Radiopharm Theranostics Ltd (ASX:RAD) has received an update note from Diamond Equity Research following the approval of its Investigational New Drug Application (IND) application for αVβ6 Integrin (RAD301) technology by US FDA.
The technology has already generated significant clinical data from 88 patients dosed across various geographies.
Radiopharm’s Phase 1 trial would commence by the end of Q1 CY23 and close approximately by the end of Q3 CY23.
Diamond’s valuation methodology has reiterated a value of A$0.70 per Radiopharm share (current price: A$0.14), contingent on successful execution by the company.
The following is an extract from the update note:
- Approval Received for αVβ6 Integrin (RAD301) Phase 1 Trial - US FDA has approved the company’s Investigational New Drug Application (IND) application for its αVβ6 Integrin (RAD301) technology, allowing RadioPharm to begin a Phase 1 trial imaging trial in ambulatory patients with pancreatic cancer. The first subject is expected to be dosed at Montefiore Einstein Cancer Center (MECC), New York. The technology has already generated significant clinical data from 88 patients already dosed across various geographies. The trial would commence by the end of Q1 CY23 and close approximately by the end of Q3 CY23.
- Publication of HER2 Nanobody (RAD201) in European Journal of Nuclear Medicine & Molecular Imaging - The company announced the publication of positive imaging data regarding its HER2 nanobody (RAD201) in the European Journal of Nuclear Medicine & Molecular Imaging, indicating RAD201’s favorable biodistribution and showing high accumulation in all HER2 positive tumor sites. Demonstrating a high target-to-background ratio, favorable tumor targeting, and rapid blood clearance due to its ability to bind to a different part of the HER2 receptor, RAD201 is a promising non-invasive tool for discriminating HER2 status in metastatic (breast) cancer, regardless of any ongoing HER2-targeted antibody treatment. HER2 positive breast cancer is around 15-20% of all breast cancer cases; being highly aggressive and hence having a higher mortality rate, any new imaging or therapeutic solutions are highly sought after.
- Appointment of New Senior Vice President - Radiopharm Theranostics announced the appointment of Dr. Rama Abu Shmeis as Senior Vice President, Chemistry and Manufacturing Controls (CMC) recently. She has over 23 years of top-shelf experience in the leading strategic, operational, and scientific aspects of CMC development and manufacturing in various companies, including TG Therapeutics (NASDAQ: TGTX), Checkpoint Therapeutics (NASDAQ:CKPT) (NASDAQ: CKPT), Eagle Pharmaceuticals (NASDAQ:EGRX) (NASDAQ: EGRX), Purdue Pharma, and Novartis Pharmaceutical Corporation, to name a few. Dr. Shmeis holds a Ph.D. in Pharmaceutics and a Bachelor of Science in Pharmacy and has presented at national and international conferences and has numerous publications in peer-reviewed journals, as well as several patents.
- Q2 FY2023 Cash Flow Update - Radiopharm Theranostics reported the financial results for the quarter ended December 2022. The Research and Development (R&D) expenses for the quarter amounted to approximately A$4.5 million. Staff costs amounted close to A$1.7 million, and other expenses, including general and administrative expenses, were reported at A$0.66 million. The company ended the quarter with an operating cash burn of A$6.01 million, out of which research and development and staff costs represented approximately 80% of the net cash used in operating activities. The company ended the quarter with a cash balance of A$24.25 million.
- Valuation - We have updated our financial model to reflect the latest financial numbers. Additionally, we have incorporated changes in comparable company analysis and updated our operating expense and cash burn estimates. Our valuation methodology reiterated a value of A$0.70 per share, contingent on successful execution by the company.
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