Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA
Clene raises $4 million from insiders and existing holders, extending its cash runway past a potential FDA accept-for-review decision on CNM-Au8 for ALS.
Rhea-AI Summary
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.
Positive
- Registered direct offering raises $4 million in gross proceeds
- Runway extended to mid-first quarter 2027 based on current plans
- Insider-led financing, including Chairman, CEO and founding investor participation
- Potential additional $6.7–$7.8 million from warrant exercise if FDA accepts NDA
Negative
- Equity financing implies shareholder dilution for common stock holders
- Additional $6.7–$7.8 million in warrant proceeds contingent on FDA NDA acceptance
Key Figures
- Gross proceeds
- $4 million
- Registered direct offering
- Cash runway
- Mid-first quarter 2027
- Expected funding period after offering
- Potential warrant proceeds
- $6.7 million to $7.8 million
- Contingent on FDA acceptance of the NDA for review
- Shares issued
- 1,219,513 shares
- Common stock offering at $3.28 per share
Previous Offering Reports
-
Priced $4 million offering to existing shareholders, with closing expected September 17.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
registered direct offering financial
nda regulatory
accelerated approval pathway regulatory
als medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Investment was led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders
$4 million registered direct offering was priced at market under Nasdaq rules- Proceeds are expected to be sufficient to fund the Company to mid-first quarter 2027, which is beyond the potential FDA decision to accept the CNM-Au8® NDA for review under the accelerated approval pathway
SALT LAKE CITY, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on ALS, today announced the closing of a registered direct offering of common stock to existing shareholders, including insiders, with total gross proceeds of
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 was made without a placement agent, underwriter, broker or dealer, and is expected to provide Clene with sufficient cash to fund its operations through mid-first quarter 2027, which is beyond the potential U.S. Food and Drug Administration (FDA) decision for accepting the New Drug Application (NDA) for review of CNM-Au8® for treatment of amyotrophic lateral sclerosis (ALS) under the accelerated approval pathway. In addition, if the FDA accepts the NDA from Clene for review, the Company could potentially receive
About Clene
Clene Inc. (Nasdaq: CLNN), along with its subsidiaries, “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding the timing of the Company’s NDA submission, that the biomarker findings support an NDA submission, and the timing of the initiation of the Phase 3 trial. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; the post hoc and exploratory nature of the biomarker analyses described in this press release, which were not prespecified, were not adjusted for multiplicity, and are based on small patient numbers, and which may not be predictive of results in future trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
Investor Contact: Kevin Gardner, LifeSci Advisors; kgardner@lifesciadvisors.com; 617-283-2856
Media Contact: Caroline Wagner, FTP; CWagner@ftpadvocacy.com; (267) 294-6563
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Who led Clene’s $4 million registered direct offering?
The offering was led by Clene’s Chairman of the Board, David Matlin, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders.
Were any intermediaries used for the Clene financing?
The company states that the offering was made without a placement agent, underwriter, broker or dealer, meaning it raised the funds directly from existing shareholders.
How does this financing relate to the CNM-Au8 NDA process?
Clene expects that proceeds from the $4 million offering will fund operations through mid-first quarter 2027, which it states is beyond the potential FDA decision on whether to accept the CNM-Au8® NDA for review for ALS under the accelerated approval pathway.