School of Medicine University of Nevada

SAN FRANCISCO, Sept. 24, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that it will host an in-person and virtual event for investors and analysts on Tuesday, October 15, 2024, at 8:00 a.m. ET in New York, NY. The event will feature presentations from prominent ophthalmology key opinion leaders (KOLs) and company management. UNITY Biotechnology Ophthalmology Day Agenda Date: Tuesday, October 15, 2024Time: 8:00 a.m. until 9:30 a.m. ETLocation: Park Terrace Hotel, New York, NY (with simultaneous webcast)Registration and Webcast Link: https://lifescievents.com/event/unitybiotechnology/ Welcome and Introductions: Anirvan Ghosh, Ph.D., Chief Executive Officer, UNITY BiotechnologySenolytic Therapeutic Hypothesis: Mike Sapieha, Ph.D., Chief Scientist, UNITY BiotechnologyUBX1325 Clinical Development Plan – BEHOLD and ASPIRE studies in DME: Robert Bhisitkul, M.D., Ph.D., UCSF School of MedicineRetina Expert Roundtable: Arshad Khanani, M.D., MA, FASRS, Sierra Eye Associates, University of Nevada Reno School of MedicineDante Pieramici, M.D., California Retina ConsultantsAlicia Tozier, Chief Strategy Officer, UNITY Biotechnology Live Q&A The event will focus on UNITY’s ongoing Phase 2b ASPIRE study evaluating foselutoclax (UBX1325) head-to-head against aflibercept in diabetic macular edema (DME). Twenty-four-week safety and efficacy data are expected in the first quarter of 2025, and 36-week data are expected in the second quarter of 2025. Retina experts will address the evolving therapeutic landscape and the potential of UBX1325 to address unmet needs in DME. For virtual attendees, the live webcasts of the presentations will be accessible through the “Investors & Media” section of the company’s website, www.unitybiotechnology.com, under “Events & Presentations.” Archived replays will be available for 90 days. Featured Retina Experts Robert Bhisitkul, M.D., Ph.D.Robert Bhisitkul, M.D., Ph.D., is an ophthalmologist and retina specialist at UCSF Health who provides medical and laser treatments for macular degeneration, diabetic retinopathy and other retinal diseases. He also performs macular hole and macular pucker surgeries (conditions that cause blurred or distorted vision), retinal detachment and complications of diabetic eye disease. Dr. Bhisitkul recruits patients to participate in UCSF clinical trials of novel therapies for macular degeneration and diabetic retinopathy, and also for studies on long-term outcomes for treatments such as surgically implantable devices that deliver medication. He has published more than 60 papers in clinical and scientific journals. Arshad M. Khanani, M.D., MA, FASRSArshad M. Khanani, M.D., MA, FASRS, is a Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani founded the clinical research department at Sierra Eye Associates, which is now one of the leading clinical research centers in the country. He has served as a principal investigator for over 100 clinical trials and has been a top enroller in the country for multiple Phase 1-3 trials. In addition, Dr. Khanani was the first to perform surgical procedures in multiple surgical clinical trials dealing with sustained delivery and gene therapy. He has published over 75 scientific publications and is a frequent guest speaker at national and international meetings. Dante Pieramici, M.D.Dante Pieramici, M.D. is currently a managing partner of the California Retina Consultants and a member of the Medical Leadership Board of the Retina Consultants of America. As the Medical Director of Clinical Research at California Retina Consultants, Dr. Pieramici has served as the principal or sub investigator, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic related eye diseases. He has served as a consultant for numerous biotech companies, helping to design, monitor and evaluate clinical trial results for retinal diseases. He has authored over 150 peer-reviewed research papers and book chapters on retinal diseases and has served as editor for the text, Ocular Trauma: Principles and Practice. Dr. Pieramici currently serves as President of the California Retina Research Foundation and serves as a long-time board member at S.E.E International. About UBX1325UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting BCL-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. About UNITYUNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn. Media ContactInizio Evoke CommsKatherine SmithKatherine.Smith@inizioevoke.com Investor ContactLifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com Source: Unity Biotechnology, Inc.

CUPERTINO, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced it will host a virtual key opinion leader (KOL) event on Wednesday, September 4, 2024 at 2:00 PM ET. To register for the event, click here. The event will feature Brian Kirkpatrick, MD (Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences, Arkansas) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York), who will discuss the unmet medical need and current treatment landscape for patients suffering from symptoms of schizophrenia, and application of speech latency as an objective vocal biomarker in schizophrenia clinical trials for evaluation of negative symptoms. The discussion will focus on reviewing results of the vocal biomarker data and their relationship to the primary efficacy endpoint and key efficacy secondary endpoints negative symptoms, social functioning, social cognition and CGI from brilaroxazine Phase 3 RECOVER-1 trial in schizophrenia. A live question and answer session will follow the formal presentations. About Brian Kirkpatrick, MD, MSPHBrian Kirkpatrick, MD, MSPH, Professor in the University of Arkansas for Medical Sciences (UAMS) Department of Psychiatry, is a nationally and internationally renowned expert on schizophrenia and related disorders, whose pioneering research has advanced many life-changing treatments. Dr. Kirkpatrick graduated from the University of Texas Medical School at Houston and completed his residency in psychiatry at the University of North Carolina at Chapel Hill (UNC). After residency, he participated in the UNC Robert Wood Johnson Clinical Scholars Program, receiving a Master of Science in Public Health with a concentration in epidemiology. He also completed a fellowship in neuropharmacology at UNC. Dr. Kirkpatrick joined the Maryland Psychiatric Research Center at the University of Maryland School of Medicine in Catonsville and later served as vice chair of psychiatry at the Medical College of Georgia. He subsequently served as chair of the Department of Psychiatry at Scott & White Hospital and the Texas A&M School of Medicine, and the Department of Psychiatry and Behavioral Sciences at the University of Nevada, Reno School of Medicine. He joined the UAMS Department of Psychiatry in 2022. Throughout his career, Dr. Kirkpatrick has focused on schizophrenia and related disorders. He co-chaired the Consensus Development Conference on Negative Symptoms sponsored by the National Institute of Mental Health (NIMH). He has received competitive funding from NIMH, the National Institute of Diabetes and Digestive and Kidney Diseases, the Brain and Behavior Research Foundation, and the Scottish Rite Foundation. He served as an associate editor of Clinical Schizophrenia and Related Psychoses and is on the editorial board of Schizophrenia Bulletin. About Mark Opler, PhD, MPHMark Opler, PhD, MPH holds the titles of Chief Research Officer at WCG Inc. and Executive Director of the PANSS Institute. Dr. Opler has served as a faculty member in the Departments of Psychiatry and Environmental Medicine at New York University School of Medicine and in the Department of Neuroscience at Columbia University, College of Physicians and Surgeons. His academic research focuses on the etiology, phenomenology, and treatment of serious and persistent mental disorders. He is a co-author and developer of several clinical assessment tools, including the SNAPSI, CGI-DS, and NY-AACENT. He is a contributor to the latest edition of the PANSS Manual©. Dr. Opler has received research support from the US NIMH, the Brain & Behavior Foundation (formerly NARSAD), the Stanley Medical Research Institute, and the Qatar National Research Fund. He has co-authored more than 50 peer-reviewed publications and has contributed to multiple book chapters and review articles on clinical assessment, research methodology, and mental health. He received his PhD and MPH from Columbia University and his BSc from SUNY at Stony Brook. He is a graduate of the Psychiatric Epidemiology Training Program at Columbia University and completed his postdoctoral fellowship at the New York State Psychiatric Institute. About BrilaroxazineBrilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathobiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathobiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications. About RevivaReviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Corporate Contact:Reviva Pharmaceuticals Holdings, Inc.Laxminarayan Bhat, PhDwww.revivapharma.com Investor Relations Contact:LifeSci Advisors, LLCBruce Macklebmackle@lifesciadvisors.com Media Contact:Kristin Politikpoliti@lifescicomms.com(646) 876-4783

Company to highlight 4D-150 product development strategy and Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including longest available interim follow-up data Overview of the 4FRONT Phase 3 clinical trial program in wet AMD Corporate webcast to be held on September 18, 2024 at 4:15 p.m. ET and followed by live Q&A with senior Company leadership and retinal disease key opinion leader (KOL) panel, including Arshad M. Khanani, M.D., M.A., FASRS, Carl D. Regillo, M.D., FACS, FASRS, and Dante Pieramici, M.D. EMERYVILLE, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the Company will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The 4D-150 Wet AMD Development Day agenda will feature presentations, KOL panel discussions and live Q&A with senior ophthalmology Company leadership, including Robert Kim, M.D. (Chief Medical Officer), Dhaval Desai, Pharm.D. (Chief Development Officer), Chris Simms (Chief Commercial Officer) and Carlos Quezada-Ruiz, M.D., FASRS (SVP, Therapeutic Area Head, Ophthalmology) and retinal disease KOLs Arshad M. Khanani, M.D., M.A., FASRS (Sierra Eye Associates), Carl D. Regillo, M.D., FACS, FASRS (Wills Eye Hospital) and Dante Pieramici, M.D. (California Retina Consultants). The agenda will include presentations on: Overview of 4D-150 Phase 1/2 Development Strategy in Wet AMD to Date (PRISM Clinical Trial): Rationale for clinical trial design and treatment cohortsPhase 1/2a Study Design (Dose Exploration / Expansion cohorts) Primary Objectives: Demonstrate safety profile, evidence of biological activity and selection of Phase 2b dosesPatient Population: Severe disease activity, high treatment burden (minimum 6 prior injections in last 12 months) and generally long disease durationAflibercept loading dose regimen design: Given heavy pre-treatment of patients on study, single loading dose given at Week -1 Phase 2b Study Design (Population Extension cohort) Primary Objective: Confirm safety & evidence of biological activity in broad patient population, select Phase 3 dose and patient population to maximize probability of technical, regulatory and commercial successPatient Population: Broad range of disease activity, prior treatment burden (1 to 6 prior injections in last 12 months) and disease durationAflibercept loading dose design: Given only 1 prior injection required, loading doses given at weeks -1 & 4 to ensure all patients receive 3 total loading injections per standard of care, and to maintain patient safety during ramp up of aflibercept transgene expression over 8-12 weeks Expected Data Presentation & Analyses: Presentation of interim longest available follow-up data for below cohorts and dose levels from PRISM based on August 26, 2024 data cutoff Follow-up Duration Phase 1/2a (Dose Exploration / Expansion cohorts; 6E9, 1E10 and 3E10 vg/eye of 4D-150 and aflibercept control arms), range of follow-up: 52 weeks to 2.5 yearsPhase 2b (Population Extension cohort; 1E10 and 3E10 vg/eye arms), range of follow-up: 32 to 52 weeks Efficacy Data Supplemental aflibercept injectionsBest Corrected Visual Acuity (BCVA)Central Subfield Thickness (CST)Subgroup analyses based on: CST <600 μmDisease durationNumber of prior injectionsApproximate target Phase 3 population Safety Data Review of 4FRONT Wet AMD Phase 3 Program Objectives, Strategy and Final Design About the KOL Panelists Arshad M. Khanani, M.D., M.A., FASRS, is a 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. He has served as the principal investigator for more than 120 clinical trials and has over 150 scientific publications. Dr. Khanani is an elected member of the Macula Society and Retina Society. He has received numerous awards of distinction including the prestigious American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award and the ASRS Presidential Award. He is the lead Principal Investigator of the 4D-150 PRISM clinical trial and the Chair of 4DMT’s Ophthalmology Advisory Board. Carl D. Regillo, M.D., FACS, FASRS, is the Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia. He is the founder and former Director of the Wills Eye Clinical Retina Research Unit, former Chairman of the American Academy of Ophthalmology Retina Basic and Clinical Science Course, former Chairman of the Wills Eye Institutional Review Board, and prior Director of the Wills Eye Retina Fellowship. Dr. Regillo has authored over 200 publications along with over 50 book chapters and nine major books. He has been an investigator on numerous major clinical trials developing new treatments for retinal disorders such as macular degeneration and diabetic retinopathy. He lectures worldwide and has served on the scientific editorial board for numerous publications. Dante Pieramici, M.D., is a Managing Partner at California Retina Consultants, President of the California Retina Research Foundation, a member of the Medical Leadership Board of the Retina Consultants of America. Currently, he is the Medical Director of Clinical Research at California Retina Consultants. Dr. Pieramici has served as the principal, sub, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic-related eye diseases. He is a Principal Investigator of the 4D-150 PRISM clinical trial and member of 4DMT’s Ophthalmology Advisory Board. 4D-150 Wet AMD Development Day Webcast Details Title:4D-150 Wet AMD Development DayDate/Time:Wednesday, September 18, 2024 from 4:15 p.m. to 6:15 p.m. ETRegistration:Link An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website: https://ir.4dmoleculartherapeutics.com/events. About 4DMT 4DMT is a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology. 4DMT’s proprietary invention platform, Therapeutic Vector Evolution, combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our wholly owned and partnered product candidates. Our product design, development, and manufacturing engine helps us efficiently create and advance our diverse product pipeline with the goal of revolutionizing medicine with potential curative therapies for millions of patients. Currently, 4DMT is advancing six clinical-stage and one preclinical product candidate, each tailored to address rare and large market diseases in ophthalmology, pulmonology and cardiology. In addition, 4DMT is also advancing programs in CNS through a gene editing partnership. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of our product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. No representation is made as to the safety or effectiveness of our product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of and regulatory interactions regarding 4D-150. The words “may," “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts: Media: Katherine SmithInizio Evoke CommsMedia@4DMT.com Investors: Julian PeiHead of Investor Relations and Corporate FinanceInvestor.Relations@4DMT.com