aweinsoff@channelchek.com, Author at Channelchek

Release – Ocugen, Inc. Announces New Appointments to Retina Scientific Advisory Board & Executive Leadership Team

Posted on July 21, 2025July 21, 2025 by aweinsoff@channelchek.com

July 21, 2025

MALVERN, Pa., July 21, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced updates to its Retina Scientific Advisory Board (SAB) and Executive Leadership Team to enhance external guidance from key opinion leaders and strengthen the Company’s internal expertise in critical functions and as it pursues its goal of three BLAs in the next three years.

“As our novel modifier gene therapy programs continue to progress and demonstrate positive data in the clinic, it is now more important than ever to solidify an optimized Retina SAB reflecting the absolute best guidance in this space as we move closer to commercialization,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Additionally, it’s imperative that we ensure our leadership team includes top talent to most effectively execute our corporate strategy.”

Three renowned retinal surgeons who are at the forefront of research and cutting-edge advancements for retinal disease are joining the Retina SAB to help the Company bring meaningful, innovative therapeutic options for patients living with serious retina diseases.

New SAB members include:

Jeffrey S. Heier, MD, Director of the Vitreoretinal Service, and Director of Retina Research at Ophthalmic Consultants of Boston. Dr. Heier is one of the leading retinal clinical researchers in the country for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation, and diagnostic imaging of the retina. Dr. Heier has contributed extensively to the ophthalmic literature, having authored or co-authored many of the landmark publications in the retinal literature, including the New England Journal of Medicine, Lancet, and numerous other journals.

Peter K Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research, Cole Eye Institute, Cleveland Clinic and Professor of Ophthalmology Case Western Reserve School of Medicine. Dr. Kaiser is the director of the Center for Ocular Research and Evaluation (CORE) and is a major contributor to medical literature having authored seven textbooks, 30 book chapters, and more than 400 peer-reviewed manuscripts. He is Associate Editor of International Ophthalmology Clinics and serves on the editorial boards of American Journal of Ophthalmology, Retina, Retina Today, and Ocular Surgery News.

Arshad M. Khanani, MD, MA, FASRS, Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine. In 2021, Dr. Khanani founded the Clinical Trials at the Summit meeting to foster discussion on clinical trial design and data. Dr. Khanani has been recognized among the top 10 researchers globally on The Ophthalmologist Power List 2025 and has received numerous prestigious awards, including the Macula Society’s Lawrence J. Singerman Medal in 2025 and the American Society of Retina Specialists Presidential Award.

Drs. Heier, Kaiser, and Khanani join SAB chair, Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center; and existing SAB members David S. Boyer, MD, Senior Partner at Retina-Vitreous Associates Medical Group and Adjunct Clinical Professor of Ophthalmology at the University of Southern California/Keck School of Medicine, and Carl D. Regillo, MD, FACS, Professor of Ophthalmology at the Sidney Kimmel Medical College at Thomas Jefferson University, Chief of the Retina Service at Wills Eye Hospital, and founder and former director of the Wills Eye Clinical Retina Research Unit.

To optimize Ocugen’s R&D and clinical efforts and build upon positive momentum pursuing strategic partnerships and developing commercial strategy, the Company has made notable leadership appointments.

Vijay Tammara, PhD, has joined Ocugen in the newly created position of Chief Development Officer and brings over 32 years of global regulatory leadership with deep expertise in biotechnology, biosimilars, 505(b)(2), and complex regulatory submissions. Dr. Tammara has made significant contributions to the approval of nine Marketing Authorizations (MAs)—Biologics License Applications and New Drug Applications (NDAs), two biosimilar MAs in emerging markets, three Abbreviated New Drug Applications, 12 Orphan Drug Designations, seven Qualified Infectious Drug Product Designations, and filed over 62 investigational NDAs with clearance in the first review cycle with no clinical holds. He has successfully led regulatory strategy and operations across the U.S., EU, Latin America, and Asia—including Japan, China, and South Korea. Prior to joining Ocugen, he held senior advisory and leadership roles at the FDA and life sciences companies including Sanofi, Wyeth/Pfizer, and Merck, in addition to leading his own consulting firm.

Abhi Gupta, MBA, has been named Executive Vice President, Commercial and Business Development, following the retirement of Mike Shine. Abhi has more than 20 years of experience across commercial strategy, gene therapy, and corporate development in the biopharmaceutical industry. He has led commercialization planning for transformative rAAV gene therapies and played a pivotal role in building Pfizer’s $5.5B gene therapy portfolio across neuromuscular, hematologic, and cardiovascular indications. Before joining Ocugen, Mr. Gupta served as SVP and Head of Cell and Gene Therapies at Syneos Health and previously held leadership roles at Pfizer, Regeneron, and Johnson & Johnson, with a track record of successful product launches, strategic partnerships, and business development initiatives.

Ocugen is honored to partner with this distinguished group of advisors and delighted to welcome Dr. Tammara and Mr. Gupta as the Company sharpens its patient-centric focus to potentially deliver paradigm-changing gene therapies.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – Tonix Pharmaceuticals Announces the Launch of the “Move Fibro Forward” Campaign to Bring Awareness to Individuals Impacted by Fibromyalgia

Posted on July 21, 2025July 21, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 21, 2025 7:00am EDT Download as PDF

CHATHAM, N.J., July 21, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that Tonix Medicines, Inc., its commercial subsidiary, launched the Move Fibro Forward campaign to bring awareness and support to individuals impacted by fibromyalgia, a debilitating condition with no new FDA-approved treatments in over 15 years.

“Millions of individuals impacted by fibromyalgia have suffered in silence for far too long,” said Thomas Englese, President of Tonix Medicines, Inc. “We believe that demonstrating our knowledge of, and compassion for, their condition and validation of their experience is an important step toward meaningful progress. This campaign is a reflection of our commitment to the community—both today and in the future.”

“Fibromyalgia can make you feel invisible,” said Sharon Waldrop, a person with lived experience and Founder of the Fibromyalgia Association. “Initiatives like Move Fibro Forward help shine a light on our experiences and encourage individuals impacted by fibromyalgia to seek education and resources.”

For more information about the campaign, visit www.movefibroforward.com.

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 an estimated 10 million adults in the U.S., approximately 90% of whom are 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.

Tonix Pharmaceuticals Holding Corp.
Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, and infectious diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc. our wholly owned commercial subsidiary, markets treatments for acute migraine.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com

Source: Tonix Pharmaceuticals Holding Corp.

Released July 21, 2025

Release – Bit Digital Inc. Continues Expansion of Ethereum Holdings to Approximately 120,000 ETH, Reinforcing Treasury Strategy

Posted on July 18, 2025July 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on BTBT

July 18, 2025

July 18, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), today announced that it has purchased approximately 19,683 Ethereum (“ETH”) using the net proceeds from its recently completed $67.3 million registered direct offering to institutional investors. Following the transaction, Bit Digital holds approximately 120,306 ETH.

“With approximately 120,000 ETH, Bit Digital is positioned among the largest institutional Ethereum treasuries in the public markets,” said Sam Tabar, Chief Executive Officer of Bit Digital. “We view Ethereum as foundational to the next phase of digital financial infrastructure. We believe Ethereum’s programmable nature, growing adoption, and staking yield model represent the future of digital assets, and we remain committed to scaling our ETH holdings as part of that long-term strategy.”

ETH is increasingly utilized across real economic activity, serving as the core collateral layer for stablecoins, tokenized assets, and decentralized applications. ETH’s ability to generate native yield and support programmable financial systems positions it as more than a digital asset. Bit Digital sees Ethereum as an integral part of how value will move and settle in modern markets, as a global coordination layer for the emerging onchain economy, and an essential component of future-facing treasury strategy.

Bit Digital operates Ethereum infrastructure as part of its broader strategy to participate directly in the network’s long-term growth. The Company stakes the majority of its ETH holdings and operates validators, earning yield while contributing to the security and performance of the Ethereum network. By combining this operational involvement with the compliance standards and oversight of a public company, Bit Digital offers investors regulated exposure to Ethereum’s underlying economics through a traditional equity vehicle.

About Bit Digital
Bit Digital is a publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies. The Company began accumulating and staking ETH in 2022 and now operates one of the largest institutional Ethereum staking infrastructures globally. Bit Digital’s platform includes advanced validator operations, institutional-grade custody, active protocol governance, and yield optimization. Through strategic partnerships across the Ethereum ecosystem, Bit Digital aims to deliver exposure to secure, scalable, and compliant access to onchain yield. For additional information, please contact ir@bit-digital.com or follow us on LinkedIn or X.

Investor Notice
Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report) and any subsequently filed quarterly reports on Form 10-Q and any Current Reports on Form 8-K. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. See “Safe Harbor Statement” below.

Safe Harbor Statement
This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Release – Ocugen, Inc. Announces First Patient Dosed in Phase 2/3 GARDian3 Pivotal Confirmatory Trial for OCU410ST—Novel Modifier Gene Therapy Candidate for Stargardt Disease

Posted on July 18, 2025July 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 18, 2025

PDF Version

MALVERN, Pa., July 18, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies).

“Dosing the first patient is an especially significant milestone and brings us closer to our goal of addressing the unmet medical need that exists for all Stargardt patients—100,000 in the U.S. and Europe and 1 million worldwide,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Progressing our second modifier gene therapy candidate into a registration clinical trial is a pivotal step in potentially providing a one-time therapy for life for the millions of patients affected by inherited retinal diseases.”

The Phase 2/3 clinical trial for OCU410ST builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow up in evaluable treated eyes compared to untreated eyes. Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes.

“Initiating dosing in this pivotal Phase 2/3 study is an important advancement for Ocugen and more importantly for the Stargardt community,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “The adaptive design of this trial, including a masked interim analysis at 8 months on 24 subjects, enables us to efficiently evaluate early signals of efficacy and safety while optimizing study conduct. This ensures we generate robust and meaningful data to support our regulatory submissions for approvals.”

“Treating the first patient with this novel gene therapy in the GARDian3 trial is a proud and hopeful moment for our team and for families affected by Stargardt disease,” said Victor H. Gonzalez, MD, Principal Investigator and retinal surgeon at Valley Retina Institute, McAllen, Texas. “For decades, patients have faced the progressive loss of central vision with no approved treatment options. The encouraging Phase 1 results give us confidence that OCU410ST could meaningfully slow disease progression and help preserve vision. This trial brings us closer to the possibility of a one-time gene therapy that could transform patients’ quality of life for years to come.”

OCU410ST maintains a favorable safety and tolerability profile with no serious adverse events or adverse events of special interest, including ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization.

The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company’s planned Biologics License Application (BLA).

The OCU410ST Phase 2/3 pivotal confirmatory trial represents Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – ACCO Brands Corporation Announces Second Quarter 2025 Earnings Webcast

Posted on July 18, 2025July 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on ACCO

07/18/2025

LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that it will release its second quarter 2025 earnings after the market close on July 31, 2025. The Company will host a conference call and webcast to discuss the results on August 1 at 8:30 a.m. EST. The webcast can be accessed through the Investor Relations section of www.accobrands.com and will be available for replay.

About ACCO Brands Corporation

ACCO Brands is the leader in branded consumer products that enable productivity, confidence and enjoyment while working, when learning and while playing. Our widely recognized brands, include AT-A-GLANCE^®, Five Star^®, Kensington^®, Leitz^®, Mead^®, PowerA^®, Swingline^®, Tilibra^® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.

For further information:
Christopher McGinnis
Investor Relations
(847) 796-4320

Kori Reed
Media Relations
(224) 501-0406

Source: ACCO Brands Corporation

Release – Updated Data from Eledon Pharmaceuticals’ Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation to be Presented at the World Transplant Congress 2025

Posted on July 17, 2025July 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

July 17, 2025

PDF Version

IRVINE, Calif., July 17, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation will be presented at the World Transplant Congress (WTC) taking place in San Francisco from August 2-6, 2025. The oral presentation will feature updated results from approximately 30 kidney transplant recipients and will be presented by Dr. John Gill from the University of British Columbia.

Details of the oral presentation are as follows:

Title: Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study
Session: Oral Presentation, Kidney Novel Immunosuppressant Strategies
Presenter: John Gill, MD, MS, University of British Columbia, Vancouver, Canada
Session Date and Time: Wednesday, August 6, 2025: 10:00 a.m. – 11:15 a.m. PT

Following the session, a copy of the presentation can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

The Company will also sponsor a satellite symposium at WTC titled: “What Truly Defines Kidney Transplant Success: Early Rejection or Lasting Function?”, to be held on Sunday, August 3, at 1:00 pm PT. Faculty include Allan Kirk, MD, Duke University School of Medicine, Oriol Bestard, MD, PhD, MD, Vall d’Hebron University Hospital, John Gill, MD, MS, University of British Columbia, Alexandre Loupy, MD, PhD, Necker Hospital and Deirdre Sawinski, MD, Weill Cornell Medical College.

In addition to the oral presentation, new preclinical data, utilizing tegoprubart for the prevention of rejection in non-human primates undergoing liver transplantation, will be presented by Dr. Andrew Adams in a poster session:

Title: Anti-CD154 Facilitates Long-Term Liver Allograft Survival in Non-Human Primates
Session: Poster Presentation
Presenter: Andrew Adams, MD, PhD, University of Minnesota
Date and Time: Sunday, August 3, 2025, 3:30 p.m. PT

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

Release – Kratos and Intelsat Successfully Demonstrate 5G NTN Over GEO

Posted on July 17, 2025July 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on KTOS

July 17, 2025 at 8:00 AM EDT

PDF VersionOver-the-air testing validates satellite’s role in delivering end-to-end 5G services

SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, today announced the successful demonstration of an end-to-end 5G-NTN network that combines the Kratos OpenSpace® software-defined satellite ground system with Intelsat’s space and ground network, including its cloud-native, virtualized 5G core. This event represents a key milestone towards the seamless extension of terrestrial 5G networks with satellite technology, providing critical validation of satellite’s role in the delivery of ubiquitous 5G services.

The Third Generation Partnership Program (3GPP) incorporated Non-Terrestrial Networks (NTNs) into its 5G specifications with 3GPP Release 17, paving the way for the seamless extension of 5G services beyond terrestrial limits. Both Kratos and Intelsat are leading the market in 5G-NTN adoption; Kratos is working with key industry partners to develop cloud native 5G-NTN solutions for satellite operators, while Intelsat is focused on building a multi-layer, next-generation software-defined network.

Kratos and its partner Radisys announced last year their plans to develop a satellite base station – a 5G NTN gNodeB — delivered completely as cloud-native software, to be deployed as part of the OpenSpace® system. The over-the-air (OTA) demo conducted by Kratos and Intelsat validated that joint solution, leveraging it to orchestrate a 5G NR-NTN cell that was activated over Intelsat’s Galaxy 19 Ku-band GEO satellite. Multiple User Equipment (UE) emulators from partner VIAVI Solutions successfully attached and established PDU) traffic flows from different locations within the 5G-NTN cell, demonstrating that any standards-compliant terminal can access the 5G network on a satellite connection. This brings the industry closer to truly ubiquitous broadband services for all customers, regardless of location.

“This demonstration represents a significant milestone in both companies’ progress in advancing ubiquitous 5G connectivity that spans both terrestrial and space networks,” said Greg Quiggle, Senior Vice President of Product Management at Kratos. “This remarkable technical accomplishment demonstrates the value of the OpenSpace virtual ground system in enabling that connectivity.”

5G-NTN opens the door to a broad range of new communications services in markets unserved or underserved by terrestrial connectivity alone. It paves the way for seamless service delivery across satellite orbits, satellite operators and for mainstreaming satellite-enabled services seamlessly across the global web of terrestrial communications networks. Kratos’ OpenSpace platform will play a key role in that revolution by bringing the dynamic software-defined networking principles that are common in today’s terrestrial networks to the legacy satellite environment and leveraging a common, standards-based architecture for the delivery of global 5G services with terrestrial network partners.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value-add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Burghoff
claire.burghoff@kratosdefense.com

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – SelectQuote Unveils New Program Designed to Elevate Health Plan Performance by Improving Medication Adherence for Polychronic Medicare Beneficiaries

Posted on July 17, 2025July 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on SLQT

07/17/2025

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today announced the expanded launch of their innovative concierge-like service designed to specifically improve medication adherence for Medicare beneficiaries managing multiple chronic conditions and complex medication regimens. SelectQuote’s SelectRx pharmacy recently trialed a new approach with a regional health plan that demonstrated over 90% adherence, strengthening HEDIS Star ratings across the triple-weighted cholesterol, diabetes and hypertension measures. The Company plans to expand to additional payers this calendar year and will roll out across SelectRx’s pharmacy platform in 2026.

This program further demonstrates SelectQuote’s deep commitment to driving better health outcomes and greater value for both patients and payer partners. This high-touch solution is purpose-built to address the critical challenge of medication non-adherence, which often leads to preventable hospitalizations, adverse drug interactions, and escalating healthcare costs for the Medicare system.

SelectRx designed the program to proactively identify and engage high- and medium-risk patients, prioritizing those with a higher likelihood of adherence gaps. These beneficiaries stand to benefit most from enhanced support in managing their complex medication schedules. SelectQuote aims to help patients overcome adherence barriers through escalations to its clinical pharmacist team, who can provide specialized intervention. The Company also plans to launch a complementary program for lower risk members to support their continued medication adherence.

“We are incredibly excited about this initiative and its potential to significantly improve medication management for our most vulnerable Medicare beneficiaries,” said Bob Grant, President of SelectQuote. “Our SelectRx pharmacy offering already dramatically improves medication adherence and other health measures through timely, convenient delivery and easy-to-use packaging. We believe this new concierge-like program underscores that we are much more than a traditional Medicare broker helping beneficiaries find the right health plan. The program now takes our foundational commitment to improving Medicare patient outcomes to the next level. It embodies our mission to provide ongoing, personalized support that directly impacts patient health and well-being, significantly reducing costly acute episodes and improving quality of life.”

Forward Looking Statements

This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

Release – Ocugen to Host Conference Call on Friday, August 1 at 8:30 A.M. ET to Discuss Business Updates and Second Quarter 2025 Financial Results

Posted on July 17, 2025July 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 17, 2025

PDF Version

MALVERN, Pa., July 17, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Friday, August 1, 2025.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 9627149
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Release – MAIA Biotechnology Announces Peer-Reviewed Journal Publication of Data Validating Second Generation Ateganosine Prodrugs for Anticancer Therapy

Posted on July 17, 2025July 17, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

July 17, 2025 9:17am EDT Download as PDF

Manuscript featured in leading open-access peer-reviewed scientific journal Nucleic Acids Research

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids Research (NAR), a leading open-access peer-reviewed scientific journal.The study, titled “Novel Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal.

In January 2023, MAIA nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate (MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies. More than 80 ateganosine-like compounds have been developed as part of MAIA’s second-generation telomere targeting program.

In the featured study, MAIA designed and synthesized divalent dinucleotide prodrugs comprised of two nucleosides. The lead THIO-containing compounds, with two THIO pharmacophores, demonstrated the strongest anticancer efficacy in vivo and induced the strongest host immune-memory responses in vivo.

“The reported study data has shown that the sequential combination of MAIA-2022-12 or MAIA-2021-20 with an immune checkpoint inhibitor demonstrated a significantly lower 50% inhibitory concentration with superior anticancer efficacy compared with the corresponding monotherapies. The results suggest that MAIA-2022-12 and MAIA-2021-20 are promising candidates for future preclinical and clinical studies,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are working now to advance at least one of the candidates into human clinical trials upon completion of required GLP-toxicity and other evaluations.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250717795359/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released July 17, 2025

Release – GeoVax Highlights Growing Urgency for Diversified Mpox Vaccine Supply as Global Outbreaks Expand

Posted on July 16, 2025July 16, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

European Medicines Agency Supports Streamlined Development Pathway for GEO-MVA Vaccine Candidate via a Single Phase 3 Immuno-bridging Trial

ATLANTA, GA – July 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement underscoring the increasing urgency of expanding global Mpox vaccine access, as recent data from the Airfinity July 2025 Mpox Report highlight significant new outbreaks and rising global transmission of Clade I and Clade II Mpox.

The company previously announced favorable Scientific Advice from the European Medicines Agency (EMA) supporting the company’s proposed expedited development pathway for GEO-MVA. EMA confirmed that a single Phase 3 immuno-bridging trial, combined with proposed preclinical data, would be sufficient to support a Marketing Authorisation Application (MAA) via the centralized procedure. Immuno-bridging studies allow for vaccine approval by demonstrating comparable immune responses—rather than requiring traditional large-scale efficacy trials—thereby reducing development time while maintaining regulatory rigor. GeoVax is now accelerating engagement with global and regional health authorities as Mpox re-emerges with more virulent and transmissible strains in vulnerable populations.

“The global Mpox situation is expanding in both scope and severity, especially with the silent spread of Clade I in China, Europe, and the United States,” said David Dodd, Chairman and CEO of GeoVax. “The increasing number of breakthrough infections, pregnancy-related complications, and international importation threats make the need for second-source MVA-based vaccines not only strategic—but urgent. We are encouraged by EMA’s endorsement of a streamlined regulatory approach, which enables us to accelerate clinical development and scale-up planning for GEO-MVA.”

Global Spread of Clade I Mpox Highlights Need for Vaccine Diversification

The Airfinity report shows:

Clade I Mpox cases now span all continents, with new detections confirmed in China, United Kingdom, Italy and the U.S., including wastewater tracing.
Local Clade I transmission in China raises concern of sustained spread in one of the world’s most populous regions.
Travel-linked cases from Ethiopia and the Democratic Republic of the Congo (DRC) indicate high exportation risk to G7 countries, including the U.S. and France.
New data from the DRC confirmed vertical transmission of Mpox—meaning the virus was passed from mother to child during pregnancy—prompting renewed calls for next-generation vaccines with broader safety data and global availability.

GEO-MVA Positioned as Scalable, Strategic Alternative

GeoVax’s GEO-MVA vaccine candidate is being positioned as a second source MVA-based vaccine to address emerging global needs with:

EMA Scientific Advice concurrence on the company’s proposed expedited development pathway offering a near-term alternative MVA supply option.
Planned transition to a modernized AGE1 continuous cell-line-based manufacturing system, offering the potential for scalable, lower-cost, and U.S.-based production.

“As the global MVA vaccine stockpile is stretched and a single supplier model becomes increasingly untenable, GEO-MVA offers both immediate and long-term solutions to expand access, improve durability, and restore resilience to the world’s Mpox vaccine infrastructure,” added Dodd.

GeoVax is actively engaging with global stakeholders, including the World Health Organization (WHO), Africa CDC, and Gavi, as well as the U.S. Administration for Strategic Preparedness and Response (ASPR) to explore advance purchase agreements, regional partnerships, and manufacturing alliances to enable rapid deployment of GEO-MVA in current and emerging hotspots.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com

Release – Bit Digital, Inc. Announces Public Filing for WhiteFiber’s Proposed Initial Public Offering

Posted on July 16, 2025July 16, 2025 by aweinsoff@channelchek.com

Research News and Market Data on BTBT

July 16, 2025

NEW YORK, July 16, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), today announced that its wholly-owned HPC subsidiary, WhiteFiber Inc. (“WhiteFiber”), has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of WhiteFiber’s ordinary shares.

The number of shares to be offered and the price range for the proposed offering have not yet been determined. The initial public offering is subject to market and other conditions and the completion of the SEC’s review process. WhiteFiber intends to list its ordinary shares on The Nasdaq Capital Market under the symbol “WYFI.”

B. Riley Securities and Needham & Company are acting as the joint-bookrunning managers for the proposed offering.

The proposed offering of these securities will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the proposed initial public offering may be obtained from: B. Riley Securities, 1300 17^th Street North, Suite 1300, Arlington, VA 22209, Attention: Prospectus Department, by telephone at (703) 312-9580 or by email at prospectuses@brileysecurities.com; or from: Needham & Company, LLC, 250 Park Avenue, 10th Floor, New York, NY 10177, Attn: Prospectus Department, prospectus@needhamco.com or by telephone at (800) 903-3268.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

This press release is being made pursuant to, and in accordance with, Rule 134 under the Securities Act of 1933, as amended (the “Securities Act”). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act and other applicable securities laws.

About Bit Digital

Bit Digital is a publicly traded digital asset platform focused on Ethereum-native treasury and staking strategies. The Company began accumulating and staking ETH in 2022 and now operates one of the largest institutional Ethereum staking infrastructures globally. Bit Digital’s platform includes advanced validator operations, institutional-grade custody, active protocol governance, and yield optimization. Through strategic partnerships across the Ethereum ecosystem, Bit Digital aims to deliver exposure to secure, scalable, and compliant access to onchain yield. For additional information, please contact ir@bit-digital.com or follow us on LinkedIn or X.

Release – InPlay Oil Corp. Announces Notice of Non-Binding Offer for Obsidian Energy Common Share Position

Posted on July 16, 2025July 16, 2025 by aweinsoff@channelchek.com

Research News and Market Data on IPOOF

Jul 16, 2025, 07:00 ET

CALGARY, AB, July 16, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company“) announces that Obsidian Energy Ltd. (“Obsidian“) has provided the Company notice of a non-binding agreement between Obsidian and a third party in respect of the sale of all 9,139,784 common shares (“Common Shares“) in the capital of InPlay currently held by Obsidian (the “Third Party Offer“).

InPlay understands that the proposed price per Common Share under the Third Party Offer is in excess of the closing price of the Common Shares on the Toronto Stock Exchange as of July 15, 2025. The sale of any Common Shares by Obsidian to the third party remains subject to numerous terms and conditions, including, without limitation, execution of a definitive agreement and the approval of the Company pursuant to its investor rights agreement with Obsidian. While negotiations are continuing, there is no assurance that any binding agreement will be entered into in the future or that any transaction will be completed.

As a result of the Third Party Offer, Obsidian announced today that it will not launch its previously announced exchange offer to purchase up to approximately $10 million of its common shares for consideration consisting of Common Shares.

InPlay does not intend to issue any further public updates regarding this matter unless the situation warrants or as may be required by applicable securities laws or stock exchange rules.

SOURCE InPlay Oil Corp.

For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Kevin Leonard, Vice President, Business & Corporate Development, InPlay Oil Corp., Telephone: (587) 893-6804