Proprietary catalytic gold nanocrystals comprising Clene's investigational drug CNM-Au8® develop a protein corona upon exposure to human blood plasma comprised of proteins that promote blood-brain barrier penetration, an important feature of the drug's neuroprotective mechanism of actionThe protein corona attracted by CNM-Au8 nanocrystals prevents aggregation upon entering the bloodstream, enabling the drug's longevity in circulation without provoking an inflammatory response SALT LAKE CITY, March 15, 2024 ...

Clene Inc. (CLNN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.02, delivering a surprise of 80%.Over the last four quarters, the company has surpassed consen ...

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].

[PART I — FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations for Clene Inc [Item 1. Financial Statements (Unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Clene Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity (deficit), and statements of cash flows, along with detailed notes explaining the company's business, accounting policies, and specific financial line items [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's total assets decreased from $44.493 million at December 31, 2022, to $39.888 million at March 31, 2023. Total liabilities slightly increased, leading to a significant decrease in total stockholders' equity (deficit) from $3.237 million to $(1.627) million, indicating a worsening financial position Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------- | :------------- | :---------------- | | Total Assets | $39,888 | $44,493 | | Total Liabilities | $41,515 | $41,256 | | Total Stockholders' Equity (Deficit) | $(1,627) | $3,237 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2023, the company reported a net loss of $11.770 million, an improvement from $13.354 million in the prior year. Total revenue significantly increased, while operating expenses decreased, contributing to a reduced loss from operations Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (%) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :--------- | | Total Revenue | $107 | $30 | 257% | | Total Operating Expenses | $10,839 | $13,366 | (19)% | | Loss from Operations | $(10,732) | $(13,336) | (20)% | | Net Loss | $(11,770) | $(13,354) | (12)% | | Net Loss Per Share (Basic & Diluted) | $(0.15) | $(0.21) | (29)% | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) The company's total stockholders' equity shifted from a positive $3.237 million at December 31, 2022, to a deficit of $(1.627) million at March 31, 2023, primarily due to a net loss of $11.770 million, partially offset by common stock issuance and stock-based compensation Condensed Consolidated Statements of Stockholders' Equity (Deficit) Highlights (in thousands) | Metric | December 31, 2022 | March 31, 2023 | | :------------------------------------ | :---------------- | :------------- | | Total Stockholders' Equity (Deficit) | $3,237 | $(1,627) | | Net Loss | N/A | $(11,770) | | Issuance of Common Stock | N/A | $4,665 | | Stock-based Compensation Expense | N/A | $2,223 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2023, net cash used in operating activities decreased to $9.218 million from $13.084 million in the prior year. Investing activities provided $4.722 million, a significant improvement from a $24.522 million outflow, mainly due to proceeds from marketable securities maturities. Financing activities provided $4.588 million, up from $0.235 million, driven by common stock issuance Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Net Cash Used in Operating Activities | $(9,218) | $(13,084) | | Net Cash Provided by (Used in) Investing Activities | $4,722 | $(24,522) | | Net Cash Provided by Financing Activities | $4,588 | $235 | | Net Increase (Decrease) in Cash, Cash Equivalents and Restricted Cash | $110 | $(37,358) | | Cash, Cash Equivalents and Restricted Cash – End of Period | $18,500 | $12,988 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the company's business, significant accounting policies, and specific financial statement line items, including information on its going concern status, clinical programs, and financial instruments. They highlight the company's focus on developing nanotechnology therapeutics for neurological disorders and its ongoing need for additional financing [Note 1. Nature of the Business](index=7&type=section&id=Note%201.%20Nature%20of%20the%20Business) Clene Inc. is a clinical-stage pharmaceutical company focused on developing novel clean-surfaced nanotechnology therapeutics for central nervous system disorders like ALS, MS, and PD. It also markets dietary supplements through a subsidiary and a licensing agreement. The company faces substantial doubt about its ability to continue as a going concern due to significant losses and negative cash flows, necessitating additional financing and cost-saving measures - Clinical-stage pharmaceutical company pioneering discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics[13](index=13&type=chunk)[135](index=135&type=chunk)[137](index=137&type=chunk) - Focuses on addressing high unmet medical needs in central nervous system disorders including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD)[13](index=13&type=chunk)[137](index=137&type=chunk) - Incurred significant losses and negative cash flows from operations since inception, with an accumulated deficit of **$205.0 million** as of March 31, 2023[15](index=15&type=chunk)[16](index=16&type=chunk)[176](index=176&type=chunk) - Substantial doubt about the Company's ability to continue as a going concern due to insufficient cash and resources within the next twelve months without additional financing[16](index=16&type=chunk)[177](index=177&type=chunk) - Plans to mitigate funding needs by exploring equity/debt financing, licensing, and utilizing existing at-the-market facility and equity purchase agreement, alongside cost-saving initiatives[17](index=17&type=chunk)[178](index=178&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=8&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the basis of presentation for the condensed consolidated financial statements, including the consolidation of subsidiaries, adherence to U.S. GAAP for interim reporting, and the use of estimates. It also details accounting policies for various financial instruments and activities, such as marketable securities, inventory, property and equipment, debt, leases, contingent earn-out liabilities, common stock warrants, grant funding, foreign currency translation, comprehensive loss, segment information, income taxes, and stock-based compensation - Condensed consolidated financial statements include Clene Inc. and its wholly-owned subsidiaries, prepared in accordance with U.S. GAAP for interim financial reporting[22](index=22&type=chunk) - Management makes estimates and assumptions that affect reported amounts, which are periodically reviewed[24](index=24&type=chunk) - Contingent Earn-outs are accounted for as a liability and subsequently remeasured to fair value at each reporting date, with changes recorded in other income (expense), net[41](index=41&type=chunk) - Operates in two reportable segments: (1) development and commercialization of novel clean-surfaced nanotechnology therapeutics ("Drugs"), and (2) development and commercialization of dietary supplements ("Supplements")[48](index=48&type=chunk) - Stock-based compensation arrangements are accounted for using a fair value-based method, recognized over the requisite service period[51](index=51&type=chunk) [Note 3. Marketable Securities](index=12&type=section&id=Note%203.%20Marketable%20Securities) As of March 31, 2023, the company held no available-for-sale securities, having received $5.0 million from maturities during the quarter. At December 31, 2022, marketable securities totaled $4.983 million, primarily commercial paper and corporate debt securities Marketable Securities (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------- | :------------- | :---------------- | | Available-for-Sale Securities | $0 | $4,983 | | Proceeds from Maturities (3 months ended March 31, 2023) | $5,000 | N/A | [Note 4. Prepaid Expenses and Other Current Assets](index=12&type=section&id=Note%204.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets increased to $6.229 million at March 31, 2023, from $5.648 million at December 31, 2022, driven by an increase in research and development tax credits receivable and other prepaid items, partially offset by a decrease in metals for R&D Prepaid Expenses and Other Current Assets (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------------------- | :------------- | :---------------- | | Research and development tax credits receivable | $3,051 | $2,777 | | Metals to be used in research and development | $2,216 | $2,290 | | Other | $962 | $581 | | Total Prepaid Expenses and Other Current Assets | $6,229 | $5,648 | [Note 5. Property and Equipment, Net](index=12&type=section&id=Note%205.%20Property%20and%20Equipment,%20Net) Property and equipment, net, slightly decreased to $10.514 million at March 31, 2023, from $10.638 million at December 31, 2022. This was primarily due to increased accumulated depreciation, despite an increase in leasehold improvements. Depreciation expense for the three months ended March 31, 2023, was $0.402 million, up from $0.195 million in the prior year Property and Equipment, Net (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------ | :------------- | :---------------- | | Total Property and Equipment, Net | $10,514 | $10,638 | | Leasehold Improvements | $9,966 | $5,677 | | Construction in Progress | $1,652 | $5,664 | | Accumulated Depreciation | $(5,664) | $(5,273) | Total Depreciation Expense (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Total Depreciation Expense | $402 | $195 | [Note 6. Accrued Liabilities](index=12&type=section&id=Note%206.%20Accrued%20Liabilities) Accrued liabilities significantly increased to $5.933 million at March 31, 2023, from $3.863 million at December 31, 2022, primarily driven by higher accrued compensation and benefits and increased accrued CRO and clinical fees Accrued Liabilities (in thousands) | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Accrued Compensation and Benefits | $2,638 | $2,007 | | Accrued CRO and Clinical Fees | $2,752 | $1,297 | | Other | $543 | $559 | | Total Accrued Liabilities | $5,933 | $3,863 | [Note 7. Leases](index=13&type=section&id=Note%207.%20Leases) The company leases laboratory and office space and equipment under operating and finance leases. Operating lease obligations had a weighted-average remaining term of 7.1 years and a discount rate of 9.6% as of March 31, 2023. Finance lease obligations had a weighted-average remaining term of 1.0 years and an interest rate of 10.8%. Total lease costs for the three months ended March 31, 2023, were $0.329 million - Operating leases primarily consist of real estate for office and laboratory space, with a weighted-average remaining term of **7.1 years** and a discount rate of **9.6%** as of March 31, 2023[63](index=63&type=chunk)[64](index=64&type=chunk) - Finance leases are mainly for lab equipment, with a weighted-average remaining term of **1.0 years** and an interest rate of **10.8%** as of March 31, 2023[65](index=65&type=chunk)[66](index=66&type=chunk) Components of Lease Cost (in thousands) | Lease Type | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------- | :-------------------------------- | :-------------------------------- | | Finance Lease Costs | $26 | $25 | | Operating Lease Costs | $253 | $230 | | Variable Lease Costs | $50 | $65 | | Total Lease Costs | $329 | $320 | [Note 8. Notes Payable and Convertible Notes Payable](index=14&type=section&id=Note%208.%20Notes%20Payable%20and%20Convertible%20Notes%20Payable) As of March 31, 2023, total notes payable (net of current portion) were $6.713 million, and total convertible notes payable were $9.907 million. The company has various loan agreements, including with Maryland DHCD, Advance Cecil Inc., and Avenue Venture Opportunities Fund, L.P., with varying interest rates and maturity dates. The Avenue loan includes a $5.0 million convertible feature and requires maintaining at least $5.0 million in unrestricted cash Notes Payable and Convertible Notes Payable (in thousands) | Debt Type | March 31, 2023 | December 31, 2022 | | :------------------------ | :------------- | :---------------- | | Notes Payable (net of current portion) | $6,713 | $9,483 | | Convertible Notes Payable | $9,907 | $9,770 | - The 2021 Avenue Loan (totaling **$20.0 million** funded) bears a variable interest rate (**14.60%** as of March 31, 2023) and includes a **$5.0 million** convertible feature[79](index=79&type=chunk)[80](index=80&type=chunk) - A covenant of the 2021 Avenue Loan requires maintaining unrestricted cash and cash equivalents of at least **$5.0 million**[81](index=81&type=chunk) Future Principal Payments (in thousands) | Year | 2019 MD Loan | 2019 Cecil Loan | 2021 Avenue Loan | 2022 MD Loan | 2022 DHCD Loan | | :-------------------- | :----------- | :-------------- | :--------------- | :----------- | :------------- | | 2023 (remainder) | $0 | $0 | $6,667 | $0 | $0 | | 2024 | $0 | $0 | $13,333 | $0 | $0 | | 2025 | $0 | $0 | $0 | $347 | $0 | | 2026 | $0 | $0 | $0 | $369 | $0 | | 2027 | $0 | $0 | $0 | $317 | $0 | | 2028 | $0 | $0 | $0 | $0 | $5,000 | | Thereafter | $664 | $132 | $0 | $0 | $0 | | Subtotal of future principal payments | $664 | $132 | $20,000 | $1,033 | $5,000 | [Note 9. Commitments and Contingencies](index=16&type=section&id=Note%209.%20Commitments%20and%20Contingencies) The company has commitments for capital expenditures totaling $0.5 million as of March 31, 2023, related to manufacturing facilities. It also has a contingent repayment obligation to the National Multiple Sclerosis Society (NMSS) for a $0.3 million grant, with potential repayments ranging from $0.2 million to $1.5 million based on future commercial sales milestones of CNM-Au8 for MS. Management assesses the likelihood of these contingent events as less than probable - Commitments for capital expenditures totaled **$0.5 million** as of March 31, 2023, related to manufacturing facilities[85](index=85&type=chunk) - Contingent repayment obligation to NMSS for a **$0.3 million** grant, with potential repayments ranging from **$0.2 million** to **$1.5 million** based on future commercial sales of CNM-Au8 for MS[87](index=87&type=chunk) - Management assesses the likelihood of occurrence of contingent events for NMSS repayment as less than probable, thus no contingent liability is recognized[87](index=87&type=chunk) [Note 10. Income Taxes](index=16&type=section&id=Note%2010.%20Income%20Taxes) The company incurred a net loss before income taxes of $11.770 million for the three months ended March 31, 2023. It is subject to taxation in the U.S., Australia, and the Netherlands. A full valuation allowance is recorded against net deferred tax assets due to cumulative losses and uncertainty of future taxable income Loss Before Income Taxes (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Net Loss Before Income Taxes | $(11,770) | $(13,354) | - A full valuation allowance is recorded against net deferred tax assets due to the uncertainty of realizing benefits from future taxable income[89](index=89&type=chunk)[198](index=198&type=chunk) [Note 11. Benefit Plans](index=16&type=section&id=Note%2011.%20Benefit%20Plans) The company maintains a 401(k) plan with matching contributions and two stock compensation plans (2014 Stock Plan and 2020 Stock Plan). Total stock-based compensation expense for the three months ended March 31, 2023, was $2.223 million, slightly up from $2.202 million in the prior year. As of March 31, 2023, $16.8 million of unrecognized stock-based compensation costs related to non-vested stock options remain - Maintains a 401(k) plan with **100%** matching contributions up to **3%** of annual compensation, limited to **$4,500**[90](index=90&type=chunk) Total Stock-Based Compensation Expense (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Total Stock-Based Compensation Expense | $2,223 | $2,202 | - As of March 31, 2023, **16,205,404** stock options were outstanding, and **812,170** stock awards were unvested[96](index=96&type=chunk)[99](index=99&type=chunk) - Approximately **$16.8 million** of unrecognized stock-based compensation costs related to non-vested stock options as of March 31, 2023, expected to be recognized over a weighted-average period of **2.36 years**[96](index=96&type=chunk) [Note 12. Fair Value](index=18&type=section&id=Note%2012.%20Fair%20Value) The company measures cash, cash equivalents, and marketable securities at fair value. Contingent earn-out liabilities are classified as Level 3 financial instruments and are remeasured at fair value each reporting period using a Monte Carlo valuation model. The fair value of these liabilities increased for the three months ended March 31, 2023, resulting in losses - Cash, cash equivalents, and marketable securities are carried at fair value[101](index=101&type=chunk) Level 3 Financial Instruments (in thousands) | Level 3 Financial Instruments | March 31, 2023 | December 31, 2022 | | :----------------------------------------- | :------------- | :---------------- | | Clene Nanomedicine contingent earn-out liability | $2,319 | $2,264 | | Initial Stockholders contingent earn-out liability | $298 | $291 | - Contingent earn-out liabilities are valued using a Monte Carlo valuation model, with inputs including expected stock price volatility (**115.00%**), risk-free interest rate (**3.90%**), and expected term (**2.75 years**) as of March 31, 2023[103](index=103&type=chunk)[104](index=104&type=chunk)[111](index=111&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) [Note 13. Capital Stock](index=19&type=section&id=Note%2013.%20Capital%20Stock) As of March 31, 2023, the company had 77,987,349 shares of common stock issued and outstanding, with 150,000,000 shares authorized. Post-quarter, stockholders approved an increase in authorized shares to 300,000,000. The company has various outstanding warrants to purchase common stock and has raised capital through public offerings and an at-the-market (ATM) agreement, selling 2,895,090 shares for $4.5 million gross proceeds in Q1 2023 Common Stock Authorization and Issuance | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------ | :------------- | :---------------- | | Authorized Common Stock Shares | 150,000,000 | 150,000,000 | | Issued & Outstanding Common Stock Shares | 77,987,349 | 74,759,591 | - On May 9, 2023, stockholders approved an amendment to increase authorized common stock shares to **300,000,000**[112](index=112&type=chunk) - Sold **2,895,090** shares of Common Stock under the ATM Agreement, generating gross proceeds of **$4.5 million** during the three months ended March 31, 2023[119](index=119&type=chunk)[190](index=190&type=chunk) - Total outstanding warrants to purchase common stock were **4,477,045** shares as of March 31, 2023[115](index=115&type=chunk) [Note 14. Net Loss Per Share](index=20&type=section&id=Note%2014.%20Net%20Loss%20Per%20Share) The basic and diluted net loss per share for the three months ended March 31, 2023, was $(0.15), an improvement from $(0.21) in the prior year. The weighted average common shares outstanding increased to 76,049,665 Net Loss Per Share (Basic and Diluted) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Net Loss Per Share (Basic & Diluted) | $(0.15) | $(0.21) | | Weighted Average Common Shares Outstanding | 76,049,665 | 62,852,863 | - Potentially dilutive securities, including convertible notes, common stock warrants, options, unvested restricted stock awards, and contingent earn-out shares, totaled **29,819,656** as of March 31, 2023[126](index=126&type=chunk) [Note 15. Related Party Transactions](index=21&type=section&id=Note%2015.%20Related%20Party%20Transactions) The company has a license and exclusive supply agreement with 4Life Research LLC, a related party, for the sale of certain dietary supplements. Total revenue from related parties for the three months ended March 31, 2023, was $0.106 million, significantly up from $0.023 million in the prior year, driven by increased product and royalty revenue - Exclusive license and supply agreement with 4Life Research LLC, a related party, for the sale of certain dietary supplements (Zinc Factor, Gold Factor)[127](index=127&type=chunk)[160](index=160&type=chunk) Total Revenue from Related Parties (in thousands) | Revenue Type | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------------------- | :-------------------------------- | :-------------------------------- | | Product Revenue from Related Parties | $63 | $0 | | Royalty Revenue from Related Parties | $43 | $23 | | Total Revenue from Related Parties | $106 | $23 | [Note 16. Segment Information](index=21&type=section&id=Note%2016.%20Segment%20Information) The company operates in two reportable segments: Drugs and Supplements. For the three months ended March 31, 2023, the Drugs segment reported a loss from operations of $10.798 million, while the Supplements segment generated income from operations of $0.066 million. Total revenue from external customers was $0.107 million, entirely from the Supplements segment - Operates in two reportable segments: Drugs (development and commercialization of novel clean-surfaced nanotechnology therapeutics) and Supplements (development and commercialization of dietary supplements)[48](index=48&type=chunk)[130](index=130&type=chunk) Segment Performance (3 months ended March 31, 2023, in thousands) | Segment | Revenue from External Customers | Loss (Income) from Operations | | :---------- | :------------------------------ | :---------------------------- | | Drugs | $0 | $(10,798) | | Supplements | $107 | $66 | | Consolidated | $107 | $(10,732) | [Note 17. Subsequent Events](index=22&type=section&id=Note%2017.%20Subsequent%20Events) Subsequent to March 31, 2023, the company sold 400,000 shares of common stock under the Purchase Agreement with Lincoln Park Capital Fund, LLC, generating $0.4 million in proceeds, and issued 2,893 additional commitment shares - Subsequent to March 31, 2023, sold **400,000** shares of Common Stock under the Purchase Agreement with Lincoln Park Capital Fund, LLC, generating **$0.4 million** in proceeds, and issued **2,893** Additional Commitment Shares[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its focus as a clinical-stage pharmaceutical company developing CSN® therapeutics for neurological disorders. It details recent clinical program developments for ALS and MS, discusses the impact of the COVID-19 pandemic, and analyzes key financial drivers including R&D, G&A expenses, and other income/expense. The company continues to face significant losses and going concern doubts, necessitating further financing [Business Overview](index=23&type=section&id=Business%20Overview) Clene Inc. is a clinical-stage pharmaceutical company focused on developing novel clean-surfaced nanotechnology (CSN®) therapeutics for central nervous system disorders like ALS, MS, and PD. Its proprietary electro-crystal-chemistry platform produces highly catalytic, non-toxic nanocrystals. The company has not generated significant drug revenue and relies on dietary supplement sales, which are small compared to operating expenses - Pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN®) therapeutics[135](index=135&type=chunk) - Development and clinical efforts focused on central nervous system disorders including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD)[137](index=137&type=chunk) - Proprietary electro-crystal-chemistry drug development platform produces nanocrystals with unusually high, unique catalytic activities[136](index=136&type=chunk) - Has never been profitable and incurred operating losses since inception; revenue from dietary supplements is small compared to operating expenses[137](index=137&type=chunk) [Recent Developments of Our Clinical Programs](index=23&type=section&id=Recent%20Developments%20of%20Our%20Clinical%20Programs) The company provided updates on its clinical programs for ALS and MS. For ALS, topline data from the Phase 2/3 HEALEY ALS Platform Trial was reported, with full analyses expected mid-2023. An international Phase 3 study (RESTORE-ALS) is planned for H1 2024, contingent on funding, with potential for accelerated FDA approval by end of 2024 if biomarker data is supportive. For MS, updated exploratory data from Phase 2 VISIONARY-MS was reported, and an international Phase 3 study is expected to initiate mid-2024, also contingent on funding - **ALS Program (CNM-Au8):** - Topline data from Phase 2/3 HEALEY ALS Platform Trial reported in October 2022; full analyses (biomarkers, efficacy) expected mid-2023[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Open Label Extension (OLE) survival data expected mid-2023, exploratory efficacy results in the second half of 2023[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Increased capacity of the second Expanded Access Program (EAP) up to **200** participants, contingent on funding[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Planning to initiate an international Phase 3 study, RESTORE-ALS, in the first half of 2024, contingent on funding[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Anticipates a request-to-file NDA meeting with the FDA in Q4 2023, with potential accelerated approval by the end of 2024 if biomarker data is supportive[139](index=139&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - **MS Program (CNM-Au8):** - Updated exploratory data from Phase 2 VISIONARY-MS clinical trial reported in February and March 2023; additional OLE results expected in the second half of 2023[143](index=143&type=chunk) - Initiated a second dosing cohort in the REPAIR-MS Phase 2 clinical trial, expected to be complete in the second half of 2023[143](index=143&type=chunk) - Planning to initiate an international Phase 3 MS study in mid-2024, contingent on funding[143](index=143&type=chunk) - CNM-Au8 was well-tolerated without long-term safety concerns in both RESCUE-ALS and the HEALEY ALS Platform Trial[142](index=142&type=chunk) [Recent Competition Update](index=24&type=section&id=Recent%20Competition%20Update) The ALS treatment landscape saw several developments, including FDA approvals for orally administered edaravone (May 2022) and Amylyx's AMX0035 (Relyvrio, Sept 2022). Prilenia's pridopidine did not meet primary endpoints in HEALEY ALS, but showed positive trends. BrainStorm's NurOwn BLA review by FDA advisory committee is pending, despite not meeting primary endpoints in Phase 3, due to subgroup and biomarker trends. Biogen's tofersen (QALSODY) received accelerated FDA approval for SOD1-ALS in April 2023, based on plasma NfL as a surrogate biomarker - FDA approved orally administered edaravone (May 2022) and Amylyx's AMX0035 (Relyvrio, September 2022) for the treatment of ALS[144](index=144&type=chunk) - Prilenia Therapeutics' pridopidine did not meet primary and key secondary endpoints in the HEALEY ALS Platform Trial, but showed consistent, positive trends and a reduction in neurofilament light chain (NfL) levels[145](index=145&type=chunk) - BrainStorm Cell Therapeutics' NurOwn BLA for ALS is under FDA advisory committee review, despite its Phase 3 trial not meeting primary endpoints, due to subgroup trends and biomarker data[146](index=146&type=chunk) - Biogen Inc.'s tofersen (QALSODY) received accelerated FDA approval for SOD1-ALS (April 2023) based on plasma NfL as a surrogate biomarker, with reductions in NfL preceding and predicting slowing of clinical decline[148](index=148&type=chunk) [Impact of the COVID-19 Pandemic](index=25&type=section&id=Impact%20of%20the%20COVID-19%20Pandemic) The COVID-19 pandemic continues to pose risks and uncertainties, potentially affecting preclinical studies, clinical trials, and regulatory activities. While the company has experienced temporary disruptions, it has not incurred material business disruptions or asset impairment losses to date. The full extent of future impact remains uncertain - The COVID-19 pandemic poses risks and uncertainties, potentially affecting the ability to initiate and complete preclinical studies and clinical trials, delay future trials, and disrupt regulatory activities[149](index=149&type=chunk) - Experienced temporary research restrictions, pauses, and early conclusion of one clinical trial, but no material business disruptions or impairment losses to date[21](index=21&type=chunk)[150](index=150&type=chunk) [Financial Overview](index=25&type=section&id=Financial%20Overview) The company's financial performance is significantly influenced by research and development (R&D) expenses, general and administrative (G&A) expenses, and other income/expense. R&D costs are expected to decrease in 2023 but increase in future years as assets advance to Phase 3. G&A expenses are contingent on FDA meetings and potential NDA filing, with increases expected for commercialization efforts or decreases if NDA filing is not pursued - Research and development expenses are a significant investment, primarily for CNM-Au8, expected to decrease in 2023 due to trial completion but increase in future years for Phase 3 advancement[152](index=152&type=chunk) - General and administrative expenses are contingent on FDA end-of-Phase 2 meetings and potential NDA filing; expected to increase for commercial build-out or decrease with cost-saving initiatives if NDA is not pursued[155](index=155&type=chunk)[156](index=156&type=chunk) - Total other income (expense), net, includes changes in fair value of common stock warrant liability and contingent earn-outs, interest income/expense, lease termination gains/losses, and R&D tax credits/grants[157](index=157&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) For the three months ended March 31, 2023, total revenue increased by 257% to $0.107 million, driven by product and royalty revenue from the Supplements segment. Total operating expenses decreased by 19% to $10.839 million, leading to a 20% reduction in loss from operations to $10.732 million. Net loss improved by 12% to $11.770 million [Revenue](index=26&type=section&id=Revenue) Total revenue for Q1 2023 was $0.107 million, a 257% increase year-over-year, primarily from product revenue ($0.064 million) and royalty revenue ($0.043 million) in the Supplements segment. This growth was due to the timing of 4Life's purchases of Zinc Factor and Gold Factor Revenue (in thousands) | Revenue Type | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (%) | | :-------------- | :-------------------------------- | :-------------------------------- | :--------- | | Product Revenue | $64 | $7 | 814% | | Royalty Revenue | $43 | $23 | 87% | | Total Revenue | $107 | $30 | 257% | - Product revenue from sales of aqueous zinc-silver ion dietary supplement (rMetx™ ZnAg Immune Boost / Zinc Factor) and aqueous gold dietary supplement (Gold Factor) through dOrbital, Inc. or 4Life[160](index=160&type=chunk) [Cost of Revenue](index=26&type=section&id=Cost%20of%20Revenue) Cost of revenue was $5,000 for the three months ended March 31, 2023, up from $0 in the prior year, related to production and distribution costs for dietary supplements Cost of Revenue (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :-------------- | :-------------------------------- | :-------------------------------- | | Cost of Revenue | $5 | $0 | [Research and Development Expense](index=27&type=section&id=Research%20and%20Development%20Expense) R&D expense decreased by 14% to $7.395 million for the three months ended March 31, 2023. This was mainly due to decreased expenses for CNM-Au8 (due to completion of blinded periods in trials) and CNM-ZnAg (due to trial completion), and reduced personnel costs. Partially offsetting this were increased expenses for EAPs, REPAIR-MS, RESCUE-ALS OLE, and unallocated costs (rent, utilities, depreciation) Research and Development Expense (in thousands) | R&D Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (%) | | :------------------------- | :-------------------------------- | :-------------------------------- | :--------- | | CNM-Au8 | $2,133 | $2,805 | (24)% | | CNM-ZnAg | $813 | $1,409 | (42)% | | Unallocated | $1,159 | $1,004 | 15% | | Personnel | $2,317 | $2,618 | (11)% | | Stock-based Compensation | $973 | $744 | 31% | | Total R&D Expense | $7,395 | $8,580 | (14)% | - Decrease in CNM-Au8 expenses primarily due to completion of blinded periods in HEALEY ALS Platform Trial, REPAIR-PD, and VISIONARY-MS clinical trials[163](index=163&type=chunk) - Increase in CNM-Au8 expenses related to two EAPs, REPAIR-MS clinical trial (initiation of second dosing cohort), and RESCUE-ALS clinical trial (ongoing OLE)[163](index=163&type=chunk) - Decrease in CNM-ZnAg expenses primarily due to completion of the clinical trial for treatment of COVID-19 in 2022[163](index=163&type=chunk) [General and Administrative Expense](index=27&type=section&id=General%20and%20Administrative%20Expense) G&A expense decreased by 28% to $3.439 million for the three months ended March 31, 2023. This reduction was primarily due to lower directors' and officers' insurance fees, legal fees, finance and accounting fees, public and investor relations costs, personnel expenses (due to headcount reduction), and stock-based compensation General and Administrative Expense (in thousands) | G&A Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------- | :-------------------------------- | :-------------------------------- | | Directors' and Officers' Insurance | $398 | $849 | | Legal | $108 | $178 | | Finance and Accounting | $259 | $411 | | Public and Investor Relations | $144 | $330 | | Personnel | $989 | $1,181 | | Stock-based Compensation | $1,250 | $1,458 | | Other | $291 | $379 | | Total G&A Expense | $3,439 | $4,786 | - Decreases across most G&A categories, including directors' and officers' insurance, legal, finance and accounting, public and investor relations, personnel (due to headcount reduction), and stock-based compensation[165](index=165&type=chunk) [Total Other Income (Expense), Net](index=28&type=section&id=Total%20Other%20Income%20(Expense),%20Net) Total other income (expense), net, was a net expense of $1.038 million for the three months ended March 31, 2023, a significant increase from a net expense of $18,000 in the prior year. This change was driven by increased interest income (due to rising rates) and interest expense, commitment share expense, and changes in fair value of contingent earn-out liabilities, partially offset by increased R&D tax credits Total Other Income (Expense), Net (in thousands) | Other Income (Expense) Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (%) | | :------------------------------ | :-------------------------------- | :-------------------------------- | :--------- | | Interest Income | $172 | $24 | 617% | | Interest Expense | $(1,066) | $(782) | 36% | | Gain on Termination of Lease | $0 | $420 | * | | Commitment Share Expense | $(399) | $0 | * | | R&D Tax Credits & Unrestricted Grants | $314 | $299 | 5% | | Total Other Income (Expense), Net | $(1,038) | $(18) | 5,667% | - Increase in interest income primarily due to increasing interest rates on cash, cash equivalents, and marketable securities[168](index=168&type=chunk) - Commitment share expense of **$0.399 million** due to shares of Common Stock issued to Lincoln Park Capital Fund, LLC as an initial fee[168](index=168&type=chunk) - Losses from changes in fair value of contingent earn-out liabilities due to changes in common stock price and valuation model assumptions[168](index=168&type=chunk) [Taxation](index=28&type=section&id=Taxation) The company is subject to income taxes in the U.S., Australia, and the Netherlands. A full valuation allowance is maintained against U.S. deferred tax assets due to cumulative losses and uncertainty of future taxable income. Clene Australia received $0.3 million in R&D tax credits for both 2023 and 2022 - Subject to taxation in the U.S. (federal **21%**, Utah **4.85%**, Maryland **8.25%**), Australia (**30%**/**25%**), and Netherlands (**15%**/**25.8%**)[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) - A full valuation allowance is recorded against U.S. net deferred tax assets due to uncertainty of realization from future taxable income[169](index=169&type=chunk)[198](index=198&type=chunk) - Clene Australia received **$0.3 million** in research and development tax credits for the three months ended March 31, 2023 and 2022[170](index=170&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company has incurred significant losses and negative cash flows since inception and expects to incur additional losses. It recognizes the need for substantial additional capital to fund operations and R&D. Primary funding sources have included equity financing ($135.1 million), debt ($59.6 million), Reverse Recapitalization ($9.4 million), R&D tax credits ($6.4 million), grants ($2.2 million), and stock option/warrant exercises ($1.0 million). The company faces substantial doubt about its ability to continue as a going concern without additional financing, despite cost-saving measures - Incurred significant losses and negative cash flows from operations since inception, expecting additional losses to fund R&D and operations[173](index=173&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk) - Primary historical funding sources include: **$135.1 million** from equity financing, **$59.6 million** from borrowings (convertible notes, notes payable), **$9.4 million** from Reverse Recapitalization, **$6.4 million** from refundable R&D tax credits, **$2.2 million** from grants, and **$1.0 million** from stock option/warrant exercises[174](index=174&type=chunk) - Substantial doubt about the Company's ability to continue as a going concern due to insufficient cash and resources within the next twelve months without additional financing[177](index=177&type=chunk) - Implemented cost-saving initiatives (delaying R&D, reducing executive compensation, hiring freeze, staff elimination) but these do not alleviate going concern doubt beyond one year[178](index=178&type=chunk) [Short-Term Material Cash Requirements](index=30&type=section&id=Short-Term%20Material%20Cash%20Requirements) For the next twelve months, primary capital requirements include funding R&D, personnel, regulatory, and clinical trial costs for CNM-Au8, as well as general and administrative expenses. Firm commitments include $0.1 million for finance lease obligations, $1.1 million for operating lease obligations, $12.5 million for notes payable principal and interest, and $0.5 million for capital expenditures. The company expects to meet these needs through cash on hand and additional financing - Primary capital requirements for the next twelve months are to fund R&D, personnel, regulatory, and clinical trial costs for CNM-Au8, and general and administrative costs[180](index=180&type=chunk) Short-Term Material Cash Requirements (in millions) | Commitment Type | Amount | | :-------------------------- | :----- | | Finance Lease Obligations | $0.1 | | Operating Lease Obligations | $1.1 | | Notes Payable (Principal & Interest) | $12.5 | | Capital Expenditures | $0.5 | [Long-Term Material Cash Requirements](index=30&type=section&id=Long-Term%20Material%20Cash%20Requirements) Beyond twelve months, the company's capital requirements will continue to fund R&D, personnel, regulatory, and clinical trial costs for CNM-Au8, and G&A expenses. Known obligations include $20,000 for finance lease obligations, $7.2 million for operating lease obligations, and $19.7 million for notes payable interest and principal repayment. Long-term liquidity is expected to be met through equity, debt, or other capital sources - Primary capital requirements beyond twelve months are to fund R&D, personnel, regulatory, and clinical trial costs for CNM-Au8, and general and administrative costs[182](index=182&type=chunk) Long-Term Material Cash Requirements (in millions) | Commitment Type | Amount | | :-------------------------- | :----- | | Finance Lease Obligations | $0.02 | | Operating Lease Obligations | $7.2 | | Notes Payable (Principal & Interest) | $19.7 | [Use of Funds](index=30&type=section&id=Use%20of%20Funds) The primary use of cash in all periods was to fund R&D, regulatory and clinical trial costs, and general corporate expenditures. For Q1 2023, net cash used in operating activities was $9.2 million, net cash provided by investing activities was $4.7 million, and net cash provided by financing activities was $4.6 million - Primary use of cash in all periods was to fund research and development, regulatory and other clinical trial costs, and general corporate expenditures[184](index=184&type=chunk) Cash Flow Activities (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net Cash Used in Operating Activities | $(9,218) | $(13,084) | | Net Cash Provided by (Used in) Investing Activities | $4,722 | $(24,522) | | Net Cash Provided by Financing Activities | $4,588 | $235 | [Operating Activities](index=30&type=section&id=Operating%20Activities) Net cash used in operating activities decreased to $9.2 million in Q1 2023 from $13.1 million in Q1 2022. This was driven by a lower net loss, non-cash adjustments (depreciation, stock-based compensation, commitment share expense), and changes in operating assets and liabilities, including a decrease in accounts payable and an increase in accrued liabilities - Net cash used in operating activities decreased to **$9.2 million** in Q1 2023 from **$13.1 million** in Q1 2022[184](index=184&type=chunk)[185](index=185&type=chunk) - Significant non-cash items in Q1 2023 included **$2.2 million** in stock-based compensation, **$0.4 million** in depreciation, and **$0.4 million** in commitment share expense[185](index=185&type=chunk) - Changes in operating assets and liabilities in Q1 2023 included a **$2.4 million** decrease in accounts payable and a **$2.1 million** increase in accrued liabilities[185](index=185&type=chunk) [Investing Activities](index=31&type=section&id=Investing%20Activities) Net cash provided by investing activities was $4.7 million in Q1 2023, a significant turnaround from a $24.5 million outflow in Q1 2022. This was primarily due to $5.0 million in proceeds from marketable securities maturities, partially offset by $0.3 million in property and equipment purchases - Net cash provided by investing activities was **$4.7 million** in Q1 2023, a significant improvement from **$24.5 million** used in Q1 2022[184](index=184&type=chunk)[188](index=188&type=chunk) - Q1 2023 investing activities consisted of **$5.0 million** in proceeds from maturities of marketable securities, partially offset by **$0.3 million** in purchases of property and equipment[188](index=188&type=chunk) [Financing Activities](index=31&type=section&id=Financing%20Activities) Net cash provided by financing activities increased to $4.6 million in Q1 2023 from $0.2 million in Q1 2022. This was mainly due to $4.3 million in proceeds from common stock issuance (net of offering costs) and $0.4 million from notes payable issuance - Net cash provided by financing activities was **$4.6 million** for Q1 2023, compared to **$0.2 million** for Q1 2022[184](index=184&type=chunk)[189](index=189&type=chunk) - Q1 2023 financing activities included **$4.3 million** from issuance of common stock (net of offering costs) and **$0.4 million** from issuance of notes payable[189](index=189&type=chunk) [Critical Accounting Estimates](index=31&type=section&id=Critical%20Accounting%20Estimates) The company's critical accounting estimates involve significant judgment and estimation uncertainty, particularly for contingent earn-out liabilities, convertible notes, income taxes, and stock-based compensation. These estimates impact reported financial condition and results of operations [Contingent Earn-Out Liabilities](index=31&type=section&id=Contingent%20Earn-Out%20Liabilities) Contingent earn-out liabilities are measured at fair value using a Monte Carlo valuation model, requiring significant judgment on inputs like expected stock price volatility (115.00%), risk-free interest rate (3.90%), and expected term (2.75 years) as of March 31, 2023. Changes in fair value resulted in losses for the three months ended March 31, 2023 and 2022 - Fair value of contingent earn-out liabilities is estimated using a Monte Carlo valuation model[193](index=193&type=chunk) Contingent Earn-Out Liabilities Valuation Inputs | Valuation Input | March 31, 2023 | December 31, 2022 | | :---------------------------- | :------------- | :---------------- | | Expected Stock Price Volatility | 115.00% | 115.00% | | Risk-Free Interest Rate | 3.90% | 4.20% | | Expected Dividend Yield | 0.00% | 0.00% | | Expected Term (in years) | 2.75 | 3.00 | - Changes in fair value resulted in a loss of **$0.1 million** for Clene Nanomedicine Contingent Earn-out and **$7,000** for Initial Stockholders Contingent Earn-out for Q1 2023[194](index=194&type=chunk) [Convertible Notes](index=31&type=section&id=Convertible%20Notes) The Avenue Conversion Feature and the 2022 DHCD Loan conversion option are not separated from the host contract and are accounted for as single liabilities at amortized cost, as they did not meet derivative accounting requirements - The Avenue Conversion Feature and the 2022 DHCD Loan conversion option are accounted for as single liabilities measured at amortized cost, as they did not meet derivative accounting requirements[195](index=195&type=chunk)[196](index=196&type=chunk) Convertible Notes Carrying Value (in millions) | Convertible Note | March 31, 2023 | December 31, 2022 | | :--------------- | :------------- | :---------------- | | 2021 Avenue Loan | $4.9 | $4.8 | | 2022 DHCD Loan | $5.0 | $5.0 | [Income Taxes](index=32&type=section&id=Income%20Taxes) The company applies a two-step process for income tax uncertainty and maintains a full valuation allowance against deferred tax assets due to cumulative losses and uncertainty of future taxable income, requiring significant judgment - Applies a two-step process to determine the amount of tax benefit to be recognized for income tax uncertainty[198](index=198&type=chunk) - Maintains a full valuation allowance against deferred tax assets due to cumulative loss position and uncertainty of generating future taxable income[198](index=198&type=chunk) [Stock-Based Compensation](index=32&type=section&id=Stock-Based%20Compensation) Stock-based compensation is accounted for using a fair value-based method. Stock options are valued using a Black-Scholes model, and restricted stock awards with market conditions use a Monte Carlo model, both requiring significant judgment on inputs like volatility, risk-free rate, and expected term - Stock options are valued using a Black-Scholes option-pricing model, and restricted stock awards with market conditions use a Monte Carlo valuation model[200](index=200&type=chunk)[201](index=201&type=chunk) Stock-Based Compensation Valuation Inputs | Valuation Input | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------------------- | :-------------------------------- | :-------------------------------- | | Expected Stock Price Volatility | 96.22% – 103.24% | 89.57% – 93.07% | | Risk-Free Interest Rate | 3.38% – 3.98% | 1.65% – 2.02% | | Expected Dividend Yield | 0.00% | 0.00% | | Expected Term (in years) | 5.00 – 6.08 | 5.00 – 6.98 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Clene Inc. is not required to provide specific quantitative and qualitative disclosures about market risk in this report - As a smaller reporting company, Clene Inc. is not required to provide information regarding quantitative and qualitative disclosures about market risk[202](index=202&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2023, due to identified material weaknesses in internal control over financial reporting. These weaknesses relate to an ineffective control environment, inadequate controls over reconciliations and manual journal entries, and deficiencies in IT general controls. Management is actively engaged in remediation efforts, including strengthening the accounting team, engaging external consultants, and implementing a new ERP system [Evaluation of Disclosure Controls and Procedures](index=32&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) As of March 31, 2023, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting - Disclosure controls and procedures were not effective as of March 31, 2023, due to material weaknesses in internal control over financial reporting[203](index=203&type=chunk) [Material Weaknesses in Internal Control over Financial Reporting](index=33&type=section&id=Material%20Weaknesses%20in%20Internal%20Control%20over%20Financial%20Reporting) Material weaknesses identified include an ineffective control environment, inadequate controls over preparation and review of reconciliations and segregation of duties for manual journal entries, and deficiencies in IT general controls (user access, program change management, computer operations, program development testing). These deficiencies could lead to material misstatements - Did not design or maintain an effective control environment commensurate with financial reporting requirements[206](index=206&type=chunk) - Did not design and maintain controls over the preparation and review of reconciliations and segregation of duties over manual journal entries[206](index=206&type=chunk) - Did not design and maintain information technology (IT) general controls for IT systems relevant to financial statements, specifically user access, program change management, computer operations, and program development testing[206](index=206&type=chunk) [Material Weakness Remediation](index=33&type=section&id=Material%20Weakness%20Remediation) Management is actively remediating material weaknesses by strengthening the internal accounting team, engaging external consultants for GAAP application and policy assessment, and implementing a new Enterprise Resource Planning (ERP) system. Additional activities include adding more technical accounting resources - Strengthened internal accounting team, including hiring a new Chief Financial Officer, to provide oversight and additional review[208](index=208&type=chunk) - Engaged external consultants to support evaluation of complex GAAP applications and assist with documenting accounting policies and procedures[208](index=208&type=chunk) - Implemented a new Enterprise Resource Planning (ERP) system to enhance financial record accuracy and enforce systematic segregation of duties[208](index=208&type=chunk) - Continuing remediation activities in 2023, including adding more technical accounting resources[208](index=208&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Other than the remediation activities described, there were no material changes in internal control over financial reporting during the quarter ended March 31, 2023 - No material changes in internal control over financial reporting during the quarter ended March 31, 2023, other than the described remediation activities[210](index=210&type=chunk) [PART II — OTHER INFORMATION](index=34&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section covers other information including legal proceedings, risk factors, equity sales, defaults on senior securities, mine safety disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings, though it may be involved in ordinary course legal matters from time to time - Not currently a party to any material pending legal proceedings[212](index=212&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the 2022 Annual Report on Form 10-K, except for an additional risk factor concerning intellectual property discovered through government-funded programs. This new risk highlights potential federal regulations like "march-in" rights, reporting requirements, and a preference for U.S.-based manufacturing, which could limit exclusive rights or ability to contract with non-U.S. manufacturers - No material changes to risk factors since the 2022 Annual Report on Form 10-K, except for an additional risk factor[213](index=213&type=chunk) - New risk factor: Intellectual property discovered through government-funded programs may be subject to federal regulations (e.g., "march-in" rights, reporting requirements, preference for U.S.-based manufacturing), potentially limiting exclusive rights or ability to contract with non-U.S. manufacturers[214](index=214&type=chunk)[215](index=215&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds reported[216](index=216&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities reported[216](index=216&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[216](index=216&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - No other information to report under Item 5[217](index=217&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation, Bylaws, Purchase Agreement, Registration Rights Agreement, and various certifications (CEO, CFO). It also includes XBRL documents - Lists exhibits filed, including corporate governance documents (Fourth Amended and Restated Certificate of Incorporation, Bylaws), financing agreements (Purchase Agreement, Registration Rights Agreement), and certifications (CEO, CFO)[217](index=217&type=chunk) - Includes Inline XBRL Instance Document and related taxonomy extension documents[217](index=217&type=chunk)

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 ( ...