On April 29, 2019 Precision BioSciences, a genome editing company dedicated to improving life (Nasdaq: DTIL) ("Precision") through the application of its proprietary ARCUS genome editing platform, reported financial and corporate results for the first quarter 2019 and provided an overview of recent accomplishments and upcoming events (Press release, Precision Biosciences, APR 29, 2019, View Source [SID1234535619]).
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Key Highlights and Recent Developments
Executed private financing and initial public offering (IPO) on Nasdaq for combined net proceeds to Precision of over $170 million
Bolstered Board of Directors with addition of Raymond Schinazi, PhD
Initiated patient dosing for Phase 1/2a clinical trial of off-the-shelf CAR T cell therapy
"The first quarter was truly transformative for Precision BioSciences, as we completed our successful initial public offering, further strengthening our ability to deliver on the promise of ARCUS genome editing," said Matt Kane, Chief Executive Officer and co-founder. "Since the completion of our IPO, we have transitioned to a clinical stage company with the dosing of the first patient in a Phase 1/2a clinical trial of our lead allogeneic CAR T therapy, targeting CD19 for the treatment of non-Hodgkin lymphoma and acute lymphoblastic leukemia. We believe our team and technology have the potential to bring meaningful benefits to the lives of many."
On March 27th, the Company priced the initial public offering of its common stock, which was underwritten by J.P Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays who served as joint book-running managers for the offering. The IPO closed on April 1, 2019 with gross proceeds to Precision of $145.3 million before underwriting discounts, commissions and offering costs. Precision issued 9,085,000 shares of common stock, inclusive of the underwriters’ overallotment option, at an offering price of $16.00 per share. The IPO was preceded by a private convertible financing of approximately $40 million. Following the closing of the IPO, Precision had approximately 50.4 million shares of common stock outstanding, including shares of preferred stock and convertible promissory notes that converted into common stock.
Earlier in the quarter, on March 14th, the Company appointed Raymond Schinazi, PhD, Hon DSc to its board of directors. Dr. Schinazi is the Frances Winship Walters Professor of Pediatrics and director of the Laboratory of Biochemical Pharmacology at Emory University. A world leader in nucleoside chemistry, he is best known for his pioneering work on HIV, HBV, and HCV drugs d4T (stavudine, Zerit), 3TC (lamivudine, Epivir), FTC (emtricitabine, Emtriva), LdT (telbivudine, Tyzeka), and sofosbuvir (Sovaldi), which are all approved by the US FDA and the EMEA. More than 94% of HIV-infected individuals in the US on combination therapy take at least one of the drugs he invented, and he has founded or co-founded several pharmaceutical companies, including Triangle Pharmaceuticals, Idenix Pharmaceuticals, and Pharmasset, Inc.
Recently, on April 17th, Precision initiated patient dosing in the Phase 1/2a clinical trial of an allogeneic CAR T cell therapy program, PBCAR0191, which is being evaluated in adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) as an off-the-shelf CAR T cell therapy. Precision believes this is the first U.S.-based clinical trial to
evaluate an allogeneic CAR T cell therapy for NHL. PBCAR0191 is made from donor-derived T cells that are modified using Precision’s ARCUS genome editing technology. These edits are designed to generate CAR T cells that specifically recognize CD19, an important target in several B-cell cancers, and to prevent graft-versus-host disease, a significant complication associated with existing donor-derived cell-based therapies.
Upcoming Events
22nd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29 – May 2, 2019
Jefferies U.S. Healthcare Conference, June 4 – 7, 2019
Goldman Sachs 40th Annual Global Healthcare Conference, June 11 – 13, 2019
Raymond James Life Sciences & MedTech Conference, Jun 18 – 19, 2019
First Quarter 2019 Financial Results
Revenues: Total revenues for the quarter ended March 31, 2019 were $5.5 million, compared to $1.5 million for the quarter ended March 31, 2018. This increase was primarily related to research funding from our joint development collaboration partners.
Research and Development Expenses: Research and development expenses were $19.9 million for the first quarter of 2019, as compared to $8.1 million for the same period in 2018. This increase of $11.8 million was primarily due to increases in direct research and development expenses including contract manufacturing costs, as well as an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities.
General and Administrative Expenses: General and administrative expenses were $5.0 million for the first quarter of 2019, as compared to $2.6 million for the same period in 2018. The increase of $2.4 million was primarily due to additional personnel and facility costs associated with our growing infrastructure needs.
Net Loss: Net loss was $31.8 million, or $1.99 per share, for the first quarter of 2019, compared to a net loss of $9.0 million, or $0.57 per share, for the same period in 2018.
Cash and Cash Equivalents: As of March 31, 2019, Precision had approximately $116.5 million in cash and cash equivalents, including proceeds of approximately $40 million from a private convertible financing and excluding the net proceeds of $130.9 million from Precision’s IPO. Precision expects that existing cash and cash equivalents, together with the net proceeds from the IPO, will be sufficient to fund its operating expenses and capital expenditure requirements through 2020.