MeiraGTx Holdings plc 2025年季度报告

FORM10-Q (Mark One)☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 For the quarterly period endedMarch 31, 2025OR TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 ☐For the transition period fromtoCommission File Number:001-38520 MeiraGTx Holdings plc (Exact Name of Registrant as Specified in its Charter) 98-1448305(I.R.S. EmployerIdentification No.) Not Applicable(Former name, former address, and former fiscalyear, if changed since last report) Securities registered pursuant to Section12(b)of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of theSecurities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required tofile such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12months (or for suchshorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer,smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “acceleratedfiler,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Accelerated filer☐ Largeacceleratedfiler☐ Smallreportingcompany☒ Non-acceleratedfiler☒ EmerginggrowthCompany☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section13(a)of theExchange Act.☐ Forward-Looking Statements This Quarterly Report on Form10-Q (the “Form10-Q”) contains forward-looking statements withinthe meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in thisForm10-Q that do not relate to matters of historical fact should be considered forward-lookingstatements, including, without limitation, statements regarding expectations regarding meetings withglobal regulatory authorities and the FDA, product pipeline, anticipated product benefits, goals andstrategic transactions or priorities, product candidate development and status and expectationsrelating to clinical trials, growth expectations or targets, pre-clinical and clinical data expectationsand expectations related to financing arrangements and the intended use of proceeds thereunder, aswell as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,”“forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate” and similarstatements of a future or forward-looking nature. These forward-looking statements are based onmanagement’s current expectations. These statements are neither promises nor guarantees, butinvolve known and unknown risks, uncertainties and other important factors that may cause actualresults, performance or achievements to be materially different from any future results, performanceor achievements expressed or implied by the forward-looking statements, including, but not limitedto, the important factors discussed under “Item1A. Risk Factors” in this Form10-Q.These and otherimportant factors could cause actual results to differ materially from those indicated by the forward-lookingstatements made in this Form 10-Q. Any such forward-looking statements representmanagement’s estimates as of the date of this Form10-Q. While we may elect to update suchforward-looking statements at some point in the future, unless required by law, we disclaim anyobligation to do so, even if subsequent events cause our views to change. Thus, one should notassume that our silence over time means that actual events are bearing out as expressed or implied insuch forward-looking statements. These forward-looking statements should not be relied upon asrepresenting our views as of any date subsequent to the date of this Form10-Q. Risk Factor Summary We are providing the following summary of the principal risk factors contained in this Form 10-Q toenhance the readability and accessibility of our risk factor disclosures. We encourage you to carefullyreview in their entirety the full risk factors set forth in the sectionof this Form 10-Q captioned “PartII—Item 1A. Risk Factors”for additional information regarding the material factors that make aninvestment in our ordinary shares speculative or risky. These risks and uncertainties include, amongothers, the following: ●We have incurred significant losses since inception and anticipate that we will incurcontinued losses for the foreseeable future, and may never achieve or maintainprof