UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 CLENE INC. (Exact name of registrant as specified in its charter) Delaware 85-2828339 (State or other jur ...

Exhibit 99.1 CLENE REPORTS FULL YEAR 2023 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Initiated discussions with FDA regarding accelerated approval pathway for CNM-Au8® for the treatment of ALS with the objective of submitting an NDA in 2024 ● Released long-term data from the open-label extension of the HEALEY ALS Platform Trial in which CNM-Au8 demonstrated statistically significant reductions of plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomiza ...

Core Viewpoint - Underappreciated penny stocks are highly unpredictable and often come with significant risks, but they also present opportunities for long-term price appreciation if investors are willing to speculate [1] Group 1: Gevo (GEVO) - Gevo is a renewable chemicals and advanced biofuels company focused on reducing greenhouse gas emissions in transportation sectors that cannot easily adopt electrification [2] - The global renewable hydrocarbon fuel market is projected to grow at a CAGR of 8.9% from 2023 to 2030, potentially reaching a value of $639.2 billion [2] - GEVO stock trades at 92 cents with a market capitalization of $220.2 million, and analysts project a price target of $4.80, indicating a 422% upside potential [3] Group 2: Eos Energy (EOSE) - Eos Energy specializes in zinc-based energy storage solutions, which could serve as a viable alternative to lithium-ion batteries [5] - EOSE stock is down about 13% over the past year but has a moderate buy rating with an average price target of $7.67, suggesting over 561% growth potential [6] Group 3: Velo3D (VLD) - Velo3D operates in the metal additive manufacturing sector, which was valued at $20.37 billion last year and is expected to grow at a CAGR of 23.3% to reach $88.28 billion by 2030 [7][8] - VLD stock has a market capitalization of under $70 million, with a price target of $2, indicating a 641% upside potential [8] Group 4: Knightscope (KSCP) - Knightscope develops security robots that address rising crime rates and labor shortages in law enforcement [10][11] - KSCP stock is rated a buy with a price target of $4, projecting a 649% growth potential [11] Group 5: Microvast (MVST) - Microvast focuses on battery technology for electric commercial vehicles and utility-scale storage systems, with the global EV battery market valued at $132.6 billion last year and expected to grow to $508.8 billion by 2033 [12] - MVST stock has a unanimous strong buy rating with an $8 target, translating to a 692% upside potential [13] Group 6: Quantum Computing (QUBT) - Quantum Computing specializes in quantum solutions, with the market size reaching $717.3 million in 2022 and projected to grow to about $6.53 billion by 2030, reflecting a CAGR of 32.1% [14][15] - QUBT stock has a price target of $8.75, indicating a growth potential of 1,068% [15] Group 7: Clene (CLNN) - Clene is a clinical-stage pharmaceutical company focused on clean-surfaced nanotechnology therapeutics, with the nanotechnology-based drug delivery market valued at $95.2 billion in 2022 and expected to grow to $308.4 billion by 2032 [16][17] - CLNN stock has a market cap of $54.3 million and is rated a strong buy with a price target of $7, suggesting a potential return of nearly 1,546% [17]

Core Insights - Clene Inc. reported significant long-term improvements in vision and cognition for participants with stable relapsing multiple sclerosis (RMS) treated with CNM-Au8 over a 35-month period, with p-values indicating strong statistical significance [1][3][7] Group 1: Clinical Trial Results - Long-term CNM-Au8 treatment showed improvement in low contrast visual acuity (LCLA) with a least-square mean difference of +8.70 letters at Week 144 compared to baseline, and +4.0 letters compared to the end of the double-blind period [2][3] - Cognitive improvement was measured by the Symbol Digit Modality Test (SDMT), showing a least-square mean difference of +8.03 at Week 144 versus baseline, and +3.11 compared to the end of the double-blind period [3][4] - Individual participants experienced sustained improvements in LCLA by up to 38 letters and cognitive improvements by up to 35 points, indicating notable enhancements in visual function and cognitive processing speed [2][3][4] Group 2: Study Design and Population - The VISIONARY-MS trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of CNM-Au8 in participants with chronic optic neuropathy [5] - The trial included nearly all participants (92%) on effective immunomodulatory disease-modifying therapies (DMTs) as background standard of care, with 73 participants randomized and 55 continuing into the long-term extension [5][6] - Placebo participants who transitioned to CNM-Au8 during the long-term extension also showed significant improvements in LCLA and SDMT, consistent with those originally assigned to CNM-Au8 [4][5] Group 3: Company Overview and Future Directions - Clene Inc. focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including multiple sclerosis [8] - The company is reviewing the trial data with prospective pharmaceutical partners interested in MS, indicating potential for future Phase 3 studies [7][8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 | --- | --- | --- | |--------------------------------------------------------------------- ...

Clinical Trials and Drug Development - Clene Inc. reported a statistically significant reduction in plasma neurofilament light chain (NfL) levels for CNM-Au8 treated participants compared to placebo after 24 weeks, with a p-value of 0.040[150]. - The LS Mean change of plasma NfL for CNM-Au8 was -0.024 (SE: 0.024) compared to +0.076 (SE: 0.042) for placebo, indicating a difference of -0.100 (SE: 0.048)[152]. - Clene Inc. plans to initiate an international Phase 3 study, RESTORE-ALS, in the first half of 2024, contingent on discussions with regulatory authorities[154]. - The company is discussing the design of an international Phase 3 MS study, expected to initiate in the second half of 2024, contingent on funding[155]. Financial Performance - Total revenue for Q2 2023 reached $269,000, a 669% increase compared to $35,000 in Q2 2022[171]. - Product revenue for Q2 2023 was $226,000, reflecting an increase of 11,200% from $2,000 in Q2 2022[171]. - Net loss for Q2 2023 was $25,143,000, a 455% increase compared to a net loss of $4,534,000 in Q2 2022[171]. - The company incurred a loss from operations of $21.1 million for the six months ended June 30, 2023, compared to a loss of $26.9 million for the same period in 2022[189]. - The accumulated deficit was $230.1 million as of June 30, 2023, compared to $193.2 million as of December 31, 2022[189]. Research and Development Expenses - Research and development expenses are anticipated to decrease in 2023 due to the completion of ongoing clinical trials but are expected to increase in future years as assets advance into Phase 3[163]. - Research and development expenses decreased by 28% to $6,615,000 in Q2 2023 from $9,166,000 in Q2 2022[171]. - Research and development expenses for the first half of 2023 totaled $14,010,000, a decrease of 21% from $17,746,000 in the first half of 2022[176]. - Stock-based compensation in research and development increased by 35% to $1,124,000 in Q2 2023 compared to $833,000 in Q2 2022[176]. Operating Expenses and Cash Flow - General and administrative expenses for Q2 2023 were $3,924,000, down 12% from $4,464,000 in Q2 2022[178]. - The company anticipates an increase in general and administrative expenses if an NDA is filed with the FDA, driven by drug development activities and commercial capabilities[168]. - The company expects general and administrative expenses to decrease if the NDA filing is not successful, leading to reduced commercial expansion projects[168]. - Net cash used in operating activities was $(16.2 million) for the six months ended June 30, 2023, compared to $(22.8 million) for the same period in 2022[189]. Funding and Capital Raising - The company raised approximately $37.4 million of net proceeds in an underwritten public equity offering during the three months ended June 30, 2023[192]. - The company plans to raise additional funding through equity financing, debt financing, and collaboration arrangements to support ongoing operations[192]. - In June 2023, the company sold 50,000,000 units at a sale price of $0.80 per unit, generating gross proceeds of $40.0 million[204]. Market and Economic Conditions - Clene Inc. is monitoring the impact of the COVID-19 pandemic on its operations, with no material disruptions reported to date[161]. - The company has no drugs approved for commercial sale and has not generated any revenue from drug sales, relying on dietary supplement sales for revenue[148]. - The company has incurred operating losses in each year since inception, with revenues from dietary supplements expected to be small compared to operating expenses[148]. Stock and Financial Metrics - The expected stock price volatility for the New Avenue Warrant was estimated at 90.00% to 110.00% as of June 30, 2023[216]. - The company terminated the ATM Agreement and the Purchase Agreement Prospectus Supplement on June 16, 2023, halting further sales of securities under these agreements[206][207]. - Probability of NDA acceptance is estimated at 30.00%[217]. - Probability of dissolution is high at 60.00%[217].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 | --- | --- | --- | |------------------------------------------------------------------------- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission file number: 01-39834 CLENE INC. (Exact name of registrant as specified in its charter) Delaware 85-2828339 ( ...

```markdown [PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Clene Inc.'s unaudited consolidated financial statements show a Q3 2022 net loss, reduced cash, and going concern doubt - Management has concluded there is **substantial doubt** about the Company's ability to continue as a **going concern**, as it projects it will **not have sufficient cash** to sustain current operations or meet obligations within the next twelve months[18](index=18&type=chunk)[189](index=189&type=chunk) - To mitigate funding needs, the company is implementing cost-saving initiatives and exploring financing options. In October 2022, an equity offering provided net cash proceeds of **$10.8 million**[19](index=19&type=chunk)[133](index=133&type=chunk)[190](index=190&type=chunk) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant decrease in total assets and a shift to a stockholders' deficit by Q3 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,267 | $50,288 | | Total current assets | $21,486 | $54,583 | | **Total Assets** | **$36,004** | **$63,063** | | **Liabilities & Equity** | | | | Total current liabilities | $6,154 | $6,026 | | **Total Liabilities** | **$45,323** | **$50,466** | | **Total Stockholders' Equity (Deficit)** | **($9,319)** | **$12,597** | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The company reported a Q3 2022 net loss of **$11.0 million**, a significant reversal from prior year's income Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $174 | $110 | $239 | $524 | | Loss from operations | ($9,805) | ($10,450) | ($36,736) | ($35,920) | | Net income (loss) | ($10,976) | $28,944 | ($28,864) | ($14,163) | | Basic Net income (loss) per share | ($0.17) | $0.47 | ($0.46) | ($0.23) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity transitioned from positive to a **$9.3 million** deficit by Q3 2022 due to cumulative net loss - Stockholders' equity shifted from a positive **$12.6 million** at December 31, 2021, to a deficit of **$9.3 million** at September 30, 2022[13](index=13&type=chunk) - The primary driver for the decrease in equity was the net loss of **$28.9 million** recorded during the first nine months of 2022[11](index=11&type=chunk)[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$31.3 million**, leading to a **$43.0 million** net decrease in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($31,295) | ($25,018) | | Net cash used in investing activities | ($12,446) | ($661) | | Net cash provided by financing activities | $875 | $27,130 | | **Net (decrease) increase in cash** | **($43,021)** | **$1,335** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business, going concern issues, accounting policies, debt, and segment performance - The company operates in two segments: "Drugs" (development of therapeutics) and "Supplements" (dietary supplements). The Drugs segment generates **no revenue** and **incurred an operating loss** of **$37.0 million** for the nine months ended Sep 30, 2022, while the Supplements segment generated **$0.2 million** in revenue and **$0.3 million** in **operating income**[47](index=47&type=chunk)[129](index=129&type=chunk) - Subsequent to the quarter end, the company raised gross proceeds of **$0.6 million** under its ATM facility and **$10.8 million** from a registered direct offering in October 2022[132](index=132&type=chunk)[133](index=133&type=chunk) - The company has a **$30.0 million** term loan with Avenue, of which **$20.0 million** was drawn as of September 30, 2022. The loan requires the company to maintain at least **$5.0 million** in unrestricted cash and cash equivalents[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, clinical program developments, increased R&D, and going concern issues - The company's lead drug candidate, CNM-Au8®, **did not meet the primary endpoint** in the Phase 2/3 Healey ALS Platform Trial, but an exploratory analysis of the 30 mg dose showed a **>90% reduction in risk of death**[142](index=142&type=chunk)[143](index=143&type=chunk) - The company has paused its commercial expansion project at its Elkton, Maryland facility until it receives further clarity from the FDA on the regulatory path for CNM-Au8[147](index=147&type=chunk) - The Phase 2 VISIONARY-MS trial for CNM-Au8 **met its primary endpoint** for low-contrast vision improvement (**p=0.056**) and a key secondary endpoint for functional improvement (**p=0.0207**)[148](index=148&type=chunk)[149](index=149&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q3 2022 revenue increased, operating loss improved, while nine-month R&D expenses rose and G&A decreased Operating Expense Comparison (Nine Months Ended Sep 30) | Expense Category | 2022 (in thousands) | 2021 (in thousands) | Change % | | :--- | :--- | :--- | :--- | | Research and development | $24,149 | $18,893 | +28% | | General and administrative | $12,807 | $16,739 | -23% | | **Total operating expenses** | **$36,975** | **$36,444** | **+1%** | - The increase in R&D expense for the nine-month period was primarily due to progression of clinical trials for CNM-Au8 (**+15%**) and CNM-ZnAg (**+278%**)[175](index=175&type=chunk)[177](index=177&type=chunk) - The decrease in G&A expense was mainly due to lower legal, finance, and accounting fees after the completion of the Reverse Recapitalization, as well as lower stock-based compensation expense[176](index=176&type=chunk)[178](index=178&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges, with insufficient cash and **substantial doubt** about **going concern** - As of Sep 30, 2022, cash, cash equivalents, and marketable securities totaled **$16.2 million**, a sharp decline from **$50.3 million** at Dec 31, 2021[186](index=186&type=chunk) - Management projects that within the next twelve months, the company will **not have sufficient cash** to sustain current operations, raising **substantial doubt** about its ability to continue as a **going concern**[189](index=189&type=chunk) - Net cash used in operating activities for the nine months ended Sep 30, 2022 was **$31.3 million**[197](index=197&type=chunk)[198](index=198&type=chunk) [Critical Accounting Policies and Estimates](index=40&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies involve significant judgment, including valuation of contingent liabilities and warrants - Critical estimates include the fair value of contingent earn-out liabilities, common stock warrant liability, accounting for convertible notes, income taxes (valuation allowance), and stock-based compensation[214](index=214&type=chunk)[215](index=215&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk) - The fair value of contingent earn-out liabilities and warrant liabilities are determined using Monte Carlo and Black-Scholes models, respectively, which are sensitive to unobservable inputs like expected stock price volatility[215](index=215&type=chunk)[219](index=219&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is **not required to provide information** for this item - As a smaller reporting company, Clene Inc. is **not required to provide information** for this item[224](index=224&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were **ineffective** due to **material weaknesses**, with remediation efforts ongoing - Management concluded that disclosure controls and procedures were **not effective** as of September 30, 2022[225](index=225&type=chunk) - The ineffectiveness is due to **material weaknesses** related to the control environment, review of reconciliations and segregation of duties, and IT general controls[228](index=228&type=chunk)[231](index=231&type=chunk) - Remediation efforts are ongoing and include strengthening the accounting team, using external consultants, and implementing a new ERP system[232](index=232&type=chunk)[233](index=233&type=chunk) [PART II—OTHER INFORMATION](index=45&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is **not currently a party to any material pending legal proceedings** - The company is **not currently a party to any material pending legal proceedings**[237](index=237&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) **No material changes** to risk factors previously disclosed in the 2021 Annual Report on Form 10-K - There have been **no material changes** to the risk factors disclosed in the 2021 Annual Report on Form 10-K[238](index=238&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported **no unregistered sales** of equity securities, use of proceeds, or purchases during the period - The company reported **no unregistered sales** of equity securities, use of proceeds, or purchases of equity securities during the period[239](index=239&type=chunk) [Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported **no defaults** upon senior securities - The company reported **no defaults** upon senior securities[240](index=240&type=chunk) [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is **not applicable** - This item is **not applicable**[241](index=241&type=chunk) [Other Information](index=45&type=section&id=Item%205.%20Other%20Information) The company reported **no information** for this item - The company reported **no information** for this item[242](index=242&type=chunk) [Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including CEO/CFO certifications and XBRL data - This section lists exhibits filed with the 10-Q, including CEO/CFO certifications and XBRL files[243](index=243&type=chunk) ```

Corporate Presentation August 2022 clene.com NASDAQ: CLNN crene 2 Forward Looking Statements This presentation 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 our or our management team's expectations ...