BOSTON, Mass. and VANCOUVER, British Columbia, October 15, 2024 – Alpha-9 Oncology (“Alpha-9” or the “Company”), a clinical stage company developing radiopharmaceuticals for the treatment of cancer patients worldwide, announced the appointment of industry veterans Jean-Jacques Bienaimé and Steven Stein, MD to its board of directors. Mr. Bienaimé’s experience leading BioMarin, combined with Dr. Stein’s success in clinical development at Incyte, add extensive operational and clinical expertise to the Company.

“We are pleased to welcome Mr. Bienaimé and Dr. Stein to our board of directors,” said David Hirsch, MD, PhD, Chief Executive Officer of Alpha-9 Oncology. “We will greatly benefit from their decades of operating experience and commitment to growth in the biopharma industry as we continue to build Alpha-9 into a leading radiopharmaceutical company.”

Jean-Jacques Bienaimé

Mr. Bienaimé brings over 40 years of experience in the biopharmaceutical industry and previously served as CEO and Chairman of the Board of Directors of BioMarin. Leading the transformation of BioMarin into an industry leader in treating genetic diseases, he has overseen the development and commercialization of seven new drugs.

“I am excited to join the board of Alpha-9 because their pioneering approach to radiopharmaceutical development not only demonstrates remarkable promise but also embodies the spirit of innovation that is essential for transforming patient care,” said Mr. Bienaimé.

Prior to BioMarin, Mr. Bienaimé also served as Chairman and CEO of Genencor, a biotech focused on targeted cancer biotherapeutics, and Sangstat, an immunology company. Mr. Bienaimé also held several senior management positions at Rhône-Poulenc Rorer Pharmaceuticals (now Sanofi), culminating in the position of Senior Vice President of Worldwide Marketing and Business Development. Mr. Bienaimé received an MBA from the Wharton School at the University of Pennsylvania and a degree in economics from the École Supérieure de Commerce de Paris.

Steven Stein, MD

Dr. Stein spent more than 30 years in the medical and biopharmaceutical industry, and currently serves as Executive Vice President, Chief Medical Officer at Incyte, where he leads the development strategy for the company’s therapeutic pipeline and oversees clinical development. Previously, he held various roles at Novartis, including Senior Vice President, U.S. Clinical Development & Medical Affairs at Novartis Oncology. Prior to Novartis, Dr. Stein served in leadership positions at GlaxoSmithKline, including Head of Medicines Development for Hematology and Supportive Care and Vice President, Global Oncology, Clinical Development. Dr. Stein earned his MBBCH from the University of Witwatersrand in Johannesburg, South Africa.

“Alpha-9’s trajectory has been impressive, and it is an honor to join the company at this pivotal time,” said Dr. Stein. “Radiopharmaceuticals are a novel modality in the treatment of cancer, and my focus will be on helping to guide the company through its clinical development journey.”

About Alpha-9

Alpha-9 Oncology is a clinical stage radiopharmaceutical company developing differentiated and highly targeted radiopharmaceuticals with the potential to meaningfully improve the treatment of people living with cancer. Applying proprietary technologies and deep-foundational expertise, Alpha-9 is on the forefront of engineering bespoke radiopharmaceuticals that are optimized to selectively deliver radiation to tumor sites while minimizing off-target effects. Alpha-9 is advancing a robust pipeline of novel radiopharmaceuticals with a systematic approach to molecule design that offers broad potential for expansion into several validated oncology targets. For more information, please visit www.a9oncology.com.

Notice Regarding Forward-Looking Statements:

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). The words “may”, “will”, “potential”, “believes” and “if” are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include but are not limited to: those associated with the success of research and development programs, the ability to raise additional funding, and the need to obtain regulatory approval. Forward-looking statements are made as of the date hereof and Alpha-9 disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Alpha-9 Contact

Corporate Communications

Stephen Mitchener

Phone: +1 617 865 1004
Email: smitchener@a9oncology.com

GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9), a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer. Under the terms of the agreement, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. ¹⁷⁷Lu) for Alpha-9’s Lutetium-based candidates.

“Entering this strategic collaboration with Alpha-9 underscores our belief in the value of developing established beta-emitters such as Lutetium-177, to advance the radiopharmaceutical industry and maximize patient benefit,” commented Steffen Schuster, CEO of ITM. “Our position as the world’s largest supplier of n.c.a. Lutetium-177 make us an ideal partner for Alpha-9. We look forward to working with a company that shares our vision of improving cancer care and outcomes for patients globally.”

“A stable and reliable supply of high-quality isotopes is key to the successful development of our pipeline, and partnering with ITM is a valuable next step in building out our proprietary offering of differentiated and precise  radiopharmaceuticals,” said David Hirsch, M.D., Ph.D., CEO of Alpha-9.

ITM will supply Alpha-9 with its n.c.a. ¹⁷⁷Lu for the clinical development of Alpha-9 radiopharmaceutical candidates comprising n.c.a. ¹⁷⁷Lu combined with undisclosed targeting molecules. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. ¹⁷⁷Lu and has marketing authorization in the EU (brand name EndolucinBeta®).

About Radiopharmaceutical Therapy (RPT)

Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.

About ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

About Alpha-9

Alpha-9 Oncology is a clinical stage radiopharmaceutical company developing differentiated and highly targeted radiopharmaceuticals with the potential to meaningfully improve the treatment of people living with cancer. Applying proprietary technologies and deep-foundational expertise, Alpha-9 is on the forefront of engineering bespoke radiopharmaceuticals that are optimized to selectively deliver radiation to tumor sites while minimizing off-target effects. Alpha-9 is advancing a robust pipeline of novel radiopharmaceuticals with a systematic approach to molecule design that offers broad potential for expansion into several validated oncology targets. For more information, please visit www.a9oncology.com.

Notice Regarding Forward-Looking Statements:

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). The words “may”, “will”, “potential”, “believes” and “if” are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: those associated with the success of research and development programs, the ability to raise additional funding, and the need to obtain regulatory approval. Forward-looking statements are made as of the date hereof, and ITM and Alpha-9 disclaim any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

ITM Contact
Corporate Communications    
Gerrit Siegers              
Phone: +49 89 329 8986 1502        
Email: communications@itm-radiopharma.com          

Investor Relations
Ben Orzelek                                                                        
Phone: +49 89 329 8986 100                                           
Email: investors@itm-radiopharma.com

Alpha-9 Contact
Corporate Communications                                               
Stephen Mitchener                                                                        
Phone: +1 617 865 1004                                           
Email: smitchener@a9oncology.com          

Dr. Jutta Wanner to lead R&D discovery efforts and support the continued expansion of Alpha-9’s differentiated radiopharmaceutical pipeline

Dr. Jason Lewis and Dr. Thomas Ruth, internationally recognized leaders in the radiopharmaceutical space, to join Alpha-9’s SAB

BOSTON, Mass. and VANCOUVER, British Columbia, March 7, 2023 – Alpha-9 Theranostics, a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the appointment of Jutta Wanner, Ph.D. as Senior Vice President of Drug Discovery. The company also announced the appointments of Jason Lewis, Ph.D. and Tom Ruth, Ph.D. to the newly formed Scientific Advisory Board.

“We are thrilled to welcome these experts to our team,” said David Hirsch, M.D., Ph.D., CEO of Alpha-9. “The addition of their knowledge and experience will accelerate our company’s growth.”

Dr. Jutta Wanner, who brings over 20 years of drug discovery experience, will lead discovery and early stage development of the company’s programs and oversee the expansion of Alpha-9’s pipeline. Her experience includes leading small molecule and targeted drug conjugate projects as the CSO and CTO of multiple biotechnology organizations, as well as a decade at Hoffmann-La Roche in a number of drug discovery roles.

“I have followed the developments in radiopharmaceuticals over the past decade as the field has made significant breakthroughs in creating highly efficacious and tolerable agents. I truly believe that radiopharmaceuticals will provide novel treatment options for patients,“ said Dr. Wanner. “Alpha-9 has a well-rounded and knowledgeable team, exciting data, and the resources to efficiently bring the next set of compounds into the clinic and beyond. I am excited to build out the R&D team and look forward to moving into our new lab space.”

Dr. Jason Lewis brings deep expertise in the development and translation of radiopharmaceuticals from decades of research developing small- and biomolecule-based therapeutics and diagnostics. He is the Emily Tow Jackson Chair at Memorial Sloan Kettering Cancer Center in New York as well as the Vice Chair for Research for the Department of Radiology, Chief Attending of the Radiochemistry and Imaging Sciences Service, and Co-Director of the Radiochemistry and Molecular Imaging Probe Core Facility.

Dr. Thomas Ruth brings more than five decades of experience in the production and application of radioisotopes for research in the physical and biological sciences. He is an Emeritus Senior Research Scientist at TRIUMF and Emeritus Senior Scientist at the British Columbia Cancer Research Centre. A leader in the production and application of radioisotopes for research in the physical and biological sciences, he has served on a multitude of national and international committees (USDOE, NAS, IAEA). Dr. Ruth was the Director for the UBC/TRIUMF PET Program for over 20 years, during which time he oversaw the installation of multiple cyclotrons and PET scanners at UBC. Dr. Ruth is also a Fellow of the Royal Society of Canada.

About Alpha-9

Alpha-9 Theranostics is a clinical stage, radiopharmaceutical company developing differentiated and highly targeted radiopharmaceuticals with the potential to meaningfully improve the treatment of people living with cancer. Applying proprietary technologies and deep-foundational expertise, Alpha-9 is on the forefront of engineering bespoke radiopharmaceuticals that are optimized to selectively deliver radiation to tumor sites while minimizing off-target effects. Alpha-9 is advancing a robust pipeline of novel radiopharmaceuticals with a systematic approach to molecule design that offers broad potential for expansion into several validated oncology targets. For more information, please visit www.alpha9tx.com.

BOSTON, Mass. and VANCOUVER, British Columbia, October 13, 2022 – Eckert & Ziegler (ISIN DE0005659700, SDAX) and Alpha-9 Theranostics Inc. (Alpha-9), a radiopharmaceutical company with offices in Vancouver and Boston, have signed an agreement for the preferred supply of GMP grade Actinium-225. The reservation gives Alpha-9 priority access to Eckert & Ziegler’s high-purity, non-carrier-added Actinium-225, a radionuclide used for the next generation of therapeutic radiopharmaceuticals.

“Following the successful completion of our supply agreement for Lutetium-177 earlier this year, we are pleased to further expand our relationship with Alpha-9 and contribute to innovation in cancer treatment through the supply of Actinium-225, a promising therapeutic radioisotope” explained Dr. Harald Hasselmann, Executive Director and responsible for the Medical segment of Eckert & Ziegler. “Access to Actinium-225 has been limited in the past which slowed down clinical research and commercial use. With the construction of our new Ac-225 production facility, we are addressing this situation and expect to be able to offer the radioisotope in limited quantities in the fourth quarter of 2023 and in larger quantities in the second half of 2024.”

“The radionuclide Actinium-225 is a key component of the therapeutic compounds in our portfolio and access is crucial to drive our development and clinical research” stated David Hirsch, CEO of Alpha-9. “We are pleased to extend our collaboration with Eckert & Ziegler to achieve our goal of improving the lives of patients affected by metastatic cancers.”

Actinium-225 is used as an active substance in cancer treatment. The radioisotope emits powerful, high-energy alpha particles with short penetration depths that enable precise treatment of tumor cells, including elusive micrometastases, with minimal impact on surrounding healthy tissue. For this purpose, Actinium-225 is combined with a suitable carrier (e.g., an antibody or peptide) that specifically binds to cancer cells, thereby selectively targeting them. Currently, radiopharmaceuticals based on Actinium-225 are being tested in many clinical indications, including prostate tumors, colorectal cancer and leukemia. Experts expect the demand for Actinium-225 to increase exponentially over the next decade.

About Eckert & Ziegler.

Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 900 employees is one of the world’s largest providers of isotope-related components for nuclear medicine and radiation therapy. The company offers services for radiopharmaceuticals at its worldwide locations, from early development to commercialization. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the SDAX index of Deutsche Börse. Contributing to saving lives.

About Alpha-9 Theranostics

Alpha-9 Theranostics is a clinical stage, radiopharmaceutical company developing imaging and therapeutic molecules for solid and hematologic malignancies. Using proprietary technology and the Company’s expertise, these differentiated molecules have the potential to meaningfully extend patients’ lives with favorable safety profiles.

BOSTON, Mass. and VANCOUVER, British Columbia, May 23, 2022 – Isotopia Molecular Imaging and Alpha-9 Theranostics, are pleased to announce the signing of a global clinical supply agreement that provides Alpha-9 with Isotopia’s medical radioisotope no-carrier-added lutetium-177 for the preclinical and clinical development of Alpha-9’s radiopharmaceutical pipeline.

“We are pleased to contribute to Alpha-9’s exciting program,” comments Director of BD Keren Moshkoviz. “Using our  well established experience in radioisotope global production and supply, we aim to further support the development of Targeted Radionuclide Therapies to improve clinical outcomes for patients worldwide.”

Alpha-9 is excited to partner with Isotopia and is committed to developing its pipeline of radiopharmaceuticals for the benefit of patients.