David Geffen School of Medicine

MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MELBOURNE, Australia, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix’s first-in-class investigational PET1 agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery. ‘CA-NINE’2 – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT3 to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx. Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and Principal Investigator on the CA-NINE trial, said, “Telix’s ZIRCON trial demonstrated the accuracy of TLX250-CDx at diagnosing localized ccRCC. However, we know that many patients die of metastatic disease, where the cancer has spread. There are plenty of data showing that metastatic ccRCC also expresses the carbonic anhydrase IX (CAIX) biomarker, which demonstrates potential use beyond localized ccRCC. We are on the cusp of a revolution in how we detect and manage advanced kidney cancer before and after surgery, and I'm excited to work with Telix to hopefully bring this technology to patients should it receive regulatory approval.” Associate Professor Jeremie Calais, MD, Director of the Theranostics Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at UCLA School of Medicine, and an investigator on the CA-NINE trial, added, “With TLX250-CDx it is exciting that we can now characterize indeterminate renal masses with greater confidence. However, this only scratches the surface of the clinical potential of this investigational agent. With conventional imaging, we are very limited in our ability to stage patients, and we are hopeful that this investigational agent will improve patient outcomes by shedding light on sites of recurrent ccRCC outside of the kidney.” Dr. David N. Cade, Chief Medical Officer at Telix, continued, “We are pleased that a first patient has been imaged in the CA-NINE trial, which supports potential label expansion for TLX250-CDx into recurrent, metastatic disease. We would like to thank Professor Shuch and Associate Professor Calais at UCLA for their commitment to addressing unmet medical need in kidney cancer, as well as the patients who will contribute to this important trial.” About TLX250-CDx TLX250-CDx (Zircaix®4 89Zr-girentuximab) is an investigational PET agent that is under development to characterize indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers5. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix’s commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S.6, named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)7, by the Australian Therapeutic Goods Administration (TGA)8, and by Health Canada9. No other Telix product has received a marketing authorization in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® and Zircaix®4 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. ______________________ 1 Positron emission tomography.2 ClinicalTrials.gov ID: NCT06447103.3 Computed tomography.4 Brand name subject to final regulatory approval.5 Shuch et al. Lancet Oncology. 2024.6 ClinicalTrials.gov ID: NCT06090331.7 Telix ASX disclosure 20 December 2021.8 Telix ASX disclosure 2 November 2021.9 Telix ASX disclosure 14 October 2022.

Yuhua Zhang, Ph.D., Principal Investigator at Doheny Eye Institute and Professor of Ophthalmology at the David Geffen School of Medicine, UCLA, will lead the development of the next generation of advanced retinal imaging technology to study cerebral small vessel disease with a multidisciplinary team of scientists PASADENA, Calif., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Doheny Eye Institute, one of the nation’s leading vision research institutions, announced that Yuhua Zhang, Ph.D., Principal Investigator at Doheny Eye Institute and Professor of Ophthalmology at the David Geffen School of Medicine, UCLA, is among an esteemed multidisciplinary group of scientists to receive a major award from the National Institutes of Health (NIH) Common Fund Venture Program Oculomics Initiative. The $4.7M a year award will be distributed annually for three years among the scientists collaborating to develop a noninvasive ocular imaging approach that can detect and characterize cerebral small vessel disease (CSVD), a common central nervous system disorder that causes failures of blood flow and contributes to vascular cognitive impairment and dementia. The Team: This effort is a multi-PI collaboration among leading research institutions, led by Jianhua (Jay) Wang, M.D., Ph.D., of the Bascom Palmer Eye Institute at the University of Miami School of Medicine. Dr. Zhang, an expert in adaptive optics high-resolution imaging and retinal hemodynamics, will serve as the principal investigator at Doheny Eye Institute. Dr. Zhang and his team at Doheny’s Advanced Ophthalmic Imaging Laboratory will design and develop the instrument at Doheny Eye Institute. Liang Liang, Ph.D., of the University of Miami Coral Gables, will be the principal investigator leading the development of Artificial Intelligence (AI) enhanced software to facilitate the measurement of the blood flow in the small retinal blood vessels including arterioles, capillaries, and venioles. Additional Bascom Palmer physicians and scientists include: Hong Jiang, M.D., Ph.D., a professor of clinical ophthalmology and neurology, who will conduct the screening and clinical efforts; Felipe Medeiros, M.D., Ph.D., professor of ophthalmology and vice-chair of research, who will provide expertise in data science, bioinformatics, and clinical studies; and statistician, Robert O'Brien, Ph.D., who will use AI to further improve the methodology. Other Miller School collaborators include physicians and scientists from the departments of radiology and neurology, including: Tatjana Rundek, M.D., Ph.D., scientific director of the Evelyn F. McKnight Brain Institute; Victor Andrade, M.D., and Jose Romano, M.D., in the Department of Neurology; Pradip Pattany, Ph.D., in the Department of Radiology and Juan Pablo de Rivero Vaccari, Ph.D., at the Miami Project to Cure Paralysis. In addition, John Detre, M.D., professor of neurology and radiology at the Perelman School of Medicine at the University of Pennsylvania, an expert on blood flow in the brain, will consult on the project. The Scientific Project: Microcirculation in the capillaries is essential for supporting the brain’s intense metabolic activities and maintaining normal brain health. The delivery of oxygen and removal of metabolic waste at the tissue level is primarily accomplished by the red blood cells that compress and flow in single file through the capillaries. While current technology such as Magnetic Resonance Imaging (MRI) can detect blood flow in larger vessels, it is unable to do so in the much smaller capillaries. As a result, new methods are needed to investigate capillary health – especially as CVSD is understood to play a major role in dementia. Oculomics, which uses the eye as a window into the health of the body and brain, is being explored as a method to help fill this important gap in detecting what is happening in the brain. With this NIH award, the team will develop a new generation of high-speed, widefield adaptive optics near-confocal ophthalmoscope (AONCO). "The retina offers a unique, non-invasive window into the central nervous system's vascular system through optical imaging," noted Dr. Zhang. "Capillary rarefaction—a hallmark of microvascular degeneration—plays a crucial role in the pathogenesis of various systemic diseases and associated retinopathies. It also serves as a predictor of multiple end-organ damage and life-threatening cardiovascular conditions. Nevertheless, understanding functional alterations within the capillary system remains a significant knowledge gap." Dr. Zhang further explained, "The pulsatile blood flow in retinal capillaries presents a distinctive biomechanical model for studying microcirculation function at the capillary level and assessing the impact of CSVD on the central nervous system’s microvasculature." The rapid fluctuations in blood velocity during a cardiac cycle reflect the time-varying hemodynamic forces and flow impedance experienced by blood cells, as well as the dynamic stress on capillary walls. These factors are crucial for blood flow regulation and vessel structural remodeling. Disruptions in normal pulsatility have been linked to systemic and central nervous system pathologies, with excess pressure and flow pulsatility potentially damaging the capillary network and resulting in target organ damage. In a pilot study, Dr. Zhang's lab has developed an innovative adaptive optics near-confocal ophthalmoscope (AONCO) capable of precisely measuring pulsatile erythrocyte flow velocity throughout the cardiac cycle. The characteristics derived from continuous velocity waveforms in retinal capillaries, akin to those used for assessing macrovasculature (e.g., arterial stiffness), demonstrate the potential to identify functional alterations in capillary pathophysiology previously unrecognized. Building on these theoretical insights and experimental successes, the team will develop a new high-speed, wide-field AONCO. This advanced instrument will enable precise assessment of higher-order flow dynamics in retinal vessels of varying sizes, from the largest arterioles to the smallest capillaries, and establish AONCO-measured retinal capillary pulsatile hemodynamics as a sensitive biomarker for cerebrovascular and systemic diseases. “Assessing microcirculation function by precisely measuring the higher-order hemodynamics of the pulsatile blood flow in retinal capillaries is conceptually innovative and a huge technological advance,” said Dr. Zhang, “Higher-order hemodynamics highlights the 'dynamic' aspect of the capillary system's mechanical property and functional status, extending beyond the measurements provided by existing methods. Unlike traditional approaches, which focus on average velocity and static characteristics such as vessel wall thickness, lumen diameter, and their changes under visual stimulation or gas breathing perturbations, this innovative approach provides a more comprehensive understanding of the microvascular function.” The NIH award number is OT2 OD038131. To learn more about the groundbreaking vision science at Doheny Eye Institute, visit www.doheny.org. About Doheny Eye InstituteDoheny Eye Institute is one of the nation’s leading vision research institutions with a history dating back over 75 years. Doheny scientists and clinician-scientists remain at the forefront of vision science investigating how retinal neurons function in health and in diseases, such as diabetic retinopathy, optic neuropathies, uveitis, age-related macular degeneration, and the use of artificial intelligence for improved diagnosis of ocular diseases. Since 2013, the Doheny and UCLA Stein Eye Institute affiliation combines the strength, reputation, and distinction of two of the nation’s top eye institutions to advance vision research, education, and patient care in Southern California. Together, Doheny Eye Institute and UCLA Stein Eye Institute are ranked in the Top 5 vision centers in the country by U.S. News & World Report. For more information visit www.Doheny.org. Contact: Molly Ann WoodsDoheny Eye Institute310-717-0955mwoods@doheny.org