Rallybio Announces Q1 2024 Financial Results and Business Updates

Rallybio Corporation, a clinical-stage biotechnology company focusing on transformative therapies for rare diseases, shared its first quarter financial results for the period ending March 31, 2024, and provided updates on recent developments. Rallybio remains on its trajectory to initiate a Phase 2 dose confirmation trial for its drug RLYB212 in pregnant women at higher risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) by the second half of 2024.

Stephen Uden, M.D., Rallybio’s CEO, emphasized the promising start to the year and highlighted a recent collaboration with Johnson & Johnson. This partnership aims to advance awareness and screening for FNAIT, offering a potential treatment option for all pregnant women at risk, irrespective of their alloimmunization status.

Rallybio is also preparing to release initial data from an epidemiologic analysis assessing genetic markers for FNAIT risk in a diverse population, broadening the understanding beyond the Caucasian demographic. The findings, along with data from an ongoing FNAIT natural history study, will help ascertain the annual number of pregnant women at high risk and expand the market opportunity for RLYB212.

Key corporate updates include:
1. The collaboration with Momenta Pharmaceuticals, now a part of Johnson & Johnson, aimed at advancing therapeutic solutions for FNAIT.
2. A portfolio prioritization in February 2024 led to a 45% reduction in workforce, focusing resources on RLYB212 and RLYB116, which target FNAIT prevention and complement-mediated diseases, respectively.

For RLYB212, the Phase 2 trial will assess the pharmacokinetics and safety of the drug when administered subcutaneously to pregnant women, starting from Gestational Week 16 and continuing every four weeks through to childbirth. The ongoing FNAIT natural history study has already screened around 10,000 pregnant women as of May 1, 2024, aiming to provide contemporary datasets on HPA-1a alloimmunization frequency.

To better understand the prevalence of HPA-1a-negative, HLA-DRB3*01:01-positive status in diverse populations, Rallybio has partnered with HealthLumen for a comprehensive epidemiological analysis, with results expected by mid-2024. Several presentations and publications are anticipated in the latter half of 2024, highlighting data from the Phase 1b proof-of-concept study and other supporting data for the RLYB212 Phase 2 dose.

For RLYB116, the manufacturing process remains on schedule for completion in the second half of 2024, alongside ongoing biomarker development work. An update on these developments is expected later in the year.

In the preclinical programs, Rallybio continues to explore options to advance its projects, including potential partnerships and non-dilutive financing. Notably, nonclinical studies for RLYB332, an improved version of the RLYB331 anti-Matriptase-2 antibody, have shown favorable results. Additionally, a collaboration with EyePoint is working on sustained delivery methods for Rallybio’s C5 inhibitor.

Financially, Rallybio reported a mild increase in research and development expenses to $12.9 million for Q1 2024, primarily due to severance costs tied to workforce reduction. General and administrative expenses slightly decreased to $6.9 million. The company faced a net loss of $19.0 million, translating to a $0.47 loss per common share. As of March 31, 2024, Rallybio held $94.2 million in cash, cash equivalents, and marketable securities, providing financial runway into mid-2026.

Rallybio's mission is to develop and commercialize treatments for severe and rare diseases, with a strong focus on maternal-fetal health, complement dysregulation, hematology, and metabolic disorders. The company's headquarters are in New Haven, Connecticut.