Clene Inc. 2025年季度报告

PART I—FINANCIAL INFORMATION CLENE INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share amounts) Table of Contents CLENE INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Table of Contents CLENE INC.CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)(In thousands, except share amounts)(Unaudited Table of Contents CLENE INC.NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Note1.Nature of the Business Clene Inc. (the “Company,” “we,” “us,” or similar such references) is a clinical-stage pharmaceutical company pioneering the discovery, development, andcommercialization of novel clean-surfaced nanotechnology therapeutics. We have developed an electro-crystal-chemistry drug development platform that enablesproduction of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applicationsprimarily in neurology. Our efforts are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophiclateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). Our patented electro-crystal-chemistry manufacturing platform further enablesus to develop very low concentration dietary supplements to advance the health and well-being of broad populations. These dietary supplements can vary greatly and We became a public company onDecember 30, 2020 (the “Closing Date”) when we completed a reverse recapitalization (the “Reverse Recapitalization”)with Tottenham Acquisition I Limited (“Tottenham”), Tottenham’s wholly-owned subsidiary, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-ownedsubsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value Going Concern We incurred a loss from operationsof$4.1millionand $9.2millionfor thethreemonths endedMarch 31, 2025and2024, respectively. Our accumulateddeficit was $282.9millionand $282.1millionas ofMarch 31, 2025andDecember 31, 2024, respectively. Our cash andcash equivalents totaled$9.8millionand$12.2millionas ofMarch 31, 2025andDecember 31, 2024, respectively, andnet cash used in operating activities was$5.0millionand $7.1millionfor thethree We have incurred significant losses and negative cash flows from operations since our inception. We havenotgenerated significant revenues since ourinception,and we do not anticipate generating significant revenues unless we successfully complete development and obtain regulatory approval forcommercialization of a drug candidate. We expect to incur additional losses in the future, particularly as we advance the development of our clinical-stage drugcandidates, continue research and development of our preclinical drug candidates, and initiate additional clinical trials of, and seek regulatory approval for, these andother future drug candidates. We expect that within the nexttwelvemonths, we willnothave sufficient cash and other resources on hand to sustain our current To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing orcollaboration arrangements withthirdparties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from theexercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance onthirdparties, and there isnoassurance that effectiveimplementation of our plans will result in the necessary funding to continue current operations. During thethreemonths endedMarch 31, 2025, we generated$2.7millionof gross proceeds from our equity distribution agreementand subsequent toMarch 31, 2025, we generated $0.9millionof gross proceeds from our equity Table of Contents The accompanying condensed consolidated financial statementshave been prepared assuming we will continue as a going concern, which contemplates therealization of assets and satisfaction of liabilities in the normal course of business. As a result, the accompanying condensed consolidated financial statementsdonot Note2.Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statementsinclude the accounts of Clene Inc. and our wholly-owned subsidiaries, Clene Nanomedicine,Inc., a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, Clene Netherlands B.V. (“CleneNetherlands”), a subsidiary incorporated in the Netherlands, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accountsand transactions. We have prepared the accompanying condensed consolidated financial statementsin accordance with United States (“U.S.”) Generally AcceptedAccounting Principles (“GAAP”) for interim f