Full Press Release Details
ORIC Pharmaceuticals Reports Third Quarter 2020
Financial and Operational Update
Expanded precision oncology pipeline through in-licensing of allosteric PRC2 inhibitor program and brain penetrant EGFR and HER2 exon 20 inhibitor program
Lead program ORIC-101 on track for multiple interim data readouts in 2021
Expect to file IND/CTAs for ORIC-533, ORIC-944 and ORIC-114 in 2021
SOUTH SAN FRANCISCO and SAN DIEGO, CA - Nov. 5, 2020 - ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results for the quarter ended September 30, 2020.
"In just over six months since our initial public offering we have made substantial progress in advancing our internally developed pipeline and also successfully executed two highly strategic business development deals to augment our pipeline with additional novel programs," said Jacob Chacko, M.D., president and chief executive officer. "These efforts have put us in position for multiple upcoming milestones in 2021, including two top line interim Phase 1b clinical readouts for our lead program, ORIC-101, as well as three IND/CTA filings for ORIC-533, -944 and -114."
Third Quarter 2020 and Other Recent Highlights
Anticipated Milestones
Third Quarter 2020 Financial Results
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC's other product candidates include (1) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding ORIC's development plans and timelines; the potential advantages and/or best-in-class nature of ORIC's product candidates and programs; plans underlying ORIC-101 clinical trials and development; the expected timing of selecting the recommended Phase 2 dose for, and reporting interim data from, the ORIC-101 clinical trials; plans underlying ORIC-533, ORIC-944, ORIC-114 or any other programs; the planned IND filings for ORIC-533 and ORIC-944 and CTA filing for ORIC-114; the planned initiation of a global Phase 1/2 tumor-agnostic trial for ORIC-114; the period over which ORIC estimates its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan; and statements by the company's president and chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-101, ORIC-533, ORIC-944, ORIC-114 or any other product candidates to differ from preclinical, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the Mirati license agreement or the Voronoi license agreement; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 5, 2020, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Dominic Piscitelli, Chief Financial Officer
ORIC PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
| September 30, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and marketable securities | $ | 186,610 | $ | 89,159 | ||||
| Prepaid expenses and other current assets | 2,448 | 840 | ||||||
| Total current assets | 189,058 | 89,999 | ||||||
| Property and equipment, net | 1,893 | 2,241 | ||||||
| Other assets | 711 | 1,853 | ||||||
| Total assets | $ | 191,662 | $ | 94,093 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,598 | $ | 152 | ||||
| Accrued other liabilities | 5,330 | 5,202 | ||||||
| Total current liabilities | 6,928 | 5,354 | ||||||
| Deferred rent - long term | 359 | 765 | ||||||
| Total liabilities | 7,287 | 6,119 | ||||||
| Convertible preferred stock | - | 178,058 | ||||||
| Total stockholders' equity (deficit) | 184,375 | (90,084 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 191,662 | $ | 94,093 |
ORIC PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 8,831 | $ | 5,632 | $ | 23,808 | $ | 15,884 | |||||||
| Acquired in-process research and development | 12,971 | - | 12,971 | - | |||||||||||
| General and administrative | 3,800 | 1,465 | 9,125 | 3,914 | |||||||||||
| Total operating expenses | 25,602 | 7,097 | 45,904 | 19,798 | |||||||||||
| Loss from operations | (25,602 | ) | (7,097 | ) | (45,904 | ) | (19,798 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income, net | 10 | 476 | 276 | 1,054 | |||||||||||
| Other income | 44 | 72 | 184 | 215 | |||||||||||
| Total other income | 54 | 548 | 460 | 1,269 | |||||||||||
| Net loss | $ | (25,548 | ) | $ | (6,549 | ) | $ | (45,444 | ) | $ | (18,529 | ) | |||
| Other comprehensive loss: | |||||||||||||||
| Unrealized loss on available-for-sale securities | (29 | ) | - | (29 | ) | - | |||||||||
| Comprehensive loss | $ | (25,577 | ) | $ | (6,549 | ) | $ | (45,473 | ) | $ | (18,529 | ) | |||
| Net loss per share, basic and diluted | $ | (0.84 | ) | $ | (3.36 | ) | $ | (2.52 | ) | $ | (9.87 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 30,314,904 | 1,946,439 | 18,022,068 | 1,876,687 |