Radiopharm Theranostics

Investor Insight

Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.

Overview

Radiopharm Theranostics (ASX:RAD) is an innovative biopharmaceutical company specializing in the development of radiopharmaceutical products for both diagnostic and therapeutic applications. Founded with a mission to address significant unmet medical needs, particularly in oncology, the company has positioned itself at the forefront of the rapidly evolving field of precision medicine.

Radiopharm Theranostics presents a compelling value proposition for investors, characterized by several key factors:

• Strategic Partnerships
  • Lantheus’ strategic investment in Radiopharm Theranostics, committing up to AU$18 million, strengthens Radiopharm's financial position and supports the advancement of its projects.
  • Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center, to develop novel radiopharmaceutical products for cancer treatment.
• Market Positioning: Radiopharm is strategically positioned to capture a significant share of the expanding theranostics market.
• Diverse Product Pipeline: The company boasts a robust pipeline of radiopharmaceutical products targeting various oncological diseases, which diversifies risk and increases potential revenue streams.
• Innovative Technology: Radiopharm's focus on leveraging technological advancements in radiopharmaceuticals, particularly in treating oncological diseases, positions it at the cutting edge of medical innovation.

Lantheus’ investment in Radiopharm marks a pivotal moment for both companies and holds substantial implications for the field of theranostics. The funding will facilitate Radiopharm's research and development efforts, accelerating its product pipeline and market presence. Under the agreement, Radiopharm will transfer two early preclinical assets to Lantheus for a further AU$3 million, fostering a collaborative relationship focused on radiopharmaceutical development. The collaboration positions Radiopharm to capitalize on the increasing demand for theranostic solutions, aligning with trends in personalized medicine. Moreover, this financial backing will support clinical trials and operational needs, while also aiming for the commercialization of their products.

Company Highlights

• Radiopharm Theranostics is focused on developing and commercializing radiopharmaceutical products and nuclear medicines for both therapeutic and diagnostic applications in precision oncology.
• Radiopharm has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.
• The company has received clearance from the US Food and Drug Administration for an investigational new drug application with two INDs (one for RAD 301 and one for RAD 101). Phase 1 for RAD 301 and for RAD 204 is in progress.
• The company aims to commercialize its pipeline for possible licensing and distribution agreements and has secured four platform technologies, which it is seeking to develop for the diagnosis and treatment of certain cancers.
• Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center.

Technology and Clinical Pipeline

Radiopharm has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.

Radiopharm’s clinical stage development in the pipeline include:

1. PD-L1 (non-small cell lung cancer indication) - currently in phase 1 in Australia;
2. HER2 (breast/gastric cancer indication) - will begin phase 1 trials this year;
3. Integrin VB6 (pancreatic cancer indication) - now in Phase I imaging in pancreatic cancer.
4. Fatty Acid Synthase (brain METS indication) - preclinical has been completed and with IND approval for Phase IIb Imaging

The company recently received FDA approval for its investigational new drug application for 18-Pivalate (RAD 101). Labelled with the radioisotope F18, Pivalate is a small molecule that targets fatty acids synthase, which is overexpressed in brain tumours but not in normal cells.

Positive data from the company’s Phase 2 imaging trial of 17 patients with brain metastases has shown significant tumour uptake. Radiopharm holds an exclusive global license for the Pivalate platform.

Radiopharm highlights that Pivalate is potentially a new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients a better option in relation to current imaging technology, which has many limitations.

Management Team

Paul Hopper – Executive Chairman

Paul Hopper is the founder of Radiopharm Theranostics. He has over 25 years of experience in the biotech, healthcare and life sciences. Focused on start-up and rapid-growth companies, he has served as the founder, chairman, non-executive director or CEO of more than 15 companies in the US, Australia and Asia. Previous and current boards include Imugene, Chimeric Therapeutics, Viralytics, Prescient Therapeutics and Polynoma. His experience covers extensive fund raising in US, Australia, Asia and Europe, and he has deep experience in corporate governance, risk management, and strategy.

Riccardo Canevari – Managing Director and Chief Executive Officer

Riccardo Canevari has broad and deep experience across specialty pharma, oncology and radiopharmaceuticals. He was most recently chief commercial officer of Novartis Advanced Accelerator Applications, one of the leading radiopharmaceutical and nuclear medicine companies, globally. He was responsible for global commercial strategy and country organizations in ~20 countries across North America, Europe and Asia. He was responsible for Lutathera’s in-market growth strategy and execution to build a blockbuster asset and for the pre-launch plan for Lu-PSMA 617 in metastatic prostate cancer. Prior to this, Canevari was senior vice-president and global head, breast cancer franchise for Novartis Oncology since 2017, overseeing the launch of major breast cancer products, including KISQALI and PIQRAY. He also held various management roles with Novartis Pharma and Ethicon/Johnson & Johnson.

Dr. Sherin Al-Safadi - Vice-president, Medical Affairs

Dr. Sherin Al-Safadi is an accomplished industry leader with many years of experience in pharmaceuticals and biotech. Most recently she was vice-president – medical affairs at POINT Biopharma, where she led the strategic and tactical planning for Phase III support and launch preparation of radiopharmaceuticals. She also provided strategic input and leadership for business development and licensing opportunities. She currently serves as co-founder and president at Foundation Amal (Canada-USA), overseeing an executive leadership team of 12 directors and members, who led the successful 2021 cross-border expansion into the USA and spearheaded the development of a successful branding and communication strategy. Al-Safadi holds a PhD in neurobiology from Concordia University, an MBA in entrepreneurship & management from the John Molson School of Business, and a MSc in pharmacology (oncology drug development) from McGill University.

Vimal Patel - Vice-president, CMC

Vimal Patel joins RAD from Orum Therapeutics where he was vice-president, head of CMC and supply chain. He was responsible for all CMC functions including process and analytical development, manufacturing, quality control, quality assurance, regulatory and supply chain. He led the successful manufacture of two ADCs and contributed to filing an IND leading to a Phase-I trial. Prior to Orum, Patel held roles of increasing responsibility in process development and manufacturing sciences at several companies, including Actinium Pharmaceuticals. Patel also held a position at Pfizer where he contributed to the refiling of Mylotarg and the filing of Besponsa BLAs. He also developed manufacturing processes for various ADCs. He also held roles at Daiichi Sankyo, Progenics Pharmaceuticals and SibTech in various capacities. Patel has MS in biotechnology from University of Connecticut and B.S. in chemical engineering from Sardar Patel University.

Noel Donnelly - Non-executive Director

Noel Donnelly brings more than 25 years of leadership experience in finance, strategy and operations within the biopharmaceutical and biotechnology industries. He has a distinguished track record of building and leading cross-functional teams, driving corporate governance and executing complex financial strategies that support rapid company. growth. Donnelly is current the chief financial officer of PepGen, where he oversaw the company's financial strategy through its successful IPO, raising U$120 million and leading subsequent financial efforts that secured an additional US$90 million. Donnelly was previously the CFO of EIP Pharma (now, CervoMed), where he led the company's IPO plannig phase. He had a 15-year tenure at Takeda/Shire PLC, in various senior roles, where he led critical R&D integrations and oversaw more than US$160 billion in integration planning and execution. He was instrumental in shaping the company's portfolio management strategy.