Full Press Release Details
ORIC Pharmaceuticals Provides Corporate Update and Highlights Key 2021 Milestones
Lead program ORIC-101 continues patient enrollment investigating two therapeutic mechanisms
of action and on track for two initial data readouts in 2021
Three IND/CTA filings for ORIC-533, -944, and -114 expected in 2021
SOUTH SAN FRANCISCO and SAN DIEGO, CA Jan. 11, 2021 ORIC
Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today provided program updates and announced key milestones for 2021, which are expected to
substantially expand and advance the company s clinical pipeline.
2020 was a transformational year for ORIC during which we significantly
broadened the pipeline via internal discovery and business development efforts, expanded the team, and strengthened the balance sheet with the completion of an IPO and follow-on financing,
said Jacob Chacko, M.D., president and chief executive officer. These efforts have positioned us for a dynamic 2021, with our first data from two ongoing trials of our lead program ORIC-101 and
three INDs/CTAs for our other product candidates, which represents a tremendous amount of development activity for a company at our stage.
Program Updates and 2021 Milestones
ORIC-101: Glucocorticoid Receptor (GR) Antagonist
ORIC-101 is a potent
and selective GR antagonist, with two distinct mechanisms of action being evaluated in two Phase 1b trials in combination with: (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane
(nab-paclitaxel) in advanced or metastatic solid tumors.
ORIC-533: CD73 Inhibitor
ORIC-533 was designed to be a highly potent, orally bioavailable CD73 inhibitor and has demonstrated more
potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule CD73 inhibitors. ORIC-533 continues to progress in Investigational New Drug (IND) enabling studies
and the company expects to file an IND with the Food and Drug Administration (FDA) in the first half of 2021. Having conducted a preclinical collaboration with an academic key opinion leader that generated compelling single agent activity in patient
derived model systems in an undisclosed tumor type, the company plans to pursue a single agent clinical development path in this indication.
ORIC-944: PRC2 Inhibitor
in-licensed in August 2020, is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2), that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated
single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. The company plans to conduct IND enabling studies and then file an IND with the FDA in the second half of 2021, with initial clinical development
as a single agent in treatment-resistant prostate cancer.
ORIC-114: EGFR/HER2 Inhibitor
ORIC-114, in-licensed in October 2020, is a brain penetrant, orally
bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. ORIC-114 has demonstrated greater brain exposure in preclinical studies
compared to other compounds being developed against exon 20 mutations and has shown strong antitumor activity in an EGFR-driven intracranial lung cancer model. The company plans to conduct IND enabling studies and then file a Clinical Trial
Application (CTA) in South Korea in the second half of 2021.
In addition to the four product candidates, the company is leveraging its resistance platform in pursuit of multiple discovery research programs that focus on
its expertise in precision oncology, hormone-dependent cancers, and key tumor dependencies. These programs highlight the company s medicinal chemistry and structure-based drug design proficiency to target drivers of resistance in solid tumors
like prostate, breast, and lung cancer that relapse with innate, acquired or bypass mechanisms of resistance. The company recently advanced one of these programs into lead optimization.
Anticipated 2021 Milestones
ORIC anticipates the
following milestones in 2021:
equivalents and marketable securities totaled $293.6 million as of December 31, 2020, which included gross proceeds of $133.3 million from the follow-on financing completed in November 2020. The
company expects its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the second half of 2023.
Presentation and Webcast
Jacob Chacko, M.D., president
and chief executive officer, will present a corporate overview at the 39th J.P. Morgan Healthcare Conference beginning at 12:40 p.m. PT on Tuesday, January 12, 2021. A live webcast will be available through the investor section of the
company s website at https://investors.oricpharma.com/. A replay of the webcast will be available for 90 days following the event.
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 of ORIC s product candidates and programs; plans underlying ORIC-101 clinical trials and development; the expected timing of 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; ORIC s anticipated 2021 milestones; 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