LAPIX Therapeutics, Inc.

- Appointment Adds Broad Expertise in Business Strategy, Collaborations, Finance, and M&A with Recent Ophthalmic Experience -ALPHARETTA, Ga., April 16, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that Anthony S. Gibney has been appointed to the Company's Board of Directors, effective April 15, 2024. “We are delighted to welcome Tony to our Board of Directors as we build on our leadership in delivering therapeutics to the suprachoroidal space,” said Clay Thorp, Chair of the Clearside Board of Directors. “We believe Tony’s significant experience driving value for biotech companies through successful pipeline development, financing, partnering and M&A will be an invaluable resource to the Clearside team as we enter this pivotal growth phase of the company.” George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside, commented, “Tony’s deep understanding of the biotech business, combined with his recent and relevant experience at Iveric Bio, will provide critical insight and guidance for our strategic and business development initiatives as we look towards a potential Phase 3 program for our lead clinical program, CLS-AX in wet AMD, and explore opportunities for suprachoroidal pipeline expansion.” “I am honored to join the Board of Directors as Clearside offers a differentiated approach in the ophthalmology space,” said Mr. Gibney. “I look forward to partnering with the leadership team and Board to generate value based on the opportunity for CLS-AX in retinal diseases and Clearside’s innovative suprachoroidal delivery platform that I believe has broad potential to improve outcomes for individuals living with a number of sight-threatening diseases.” Anthony S. Gibney is an experienced biotechnology executive and former investment banker who brings over 25 years of experience dedicated to advising biotechnology companies in the U.S. and Europe on business strategy, collaboration transactions, financings, and mergers and acquisitions. Most recently, Mr. Gibney served as the Executive Vice President, Chief Business & Strategy officer of Iveric Bio, Inc. until the company’s acquisition by Astellas Pharma Inc. in July 2023. Prior to that, Mr. Gibney served as Chief Financial Officer and Chief Business Officer at Fog Pharmaceuticals, Inc., where he oversaw its business development, strategy and finance functions, and he served as Executive Vice President and Chief Business Officer at Achillion Pharmaceuticals, where he led the sale of Achillion to Alexion Pharmaceuticals, Inc. in 2020. Before Achillion, Mr. Gibney was a Managing Director and Co-head of the biotechnology investment banking team at Leerink Partners LLC, and Managing Director of Merrill Lynch’s healthcare group. He currently serves on the boards of directors of LAPIX Therapeutics, Inc. and InflaRx N.V. Mr. Gibney received a B.A. in Economics and a B.A. in History from Yale University. About Clearside Biomedical, Inc. Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2b clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com and follow us on LinkedIn and X. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, the reporting of results from the ODYSSEY clinical trial, the potential benefits of Mr. Gibney joining the Board of Directors and the potential benefits of CLS-AX and other product candidates using Clearside’s SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Source: Clearside Biomedical, Inc. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1dc9e939-b913-4861-947a-500542b41a20

BOSTON, Feb. 07, 2024 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced the appointments of Henry A. McKinnell, Ph.D., and Anthony Gibney to its Board of Directors and Francisco Leon, MD, Ph.D. as a Board Observer. These appointments bring more than five decades of scientific acumen and growth-focused leadership to LAPIX as the company works to transform how medical communities treat and support patients diagnosed with serious and complex autoimmune diseases. “We are thrilled to announce the appointment of our newest board members, whose arrivals mark a pivotal moment for LAPIX, especially as we complete the ongoing Phase I study and move LPX-TI641 towards Phase II,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “Dr. McKinnell, Mr. Gibney and Dr. Leon are exceptionally well-equipped to contribute to LAPIX's strategic vision, providing insights that will undoubtedly shape the future trajectory of our company and our pursuit of immune restoration strategies.” Dr. McKinnell is the former Chairman and CEO of Pfizer, Inc., former chairman of Moody’s, and co-founder and past Chairman of the Infectious Disease Institute in Kampala, Uganda. He is a member of the boards of directors of Nexcella and the Science and Technology in Society Forum. He serves as chairman emeritus of the Connecticut Science Center, the Business Roundtable, the Pharmaceutical Research Manufacturers Association, the Food and Drug Law Institute, and the Medical Device Manufacturers Association. He also currently serves as a Senior Advisor to Quris AI and Spire. Dr. McKinnell holds a Bachelor of Commerce in business from the University of British Columbia and MBA and Ph.D. degrees from Stanford Graduate School of Business. Bringing over 25 years of life-science and investment banking experience to Lapix, Mr. Gibney has previously held Chief Financial Officer and/or Chief Business Officer positions at Iveric Bio (acquired by Astellas Pharma), FogPharma, and Achillion Pharmaceuticals (acquired by Alexion). His dual expertise in finance and biotech uniquely positions his insights at the intersections of financial strategy and operational expertise. He also served as Managing Director and Co-Head of the Biotechnology Investment Banking Team at Leerink Partners, and lead the East Coast effort at Merrill Lynch as a Managing Director. Mr. Gibney holds a Bachelor of Arts in Economics and in History from Yale University. Joining the Board as a Board Observer, Dr. Leon will lend his significant expertise in clinical immunology, translational medicine and as a successful drug developer. Dr. Leon is currently the founder and CEO of Tolerance Bio and previously served as the Chief Scientific Officer and cofounder at Provention Bio (acquired by Sanofi), co-founder and CEO of Celimmune (acquired by Amgen) and Vice President & Head, Immunology Translational Medicine J&J/Janssen amongst other endeavors. He has played a pivotal role in the development and success of these organizations and has been responsible for the translational strategies and early clinical development of biologic and small molecule therapies for immune-mediated diseases. His dedication to immunology spans 30 years, culminating in the FDA approval of teplizumab/TZIELD®, the first-ever non-chronic immune resetting agent in T cell autoimmunity. He earned a Ph.D. in Mucosal Immunology from the Universidad Autónoma de Madrid and completed a Specialist program in Clinical Immunology at Hospital Ramon y Cajal, Madrid. He earned a MD from the Universidad Autónoma de Madrid. "I am honored to welcome new colleagues to the board,” added Dr. Fathallah. "Their considerable and demonstrated capacity to offer strategic guidance to companies poised for growth is an invaluable asset as we collectively navigate the intricate challenges of developing cures for autoimmune diseases." About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases and immune function restoration therapies for oncology. To learn more, visit www.lapix.com or follow us on LinkedIn and Twitter. Contact:Anas M. Fathallah, Ph.D.CEO and Co-Founderinfo@lapixtherapeutics.com

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that the first participants have been dosed in the Phase 1 study of the Company’s LPX-TI641therapy. LPX-TI641 is a novel, and proprietary first-in-class orally bioavailable small molecule designed as a T cell immunoglobulin and mucin domain-containing protein (Tim) 3/4 receptor agonist. The Tim family of receptors plays an important role in autoimmunity. LPX-TI641 restores the balance of regulatory immune cells (T- and B-regs) to autoreactive T-cells reestablishing immune tolerance. It is being developed for the treatment of Multiple Sclerosis (MS) and potentially other autoimmune diseases such as rheumatoid arthritis and lupus. “The dosing of the first participants is a major milestone in the clinical development of LPX-TI641,” said Anas M. Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “We are excited to begin the clinical evaluation of our antigen-agnostic immune tolerance restoration therapy. We look forward to evaluating the therapeutic potential of LPX-TI641 and believe it will be a transformative and safer option for patients suffering from MS and other autoimmune diseases. The design of the Phase I study will allow us the flexibility to leverage the clinical data for other indications, enabling rapid pivots into other autoimmune diseases,” added Dr. Fathallah. The study is a randomized, double-blind, placebo-controlled study in healthy adult volunteers to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 after single ascending oral doses. Exploratory pharmacodynamic and biomarker analysis will also be evaluated as part of this study. More information about the study can be found at NCT05853835 About LPX-TI641 LPX-TI641’s primary pharmacology is the upregulation of Foxp3+/CD4+ T-cells (T-regs) and of Tim1+/CD25+/CD19+ (B-regs) and inhibition/downregulation of Th17. The combined effects of LPX-TI641’s pharmacology is to allow the adaptive immune system to re-establish self-tolerance (T-reg/Th17 balance and B-regs) without affecting the innate immune system. The efficacy of LPX-TI641 versus standards of care has been evaluated in several animal models of MS and those models have shown favorable efficacy of LPX-TI641 in treatment escalation and treatment induction/maintenance paradigms mimicking current clinical management paradigms of MS without inducing neutropenia or lymphocytopenia suggesting better safety as well. It is currently under development for neuro-autoimmune indications such as MS, with the intent to expand into rheumatoid arthritis and lupus amongst other autoimmune conditions. About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy, and immune function restoration therapies for oncology. To learn more, visit or follow us on LinkedIn and X. Contact: Anas M. Fathallah, Ph.D. CEO and Co-Founder info@lapixtherapeutics.com