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News

Histogen Publishes New Preclinical Data On Its HST 003 Orthopedic Program

Author: Benzinga Newsdesk | April 15, 2020 08:05am

SAN DIEGO, April 15, 2020 (GLOBE NEWSWIRE) -- Histogen Inc., a regenerative medicine company with a novel biological platform that replaces and regenerates tissues in the body, announced today the publication of data on its human extracellular matrix (hECM) for cartilage regeneration in the Journal of Orthopaedic and Trauma Care.
 

Histogen has developed a patented embryonic-like hECM that contains components associated with stem cell niches in the body and scar-less healing of fetal skin including laminins, osteonectin, decorin, hyaluronic acid, collagen type IV, SPARC, CXCL12, NID1, NID2, NOTCH2, tenascin, thrombospondin, fibronectin, versican, and fibrillin-2. In vitro studies have demonstrated that HST 003 induces the proliferation of human mesenchymal stem cells (hMSCs) while retaining their stemness and causing them to down regulate collagen 1 and up regulate aggrecan, both important characteristics of forming hyaline cartilage.

"We have now tested HST 003 in three animal models, and the results have been consistent and exciting," said Dr. Gail Naughton, Founder and Chief Science Officer of Histogen. "The stimulation of native stem cells to infiltrate the cartilage defect and differentiate, the reduction of local inflammation, and the regeneration of hyaline cartilage and mature bone was clearly demonstrated."

In vivo preclinical studies showed that treating full thickness osteochondral lesions with HST 003 resulted in hyaline cartilage and mature bone formation in rats (O'Driscoll score p<0.001), and rabbits (p<0.001). Similar results were seen in the large defect goat model, where the untreated lesions showed only scar tissue and hECM treated defects had excellent regeneration with normal tissue.

"The results seen in these latest preclinical studies support the advancement of our key HST 003 program," said Richard Pascoe, Chairman and CEO of Histogen. "We look forward to the submission of our IND to study HST 003 in the regeneration of focal cartilage lesions in the knee, which we anticipate will be in Q3 2020."

Approximately 18 million U.S. patients suffer from knee osteoarthritis, a debilitating degenerative disease characterized by softening and disintegration of cartilage. For these patients, as well as the one million experiencing acute cartilage injury, a treatment with the ability to restore hyaline cartilage, accelerate recovery and improve long-term surgical results could be revolutionary.

The research paper entitled "Extracellular Matrix Regenerative Treatment for Cartilage Repair" has been published in Volume 2, Issue 1 of Journal of Orthopaedic and Trauma Care, and is currently available electronically at https://escientificpublishers.com/extracellular-matrix-regenerative-treatment-for-cartilage-repair-JOTC-02-0007.

Histogen's Planned Merger with Conatus Pharmaceuticals

On January 28, 2020, Histogen announced that it entered into a definitive agreement with Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) 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.

About Histogen

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, please visit www.histogen.com.

About Conatus Pharmaceuticals

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

Posted In: CNAT