Radiopharmaceutical Quarterly Report

Q3/2024 Radiopharmaceutical News

Disclaimer: The views and opinions expressed in this publication are solely my own and do not reflect the official policy or position of my employer, any of its affiliates, partners, or any other organization with which I am associated. Any content provided is intended for informational purposes only and is based on my personal perspective. I am not responsible for any actions taken by individuals or organizations based on the information provided in this publication.

As the interest in the field of Radiopharmaceuticals grows, I endeavour to publish a quarterly review on the latest developments in the field and also provide some personal commentary as context on specific areas of interest. I will publish the quarterly reports in digestable sections covering ?General announcements, Fund raising & Financial updates, manufacturing & supply chain notices, and clinical & strategic partnerships annoucements.

Commentary: Telix’s latest announcement of the approval of Pixclara is the latest in a series of major wins for the pioneering Australian radiopharma. 2024 has seen Telix purchase radiopharma focused CDMOs RLS (network of 31 radiopharmacies in 18 states for 250M) ?and isotherapeutics (13.6M), along with cyclotron hardware Co. ARTMS (a spinout from Canada’s TRIUMF for 82M). All this on the heels of the annouced plans ?for accelerated American depository Share filing on the NASDAQ, and the latest news of the spinout of Rhine Pharma. Rhine is a collaboration with Heidelburg Unviersity. The new spinout will focus on generator sourced Technetium-99m and rhenium-188 (Oncobeta is the only other generator based Re-188 based Co.). Rhine’s leading asset, RHN001 is moving into a Ph.1/2a trial. The asset was jointly developed with Heidelberg and targets PSMA2.

Q3 also saw a flurry of funding announcements which included new money for Nusano, Aktis, Alpha9 Oncology, and PanTera. Also, PentixPharm debuted on the Frankfurt Stock Exchange bringing in 20 million euros. The sector remains a hotbed (pardon the obvious nuclear pun) for Life Science investors and there doesn’t seem to be any indication this will end soon. However, with big pharma already gobbling up the most commercial ready acquisition targets in POINT, Fusion Pharma (both Canadian spinouts from McMaster University’s CPDC), and Rayzebio, there aren’t many other candidates that have both a robust R/D pipeline and manufacturing capabilities with the exception of Perspective therapeutics and RadioMedix. ?The later just announcing the out-licensing of their lead clinical asset AlphaMedix (with partner OranoMed) to Sanofi. ?

ITM—announced a significant step forward in their partnership with Technical University of Munich and TUM University Hospital (MRI). Together, they have signed a new framework agreement to advance innovative radiopharmaceutical treatments. This agreement builds on many years of successful collaboration, aiming to accelerate the development of nuclear medicine by uniting TUM’s cutting-edge research, MRI’s renowned clinical expertise, and ITM’s expertise in radioisotope production and radiopharmaceutical development with TUM’s cutting-edge research capabilities in nuclear physics (FRM II research reactor) and medical applications, alongside MRI’s renowned clinical expertise in diagnostics and patient care. The framework agreement also outlines how ITM and TUM will share and transfer the rights to any results or inventions that come from their future collaboration. Additional details of the framework agreement have not been disclosed.

Telix Pharmaceuticals—announced that the FDA has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara?), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025. Pixclara(18F-floretyrosine or 18F-FET) is a PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S. Given its potential to address significant unmet medical need, Pixclara has been designated as an orphan drug and granted fast track designation by the FDA.? There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumours of the central nervous system, particularly in the post-treatment setting.

Telix also unveiled Rhine Pharma, a new entity born from a collaboration between Telix and Germany’s Heidelberg University Hospital that's setting out to expand access to radiopharmaceuticals for cancer treatment and imaging alike. While most Radiopharmaceuticals today rely on lutetium-177 or actinium-225, Rhine is leveraging the isotopes technetium-99m and rhenium-188 for imaging and therapeutic uses, respectively.

Notably, Rhine’s isotopes are produced in generators rather than the reactors or cyclotrons predominantly used to churn out current nuclear medicines. The use of on-site generators, coupled with rhenium’s short half-life of 16.9 hours, could ease production of radiopharmaceuticals in places with limited manufacturing infrastructure and simplify patient workflows at busy treatment centers. Telix and Heidelburg initially teamed up to develop a small molecule that could target the protein PSMA2. The idea was to be able to label the drug with either technetium for single-photon emission computed tomography (SPECT) scans or rhenium for a radioligand therapy. In turn, Telix and Heidelburg created a potential next-generation theranostic compound dubbed RHN001, which Rhine is now moving into a phase 1/2a clinical study to assess the safety and efficacy of the isotopes in patients with advanced prostate cancer.

?

Fund Raising & Financial Announcements:

Alpha-9 Oncology— announced an oversubscribed $175 million Series C financing to support the progression of its pipeline. The financing was led by Lightspeed Venture Partners and Ascenta Capital. A selected syndicate of new investors – General Catalyst, a16z Bio + Health, RA Capital Management, Janus Henderson Investors, Delos Capital, Digitalis Ventures, Lumira Ventures and a healthcare fund managed by abrdn Inc. – joined the round, in addition to existing investors Frazier Life Sciences, Longitude Capital, Nextech Invest, BVF Partners LP, and Samsara BioCapital. Shelley Chu, head of Lightspeed Venture Partners’ healthcare team and Evan Rachlin, co-founder and managing partner of Ascenta Capital will join the Company’s Board of Directors.

Alpha-9 has built a diversified portfolio of clinical and discovery assets across both validated and novel targets. The Series C will fund human studies for the clinical stage assets and advancement of discovery stage assets to clinic-ready development candidates. Furthermore, the Series C will fund expanded R&D capabilities and continued investment in CMC and supply chain.

PanTera— raised up 93 million euros ($102.5 million) as part of an investment round led by EQT Life Sciences. PanTera said early last month that it plans to channel the bulk of the cash into the construction of a new manufacturing facility in Belgium. It is the largest Series A round ever for a Belgian company in the life sciences sector, according to EQT, and is evidence of the booming interest in radiopharmaceuticals for their ability to precisely target cancer cells. The investment will largely support the construction of a new manufacturing facility in Belgium. The funding round also includes some debt and convertible loan funding, bringing its total to 134 million euros ($148 million). On the supply side, PanTera signed on seven months ago with Bayer to provide it with 225-Ac for clinical trials. It was PanTera’s first deal with a major drugmaker.

Telix— announced that it has publicly filed a Form 20-F registration statement (Registration Statement) with the United States (U.S.) Securities and Exchange Commission (SEC) relating to a proposed listing of American Depository Shares (ADS), representing the Company’s ordinary shares, on the Nasdaq Stock Market (Nasdaq). The proposed Nasdaq listing is expected to be established as a Level II American Depositary Receipt (ADR) program, enabling streamlined and simplified access to Telix shares by the U.S. market. The Company believes this decision will further facilitate significant interest in the Company from U.S. and global investors, as well as simplify access to Telix’s securities and equity-related incentives for U.S. domiciled employees. Telix is not proposing to raise capital or issue any new shares under the Registration Statement or as part of the proposed Nasdaq listing. The Company expects to retain its primary listing for its ordinary shares on the Australian Securities Exchange (ASX) for the foreseeable future, alongside the proposed Nasdaq listing. Each ADS will represent one fully paid ordinary share of the Company and will trade on Nasdaq under the ticker symbol “TLX”.

Nusano— announced a Series C financing round with funding commitments of over $115 million in total proceeds. The financing will support the company’s initial product launches of non-carrier-added lutetium-177 (n.c.a. Lu-177) and actinium-225 (Ac-225). The round was led by The Wasatch Group, with additional participation by S32. Previous investors in Nusano include Verily and the American Cancer Society’s BrightEdge. The most in-demand isotope in radiotherapeutics today is n.c.a. Lu-177. Nusano has developed a proprietary isotope separation process to enable n.c.a. Lu-177 production on a scale far greater than existing methods. The company’s n.c.a. Lu-177 program is scheduled to begin Q1 2025 to supply current and anticipated medical needs. Opening in 2025 in West Valley City, Utah, the Nusano production platform will support the company’s Ac-225 production and be capable of generating more than 25 radioisotopes applicable to medical and industrial uses.

Aktis Oncology— announced the successful closing of an oversubscribed and upsized $175 million Series B financing. The financing was led by RA Capital Management, and co-led by RTW Investments and Janus Henderson Investors. A select syndicate of additional new investors joined the financing, including funds and accounts advised by T. Rowe Price Associates, Inc., Avidity Partners, and an undisclosed life sciences-focused investment fund. All existing institutional investors participated, as well as existing strategic investors Bristol Myers Squibb, Eli Lilly and Company, and MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc. In conjunction with the financing, Andrew Levin, MD, PhD, Partner and Managing Director at RA Capital Management, will join the Aktis Oncology Board of Directors. Lauren Lee, PhD, from RTW Investments, and Vish Sridharan, MD, from Janus Henderson Investors, will join as Observers to the Board of Directors.

Pentixapharm—has brought in almost 20 million euros ($22 million) from an IPO, with the German biotech earmarking the proceeds to push ahead with the clinical development of its two lead radiopharmaceuticals. The Würzburg, Germany-based company’s offering consisted of 3.9 million shares, which Pentixapharm had been hoping to price somewhere between 4.7 euros and 6 euros apiece. The stock debuted on the Frankfurt Stock Exchange this morning at 5.10 euros, resulting in a market capitalization of 126.5 million euros ($139.6 million).

?

?