Passage Bio, the Philadelphia-based gene therapy outfit that launched a strategic review earlier this year after tough feedback from the FDA, has found an exit in an all-stock reverse merger with RNA specialist Remix Therapeutics.
Should the merger go through, Passage Bio shareholders will own 7% of the combined company, which will keep the Remix name. The proposed merger was announced in conjunction with an approximately $100 million private placement, and grants Remix a place on the Nasdaq under the ticker $RMTX.
“This transaction is transformative as it positions Remix to lead in the new category of RNA targeted therapeutics, advance a differentiated clinical pipeline and deliver important milestones in the near and midterm,” Remix co-founder and CEO Peter Smith, Ph.D., said in a Wednesday conference call.
Passage launched a strategic review in May after the FDA disapproved of the biotech’s plan for a single-arm trial of its gene therapy candidate for frontotemporal dementia, PBFT02. The review was paired with a major layoff round that saw the company pare back its workforce by 75%.
The remixed Remix should have enough cash to last into 2028, William Chou, Ph.D., Passage Bio’s CEO, said during the call.
“This all-stock transaction represents an important moment for Passage shareholders and follows a comprehensive evaluation of strategic alternatives by our board of directors,” Chou said. “We are excited to enter into this merger and look forward to the progress of the combined company under the dedicated and talented Remix leadership team.”
Smith will retain his role as CEO once the merger closes, he said during the call.
Remix’s approach is to use small molecules to tinker with RNA, with its lead candidate, REM-422, meant to degrade the RNA that codes for a transcription factor called MYB, which is implicated in numerous cancers but has long been considered undruggable. Remix’s candidate has generated “preliminary clinical data demonstrating excellent therapeutic potential,” Chou said.
REM-422 is currently in a pair of clinical trials, Smith added, a phase 1/2 study in adenoid cystic carcinoma (ACC) and a phase 1 test in acute myeloid leukemia and high-risk myelodysplastic syndromes. The biotech hopes to have data from the phase 2 portion of the ACC trial in mid-2027, the CEO said, while the other trial is currently enrolling.
Remix also plans to put forth another mRNA degrader next year, this one targeting another transcription factor called MYC, Smith said.