Precision BioSciences Plans $100M IPO

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Durham-based Precision BioSciences, a genome-editing company focused on creating better foods and medicines, wants to raise up to $100 million in an initial public offering (IPO) of stock.

In a March 1 registration statement filed with the U.S Securities and Exchange Commission, the company said it would use proceeds from the IPO to advance and expand its clinical and preclinical development programs and build out its planned manufacturing facility, compliant with current Good Manufacturing Practices (cGMP) set by U.S. Food and Drug Administration (FDA).

The company’s common shares would be traded on the Nasdaq Global Market under the symbol DTIL. No pricing terms were disclosed.

Platform has broad applications

Precision, which has about 125 employees, has developed a genome-editing platform called ARCUS that has applications in food, agriculture and health care. Its lead therapeutic product candidate is a cancer immunotherapy for two types of blood cancer: B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma.

The company received authorization from the FDA last year to begin a study of the therapy, known as an allogeneic anti-CD19 CAR T therapy. A Phase 1/2a clinical trial of the therapy is expected to begin in the first half of this year in patients with acute lymphoblastic leukemia and non-Hodgkin lymphoma.

Precision is also developing an in vivo gene-correction platform for addressing various genetic diseases.

Last year the company created a new name and brand identity, Elo Life Systems, for its food and agriculture business. Elo will use the ARCUS platform and other new technologies for applications in crop improvement, animal genetics, industrial biotechnology and sustainable agriculture.

Major deals signed with Gilead, Servier

Precision signed a collaboration agreement with Gilead Sciences, a pharmaceutical company based in Foster City, Calif., last year to develop genome editing-tools using ARCUS to target viral DNA associated with the hepatitis B virus. Precision is entitled to receive up to about $40 million in research funding from Gilead over an initial three-year term and milestone payments of up to $445 million, along with tiered royalties on worldwide net sales of products developed.

Precision also signed a collaboration agreement in 2016 with Servier, an international pharmaceutical company based in Suresnes, France. Servier will use ARCUS to developallogeneic chimeric antigen receptor T cell therapies for up to six unique antigen targets.

Precision received an upfront payment of $105 million from Servier and could receive up to $1.5 billion more in milestone payments, in addition to tiered royalties on worldwide net sales of any products developed.

Since it was spun out of Duke University in 2006, Precision has raised about $300 million in venture capital, government grants and collaboration agreements.

Preferred stock investors include venBio, F-Prime, ArrowMark Partners, Franklin Templeton, Cowen Healthcare, Gilead, Brace Pharma, Portfax AgTech, OCV Partners, Adage Capital, RA Capital, Amgen Ventures, Vivo and Ridgeback Capital, among others.

Last November, Precision won recognition at the SEBIO Investor and Partnering Forum in Atlanta for best venture funding deal after securing $110 million in Series B financing earlier that year.

Scientific advisory board established

In January the company announced the formation of its scientific advisory board with four key appointments: Kenneth C. Anderson, M.D., Hagop Kantarjian, M.D., Raymond Schinazi, Ph.D., D.Sc., and Cameron Turtle, MBBS, Ph.D. The four advisors have expertise in hematological malignancies, immuno-oncology and infectious disease with demonstrated success guiding innovative new therapies through clinical development and FDA approval.

Anderson is the program director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at the Dana-Farber Cancer Institute and Kraft Family Professor of Medicine at Harvard Medical School.

Kantarjian is chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, where he is also the Samsung Distinguished Leukemia Chair in Cancer Medicine.

Schinazi is the Frances Winship Walters Professor of Pediatrics and director of the Laboratory of Biochemical Pharmacology at Emory University.

Turtle is an Associate Member at Fred Hutchinson Cancer Research Center, an Associate Professor at the University of Washington and an attending physician on the Immunotherapy Service and Hematopoietic Stem Cell Transplant Service at the Seattle Cancer Care Alliance.

Barry Teater, NCBiotech Writer
Tue, 03/05/2019 - 09:05