VEGFR3

MELBOURNE, Australia and PRINCETON, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT; “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced it will host a virtual key opinion leader (KOL) event on Wednesday, April 3, 2024, from 10:00 to 11:30 am ET, featuring presentations from global retina experts: Arshad M. Khanani, MD, MA, FASRS, Sierra Eye Associates and University of Nevada, Reno School of Medicine Charles C. Wykoff, MD, PhD, Retina Consultants of Texas and Blanton Eye Institute, Houston Methodist Hospital Veeral S. Sheth, MD, MBA, FASRS, FACS, University Retina and Macula Associates, University of Illinois at Chicago This event will focus on the potential of sozinibercept to transform patient outcomes by delivering superior vision gains in wet age-related macular degeneration (wet AMD), with KOL perspectives on (1) the wet AMD treatment landscape and unmet medical need addressed by sozinibercept’s novel mechanism of action, (2) the Phase 2b data demonstrating superiority in combination with standard-of-care therapy, and (3) the company's two ongoing global Phase 3 registrational trials (COAST and ShORe) evaluating sozinibercept in combination with standard-of-care VEGF-A inhibitors. Additionally, Opthea will provide a strategic outlook. A live question and answer session will follow the formal presentations. To register for this live webcast, click here. A replay of the webcast will be made available on the Company’s website. About Arshad M. Khanani, MD, MA, FASRS Arshad M. Khanani, MD, MA, FASRS is dedicated to advancing innovative treatment options for patients suffering from retinal diseases. Over a decade ago, he established the clinical research department at Sierra Eye Associates, which has since evolved into one of the foremost clinical research sites nationwide. With a wealth of experience, he has assumed the role of principal investigator for more than 120 clinical trials, consistently ranking as a top enroller in the nation across multiple Phase 1-3 trials. Notably, Dr. Khanani recently chaired the Phase 3 GATHER2 steering committee for IZERVAY™, playing a pivotal role in IZERVAY's approval for geographic atrophy. His contributions extend to over 100 authored or contributed scientific publications in prominent ophthalmology journals. Dr. Khanani actively participates as a member of national and international clinical trial steering committees, in addition to serving on scientific advisory boards. Dr. Khanani also serves as the lead principal investigator for multiple national and global clinical trials. He is often sought after as a guest speaker and lecturer at prestigious national and international gatherings. In pursuit of advancements in vitreoretinal care, Dr. Khanani initiated the Clinical Trials at the Summit (CTS) meeting, aiming to foster dialogue on clinical trial execution, design, and data analysis. Dr. Khanani holds elected membership in esteemed organizations such as the Macula Society and Retina Society, in addition to being the recipient of numerous distinguished awards. In 2019, he was honored with the Nevada Business Magazine Healthcare Heroes Physician of the Year award in recognition of his unwavering commitment to the field of ophthalmology. Dr. Khanani has been bestowed with the Senior Honor Award from the American Society of Retina Specialists (ASRS) and was also awarded the prestigious ASRS Presidents’ Young Investigator Award in 2021. Furthermore, in 2023, he was invited to deliver the esteemed Ernst Bodenheimer Memorial Lecture at the Wilmer Eye Institute at Johns Hopkins University. In February 2024, Dr. Khanani joined Opthea as its Chief Medical Advisor, while retaining his practice, sponsorship, and research activities. Prior to his new role at Opthea, Dr. Khanani served as a principal investigator for Opthea’s ShORe Phase 3 pivotal trial. About Charles C. Wykoff, MD, PhD Charles C. Wykoff, MD, PhD is a board-certified Medical and Surgical Retina Specialist and ophthalmologist with Retina Consultants of Texas (RCTX). Leading a top international research facility for vitreoretinal diseases, Dr. Wykoff serves as Director of Research at RCTX and the Greater Houston Retina Research Foundation (GHRRF), and Chairman of the Research and Clinical Trials Subcommittee, Retina Consultants of America. In addition, he serves as the elected Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital. Dr. Wykoff has been awarded the American Academy of Ophthalmology Secretariat and Achievement Awards as well as the American Society of Retina Specialists Senior Honor and Young Investigator Awards. Dr. Wykoff serves as the Chief Investigator for Opthea’s COAST Phase 3 pivotal trial and is on Opthea’s Clinical Advisory Board. About Veeral S. Sheth, MD, MBA, FASRS, FACS Veeral Sheth, MD, MBA, FACS, is a native Chicagoan that specializes in diseases of the retina and vitreous. He also is a Clinical Assistant Professor at the University of Illinois at Chicago. Dr. Sheth completed his ophthalmology residency at the Illinois Eye and Ear Infirmary where he served as Chief Resident. After residency, Dr. Sheth completed his fellowship at the University of Chicago in Retinal Surgery. He completed his MBA at Northwestern University’s Kellogg School of Management. Dr. Sheth is a Partner at University Retina and Macula Associates. He is Director of Clinical Trials at one of the busiest clinical trial sites in the country. He has been principal investigator for over 60 clinical trials and has research interests in macular degeneration, diabetic retinopathy, vein occlusion, as well as surgical pathology. He is involved in clinical trials developing new drugs, delivery devices, and gene therapy. Dr. Sheth is an active member of the American Society of Retina Specialists, Retina Society, American Academy of Ophthalmology, The Association for Research in Vision and Ophthalmology, and the European Society of Retina Specialists. He is the Chairman Emeritus of the Board of Directors for Meals on Wheels Chicago. Dr. Sheth is fluent in English, Spanish, and Gujarati. Dr. Sheth is a principal investigator for Opthea’s ShORe Phase 3 pivotal trial. About Sozinibercept Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases including wet AMD. Sozinibercept has received Fast Track Designation from the U.S. FDA for the treatment of wet AMD. Positive results from the Phase 2b study of sozinibercept, administered in combination with standard of care, LUCENTIS® (ranibizumab), for the treatment of wet AMD, published in Ophthalmology, met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive for the combination therapy with sozinibercept, including more participants with gains in vision of 10 or more letters and improved anatomy, with a reduction in swelling and vascular leakage, with a favorable safety profile. About Opthea Opthea (ASX:OPT; NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610,) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to the standard-of-care anti-VEGF-A agents. To learn more, visit our website and follow us on X and LinkedIn. IZERVAY™ is a registered trademark of Astellas Pharma Inc. LUCENTIS® is a registered trademark of Genentech USA, Inc. A member of the Roche Group. Authorized for release to ASX by Fred Guerard, CEO Investor Enquiries PJ Kelleher LifeSci Advisors Email: pkelleher@lifesciadvisors.com Phone: 617-430-7579 Media Silvana Guerci-Lena NorthStream Global Partners Email: silvana@nsgpllc.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Source: Opthea Limited

SYDNEY, March 13, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data for both its pipeline molecules, paxalisib and EVT801, at the upcoming Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California, from 5-10 April 2024. There will be three presentations in total at AACR, including data from the phase 1 study of EVT801 in advanced solid cancers. The data being presented will outline initial clinical data from the phase 1 study and provides support and direction for the next stage of the study. In addition, data will be presented on the results of the combination therapy of paxalisib and gemcitabine for patients with relapsed/recurrent atypical teratoid/rhabdoid tumors AT/RT. Based on these findings, the Pacific Pediatric Neuro-Oncology Consortium (PNOC) is planning to include this therapy in its next AT/RT international clinical trial. Summary of Abstracts Session PO.CL01.15 - Early Detection Biomarkers 1 April 7, 2024 – 1:30pm-5:00pm Abstract 1059 / 7: Biomarkers analysis on samples from patients in EVT801 clinical trial: Patient characterization and immunomonitoring L. Davenne, M. Fitzgerald, P.-B. Ancey, O. Delpuech, C. Poussereau-Pomié, M. Esquerre, M. R. Paillasse, M. Mandron, P. Rochaix, M. Ayyoub, C. Scarlata, C. Caux, P. Cassier, C. Gomez-Roca, J.-P. Delord, J. Friend, P. Fons Evotec International GmbH, Toulouse, France, Kazia Therapeutics, Sydney, Australia, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France, Centre Léon Bérard, Lyon, France Session PO.CTP01.01 - Phase I Clinical Trials in Progress 1 April 8, 2024 – 9:00am-12:30pm Abstract CT088 / 15: EVT801, a novel selective VEGFR-3 inhibitor targeting tumor angiogenesis, is pursuing dose escalation stage of phase I first-in-human study C. Gomez-Roca, P. Cassier, M. Fitzgerald, L. Davenne, C. Costantin, P. Rochaix, J.-P. Delord, J. Friend, A. Nizzardo, A. Tagliavini, M. Pergher, P. Fons, M. Mandron Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France, Centre Léon Bérard, Lyon, France, Kazia Therapeutics, Sydney, Australia, Evotec International GmbH, Toulouse, France, Evotec International GmbH, Verona, Italy Session MS.CL08.01 - Novel Approaches for Targeted Therapies April 9, 2024 – 2:50pm-3:05pm Abstract 6565 - Improving survival of atypical teratoid/rhabdoid tumor orthotopic xenografts through the combination of PI3K inhibitor paxalisib and nucleoside analog gemcitabine T. Findlay, K. Malebranche, A. Geethadevi, C. Eberhart, J. Rubens, E. Raabe Johns Hopkins University School of Medicine, Baltimore, MD About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, is ongoing, with final data expected in 1H2024. Other clinical trials are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and FTD for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study is ongoing and preliminary data is anticipated in CY2024. For more information, please visit or follow us on Twitter @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr John Friend, CEO. Company Codes: NASDAQ-SMALL:KZIA

Enrollment completion of sozinibercept Phase 3 program for wet AMD expected in calendar year (CY) Q2 2024 with top-line data mid-CY 2025 Expanded U.S. leadership team with the appointments of Dr. Frederic Guerard as CEO, Peter Lang as CFO, and Dr. Arshad M. Khanani as Chief Medical Advisor Cash and cash equivalents of $157.1 million as of December 31, 2023 MELBOURNE, Australia and PRINCETON, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT; “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced financial results for the six months ended December 31, 2023 and highlighted recent corporate and clinical updates. “It is a transformative time for Opthea. We substantially advanced the development of sozinibercept, our lead product candidate for the treatment of wet age-related macular degeneration (wet AMD), expanded our U.S. leadership team, strengthened our clinical and regulatory organization, and received US$143 million in funding. We recently announced the completion of enrollment in our first pivotal Phase 3 trial (COAST), in combination with EYLEA® (aflibercept),” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “We believe that sozinibercept has the potential to deliver superior vision gains for millions of people with wet AMD based on our Phase 2b trial results which demonstrated superior and statistically significant improvements in visual acuity for patients treated with sozinibercept in combination with LUCENTIS®(ranibizumab). Sozinibercept therefore has the potential to be the first product in more than 15 years to improve the standard of care in wet AMD and make a tangible difference in the lives of patients,” continued Dr. Guerard. Peter Lang, Chief Financial Officer of Opthea, added, “We are excited about Opthea’s progress. Looking ahead, we expect to complete enrollment in our second Phase 3 trial (ShORe), in combination with the standard of care ranibizumab, in the second quarter of CY 2024. In addition, we intend to report the top-line data on the COAST and ShORe trials in mid-CY 2025. We are encouraged by the positive momentum in the sozinibercept program.” Anticipated Milestones Enrollment completion in the second Phase 3 pivotal ShORe trial, evaluating sozinibercept in combination with ranibizumab, expected in Q2 CY 2024.Top-line Phase 3 results from the COAST and ShORe trials expected by mid-CY 2025. Corporate Highlights In February 2024, completed enrollment in the COAST Phase 3 pivotal trial evaluating sozinibercept in combination with aflibercept.In February 2024, Dr. Arshad M. Khanani, FASRS, a global retina expert joined as Chief Medical Advisor to support sozinibercept development and launch preparation.In February 2024, strengthened the organization with key clinical and regulatory hires including Dr. Julie Clark as SVP, Clinical Development, and Dr. Fang Li as SVP, Regulatory Affairs.In December 2023, Opthea received US$85 million in non-equity funding consisting of the remaining US$35 million from the previously announced Development Funding Agreement (DFA) with Carlyle and its life science franchise, Abingworth, and an additional US$50 million under an amended DFA with a new co-investor.In October 2023, appointed U.S.-based leadership team with Dr. Frederic Guerard as Chief Executive Officer and Peter Lang, MBA, as Chief Financial Officer, and the transition of Dr. Megan Baldwin to the role of Founder, Chief Innovation Officer.In August 2023, Opthea successfully completed a private placement and rights equity offering raising A$90 million (US$58 million) in Australia. Financial Results US$157.1 million in cash and cash equivalents, as of December 31, 2023.Operating Expenses (Research and Development, Patent and Intellectual Property, and Administrative Expenses) totaled US$93.9 million for the six months ended December 31, 2023, up 19% compared to the prior year period, primarily driven by progress in the pivotal Phase 3 clinical program and chemistry, manufacturing, and controls (CMC) activities.Net Cash Flows Used in Operating Activities for the six months ended December 31, 2023 ended at ($69.4) million, a slight increase from ($69.3) million for the prior year period. Upcoming Events Leerink Partners Global Biopharma Conference 2024, March 11-13, 2024 See Opthea’s 2024 Half Year FY Report, as lodged today on ASX and filed as an exhibit to the Form 6-K furnished with the U.S. Securities and Exchange Commission (the “SEC”) on February 29, 2024, for more detailed information, which report can be accessed without charge at www.sec.gov. A copy can also be accessed under the investor section of the www.opthea.com website. About Sozinibercept Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage, which contribute to the pathophysiology of retinal diseases including wet AMD. Sozinibercept has received Fast Track Designation from the U.S. FDA for the treatment of wet AMD. Positive results from the Phase 2b study of sozinibercept, administered in combination with standard of care, LUCENTIS® (ranibizumab), for the treatment of wet AMD, published in Ophthalmology, met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive for the combination therapy with sozinibercept, including more participants with gains in vision of 10 or more letters and improved anatomy, with a reduction in swelling and vascular leakage, with a favorable safety profile. About Opthea Opthea (ASX:OPT; NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636 and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to the standard-of-care anti-VEGF-A agents. To learn more, visit www.opthea.com and follow us on X and LinkedIn. EYLEA® is a registered trademark of Regeneron Pharmaceuticals, Inc.LUCENTIS® is a registered trademark of Genentech USA, Inc. A member of the Roche Group. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe,” “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding expectations on the outcomes of Opthea’s Phase 3 clinical trials of sozinibercept, the potential for sozinibercept as a combination therapy to be the first therapy to achieve superior visual outcomes over anti-VEGF-A monotherapy and improve vision outcomes for patients with wet AMD, the expected timing for completion of enrollment for ShORe and top-line data for Opthea’s Phase 3 clinical trials of sozinibercept, the market opportunity for sozinibercept, and the future performance of Opthea. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of ShORe clinical trial patient enrollment and clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023, Opthea’s 2024 Half Year Report included as an exhibit to the Form 6-K filed with the SEC on February 29, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Fred Guerard, CEO Investor Enquiries PJ KelleherLifeSci AdvisorsEmail: pkelleher@lifesciadvisors.comPhone: 617-430-7579 Media: Silvana Guerci-LenaNorthStream Global Partnerssilvana@nsgpllc.com Join our email database to receive program updates:Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com