Clene Announces Registered Direct Offering Over $28M
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.
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- Presentation Schedule: Clene Inc. will present a corporate update at the Emerging Growth Conference on January 21, 2026, at 3:10 p.m. ET, showcasing its latest advancements in treating neurodegenerative diseases, which is expected to attract significant investor interest.
- Innovation Showcase: Clene focuses on improving mitochondrial health and protecting neuronal function, particularly targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), with its investigational therapy CNM-Au8® aiming to enhance central nervous system cell survival through mitochondrial function targeting.
- Webcast Availability: The presentation will be available via a webcast on Clene's website under the “Events” section, and a replay will also be accessible through the conference portal and YouTube channel, ensuring that investors unable to attend live can still access the information.
- Investor Relations Enhancement: The Emerging Growth Conference provides Clene with an effective platform to present its innovative products and services to potential individual and institutional investors, further strengthening the company's market presence in the biopharmaceutical sector.
- Presentation Schedule: Clene Inc. will present a corporate update at the Emerging Growth Conference on January 21, 2026, at 3:10 p.m. ET, which is expected to attract significant investor interest in its new products and services.
- Webcast Availability: The presentation will be available via webcast on Clene's website under the 'Events' section, and a replay will also be accessible through the conference portal and the Emerging Growth YouTube channel, ensuring investors can access the information at their convenience.
- Company Background: Clene Inc. is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis and multiple sclerosis, showcasing its innovative potential in the biopharmaceutical sector.
- Product Development Highlight: Its investigational therapy CNM-Au8® is a first-in-class treatment aimed at enhancing the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway, indicating promising therapeutic prospects for neurodegenerative diseases.

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- FDA Review Progress: Argenx SE's supplemental Biologics License Application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis, has been accepted for priority review by the FDA, with a target action date of May 10, 2026, indicating potential for expanded indications.
- Market Trends: Cosmos Health Inc. saw its stock rise 6.09% to $0.4961 despite no specific news, reflecting speculative interest and momentum trading in the micro-cap healthcare sector.

- FDA Meeting Approval: Clene Inc. has received FDA approval for an in-person Type C meeting in Q1 2026 to discuss the association of NfL biomarkers with ALS patient survival, marking a significant step in the company's accelerated approval pathway.
- NfL Reduction and Survival Link: In the HEALEY ALS Platform Trial, CNM-Au8 treatment resulted in approximately 10% reduction in NfL levels, significantly associated with an 8-13% lower mortality risk, indicating potential clinical benefits in rapidly progressive ALS.
- IGFBP7 Biomarker Discovery: The decline in IGFBP7 levels was strongly associated with a 78% reduction in mortality risk among responders to CNM-Au8 treatment, further supporting the importance of this biomarker in ALS therapy and potentially guiding future treatment strategies.
- Clinical Data Support: Clene's pre-meeting briefing package includes statistically significant reductions in NfL and GFAP, suggesting that changes in these biomarkers may predict clinical benefits for ALS patients, enhancing the company's competitive position in the biopharmaceutical sector.

- FDA Meeting Approval: Clene Inc. has received FDA approval for an in-person Type C meeting in Q1 2026 to discuss the association of NfL biomarkers with ALS patient survival, potentially paving the way for accelerated approval.
- NfL Reduction and Survival Link: In the HEALEY ALS Platform Trial, CNM-Au8 treatment resulted in approximately 10% reduction in NfL levels, significantly correlating with an 8-13% lower mortality risk, indicating potential improvement in survival expectations for ALS patients.
- IGFBP7 as a Biomarker: The study identified a decline in IGFBP7 levels associated with CNM-Au8 treatment, showing a 78% reduction in mortality risk for responders (HR 0.22, p=0.01), providing new biomarker support for ALS treatment.
- Clinical Data Support: Clene's pre-meeting briefing package includes significant reductions in NfL and GFAP, supporting NfL as a candidate biomarker for accelerated approval, which could change the future of ALS treatment.
- Successful Financing: Clene Inc. has completed a registered direct offering raising over $28 million, attracting top-tier investors like Boxer Capital, which is expected to fund the company into early 2027, facilitating the commercialization of its ALS drug CNM-Au8.
- Funding Allocation: The initial financing tranche exceeds $6 million, projected to sustain operations through Q3 2026, while two additional tranches totaling over $22 million are contingent on FDA approval of the New Drug Application, ensuring financial stability.
- Investor Confidence: CEO Rob Etherington noted that the investment reflects strong validation of Clene's efforts in ALS, reinforcing the promise of ALS biomarkers and survival data for the upcoming drug application.
- Market Outlook: This financing not only provides essential capital support but also enhances Clene's competitive position in the neurodegenerative disease treatment landscape, particularly in the potential commercialization opportunities within the ALS market.






