The Oncology Institute, Inc. (TOI) – Improving Oncology Treatment While Cutting Costs


Wednesday, July 23, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating Coverage of The Oncology Institute With An Outperform Rating. The Oncology Institute of Hope & Innovation (TOI) is a medical practice management company specializing in community-based oncology practices. It manages and operates oncology clinics in five states using its proprietary, value-based methodology. These treatment regimens have improved outcomes for patients while reducing the cost of care.

TOI Uses Capitated Contracts To Control Costs. TOI enters into contracts with third-party payers to treat a specified number of health plan members based on the estimated per-member, per-month cost. This method of providing coverage based on population size is known as capitation. It also offers traditional fee-for-service as well as value-based oncology care.  This provides TOI with the flexibility to contract with more insurance plans.


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Release – GeoVax to Report Second Quarter 2025 Financial Results and Provide Corporate Update on July 28, 2025

Research News and Market Data on GOVX

    GeoVax to Host Conference Call at 4:30 PM ET

    Atlanta, GA, July 22, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that it will report second quarter 2025 financial results on Monday, July 28, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

    Conference Call Details

    To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

    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.

    Company Contact:

    info@geovax.com

    678-384-7220

    Investor Relations Contact:

    geovax@precisionaq.com

    212-698-8696

    Media Contact:

    Jessica Starman

    media@geovax.com 

    ARCHIMED’s $730M ZimVie Buyout Signals Renewed Interest in Undervalued Healthcare Plays

    Key Points:
    – ARCHIMED to acquire ZimVie Inc. for $19/share, nearly doubling its 90-day average price.
    – The $730M deal will take ZimVie private, accelerating its dental technology growth.
    – Positive signal for middle market healthcare investors as valuations rebound.

    In a strategic move that underscores growing momentum in middle-market healthcare, ZimVie Inc. (Nasdaq: ZIMV), a leader in dental implant technology, has entered into a definitive agreement to be acquired by healthcare-focused investment firm ARCHIMED. The all-cash transaction values ZimVie at approximately $730 million, or $19.00 per share — nearly double its 90-day volume-weighted average price of $9.57.

    For ZimVie shareholders, the nearly 99% premium represents a compelling exit, especially as the company faced headwinds in public markets. The deal will take the Florida-based firm private, offering it the strategic flexibility and financial backing often difficult to realize under the scrutiny of quarterly earnings and shareholder pressure.

    The acquisition is expected to close by the end of 2025, pending regulatory and shareholder approvals. Until then, ZimVie will continue to operate independently.

    ZimVie has carved out a niche in the global dental implant market, developing and delivering a comprehensive portfolio of restoration products and digital workflow solutions. Its global footprint and innovation in oral health make it a prime example of a middle-market firm with strong fundamentals and potential for accelerated growth under private ownership.

    ARCHIMED’s interest aligns with a broader trend: private equity firms are showing renewed appetite for small and mid-cap healthcare players that have proven tech, scalable platforms, and room for international expansion. ARCHIMED, which manages €8 billion across its healthcare-focused funds, has a track record of guiding companies through global scaling, M&A, and innovation cycles.

    While this deal removes a promising small-cap from public investor reach, it also sends a positive signal to investors looking to identify the next undervalued gem. ZimVie’s valuation leap shows that quality middle-market healthcare firms can still command significant premiums — and that smart capital is actively hunting in this space.

    Notably, ZimVie has entered a 40-day “go-shop” period, during which it can solicit competing bids. Though there’s no guarantee of a superior proposal, this opens the door for additional interest, potentially raising the final sale price — a factor for investors still holding shares.

    As healthcare innovation continues to be a resilient sector, especially in medtech and dental care, this deal could be a bellwether. Middle market investors may find increasing value in companies that combine specialized solutions with long-term demand — especially before they’re targeted by institutional buyers.

    Release – GeoVax Highlights EMA Regulatory Milestone as Catalyst for Near-Term Revenue from GEO-MVA Mpox Vaccine

    Research News and Market Data on GOVX

      Positive EMA Scientific Advice Positions GeoVax for Expedited European Approval

      ATLANTA, GA – July 21, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today reinforced the strategic and commercial significance of the recent positive Scientific Advice (SA) received from the European Medicines Agency (EMA) for its GEO-MVA vaccine targeting Mpox and smallpox.

      The EMA’s feedback indicated that a single Phase 3 immuno-bridging trial—bypassing the need for Phase 1 and 2 studies—may be sufficient to support a Marketing Authorization Application (MAA) under the EU’s centralized procedure. The ability to proceed without Phase 1 and 2 clinical trials substantially reduces development risk and timelines, positioning GeoVax to achieve product commercialization and revenue generation significantly earlier than previously anticipated.

      Immuno-bridging studies allow for vaccine approval by the immune response elicited by a candidate vaccine comparable to that of an already approved vaccine. This approach, when accepted by regulatory authorities, can reduce the need for large-scale efficacy trials, thereby reducing development time while maintaining regulatory standards for safety and immunogenicity.

      “This EMA guidance is more than a regulatory milestone—it represents a potential commercial inflection point,” said David Dodd, Chairman and CEO of GeoVax. “We now have a clear, expedited path to commercialization in one of the world’s largest vaccine markets. With the Phase 3 trial in operational preparation, we are entering a potential revenue acceleration phase supported by growing global demand, regulatory momentum, and our progressing advanced MVA manufacturing platform.”

      Key Investor Highlights:

      • Expedited Approval Path: EMA confirmed that one Phase 3 immuno-bridging trial—if successful—meets criteria for market authorization in all 27 EU countries.
      • De-Risked Development:  Moving directly to a Phase 3 immuno-bridging trial significantly reduces development timelines, cost, and clinical execution risk.
      • Market Timing Advantage: EMA guidance coincides with the WHO’s fourth Mpox PHEIC declaration and Clade I outbreaks across multiple continents.
      • First-Mover Opportunity: GEO-MVA would be the only MVA-based Mpox vaccine alternative to Bavarian Nordic’s Imvanex/Imvamune, addressing global supply constraints and monopolistic risk.
      • Revenue Visibility: GeoVax expects to initiate its Phase 3 trial in 2H 2026.
      • Manufacturing Readiness: Current CEF-based production supports near-term supply; transition to AGE1 cell line to enable scalable, cost-efficient output for global procurement.

      GeoVax is actively engaging with European regulatory bodies, public health stakeholders, and procurement agencies to advance GEO-MVA access and funding partnerships in support of both public health and commercial goals.

      “From an investor perspective, this EMA development potentially shortens our path to revenue generation and significantly enhances our strategic value,” said Dodd. “GeoVax is now on the radar as a viable near-term commercial vaccine company, not just a development-stage biotech.”

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

      Research News and Market Data on OCGN

      July 21, 2025

      PDF Version

      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

      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 

      Primary Logo

      Source: Tonix Pharmaceuticals Holding Corp.

      Released July 21, 2025

      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

      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 – 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

      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: LinkedInTwitter

      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 – 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

      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.

      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, 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

      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.

      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

      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 

        SelectQuote (SLQT) – Temporary Pressure, Strong Path Forward


        Wednesday, July 16, 2025

        Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

        Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

        Refer to the full report for the price target, fundamental analysis, and rating.

        Setting up fiscal 2026. We are adjusting our fiscal Q4 estimates to reflect updated expectations for the Medicare Advantage market, with a particular focus on recent regulatory changes affecting Special Needs Plans (SNPs). While these developments introduce near-term challenges, we believe SelectQuote is well-positioned heading into fiscal 2026. We expect the company to rebuild agent capacity ahead of the next Annual Enrollment Period (AEP), to support a trajectory of sustained revenue growth and adj. EBITDA margin expansion.

        Special Needs changes. Our revised Q4 outlook is primarily driven by recent changes implemented by CMS that restructure Special Needs Plan switching rights. The policy shift narrows mid-year enrollment flexibility for a significant portion of dual-eligible consumers (those enrolled in non-integrated D-SNPs), leading to the prospect of a smaller pool of shopping beneficiaries during the middle of calendar 2025. In addition, we are accounting for SelectQuote’s reduced year-over-year agent count, which entered fiscal 2025 approximately 22% below the prior-year level due to capital constraints at the time. These factors combined create a more muted backdrop for near-term Medicare Advantage performance.


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        This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

        *Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

        Breakthrough in Type 1 Diabetes: Stem Cell-Derived Islets Offer Hope for a Cure

        In a major milestone for type 1 diabetes treatment, a groundbreaking clinical trial has shown that stem cell-derived islet cell transplantation can effectively eliminate the need for insulin in patients. This advancement marks a turning point in diabetes care and highlights the efforts of leading researchers, including Dr. Piotr Witkowski at the University of Chicago, and the collaborative work of Vertex Pharmaceuticals (VRTX) and Eledon Pharmaceuticals (ELDN).

        Historically, islet cell transplantation involved harvesting pancreatic islets from deceased organ donors—a limited and logistically challenging source. Patients often required multiple transplants to see long-term benefits, and donor scarcity severely limited access to the therapy. But now, lab-manufactured islets derived from stem cells are changing the game, offering a consistent, scalable, and potentially off-the-shelf solution to treating the most severe forms of type 1 diabetes.

        In the ongoing multicenter clinical trial, presented at the American Diabetes Association’s Scientific Sessions and published in the New England Journal of Medicine, 10 of 12 patients remained insulin-independent for over a year after just a single infusion of stem cell-derived islets. This level of success, particularly from a single dose, is unprecedented in the field and demonstrates the power of scientific innovation to transform chronic disease management.

        Dr. Witkowski, a lead investigator and transplant surgeon at the University of Chicago, has been at the forefront of this effort. His involvement traces back to the early development of the clinical protocol in 2019 with Andrea Vergani at Semma Therapeutics. After Vertex Pharmaceuticals acquired Semma, Dr. Witkowski continued his work as a member of the Scientific Advisory Board and as a principal investigator performing transplants. As of last week, his team has successfully infused their 10th patient with Vertex’s stem cell-derived islets.

        While these results are promising, patients receiving the treatment still require immunosuppressive therapy to prevent rejection—typically involving drugs like tacrolimus, which can be toxic over time. That’s where Eledon Pharmaceuticals (ELDN) enters the picture. In a parallel pilot study, researchers are evaluating Tegoprubart, Eledon’s novel immunosuppressive agent designed to reduce toxicity while maintaining immune protection. If successful, Tegoprubart could offer a safer path forward and expand access to islet transplantation for a broader population.

        The future is bright. Trials are now underway to test the therapy in kidney transplant recipients—patients already on immunosuppressants—providing an ideal setting to further prove the therapy’s safety and effectiveness. With continued success, stem cell-derived islets could soon become a standard-of-care treatment, immediately benefitting the 40,000+ patients in the U.S. suffering from the most unmanageable forms of diabetes.

        Thanks to the visionary work of scientists, clinicians, and companies like Vertex and Eledon, what was once a highly experimental and limited therapy is on track to become a scalable medical solution. As Dr. Piotr Witkowski and his team continue their work, the path to a functional cure for type 1 diabetes is finally within reach.

        Learn more about Eledon Pharmaceuticals here.