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CLNN News
CLNN Events
Clene Reports Q3 Revenue of $56,000, Below Consensus
Reports Q3 revenue $56,000, consensus $59,200. "Clene's submission of the NDA for CNM-Au8 is a pivotal achievement for the company and, more importantly, a meaningful step toward bringing new treatment options to people living with ALS," said Rob Etherington, President and CEO of Clene. "People living with ALS urgently need additional treatment options, and we appreciate the FDA's constructive engagement throughout this process. We look forward to working closely with the Agency during its pending review. We believe CNM-Au8 has the capacity to restore and protect neuronal health and function and improve survival."
Clene Submits NDA for Accelerated Approval of CNM-Au8
Clene announced that it has submitted a new drug application, or NDA, earlier in October to the FDA seeking accelerated approval of CNM-Au8 for the treatment of amyotrophic lateral sclerosis, or ALS.
Clene Prices Direct Offering of 1,219,513 Shares at $3.28, Raising $4M
Clene announced the pricing of a registered direct offering of 1,219,513 shares at a purchase price of $3.28 per share to existing shareholders, including insiders, with total gross proceeds of $4M. The offering is expected to close on September 17. The offering was led by Clene's Chairman of the Board of Directors, David Matlin, alongside founding investor Kensington Capital Holdings, Clene's Chief Executive Officer and other existing shareholders. The offering is expected to provide Clene with sufficient cash to fund its operations through mid-first quarter 2027. The offering is being made without a placement agent, underwriter, broker or dealer.
Clene Reports Q1 Revenue of $15 Million, Below Expectations
Reports Q1 revenue $15,000, consensus $33,830. "We were encouraged by the constructive dialogue during our recent Type C meeting with the FDA and appreciate the Agency's engagement as we advance toward a planned NDA submission for CNM-Au8 under the accelerated approval pathway for patients with ALS," said Rob Etherington, President and CEO of Clene. "People living with ALS continue to need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function, leading to improved survival. We look forward to continuing to work collaboratively with the FDA as the Agency reviews our extensive clinical efficacy and safety data."
Clene Receives Final Meeting Minutes from FDA, Plans to Submit ALS NDA in 2026
Clene announced receipt of final meeting minutes following its recent Type C meeting with the FDA. During the meeting and confirmed in the final meeting minutes, the FDA stated that Clene's "proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of ALS." The FDA reminded the company that the submission should demonstrate the effectiveness of an effect of CNM-Au8 on NfL and show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS. Clene intends to submit its NDA in the third quarter of 2026, which will remain a matter of FDA review. The agency also noted that "NfL could potentially serve as a reasonably likely surrogate endpoint to support (an) accelerated approval." This submission would occur under the Subpart H accelerated approval pathway in ALS. The Agency has also requested that the company provide additional information in its NDA, including to support a connection between the reported magnitude of reduction in NfL and clinical benefit, which Clene has prepared and will include in the submission.
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