Sofie Biosciences, Inc.

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, April 5, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE's radiopharmaceutical manufacturing site located in Cleveland, Ohio. The first doses have been made available on April 4, 2024. Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "By adding Cleveland to our distribution network, Life Molecular Imaging is thrilled to provide additional availability of Neuraceq®, an important imaging tool for the detection of beta-amyloid plaques in the brain. Our continued collaboration with SOFIE provides greater availability of our approved beta-amyloid tracer Neuraceq®. We believe this additional access to Neuraceq® benefits physicians and patients, as well as our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. Brian Schumer, PharmD, SOFIE COO states, "We are excited to bring Neuraceq® availability to another SOFIE network site. The continued growth and advancement in Alzheimer's disease diagnosis and treatment is very promising for patients and their families. SOFIE is committed to the further expansion and availability of LMI's Neuraceq® PET diagnostic tracer throughout our national PET manufacturing and dispensing network." About Neuraceq (florbetaben 18F) Indication Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq have not been established for: Predicting development of dementia or other neurologic conditions Monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. Radiation Risk Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Common Adverse Reactions The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%). For more information please visit: neuraceq.com About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: | For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging

MELBOURNE, Australia, March 11, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce the appointment of Dr. Darren Patti as Group Chief Operating Officer (COO), effective 11 March 2024. Dr. Patti joined Telix in March 2021 to lead the Company's United States (U.S.) operations. Over the past three years as U.S. Chief Operating Officer and General Manager for the Americas region he has overseen the successful launches of Illuccix® in the U.S. and Canada, has led ongoing market development for Telix in Brazil and the Latin America (LATAM) region, and has been a key figure in the launch preparations for Telix's follow-on imaging products Zircaix®[1] and Pixclara™[1] (subject to regulatory approval). Prior to joining Telix, Darren held a variety of roles at Sofie Biosciences over a period of 15 years, most recently as Vice President of Operations leading the operationalisation of the Sofie-Lantheus PSMA-PET imaging program. Darren holds a Doctor of Pharmacy (Pharm.D.) from the University of Illinois at Chicago and is an Authorised Nuclear Pharmacist. Dr. Christian Behrenbruch, Managing Director and Group CEO commented, "Darren has been an exemplary leader in our Americas region and fundamental to the success of our commercial operations and vertical integration strategy. Darren's deep experience in radiopharmacy network management and operations, combined with an intricate understanding of the Telix business makes him the ideal leader for our global operations function as we expand into new commercial markets and bolster our manufacturing capabilities to support our therapeutic and imaging programs. I am looking forward to continuing to work closely with Darren in this new role as we prepare to bring additional diagnostic products to market and drive towards our next phase as a leader in therapeutic radiopharmaceuticals and precision medicine." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic 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). Visit 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'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),[2] by the Australian Therapeutic Goods Administration (TGA),[3] and by Health Canada.[4] Telix's miniaturised surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, has attained a marketing authorisation in the U.S., having been registered with the FDA and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for the intra-operative detection of sentinel lymph nodes (SLNs). With the exception of Illuccix® and SENSEI® as noted above, no Telix product has received a marketing authorisation in any jurisdiction. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. 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. The information contained in this announcement is subject to change without notification. 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", "outlook", "forecast" and "guidance", or other similar words. 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 the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company'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 studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; 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. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals, Illuccix®, SENSEI®, Zircaix®[1] and Pixclara™[1] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Logo -

CINCINNATI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Onconetix, Inc., (Nasdaq: ONCO) ("Onconetix" or the “Company”), a commercial stage biotechnology company focused on developing and commercializing therapeutics, diagnostics, and services for clinicians and patients in oncology, today announced the appointment of Ajit Singh, Ph.D. and Thomas Meier, Ph.D. to its Board of Directors. “We are thrilled to announce the addition of Dr. Singh and Dr. Meier to the Board of Directors of Onconetix,” stated Chairman of the Board James Sapirstein. “They bring enormous experience in the biotech industry to their roles, particularly in a commercial execution capacity, and we look forward to taking advantage of their knowledge as we move the company forward into a new era.” Dr. Singh is currently a Partner at Silicon Valley-based Artiman Ventures, a firm focused on early-stage technology and life science investments with over $1 billion in assets under management, and serves on the boards of Artiman portfolio companies, Sofie Biosciences, Leo Cancer Care, Artidis and Chronus Health, and is also a member of the Board of Trustees of the American Association for Cancer Research (AACR) Foundation. Dr. Singh serves as an Adjunct Professor in the School of Medicine at Stanford, where he teaches clinical diagnostics and entrepreneurship. Prior, Dr. Singh was President and CEO of Biolmagene (acquired by Roche Pharmaceuticals), a company specialized in AI-based cancer diagnostics, and also served as the global CEO of Siemens Oncology and Siemens Digital Imaging Systems. Dr. Singh has held several board positions including Lead Director at Max Healthcare, board member at Cadila Pharmaceuticals, and Senior Advisor to the Tata Trusts Cancer program. “I am honored to join the Board and look forward to contributing to the development of new diagnostics and therapeutics in oncology, an area in which I am very familiar, and one that still has great need to improve patient outcomes. I look forward to working with the team at Onconetix,” stated Dr. Singh. Dr. Meier, Managing Partner of Viopas Venture Consulting GmbH, is an internationally recognized life science entrepreneur, with more than two decades of experience across different facets of biotechnology company operations, including fundraising, deal creation, product approvals and launches, and advisement. Dr. Meier was a co-founder of Santhera Pharmaceuticals Holding AG, where he has held several executive positions, contributed to Santhera’s initial public offering on the Swiss Stock Exchange and raised approximately $300 million to advance Santhera’s pipeline. Dr. Meier managed the regulatory approval process for Raxone® indicated in Europe for the treatment of Leber hereditary optic neuropathy and currently is the chairman of Santhera. He is co-founder, board member and advisor for several biotech companies in Switzerland and the US. He acted as advisor to the sellers in the transaction merging Proteomedix AG and Blue Water Biotech, Inc. to form Onconetix, and serves as Proteomedix’s representative during the post-merger integration. “I am happy to join the Onconetix Board of Directors, and I look forward to leveraging my skills and experience in support of the company and to help it succeed as it moves into a new phase of growth,” said Dr. Meier. About Onconetix, Inc. Onconetix, Inc. (Nasdaq: ONCO) (formerly Blue Water Biotech, Inc. (BWV)) is a commercial stage biotechnology company focused on the research, development and commercialization of proprietary therapeutics, diagnostics and services for clinicians and patients for oncology. The Company currently has Entadfi®, an FDA approved, oral therapeutic for the treatment of benign prostatic hyperplasia (BPH), a disorder of the prostate, and Proclarix®, an advanced proprietary diagnostic system for screening and diagnosis for men with indeterminate Prostate Specific Antigen (PSA) assessments in prostate cancer oncology. For more information, visit www.onconetix.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to Onconetix’s ability to integrate the acquisition of Proteomedix (the “Transaction”); risks related to Onconetix’s ability to commercialize ENTADFI® and Proclarix® described herein; risks related to Onconetix’s ability to expand its business scope and integrate the assets and commercial operations acquired in the Transaction into Onconetix’s business; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the company’s commercial products; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates in oncology; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor and Media Contact Information: Russo Partners, LLCNic Johnson Telephone: (212) 845-4242Email: Nic.Johnson@russopartnersllc.com