Clene (NasdaqCM:CLNN) Conference Transcript

Clene Inc. Conference Call Summary Company Overview - Clene Inc. is a clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS (Amyotrophic Lateral Sclerosis) and MS (Multiple Sclerosis) [1] Key Accomplishments and FDA Interactions - Clene has achieved an in-person meeting with the FDA this quarter, marking the fifth meeting in 14 months to discuss extensive biomarker and survival data [2] - The company presented significant biomarker analyses showing reductions in neurofilament and GFAP (glial fibrillary acidic protein), which are associated with longer survival in ALS patients [3][4] - Clene aims to file a new drug application (NDA) under the accelerated approval pathway, utilizing biomarker data as a surrogate endpoint due to missed primary endpoints in previous studies [5][6] Biomarker Data and Clinical Evidence - The company has demonstrated that reductions in neurofilament levels are quantitatively associated with improved survival, with a noted reduction of 9%-10% linked to lower mortality risk [8] - Clene is pursuing a three-pronged approach to validate the biomarker benefits, including proving substantial biomarker benefit, establishing an independent association with mortality, and demonstrating consistent clinical benefits [7][9] Future Plans and Timeline - The FDA meeting is scheduled for later this quarter, with the intent to file the NDA in the second quarter of 2024 if the FDA concurs with the data presented [11][12] - If accepted, commercialization could begin by early 2025, with aspirations to approve CNM-Au8 for ALS patients [13] Financing and Cash Runway - Clene raised approximately $6 million at a price of $6.50 per share through a tranche financing, extending its cash runway by an additional quarter [17] - Future tranches are planned, with potential raises of $7 million at $7 per share and $15 million at a $12.50 strike price upon approval [18] Industry Context and Need for New Treatments - There are over 30,000 ALS patients in the U.S., with a uniform mortality rate of 2-4 years without treatment, highlighting the urgent need for new drugs [19] - Clene is also working to reauthorize funding for ALS research at the Congressional level, emphasizing the critical need for advancements in treatment options [19] Conclusion - Clene Inc. is positioned to make significant strides in ALS treatment through its ongoing FDA interactions and biomarker research, with a clear plan for future drug application and funding strategies [20]