Histogen Announces Investigational Device Exemption Application

Histogen Inc. recently announced it has submitted an Investigational Device Exemption (IDE) application with the US FDA for the initiation of a Phase 1 clinical trial of HST 002 for the treatment of facial folds and wrinkles.

HST 002 is a naturally produced collagen and extracellular matrix dermal filler targeting the treatment of facial folds and wrinkles. The planned Phase 1 clinical trial is designed to assess the safety and tolerability of HST 002, as well as look for early indications of efficacy versus a placebo control.

“The submission of this Investigational Device Exemption for HST 002 is an important milestone for Histogen as we continue to advance our development pipeline following the recent submission of our Investigational New Drug Application Amendment for HST 001 for hair loss,” said Richard W. Pascoe, Histogen’s Chairman and Chief Executive Officer. “We look forward to moving both of these assets into the clinic following FDA acceptance of these applications. Moreover, we look forward to completing our previously announced merger with Conatus Pharmaceuticals, which is on track to close in the second quarter of this year.”

If successful, HST 002 would be novel in the dermal filler market as it is composed of all-human and naturally produced collagen with dermal matrix proteins with the potential to reduce the risk of inflammation. In addition to clinical development of HST 002, Histogen recently announced the filing of an IND amendment for its lead product for hair loss (HST 001) and the anticipated IND filing for its joint cartilage regeneration (HST 003) product candidate in 2020.

On January 28, 2020, Histogen announced that it entered into a definitive agreement with Conatus Pharmaceuticals Inc. pursuant to which Histogen will merge with and into a wholly owned subsidiary of Conatus in an all-stock transaction. The combined company is expected to operate under the name Histogen Inc., and after closing, the combined company is expected to change its trading symbol to HSTO and trade on the Nasdaq Capital Market, and to focus on advancement of its patented technology for dermatological and orthopedic indications.

Under the terms of the merger agreement, pending stockholder approval of the transaction, Histogen will merge with a wholly owned subsidiary of Conatus, and Histogen stockholders will receive newly issued shares of Conatus common stock. The exchange ratio used to determine the number of shares of Conatus common stock issuable to Histogen stockholders pursuant to the merger will be determined using a pre-transaction valuation of $100 million for Histogen’s business, based on its latest priced investment round and clinical pipeline advancement, and $35.135 million for Conatus’ business, an approximately 155% premium to the 20-day volume weighted average closing share price of Conatus common stock prior to the announcement date on the Nasdaq Capital Market. As a result, current Conatus stockholders will collectively own approximately 26%, and Histogen stockholders will collectively own approximately 74%, of the combined company on a fully-diluted basis, after taking into account Histogen’s and Conatus’ outstanding options and warrants at the time of closing, irrespective of the exercise prices of such options and warrants, with such ratio subject to adjustment based on each company’s net cash balance at closing.

The combined company, led by Histogen’s current management team, will be named Histogen Inc. and be headquartered in San Diego, CA. After closing, the combined company is expected to change its trading symbol to HSTO and trade on the Nasdaq Capital Market. At closing, the combined company’s board of directors is anticipated to consist of eight members, including six members of Histogen’s current board and two members of Conatus’ current board. The merger agreement has been unanimously approved by the board of directors of each company, who have also recommended to their respective company’s stockholders that they approve the merger agreement, the merger and, with respect to Conatus’ stockholders, a reverse stock split. The merger is expected to close by the end of the second quarter of 2020, subject to approvals by the stockholders of Histogen and Conatus, a reverse stock split being implemented by Conatus, the continued listing of the combined company on Nasdaq and other customary closing conditions.

A more complete description of the terms of and conditions of the merger can be found in Conatus’ Form 8-K filed on January 28, 2020 with the SEC and in the Merger Agreement, which is filed as an exhibit to that Form 8-K.

Histogen is a regenerative medicine company developing patented technologies that replace and regenerates tissues in the body. The company’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells, developing therapeutic products that address underserved, multi-billion US dollar global markets. For more information, visit www.histogen.com.

Conatus is a biotechnology company that had been focused on the development of novel medicines to treat chronic diseases with significant unmet need. For more information, please visit www.conatuspharma.com.