ORIC 8-K
Oric Pharmaceuticals, Inc. (ORIC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 11, 2024, ORIC Pharmaceuticals, Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ORIC PHARMACEUTICALS, INC. |
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Date: March 11, 2024 |
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By: |
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/s/ Dominic Piscitelli |
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Dominic Piscitelli Chief Financial Officer |
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Exhibit 99.1 |
ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Updates
Presented initial Phase 1b data from three clinical programs that support potential best in class profiles, with ORIC-944 and ORIC-114 prioritized for further advancement towards registrational studies
Initiation of combination study of ORIC-944 with AR inhibitor(s) in metastatic prostate cancer expected in first half of 2024 and program update expected in mid-2024
Initiation of multiple dose expansion cohorts for ORIC-114 in patients with mutated NSCLC expected in first half of 2024 and updated Phase 1b data expected in first half of 2025
Strengthened cash position with $210 million from two private placement financings; cash and investments expected to fund operating plan into late 2026
SOUTH SAN FRANCISCO and SAN DIEGO, CA – March 11, 2024 – ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter and year ended December 31, 2023.
“We’ve made significant progress over the past year as we presented initial positive data readouts across our three clinical programs, ORIC-114, ORIC-944 and ORIC-533, demonstrating their potential as best-in-class cancer therapeutics,” said Jacob M. Chacko, M.D., president and chief executive officer. “We strengthened our balance sheet with the completion of two PIPE financings totaling $210 million from top-tier healthcare specialist funds and prioritized our clinical pipeline around ORIC-114 and ORIC-944. We are building on the momentum generated in 2023 with multiple clinical milestones planned through the first half of 2025 as we advance two programs towards the initiation of registrational studies in the second half of 2025.”
Fourth Quarter 2023 and Other Recent Highlights
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor
ORIC-944: a potent and selective allosteric inhibitor of PRC2
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73
Discovery Pipeline:
Corporate Highlights:
Fourth Quarter and Full Year 2023 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 clinical stage product candidates include (1) 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, (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-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. Beyond these three 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, and follow us on X 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 the continued clinical development of ORIC-114 and ORIC-944; ORIC-114, ORIC-944 and ORIC-533 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-114 and ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of the initiation of studies and program and data updates; 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 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’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts 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 and collaboration agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; 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 titled “Risk Factors” in ORIC’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2024, 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.
Contact:
Dominic Piscitelli, Chief Financial Officer
ORIC PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash, cash equivalents and short-term investments |
$ |
208,187 |
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$ |
206,272 |
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Prepaid expenses and other current assets |
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4,410 |
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4,185 |
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Total current assets |
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212,597 |
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210,457 |
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Long-term investments |
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26,852 |
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21,951 |
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Property and equipment, net |
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2,862 |
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3,253 |
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Other assets |
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9,696 |
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11,517 |
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Total assets |
$ |
252,007 |
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$ |
247,178 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
$ |
944 |
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$ |
1,320 |
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Accrued liabilities |
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19,514 |
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14,068 |
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Total current liabilities |
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20,458 |
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15,388 |
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Other long-term liabilities |
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7,461 |
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9,439 |
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Total liabilities |
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27,919 |
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24,827 |
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Total stockholders' equity |
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224,088 |
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222,351 |
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Total liabilities and stockholders' equity |
$ |
252,007 |
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$ |
247,178 |
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ORIC PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
24,481 |
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$ |
16,295 |
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$ |
85,172 |
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$ |
61,680 |
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General and administrative |
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6,947 |
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5,824 |
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25,608 |
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25,087 |
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Acquired in-process research and development |
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— |
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— |
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— |
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5,000 |
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Total operating expenses |
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31,428 |
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22,119 |
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110,780 |
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91,767 |
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Loss from operations |
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(31,428 |
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(22,119 |
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(110,780 |
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(91,767 |
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Other income, net |
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3,098 |
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1,272 |
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10,083 |
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2,645 |
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Net loss |
$ |
(28,330 |
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$ |
(20,847 |
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$ |
(100,697 |
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$ |
(89,122 |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on investments |
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627 |
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456 |
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1,549 |
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(1,188 |
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Comprehensive loss |
$ |
(27,703 |
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$ |
(20,391 |
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$ |
(99,148 |
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$ |
(90,310 |
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Net loss per share, basic and diluted |
$ |
(0.49 |
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$ |
(0.52 |
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$ |
(1.96 |
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$ |
(2.25 |
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Weighted-average shares outstanding, basic and diluted |
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57,464,041 |
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40,125,286 |
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51,450,848 |
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39,655,260 |
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