectations that are subject to risks and uncertainties. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
The forward-looking statements contained in this press release are based on the Company’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting the Company will be those that the Company has anticipated. Forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s 2025 Annual Report on Form 20-F, filed by the Company on March 31, 2026, and other documents filed by the Company from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Presentation of Non-IFRS Financial Measures
In addition to the results provided in accordance with IFRS throughout this press release, the Company has provided the non-IFRS financial measure “Adjusted EBITDA” (the “Non-IFRS Financial Measure”). The Company defines Adjusted EBITDA as the profit/loss for the period, net of tax as presented in the Company’s financial statements in accordance with IFRS, adjusted to exclude (i) goodwill and investments in equity-accounted associates’ impairment, (ii) loss on disposal of subsidiaries, (iii) income tax expense, (iv) other financial income, finance income and expenses other than foreign exchange gains and losses and bank charges, (v) change in fair value of share warrant obligations and other financial instruments, (vi) share of loss of equity-accounted associates, (vii) depreciation and amortization, (viii) share-based payments expense and (ix) certain non-cash or other special items that we do not consider indicative of our ongoing operating performance. The Company uses this Non-IFRS Financial Measure for business planning purposes and in measuring its performance relative to that of its competitors. The Company believes that this Non-IFRS Financial Measure is a useful financial metric to assess its operating performance from period-to-period by excluding certain items that the Company believes are not representative of its core business. This Non-IFRS Financial Measure is not intended to replace, and should not be considered superior to, the presentation of the Company’s financial results in accordance with IFRS. The use of the Non-IFRS Financial Measure terms may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures.
Reconciliation of the profit for the period, net of tax to the Adjusted EBITDA
2 Adjusted finance income/expenses consist of finance income and expenses other than foreign exchange gains and losses and bank charges, net.
View original content to download multimedia:
