Rallybio Corp 2025年季度报告

(Mark One) xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedMarch 31, 2025ORoTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________Commission File Number:001-40693_____________________________________ RALLYBIO CORPORATION Registrant’s telephone number, including area code: (203)859-3820_____________________________________ The NASDAQ Global Select Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during 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 filingrequirements for the past 90 days.YesxNoo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).YesxNoo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” inRule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with anynew or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YesoNox Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the SecuritiesExchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. YesxNoo As of May2, 2025, the registrant had41,613,964shares of common stock, $0.0001 par value per share, outstanding. Table of Contents Financial Statements7Unaudited Condensed Consolidated Balance Sheets7Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss8Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity9Unaudited Condensed Consolidated Statements of Cash Flows10Notes to Unaudited Condensed Consolidated Financial Statements11Management’s Discussion and Analysis of Financial Condition and Results of Operations21Quantitative and Qualitative Disclosures About Market Risk32Controls and Procedures32 PART II. Item 1.Legal Proceedings34Item 1A.Risk Factors34Item 2.Unregistered Sales of Equity Securities and Use of Proceeds84Item 5.Other Information85Item 6.Exhibits86Signatures87 Cautionary Note Regarding Forward-Looking StatementsThis Quarterly Report on Form 10-Q contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historicalfacts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identifyforward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,”“project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or othersimilar expressions, although not all forward-looking statements contain these words. Forward-looking statements include,but are not limited to, statements concerning: •the initiation, timing, progress, results, and cost of our research and development programs, and our current andfuture preclinical and clinical studies, including statements regarding timing of initiation and completion of ourclinical trials for RLYB116, and the natural history study in fetal and neonatal alloimmune thrombocytopenia, andrelated preparatory work, and the period during which the results of the trials will become available and the timingof initiation of preclinical and clinical development activities for REV102; •the success, cost and timing of the clinical development of our product candidates, including RLYB116; •the potential of our product candidates to treat certain target diseases; •our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace that we project; •our ability to obtain and maintain regulatory designations allowing for priority review of our product candidates,and our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions,limitations or warnings in the label of any of our product candidates, if approved; •our abili