Rallybio is shedding weight for the next leg of its race, parting ways with 45% of its staff and focusing on its two phase 2-ready programs to extend its cash runway into the middle of 2026.
The biotech’s journey up to this point has featured twists and turns. Ten months ago, Rallybio eliminated its lead candidate and switched to a second-generation prospect aimed at the same opportunity, namely prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Another candidate, RLYB116, suffered a smaller setback late last year when Rallybio began focusing on manufacturing improvements.
Focusing on manufacturing, rather than powering into phase 2, extended Rallybio’s runway by around six months. Now, the biotech has found a way to get around nine months more out of the $109.9 million it had at the end last year.
The push to reduce spending is costing 19 people their jobs. Rallybio plans to complete most of the cuts by the end of the first quarter, triggering one-time charges of around $3.3 million but reducing its outgoings by enough to keep the lights on until mid-2026.
Rallybio’s focus is unchanged. The biotech plans to provide an update on talks with European regulators about a phase 2 study for its lead prospect, RLYB212, in the first half of the year, and to start a midphase trial in pregnant women at higher risk of FNAIT in the second half of the year.
Manufacturing improvements remain the priority for RLYB116. Results reported in December persuaded Rallybio that, while the data support further development in generalized myasthenia gravis, the tolerability of the candidate would need to improve to enable the higher doses required to unlock other indications. The biotech is “encouraged” by data on the potential for manufacturing to boost tolerability.
Rallybio still expects to complete manufacturing work and update the development plan for RLYB116 in the second half of the year. By then, the company should have preclinical data on the MTP-2 inhibitor it picked up from Sanofi and have made an update on the eye disease sibling to RLYB116. Rallybio’s alliances with AbCellera and Exscientia are scheduled to reach milestones in the second half of the year.
The new spending plan provides support for the preclinical programs through to the 2024 milestones. Beyond that, Rallybio will “seek alternative options ... including additional partnerships and other forms of non-dilutive financing” to push the programs forward.