Patent Lawsuit Against Histogen Forces Layoffs And A Scramble For New Funding

A patent infringement lawsuit filed last month against Histogen has triggered a funding crisis at the San Diego biomedical startup, which was forced to lay off all 36 of its employees at the end of January.

Histogen founder and CEO Gail Naughton told me this afternoon the suit filed by rival SkinMedica of Carlsbad, CA, prompted a group of angel investors to withdraw their planned $2.4 million investment in Histogen at the end of January. The ensuing funding crisis has been playing out behind the scenes at Histogen, even while Naughton reported promising findings on the startup’s experimental hair regrowth treatment last week at the 4th Annual Stem Cell Summit in New York.

“The lawsuit really took us by surprise, particularly because it was an infringement suit that was filed when we don’t even have a product on the market,” Naughton told me. “It really cut us off at the knees.”

Since then, Naughton says she has been working on two fronts to find new funding for Histogen. But losing the early stage funding, which had been set to close on Jan. 29, necessitated the immediate layoff of all Histogen employees, she said. About 20 employees have volunteered to continue working despite the layoffs, which were first reported today by The San Diego Union-Tribune.

“I’m not trying to take advantage,” Naughton told me. “They are an unbelievably engaged and passionate group of people who really believe in what we’re doing, and I’m very grateful.”

Privately held SkinMedica provides both prescription-based and cosmetic skin-care products to dermatologists and others to improve the health and appearance of skin. SkinMedica’s suit alleges that Naughton, Histogen, and its cosmetics subsidiary, Histogen Aesthetics, are infringing on two SkinMedica patents covering its “NouriCel” product line and related proprietary technology for culturing human cells in growth media. SkinMedica acquired the patents in 2003 from Naughton’s previous company, San Diego-based Advanced Tissue Sciences, which filed for bankruptcy in 2002 after spending 14 years developing living tissue skin patches.

Naughton denied that Histogen or its subsidiary are infringing on SkinMedica’s patents.

Naughton says she’s been meeting over the past four weeks with a whole new group of investors, whose primary interest is in the potential use of ReGenica, Histogen’s lead product in development, as a hair regrowth product. Histogen says ReGenica is made from proteins and other molecules secreted by human fibroblast cells grown in proprietary bioreactors that mimic the embryonic environment. Last week, Naughton reported early results from a clinical trial that suggests that injecting ReGenica into the scalp promotes hair growth. She says she also has been having simultaneous discussions with four pharmaceutical companies about forming a partnership to help bring certain Histogen products to market.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.