RLYB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• We are a clinical-stage biotechnology company comprised of experienced biopharma industry leaders with extensive research, development, and rare disease expertise with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Our lead program, RLY…

• On March 1, 2026, Rallybio Corporation and subsidiaries ("Rallybio", the "Company", "we", "our", or "us") entered into an Agreement and Plan of Merger and Reorganization with Candid Therapeutics, Inc ("Candid") (the "Merger Agreement") pursuant to which the parties intended to undertake a business c…

• On May 3, 2026, Candid terminated the Merger Agreement concurrently with entering into a Permitted Alternative Agreement (as defined in the Merger Agreement) with UCB S.A. (“UCB”). As a result of the termination of the Merger Agreement, we were paid on May 4, 2026 a $50.0 million Parent Termination …

• We completed a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers in 2025 and reported data in the first quarter of 2026.

• In July 2025, we entered into a Membership Interest Purchase Agreement (the “ENPP1 Purchase Agreement”) with Recursion Exscientia Ventures I, Inc., an indirect wholly-owned subsidiary of Recursion (“Buyer”) and Rallybio IPB, LLC, a wholly-owned subsidiary of Rallybio Corporation to sell our interest…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are a clinical-stage biotechnology company comprised of experienced biopharma industry leaders with extensive research, development, and rare disease expertise with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Our lead program, RLY…

• RLYB116 is a novel, potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. We intend to initially focus on two hematologic conditions with significant unmet need including: immune platelet transfusion refractori…

• We have completed a Phase 1 clinical study in healthy participants that included the study of RLYB116 as a single ascending dose ("SAD") and a multiple ascending dose ("MAD"). The SAD portion of the RLYB116 clinical study included five cohorts with a dose ranging from 2mg up to 300mg. Data from the …

• The MAD portion of the RLYB116 Phase 1 study included an adaptive single-blind design with a 4-week treatment duration to evaluate the safety, tolerability, PK, and PD of RLYB116 with multiple dose SC

• administration. The MAD portion of the study included four cohorts: Cohort 1 (weekly dosing of 100 mg), Cohort 2 (three doses of 100 mg the first week followed by weekly dosing), Cohort 3 (150 mg weekly dosing reduced to 125 mg weekly dosing) and Cohort 4 (75 mg twice the first week followed by 100 …

Text added vs the prior filing · source: 10-Q · 2026-05-13

• carryforwards to offset future taxable income. Some of our historical NOLs may be subject to annual limitations on our ability to use them due to prior ownership changes. Additionally, we may experience such ownership changes in the future as a result of future transactions in our stock, some of whi…

• Before obtaining marketing approval from the FDA, EMA or other comparable regulatory authorities for the sale of our product candidates, we must complete preclinical studies and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. To initiate clinical trials fo…

• If we continue to progress the development of our product candidates, we may experience events that could delay or prevent our ability to complete current clinical trials or initiate and complete new trials, any of which may impact our product development timelines, result in increased costs, affect…

• will support the safety and efficacy requirements sufficient to obtain regulatory approval, and, as a result, our clinical development plans may be materially harmed.

• We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation of marketing approval based on preclinical studies or early-stage clinical trials. Even if the side effects do not preclude the drug from obtaining or maintaining marketing …

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• ▪our ability to maintain our collaboration with AbCellera on favorable terms and establish new collaborations;

• further limited. For these reasons, we may not be able to use a material portion of our NOLs or tax credit carryforwards, even if we attain profitability.

• Before obtaining marketing approval from the FDA, EMA or other comparable regulatory authorities for the sale of our product candidates, we must complete preclinical studies and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. To initiate clinical trials fo…

• along with other information, including information about CMC and our proposed clinical trial protocol, as part of an IND or similar regulatory filing that must be accepted by the FDA, EMA or other applicable regulatory authorities before we may proceed with clinical development. In the event that r…

• We may experience events that could delay or prevent our ability to complete current clinical trials or initiate and complete new trials, any of which may impact our product development timelines, result in increased costs, affect our ability to obtain marketing approval according to our plans, and …