Daily Brief Health Care: Lexaria Bioscience , Newron Pharmaceuticals, Oryzon Genomics, Tissue Regenix Group and more

• Zacks Small-Cap Research Note for Lexaria Bioscience Corp. (LEXX)

Newron Pharmaceuticals’ H124 results reflect a period of positive traction for lead clinical asset evenamide, with stellar clinical data as an add-on treatment in schizophrenia, building a strong foundation for the upcoming, potentially pivotal Phase III programme (study 017). While the Phase III trial will initially focus on treatment-resistant schizophrenia (TRS), we note the likelihood of the trial expanding to cover patients with poorly managed symptoms, as evaluated in the prior Phase II/III 008A study, which we have reflected in our estimates. With discussions focused on securing the most beneficial partnering option, management expects the trial to initiate in H125, with funding in place to achieve this milestone. Our valuation adjusts to CHF245.8m or CHF12.8/share (previously CHF219.1m or CHF12.3/share).

Oryzon has presented the results of the final analysis from the Phase IIb PORTICO trial, which evaluated the efficacy and safety of vafidemstat in borderline personality disorder (BPD). While top-line results were initially published in January, the final data (presented at the 37th ECNP 2024 congress) show notable improvements across key efficacy measures, reaffirming the potential of the candidate to deliver meaningful benefits to patients with BPD, a highly underserved condition with no approved drugs. Management also confirmed that the data, and a registrational Phase III programme, have been discussed with the FDA at an end-of-Phase II (EoP2) meeting. We view this update as highly encouraging for Oryzon and await the announcement of a formal outcome from the FDA on the proposed Phase III programme, which we anticipate in early-Q424.

• TRX is focused on the development and commercialisation of two proprietary processing technologies for the repair of soft tissue (dCELL®) and bone (BioRinse®).
• It has a broad portfolio of products used in biosurgery, orthopaedics and dental markets.
• Investment in tissue processing, manufacturing capacity and strong commercial partners, together with its “4S” strategy, has generated seven consecutive reporting periods of strong growth, with TRX becoming profitable in 1H’24.