WOBURN, MASSACHUSSETTS — Biotech startup Frequency Therapeutics has set a preliminary $100 million IPO target, according to paperwork filed with the US Securities Exchange Commission (SEC) on Friday. The company has applied for a Nasdaq listing under the stock symbol ‘FREQ’.
Frequency plans to use the money raised by the IPO to complete the Phase 2a trial of FX-322, a regenerative therapeutic for the treatment of sensorineural hearing loss and also to advance discovery programs in other therapeutic areas using its proprietary Progenitor Cell Activation (PCA) platform.
Promising Results for Hearing Restoration Candidate, FX-322
Frequency recently completed a Phase 1/2 clinical study in the U.S. in which FX-322 was observed to be well-tolerated following a single intratympanic injection, with no serious adverse events. Improvements in hearing function were observed in multiple FX-322 treated patients. Frequency plans to initiate a Phase 2a study in the fourth quarter of 2019.
FX-322 is a proprietary combination of small-molecule drugs designed to restore hearing function by activating inner ear progenitor cells already present in the body to induce hair cell regeneration. Sensorineural hearing loss is the result of damage to and/or loss of sensory hair cells in the inner ear. These inner ear hair cells do not spontaneously regenerate once damaged, although progenitor cells capable of regenerating hair cells remain present in the ear in an inactive state.
Frequency has already successfully raised $147M in equity financing and recently announced a collaboration agreement with Astellas Pharma Inc. for the global development and ex-US commercialization of FX-322, which included an $80 million upfront payment and $545 million in potential milestone payments.
About Progenitor Cell Activation
Frequency is pioneering a new class of small-molecule therapeutics designed to activate progenitor cells already present within the body to create healthy functional tissues and organs. This approach may bypass the challenges presented by stem cell therapies by temporarily reactivating progenitor cells already located at the tissue target site and pre-programmed to make specific cell types. Potential applications of its PCA platform include, but are not limited to, diseases of the muscle, gastrointestinal tract, skin, and bone.
About Frequency Therapeutics
Frequency Therapeutics is a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases. The approach, called Progenitor Cell Activation (PCA) uses combinations of small molecule drugs to activate progenitor cells within the body to create functional tissue. Through the transitory activation of these cells, Frequency aims to develop therapies that can enable disease modification without the complexity of genetic engineering. Frequency’s lead program, FX-322, is a potential first-in-class therapeutic candidate targeting hearing restoration.