Daily Brief Health Care: Telix Pharmaceuticals, Oramed Pharmaceuticals , Recce Ltd, Revelation Biosciences and more

• Telix Pharmaceuticals (TLX AU) initiated Phase 3 ZIRCON-CP trial of PET imaging candidate TLX250-CDx for clear cell renal cell carcinoma and dosed first patient in a cancer hospital in China.
• Telix is focused on expanding the near-term opportunity in precision medicine diagnostics with three new products planned for launch in 2025.
• CMS will unbundle and pay separately for specialized diagnostic radiopharmaceuticals for Medicare patients with per-day costs exceeding $630. The new payment decision is in favor of Telix.

• ORMP is leveraging its strong balance sheet – ~$142m in cash, equivalents, ST investments & deposits, no LT debt – to optimize its cash position.
• The company is augmenting its cash position with repayments / interest from collateralized loans issued to Scilex & to a domestic real estate project.
• Management expects its resources are sufficient to maintain planned activities for roughly at least the next year as clinical activities pick-up and as it maintains strategic share repurchases under its 2024 share buyback plan.

Recce Pharmaceuticals has made several strides in advancing its topical gel formulation (R327G) of lead anti-infective therapeutic drug candidate RECCE® 327 (R327) as a topical treatment for acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs). The company received Human Research Ethics Committee (HREC) approval to start a registrational Phase III DFI study in Indonesia, which, if successful, could lead to a commercial launch in South-East Asia in CY26. With the near-term focus on advancing the ABSSSI and DFI indications providing a clearer path to future revenues, we have pushed back our timing expectations for the IV R327 formulation, resulting in an updated risk-adjusted net present value (rNPV) of A$593.6m (or A$2.60/share), versus A$688.5m (or A$3.07/share share) previously.

• Revelation Biosciences is a life sciences company whose development of immunologic-based therapies is based on the well-established biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system.
• The company announced that the FDA has accepted its IND application for Gemini and that it expects to begin the study in early 2025.