Daily Brief Health Care: Clarity Pharmaceuticals Ltd, Aft Pharmaceuticals, D.Western Therapeutics Institute Inc., Nurexone Biologic and more

• Clarity Pharmaceuticals Ltd (CU6 AU) announced that two participants have been dosed with 64Cu-SAR-bisPSMA and imaged days after the commencement of the Co-PSMA Investigator-Initiated Trial (IIT).
• SARTATE completes final assessment in Phase II diagnostic trial for neuroendocrine tumours. SAR-Bombesin began trial for castrate resistant prostate cancer.
• Clarity’s copper platform, strong prostate pipeline, and therapeutic and diagnostic efficacy data represent an attractive opportunity to grow a significant radiopharmaceutical franchise in oncology and other indications.

AFT Pharmaceuticals reported H125 revenues of NZ$86.7m, a 3.7% y-o-y increase, albeit lower than expected due to one-off factors such as inventory rationalisation by certain international customers and a prolonged doctors’ strike in South Korea (combined sales of NZ$10m vs NZ$18.2m in H124). These factors, along with continued R&D and marketing efforts, weighed on profits, with AFT reporting an operating loss of NZ$1.8m in H125 (profit of NZ$3.3m in H124). The strong domestic Australia and New Zealand (ANZ) market performance provided a positive offset, with 17.4% y-o-y revenue growth to NZ$76.7m and improved operating profitability. Management expects a recovery in H2 but has lowered full-year operating profit guidance to NZ$15–20m (from NZ$22–25m previously) to reflect the H1 impact. The longer-term target is to achieve NZ$300m in sales by end-FY27, driven by expansion efforts. Factoring in the new FY25 guidance, we have lowered our valuation to NZ$697.4m or NZ$6.65/share (from NZ$725.5m or NZ$6.92/share).

• For H-1337, DWTI completed dosing of subjects in the Phase IIb clinical trial in August, and top-line data was announced on November 18.
• All three doses of H- 1337 achieved clinically and statistically significant decreases of up to 30% in intraocular pressure (IOP) which was in the same range as the positive control, existing beta-blocker timolol (p <0.001), and DWTI expects H-1337 will proceed to Phase 3 study based on these results (see P10 for details).
• For DWR-2206, DWTI submitted a notification of clinical trial plan for domestic Phase II clinical trials to the PMDA in March, and the transplant for the first subject was performed in July.

• NurExone (OTC-NRXBF) is a preclinical stage biotech company that is developing a breakthrough treatment for spinal cord injuries that has the potential to dramatically improve lives.
• The technology involved also has the potential to more efficiently get other treatments to the needed area.
• The company released its 3Q earnings results that highlighted the progress the company has made and also showed management’s commitment to controlling expenses.