Clene Eyes Q3 2026 CNM-Au8 NDA After Positive FDA Meeting, Raises $35M
CLNN•Clene targets filing its NDA for CNM-Au8 under the accelerated approval pathway in Q3 2026 after a positive FDA Type C meeting. The company raised $35 million in recent offerings and extended its $10 million convertible debt maturity to August 2027, securing cash runway into late 2026.
1. FDA Meeting and NDA Submission
Clene held a successful FDA Type C meeting in Q1 2026, where the agency indicated that the observed reductions in neurofilament light may support an accelerated NDA pathway. The company plans to submit the New Drug Application for CNM-Au8 in the third quarter of 2026.
2. Capital Raises and Debt Extension
In January 2026, Clene completed an oversubscribed registered direct offering raising over $28 million, including milestone-linked tranches, and in May 2026 closed a $7 million offering. Concurrently, Clene amended its $10 million convertible debt facility, extending maturity to August 2027 and deferring principal and interest payments.
3. Q1 2026 Financial Results and Runway
As of March 31, 2026, Clene reported cash and cash equivalents of $5.9 million, up from $5.2 million at year-end. The company expects its combined proceeds and debt amendments to fund operations into the fourth quarter of 2026, with potential extension into 2027 through $7 million in future warrant exercises tied to NDA acceptance.
4. Phase 3 RESTORE-ALS Trial Plans
Clene intends to initiate the confirmatory RESTORE-ALS Phase 3 trial in the first quarter of 2027, focusing on improved survival as its primary endpoint and delayed clinical worsening events as secondary efficacy measures.
