Clene Reports Third Quarter 2026 Financial Results and Recent Operating Highlights
Quarterly profit reflected liability fair-value changes, while Clene expects its operating runway to extend through mid-first quarter 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Clene (Nasdaq: CLNN) reported third-quarter 2026 net income of $3.9 million and submitted its application for accelerated approval of CNM-Au8. The October submission seeks approval for amyotrophic lateral sclerosis (ALS). Quarterly earnings were $0.30 per basic share and $0.05 per diluted share, versus a $0.85 loss per share a year earlier. Other income of $10.3 million, primarily reflecting liability fair-value changes, supported the profit; the operating loss widened to $6.347 million from $5.648 million.
A September common-stock offering raised $4.0 million at $3.28 per share. Cash was $9.9 million at September 30, versus $5.2 million at December 31, 2025. Clene expects resources to fund operations through mid-first quarter 2027 and plans to start randomizing participants in its Phase 3 RESTORE-ALS trial in second-quarter 2027. Potential warrant proceeds depend on FDA acceptance of the application for review.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointCNM-Au8’s October 2026 application submission advances Clene’s request for accelerated approval in ALS.
- Moderate pointSeptember’s registered direct offering raised $4.0 million from existing stockholders, including insiders. 7.5% of market cap
- Moderate pointCash increased to $9.9 million at September 30, 2026, from $5.2 million at December 31, 2025.
- Moderate pointThird-quarter net income reached $3.915 million, versus an $8.777 million loss a year earlier.
- Moderate pointNine-month operating cash use declined to $11.7 million from $13.7 million in the comparable 2025 period.
- Moderate pointNine-month operating loss narrowed to $13.755 million from $15.588 million a year earlier.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Clene plans first participant randomization in Phase 3 RESTORE-ALS in second-quarter 2027.
7 minor points
- Minor pointThird-quarter earnings were $0.30 basic and $0.05 diluted per share, versus a $0.85 loss for both.
- Minor pointThird-quarter other income was $10.262 million, versus $3.129 million expense, primarily reflecting liability fair-value changes.
- Minor pointThird-quarter revenue increased to $56,000 from $15,000 a year earlier.
- Minor pointThird-quarter general and administrative expenses fell to $1.940 million from $2.150 million a year earlier.
- Minor pointNine-month revenue rose to $161,000 from $123,000 in the comparable 2025 period.
- Minor pointNine-month research and development expenses declined to $8.247 million from $8.508 million a year earlier.
- Minor pointNine-month general and administrative expenses declined to $5.617 million from $7.183 million a year earlier.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Clene expects operating resources to last only through mid-first quarter 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Potential warrant proceeds of $6.7 million to $7.8 million depend on FDA acceptance for review. 13% of market cap
- Moderate pointSeptember’s offering issued common stock at $3.28 per share, diluting existing holders.
- Moderate pointThird-quarter operating loss widened to $6.347 million from $5.648 million a year earlier.
- Moderate pointNine-month net loss widened to $17.600 million from $16.947 million; per-share loss narrowed to $1.42 from $1.77.
- Moderate pointCurrent liabilities were $17.114 million against $14.494 million in current assets at September 30, 2026.
3 minor points
- Minor pointThird-quarter research and development expenses increased to $4.447 million from $3.513 million a year earlier.
- Minor pointNine-month other expense increased to $3.845 million from $1.359 million in the comparable 2025 period.
- Minor pointStockholders’ deficit remained $14.808 million at September 30, versus $17.592 million at December 31, 2025.
News Explained
In September, Clene completed a
Key Figures
- NDA submission
- October 2026
- CNM-Au8 for ALS; seeking accelerated approval
- RESTORE-ALS participant randomization
- Second quarter of 2027
- Planned start of the Phase 3 confirmatory trial
- Registered direct offering
- $4.0 million
- Closed in September 2026
- Offering price
- $3.28 per share
- Registered direct offering
- Cash and cash equivalents
- $9.9 million
- As of September 30, 2026
- Operating runway
- Through mid-first quarter 2027
- Expected from resources as of September 30, 2026
- Potential warrant proceeds
- $6.7 million to $7.8 million
- Conditional on FDA acceptance of the NDA for review
- Net income
- $3.9 million
- Third quarter 2026; other income included fair-value changes in warrant and derivative liabilities
Previous Earnings Reports
-
Q2 report planned an early-Q4 NDA filing; the current report says submission was completed in October.
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Q1 report planned an NDA submission in Q3; the current report says submission was completed in October.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
nda regulatory
accelerated approval regulatory
nfl biomarker medical
open-label extension medical
registered direct offering financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October 2026 seeking accelerated approval for CNM-Au8® in amyotrophic lateral sclerosis (ALS)
- Completed a
$4.0 million registered direct offering in September that is expected to fund operations through mid-first quarter 2027 - Plans to initiate the Phase 3 RESTORE-ALS confirmatory trial of CNM-Au8 in ALS in the second quarter of 2027
SALT LAKE CITY, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced its third quarter 2026 financial results and provided updates on its CNM-Au8 programs.
“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.”
Third Quarter 2026 and Recent Operating Highlights
CNM-Au8 for the treatment of ALS
In October, Clene submitted an NDA to the FDA seeking accelerated approval of CNM-Au8 for ALS. The NDA is supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access Protocol for CNM-Au8.
Clene plans to randomize the first participants for the Phase 3 RESTORE-ALS trial in the second quarter of 2027. The trial will evaluate the effect of CNM-Au8 on survival (primary endpoint) and time to ALS clinical worsening events (secondary efficacy endpoint).
Corporate Update
In September, the Company closed a
The Company expects the proceeds from the offering to fund operations through mid-first quarter 2027. Subject to FDA acceptance of the NDA for review, the Company could receive
Third Quarter 2026 Financial Results
Clene’s cash and cash equivalents totaled
Research and development expenses were
General and administrative expenses were
Total other income, net, was
Clene reported net income 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 FDA’s review and potential acceptance of the Company’s NDA for CNM-Au8, the potential for accelerated approval of CNM-Au8, the timing of the Company’s confirmatory Phase 3 RESTORE-ALS trial, the sufficiency of the Company’s cash runway, the potential receipt of proceeds from the exercise of warrants, and the potential benefits of CNM-Au8. 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
Media Contact: Caroline Wagner, FTP; CWagner@ftpadvocacy.com; 267-294-6563
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 43 | $ | — | $ | 118 | $ | 65 | ||||||||
| Royalty revenue | 13 | 15 | 43 | 58 | ||||||||||||
| Total revenue | 56 | 15 | 161 | 123 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | 16 | — | 52 | 20 | ||||||||||||
| Research and development | 4,447 | 3,513 | 8,247 | 8,508 | ||||||||||||
| General and administrative | 1,940 | 2,150 | 5,617 | 7,183 | ||||||||||||
| Total operating expenses | 6,403 | 5,663 | 13,916 | 15,711 | ||||||||||||
| Loss from operations | (6,347 | ) | (5,648 | ) | (13,755 | ) | (15,588 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 50 | 40 | 152 | 183 | ||||||||||||
| Interest expense | (665 | ) | (649 | ) | (2,151 | ) | (1,936 | ) | ||||||||
| 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 | 7,493 | (1,728 | ) | 2,301 | 267 | |||||||||||
| Change in fair value of derivative liabilities | 3,368 | (797 | ) | 748 | (89 | ) | ||||||||||
| Research and development tax credits and unrestricted grants | 16 | 5 | 80 | 216 | ||||||||||||
| Total other income (expense), net | 10,262 | (3,129 | ) | (3,845 | ) | (1,359 | ) | |||||||||
| Net income (loss) before income taxes | 3,915 | (8,777 | ) | (17,600 | ) | (16,947 | ) | |||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Net income (loss) | $ | 3,915 | $ | (8,777 | ) | $ | (17,600 | ) | $ | (16,947 | ) | |||||
| Other comprehensive income: | ||||||||||||||||
| Foreign currency translation adjustments | $ | 19 | $ | 1 | $ | 55 | $ | 79 | ||||||||
| Total other comprehensive income | 19 | 1 | 55 | 79 | ||||||||||||
| Comprehensive income (loss) | $ | 3,934 | $ | (8,776 | ) | $ | (17,545 | ) | $ | (16,868 | ) | |||||
| Net income (loss) per share – basic and diluted | ||||||||||||||||
| Basic | $ | 0.30 | $ | (0.85 | ) | $ | (1.42 | ) | $ | (1.77 | ) | |||||
| Diluted | $ | 0.05 | $ | (0.85 | ) | $ | (1.42 | ) | $ | (1.77 | ) | |||||
| Weighted average common shares used to compute basic and diluted net income (loss) per share | ||||||||||||||||
| Basic | 13,079,599 | 10,284,674 | 12,374,096 | 9,549,661 | ||||||||||||
| Diluted | 14,668,742 | 10,284,674 | 12,374,096 | 9,549,661 | ||||||||||||
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,887 | $ | 5,189 | ||||
| Accounts receivable | 43 | — | ||||||
| Inventory | 41 | 37 | ||||||
| Prepaid expenses and other current assets | 4,523 | 3,751 | ||||||
| Total current assets | 14,494 | 8,977 | ||||||
| Restricted cash | 58 | 58 | ||||||
| Operating lease right-of-use assets | 2,587 | 3,073 | ||||||
| Property and equipment, net | 5,018 | 6,023 | ||||||
| TOTAL ASSETS | $ | 22,157 | $ | 18,131 | ||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 862 | $ | 892 | ||||
| Accrued liabilities | 2,510 | 5,002 | ||||||
| Operating lease obligations, current portion | 788 | 808 | ||||||
| Notes payable, current portion | 4,974 | 1,696 | ||||||
| Convertible notes payable, current portion | 7,980 | 2,378 | ||||||
| Total current liabilities | 17,114 | 10,776 | ||||||
| Operating lease obligations, net of current portion | 2,603 | 3,250 | ||||||
| Notes payable, net of current portion | 964 | 3,741 | ||||||
| Convertible notes payable, net of current portion | 5,295 | 9,800 | ||||||
| Common stock warrant liabilities | 8,644 | 5,063 | ||||||
| Derivative liabilities | 2,345 | 3,093 | ||||||
| TOTAL LIABILITIES | 36,965 | 35,723 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit: | ||||||||
| Common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 310,860 | 290,531 | ||||||
| Accumulated deficit | (325,896 | ) | (308,296 | ) | ||||
| Accumulated other comprehensive income | 227 | 172 | ||||||
| TOTAL STOCKHOLDERS’ DEFICIT | (14,808 | ) | (17,592 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | 22,157 | $ | 18,131 | ||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Clene submit to the FDA for CNM-Au8?
Clene submitted a New Drug Application in October 2026 seeking accelerated approval of CNM-Au8 for ALS. Supporting evidence includes NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access Protocol.
How much did Clene raise in its September 2026 offering?
Clene raised $4.0 million through a registered direct offering of common stock priced at $3.28 per share. Existing stockholders, including insiders, participated. Clene expects the proceeds to fund operations through mid-first quarter 2027.
What will Clene’s Phase 3 RESTORE-ALS trial measure?
RESTORE-ALS will evaluate CNM-Au8’s effect on survival as its primary endpoint and time to ALS clinical worsening events as its secondary efficacy endpoint. Clene plans to randomize the first participants in second-quarter 2027.
Why did Clene’s third-quarter 2026 research and development expenses increase?
Research and development expenses increased primarily because of higher regulatory expenses for the application submission, manufacturing expenses and personnel expenses. Lower grant revenue also increased reported expense because grants reduce research and development expense. Lower clinical expenses for the ALS and multiple sclerosis programs and lower stock-based compensation partially offset these increases.