On June 26, 2025 Incyte (Nasdaq:INCY) reported that the Company’s Board of Directors has unanimously appointed Bill Meury as President and Chief Executive Officer (CEO) and a member of the Company’s Board of Directors, effective immediately (Press release, Incyte, JUN 26, 2025, View Source [SID1234654148]).

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Bill Meury succeeds Hervé Hoppenot who will retire from the Company after 11 years of service. Mr. Hoppenot will serve as an advisor to the CEO and will remain as a member of the Board through the end of the year to ensure a smooth transition. In addition, Lead Independent Director Julian Baker has been elected Chairman of the Board of Directors.

Mr. Meury is a proven enterprise leader with expertise in organizational strategy, pipeline and commercial execution and capital allocation. He most recently served as CEO of Anthos Therapeutics, where he successfully scaled the company for its next stage of growth. Prior to that, he was CEO of Karuna Therapeutics, leading its transition into a fully integrated R&D and commercial organization. Before Karuna, Mr. Meury spent more than two decades at Allergan, serving as Chief Commercial Officer, managing a global business with fifty products, $16 billion in revenue and approximately 8,000 employees across a range of therapeutic areas.

"I am honored to join Incyte at this pivotal moment and thank Hervé for his support during this transition," said Mr. Meury. "Incyte’s track record for discovering innovative treatments for complex problems in human health is outstanding. My priority is to build upon our exceptional R&D and commercial capabilities to accelerate new product flow, drive sustainable growth and create value for all stakeholders. I look forward to working with the Incyte team to continue to grow the company for enduring success."

"Bill is a decisive and collaborative leader who possesses the strategic planning and executional skills necessary to accelerate Incyte’s growth and maximize the tremendous opportunities we have in oncology and immunology," said Mr. Baker. "During our thoughtful succession process, Bill’s leadership experience stood out, including his ability to effectively translate scientific breakthroughs into business results. Bill is a great listener, a tireless learner and a direct and open communicator. I believe that he embraces Incyte’s values of hard work, commitment to excellence in science and business and dedication to bringing novel, innovative and life changing medicines to patients in need. In my new role as Chairman, I look forward to working closely with Bill to create long-term value for our shareholders."

"On behalf of the entire Board of Directors, I want to thank Hervé for his unwavering service as Chairman and CEO of Incyte," continued Baker. "It was at Hervé’s request last Fall that the Board of Directors engaged in a thorough succession planning process that led us to today’s transition. Hervé’s leadership and vision have been invaluable over the past decade, growing Incyte into a leading, diversified company. Hervé joined Incyte in 2014 when it was a single product, U.S.-only company. During Hervé’s tenure, Incyte launched six novel medicines plus two new indications for Jakafi, expanded commercial operations into Europe, Japan and Canada and grew revenues from $355 million dollars in 2013 to $4.2 billion today. Hervé fostered a culture of innovation and collaboration that will carry on at Incyte. I would like to thank him for his hard work and dedication to the Company, which I expect will continue through the coming years, and wish him the best in his retirement."

"It has been a privilege to lead Incyte over the past eleven years," said Mr. Hoppenot. "Guided by our mission to Solve On. and relying on great science, together we have achieved remarkable success in our effort to address unmet medical needs. I am proud to retire at a time when Incyte has the strongest management team, internal R&D pipeline and commercial portfolio ever. With Bill’s leadership, I am confident that the Company will continue its legacy of delivering transformative solutions to patients for many years to come."

About Bill Meury

Bill Meury was formerly CEO of Anthos Therapeutic, a Blackstone Life Sciences portfolio company, which was acquired by Novartis in April 2025. Mr. Meury joined Anthos after leading Karuna Therapeutics, a biopharmaceutical company focused on neuroscience, until its merger with Bristol Meyers Squibb in March 2024. Prior to Karuna, he served as a Partner at Hildred Capital Management, a private equity firm focusing on healthcare products and services. Prior to Hildred Capital Management, he was Executive Vice President and Chief Commercial Officer at Allergan, until the time of its acquisition by AbbVie, where he had responsibility for over 50 products with $16 billion in revenue and over $3 billion in operating investment. In this role, he led multiple global divisions totaling approximately 8,000 employees, including marketing, sales, business development, marketing analytics, managed care and customer service. Mr. Meury has experience across a broad range of therapeutics areas and has been involved with over 20 U.S. Food and Drug Administration (FDA) approvals and new product launches. He also served as Allergan’s President, Branded Pharma and Executive Vice President, Commercial, North American Brands, and as Executive Vice President Commercial Operations, at Forest Laboratories prior to its acquisition by Allergan.

Mr. Meury currently serves on the board of directors of the Jed Foundation. He received his B.A. in Economics from the University of Maryland.

About Julian Baker

Julian Baker is Managing Partner of Baker Bros. Advisors LP ("BBA") a biotechnology-focused, long-term investment adviser. Mr. Baker founded BBA, together with his brother and Co-Managing Partner Dr. Felix Baker, in 2000. Prior to BBA, Mr. Baker and his brother were portfolio managers of a biotech-focused investment partnership at Tisch Financial Management from 1994 to 1999. Previously, Mr. Baker was employed from 1988 to 1993 by the private equity investment arm of Credit Suisse First Boston Corporation.

In addition to Incyte, Mr. Baker serves as Chairman of Madrigal Pharmaceuticals, Chairman of Denali Therapeutics and as a Director of Acadia Pharmaceuticals. Mr. Baker holds an A.B. Magna Cum Laude from Harvard University.

On June 26, 2025 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported dosing of the first patient in the DENALI-1 (NCT06682793) clinical study. DENALI-1 is a multicenter phase 1/2 dose-escalation clinical study to evaluate the safety and efficacy of A2B395, an allogeneic logic-gated CAR T cell therapy, in participants with solid tumors that express EGFR and have lost HLA-A*02 expression (Press release, A2 Biotherapeutics, JUN 26, 2025, View Source [SID1234654147]). A2B395 is the first allogeneic therapy utilizing the A2 Bio Tmod technology platform to advance into clinical development.

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A2 Bio is advancing A2B395 as a potential new precision cell therapy in participants with solid tumors that express EGFR, including colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and renal cell carcinoma.

"Dosing of the first patient in DENALI-1 is a key milestone toward providing a precise, novel ‘off the shelf’ CAR T cell therapy for patients with solid tumors that express EGFR. No curative therapies are available for people living with these cancers, and current treatments can be toxic, debilitating, and fatal. All of us at A2 Bio are grateful to the patients, investigators, and clinical care providers participating in DENALI-1," said John Welch, M.D., Ph.D, interim chief medical officer of A2 Bio.

Significant unmet needs remain for people living with EGFR-positive cancers, despite recent advances that have produced new targeted therapies, antibody-based therapies, and immunotherapies.1,2 In the recurrent unresectable, locally advanced, or metastatic setting, the intent of standard of care treatment is typically palliative rather than curative, and has not changed significantly in several decades.

Precision medicine enables efficient identification of patients in the A2 Bio clinical studies. Patients are enrolled in DENALI-1 through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in DENALI-1. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to DENALI-1 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.3, 4

In addition to A2B395, A2 Bio continues to advance its clinical development of A2B694, the BASECAMP-1 prescreening study, as well as other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for various cancers and beyond.

The Tmod platform utilizes a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This dual-receptor design is intended to provide selective killing of tumor tissues that express EGFR and have lost the HLA-A*02 gene permanently. This novel design is aimed at tackling the fundamental challenge in solid tumor cancer medicines – the ability to selectively kill tumor cells and protect normal cells.

About DENALI-1

DENALI-1 (NCT06682793) is a phase 1/2, open-label, nonrandomized study evaluating the safety and efficacy of A2B395 in adults. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression the participant may screen for enrollment in DENALI-1.

More information about DENALI-1 and clinical trial sites participating in the study are available on the A2 Bio clinical trials website.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

On June 26, 2025 The NextGen EV Therapeutics Forum, hosted by China Medical University and Healthcare System, reported bringing together leading scientists, clinical experts, and biotech industry leaders from Taiwan and the United States to explore the forefront of extracellular vesicle (EV) research and translation (Press release, China Medical University, JUN 26, 2025, View Source [SID1234654146]). The forum showcased emerging EV-based applications in oncology, neurodegenerative disorders, immune modulation, and regenerative medicine, highlighting the rapid advances toward clinical implementation.

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A highlight of the event was the announcement of a strategic partnership between China Medical University Hospital (CMUH) and Shine-On Biomedical Co., Ltd. This collaboration aims to accelerate Taiwan’s leadership in EV-based precision medicine on the global stage. As part of this initiative, Dr. Randy W. Schekman, the 2013 Nobel Laureate in Physiology or Medicine, was appointed International Scientific Advisor. In his keynote address, Dr. Schekman emphasized the critical importance of grounding therapeutic innovation in rigorous basic science, particularly in the evolving roles of EVs in intercellular communication and nucleic acid delivery.

Global Breakthrough: SOB100 Platform Targets HLA-G Tumors

At the center of this three-party collaboration is SOB100, the world’s first engineered exosome platform targeting HLA-G, an immunosuppressive tumor antigen. The platform is capable of crossing the blood-brain barrier and delivering nucleic acid drugs with high specificity, offering a potential therapeutic breakthrough for glioblastoma (GBM) and triple-negative breast cancer (TNBC).

Dr. Hui-Chun Ho, Vice President of Shine-On Biomedical, noted that SOB100 has received U.S. FDA approval to enter Phase I clinical trials and was recently featured in Nature Communications. She emphasized that the platform has demonstrated exceptional targeting precision and delivery efficiency in preclinical studies. With Dr. Schekman’s advises, the company aims to further enhance nucleic acid payload efficiency to unlock even greater therapeutic impact.

U.S.-Taiwan Scientific Exchange and Industry Insight

The forum also featured a keynote speech by Dr. Kenneth Witwer, Professor at Johns Hopkins School of Medicine and President of the International Society for Extracellular Vesicles (ISEV). Dr. Witwer provided a global perspective on the progress and challenges in EV therapeutics and called for greater standardization in EV engineering to support clinical scalability.

CMU System showcased several of its internally developed technologies, including:

In Vivo CAR-T Production via EVs for Solid Tumors
Targeted EV Drug Delivery for Parkinson’s Disease
Mitochondrial EVs from CRISPR-Engineered Stem Cells for MASLD
Engineered EVs for Cardiac Repair in Heart Failure
These innovations demonstrate CMU’s leadership in building an end-to-end EV research and clinical pipeline and underscore its commitment to integrating academia, healthcare, and biotech industry in Taiwan.

Building a Global Innovation Ecosystem for Precision EV Therapeutics

Dr. Mien-Chie Hung, President of China Medical University, remarked, "Extracellular vesicles are one of the most promising delivery vectors for the next generation of precision medicine. This forum not only showcases Taiwan’s research capabilities but also highlights our ability to mobilize global expertise."

Dr. Der-Yang Cho, Superintendent of CMUH, added, "EVs are emerging as a core technology for next-generation therapies. We are committed to building a globally connected precision medicine ecosystem with EVs at its center—driven by translational science and patient benefit."

The forum also gathered leading voices from Taiwan’s top research institutions, including the National Health Research Institutes, Academia Sinica, and National Taiwan University. Prominent researchers such as Prof. Hua-Jung Lee, Prof. Chia-Ning Shen, Prof. Tang-Long Shen, and Prof. Han-Yi Chou shared the latest advancements, strengthening Taiwan’s role in advancing EV-based precision medicine.

On June 26, 2025 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting Smart Allostery platform-identified regulatory sites on proteins referred to as "natural hotspots," reported it will present preclinical data from the Company’s CARD11-BCL10-MALT1 (CBM) program in two poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place July 2-5, 2025, in Barcelona, Spain (Press release, HotSpot Therapeutics, JUN 26, 2025, View Source [SID1234654145]).

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Presentation details are as follows:

Title: Synthetic lethality of CBM signalosome inhibition for KRAS-Mutant Colorectal Cancers
Poster Number: 124P
Session: Poster Display Session 2
Session Date and Time: Fri., Jul. 4, 5:30-6:30 CEST
Location: Foyer, International Barcelona Convention Center, Barcelona, Spain

Title: Novel CBM signalosome inhibitor revealed the essentiality of CBM signalosome for KRAS mutant colorectal cancer
Poster Number: 125P
Session: Poster Display Session 2
Session Date and Time: Fri., Jul. 4, 5:30-6:30 CEST
Location: Foyer, International Barcelona Convention Center, Barcelona, Spain

On June 26, 2025 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal fourth quarter ended March 31, 2025, and provided an update on recent developments (Press release, Aethlon Medical, JUN 26, 2025, View Source [SID1234654144]).

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Key Fiscal 2025 Highlights

First three patients treated in Hemopurifier cancer trial at Australian sites
Indian regulatory approval received to initiate a similar oncology study
Study protocol expanded to reflect evolving immunotherapy standard of care
Preclinical data demonstrate 98.5% removal of platelet-derived EVs in simulated Hemopurifier treatment
Collaboration with UCSF to investigate Long COVID with findings to be presented at the Keystone Symposium
Operating expenses reduced significantly through streamlined operations
Clinical Progress in Cancer Trial

Aethlon completed Hemopurifier treatments in the first three participants enrolled in its safety, feasibility, and dose-finding study of patients with solid tumors unresponsive to anti-PD-1 agents. Participant #1 was treated at Royal Adelaide Hospital in January 2025, while Participants #2 and #3 received treatment at Royal North Shore Hospital in Sydney in June 2025. All participants completed a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications and have now completed the pre-specified 7-day safety follow-up.

This milestone triggers the first meeting of an independent Data Safety Monitoring Board (DSMB), to review safety data and recommend advancement to the second treatment cohort. In the next cohort, participants will receive two Hemopurifier treatments during a one-week period.

Preliminary data from the first cohort, including effects on extracellular vesicle (EV) removal and anti-tumor T-cell activity, are expected in approximately three months.

In parallel, the trial protocol was amended to broaden eligibility to include patients receiving combination therapies with Pembrolizumab (Keytruda) or Nivolumab (Opdivo), in line with current treatment practices.

Currently, only about 30% of patients receiving pembrolizumab or nivolumab experience lasting clinical responses. EVs released by tumors have been implicated in cancer progression and resistance to anti-PD-1 therapies. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving the therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

As a reminder, the primary endpoint for the approximate 9 to 18-patient study is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period.

In addition to safety, the study includes exploratory analyses evaluating how many Hemopurifier treatments are needed to decrease the concentration of EVs, and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These findings are intended to guide the design of future safety and efficacy trials, including a potential Premarket Approval (PMA) study required by the FDA and other global regulatory agencies.

Regulatory Approval India

On June 19, 2025, the Company received formal approval from India’s Central Drugs Standard Control Organization (CDSCO) to initiate a similar trial at Medanta Medicity Hospital. The approval followed a meeting with the Subject Expert Committee and prior Ethics Committee clearance. The trial will begin following a Site Initiation Visit (SIV) conducted by Aethlon’s India-based CRO, Qualtran.

Preclinical Study Supports Broader Applications

On May 12, 2025, the results from Aethlon’s preclinical ex vivo study were published in bioRxiv, and the manuscript has been submitted to a peer-reviewed journal for publication. Those results showed that the Hemopurifier, using proprietary Galanthus nivalis agglutin (GNA) affinity resin, removed 98.5% of platelet -derived extracellular vesicles (PD-EVs) from human plasma during a timepoint equivalent to a 4-hour HP treatment. Excessive levels of PD-EVs have been implicated in a myriad of diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer’s disease, sepsis, acute and Long COVID. The results of this study support the ongoing oncology trial in Australia and suggest potential applications of the Hemopurifier in other EV-associated diseases.

The manuscript describing this study has been submitted to a peer-reviewed journal for publication.

Scientific Collaboration in Long COVID Research

Aethlon’s collaborative research with the UCSF Long COVID Clinic was accepted for a poster presentation at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes (August 10-13, 2025). The study analyzed blood samples from participants with Long COVID as well as controls that had recovered from COVID-19 infection to evaluate the binding of larger and smaller extracellular vesicles to the Hemopurifier’s lectin affinity resin, respectively. These findings build on prior clinical evidence and support further investigation of the Hemopurifier in Long COVID, an unmet medical need affecting approximately 44 and 48 million people in the United States alone, with an estimated economic burden of 2 billion dollars in those with symptoms lasting a year.

Operational Achievements

In fiscal 2025, Aethlon streamlined operations and significantly reduced its operating expenses, positioning the company for sustained focus on its clinical and regulatory goals.

Financial Results for the Fiscal Fourth Quarter Ended March 31, 2025

As of March 31, 2025, Aethlon had a cash balance of approximately $5.5 million.

Consolidated operating expenses for the fiscal year ended March 31, 2025, were approximately $9.3 million, representing a decrease of $3.3 million or approximately 26%, compared to $12.6 million for the fiscal year ended March 31, 2024. This reduction was primarily driven by lower payroll and related expenses, professional fees, and general and administrative costs.

Payroll and related expenses declined by an approximate $1.3 million, reflecting an approximate $900,000 reduction in salaries and related expenses and an approximate $800,000 decrease in stock-based compensation. These reductions were primarily attributable to the termination of three executives—one in the fiscal year 2024, one in July and October 2024—and a workforce reduction of non-executive staff in August 2024. The decrease in stock-based compensation was primarily due to the absence of accelerated vesting charges recognized in the prior year related to the termination of our former Chief Executive Officer, as well as reduced expenses following the departure of executives and staff. These decreases were partially offset by an increase of approximately $400,000 in severance expenses associated with the termination of two former executives.

Professional fees also declined by approximately $1.3 million. This decrease includes $600,000 in legal costs savings resulting from a transition to a new legal firm, and an approximate $500,000 related to the termination of services with a contract manufacturing organization and the completion of a project that involved using an outside lab to process samples. Consulting fees related to scientific projects and regulatory projects declined by approximately $300,000. These reductions were partially offset by an approximate $85,000 increase in accounting fees associated with obtaining audit firm consents for various securities filings.

General and administrative expenses decreased by approximately $660,000. The reduction was driven primarily by a $534,000 reduction in costs related to fewer raw material purchases, no cleanroom certification expenses, and reduced reliance on outside services for maintenance of the manufacturing facility. Laboratory supplies and testing costs also declined by $337,000 following the completion of oncology and transplant-related projects. Insurance expenses decreased by $141,000, reflecting lower medical and workers’ compensation premiums due to reduced headcount, as well as an overall decrease in business insurance costs. Additional reductions included $44,000 in travel and entertainment expenses, $24,000 decrease in office supplies, and $19,000 in depreciation expense related to the disposal of certain equipment. These decreases were partially offset by a $467,000 increase in clinical trial expenses associated with our ongoing oncology study in Australia.

As a result of the above factors, our operating loss decreased to $9.3 million for the fiscal year ended March 31, 2025, from $12.6 million for the fiscal year ended March 31, 2024.

Other Income (Expense)

Other expenses for the year ended March 31, 2025, included a non-cash charge of approximately $4.6 million related to a warrant inducement offer. In March 2025, we offered certain warrant holders the opportunity to exercise existing warrants at a temporarily reduced exercise price in exchange for the issuance of new warrants. The inducement expense recognized represents the combined fair value of the new warrants issued and the incremental fair value resulting from the modification of the exercise price of the existing warrants. This transaction did not impact cash flows from operating activities.

During the fiscal year ended March 31, 2025, we recognized approximately $324,450 in other income related to the Employee Retention Tax Credit (ERTC) under the CARES Act and subsequent legislation. We recorded the ERTC as other income in the periods in which the payments were received. In addition, we recognized $36,339 in interest income related to the ERTC during fiscal 2025. As of March 31, 2025, the remaining expected credit was recorded as a receivable within other current assets on our consolidated balance sheet. No amounts were recorded in the prior fiscal year.

The consolidated balance sheets for March 31, 2025 and March 31, 2024, and the consolidated statements of operations for the fiscal years ended March 31, 2025 and 2024 follow at the end of this release.

Conference Call

Management will host a conference call today, Thursday, June 26, 2025, at 4:30 p.m. ET to review the company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.