New, Leading Technology Engine Configuration of Firejet is First-to-Market Tactical Jet UAS in the High-Performance, Affordable sub-$500,000 Class
SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, today announces that it has completed the initial flight series of the Kratos J85 engine version of the Firejet unmanned aerial system (UAS), dubbed Mk1 Firejet. This second major configuration of the Firejet enables users/customers to select the model that best suits their operational requirements. With the new J85 engine configuration, the Firejet takes a major step forward in the aero-performance category for customers who need the extra performance.
Classic Firejet, the baseline Firejet target system, supports key missions for the U.S. Army Target Systems Management Office (TSMO) at a high level of aerodynamic performance. Flying since the early 2010s with JetCat engines, Classic Firejet has evolved and been adapted to meet the customer performance and threat representation requirements over time. In addition to the U.S. Army operating the Classic Firejet, ally countries around the world operate the Classic Firejet, most recently including Taiwan, which has selected the Tactical Firejet named Mighty Hornet IV for their configuration.
With the new Kratos Spartan engine production facility established in late 2025, production is ramping up for the J85 and other Spartan engine models. Production rates are expected to be in the thousands by later this year and tens of thousands over the next few years meeting the demand for recapitalization which is becoming even more important this year with depletion of U.S. and ally inventories.
Steve Fendley, President of Kratos Unmanned Systems, said, “Kratos is committed to developing and providing threat-representative target aircraft systems and to offering survivable tactical UAS. With this new version of the Firejet in both target or tactical applications, we increase range, endurance, speed, and climb rate without penalizing survivability. Importantly, we also reduce supply chain risk by using an American-made Kratos engine with engine components sourced in the U.S.A. With the two Firejet models, Mk1 and Classic Firejet, we can now meet the cost-performance levels aligned with various customers’ needs.”
Eric DeMarco, President and CEO of Kratos, said, “With our rapid advancement and in production, military-grade jet engines, Kratos is making internal investments to answer the Department of War’s call to industry to deliver affordable, high performance, military capability today. Kratos has invested significant internal resources and together with Army TSMO, have integrated a leading technology engine with the Firejet jet drone system. In addition to the increased performance as a target, this engine configuration of Firejet is first-to-market as a CCA type, tactical jet UAS, in the high-performance, sub-$500,000 arena; another example where affordability is a technology.”
At the high-performance end of the low-cost or affordable jet aerial target market, Kratos’ Firejet delivers unmatched fighter-like performance and versatility, representing the most lethal threats of the United States and its allies’ potential adversaries. Kratos’ Firejet provides the opportunity for customers to train their military personnel and to test multiple weapon systems with a single flexible and affordable high performance unmanned aerial target drone system. The Firejet supports both surface-to-air and air-to-air engagements with a combination of internal and external mission kits including tow targets, proximity scoring, passive & active RF augmentation, and infrared (IR) augmentation.
Additionally, the Tactical Firejet, a variant of the baseline Firejet developed in response to recent years’ world events and configured to enable and perform key tactical drone operations, rather than use for target missions, maintains key Kratos platform features, including high subsonic speed, high-g maneuverability, optimized performance-per-cost class, and sensor/weapons capability.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2025, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing healthcare services platform, today announced it will release its fiscal third quarter 2026 financial results before market open on Tuesday, May 5, 2026. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (May 5, 2026) at 8:30 am ET to discuss the results.
For those interested in dialing into the conference call, please register using this link. After registering, confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at least 10 minutes before the start of the call.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
RESTON, Va., April 20, 2026 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report first quarter 2026 financial results on Monday, May 4, 2026, after market close. Senior management will conduct a conference call at 4:30 p.m. ET that same day.
U.S.-based participants may dial in to the conference call at 877-300-8521, while international participants may dial 412-317-6026. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/Q291YZzYJpN and on the Investors section of the V2X website at https://gov2x.com/.
A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through May 18, 2026, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10208314.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations [email protected] 719-637-5773
ST. PETERSBURG, Fla., April 20, 2026 (GLOBE NEWSWIRE) — Superior Group of Companies, Inc. (NASDAQ: SGC) (the “Company”) today announced that it will release the results of its operations for the first quarter 2026 before the market open on Monday, May 4, 2026. Michael Benstock, Chairman and Chief Executive Officer, and Mike Koempel, President and Chief Financial Officer, will host a teleconference at 8:00 am Eastern Time that day to discuss the Company’s results.
The live webcast and archived replay can be accessed in the investor relations section of the Company’s website at https://ir.superiorgroupofcompanies.com/presentations. Interested individuals may also join the teleconference by dialing 1-844-861-5505 for U.S. dialers and 1-412-317-6586 for international dialers. The Canadian toll-free number is 1-866-605-3852. Please ask to join the Superior Group of Companies call.
A telephone replay of the teleconference will be available through May 11, 2026. To access the replay, dial 1-855-669-9658 in the United States and Canada or 1-412-317-0088 from international locations. Please reference conference number 4789430 for replay access.
About Superior Group of Companies, Inc. (SGC): Established in 1920, Superior Group of Companies is comprised of three attractive business segments each serving large, fragmented and growing addressable markets. Across Healthcare Apparel, Branded Products and Contact Centers, each segment enables businesses to create extraordinary brand engagement experiences for their customers and employees. SGC’s commitment to service, quality, advanced technology, and omnichannel commerce provides unparalleled competitive advantages. We are committed to enhancing shareholder value by continuing to pursue a combination of organic growth and strategic acquisitions. For more information, visit www.superiorgroupofcompanies.com.
CHICAGO, April 20, 2026 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL), a diversified manufacturer of railroad freight cars, today announced that it will release its first quarter 2026 financial results on Monday, May 4, 2026, after the market close, and host a teleconference to discuss its first quarter 2026 results on the following day. Teleconference details are as follows:
Please note that the webcast is listen-only and webcast participants will not be able to participate in the question and answer portion of the conference call. Interested parties are asked to dial in approximately 10 to 15 minutes prior to the start time of the call.
An audio replay of the conference call will be available beginning at 3:00 p.m. (Eastern Time) on Tuesday, May 5, 2026, until 11:59 p.m. (Eastern Time) on Tuesday, May 19, 2026. To access the replay, please dial (844) 512-2921 or (412) 317-6671. The replay passcode is 13760024. An archived version of the webcast will also be available on the FreightCar America Investor Relations website.
About FreightCar America
FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a leading artificial intelligence (“AI”) company offering AI and augmented reality (“AR”) powered solutions to beauty, fashion, photo and video creative industries, today announced that the independent special committee (the “Special Committee”) of the Company’s board of directors (the “Board”), formed to evaluate and consider the previously announced preliminary non-binding proposal letter dated March 18, 2026 (the “Proposal”), has selected Kroll LLC. as its financial advisor and DLA Piper as its international legal counsel.
The Special Committee is continuing its review and evaluation of the Proposal. The Board cautions its shareholders and others considering trading in its securities that neither the Board nor the Special Committee has made any decision with respect to the Proposal. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the transaction contemplated by the Proposal, or that the transaction contemplated by the Proposal or any other similar transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law.
About Perfect Corp.
Founded in 2015, Perfect Corp. is a leading AI company offering self-developed AI- and AR- powered solutions dedicated to transforming the world with digital tech innovations that make your virtual world beautiful. On Perfect’s direct consumer business side, Perfect operates a family of YouCam consumer apps and web-editing services for photo, video and camera users, centered on unleashing creativity with AI-driven features for creation, beautification and enhancement. On Perfect’s enterprise business side, Perfect empowers major beauty, skincare, fashion, jewelry, and watch brands and retailers by supplying them with omnichannel shopping experiences through AR product try-ons and AI-powered skin diagnostics. With cutting-edge technologies such as Generative AI, real-time facial and hand 3D AR rendering and cloud solutions, Perfect enables personalized, enjoyable, and engaging shopping journey and helps brands elevate customer engagement, increase conversion rates, and propel sales growth. Throughout this journey, Perfect maintains its unwavering commitment to environmental sustainability and fulfilling social responsibilities. For more information, visit https://ir.perfectcorp.com/.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on beliefs and assumptions and on information currently available to Perfect. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including strategies or plans, are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. These statements are based on Perfect’s reasonable expectations and beliefs concerning future events and involve risks and uncertainties that may cause actual results to differ materially from current expectations. These factors are difficult to predict accurately and may be beyond Perfect’s control. Forward-looking statements in this communication or elsewhere speak only as of the date made. New uncertainties and risks arise from time to time, and it is impossible for Perfect to predict these events or how they may affect Perfect. In addition, risks and uncertainties are described in Perfect’s filings with the Securities and Exchange Commission. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Perfect cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that Perfect presently does not know or that Perfect currently does not believe are immaterial that could also cause actual results to differ from those contained in the forward looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Perfect, its directors, officers or employees or any other person that Perfect will achieve its objectives and plans in any specified time frame, or at all. Except as required by applicable law, Perfect does not have any duty to, and does not intend to, update or revise the forward-looking statements in this communication or elsewhere after the date of this communication. You should, therefore, not rely on these forward-looking statements as representing the views of Perfect as of any date subsequent to the date of this communication.
STAFFORD, Texas, April 20, 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 AACR Meeting 2026.
The abstract is shown below and the poster being presented today can be seen and downloaded at the bottom of Phase III clinical trial tab on the Company’s website here.
This is the first abstract and poster presented jointly with the Steering Committee of FLAMINGO-01 with statistically significant delayed-type-hypersensitivity (DTH) 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 and other methods. The other methods will be presented at a future conference.
A DTH reaction (redness and/or induration) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was also measured 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 a DTH reaction (redness) in month 4 or month 6 compared to baseline. There were 191 patients with both baseline and month 4 or 6 assessments.
The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
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.
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 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.
A 1% per year recurrence rate is so low that the number of recurrence events is too few to correlate a negative or lack of immune response to recurrence. The same constraint existed with the Phase IIb data which has a similarly low recurrence rate per year. While DTH immune response may be valuable at an aggregate level looking at whole patient populations, the recurrence rate is too low to validate any immune response measure as a biomarker for individual patient treatment decisions. It is also likely that some responding patients may not exhibit any immune response but still could be protected by GLSI-100 vaccination, thus helping to preserve the blind on the randomized arms of FLAMINGO-01.
The immune response abstract and poster conclusion: The statistically significant increase in the incidence of DTH 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.
In addition, the second poster describing the Phase III trial design, which is being presented on Tuesday, April 21, can be downloaded and seen on the website using the same link. This poster provides an update that over 1,300 patients have been screened to date in FLAMINGO-01. The new protocol amendment, which is still under regulatory review in certain countries, is not discussed.
CEO Snehal Patel commented, “This new immune response data further supports the combination of HLA-A*02 and non-HLA-A*02 patients in the same randomized arms. In the US, the FDA recently reviewed such protocol changes and the many non-HLA-A*02 patients on waiting lists that were previously screened are now being enrolled. The screen rate continues to be encouraging, reflecting the high patient interest in the study as we have now screened over 1,300 patients. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients together using the increased statistical power of a combined analysis of the two patient groups or to pursue subgroups based on planned multiple interim analyses.”
The abstract from today’s immune response data and the members of the Steering Committee follow:
Abstract Number: CT138 – Poster Section 52 on April 20, 2026, 2-5pm PT
Abstract Title: Preliminary delayed-type-hypersensitivity immune response results from open-label arm of on-going Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01
Snehal S. Patel1, Jaye Thompson1, F. Joseph Daugherty1, Francois-Clement Bidard2, William J. Gradishar3, Marcus Schmidt4, Miguel Martin5, Joyce A. O’Shaughnessy6, Hope S. Rugo7, Cesar A. Santa-Maria8, Laura M. Spring9, Mothaffar F. Rimawi10
1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL,4University Medical Center Mainz, Mainz, Germany,5GEICAM, Madrid, Spain,6Sarah Cannon Research Institute, Dallas, TX,7City of Hope Comprehensive Cancer Center, Duarte, CA,8Johns Hopkins University, Baltimore, MD,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX
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 trastuzumab-based therapy.
Results: All patients (n=247) were vaccinated with GLSI-100 and continue in treatment and follow-up. A DTH reaction (redness) was used to assess in vivo immune responses in patients. The DTH orthogonal mean was measured 48-72 hours after injection. In this preliminary data analysis, there was a significant increase in percentage of subjects experiencing a DTH reaction in month 4 or month 6 compared to baseline. The frequency of DTH reactions increased by approximately 4x from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001). The study is ongoing and data collection and cleaning continue so final results may vary.
Conclusions: The increase in the incidence of DTH 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 the HLA-A*02 genotype. Subjects 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.
The Steering Committee authoring abstract CT138 is comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:
Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Hope S. Rugo – Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Professor Emeritus, University of California, San Francisco
Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital
About the AACR Annual Meeting 2026
The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
About FLAMINGO-01 Open Label Phase III Data More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Onvansertib in combination with trastuzumab deruxtecan demonstrated enhanced antitumor activity, including tumor regression and apoptosis in HER2-low breast cancer models, supporting its potential for patients with limited treatment options
SAN DIEGO, Calif., April 17, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, will present new preclinical data in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego, California. These data highlight the potential of Cardiff’s highly specific oral PLK1 inhibitor, onvansertib, in combination with the HER2-targeted antibody-drug conjugate (ADC), trastuzumab deruxtecan (T-DXd), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.
“These preclinical findings highlight a potential new opportunity for onvansertib, demonstrating its ability to enhance the activity of ADCs, which are becoming mainstays in oncology across multiple indications,” said Tod Smeal, Ph.D., Chief Scientific Officer of Cardiff Oncology. “By enhancing and prolonging DNA damage, this combination appears to drive greater apoptosis than either agent alone, offering a promising new approach for patients whose cancers have become resistant to standard-of-care treatments.”
Poster Presentation Highlights:
Onvansertib + T-DXd synergistically inhibited the viability of HER2-low breast cancer cell lines, including fulvestrant- and CDK4/6i-resistant cells
In the resistant triple-negative breast cancer model and two hormone receptor-positive models, the combination drove tumor regression in nearly all mice, with complete response rates up to 62%
Increased tumor regression, improved tumor growth inhibition, and extended event-free survival across models
Combination showed favorable tolerability in vivo
Following the presentation on April 19, 2026 from 2:00–5:00 PM PT, the poster titled “PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models” will be available on the Scientific Publications page of the Company’s website.
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It 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 the outbreak of COVID-19 coronavirus and 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.
PLANTATION, Fla., April 17, 2026 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, is thrilled to release the legendary Ozzy Osbourne for their new Record Store Day (RSD) Series. This figure is limited to 2000 units and will be available exclusively at independent record stores on April 18, 2026.
“Record Store Day is the most important celebration of independent music retail,” said Tony Moyers, SVP of Collectibles at Alliance Entertainment. “We’re thrilled to introduce this Handmade by Robots Record Store Day release with the iconic debut of Ozzy Osbourne. This figure is part of our new RSD Series, with releases planned for every future Record Store Day, and we couldn’t be more excited to celebrate this moment alongside record stores and collectors alike.”
“Record Store Day gives us a powerful opportunity to connect music culture and collectibles in a way that feels authentic to independent retailers,” said Ken Glaser, SVP of Sales at Alliance Entertainment. “Since introducing Handmade by Robots at Record Store Day Summer Camp in 2025, we’ve been focused on expanding the brand’s music-related offerings. This debut is just the start, and we see meaningful opportunity to grow the series with future Record Store Day exclusives.”
“Record Store Day hasn’t done any vinyl figures since the Frank Kozik designed RSD robot figures back in 2011 and Kozik’s Nick Cave RSD figure back in 2014, so it’s exciting to be able to offer the Ozzy Osbourne RSD figure this year. We’re always looking for new ways to have some fun, so Handmade by Robots is a perfect partner.” – Michael Kurtz, co-founder Record Store Day
Crafted in Handmade by Robots’ signature “knit-look” aesthetic, each figure looks as though it’s been hand-stitched yet is precision-molded from high-quality vinyl for lasting display.
Since the acquisition of Handmade by Robots in December 2024, Alliance has rapidly expanded the brand’s retail footprint and licensing pipeline. Major new figure releases slated for the second half of 2025 and 2026 include characters from Sanrio, Jurassic World, Peanuts, Sonic the Hedgehog, SpongeBob SquarePants, Toho, and more.
For more information, visit www.handmadebyrobots.com
About Alliance Entertainment
Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 325,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. The company’s growing collectibles portfolio includes Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises. Leveraging decades of operational expertise, exclusive licensing partnerships, and a capital-light, scalable infrastructure, Alliance is a trusted partner to the world’s top entertainment brands and retailers. Our omnichannel platform connects collectors and fans to the products, franchises, and experiences they love – across formats and generations. For more information, visit www.aent.com.
Forward Looking Statements
Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance.
These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks and failure by Alliance to meet the covenant requirements of its revolving credit facility, including a fixed charge coverage ratio; risks that a breach of the revolving credit facility, including Alliance’s recent breach of the covenant requirements, could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; risk that the COVID-19 pandemic, and local, state, and federal responses to addressing the pandemic may have an adverse effect on our business operations, as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that it will release its first quarter 2026 earnings after the market close on April 30, 2026. The Company will host a conference call and webcast to discuss the results on May 1 at 8:30 a.m. EDT. The webcast can be accessed through the Investor Relations section of www.accobrands.com and will be available for replay.
About ACCO Brands Corporation
ACCO Brands is the leader in branded consumer products that enable productivity, confidence and enjoyment while working, when learning and while playing. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.
Company highlights ongoing transition toward a broader multi-platform portfolio supported by new indie releases, expanding partnerships, and long-term AAA development roadmap
CULVER CITY, Calif., April 16, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, today announced that Survivor Mercs will officially launch its 1.0 version on April 30, 2026. Published under the Company’s indie label, Wandering Wizard, the game will be available on Steam, Xbox, and PlayStation, marking its transition from Early Access into a full global release.
Built alongside its community over multiple updates, Survivor Mercs heads into 1.0 with expanded content, refined systems, and a gameplay experience designed to support long-term player engagement. With its debut on consoles, the title has the potential to reach a broader audience, further strengthening Snail Games’ multi-platform presence.
The release also reflects Wandering Wizard’s growing role within the Company’s publishing strategy. By supporting projects through development and community feedback, the label continues to bring titles to market that are both polished and positioned for long term relevance, supporting a broader shift toward scalable, internally driven growth.
This direction was recently underscored in an interview with Proactive Investors, where Snail Games highlighted its strategy forming a growing pipeline of titles. CFO Heidy Chow noted, “We don’t want to rely on just one IP, we want to be more diversified. Our focus is on building a broader portfolio across genres, platforms, and development models to create a more balanced foundation that can support long-term growth.” CFO Chow also highlighted the Company’s recently amended Software License Agreement with SDE Inc., which provides the Company with an exclusive worldwide license to publish and sell ARK: Survival Evolved and ARK Survival Ascended. Under this amended agreement, the annual license fee was reduced by $6 million, with the savings being redirected back into internal development and operations. Snail Games is actively broadening its business beyond the ARK franchise through a diversified slate of indie, mid-core, and AAA experiences.
Progress with this strategy is exemplified by Snail Games seeing encouraging traction across its broader pipeline. Echoes of Elysium, an upcoming title currently surpassing 170,000 wishlists, continues to build visibility as it progresses toward its own 1.0 release. Ongoing updates and steady community growth point to strong early interest and reinforce the game’s positioning as a high-potential addition to the Company’s portfolio.
The Company’s expanding pipeline is supported by increased investment in internal development, global studio partnerships, and a continued focus on long-term content creation. Bellwright, developed by Polish studio Donkey Crew, of which Snail Games holds a strategic ownership stake, serves as a clear example of this approach in action. The title surpassed 1 million lifetime downloads earlier this year and continues to see ongoing expansion following its early access launch. It will also be featured in Steam’s Medieval Fest next week, providing additional visibility and further engagement opportunities before its 1.0 release and console port.
This approach extends further into the longer term pipeline, where three internally developed AAA titles are currently in progress for 2027, including For The Stars. Together, this combination of active releases and future facing development supports a more continuous content cycle designed to expand global reach and build a more diversified and durable portfolio over time.
For content creators interested in collaborations, please reach out to [email protected]
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) is a leading global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs, and mobile devices. For more information, please visit: https://snail.com/
Forward-Looking Statements: This press release contains statements that constitute forward-looking statements within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding officially launching Survivor Mercs in 1.0 on April 30, the game being available on Steam, Xbox, and PlayStation, designing the gameplay experience to support long-term player engagement, the title having the potential to reach a broader audience, further strengthening Snail Games’ multi-platform presence, Wandering Wizard’s growing role within the Company’s publishing strategy, the label continuing to bring titles to market that are both polished and positioned for long term relevance, supporting a broader shift toward scalable, internally driven growth, forming a growing pipeline of titles, being more diversified, building a broader portfolio across genres, platforms, and development models to create a more balanced foundation that can support long-term growth, the deliberate effort to expand across indie, mid-core, and AAA experiences, seeing encouraging traction across the Company’s broader pipeline, Echoes of Elysium continuing to build visibility as it progresses toward its own 1.0 release with its latest update, ongoing updates and steady community growth pointing to strong early interest and reinforcing the game’s positioning as a high-potential addition to the Company’s portfolio, the Company’s expanding pipeline being supported by increased investment in internal development, global studio partnerships, and a continued focus on long-term content creation, Bellwright continuing to see ongoing expansion following its early access launch, Bellwright being featured in Steam’s Medieval Fest next week, providing additional visibility and further engagement opportunities before its 1.0 release and console port, three internally developed AAA titles being currently in progress for 2027, including For The Stars, and the combination of active releases and future facing development supporting a more continuous content cycle designed to expand global reach and build a more diversified and durable portfolio over time. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to build a broader portfolio across genres, platforms, and development models to create a more balanced foundation that can support long-term growth, acceptance of our titles in the marketplace and the successful development, marketing or sale of our titles and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2025, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 [email protected]
NORWOOD, Mass., April 15, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQB: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its first quarter 2026 financial results on May 13, 2026 after the markets close. Management will host a conference call on May 14, 2026 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q1 2026 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. The Company is also recognized for delivering exceptional customer service at our 13 Thrive Dispensary retail locations across five states. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: [email protected] Phone: (781) 277-0007
Pivotal Phase 3 Trial for GEO-MVA (Mpox/Smallpox Vaccine)
Scheduled to Initiate During the Second Half of This Year
ATLANTA, GA, April 15, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced its financial results and key operational accomplishments for the year ended December 31, 2025.
“During 2025, we made significant progress advancing GEO-MVA toward late-stage clinical development, supported by regulatory alignment with the European Medicines Agency (EMA) and key manufacturing milestones,” stated David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe GEO-MVA represents a critically important opportunity to eliminate the current global supply constraint in orthopoxvirus vaccines, while supporting broader public health preparedness and biosecurity objectives. As such, we look forward to initiating the planned Phase 3 immuno-bridging study in the second half of this year, which represents the next key step in advancing GEO-MVA to regulatory approval and access, providing a critically needed supply source of MVA-vaccine.”
Mr. Dodd concluded, “As we look ahead, our priority is executing key GEO-MVA clinical and regulatory milestones, strengthening strategic partnerships, while selectively advancing other programs, addressing critical medical needs worldwide, while maximizing long-term value to shareholders and stakeholders.”
Corporate and Operational Highlights
Priority Program – GEO-MVA
GeoVax’s primary near-term strategic development focus is the advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. GEO-MVA is the Company’s most advanced program and its most direct path to potential regulatory approval and commercialization. GEO-MVA is being developed on an expedited regulatory pathway to address a documented global supply constraint in orthopoxvirus vaccines, while supporting both public health preparedness and biosecurity needs, including diversification of supply beyond a single foreign manufacture.
During 2025, the Company achieved several key milestones, advancing GEO-MVA toward late-stage development and commercial readiness:
Regulatory Alignment: GeoVax received formal Scientific Advice from the European Medicines Agency (EMA), supporting a streamlined and accelerated development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without the need for prior Phase 1 or Phase 2 trials.
Phase 3 Readiness: The Company is preparing to initiate a pivotal Phase 3 clinical trial in the second half of 2026, representing the critical next step toward potential regulatory approval and product distribution.
Manufacturing Progress: GeoVax completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.
GeoVax believes GEO-MVA is uniquely positioned at the intersection of:
Recurring global mpox outbreaks and evolving viral strains
Depleted government stockpiles following recent outbreaks
Policy-driven demand for diversified and domestic vaccine supply
Given these dynamics, GEO-MVA is expected to play a central role in global orthopoxvirus preparedness strategies. The Company is actively aligning GEO-MVA with public health preparedness and biosecurity procurement frameworks, including engagement with international regulatory and governmental stakeholders.
Additional Progress Across Clinical Pipeline
Beyond GEO-MVA, GeoVax continues to advance a diversified pipeline spanning infectious diseases and oncology:
GEO-CM04S1 (COVID-19 Vaccine):
Advancing through multiple Phase 2 clinical trials targeting immunocompromised populations, including stem cell transplant and CLL patients.
Data readouts expected in 2026, including from a completed booster trial in healthy adults.
Interim DSMB findings in the CLL study indicated superior immune responses versus mRNA comparator, supporting continued development.
Gedeptin® (Oncology):
Completed Phase 1/2 clinical evaluation in advanced head and neck cancer.
Entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors.
Planning Phase 2 trial for first-line treatment in locally advanced head and neck squamous cell carcinoma (2027).
2025 Full Year Financial Results
Net Loss: Net loss for the year ended December 31, 2025, was $21.5 million, or $22.40 per share, as compared to $25.0 million, or $120.46 per share, for the year ended December 31, 2024.
Revenue: For the year ended December 31, 2025, the Company reported $2.5 million of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $4.0 million during 2024. In April 2025, GeoVax received notification that BARDA determined to terminate the contract for convenience to the government.
R&D Expenses: Research and development expenses were $18.1 million for 2025, compared to $23.7 million in 2024, with the overall decrease primarily related to discontinued costs associated with termination of the BARDA/RRPV contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs.
G&A Expenses: General and administrative expenses were $6.0 million for 2025, compared to $5.4 million in 2024, with the overall increase primarily due to higher personnel costs, investor relations consulting and other programmatic expenses, patent costs, and stock-based compensation expense.
Cash Position: GeoVax reported cash balances of $3.1 million on December 31, 2025, as compared to $5.5 on December 31, 2024.
Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.
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 biosecurity 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.
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