NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (Nasdaq: VNCE) (“VNCE” or the “Company”), a global retail platform, today announced that it plans to report its first quarter 2026 financial results pre-market on Tuesday, June 16, 2026. The Company also plans to hold a conference call to discuss its financial results on the same day at 8:30 a.m. ET. During the conference call, the Company may answer questions concerning business and financial developments, trends and other business or financial matters. The Company’s responses to these questions, as well as other matters discussed during the conference call, may contain or constitute information that has not been previously disclosed.
Those who wish to participate in the call may do so by dialing (833) 461-5787, conference ID 639507707. Any interested party will also have the opportunity to access the call via the Internet at http://investors.vince.com/. To listen to the live call, please go to the website at least 15 minutes early to register and download any necessary audio software. For those who cannot listen to the live broadcast, a recording will be available for 12 months after the date of the event. Recordings may be accessed at http://investors.vince.com/.
ABOUT VINCE HOLDING CORP. Vince Holding Corp. is a global retail platform that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 42 full-price retail stores, 12 outlet stores, and its e-commerce site, vince.com, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.
CULVER CITY, Calif., June 02, 2026 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, today celebrates the 11-year anniversary of the ARK franchise, highlighting the game’s continued commercial momentum, expanding content roadmap, and long-term growth strategy for the ARK franchise.
More than a decade after its original launch, the ARK franchise continues to demonstrate strong player engagement and commercial performance across both legacy and next-generation experiences. During the first quarter of 2026, ARK: Survival Evolved (“ASE”) sold approximately 573,000 units, while ARK: Survival Ascended (“ASA”) sold approximately 1.4 million units globally. Player activity across the franchise also remained strong during the quarter. ASE recorded a peak DAU of 143,000, while ASA achieved a peak DAU of 188,000.
As part of the anniversary celebration, Jeremy Stieglitz, co-founder and co-creator of the ARK franchise, will appear at IGN Live in downtown Los Angeles on June 6, 2026, where he is expected to share exclusive new insights regarding upcoming ARK expansions.
Snail believes the breadth of ARK’s roadmap reflects its continued investment in extending the lifecycle of the ARK franchise through premium content. Since its original launch in 2015, the ARK franchise has grown into one of the most recognizable survival game IPs worldwide, spanning multiple titles, expansion packs, and platforms while cultivating a dedicated global player community. Eleven years later, it shows no signs of slowing down as ARK’s latest content roadmap includes multiple expansions, new content, and creator-focused initiatives scheduled throughout 2026 and 2027.
This includes the ARK Fantastic Tames Season 1, which recently launched on May 20, 2026. The Burrowback tame was released at launch, with Cerberax and Enigmasaur scheduled for Q3 and Q4 2026, respectively. Alongside the launch of the ARK Fantastic Tames Season 1, ARK: Survival Ascended‘s May 2026 sale generated a 23.5x increase in average daily unit sales versus the immediately preceding non-sale period, demonstrating continued consumer demand and engagement across the franchise. The phased release strategy for Fantastic Tames is designed to extend player engagement throughout the content cycle, complementing upcoming DLC releases and supporting recurring revenue opportunities within the ARK ecosystem.
ARK Future Pipeline Outlook ARK: Tides of Fortune (ASA DLC) – June 2026 ARK: Genesis Part 1 Remake (ASA DLC Remake) – June 2026 ARK: Dragontopia (ASA DLC) – December 2026 ARK: World Creators (ASA Content Creation Tool) – 2026 ARK: Survival of the Fittest (ASA Game Mode) – 2026 ARK: Atlantis (ASA DLC) – 2027 ARK: Galaxy Wars (ASA DLC) – 2027 ARK: Legacy of Santiago (ASA DLC) – 2027
As mentioned in last month’s 2026 Annual Meeting of Stockholders, with continued player engagement, a multi-year content roadmap, and ongoing franchise expansion initiatives, Snail Games believes ARK remains a long-term pillar within its portfolio and one of the industry’s most enduring survival gaming franchises.
For creators interested in collaborations please reach out to [email protected]
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. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: the game’s continued commercial momentum; the ARK franchise continuing to demonstrate strong player engagement and commercial performance across both legacy and next-generation experiences; Jeremy Stieglitz, sharing exclusive new insights regarding upcoming ARK expansions; the breadth of ARK’s roadmap reflecting its continued investment in extending the lifecycle of the ARK franchise through premium content and ARK remaining a long-term pillar within the Company’s portfolio and one of the industry’s most enduring survival gaming.
Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, the ARK franchise continuing to attract players and continuing its commercial momentum; 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]
PLANTATION, Fla., June 02, 2026 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a leading distributor and omnichannel fulfillment partner to the entertainment and pop-culture collectibles industry, today announced that its Alliance Home Entertainment division has secured the exclusive physical and electronic sell through (EST) home entertainment rights to the critically acclaimed Crave Original series, Heated Rivalry, from Sphere Abacus.
Under the agreement, Alliance Home Entertainment will oversee the DVD, Blu ray, and transactional digital (EST) release of Heated Rivalry – Season 1. The series will debut on digital transactional platforms in June 2026, followed by physical releases in Q4 2026, bringing the title to collectors and digital storefronts across North America for physical formats and the United States for EST.
Alliance Home Entertainment will collaborate closely with the series’ creators to develop a range of premium, collection-worthy physical editions designed to meet the passion and expectations of Heated Rivalry‘s devoted fanbase. These releases will feature elevated packaging, curated bonus content, and exclusive materials that celebrate the characters, storytelling, and cultural impact that have driven the series’ breakout success.
Based on Rachel Reid’s bestselling Game Changers book series, Heated Rivalry has already demonstrated exceptional cross-platform momentum, with the novels seeing a dramatic resurgence in sales and readership following the show’s debut. Heated Rivalry‘s deeply engaged audience – spanning readers, collectors, and audiences around the world – positions it as a powerful long-tail property within the premium home entertainment market.
“Heated Rivalry has developed an incredibly passionate audience, and we’re excited to partner with Sphere Abacus to bring the series to fans in a way that reflects that enthusiasm,” said Jeff Hayne, SVP of Licensing and Productions at Alliance Home Entertainment. “This is exactly the kind of high engagement, event level television that benefits from a thoughtfully curated physical and EST release strategy.”
“We’re seeing a growing number of studios partner with Alliance as physical media evolves into a more curated, fan-driven category,” said Robert Oram, EVP of Alliance Home Entertainment. “Our ability to combine product development, demand planning, and go-to-market execution into a single, integrated model is increasingly important for high-engagement franchises like Heated Rivalry. We’re excited to work with Sphere Abacus to bring this series to market in a way that fully reflects the passion of its audience.”
“We are very proud to be the distributors of the global hit Heated Rivalry. Alliance is the right partner for this next phase in the series’ lifecycle. They clearly understand the values of this incredible show, its audience, and the opportunities that physical and EST formats will bring,” said Anne Corsak, Sales Director (North America) at Sphere Abacus.
With a focus on quality, authenticity, and fan connection, Alliance Home Entertainment’s approach will prioritize releases that not only capture the excitement surrounding the series but also create lasting value for collectors.
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 340,000 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. Alliance also owns and operates proprietary collectibles brands, including Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises, and Alliance Authentic™, a premium platform for authentic, certified, and individually numbered entertainment collectibles. In addition, Alliance operates Endstate Authentic, a dedicated NFC-enabled authentication and digital product identity platform supporting authenticated collectibles, resale, and brand protection. Leveraging decades of operational expertise, exclusive sourcing relationships, and a capital-light, scalable infrastructure, Alliance connects fans and collectors to the products, franchises, and experiences they value across formats and generations.
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 that a breach of the revolving credit facility 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, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; 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.
For investor inquiries, please contact:
Dave Gentry RedChip Companies, Inc. 1-800-REDCHIP (733-2447) 1-407-644-4256 [email protected]
- The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -
- 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -
- Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -
– Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -
– Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -
– Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib –
SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC.
“RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers,” said Dr. Lenz. “With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients.”
Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026): In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:
Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.
Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.
No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.
Safety/Tolerability: Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.
“We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC,” said Mani Mohindru, PhD, President and Chief Executive Officer. “The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months.”
The ASCO presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation.
Conference Call and Webcast The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded.
CRDF-004 Trial Design The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.
For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).
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; ; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. with respect to our license agreement with Nerviano; 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.
CHICAGO, June 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that its founder and CEO Vlad Vitoc, M.D. and Director Stan V. Smith, Ph.D. have increased their ownership positions through open market purchases.
Approximately 72,700 shares of MAIA common stock were purchased by Dr. Vitoc on June 6, 2026, at an average common stock price of $1.3877. Approximately 75,000 shares of MAIA common stock were purchased by Dr. Smith on June 6, 2026, at an average common stock price of $1.336.
“Our continuing investments underscore our strong confidence in the telomere-targeting immuno-oncology platform we’ve established,” said Dr. Vitoc. “As the ateganosine program advances toward later-stage development, we believe ateganosine could become an important new standard of care for patients with advanced non-small cell lung cancer.”
“MAIA continues to advance what I believe is a differentiated approach to cancer treatment with strong scientific rationale and encouraging clinical momentum,” Dr. Smith added. “I’m a strong believer in the incredible potential future that MAIA has in contributing to the patients and investors alike.”
To date, directors and officers of MAIA hold a 20.46% stake in the Company.
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 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.
Company Projects $25 Million Annualized International Revenues in 2026
BOCA RATON, FL / ACCESS Newswire / June 2, 2026 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) announced today that the Company is experiencing rapid growth in its international television distribution, advertising and licensing business, with annualized international revenues expected to reach approximately $25 million in 2026.
The growth in international licensing substantially exceeds the Company’s original internal projections. Newsmax expects to see licensing revenues of approximately $16 million this year – up significantly from $3.6 million reported for 2025.
Newsmax currently distributes its flagship U.S. cable news channel, Newsmax, in more than 100 countries through pay television operators, satellite providers and OTT streaming platforms.
In addition, a growing number of international media partners have licensed the Newsmax name and brand to launch localized Newsmax channels and programming in local languages.
Under these agreements, Newsmax typically receives a combination of brand licensing fees, advertising revenues and other partnership income.
The Company has also signed agreements to expand the Newsmax brand into Germany, Italy, Greece, Hungary, Bulgaria and Ukraine, with partners carrying local language channels.
In 2022, Newsmax launched a partnership with Telekom Serbia, a leading telecom and broadband provider in Eastern Europe. Soon after Newsmax Balkans, a regional Serbian-language news channel, was launched to serve audiences throughout the Balkans.
Newsmax and Telekom Serbia are scheduled to officially launch Newsmax Poland next week at a special launch event in Warsaw.
“Newsmax’s international growth has exceeded our expectations,” said Andy Biggers, Vice President of Distribution for Newsmax. “Our partners around the world recognize the demand for trusted news programming. We see substantial additional opportunities for growth in advertising, licensing and distribution across Europe and other international markets.”
Christopher Ruddy, CEO of Newsmax, said the Company’s expanding international footprint reflects the growing recognition of the Newsmax brand globally.
“Newsmax has built one of the strongest and most recognized news brands in America, and we are now seeing that brand resonate internationally as well,” Ruddy said. “Our international partnerships are creating significant new revenue opportunities while extending the reach of the Newsmax brand to millions of viewers worldwide.”
The Newsmax news channel is the fourth highest-rated cable news channel in the U.S., reaching 30 million Americans on pay-TV systems. Newsmax reaches millions more through its OTT channel, digital platforms and through social media.
The Company recently reported strong first quarter financial results during its latest earnings call and reaffirmed guidance for continued revenue and business growth throughout 2026.
The Company has given guidance of a 13% projected increase in revenues this year. There is no change in guidance at this time, but the Company will review numbers after second quarter results are finalized.
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 25 million combined followers. Reuters Institute has said Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding expected international revenue growth, anticipated partner launches, advertising and licensing opportunities, distribution expansion, geographic growth, future business performance, timing of localized channel launches, partner performance, and anticipated benefits of international distribution and licensing arrangements. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including delays or changes in partner launches, failure of partners to launch or operate localized channels as expected, termination or modification of agreements, lower-than-expected advertising demand, changes in distribution arrangements, foreign currency fluctuations, regulatory, political and geopolitical risks, local market conditions, competitive conditions, revenue recognition timing, collection risk, and the other risks described in the Company’s filings with the SEC. The Company undertakes no obligation to update forward-looking statements except as required by law.
Largest FIFA Tournament in History Expected to Draw 6.5 Million Attendees Across North America and More Than 1.2 Million International Visitors to U.S. Host Cities Amid Growing Concerns Regarding Mpox, Ebola, Hantavirus, Measles, and Other Emerging Infectious Disease Threats
ATLANTA, GA – June 1, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today welcomed the upcoming FIFA World Cup 2026 and highlighted the importance of public health readiness, healthcare capacity, and biodefense capabilities as North America prepares to host the largest sporting event in history.
According to a recent economic impact analysis conducted by Oxford Economics and Tourism Economics, FIFA World Cup 2026 is expected to attract approximately 6.5 million attendees across the United States, Canada, and Mexico, including more than 1.2 million international visitors traveling to U.S. host cities alone. For public health authorities, healthcare systems, emergency management agencies, and national security planners, the tournament represents a real-world test of disease surveillance, healthcare capacity, emergency response coordination, vaccine availability, and critical public health infrastructure at a scale rarely encountered outside of a global crisis.
The event arrives amid a period of increasing infectious disease activity marked by ongoing Clade I mpox transmission, the escalating Bundibugyo Ebola outbreak in Central Africa, renewed concern surrounding zoonotic pathogens such as hantavirus and avian influenza, and growing measles outbreaks in multiple regions. Together, these developments reinforce a broader reality: biological threats are becoming more global, more interconnected, and increasingly simultaneous.
“FIFA 2026 represents more than a sporting event. It is a large-scale operational challenge occurring in an era of persistent biological risk,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “When millions of people move across borders, transportation networks, and densely populated urban environments over a compressed period of time, health security becomes an operational necessity. The ability to detect, monitor, and respond rapidly to emerging infectious disease threats will be as important as the infrastructure supporting the tournament itself.”
Mass gatherings do not create outbreaks. However, they can amplify the operational consequences of existing vulnerabilities. Millions of visitors moving through airports, public transportation systems, hotels, entertainment venues, and urban centers create conditions that test disease surveillance systems, laboratory capacity, healthcare surge capabilities, public communication networks, and cross-jurisdictional coordination.
Recent outbreaks have reinforced the reality that governments can no longer focus on a single pathogen at a time. The continued spread of mpox beyond historically endemic regions, the emergence of more virulent viral strains, and the ongoing Bundibugyo Ebola outbreak, which currently lacks a broadly licensed vaccine specifically approved for widespread deployment, underscore the need for flexible response capabilities able to address multiple evolving threats simultaneously.
“The central challenge is no longer responding to a single outbreak,” continued Dodd. “Governments and health systems increasingly require the ability to manage multiple biological threats at once. Health security today means more than surveillance. It requires manufacturing capacity, supply-chain diversification, stockpile availability, operational coordination, and the ability to rapidly deploy effective countermeasures when and where they are needed.”
GeoVax believes several priorities warrant increased attention as FIFA 2026 approaches:
Expanding domestic vaccine manufacturing capacity
Diversifying critical medical countermeasure supply chains
Enhancing disease surveillance and rapid-response capabilities
Strengthening public-private health security partnerships
Improving stockpile management and deployment logistics
A New Era of Biological Risk
The World Cup does not create vulnerabilities. It has the potential to expose them.
Recent mpox outbreaks demonstrated how rapidly demand for vaccines and medical countermeasures can outpace available supply. The Bundibugyo Ebola outbreak has highlighted continuing gaps in available tools for emerging pathogen variants. At the same time, concerns regarding zoonotic spillover events, international mobility, and supply-chain concentration have reinforced the importance of scalable manufacturing capacity, diversified sourcing, flexible vaccine technologies, and geographically distributed biodefense infrastructure.
The ongoing mpox environment has also highlighted the strategic importance of poxvirus vaccine availability. Today, global supply of MVA-based poxvirus vaccines remains concentrated among a single non-U.S. manufacturer, creating potential constraints during periods of heightened demand. Expanding manufacturing capacity and strengthening supply diversity may play an important role in future health security efforts.
GeoVax’s development portfolio is anchored by GEO-MVA, an MVA-based poxvirus vaccine candidate being advanced for protection against mpox and smallpox and intended to support a more diversified global poxvirus vaccine supply. GeoVax is also advancing Gedeptin®, an immuno-oncology program designed to enhance anti-tumor immune responses in solid tumors. The Company’s broader technology portfolio includes preclinical vaccine candidates targeting hemorrhagic fever pathogens, including Ebola and Marburg viruses, which have demonstrated encouraging efficacy in animal studies and may provide future strategic optionality for biodefense and global health applications.
“As the world comes together to celebrate FIFA World Cup 2026, we extend our congratulations to the athletes who have dedicated years to reaching this global stage and to the organizers responsible for bringing this remarkable event to life,” concluded Dodd. “The success of gatherings like these depends not only on what happens on the field, but also on the public health systems, healthcare infrastructure, and operational planning that support them behind the scenes. By investing in manufacturing capacity, disease surveillance, and biodefense capabilities today, we can help ensure that the world’s attention remains focused where it belongs – on the athletes, the competition, and the spirit of international cooperation.”
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.
VANCOUVER, B.C., June 1, 2026 – Nicola Mining Inc. (NASDAQ: NICM) (TSXV: NIM) (FSE: HLIA), (the “Company” or “Nicola”) is pleased to announce that it is in the final stages of preparation to commence gold and silver extraction operations at its Dominion Gold Project (“Dominion”). The high-grade gold project is located approximately 43 kilometres northeast of the Town of Wells and 110 kilometres southeast of Prince George, British Columbia. Material extracted from Dominion will be processed at the Company’s wholly owned Merritt Mill, the only fully permitted milling facility in British Columbia authorized to process gold and silver material sourced from throughout the province.
In anticipation of commencement of operations, the Company has advanced multiple key infrastructure, equipment, and operational initiatives, while also strengthening its reclamation profile through an additional $251,000 payment toward reclamation bonding requirements under Mines Act Permit MX-100000488[1], as well as the following:
Completion of the final payment for the purchase and installation of a fully furnished 14-person operational camp, including all required site facilities[2];
Acquisition of three CATERPILLAR 336-07 excavators;
Acquisition of Traxxon TR-EX2000 High Performance Rock Drill attachment;
Securing of a John Deere 310E haul truck;
Hiring of operational crews and engagement of key mining contractor
Mill feed extraction is expected to commence first week of July.
Mr. Peter Espig, CEO of Nicola Mining Inc., commented:
“Dominion represents a highly compelling high-grade gold asset that we believe possesses both exceptional near-term production potential and significant long-term strategic value for Nicola. The project has consistently demonstrated robust mineralization, with vein systems remaining open in all directions and returning grades of up to 113 grams of gold per tonne (3.31 ounces of gold per tonne)[3]. As we transition toward extraction, we are particularly excited by the opportunity to establish Dominion as a meaningful and sustainable source of premium-grade mill feed for our Merritt Mill operations. Concurrently, we continue to work closely with Blue Lagoon Resources Inc., which continues to achieve important production milestones while maintaining strong operational discipline and grade control. We believe the convergence of these developments positions Nicola for a transformative period of operational growth and increasing cash flow generation.”
Qualified Person
The scientific and technical disclosures included in this news release have been reviewed and approved by Will Whitty, P.Geo., who is the Qualified Person as defined by NI 43-101. Mr. Whitty is Vice President of Exploration for the Company.
DOMINION CREEK PROPERTY HISTORY
The Dominion Creek Property consists of 9 mineral claims (55 units) totaling approximately 1,058 hectares. The property was acquired from the prospector N. Kencayd by Noranda Exploration Company Ltd. in 1986. Noranda subsequently conducted geological, geochemical, and geophysical surveys which culminated in an increase in their land position. Between 1987 and 1990, Noranda’s exploration program included a small (20 samples) geochemical silt sample survey. Encouraged by those results, a larger soil geochemical survey (3,399 samples) was conducted. Noranda drilled a total of 53 shallow diamond drill holes, totaling 3,483.86 meters (average depth of approximately 65.7 meters). Trenching of several coincident Pb, Zn, Cu, Ag and Au soil geochemistry anomalies resulted in the discovery of several mineralized quartz veins.
A Technical Report[4] on the Dominion Creek Project was completed by Geospectrum Engineering on August 22, 2003.
About Nicola Mining
Nicola Mining Inc. is a junior mining company listed on the NASDAQ, the TSX Venture Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia. It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.
The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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 provided an update on its Form 10-K filing for the fiscal year ending December 31, 2025.
The Form 10-K for the fiscal year ending December 31, 2025, continues to be audited by our new auditor and we believe it is in the final approval steps. The Form 10-K also includes the 2024 audit that was previously audited by the prior auditor. As previously indicated, the accounts payable adjustments are related to the large global Phase III clinical trial underway and the unexpectedly large increase in screening and patient enrollment in Europe in 2024 and 2025. Both auditors in a dual auditor filing must agree in order to make timely filings, which did not occur in March or April, and such coordination is still required as part of the final approval steps.
The Company believes that it did not contribute to the delays in filing and instead did everything possible to file on time. The Company provided the 10K filing information with large increases to accounts payable to the auditors for review in early February 2026 and requested and anticipated an early filing. The Company has further improved its accounts payable estimations using current clinical trial data in its financials for Form 10-Q for the period ending March 31, 2026.
The Company believes that the accounts payable adjustments are not material to the Company or its investors and does not change the fundamentals of the Company. The shift in expenses does not change the cash balance or the net cash used in operating activities of the Company. As previously announced, the Company’s ending cash balance as of March 31, 2026 is approximately $10.5 million, which the Company believes is an improvement over 2025 ending cash balances, and includes the retirement of over 75% of accounts payable for the fiscal year ending December 31, 2025. This $10.5 million cash balance is more than the 2025 net cash used in operating activities which is approximately $9.9 million. The above figures are unaudited and are subject to change following the completion of the Company’s financial audit for the year ending December 31, 2025 and the review for the period ending March 31, 2026.
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 can be downloaded here.
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.
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.
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.
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