Azura Ophthalmics Ltd.

TEL AVIV, Israel--(BUSINESS WIRE)--Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing AZR-MD-001, an investigational, potentially first-in-class, Ophthalmic Keratolytic targeting Meibomian Gland Dysfunction (MGD), today announced that it has received positive feedback from a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) confirming that the company’s existing clinical development program for AZR-MD-001 is sufficient to support its planned NDA submission. “We are very encouraged by the FDA’s feedback and pleased by their determination that our existing clinical data package satisfies the requirements for a sign and symptom in two adequate and well-controlled confirmatory efficacy studies,” said Marc Gleeson, CEO of Azura Ophthalmics. “We believe AZR-MD-001 has the potential to redefine how patients with Meibomian Gland Dysfunction and Dry Eye Disease are treated by directly targeting gland function with a novel, easy-to-administer, twice-weekly ophthalmic ointment. As a company, we are focused on submitting our NDA package in the second half of 2026.” The FDA confirmed the CELESTIAL and ARIES study data fulfill the regulatory efficacy requirements for approvability of AZR-MD-001 for the treatment of the signs and symptoms of Dry Eye Disease (DED). The results from these two studies demonstrate statistically significant improvement in a sign, Meibomian Glands Yielding Liquid Secretion (MGYLS), and symptomatic benefit in Ocular Surface Disease Index (OSDI©) in CELESTIAL and increased comfortable contact lens wear time in ARIES. The FDA indicated that the safety database across CELESTIAL, ARIES, and ASTRO is sufficient for submission, with long-term safety data from the ongoing ASTRO study expected to be shared in Q1 2026, further supporting the application. The company believes that AZR-MD-001’s robust product profile, including its unique triple mechanism of action, keratolytic, keratostatic, and lipogenic, supports its differentiation from existing DED therapies. AZR-MD-001 is administered directly to the lower eyelid margin twice weekly at bedtime. It is designed to restore meibomian gland function, improve tear stability, and reduce symptoms associated with DED, including Contact Lens Discomfort (CLD). “We continue to see growing recognition among physicians that AZR-MD-001 addresses meibomian gland obstruction, an important and previously untreated root cause of Dry Eye Disease,” said Dr. Francis Mah, Director of Cornea and External Disease and Co-Director, Refractive Surgery at Scripps Clinic Medical Group, La Jolla, Calif. “A product that can open and restore gland function with a convenient, twice-weekly dose could be practice-changing for millions of patients.” AZR-MD-001 is an investigational drug candidate and has not been approved by the U.S. FDA. To date, over 500 patients have been treated with AZR-MD-001 in clinical trials, and the product appears to be safe and well-tolerated. About Meibomian Gland Dysfunction (MGD) Meibomian Gland Dysfunction (MGD) is a chronic and progressive condition that affects the quality and flow of meibum from the meibomian glands. MGD is a leading cause of Dry Eye Disease (DED). Without treatment, MGD may lead to glandular dropout and increased ocular surface damage, which reduces quality of vision and decreases quality of life. Current therapies for DED primarily focus on inflammation or tear production and do not address the underlying glandular dysfunction that characterizes MGD. About CELESTIAL1,2 CELESTIAL, a multicenter, vehicle-controlled, randomized study to evaluate the safety, tolerability, systemic pharmacokinetics, and pharmacodynamics of AZR-MD-001 in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED) was a parallel group study of AZR-MD-001 (0.5% and 1.0%) and vehicle in a 1:1:1 ratio, dosed twice-weekly in the evening (at bedtime). Patients were followed for a total of 6 months. The pre-specified primary efficacy endpoints were Meibomian Glands Yielding Liquid Secretion (MGYLS) and total Ocular Surface Disease Index (OSDI©) change from baseline to Month 3. About ARIES3 ARIES was a multi-center, vehicle-controlled study to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 and to determine common symptoms in patients with Dry Eye Disease (DED) characterized by signs of Meibomian Gland Dysfunction (MGD) and an inability to wear their contact lenses as desired. Patients were treated with either AZR-MD-001 0.5% and vehicle in a 1:1 ratio, dosed twice-weekly in the evening (at bedtime). Patients with DED were challenged with Contact Lens Wear and were followed for a total of 3 months. The primary efficacy sign endpoint was Meibomian Glands Yielding Liquid Secretion (MGYLS), and the symptom endpoint was Comfortable Contact Lens Wear Time in hours. About ASTRO ASTRO, a phase 3, multicenter, vehicle-controlled, randomized study to evaluate the efficacy, safety, and tolerability of AZR-MD-001 in patients with abnormal meibomian gland function and associated symptoms of Dry Eye Disease (DED), is an ongoing parallel group study of AZR-MD-001 0.5% and vehicle randomized in a 1:1 ratio. The study drug is dosed twice-weekly to the lower eyelid in the evening (at bedtime). The study objective supporting the New Drug Application (NDA) is to evaluate the safety and tolerability of AZR-MD-001 sterile ophthalmic ointment 0.5% or vehicle dosed twice-weekly through Month 12. About AZR-MD-001 AZR-MD-001 is the first and only Ophthalmic Keratolytic investigational therapy in development as a foundational treatment for Meibomian Gland Dysfunction (MGD), a leading cause of Dry Eye Disease (DED). Delivered as a twice-weekly selenium sulfide ointment applied to the lower eyelid margin, AZR-MD-001 is designed to restore meibomian gland function by improving the quality and quantity of meibum, rejuvenating the lid margins, and alleviating evaporative dry eye symptoms. The therapy’s unique triple mechanism of action, keratolytic, keratostatic, and lipogenic, targets the root cause of MGD. About Azura Ophthalmics Azura Ophthalmics (“Azura”) is utilizing its deep understanding of ocular surface diseases and drug development to deliver a potential new therapeutic class of Ophthalmic Keratolytics to treat underserved ophthalmic conditions. The company’s differentiated approach combines ophthalmologic and dermatologic science to harness the unique properties of keratolytics for the treatment of Dry Eye Disease (DED) by targeting Meibomian Gland Dysfunction (MGD) and other ocular diseases. Azura’s pipeline of internally discovered new chemical entities represents a portfolio of potentially first-in-class ophthalmic therapeutics for significant unmet needs. For more information, visit www.azuraophthalmics.com and follow Azura on LinkedIn. References Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-46. Downie LE, Craig JP, Stapleton F, Tan J, Jones LW, Ng A, et al. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction over six months of treatment: A Phase 2, vehicle-controlled, randomized extension trial. Ocul Surf. 2025 Jan:35:15-24. Stapleton F, Hinds M, Tan J, Jones L, Chalmers R, Bosworth C, Alster Y. AZR-MD-001 0.5% selenium sulfide ophthalmic ointment for the treatment of contact lens discomfort: A vehicle-controlled, randomized, clinical trial. Ocul Surf. 2024 Dec 28:S1542-0124(24)00144-7.

Dr. Margaret A. Liu, global expert in vaccines, gene therapy, and cancer immunotherapy; chief executive officer of PAX Therapeutics and member of several boardsMs. Anat Naschitz, proven life science investor and entrepreneur; co-founder of OrbiMed Israel PARIS and CAMBRIDGE, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as observers to its Supervisory Board. “We are thrilled at the opportunity to welcome Ms. Anat Naschitz and Dr. Margaret A. Liu to the Nanobiotix Supervisory Board as we push toward delivering on the practice-changing potential of nanophysics-based therapies for the treatment of cancer and other major diseases,” said Laurent Levy, Ph.D., Nanobiotix Chief Executive Officer and Chairman of the Executive Board. “Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy that could prove critical in making the Nanobiotix vision a reality at this important moment in the Company’s history. Ms. Naschitz brings world-class fluency in the language of capital and how that capital can be best utilized to support disruptive innovation for the benefit of patients, healthcare professionals and investors.” Margaret A. Liu, M.D., is a world-renowned expert in the fields of gene therapy, vaccines and immunotherapy. She currently serves as Chief Executive Officer (“CEO”) of PAX Therapeutics, as an Adjunct Full Professor at the University of California, San Francisco, and as Hedersdoktor with scientific affiliation in the Department of Medicine at the Karolinska Institutet. Dr. Liu pioneered DNA vaccines and bispecific antibodies and has received a number of international awards. Dr. Liu widely consults for companies and scientific governmental and non-governmental organizations such as the World Health Organization (WHO) through her activities as Principal of ProTherImmune and previously held positions of increasing responsibility at Merck & Co. and Chiron Corporation. She is currently a board member of Ipsen, where she chairs the Ethics and Governance Committee and is a member of the Innovation and Development Committee, and as a member of the board, and President Emerita, of the International Society for Vaccines. She also serves on the board of MacroGenics as well as the Science and Technology Committee. Previously she served on the boards of Transgene, Sangamo Biosciences, Adjuvance Technologies and the United Nations Development Programme-established International Vaccine Institute and was Senior Advisor in Vaccinology at the Bill & Melinda Gates Foundation. Dr. Liu earned an M.D. from Harvard Medical School and completed an internship and residency in Internal Medicine followed by an Endocrinology Fellowship at Massachusetts General Hospital. She also served on the faculty at Harvard Medical School and was a Visiting Scientist at the Massachusetts Institute of Technology. She obtained a B.A. in Chemistry summa cum laude from Colorado College. Anat Naschitz is a life science investor and entrepreneur, with over three decades of experience across biotech, pharmaceuticals, computational R&D, digital health and medical devices, in multiple therapy areas and stages. Throughout her career Ms. Naschitz has founded companies and nurtured them through success with public and private board involvement and investment. Currently, she is co-founder and CEO of 9xchange, a computational company creation engine that uses artificial intelligence and machine learning to mine and optimize biopharma assets. Ms. Naschitz co-founded and co-led OrbiMed Israel as part of the ± $17bn global healthcare investment firm and was previously with ± €65bn private equity firm Apax where she invested in healthcare companies. Companies Anat has nurtured and on whose boards she has served include 89bio (Nasdaq: ETNB), currently running two cardiometabolic Phase 3 trials, where she led the creation of the company as a pharma spinout and was instrumental in driving a public offering 18 months later, subsequently continuing to serve on the board and several committees; Azura Ophthalmics, in Phase 3 with a drug for Meibomian Gland Disorder which is the root cause behind most dry eye disease; ForSight Vision 6, running a pivotal trial with a truly Accommodating Intraocular Lens under a strategic alliance; TytoCare, a growth-stage company commercializing the Home Smart Clinic; and MDClone, commercializing a synthetic data and analytics platform. Earlier in her career, Ms. Naschitz was an Associate Partner with McKinsey in London, where she advised the senior management of leading pharmaceutical companies on strategy, acquisitions and spinouts. Sobi (STE: SOBI.ST) ultimately resulted from one such spinout. Ms. Naschitz earned her M.B.A. at INSEAD and her L.L.B. at Tel Aviv University. “Both Ms. Naschitz and Dr. Liu possess extensive global experience in the biopharmaceutical industry,” said Gary Phillips, M.D, Nanobiotix Supervisory Board chairman. “We expect their expertise to reinforce our ongoing strategic initiatives in oncology for NBTXR3 and expand development and collaboration opportunities for Nanobiotix platforms beyond NBTXR3.” These nominations will be submitted for ratification at the next Nanobiotix shareholders’ meeting. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024 and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Nanobiotix Communications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentCraig WestSVP, Investor Relations+1 (617) 583-0211investors@nanobiotix.com Media Relations FR – Ulysse CommunicationLaurent Wormser+ 33 (0)6 13 12 04 04lwormser@ulysse-communication.com   Global – LifeSci AdvisorsKevin Gardner+1 (617) 283-2856kgardner@lifesciadvisors.com Attachment 2024-09-04 -- NBTX -- Two New Supervisory Board Members -- FINAL

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, the “Company”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the appointment of Heather Preston, M.D. and Margarita Chavez, J.D. as Class II Independent Directors to the Board of Directors, effective August 7, 2024. Dr. Preston will join the Nominating and Corporate Governance Committee as Chair and Ms. Chavez will join the Audit Committee. “We are pleased to announce the appointment of Dr. Heather Preston and Margarita Chavez to our Board of Directors,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Both Heather and Margarita bring substantial expertise across the life sciences spectrum. We look forward to their important contributions towards ensuring Aligos’s success.” Heather Preston is an experienced healthcare investor and company builder, with more than 30 years of industry experience. She is currently a Senior Advisor to TPG Biotech and serves on the Boards of Oxford Biomedica (OXB:LSE), Oxford Nanopore Technologies (ONT:LSE), and Azura Opthalmics. Previously, she was a Managing Partner of Pivotal BioVentures and a Firm Partner and Managing Director of TPG Biotech. She also held investing roles at JP Morgan Partners and New Enterprise Associates. Prior to her investing career, Dr. Preston spent five years at McKinsey & Co, where she was a leader of their pharmaceutical and medical products consulting practice. Dr. Preston has an undergraduate degree in biochemistry from the University of London and a medical degree from the University of Oxford. Dr. Preston completed a post-doctoral fellowship in molecular biology at the Dana Farber Cancer Institute, Harvard University and trained in Internal Medicine at the Massachusetts General Hospital and subspecialized in Gastroenterology and Hepatology at UCSF. During her academic medical career, she was the recipient of a Fulbright Scholarship, a Fulbright Cancer Research Scholarship, a Harlech Scholarship and a Science and Engineering Research Council Post-Doctoral Fellowship Award. “I am thrilled to join the Board at Aligos,” stated Dr. Heather Preston. “This is an exciting time as Aligos has two potential best-in-class oral drugs for MASH and CHB. I look forward to the opportunity of working with the other Board members and the Senior Leadership Team as the Company continues to progress its promising drug candidates through the clinic.” Margarita Chavez is a seasoned biopharmaceutical executive, with over 25 years of dealmaking experience in the healthcare industry. She is currently a Venture Partner at Wellington Partners and is an independent investor and advisor in early-stage biotechs. Margarita also currently serves on the Board of Newron Pharmaceuticals (NWRN:SIX). Margarita was previously Managing Director at AbbVie Ventures and was responsible for investments in Morphic Therapeutics, Alector Therapeutics, Carisma Therapeutics, Jnana Therapeutics, Enthera Pharmaceutials, Palleon Pharmaceuticals, and Accent Therapeutics, among others. As a Director on the Licensing & Acquisitions team of Abbott / AbbVie, Margarita was involved in the in-licensing of Oralissa, and the acquisitions of Immuven and Solvay. Early in her career, Margarita practiced as a corporate and securities lawyer, advising clients on mergers, acquisitions, public and private financings at Brobeck, Phleger & Harrison LLP in Silicon Valley. Outside of her venture work, Margarita serves on the Board of Regents at Santa Clara University and on the Board of P33 Chicago. “I look forward to collaborating with the Board to guide the team at Aligos to continue delivering for shareholders and patients in need,” stated Margarita Chavez, J.D. “Aligos’ dedication to science in order to bring the best drug candidates forward is a mission that I look forward to supporting.” About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics Contact Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com