Clene Inc.

Clene Inc. announced new biomarker analyses from its Phase 2 ALS trials (HEALEY and RESCUE-ALS) for CNM-Au8, which will be included in its planned New Drug Application (NDA) seeking accelerated approval. The analyses showed that CNM-Au8-treated patients whose neurofilament light chain (NfL) biomarker levels declined or stabilized lived significantly longer and had better functional outcomes than concurrently randomized controls. The company believes these findings address questions raised by the U.S. FDA and support the accelerated approval standard.

Clene Inc. announced that its management will present at the Canaccord 46th Annual Growth Conference on August 11, 2026, at 10:30 AM ET in Boston, MA. The company will also host one-on-one investor meetings during the event. A webcast of the presentation will be accessible via the "Events" section of Clene's website.

Clene Inc. amended its senior secured convertible promissory notes, extending the maturity date to August 13, 2027, or a change in control, and deferring monthly principal and interest payments of $150,000 until the new maturity date. Additionally, stockholders approved an amendment to the 2020 Stock Plan, increasing the shares reserved for issuance by 1,000,000. At its Annual Meeting, the company also elected three Class III directors, ratified Deloitte & Touche LLP as its independent auditor, and approved executive compensation on an advisory basis.

Clene Inc. announced plans to submit a New Drug Application (NDA) for CNM-Au8® for ALS under the accelerated approval pathway in Q3 2026, following a successful Type C meeting with the FDA. The company also amended its $10 million convertible debt facility, extending the maturity to August 2027 and eliminating monthly principal and interest payments until then, which is expected to extend its operating runway. For the first quarter of 2026, Clene reported a net loss of $8.1 million and ended the period with $5.9 million in cash and cash equivalents, after completing two registered direct offerings totaling $35 million in gross proceeds.

Clene Inc. reported a significant widening of its net loss to $8.1 million for the first quarter of 2026, compared to a $0.8 million loss in the same period last year. Total revenue also saw a sharp decline to $15 thousand from $81 thousand year-over-year. The company explicitly stated that these conditions raise substantial doubt about its ability to continue as a going concern, despite having raised $6.0 million in gross proceeds from an equity offering during the quarter and an additional $7.0 million subsequent to quarter-end.

Clene Inc. announced an underwritten public offering of 1,000,000 shares of common stock at $7.00 per share, expecting to raise approximately $7 million in gross proceeds. The net proceeds, estimated at $6.4 million after expenses, will be used for general corporate purposes, including funding the New Drug Application (NDA) for its lead drug candidate CNM-Au8, supporting ongoing clinical trials, manufacturing expansion, and future commercialization efforts. The offering is expected to close on May 6, 2026, with Canaccord Genuity LLC acting as the sole bookrunner. Certain insiders are subject to a 60-day lock-up period.

Clene Inc. announced the pricing of an underwritten registered direct offering of 1,000,000 shares of common stock at a purchase price of $7.00 per share to a single investor. The offering is expected to generate approximately $7 million in gross proceeds. Clene plans to use the net proceeds, along with existing cash, for general corporate purposes, including the preparation and filing of the New Drug Application (NDA) for CNM-Au8®, funding ongoing clinical trials, manufacturing expansion, potential commercialization efforts, and additional early-stage research and development activities. The offering is anticipated to close around May 6, 2026.

Clene Inc. announced its participation in two investor conferences in May 2026. The company will present virtually at the Emerging Growth Conference on May 6 and hold one-on-one meetings at the D. Boral Capital Global Conference in New York on May 7. These engagements aim to connect with the investment community.

Clene Inc. announced plans to file an accelerated approval New Drug Application (NDA) for CNM-Au8 in amyotrophic lateral sclerosis (ALS) following a successful Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA stated that Clene's proposed data may support an NDA submission under the accelerated approval pathway, acknowledging neurofilament light (NfL) as a potential surrogate endpoint. Clene intends to submit the NDA in the third quarter of 2026, supported by data from Phase 2 HEALEY ALS Platform Trial, RESCUE-ALS Trial, and an NIH-sponsored Expanded Access Protocol. A Phase 3 confirmatory study for CNM-Au8 is planned to commence in the first quarter of 2027.

Clene Inc. announced receipt of final meeting minutes from its Type C meeting with the FDA, confirming that the proposed data for CNM-Au8 may support an NDA submission under the accelerated approval pathway for ALS. The FDA acknowledged that neurofilament light (NfL) could potentially serve as a reasonably likely surrogate endpoint. Clene plans to submit its NDA for CNM-Au8 in the third quarter of 2026, representing a critical step for the potential first-in-class therapeutic approach for ALS.