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ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Update Announces decision to discontinue development of ORIC-101 Company will focus on advancing its three single agent Pha

Key Takeaway: ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Update Announces decision to discontinue development of ORIC-101 Company will focus on advancing its three single agent Phase 1 programs, ORIC-533 in multiple myeloma, ORIC-114 in

Full Press Release Details

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2021
Financial Results and Operational Update
Announces decision to discontinue development of ORIC-101
Company will focus on advancing its three single agent Phase 1 programs, ORIC-533 in multiple
myeloma, ORIC-114 in EGFR/HER2 cancers, and ORIC-944 in prostate cancer, with initial data expected from the three programs in 1H 2023
With cash and investments of $280.4 million, cash runway extended into 2H 2024
Conference call and webcast today at 5:00 p.m. ET
SOUTH SAN FRANCISCO and SAN DIEGO, CA March 21, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage
oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the discontinuation of ORIC-101 and also reported financial results and operational updates
for the quarter and year ended December 31, 2021. The company conducted planned interim analyses of two Phase 1b studies and concluded that ORIC-101 did not demonstrate sufficient clinical activity to
warrant further development.
We are disappointed in the outcome of the ORIC-101 studies in combination with
nab-paclitaxel in various solid tumors and in combination with enzalutamide in metastatic prostate cancer, two late-line patient populations for whom limited treatment options exist today. We believe both
studies were well designed, allowing us to thoroughly and efficiently answer an important clinical question. With this decision to discontinue ORIC-101 development, we would like to thank the investigators,
site staff, the ORIC team, and most importantly, patients and families who participated in the trials, said Pratik S. Multani, MD, chief medical officer.
We ve always been committed to rapid, data driven decision making and allocating resources efficiently and prudently, said Jacob M. Chacko,
MD, chief executive officer, We intentionally built a diverse pipeline of differentiated programs, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor. We expect to report initial data from each study in the
first half of 2023. As a result of the ORIC-101 discontinuation, we project our cash runway to extend into the second half of 2024, well beyond the planned initial data disclosures from these three clinical
Fourth Quarter 2021 and Other Recent Highlights
ORIC-101: Glucocorticoid Receptor Antagonist
Based on interim analyses from the two Phase 1b studies, ORIC-101 did not demonstrate sufficient clinical activity and,
therefore, the company has discontinued further development.
The dose expansion portion of the Phase 1b clinical trial of
ORIC-101 in combination with enzalutamide enrolled 28 patients at the recommended phase 2 dose (RP2D) with metastatic prostate cancer progressing on enzalutamide. The RP2D was well tolerated with a safety
consistent with previously reported results. ORIC-101 in combination with enzalutamide did not translate into a meaningful clinical benefit, with a median
progression-free survival (PFS) in the target patient population of 3.7 months.
The dose expansion portion of the Phase 1b clinical trial of ORIC-101 in combination with nab-paclitaxel enrolled 61 patients at the RP2D across four cohorts: pancreatic ductal adenocarcinoma (PDAC), ovarian cancer, triple negative
breast cancer (TNBC), and other advanced solid tumors. The RP2D was well tolerated with a safety profile consistent with previously reported results. There were no objective responses in the PDAC cohort (n=21) and there was one confirmed partial
response in the ovarian cancer cohort (n=13). There was no meaningful clinical benefit based on median PFS across all cohorts (PDAC: 1.9 months, and ovarian cancer: 2.2 months).
ORIC-533: CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 and has demonstrated more potent
adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway.
ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2
with high potency against exon 20 insertion mutations.
ORIC-944: PRC2 Inhibitor
ORIC-944 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.
PLK4 Inhibitor Program
company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a
TRIM37 DNA amplification. Breast cancer models as well as other tumor models with this TRIM37 amplification have a key tumor dependency on PLK4 and our therapeutic approach is to selectively inhibit this enzyme.
In November 2021, the company appointed
Angie You, PhD, to its board of directors. Dr. You was most recently CEO of Amunix Pharmaceuticals, which was acquired by Sanofi, and brings broad experience spanning venture capital, business development and public company leadership roles.
Anticipated Program Milestones
ORIC anticipates the
following upcoming milestones:
Fourth Quarter and Full year 2021 Financial Results
Webcast and Conference Call
host a conference call and webcast today at 5:00 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international)
and refer to conference ID 8637367. A live webcast and audio archive of the conference call will be available through the investor section of the company s website at www.oricpharma.com. The webcast will be available for replay for 90
days following the presentation.
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients lives by Overcoming
Resistance In Cancer. ORIC s clinical stage 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, being developed for multiple myeloma,
(2) 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,
and (3) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer. Beyond these four product candidates, ORIC is also
Twitter or LinkedIn.
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 s clinical trials and development; the expected timing of reporting initial data from the
ORIC-533, ORIC-114 and ORIC-944 clinical trials; plans underlying any of ORIC s other programs; ORIC s anticipated
milestones; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company s chief medical officer 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-533, ORIC-114, ORIC-944 or any other product candidates to differ from preclinical, interim, 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
ORIC s license agreements; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC ) on March 21, 2022, 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)
December 31,
2021 2020
Assets
Current assets:
Cash, cash equivalents and short-term investments $ 236,979 $ 293,600
Prepaid expenses and other current assets 3,543 3,097
Total current assets 240,522 296,697
Investments, available-for-sale 43,386
Property and equipment, net 2,413 1,981
Other assets 12,321 319
Total assets $ 298,642 $ 298,997
Liabilities and Stockholders Equity
Current liabilities:
Accounts payable $ 1,886 $ 757
Accrued liabilities 13,265 8,245
Total current liabilities 15,151 9,002
Other long-term liabilities 10,515 219
Total liabilities 25,666 9,221
Total stockholders equity 272,976 289,776
Total liabilities and stockholders equity $ 298,642 $ 298,997
ORIC PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
except share and per share amounts)
Three Months Ended December 31, Twelve Months Ended December 31,
2021 2020 2021 2020
Operating expenses:
Research and development $ 16,745 $ 12,113 $ 56,858 $ 35,921
General and administrative 6,060 4,297 22,013 13,422
Acquired in-process research and development 11,872 24,843
Total operating expenses 22,805 28,282 78,871 74,186
Loss from operations (22,805 ) (28,282 ) (78,871 ) (74,186 )
Other income:
Interest income, net 34 30 141 306
Other (7 ) 15 177
Total other income 34 23 156 483
Net loss $ (22,771 ) $ (28,259 ) $ (78,715 ) $ (73,703 )
Other comprehensive loss:
Unrealized loss on available-for-sale securities (101 ) (2 ) (72 ) (31 )
Comprehensive loss $ (22,872 ) $ (28,261 ) $ (78,787 ) $ (73,734 )
Net loss per share, basic and diluted $ (0.58 ) $ (0.84 ) $ (2.07 ) $ (3.36 )
Weighted-average shares outstanding, basic and diluted 39,386,166 33,618,477 37,954,280 21,942,476
Last updated: Mar 21, 2022