Clene Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Clene Inc. filed its 2023 10-K, reporting $128.4M in assets and $74.8M in cash, with no debt.</b>

AI Summary

Clene Inc. (CLNN) filed a Annual Report (10-K) with the SEC on March 13, 2024. Clene Inc. reported financial results for the fiscal year ended December 31, 2023. The company's total assets were $128,422,851 as of December 31, 2023. Total debt was $0 as of December 31, 2023. The company had $74,759,591 in cash and cash equivalents as of December 31, 2023. The filing details various warrants and their potential impact on common stock.

Why It Matters

For investors and stakeholders tracking Clene Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Clene Inc.'s financial health and operational status for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. Details on outstanding warrants and their potential dilution are important for understanding the current equity structure and potential impact on shareholder value.

Risk Assessment

Risk Level: medium — Clene Inc. shows moderate risk based on this filing. The company's financial disclosures, particularly regarding its cash position and the nature of its outstanding warrants, suggest a need for careful investor scrutiny regarding potential dilution and future funding needs.

Analyst Insight

Investors should closely examine the details of Clene Inc.'s warrant agreements and their potential impact on share dilution, as well as monitor the company's cash burn rate and future financing plans.

Financial Highlights

total Assets

128,422,851

total Debt

0

cash Position

74,759,591

Key Numbers

• 128,422,851 — Total Assets (As of December 31, 2023)
• 74,759,591 — Cash and Cash Equivalents (As of December 31, 2023)
• 0 — Total Debt (As of December 31, 2023)
• 300,000,000 — Authorized Common Stock (As of December 31, 2023)
• 150,000,000 — Authorized Preferred Stock (As of December 31, 2023)
• 2034-12-31 — Original Avenue Warrant Expiration (As of December 31, 2023)
• 2032-12-31 — New Avenue Warrant Expiration (As of December 31, 2023)

Key Players & Entities

• Clene Inc. (company) — Filer name
• CLNN (company) — Ticker symbol
• 20231231 (date) — Fiscal year end
• 20240313 (date) — Filing date
• SALT LAKE CITY (location) — Business address city
• UT (location) — Business address state
• 801-676-9695 (phone) — Business phone
• Chelsea Worldwide Inc. (company) — Former company name

FAQ

Risk Factors

• Going Concern [high — financial]: The company's ability to continue as a going concern is dependent on its ability to secure additional financing and achieve profitability.
• Warrant Dilution [medium — financial]: A significant number of outstanding warrants could lead to substantial dilution of common stock upon exercise.
• Regulatory Compliance [medium — regulatory]: The company must comply with various SEC regulations and reporting requirements.

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value CLNN The Nasdaq Capital M
• $11.50 — e-half of one share of Common Stock for $11.50 per share CLNNW The Nasdaq Capital
• $0.88 — n stock on the Nasdaq Capital Market of $0.88 per share. The number of shares outsta

Filing Documents

• clnn20231231_10k.htm (10-K) — 2545KB
• ex_584128.htm (EX-4.1) — 25KB
• ex_584129.htm (EX-21.1) — 6KB
• ex_584130.htm (EX-23.1) — 3KB
• ex_584131.htm (EX-31.1) — 12KB
• ex_584132.htm (EX-31.2) — 12KB
• ex_584133.htm (EX-32.1) — 6KB
• ex_584134.htm (EX-32.2) — 6KB
• ex_625242.htm (EX-97.1) — 39KB
• figure1v3.jpg (GRAPHIC) — 27KB
• figure2v2.jpg (GRAPHIC) — 49KB
• figure3full.jpg (GRAPHIC) — 57KB
• figure4v2.jpg (GRAPHIC) — 82KB
• figure5av2.jpg (GRAPHIC) — 37KB
• figure5bv3.jpg (GRAPHIC) — 53KB
• figure6v3.jpg (GRAPHIC) — 55KB
• figure8.jpg (GRAPHIC) — 72KB
• figure9at35percent.jpg (GRAPHIC) — 64KB
• newpipeline.jpg (GRAPHIC) — 110KB
• 0001437749-24-007542.txt (&nbsp;) — 12645KB
• clnn-20231231.xsd (EX-101.SCH) — 96KB
• clnn-20231231_cal.xml (EX-101.CAL) — 77KB
• clnn-20231231_def.xml (EX-101.DEF) — 594KB
• clnn-20231231_lab.xml (EX-101.LAB) — 595KB
• clnn-20231231_pre.xml (EX-101.PRE) — 641KB
• clnn20231231_10k_htm.xml (XML) — 1752KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 46 Item 1B. Unresolved Staff Comments 79 Item 1C. Cybersecurity 80 Item 2.

Properties

Properties 83 Item 3.

Legal Proceedings

Legal Proceedings 83 Item 4. Mine Safety Disclosures 83 PART II 84 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 84 Item 6. [Reserved] 84 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 85 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 98 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 99 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 100 Item 9A.

Controls and Procedures

Controls and Procedures 100 Item 9B. Other Information 101 Item 9C. Disclosures Regarding Foreign Jurisdictions that Prevent Inspections 101 PART III 102 Item 10. Directors, Executive Officers and Corporate Governance 102 Item 11.

Executive Compensation

Executive Compensation 102 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 102 Item 13. Certain Relationships and Related Transactions, and Director Independence 102 Item 14. Principal Accountant Fees and Services 102 PART IV 103 Item 15. Exhibit and Financial Statement Schedules 103 Item 16. Form 10-K Summary 105 2 Table of Contents PART I Throughout this Annual Report on Form 10-K (the " Annual Report " ), the " Company, " and references to " we, " " us, " or similar such references should be understood to be references to Clene Inc. and its consolidated subsidiaries. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Certain statements in this Annual Report may constitute "forward-looking statements" for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Annual Report may include, for example, statements about: our future financial performance, including our ability to continue as a going concern; our plans and strategies to raise additional funding; the clinical results of our drug candidates; the likelihood of commercial success for our drug candidates; our plans and strategies to obtain and maintain regulatory approvals of our drug

Business

Item 1. Business Overview We are a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology ("CSN ") therapeutics. CSN therapeutics are comprised of atoms of transition elements that, when assembled in nanocrystal form, possess unusually high, unique catalytic activities not present in those same elements in bulk form. These catalytic activities drive, support, and maintain beneficial metabolic and energetic cellular reactions within diseased, stressed, and damaged cells. Our patent-protected, proprietary position affords us the potential to develop a broad and deep pipeline of novel CSN therapeutics to address a range of diseases with high impact on human health. We innovated an electro-crystal-chemistry drug development platform that draws from advances in nanotechnology, plasma and quantum physics, material science, and biochemistry. Our platform process results in nanocrystals with faceted structures and surfaces that are free of the chemical surface modifications that accompany other production methods. Many traditional methods of nanoparticle synthesis involve the unavoidable deposition of potentially toxic organic residues and stabilizing surfactants on the particle surfaces. Synthesizing stable nanocrystals that are both nontoxic and highly catalytic has overcome this significant hurdle in harnessing transition metal catalytic activity for therapeutic use. Our clean-surfaced nanocrystals exhibit catalytic activities many-fold higher than other commercially available nanoparticles, produced using various techniques, that we have comparatively evaluated. We have multiple drug assets currently in development and/or clinical trials for applications primarily in neurology. Our development and clinical efforts are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis ("ALS"), multiple sclerosis ("

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View this 10-K filing on SEC EDGAR