TELABio公司2025年度季度报告

TABLE OF CONTENTS PARTI FINANCIAL INFORMATION Item1.Financial Statements4Item2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations18Item3.Quantitative and Qualitative Disclosures About Market Risk28Item4.Controls and Procedures29PARTII OTHER INFORMATIONItem1.Legal Proceedings29Item1A.Risk Factors29Item2.Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases ofEquity Securities30Item3.Defaults Upon Senior Securities30Item4.Mine Safety Disclosures30Item5.Other Information30Item6.Exhibits30Signatures31 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (this “Quarterly Report”) and the documents incorporated byreference herein contain “forward-looking statements” within the meaning of the Private SecuritiesLitigation Reform Act of 1995. In addition, we may, through our officers and other authorized Forward-looking statements are neither statements of historical facts nor assurances of futureperformance, but instead discuss the future of our business, operations, future financial performance,future financial condition, plans, anticipated growth strategies, anticipated or perceived trends in ourbusiness, the industry in which we operate or the broader economy, and other objectives ofmanagement. In some cases, you can identify forward-looking statements by terminology such as“aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” You should understand that the following important factors could affect our future results and couldcause those results or other outcomes to differ materially from those expressed or implied in our ●estimates regarding future results of operations, financial position, research and developmentcosts, capital requirements and our needs for additional financing;●the commercial success and degree of market acceptance of our products;●the introduction of new products or product enhancements by us or others in our industry,including new products which may be perceived to negatively impact the demand for ourproducts now or in the future;●our ability to expand, manage and maintain our direct sales and marketing organization andto market and sell our products in the U.S. and Europe;●the performance of our exclusive contract manufacturer for our OviTex and OviTex PRSproducts, Aroa Biosurgery Ltd. (“Aroa”), in connection with the supply of product and in thedevelopment of additional products and product configurations within these products;●our ability to maintain our supply chain integrity and expand our supply chain to manageincreased demand for our products;●our ability to compete successfully with larger competitors in our highly competitiveindustry;●our ability to achieve and maintain adequate levels of coverage or reimbursement for ourcurrent products and any future products we may seek to commercialize;●our ability to enhance our products, expand our indications and develop and commercializeadditional products;●the development, regulatory approval, efficacy and commercialization of competingproducts;●our business model and strategic plans for our products, technologies and business,including our implementation thereof; staffing shortages, supply chain disruptions to critical surgical and hospital supplies, and any ●the volatility of capital markets and other adverse macroeconomic factors, including due toinflationary pressures, interest rate and currency rate fluctuations, economic slowdown orrecession, banking instability, monetary policy changes, changes in trade policies (includingtariffs and trade protection measures that have been or may in the future be imposed by theU.S. or other countries), geopolitical tensions or the outbreak of hostilities or war, including from the ongoing Russia-Ukraine conflict, the current conflicts in the Middle East (including controls;●our ability to establish and maintain intellectual property protection for our products, as wellas our ability to operate our business without infringing the intellectual property rights ofothers;●our expectations regarding the use of proceeds from recent and any future financings, if any;●the occurrence of adverse safety events, restrictions on use with our products or productliability claims; and●other risks and uncertainties, including those listed under the caption “Risk Factors” in ourAnnual Report on Form 10-K for the year ended December 31, 2024 (our “Annual Report”),our subsequent Quarterly Reports on Form 10-Q and the other documents we file with theSecurities and Exchange Commission (the “SEC”). These forward-looking statements are based on management’s current expectations, estimates,forecasts and projections about our business and the industry in which we operate, and management’sbeliefs and assumptions are not guarantees of future performance or development and involve knownand unknown risks, uncertainties and other factors that are in some cases beyond our control. In li