Rallybio to begin RLYB212 study in 2H, cash runway extended into Q3

Rallybio (RLYB) provided an update on recent accomplishments and announced expected 2024 milestones. The Company will present these updates at the 42nd Annual J.P. Morgan Health Care Conference in San Francisco, California on Wednesday, January 10. “Over the past twelve months we made significant progress towards building a broad and sustainable pipeline of transformative therapeutics for rare diseases with severe unmet needs,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “In 2023, we announced encouraging Phase 1 results for our lead program, RLYB212, for the prevention of fetal and neonatal alloimmune thrombocytopenia, as well as for RLYB116, our C5 inhibitor. In parallel, we completed critical work on our earlier stage pipeline programs while carefully managing our expenses.” “We are committed to building on this momentum in 2024. We remain on track to initiate a Phase 2 study for RLYB212 in the second half of 2024 to confirm the dose regimen for RLYB212 in pregnant women at higher risk for FNAIT. Furthermore, we believe RLYB116 is a promising drug candidate that has the potential to address an unmet need for patients by delivering a more convenient once-a-week self-administered therapy, and our earlier stage programs are expected to reach important milestones in 2024. We are also pleased that through careful management of our cash, our current cash runway guidance has been extended into the third quarter of 2025. We expect to have additional updates to our plans and cash runway before the end of the first quarter.”..Rallybio expects to provide an update on Phase 2 discussions with the European Medicines Agency EMA for RLYB212, a novel human monoclonal anti-HPA-1a antibody in development for the prevention of fetal and neonatal alloimmune thrombocytopenia FNAIT , in the first half of 2024. …Rallybio, together with its partner AbCellera (ABCL), are focused on the discovery, development, and commercialization of novel antibody-based therapeutics for rare diseases. The partnership’s first discovery program is focused on identifying a novel treatment for patients with rare metabolic diseases. Cash, cash equivalents, and marketable securities were $121.4M as of September 30, 2023. The Company currently expects its cash runway to extend into the third quarter of 2025.