On May 20, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results for the quarter ended March 31, 2020 (Press release, ORIC Pharmaceuticals, MAY 20, 2020, View Source [SID1234558325]).
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"Throughout 2019 and the first quarter of 2020, we made substantial progress across all aspects of our business, including important advancements with respect to our programs, people and funding," said Jacob Chacko, president and chief executive officer. "With the success of our recently completed initial public offering and key additions to our leadership team over the last eighteen months, ORIC is well-positioned to execute our strategy of developing a broad pipeline of novel treatments that address mechanisms of therapeutic resistance in cancer."
First Quarter 2020 and Other Recent Highlights
First Patient Dosed in ORIC-101 Phase 1b Combination Trial for Prostate Cancer: In January 2020, ORIC announced the dosing of its first patient in a Phase 1b clinical trial being conducted under a collaboration with Astellas Pharma, Inc., to evaluate the combination of ORIC-101 with XTANDI (enzalutamide) as a treatment for patients with metastatic prostate cancer that is progressing on enzalutamide. This marked ORIC’s second Phase 1b clinical trial of ORIC-101, following the initiation in 2019 of a Phase 1b trial of ORIC-101 in combination with Abraxane (nab-paclitaxel) in patients with solid tumors.
Preclinical Data on CD73 Inhibitor Program Presented at AACR (Free AACR Whitepaper): In April 2020, ORIC presented research that led to the discovery of ORIC-533, an orally bioavailable small molecule inhibitor of CD73, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting I. ORIC’s small molecule CD73 inhibitor demonstrated more potent blocking of adenosine production compared to an antibody
approach in preclinical studies. ORIC-533 demonstrated significant anti-tumor single agent efficacy when dosed once a day, with corresponding reduction of adenosine levels in the tumor microenvironment.
Completed Initial Public Offering: On April 28, 2020, the company completed its initial public offering selling 8,625,000 shares of common stock, which included the full exercise by the underwriters of their option to purchase up to 1,125,000 additional shares, at $16.00 per share. Gross proceeds from the IPO, excluding underwriting discounts and commissions and other estimated offering costs, were $138.0 million.
Strengthened Executive Leadership and Board: In April 2020, the company appointed Christian V. Kuhlen, MD, as its General Counsel, following his most recent tenure as General Counsel of Synthorx, Inc. In March 2020, the company appointed Mardi C. Dier, a 20+ year biotech leader and current CFO/CBO of Portola Pharmaceuticals, Inc, to its board of directors.
Response to the COVID-19 Pandemic: The company implemented certain risk mitigation measures and adjusted its operations in response to the COVID-19 pandemic and continues to evaluate the impact of the COVID-19 pandemic on its business.
Anticipated Milestones
ORIC expects to select the recommended Phase 2 dose for its two ongoing ORIC-101 combination trials in the second half of 2020 and to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.
ORIC expects to file an Investigational New Drug Application for ORIC-533 with the Food and Drug Administration in the first half of 2021.
First Quarter 2020 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents totaled $79.4 million as of March 31, 2020, which excludes the gross proceeds of $138.0 million from the company’s initial public offering, compared to $89.2 million as of December 31, 2019. The company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2023.
R&D Expenses: Research and development expenses were $7.3 million for the three months ended March 31, 2020, compared to $5.2 million for the three months ended March 31, 2019, an increase of $2.0 million. This increase was primarily driven by $1.2 million higher personnel costs related to the addition of a clinical development team and $0.8 million of external costs driven by the advancement of ORIC-101 trials and ORIC-533 preclinical development.
G&A Expenses: General and administrative expenses were $1.9 million for the three months ended March 31, 2020, compared to $1.1 million for the three months ended March 31, 2019, an increase of $0.8 million. The increase was primarily due to higher professional services and personnel costs to support the growth of the company.