On August 5, 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 June 30, 2020 (Press release, ORIC Pharmaceuticals, AUG 5, 2020, View Source [SID1234562921]).
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"Since the beginning of the year, we have realized substantial progress advancing our wholly owned, internally developed pipeline," said Jacob Chacko, M.D., president and chief executive officer. "Looking forward, we see a number of important events as we continue to execute against our strategic plans. We expect to select the recommended Phase 2 dose and initiate the expansion cohorts in both of our ongoing ORIC-101 clinical studies in the second half of the year. Additionally, we are preparing for the development of our newly licensed, potential best-in-class PRC2 inhibitor, ORIC-944, which along with ORIC-533, we anticipate as IND candidates for 2021."
Second Quarter 2020 and Other Recent Highlights
Licensed Exclusive Worldwide Rights to PRC2 Inhibitors: In August 2020, ORIC licensed exclusive worldwide development and commercialization rights to a potential best-in-class PRC2 inhibitor, ORIC-944, from Mirati Therapeutics, Inc. Under the terms of the agreement with Mirati, ORIC paid to Mirati a one-time non-cash payment of $20 million in shares of ORIC common stock. The number of shares issued was based on a price of $34.00 per share, representing a premium of 10% to the 60-day trailing volume weighted average trading price of ORIC’s common stock. ORIC is not subject to any future milestone or royalty payment obligations to Mirati.
Preclinical Data on ORIC-101 Presented at AACR (Free AACR Whitepaper): In June 2020, ORIC presented three poster presentations at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Virtual Meeting II. Key findings of the presentations included:
— A transcriptional signature of glucocorticoid receptor (GR) activity was identified in a panel of 32 cell lines across triple negative breast cancer, non-small cell lung cancer and pancreatic ductal adenocarcinoma, which translated from preclinical models to human tumors;
— ORIC-101 overcame GR-mediated resistance to chemotherapeutic agents including taxanes, antimetabolites and platinum agents, in both in vitro and in vivo efficacy studies spanning a variety of solid tumors; and
— Transcriptional and histological profiling showed that ORIC-101 reversed GR-activated pathways involved in drug resistance and reversed in vivo markers of epithelial-to-mesenchymal transition, antiapoptosis, and hypoxia.
Preclinical Data on CD73 Inhibitor Program Presented at AACR (Free AACR Whitepaper): In June 2020, ORIC presented two poster presentations at the 2020 AACR (Free AACR Whitepaper) Annual Virtual Meeting II. Key findings of the presentations included:
— ORIC’s CD73 inhibitors demonstrated suppression of adenosine production in vitro across multiple cell types and rescued activation of CD8+ T cells exposed to AMP with greater potency than competitor compounds;
— ORIC-533 was shown to result in sustained inhibition of adenosine production after drug washout, consistent with its slow off-rate, and differentiating from other CD73 inhibitors;
— ORIC-533 potency in high AMP environments distinguishes it from other compounds, with activity in AMP concentrations as high as 1 millimolar, which may better reflect certain tumor microenvironments; and
— Daily oral delivery of ORIC’s CD73 inhibitors significantly inhibited tumor growth, with corresponding in vivo reduction of adenosine levels in tumors, and immune modulation consistent with decreased immunosuppression.
Expanded and Strengthened its Board: In June 2020, the company appointed Lori Kunkel, M.D., to its board of directors. Dr. Kunkel brings more than twenty-five years of experience in oncology and immunology drug development and commercialization.
Completed $138 Million Initial Public Offering: On April 28, 2020, the company completed its initial public offering (IPO), 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.
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 (IND) Application for ORIC-533 with the Food and Drug Administration (FDA) in the first half of 2021.
ORIC expects to file an IND Application for ORIC-944 with the FDA in the second half of 2021.
Second Quarter 2020 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents totaled $196.6 million as of June 30, 2020, which includes the gross proceeds of $138.0 million from the company’s IPO in April 2020. The company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into the fourth quarter of 2022.
R&D Expenses: Research and development (R&D) expenses were $7.7 million for the three months ended June 30, 2020, compared to $5.0 million for the three months ended June 30, 2019, an increase of $2.7 million. For the six months ended June 30, 2020, R&D expenses were $15.0 million compared to $10.3 million for the same period of 2019, an increase of $4.7 million. The increases were primarily due to the continued advancement of the ORIC-101 and ORIC-533 programs and higher personnel and related expenses, including non-cash stock-based compensation.
G&A Expenses: General and administrative (G&A) expenses were $3.4 million for the three months ended June 30, 2020, compared to $1.3 million for the three months ended June 30, 2019, an increase of $2.1 million. For six months ended June 30, 2020, general and administrative expenses were $5.3 million compared to $2.4 million for the same period in 2019, an increase of $2.9 million. These increases were primarily due to higher professional services and related costs to operate as a public company, and higher personnel costs, including non-cash stock-based compensation.
Webcast and Conference Call
ORIC will host a webcast and conference call today, August 5th, at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and refer to conference ID: 5167646. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company’s website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.