Aerpio Pharmaceuticals And Aadi Biosciences Enter Merger

Aerpio Pharmaceuticals Inc. (“Aerpio”) (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that cause Tie2, and Aadi Bioscience, Inc. (“Aadi”), a privately-held biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in the mTOR pathway genes, have announced the signing of a definitive merger agreement.

Aerpio’s name will be changed to “Aadi Bioscience, Inc.” following the planned acquisition, and the combined public entity will concentrate on promoting Aadi’s lead product candidate, FYARRO. Aerpio Pharmaceuticals has entered into subscription agreements with Acuta Capital Partners and KVP Capital, and Avoro Capital Advisors to raise $155 million in Private Investment in Public Equity (PIPE) funding to fund the merger.

The PIPE funding is supposed to be completed at the same time as the merger closes. The proceeds from the PIPE funding will be used to commercialize FYARRO in advanced malignant PEComa. A planned tumor-agnostic registrational trial will occur in solid tumors with inactivating mutations in the mTOR pathway genes TSC1 and TSC2, scheduled to begin by the end of 2021.

Advanced malignant PEComa, Aadi’s first symptom, is an ultra-rare sarcoma with TSC1 and TSC2 alterations. The FDA has given Aadi Orphan Drug Designation, Fast Track Designation, and Breakthrough Therapy Designation for FYARRO, a treatment for advanced malignant PEComa.

When combined with cash anticipated from both companies at closing, the net proceeds of the PIPE funding are expected to finance the business through 2024. This will allow for future approval and commercial launch in PEComa. It will be a completion of a registrational trial in tumors harboring TSC1 or TSC2 inactivating alterations.