Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights
Rhea-AI Summary
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.
AI-generated analysis. Not financial advice.
Positive
- FDA indicated CNM-Au8 data may support accelerated approval NDA for ALS
- Planned CNM-Au8 NDA submission in Q3 2026 and Phase 3 trial in Q1 2027
- January 2026 oversubscribed registered direct offering raised over $28M
- May 2026 underwritten registered direct offering added $7M gross proceeds
- Convertible debt maturity extended to August 2027 with no payments until then
- R&D expenses fell to $0.3M from $1.5M year over year
- G&A expenses declined to $1.7M from $2.7M year over year
- Cash runway expected into Q4 2026, potentially into 2027 with $7M warrants
Negative
- Net loss widened to $8.1M from $0.8M year over year
- Total other expense was $6.0M versus prior-year other income of $3.3M
- Higher interest expense in 2026 due to larger debt balances
- Significant non-cash costs tied to warrant liabilities and January 2026 financing
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves, with names like BRLS and LSF up around 3–4% while ATPC and PAVS are down. With CLNN flat pre-release and no clear direction, any reaction to this earnings report would likely be stock-specific rather than explained by these offsetting sector moves.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 12 | Full-year 2025 results | Positive | +6.1% | Reported 2025 financials with reduced loss and outlined Type C meeting and NDA plans. |
| Nov 13 | Q3 2025 results | Positive | -22.4% | Q3 2025 update on CNM-Au8 programs, cash of $7.9M, and NDA/Phase 3 timelines. |
| Aug 14 | Q2 2025 results | Positive | -1.4% | Q2 2025 earnings with lower R&D and G&A and promising MS clinical data. |
| May 07 | Q1 2025 results | Positive | -10.5% | Q1 2025 results plus ALS survival data and plans for an ALS NDA in 2025. |
| Mar 24 | Full-year 2024 results | Positive | -5.3% | Full-year 2024 update with lower expenses, new $10M debt, and RESTORE-ALS plans. |
Earnings releases have often coincided with negative next-day moves, even when highlighting clinical and financial progress, suggesting a pattern of cautious market response to Clene’s updates.
Over the past five earnings and annual reports from March 2024 through March 2026, Clene repeatedly paired financial updates with progress on CNM-Au8 and accelerated-approval plans in ALS. Cash positions trended in the single-digit millions, with new debt facilities and offerings used to extend runway into 2026. Prior releases emphasized reduced R&D and G&A spending and narrower net losses. Today’s Q1 2026 results continue this theme, showing lower operating expenses, additional financings, and a clearer path toward an ALS NDA and confirmatory Phase 3 plan.
Historical Comparison
Past earnings-related releases saw an average next-day move of -6.71%. Relative to that history, a flat or modest reaction to this Q1 2026 update would represent a milder response than typical.
Earnings releases have tracked CNM-Au8’s ALS path from early NDA planning in 2024–2025 toward clearer Type C feedback and a defined NDA and confirmatory Phase 3 timeline by early 2026, alongside gradually reduced operating expenses.
Regulatory & Risk Context
An effective S-3 shelf filed on September 5, 2025 covers up to 491,496 shares of common stock for resale by existing holders, largely tied to conversions of senior secured notes. Clene receives no cash from these resales, having already obtained proceeds from the note issuances. The filing also acknowledges recurring losses, low cash levels, covenant constraints, and substantial doubt about the company’s ability to continue as a going concern without further financing.
Market Pulse Summary
This announcement combines Q1 2026 financials with important regulatory milestones for CNM-Au8. Clene reports cash of $5.9 million, materially reduced R&D and G&A expenses, and recent equity and debt transactions that extend runway into late 2026. At the same time, net loss expanded to $8.1 million on warrant and financing-related charges. Investors may track cash burn, future trial initiation, the planned ALS NDA submission, and any additional use of existing financing structures.
Key Terms
nda regulatory
accelerated approval pathway regulatory
neurofilament light (nfl) medical
phase 3 trial medical
expanded access programs (eaps) medical
gross proceeds financial
convertible debt facility financial
AI-generated analysis. Not financial advice.
- After successful completion of FDA Type C meeting, Clene expects to submit an NDA for CNM-Au8® under the accelerated approval pathway in the third quarter of 2026
- In January 2026, Clene completed an oversubscribed registered direct offering totaling over
$28 million , including an initial tranche of more than$6 million and two additional tranches totaling over$22 million tied to regulatory milestones - In May 2026, Clene amended its existing
$10 million convertible debt facility, extending maturity by six months to August 2027 and eliminating required monthly principal and interest payments before maturity - In May 2026, Clene completed a
$7 million underwritten registered direct offering with a single investor
SALT LAKE CITY, May 14, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late-stage clinical biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2026 financial results and provided recent updates on its CNM-Au8 programs.
“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.”
First Quarter 2026 and Recent Operating Highlights
CNM-Au8 for the treatment of ALS
Clene had a successful Type C in-person meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to discuss the statistically significant reductions in neurofilament light (NfL), including the relationship between the magnitude of NfL reduction and clinical benefits, including longer survival in participants treated with CNM-Au8. During the meeting, and as confirmed in the final meeting minutes, the FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway for the treatment of ALS.” The FDA also reminded the Company that the submission should demonstrate that CNM-Au8 has an effect on NfL and that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS.
Clene intends to submit the New Drug Application (NDA) in the third quarter of 2026. Also, Clene plans to commence the confirmatory Phase 3 trial in the first quarter of 2027. The RESTORE-ALS trial is designed to investigate the effects of CNM-Au8 on improved survival (primary endpoint) and delayed time to ALS clinical worsening events (secondary efficacy endpoint).
Corporate Update
In January, Clene announced an oversubscribed registered direct offering of over
In May, the Company closed an underwritten registered direct common stock offering to a single investor totaling
Also in May, the Company amended its existing
First Quarter 2026 Financial Results
Clene’s cash and cash equivalents totaled
Research and development expenses were
General and administrative expenses were
Total other expense, net, was
Clene reported a net loss of
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.
About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.
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 and our cash runway. 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; 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
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 1 | $ | 64 | ||||
| Royalty revenue | 14 | 17 | ||||||
| Total revenue | 15 | 81 | ||||||
| Operating expenses: | ||||||||
| Cost of revenue | — | 20 | ||||||
| Research and development | 329 | 1,481 | ||||||
| General and administrative | 1,747 | 2,656 | ||||||
| Total operating expenses | 2,076 | 4,157 | ||||||
| Loss from operations | (2,061 | ) | (4,076 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest income | 47 | 81 | ||||||
| Interest expense | (791 | ) | (608 | ) | ||||
| Issuance costs for common stock warrant liabilities | (393 | ) | — | |||||
| Loss on initial issuance of equity | (4,582 | ) | — | |||||
| Change in fair value of common stock warrant liabilities | (1,060 | ) | 2,510 | |||||
| Change in fair value of derivative liabilities | 713 | 1,147 | ||||||
| Research and development tax credits and unrestricted grants | 36 | 195 | ||||||
| Total other income (expense), net | (6,030 | ) | 3,325 | |||||
| Net loss before income taxes | (8,091 | ) | (751 | ) | ||||
| Income tax expense | — | — | ||||||
| Net loss | $ | (8,091 | ) | $ | (751 | ) | ||
| Other comprehensive income: | ||||||||
| Foreign currency translation adjustments | $ | 44 | $ | 15 | ||||
| Total other comprehensive income | 44 | 15 | ||||||
| Comprehensive loss | $ | (8,047 | ) | $ | (736 | ) | ||
| Net loss per share – basic and diluted | $ | (0.69 | ) | $ | (0.09 | ) | ||
| Weighted average common shares used to compute basic and diluted net loss per share | 11,644,214 | 8,824,673 | ||||||
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,939 | $ | 5,189 | ||||
| Inventory | 54 | 37 | ||||||
| Prepaid expenses and other current assets | 7,030 | 3,751 | ||||||
| Total current assets | 13,023 | 8,977 | ||||||
| Restricted cash | 58 | 58 | ||||||
| Operating lease right-of-use assets | 2,916 | 3,073 | ||||||
| Property and equipment, net | 5,668 | 6,023 | ||||||
| TOTAL ASSETS | $ | 21,665 | $ | 18,131 | ||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,309 | $ | 892 | ||||
| Accrued liabilities | 2,729 | 5,002 | ||||||
| Operating lease obligations, current portion | 826 | 808 | ||||||
| Notes payable, current portion | 990 | 1,696 | ||||||
| Convertible notes payable, current portion | 876 | 2,378 | ||||||
| Total current liabilities | 6,730 | 10,776 | ||||||
| Operating lease obligations, net of current portion | 3,017 | 3,250 | ||||||
| Notes payable, net of current portion | 4,633 | 3,741 | ||||||
| Convertible notes payable, net of current portion | 11,706 | 9,800 | ||||||
| Common stock warrant liabilities | 12,005 | 5,063 | ||||||
| Derivative liabilities | 2,380 | 3,093 | ||||||
| TOTAL LIABILITIES | 40,471 | 35,723 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit: | ||||||||
| Common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 297,364 | 290,531 | ||||||
| Accumulated deficit | (316,387 | ) | (308,296 | ) | ||||
| Accumulated other comprehensive income | 216 | 172 | ||||||
| TOTAL STOCKHOLDERS’ DEFICIT | (18,806 | ) | (17,592 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | 21,665 | $ | 18,131 | ||||
