- Alpine Immune Sciences, a privately held biotech based in Seattle, plans to combine with tiny Nivalis Therapeutics in a reverse merger that will give Alpine access to public markets plus an additional $17 million in funding stumped up by the company's original venture backers.
- The newly created company will be led by Alpine's current CEO, former Dendreon head Mitch Gold, and trade on the Nasdaq Global Market exchange. Both company's boards have approved the deal, which is expected to close in the third quarter.
- Nivalis has been searching for a new path forward since a mid-stage trial of its experimental cystic fibrosis drug failed in November 2016, leading to layoffs for much of the biotech's staff and the shuttering of further R&D. Current Nivalis shareholders will own approximately 26% of the combined company.
Mitch Gold rose to biotech stardom as head of cancer biotech Dendreon, helming the company during the development of Provenge (sipuleucel-T), a cell therapy which won U.S. approval for prostate cancer in 2010.
Dendreon struggled to market the drug, however, hamstrung by manufacturing challenges and new competition. Gold left the company in 2012 and Dendreon filed for bankruptcy two years later, marking a rapid demise for a company which had paved the way for many of the cell therapy efforts now in development across the industry.
After starting a venture fund in 2013, Gold launched Alpine Immune Sciences in 2015 and last year secured $48 million in Series A funding to advance development of Alpine's immune modulation platform.
Tuesday's reverse merger with Nivalis will boost Alpine's financial resources and give it access to public markets without the lengthy process of an initial public offering.
At close, the combined company will have roughly $90 million in cash and equivalents on its balance sheet, about $44 million of which comes from Nivalis.
"We have such a broad pipeline that we needed a strong balance sheet to be able to move those forward," said Gold in an interview. "This gave us the ability to move three programs forward into the clinic and gave us about three years of operating capital."
The first program, a dual ICOS/CD28 antagonist, is expected to enter Phase 1 clinical testing in the second half of 2018 for autoimmune and inflammatory-related conditions.
Alpine's platform is designed to modulate the body's immune response in both directions, increasing or decreasing activity.
"Alpine Immune Sciences is not just a single product company. We are a platform company," said Gold. "We have the ability to both amplify the immune system for products related to immuno-oncology. But we can also flip that coin on its head and dampen the immune system for products for inflammation."
Early on, Alpine signed a research and license deal with Kite Pharmaceuticals, granting Kite a license to two of its programs for use in further engineering CAR-T and TCR product candidates.
Gold indicated Alpine is also open to partnering on inflammation-focused programs as well, given the nature of Alpine's platform.
Once the merger closes, the combined company will operate under the Alpine Immune Sciences banner and will carry a different ticker than Nivalis' current NVLS.