Business
Rallybio Reports Third Quarter 2023 Financial Results and Provides Business Updates
-- RLYB212 Phase 1 Multiple Dose Cohort Complete and on Track for 4Q 2023 Data Release -- -- Initial Data from RLYB116 Phase 1 Multiple Ascending Dose Study
About this update from Rallybio Corporation
[{"type":"text","content":"\n-- RLYB212 Phase 1 Multiple Dose Cohort Complete and on Track for 4Q 2023 Data Release --\n\n\n-- Initial Data from RLYB116 Phase 1 Multiple Ascending Dose Study Including Safety, PK and PD on Track for 4Q 2023 Release --\n\n\n-- $121.4 million cash, cash equivalents and marketable securities as of September 30, 2023; Provides Runway into 1Q 2025 --\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB) today reported financial results for the third quarter ended September 30, 2023 and provided an update on recent program and corporate developments.\n\n\n“We are pleased with the continued progress across our portfolio in recent months, further demonstrating the ability of our team to efficiently advance clinical trials across diverse therapeutic areas. Prior to the end of 2023, we expect to finalize the toxicology package for RLYB212, our anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT), to support our planned Phase 2 and Phase 3 studies in pregnant women. In addition, we have completed the multiple dose cohort of our ongoing Phase 1 study for RLYB212 and have initiated regulatory discussions for RLYB212 to support the initiation of a Phase 2 dose confirmation study in pregnant women at higher risk for FNAIT. We also look forward to sharing more about the ongoing FNAIT natural history study at the upcoming American Society of Hematology Annual Meeting in December,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio.\n\n\nDr. Uden continued, “Our multiple ascending dose Phase 1 study for RLYB116, an inhibitor of complement component 5 (C5), remains on track and we expect to share initial data from this study, including our indication strategy, prior to the end of 2023. In parallel, we continue to advance our preclinical programs albeit with a focus on capital conservation and believe our existing capital will be sufficient to fund our operating expenses and capital expenditure requirements into the first quarter of 2025.”\n\n\nMaternal Fetal Blood Disorders\nRallybio expects to achieve the following milestones in the fourth quarter of 2023 for RLYB212, an anti-HPA-1a monoclonal antibody being developed for the prevention of FNAIT:\n\n\n\nFinalize toxicology package for RLYB212, including maternal-fetal toxicology to support our planned...