Ernекса治疗公司2025年季度报告

FORM10-Q For the quarterly period endedMarch 31,2025 or Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every interactive data file required to be submitted pursuantto Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting Large accelerated filerNon-accelerated filer If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of May 7, 2025, the registrant had outstanding62,363,763shares of common stock, $0.005par value per share. TABLE OF CONTENTS PART I – FINANCIAL INFORMATION CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains “forward-looking statements” as that term is defined under the Private SecuritiesLitigation Reform Act of 1995 (“PSLRA”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements relatedto future events, results, performance, prospects and opportunities, including statements related to our strategic plans, capital needs,and our financial position. Forward-looking statements are based on information currently available to us, on our current expectations,estimates, forecasts, and projections about the industries in which we operate and on the beliefs and assumptions of management.Forward looking statements often contain words such as “expects,” “anticipates,” “could,” “targets,” “projects,” “intends,” “plans,”“believes,” “seeks,” “estimates,” “may,” “will,” “would,” and similar expressions. In addition, any statements that refer to projectionsof our future financial performance, our anticipated growth and trends in our business, and other characterizations of future events or Readers are urged not to place undue reliance on the forward-looking statements in this Quarterly Report on Form 10-Q, which speakonly as of the date of this Quarterly Report on Form 10-Q. We are including this cautionary note to make applicable, and takeadvantage of, the safe harbor provisions of the PSLRA. Except as required by law, we do not undertake, and expressly disclaim any We believe that the expectations reflected in forward-looking statements in this Quarterly Report on Form 10-Q are based uponreasonable assumptions at the time made. However, given the risks and uncertainties, you should not rely on any forward-lookingstatements as a prediction of actual results, developments or other outcomes. You should read these forward-looking statements with Unless stated otherwise or the context otherwise requires, all references in this Quarterly Report on Form 10-Q to “Ernexa” refer toErnexa Therapeutics Inc., references to the “Company,” “we,” “us” or “our” refer to Ernexa and its subsidiaries, including Novellus, 1)DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION Description of Business Ernexa Therapeutics Inc. (the “Company”) is a preclinical-stage synthetic allogeneic iMSC therapy company. Its vision is toimprove the lives of patients with difficult-to-treat diseases through innovative, effective, and safe, but accessible cellular therapies,and its mission is to develop allogenic off-the-shelf cellular therapies, leveraging induced pluripotent stem cell (“iPSC”)-derived As used herein, the “Company” or “Ernexa” refers collectively to Ernexa and its consolidated subsidiaries (EternaTherapeutics LLC, Novellus, Inc. and Novellus Therapeutics Limited) unless otherwise stated or the context otherwise requires. InApril 2025, the Company formed a new wholly owned Texas subsidiary named Ernexa TX2 Inc., and the Company dissolved Eterna Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance withaccounting principles generally accepted in the United States (“GAAP”) for interim financial statements and with the instructions toForm 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include