Gameto, a clinical-stage biotechnology company developing stem-cell-derived therapies for reproductive health, has completed a $44 million Series C financing round, according to the company. The financing was led by Overwater Ventures and included participation from Insight Partners, RA Capital, Two Sigma Ventures, BOLD Capital Partners, Future Ventures, Ingeborg Investments, Arcadia Investment Partners, PAGS Group, Pontiva Healthcare Partners, Portfolia, and others.
With this funding, Gameto’s total capital raised now stands at $127 million, the company said that the round positions it to complete its ongoing Phase 3 trial for its lead program, Fertilo, and to pursue regulatory approvals globally. Fertilo, which uses engineered ovarian support cells derived from induced pluripotent stem cells (iPSCs), is already cleared for use in clinics across Peru, Mexico, Australia, Japan, India, Singapore, Guatemala, Argentina, Dominican Republic, and Paraguay. The company said that to date, Fertilo has resulted in five births and over 20 pregnancies.
Gameto claims that Fertilo is the first iPSC-derived therapy to reach late-stage clinical development in the United States and expects an interim readout from its randomized, controlled, double-blind Phase 3 study (FIRST) in late 2026.
Beyond Fertilo, the company said that it is developing menopause therapies through its Ameno program, which received funding from ARPA-H and includes both an implantable cell therapy and a vaginal ring, with the ring entering Phase 1 trials in the near future.
