Rallybio Prioritizes Portfolio and Reduces Workforce by 45 Percent

Rare Daily Staff

Rallybio said it is cutting its workforce by 45 percent as it focuses resources on its phase 2-ready clinical stage programs, RLYB212 for the prevention of FNAIT and RLYB116, a C5 inhibitor for the treatment of patients with complement-mediated diseases.

The company will eliminate 19 positions. Rallybio estimates that the workforce reduction will result in aggregate charges of approximately $3.3 million, primarily for one-time employee severance and benefit costs and excluding share-based compensation expense.

The revised operating plan will fund preclinical program activities to important 2024 milestones, after which Rallybio will seek alternative options to further advance these programs, including additional partnerships and other forms of non-dilutive financing.

Based on the actions it is taking, Rallybio expects to fund its revised operating plan into mid-2026. As of December 31, 2023, the company had approximately $109.9 million in cash, cash equivalents, and marketable securities.

RLYB212 is a novel human monoclonal anti-HPA-1a antibody in development for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT), and RLYB116 is a once-weekly, low volume subcutaneously injected inhibitor of complement component 5 (C5) in development for patients with complement-mediated diseases. With these changes, Rallybio expects to extend its cash runway into mid-2026.

“Following a thorough review of our business, we have made the decision to prioritize our portfolio. We believe that these difficult but necessary decisions to streamline our operations and align resources are critical to extend our cash runway, support the advancement of our two clinical-stage programs, and put us on a path toward long-term success,” said Stephen Uden, CEO of Rallybio.

Rallybio expects to initiate a phase 2 dose confirmation study for RLYB212 in pregnant women at higher risk of FNAIT in the second half of 2024 and continues to screen mothers in the FNAIT natural history alloimmunization study, a non-interventional study designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. Rallybio expects to provide an update on screening numbers in its full-year earnings release in March 2024.

The company says it is encouraged by data indicating the potential to achieve improved tolerability at higher doses of RLYB116. While the exposure levels of RLYB116 demonstrated in the Phase 1 study are expected to be suitable for the treatment of patients with generalized myasthenia gravis, Rallybio believes the ongoing enhancements will enable higher exposure to RLYB116, supporting the treatment of patients with a broader range of complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria and antiphospholipid syndrome.

Photo: Stephen Uden, CEO of Rallybio