Blue Earth Diagnostics Ltd.

Several external investors, including Soleus Capital and Sands Capital Management, join with initial investor Bracco Imaging S.p.A. in the financing Resources support Phase 2 studies for Lutetium (177Lu) rhPSMA-10.1 and Actinium (225Ac) rhPSMA-10.1, and development of differentiating data compared to 1st generation prostate cancer radioligand therapies OXFORD, United Kingdom, Oct. 30, 2024 /PRNewswire/ -- Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced closing of a $76.5M Series A financing. The round was led by Soleus Capital and co-led by Sands Capital Management with existing investor Bracco Imaging SpA also participating. Woodline Partners and PBM Capital also joined in the financing as new institutional investors. The new funding comes from a broad spectrum of experienced biotech investors and enables Blue Earth Therapeutics to further advance its clinical stage PSMA-targeted radioligand therapies. "With the new investors and the team we have assembled, we now have a great mix of expertise and the resources to further our mission to develop radioligand therapies with the potential to improve patient outcomes by delivering high radiation doses to tumours without compromising on normal organ safety," said David Gauden, Blue Earth Therapeutics CEO. "With our recent announcement on completion of the Phase 1 clinical trial, we are making excellent progress on both our beta emitter Lutetium (177Lu) rhPSMA-10.1 and alpha emitter Actinium (225Ac) rhPSMA-10.1 agents and look forward to sharing further progress updates." "The establishment of PSMA-targeted radiopharmaceuticals as a class of therapy in prostate cancer represents a huge opportunity to improve outcomes for prostate cancer patients. Our new investors share our strong belief that Blue Earth Therapeutics' radiohybrid agents could be a significant improvement over currently approved treatment options," said Fulvio Renoldi Bracco, CEO of Bracco Imaging SpA. "We have observed the rapid acceptance of Pluvicto® as the first PSMA-targeted radioligand therapy for the treatment of prostate cancer, and at the same time see opportunities to do better," said David Canner, partner at Soleus Capital. "The early data the company has developed supports differentiation and gives us confidence to invest in the Blue Earth team. We look forward to advancing Blue Earth Therapeutics' compounds to later stage trials." David Canner from Soleus Capital and Michael Ginder from Sands Capital Management are joining the Board of Directors alongside representatives from Bracco Imaging SpA and experienced industry CEO David Gauden. About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . Contacts: For Blue Earth Therapeutics Robert Dann Vice President, Strategy & Planning (617) 631-0234 [email protected] Media Edelman Inc. Amanda Lazaro (M) +1 617 775-1306 [email protected] SOURCE Blue Earth Therapeutics Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The radiopharma field continues to buzz with private financings and more clinical-stage programs. The latest is Oxford, UK-based Blue Earth Therapeutics, which unveiled a $76.5 million Series A on Wednesday morning to bring its lutetium-based radioligand therapy into Phase 2 and its actinium-based asset into Phase 1. Both of those trials will begin in early 2025, CEO David Gauden told Endpoints News . The funding adds to a steady drumbeat of investor and pharma interest in the field. Alpha-9 Oncology bagged a $175 million Series C last week, the same amount that Aktis Oncology secured in a Series B last month. Gauden said the company will have key clinical data in about 12 to 18 months, at which point it could entertain pharma partnerships, another private funding round or an IPO if the markets are right. Industry interest is certainly there. Lilly, Novartis and Bristol Myers have all made radiopharma deals in the past 12 months. But a few other big pharmas haven’t “taken the plunge,” Gauden said, meaning there could be even more dealmaking activity in the years to come. Blue Earth seeks to make better PSMA-targeted radiopharmaceuticals than the first generation, which Novartis broke open with Pluvicto, Gauden said. The company hopes to double the amount of radiation delivered to prostate cancer lesions without compromising safety and side effects on normal organs, he added. Blue Earth works with external manufacturers, and it has three partners that can make drug product with access to about half a dozen suppliers for lutetium, Gauden said. Actinium 225-based radiopharmaceuticals have run into some supply constraints. Gauden said Blue Earth has enough for its upcoming Phase 1 and that the actinium supply chain should be where lutetium is today in about three to four years. The startup will continue to have “some shared activities and resources” with its sister company Blue Earth Diagnostics for about another year, Gauden said, but they’re “largely independent” at this point. Gauden became CEO of the therapeutics company in July after serving in the same post at the diagnostics business, which has FDA-approved imaging agents . Both are backed by Milan-based Bracco Imaging. In addition to Bracco, Blue Earth Therapeutics’ investors also include Soleus Capital, Sands Capital Management, Woodline Partners and PBM Capital.

OXFORD, UK I October 8, 2024 I Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced further positive developments for its novel investigational radioligand therapies. Enrolment of patients in the Phase 1 trial of Lutetium ( 177 Lu) rhPSMA-10.1 Injection was completed in July. Early data from the trial suggests an encouraging safety profile. Radiation dosimetry performed for up to three cycles showed delivery of high tumour absorbed radiation doses relative to the dose delivered to the key normal organs, such as kidney and salivary glands. While final analysis is ongoing, the ratio between radiation dose to tumours vs. dose to the kidneys and salivary glands was compelling vs. published data 1 for first generation radioligand therapies. This data opens the way for the Phase 2 portion of the Phase 1/2 trial to start later this year. The company has shared the intended Phase 2 study design with regulators and, subject to trial safety committee agreement, will test innovative dosing regimens in the Phase 2 study. Based on the advantageous results for absolute tumour and normal organ uptake seen in Phase 1, the Phase 2 study will explore the following concepts: In combination with the positive radiation dosimetry results seen in Phase 1 for Lutetium ( 177 Lu) rhPSMA-10.1 Injection, these factors should further support the ultimate goal of delivering better outcomes for patients. “We are excited by the new data which support our best-in-class thesis and to have a clear path to move from Phase 1 to Phase 2 in the development of our lead therapy,” said David Gauden, CEO. “We remain on track for the opening of Phase 2 in the next few months. We also expect to see the full Phase 1 results presented at a scientific meeting in 2025.” “The available science increasingly highlights that fixed dosing at fixed intervals is unlikely to be optimal. Front loading radioactivity and extending the time on therapy may lengthen time to disease progression. We will explore these concepts in Phase 2. Our intention is to optimize dosing now, with the aim of achieving the best possible outcomes for patients in a future pivotal trial,” commented Dr Daniel Stevens, Head of Clinical Development and Medical at Blue Earth Therapeutics. “We think that adapting dosing based on data from the individual patient will be important for improved results.” The Phase 2 clinical trial of Lutetium ( 177 Lu) rhPSMA-10.1 Injection is planned to open at approximately 15 sites across the US and Europe and enroll approximately 70 patients. 1 Ells, Zachary, et al. “Dosimetry of [ 177 Lu] Lu-PSMA-Targeted Radiopharmaceutical Therapies in Patients with Prostate Cancer: A Comprehensive Systematic Review and Meta analysis.” Journal of Nuclear Medicine (2024). About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid (“rh”), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: https://www.blueearththerapeutics.com . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com . SOURCE: Blue Earth Therapeutics