Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) and Histogen Inc., a privately-held regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, today announced the companies have entered into a definitive agreement under which Histogen will merge with a wholly-owned subsidiary of Conatus in an all-stock transaction. The combined company will operate under the name Histogen, Inc., is expected to trade on the Nasdaq Capital Market under a new ticker symbol still to be determined and will focus on advancement of its patented technology for dermatological and orthopedic indications.
“After completing a comprehensive review of multiple strategic alternatives, we determined that the proposed merger with Histogen would provide the best opportunity for Conatus shareholders moving forward,” said Steven J. Mento, Ph.D., President, Chief Executive Officer and co-founder of Conatus. “We believe that Histogen’s clinical-stage dermatological and orthopedic product development programs, under the continued guidance of the established Histogen senior management team, offer significant potential to drive future value for the combined company.”
Histogen has built a pipeline of novel product candidates with demonstrated clinical activity that target high value markets. Its lead product candidate, HST 001 or Hair Stimulating Complex (HSC), is a minimally-invasive treatment to promote new hair growth in patients with male pattern hair loss, addressing an underserved multi-billion-dollar global market. In addition, Histogen is developing HST 002, a human-derived collagen and extracellular matrix dermal filler, and HST 003, an extracellular matrix scaffold for the treatment of articular cartilage defects. Histogen expects all three product candidates to reach clinical and regulatory inflection points in 2020.
“This merger is transformative for Histogen as we look to advance our novel regenerative medicine pipeline,” said Richard Pascoe, Chairman and CEO of Histogen. “We believe the target product profile of our product candidates combined with their market potential provides an opportunity for Histogen to become a leader in the aesthetics and orthopedic medicine markets.”
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Histogen currently anticipates meeting the following upcoming development milestones:
- File an Investigational New Drug Application Amendment in Q2 2020 and initiate a Phase 1b/2a study of HST 001 for the treatment of male pattern baldness in Q2 2020.
- File an Investigational Device Exemption in Q2 2020 and initiate a Phase 1 study of HST 002 as a dermal filler in Q2 2020.
- File an Investigational New Drug Application in Q3 2020 and initiate a Phase 1 study of HST 003 for the treatment of articular cartilage defects in the knee in Q3 2020.
- Announce top-line results from Phase 1 study of HST 002 for the treatment of nasolabial folds in Q3 2020.
- Announce top-line results from Phase 1b/2a study of HST 001 for the treatment of male pattern baldness in Q4 2020.
Histogen’s pipeline is derived from a single patented manufacturing process that yields multiple biologic products from a single bioreactor. Histogen’s first aesthetic application, a naturally secreted cell conditioned media ingredient for topical skin care products, is marketed by leading global biopharmaceutical company Allergan plc within its SkinMedica A+ brand.
Source: BioSpace
