Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
Clene (Nasdaq: CLNN) submitted a New Drug Application to the FDA earlier in October 2026 seeking accelerated approval of CNM-Au8 for ALS.
The application seeks approval to treat amyotrophic lateral sclerosis (ALS) based on neurofilament light chain biomarker data, a biological measure, and clinical outcomes. The submission is a regulatory step, not an approval.
Clene said it plans to work with the FDA during the review process while continuing preparations for the confirmatory Phase 3 RESTORE-ALS study. The company has not described that study as underway.
Clene (CLNN) will participate in two investor conferences on September 29–30, 2026, offering presentations and 1x1 investor meetings.
Management will attend the 5th Annual ROTH Healthcare Opportunities Conference in New York on September 29, where meetings are arranged via ROTH representatives. Clene will also present at the Lytham Partners Investor Conference Fall Event, held virtually September 29–30, with a presentation at 9:45 a.m. ET and additional 1x1 meetings scheduled through Lytham representatives. A webcast of the Lytham presentation will be accessible through the Events section of Clene’s website or via the provided webcast links.
Clene (CLNN) closed a $4 million registered direct offering of common stock to existing shareholders, including insiders, priced at market under Nasdaq rules.
The investment was led by Chairman David Matlin, founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other current shareholders. The offering was completed without a placement agent, underwriter, broker or dealer, so all gross proceeds go directly to the company. Clene expects the capital to fund operations until mid-first quarter 2027, which it states extends beyond a potential U.S. Food and Drug Administration (FDA) decision on whether to accept the CNM-Au8® New Drug Application (NDA) for review for amyotrophic lateral sclerosis (ALS) under the accelerated approval pathway.
If the FDA accepts the NDA for review, Clene could potentially receive an additional $6.7 million to $7.8 million from the exercise of common stock warrants issued in a January 2026 financing.
Clene (CLNN) has priced a registered direct offering of 1,219,513 shares of common stock at $3.28 per share to existing shareholders, for total gross proceeds of $4 million, with closing expected on September 17, 2026.
The investment is led by Clene’s chairman David Matlin, founding investor Kensington Capital Holdings, the chief executive officer and other existing shareholders, and is being conducted without a placement agent, underwriter, broker or dealer. Clene expects the proceeds, together with existing cash, to fund operations through mid-first quarter 2027 and plans to use the funds primarily for general corporate purposes and to support regulatory dialogue, filings, expanded access protocols, potential commercialization and manufacturing expansion for CNM-Au8.
Clene (CLNN) will present at two September 2026 investor conferences and host one-on-one investor meetings.
The company presents at the 2026 Cantor Global Healthcare Conference/b) on at 9:10 a.m. ET in New York, and at the HC Wainwright 28th Annual Global Investment Conference on September 15, 2026 at 1:30 p.m. ET, also in New York. Webcasts will be available via Clene’s website “Events” section or the provided webcast links.
Clene (Nasdaq: CLNN) announced that its management will deliver a virtual corporate update at the Emerging Growth Conference on August 19, 2026, at 3:10 p.m. ET. The presentation will be webcast via the Events section of Clene’s website and through a dedicated registration link.
According to Clene, a replay will be available through the conference portal and the Emerging Growth YouTube Channel after the event. Clene is a late clinical-stage biopharmaceutical company developing CNM-Au8, an investigational therapy targeting mitochondrial function for neurodegenerative diseases such as ALS, Parkinson’s disease, and multiple sclerosis.
Clene (Nasdaq: CLNN) reported second quarter 2026 results and ALS program updates. The company plans to submit a New Drug Application for CNM-Au8 in ALS under the FDA’s accelerated approval pathway in early Q4 2026, following FDA minutes stating its proposed data may be capable of supporting such an NDA.
New biomarker analyses from two Phase 2 ALS trials showed CNM-Au8-treated patients whose NfL declined or stabilized lived longer and performed better on combined survival and functional measures than randomized controls. Clene closed a $7.0 million underwritten registered direct offering and extended $11.5 million of senior secured convertible debt maturities to August 2027.
As of June 30, 2026, cash and cash equivalents were $9.7 million, providing runway through late Q4 2026. Q2 revenue was $0.1 million, net loss was $13.4 million ($1.08 per share), and total liabilities exceeded assets, resulting in a $24.8 million stockholders’ deficit.
Clene (Nasdaq: CLNN) reported new post hoc biomarker analyses from its Phase 2 ALS trials HEALEY and RESCUE-ALS, linking CNM-Au8® 30 mg treatment, neurofilament light chain (NfL) decline or stabilization, and improved survival and function. These data will be included in a planned NDA seeking U.S. FDA accelerated approval.
Across analyses, CNM-Au8–treated participants whose NfL declined or stabilized showed substantially lower risk of death versus concurrently randomized or propensity-matched controls, and better outcomes on combined survival-function measures (ALSFRS-R and Slow Vital Capacity). A causal, randomization-based analysis suggested the survival benefit was concentrated in predicted NfL responders. Clene also highlighted more than 1,280 participant-years of CNM-Au8 exposure with no serious adverse events assessed as related to treatment and no long-term safety signals. A Phase 3 RESTORE-ALS trial is planned to prospectively evaluate the NfL relationship.
Clene (Nasdaq: CLNN) announced that its management will present at the Canaccord 46th Annual Growth Conference and host 1x1 investor meetings. The late clinical-stage biopharmaceutical company, focused on neurodegenerative diseases such as ALS and MS, is scheduled to present on August 11, 2026 at 10:30 a.m. ET in Boston, MA. A live webcast will be accessible via the Clene website’s Events section, with online registration available for remote viewers.
Clene (Nasdaq: CLNN) reported first quarter 2026 results and key regulatory advances for CNM-Au8 in ALS. Following a successful FDA Type C meeting, the FDA indicated the proposed data may support an NDA under the accelerated approval pathway, and Clene plans NDA submission in Q3 2026 and a confirmatory Phase 3 trial in Q1 2027.
Clene completed an oversubscribed $28M registered direct offering in January 2026, a $7M underwritten registered direct in May, and amended a $10M convertible debt facility. Q1 2026 net loss was $8.1M ($0.69/share), with cash of $5.9M and runway projected into Q4 2026, potentially into 2027 with warrant exercises.