CLNN News & Events

Reports FY25 revenue $200k, consensus $152k. "Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration on Clene's biomarker and survival data, which if positive, will facilitate filing of an new drug application under an accelerated approval pathway for ALS by the end of the second quarter of 2026," said Rob Etherington, President and CEO of Clene. "In parallel, we continue to advance plans to initiate our confirmatory Phase 3 trial in ALS, which is required to be "underway" by CNM-Au8 approval in ALS, as well as to continue working with the FDA on the initiation of a Phase 3 clinical trial using cognition as an endpoint in MS. Based on our combined findings to date, we continue to believe that patients across multiple neurodegenerative conditions may benefit from the improved mitochondrial function plus energy metabolism associated with CNM-Au8 treatment."

Clene and its wholly owned subsidiary Clene Nanomedicine issued a letter to stockholders outlining key anticipated regulatory and clinical milestones for CNM-Au8 in 2026. "AFollowing the completion of multiple Phase 2 clinical trials and continued support of open label expanded access programs, we have now treated over 800 patients with CNM-Au8, our orally administered nanocrystal suspension, encompassing one of the largest sets of clinical experience in ALS. The learnings and data that we have discovered place us at an exciting and critical juncture... Sufficient cash to fund operations into the fourth quarter of 2026... Based on the significance of our clinical data and our engagement with the FDA, we believe that CNM-Au8 is well suited for the accelerated approval pathway as described below: 1. Prolonged Survival and Associated Declines in Biomarkers of Neurodegeneration: We have generated extensive clinical data demonstrating prolonged survival in ALS associated with CNM-Au8 30mg treatment... 2. Favorable Safety and Benefit/Risk Profile: CNM-Au8's groundbreaking clean-surfaced nanotherapeutic suspension, an oral liquid that patients drink daily and tastes like water, has demonstrated a consistent safety and tolerability profile... 3. Confirmatory Phase 3 RESTORE-ALS Trial Planned to Begin Later in 2026: To confirm the survival benefit observed with CNM-Au8 30 mg treatment across several Phase 2 trials and to meet FDA requirements for the accelerated approval pathway, we are planning to dose the first patient in our confirmatory Phase 3 RESTORE-ALS trial later this year."

Clene announced that the U.S. Food and Drug Administration, FDA, has granted Clene an in-person Type C Meeting later this quarter. Key highlights: The FDA has granted an in-person Type C meeting during the first quarter of 2026; New independent analyses across large observational ALS cohorts demonstrate that modest NfL reductions are significantly associated with lower mortality risk, supporting NfL reduction as a candidate surrogate endpoint for accelerated approval; New exploratory findings demonstrate that in responders with IGFBP7 biomarker decline, CNM-Au8 30mg was strongly associated with 78% reduced mortality risk in the HEALEY ALS Platform Trial, consistent with emerging genetic evidence linking lower IGFBP7 to ALS reversals

Clene announced a registered direct offering priced above market under Nasdaq rules of over $28M by new and existing investors. On January 9, 2026, Clene entered into securities purchase agreements for the issuance and sale of: 928,333 shares of common stock and accompanying warrants at an offering price of $6.50 per unit for each investor, totaling $6.03M of gross proceeds, which is expected to fund Clene into Q3; Series A Warrants, which entitle each purchaser to purchase its pro rata share of the number of shares of common stock determined by dividing $6,684,000 by the applicable exercise price. Each Series A Warrant will have an initial exercise price of $6.00 per share. All Series A Warrants will be exercisable immediately upon issuance. The exercise price of each Series A Warrant will increase to $7.00 per share if either: the warrant is exercised prior to the Company's public announcement of the FDA's posted PDUFA action date for the CNM-Au8 NDA which is expected to occur in Q1; or the volume-weighted average price of the Company's common stock equals or exceeds $10.00 on the measurement date associated with the PDUFA Date Announcement. The measurement date is the trading day of the announcement if made before 9:00 a.m. New York City time, or the next trading day if made at or after 9:01 a.m. New York City time or on a non-trading day. The potential gross proceeds from the exercise of the Series A Warrants totals approximately $6.7M and is expected to fund the Company through the end of 2026; and Series B Warrants, which entitle each purchaser to purchase its pro rata share of the number of shares of common stock determined by dividing $15,596,000 by the applicable exercise price. Each Series B Warrant will have an initial exercise price of $6.00 per share. All Series B Warrants will be exercisable immediately upon issuance. he exercise price of each Series B Warrant is subject to increase based on the timing of exercise and the common stock's volume-weighted average price in connection with the Company's public announcement of its receipt of written FDA approval for the CNM-Au8 NDA in ALS. The exercise price will increase to $12.50 per share if the Series B Warrant is exercised before the FDA Approval Announcement. If the Series B Warrant is exercised after the FDA Approval Announcement, it will increase to: $10.00 per share, if the volume-weighted average price of Clene's common stock on Nasdaq is equal to or greater than $20.00 on the measurement date associated with the FDA Approval Announcement or $12.50 share, if the volume-weighted average price of Clene's common stock on Nasdaq is equal to or greater than $25.00 on the measurement date. The measurement date is the trading day of the announcement if made before 9:00 a.m. New York City time, or the next trading day if made at or after 9:01 a.m. New York City time or on a non-trading day. The potential gross proceeds from the exercise of the Series B Warrants totals approximately $15.6M and is expected to fund the Company's commercialization efforts. BTIG is acting as sole placement agent for the offering. The offering is expected to close on or about January 12, 2026, subject to the satisfaction of customary closing conditions.