MASSACHUSETTS GENERAL HOSPITAL

Alzamend Neuro reported Q2 2025 financial results, showing $8.3M net cash from financing, $3.8M stockholder equity, and $4.1M cash position. The company secured $25M in preferred stock and $6.5M in at-the-market sales agreements, regaining Nasdaq compliance and preparing for five clinical trials in 2025, including Phase II trials for AL001 at Massachusetts General Hospital and resumption of ALZN002 trials.

A study suggests complete blood count (CBC) tests could help identify or predict multiple diseases, including heart problems, type 2 diabetes, osteoporosis, and kidney disease. CBC measures blood cells and could provide timely information on various diseases, with personalized set points potentially diagnosing early-stage conditions. Associations include lower hemoglobin with heart risks, increased white blood cells with diabetes, red blood cell size with osteoporosis, and red blood cell percentage with kidney disease.

A study by Mass General Brigham reveals that CBC setpoints are unique to each patient, suggesting a personalized approach could improve health assessment and early disease diagnosis.

The 115th Nobel Prizes, established by Alfred Nobel, include awards in Medicine, Chemistry, and more, with laureates like Victor Ambros, Gary Ruvkun, David Baker, Demis Hassabis, and John M. Jumper. Ambros and Ruvkun discovered microRNA, influencing drug development for conditions like heart failure and cancer. Baker's AI-driven protein design and Hassabis and Jumper's AlphaFold advancements revolutionize protein structure prediction and therapeutic development.

Clene received FDA guidance on an accelerated approval pathway for CNM-Au8 in ALS, recommending leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial. Clene plans to submit an NDA in mid-2025, incorporating EAP NfL biomarker analyses, and commence the RESTORE-ALS Phase 3 trial before NDA submission.

Clene Inc. received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS, following a November 1 meeting where additional data was presented. The FDA recommended leveraging data from ongoing compassionate use EAPs to substantiate CNM-Au8's effect on NfL decline. Clene plans to submit additional NfL biomarker data by Q2 2025 and commence the Phase 3 RESTORE-ALS trial before NDA submission.

Clene plans to submit an NDA for ALS in mid-2025, incorporating NfL biomarker analyses from EAPs. The FDA recommends leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial to support earlier findings and suggests a follow-up meeting to discuss analyses for accelerated approval.

Klotho Neurosciences appoints Dr. Merit Cudkowicz to its Scientific Advisory Board to guide clinical trial design for ALS therapies, leveraging her expertise in neurological disorders.

Theralase®'s Phase 2 study for BCG-Unresponsive NMIBC CIS shows 68.3% Total Response (CR and IR) and 100% safety. 14 clinical sites in North America are enrolling patients, with an additional site planned for 1Q2025.