Rallybio reins in preclinical R&D, while Monopar pivots to radiopharma to eke out cash

The need to stretch strained bank balances has hit pipelines once again. Rallybio and Monopar are the latest biotechs to rethink their spending, respectively stopping preclinical investment and pivoting to radiopharmaceuticals to stretch limited resources.

Rallybio shifted gears around 14 months ago, dropping its lead candidate for a second-generation asset in the same indication. The new lead candidate may be easier to deliver and manufacture but the switch delayed the biotech’s journey to a registrational trial. Since then, Rallybio has been shedding weight to free up financial fuel for its lead program.

Having laid off 45% of its workforce in February, the biotech revealed in its first-quarter earnings results that it has now decided to stop pumping cash into its preclinical pipeline. Rallybio said it continues to believe in the promise of the prospects but will look for external sources of funding such as partnerships to take the candidates forward.

The preclinical pipeline includes RLYB332, a long-acting version of RLYB331, an anti-Matriptase-2 antibody. Rallybio plans to present nonclinical data on a candidate it sees as a potentially best-in-class therapeutic for treating diseases of iron overload in the second half of the year.

Over at Monopar, management has completed the pivot to radiopharma. The modality wasn’t on the biotech’s roadmap when it went public in 2019. But a preclinical anti-uPAR antibody that sat at the back of its pipeline at the time of the IPO later emerged as an enabler of a strategic shift. By conjugating the antibody to radioisotopes, Monopar has created a radiopharmaceutical program.

With imaging and therapeutic opportunities on its plate, the biotech is dropping non-radiopharma assets including the phase 1b cancer candidate camsirubicin. Monopar ended March with just shy of $9 million, according to its own earnings release, a sum it forecasts will keep it going into at least next summer. Over that time, the biotech will continue to study its imaging asset in humans and move its first therapeutic radiopharmaceutical into the clinic. 

Monopar’s share price has rarely topped $1 over the past year, but the company used its radiopharma pivot to remind investors of the flurry of recent $1 billion-plus acquisitions by AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis in the space.

Elsewhere, RAPT Therapeutics is winding down two phase 2 trials recently placed on FDA clinical hold. The biotech reported in its first quarter earnings Thursday that it would close and unblind a phase 2a study testing zelnecirnon in patients with asthma and a phase 2b study in patients with atopic dermatitis. The hold was placed after a patient in the atopic dermatitis trial experienced liver failure, ultimately leading to organ replacement. The company first announced the holds in February, saying then that the cause was "characterized as potentially related to zelnecirnon." 

CEO Brian Wong, M.D., Ph.D., said in a release that the company still expects to have enough data to chart the drug’s path forward, even if they aren’t statistically significant. RAPT expects to finish its analysis of the data by the third quarter of the year, while continuing to investigate the adverse event. 

Editor's note: This story was updated to include details from RAPT Therapeutics' first quarter earnings.