Form 8-K

8-K — Clene Inc.

Accession: 0001437749-26-026653

Filed: 2026-08-10

Period: 2026-08-10

CIK: 0001822791

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — clnn20260806_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ex_1001928.htm)

EX-99.2 — EXHIBIT 99.2 (ex_1000745.htm)

GRAPHIC (slide01.jpg)

GRAPHIC (slide02.jpg)

GRAPHIC (slide03.jpg)

GRAPHIC (slide04.jpg)

GRAPHIC (slide05.jpg)

GRAPHIC (slide06.jpg)

GRAPHIC (slide07.jpg)

GRAPHIC (slide08.jpg)

GRAPHIC (slide09.jpg)

GRAPHIC (slide10.jpg)

GRAPHIC (slide11.jpg)

GRAPHIC (slide12.jpg)

GRAPHIC (slide13.jpg)

GRAPHIC (slide14.jpg)

GRAPHIC (slide15.jpg)

GRAPHIC (slide16.jpg)

GRAPHIC (slide17.jpg)

GRAPHIC (slide18.jpg)

GRAPHIC (slide19.jpg)

GRAPHIC (slide20.jpg)

GRAPHIC (slide21.jpg)

GRAPHIC (slide22.jpg)

GRAPHIC (slide23.jpg)

GRAPHIC (slide24.jpg)

GRAPHIC (slide25.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: clnn20260806_8k.htm · Sequence: 1

clnn20260806_8k.htm

false

0001822791

2026-08-10

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 10, 2026

CLENE INC.

(Exact name of registrant as specified in its charter)

Delaware

001-39834

85-2828339

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

Identification No.)

6550 South Millrock Drive, Suite G50

Salt Lake City, Utah

84121

(Address of principal executive offices)

(Zip Code)

(801) 676-9695

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value

CLNN

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On August 10, 2026, Clene Inc. (the “Company”) released an updated corporate presentation (the “Corporate Presentation”) on its website, invest.clene.com. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933 (the “Securities Act”), as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On August 10, 2026, the Company issued a press release announcing biomarker analyses to be included in the Company’s NDA submission supporting ALS accelerated approval. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number

Exhibit Description

99.1

Corporate presentation.

99.2

Press release, dated August 10, 2026, announcing biomarker analyses to be included in NDA submission supporting ALS accelerated approval.

104

Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

CLENE INC.

Date: August 10, 2026

By:

/s/ Robert Etherington

Robert Etherington

President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ex_1001928.htm · Sequence: 2

Image Exhibit

Exhibit 99.1

EX-99.2 — EXHIBIT 99.2

EX-99.2

Filename: ex_1000745.htm · Sequence: 3

ex_1000745.htm

Exhibit 99.2

CLENE ANNOUNCES BIOMARKER ANALYSES TO BE INCLUDED IN

NDA SUBMISSION SUPPORTING ALS ACCELERATED APPROVAL

●

Survival benefit is concentrated in participants with NfL biomarker response: CNM-Au8®-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls

●

Functional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated patients whose NfL declined or stabilized had significantly better outcomes on combined measures of survival and function, including daily function (ALSFRS-R) and breathing capacity (Slow Vital Capacity), than concurrently randomized controls

SALT LAKE CITY, August 10, 2026 — Clene Inc. (Nasdaq: CLNN) today announced results from new analyses examining clinical outcomes among CNM-Au8®-treated patients whose neurofilament light chain (NfL) biomarker levels declined or stabilized. These findings will be included in Clene’s planned New Drug Application (NDA) seeking accelerated approval and are intended to address the questions raised by the U.S. Food and Drug Administration (FDA) during a March 2026 Type C meeting. At that meeting, the FDA acknowledged that NfL, a recognized blood marker of nerve-cell injury, has established prognostic value in amyotrophic lateral sclerosis (ALS) and could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.

New biomarker analyses of Clene’s two completed Phase 2 ALS trials revealed additional evidence that CNM-Au8-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls and performed significantly better on combined measures of survival and function, including ALS Functional Rating Scale-Revised (ALSFRS-R) and breathing capacity (Slow Vital Capacity; SVC).

These findings were derived from multiple lines of analysis: clinical benefit versus concurrently randomized controls; the relationship between the size of the NfL reduction and clinical outcome; a causal analysis that identified likely NfL responders from pre-treatment characteristics alone, preserving the randomized comparison; and replication of the association between NfL change and survival across independent datasets.

Among patients treated with CNM-Au8:

●

Participants randomized to CNM-Au8 30 mg had a 74% lower risk of death after 12 months of follow-up than concurrently randomized controls from another regimen in the HEALEY ALS Platform Trial (HEALEY) (p=0.0124)

●

Analyses in more than 2,000 ALS patients who never received CNM-Au8 showed that a 10% NfL decline was associated with a 6% to 10% lower risk of death (APST, p < 0.0001; ANSWER ALS, p = 0.001)

●

Survival improved in participants whose NfL declined or stabilized, a 38% lower risk of death than concurrently randomized controls over the full follow-up period (HR 0.621, 95% CI 0.397–0.972; p = 0.037) in HEALEY; the average survival gain reached nearly six months at four years of follow-up (p = 0.012)

●

Participants whose NfL declined or stabilized scored significantly better on the Combined Assessment of Function and Survival (CAFS), whether measured by daily function (ALSFRS-R, p = 0.032) or breathing capacity (SVC, p = 0.003), compared with concurrently randomized controls from HEALEY

●

An FDA-requested causal analysis identifying likely NfL responders from pre-treatment characteristics alone found a 41% lower risk of death on CNM-Au8 30 mg versus controls in the predicted NfL responder group (HR 0.593; p = 0.026), with no significant difference among those predicted not to respond

These biomarker analyses are post hoc and exploratory. We believe the totality of this evidence addresses the accelerated approval standard, which the FDA will evaluate during its review of the NDA.

Clinical Benefit Tracked NfL Response Across Phase 2 Trials

In HEALEY, the CNM-Au8 30 mg group was compared with concurrently randomized controls — participants originally randomized into concurrent regimens over the same period, under the same master protocol and the same core eligibility criteria. These controls comprise both placebo recipients and recipients of other investigational agents studied in those regimens, none of which met its primary endpoint, and none received CNM-Au8.

Survival improved in CNM-Au8-treated participants whose NfL declined or stabilized in HEALEY. Participants whose NfL declined or stabilized lived significantly longer than concurrently randomized controls at every measured timepoint, showing an expanding survival benefit that reached nearly six months (177 days) at four years of follow-up (Day 1,463; p = 0.012). By comparison, participants whose NfL increased did not demonstrate a statistically significant difference in survival benefit at any timepoint.

Relationship between longer survival and NfL decline or stabilization also observed in RESCUE-ALS. RESCUE-ALS, a smaller, nine-month placebo-controlled trial, was evaluated to test whether the NfL-to-outcome relationship observed in HEALEY was also present in a separate CNM-Au8 30 mg population; the comparisons below are within the treated group or against propensity-matched real-world ALS controls. Among the 22 CNM-Au8-treated participants whose NfL response could be classified, the 11 participants whose NfL declined or stabilized had a 76% lower adjusted risk of death than the 11 whose NfL increased (HR 0.24; p = 0.008), with median survival of 43.5 months versus 19.9 months (log-rank p = 0.040). In RESCUE-ALS, participants whose NfL declined or stabilized had a 69% lower risk of death than propensity-matched real-world ALS controls (MiNDAUS; HR 0.31; 95% CI 0.13–0.76; p = 0.011); those whose NfL rose did not differ significantly from the matched controls. Within the treated arm, NfL responders also scored significantly better on CAFS (rank difference +7.7, 95% CI 3.1–12.3; p = 0.002) compared to NfL non-responders.

ALSFRS-R and SVC function and survival improved together among participants who had NfL decline or stabilization in HEALEY. On CAFS, NfL responders scored significantly better than concurrently randomized controls on both function and breathing: a least-squares mean difference of 62.6 (95% CI 5.3–119.9; p = 0.032) combining ALSFRS-R with survival, and 86.3 (95% CI 30.3–142.2; p = 0.003) combining SVC (% predicted) with survival. On death-imputed analyses, which score participants zero after death and therefore capture survival and function jointly, the advantage reached 7.0 points on the ALSFRS-R (p < 0.0001) and 15.6 points on SVC (% predicted; p = 0.004) at Week 52. Participants whose NfL increased showed no statistically significant difference on any of these measures.

Evidence Connecting the Magnitude of NfL Reduction to Clinical Benefit

●

CNM-Au8 reduced NfL during the randomized, double-blind period. As previously reported, plasma NfL declined in CNM-Au8-treated participants and increased in placebo recipients over the 24-week double-blind period of HEALEY, a least-squares mean difference of −0.100 on the natural log scale (SE 0.048; p = 0.040), with larger differences in faster progressors (−0.144; p = 0.014) and in participants with above-median baseline NfL (−0.150; p = 0.031) (Berry et al., JAMA 2025).

●

A decline of ~10% was associated with a measurable survival difference. In prespecified analyses of the ALS observational cohorts, German/Austrian APST (1,671 evaluable) and U.S. ANSWER ALS (380 evaluable), none of whose participants received CNM-Au8, a 10% decline in NfL was associated with a 6% to 10% reduction in the hazard of death (p < 0.0001 and p = 0.001, respectively), independent of baseline NfL level.

●

Dramatic biomarker reductions were not required with CNM-Au8. Modeling the relationships observed in HEALEY, a 5% to 10% reduction in NfL corresponded to 1.4 to 2.9 additional points on the ALSFRS-R at Week 64 and a 7.8% to 15.3% reduction in the modeled hazard of death. These are model-derived projections rather than observed treatment effects. Holding NfL steady, or achieving even a modest decline, was associated with better outcomes.

Survival Benefit Concentrated in NfL Responders (Evidenced by Randomization-based Causal Analysis)

Because participants were grouped by how their NfL responded after treatment began, the comparisons reported above are observational. A principal stratum analysis was performed to address this, classifying every participant, treated and control, by pre-treatment characteristics alone and thereby preserving the randomized comparison in HEALEY. The survival benefit of CNM-Au8 30 mg was concentrated in the predicted NfL-responder stratum: a 41% reduction in the hazard of death (HR 0.593, 95% CI 0.374–0.940; p = 0.026) and approximately 3.4 months of survival gain at Day 878, the end of the open-label extension (p = 0.004), with no statistically significant difference in the predicted NfL increase stratum (HR 1.199, 95% CI 0.643–2.239; p=0.568). The same pattern was observed across the functional endpoints tested. This is the strongest causal evidence in the planned NDA package that the CNM-Au8 30 mg treatment benefit operates through a mechanism related to NfL response.

CNM-Au8 30 mg Treatment Benefit Operates through a Mechanism Specific to NfL Response

The benefit was specific to NfL, not an artifact of the analytic method. Four negative controls (sex, body mass index change, glial fibrillary acidic protein change and Tau change) were each substituted for NfL and run through the identical analysis in the HEALEY dataset. All four analyses were null for both composite functional benefit and survival, whereas the NfL analysis was positive on both. RESCUE-ALS also reproduced the same null result for the negative controls, BMI and sex.

Safety and Tolerability Profile

CNM-Au8 has demonstrated a consistent safety and tolerability profile across its clinical trial and expanded access programs, now totaling more than 1,280 collective participant-years of treatment as of July 31, 2026, including more than 1,100 participant-years in ALS, with the longest continuous treatment duration for ALS exceeding 6.8 years. As of August 10, 2026, no serious adverse events have been assessed as related to CNM-Au8, and no safety signals have been associated with long-term use. The safety-tolerability profile of CNM-Au8 is directly relevant to the benefit-risk assessment the FDA will conduct in reviewing the NDA.

Phase 3 Confirmatory Trial Will Evaluate the NfL Relationship Prospectively

Clene’s planned Phase 3 confirmatory trial, RESTORE-ALS, is designed to evaluate the NfL biomarker relationship prospectively. The trial will use a patient’s baseline NfL level as a prospective enrollment stratification factor and will include prespecified, NfL-stratified analyses, building on the concordance evidence described here.

“ALS is a heterogeneous disease, and it matters that a biomarker signal, NfL decline or stabilization, marks the patients in whom CNM-Au8 appears to be providing the greatest benefit,” said Ben Greenberg, Head of Medical at Clene. “In the HEALEY analyses, we were able to go a step further: using pre-treatment characteristics alone, we could identify the patients likely to show NfL response, and the treatment benefit was concentrated in exactly that group. The FDA’s accelerated approval of another drug for SOD1-ALS established that a reduction in NfL can be reasonably likely to predict clinical benefit in a defined ALS population.”

“Observing the NfL biomarker-to-clinical-benefit relationship replicated in two independent trials, and NfL’s prognostic value confirmed in more than 2,000 patients who never received CNM-Au8, is exactly the kind of evidence that gives us confidence in what we’re submitting to the FDA,” said Rob Etherington, President and Chief Executive Officer of Clene. “HEALEY and RESCUE-ALS were designed differently and enrolled under different criteria, and in both, the patients whose NfL responded to CNM-Au8 lived substantially longer, strengthening our New Drug Application planned for filing early Q4.”

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.

About These Analyses

The HEALEY and RESCUE-ALS biomarker analyses described in this release are post hoc and exploratory; neither trial met its prespecified primary efficacy endpoint, no adjustment was made for multiple comparisons, and reported p-values are nominal. The HEALEY analyses are based on 57 CNM-Au8 30 mg treated participants with an evaluable NfL trajectory (38 NfL Decline/Stable, 19 NfL Increase); the RESCUE-ALS analyses on 22 participants (11 per group). Each NfL stratum was compared with concurrently randomized controls rather than with the other stratum; with 38 and 19 participants respectively, these analyses were not powered for a direct statistical comparison between the two strata. The principal stratum analysis provides the randomization-preserving assessment of whether treatment benefit depends on NfL response. Because patients were classified by NfL response after treatment began, responder-versus-control comparisons are observational; the principal stratum analysis, which classifies patients on pre-treatment characteristics only, was included to provide a randomization-anchored estimate, and is itself post hoc. The HEALEY comparator comprised all 329 participants randomized to concurrent regimens, approximately three-quarters of whom received another investigational agent and one-quarter placebo; survival did not differ between active and placebo recipients within either control regimen at the timepoints assessed. By contrast, the supporting observational-cohort analyses in the APST (1,671 evaluable of 2,059 enrolled) and ANSWER ALS (380 evaluable of 742 enrolled) cohorts were prespecified, and their primary and secondary analyses each rejected the null hypothesis in both cohorts. No participant in either cohort received CNM-Au8; approximately 55% and 69% respectively were receiving riluzole. These cohorts establish that NfL trajectory is prognostic at the individual level; whether a treatment’s effect on NfL predicts its effect on survival is addressed by the trial analyses described above. FDA accepted NfL reduction as reasonably likely to predict clinical benefit in SOD1-ALS in the context of the tofersen accelerated approval; the acceptability of a surrogate endpoint is determined program by program, and FDA has made no such determination for CNM-Au8.

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. Clene’s forward-looking statements also include, but are not limited to, statements regarding whether the FDA will agree that a change in NfL is reasonably likely to predict clinical benefit in ALS, whether the FDA will accept the NDA for filing or grant accelerated approval, and whether the results of post hoc, exploratory analyses will be confirmed in the planned Phase 3 confirmatory 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

GRAPHIC

Filename: slide01.jpg · Sequence: 8

Binary file (123022 bytes)

Download slide01.jpg

GRAPHIC

Filename: slide02.jpg · Sequence: 9

Binary file (349337 bytes)

Download slide02.jpg

GRAPHIC

Filename: slide03.jpg · Sequence: 10

Binary file (125989 bytes)

Download slide03.jpg

GRAPHIC

Filename: slide04.jpg · Sequence: 11

Binary file (151071 bytes)

Download slide04.jpg

GRAPHIC

Filename: slide05.jpg · Sequence: 12

Binary file (164561 bytes)

Download slide05.jpg

GRAPHIC

Filename: slide06.jpg · Sequence: 13

Binary file (147878 bytes)

Download slide06.jpg

GRAPHIC

Filename: slide07.jpg · Sequence: 14

Binary file (198257 bytes)

Download slide07.jpg

GRAPHIC

Filename: slide08.jpg · Sequence: 15

Binary file (229063 bytes)

Download slide08.jpg

GRAPHIC

Filename: slide09.jpg · Sequence: 16

Binary file (182695 bytes)

Download slide09.jpg

GRAPHIC

Filename: slide10.jpg · Sequence: 17

Binary file (119384 bytes)

Download slide10.jpg

GRAPHIC

Filename: slide11.jpg · Sequence: 18

Binary file (205432 bytes)

Download slide11.jpg

GRAPHIC

Filename: slide12.jpg · Sequence: 19

Binary file (160281 bytes)

Download slide12.jpg

GRAPHIC

Filename: slide13.jpg · Sequence: 20

Binary file (213654 bytes)

Download slide13.jpg

GRAPHIC

Filename: slide14.jpg · Sequence: 21

Binary file (146498 bytes)

Download slide14.jpg

GRAPHIC

Filename: slide15.jpg · Sequence: 22

Binary file (151041 bytes)

Download slide15.jpg

GRAPHIC

Filename: slide16.jpg · Sequence: 23

Binary file (157699 bytes)

Download slide16.jpg

GRAPHIC

Filename: slide17.jpg · Sequence: 24

Binary file (197146 bytes)

Download slide17.jpg

GRAPHIC

Filename: slide18.jpg · Sequence: 25

Binary file (188052 bytes)

Download slide18.jpg

GRAPHIC

Filename: slide19.jpg · Sequence: 26

Binary file (155067 bytes)

Download slide19.jpg

GRAPHIC

Filename: slide20.jpg · Sequence: 27

Binary file (167390 bytes)

Download slide20.jpg

GRAPHIC

Filename: slide21.jpg · Sequence: 28

Binary file (203739 bytes)

Download slide21.jpg

GRAPHIC

Filename: slide22.jpg · Sequence: 29

Binary file (175184 bytes)

Download slide22.jpg

GRAPHIC

Filename: slide23.jpg · Sequence: 30

Binary file (120581 bytes)

Download slide23.jpg

GRAPHIC

Filename: slide24.jpg · Sequence: 31

Binary file (258086 bytes)

Download slide24.jpg

GRAPHIC

Filename: slide25.jpg · Sequence: 32

Binary file (67199 bytes)

Download slide25.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 34

v3.26.1

Document And Entity Information

Aug. 10, 2026

Document Information [Line Items]

Entity, Registrant Name

CLENE INC.

Document, Type

8-K

Document, Period End Date

Aug. 10, 2026

Entity, Incorporation, State or Country Code

Entity, File Number

001-39834

Entity, Tax Identification Number

85-2828339

Entity, Address, Address Line One

6550 South Millrock Drive

Entity, Address, Address Line Two

Suite G50

Entity, Address, City or Town

Salt Lake City

Entity, Address, State or Province

Entity, Address, Postal Zip Code

84121

City Area Code

801

Local Phone Number

676-9695

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock

Trading Symbol

CLNN

Security Exchange Name

NASDAQ

Entity, Emerging Growth Company

false

Amendment Flag

false

Entity, Central Index Key

0001822791

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

No definition available.

+ Details

Name:

dei_DocumentInformationLineItems

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration