Oric(ORIC) - 2025 Q2 - Quarterly Results

ORIC Pharmaceuticals Q2 2025 Report Overview Executive Summary ORIC Pharmaceuticals reports positive ORIC-944 clinical data, strengthened cash, and revised operational plans extending cash runway to late 2028 - The Phase 1b trial of ORIC-944 combined with AR inhibitors for mCRPC patients reported potentially best-in-class clinical efficacy and safety data[1] - The company's cash position was strengthened by $244 million in proceeds from a $125 million private placement and a $119 million ATM offering, concluding the use of the ATM facility[1] - Operational plans were revised to significantly reduce investment in discovery research, preparing for potential registrational trials of ORIC-944 and enozertinib (ORIC-114) in 2026[1][2] - With revised operational plans and additional financing, cash and investments are projected to support operations into late 2028 (previously late 2027), covering primary endpoint data readouts for the first Phase 3 trials of ORIC-944 and enozertinib[1][2] Second Quarter 2025 and Other Recent Highlights The company detailed progress on key clinical programs, completed financing, prioritized its pipeline, and extended its cash runway ORIC-944 Clinical and Preclinical Data ORIC-944 Phase 1b trial data in mCRPC patients showed promising efficacy and safety, supported by synergistic preclinical activity - The Phase 1b trial of ORIC-944 combined with AR inhibitors for metastatic castration-resistant prostate cancer (mCRPC) reported preliminary efficacy and safety data: * PSA50 response rate reached 59% (47% confirmed), PSA90 response rate reached 24% (all confirmed)[3][6] * PSA responses were observed across all ORIC-944 dose levels, with similar response rates when combined with apalutamide and darolutamide[3][6] * Both combination regimens demonstrated safety compatible with long-term administration, with the vast majority of adverse events being Grade 1 or 2, and no Grade 4 events[3][6] - Preclinical data for ORIC-944 presented at the 2025 AACR Annual Meeting showed synergistic activity and improved progression-free survival in both castration-resistant and castration-sensitive prostate cancer models when combined with androgen receptor pathway inhibitors[6] Enozertinib (ORIC-114) Updates Enozertinib (ORIC-114) continues patient enrollment in Phase 1b NSCLC trials and has received its non-proprietary name - Continued enrollment of advanced non-small cell lung cancer (NSCLC) patients with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations, including those with or without symptomatic but untreated CNS metastases, in the enozertinib monotherapy Phase 1b trial[6] - Continued enrollment of 1L NSCLC patients with EGFR exon 20 mutations in the enozertinib combined with subcutaneous (SC) amivantamab Phase 1b trial[6] - The World Health Organization International Nonproprietary Names (INN) Expert Committee has approved "enozertinib" as the nonproprietary (generic) name for ORIC-114[6] Corporate Highlights The company completed financing, strategically prioritized its pipeline, reduced its workforce, and extended its cash runway - Completed a $125 million private placement and issued $119 million from an at-the-market (ATM) facility, with the company concluding the use of the ATM facility given current cash and investment status, with no anticipated future use[6] - Announced strategic pipeline prioritization, focusing operational and financial resources on advancing two key clinical programs, ORIC-944 and enozertinib, leading to the dissolution of the discovery research team and a 20% workforce reduction[6] - Anticipates approximately $1.9 million in one-time charges in Q3, primarily related to termination benefits, including severance and health-related benefits[6] - Due to strategic pipeline prioritization, the cash runway is projected to support revised operational plans into late 2028 (previously late 2027), extending beyond the primary endpoint data readouts for the first Phase 3 trials of ORIC-944 and enozertinib[6] Anticipated Program Milestones ORIC Pharmaceuticals outlined key data milestones for ORIC-944 and enozertinib from late 2025 through mid-2026 - ORIC-944 (mCRPC) Milestones: * Late 2025: Updated Phase 1b data with AR inhibitor combination[10] * Q1 2026: Dose optimization data with AR inhibitor combination[10] - Enozertinib (ORIC-114) (NSCLC) Milestones: * Late 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20, and 2L+ EGFR atypical data[10] * Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 with SC amivantamab combination data[10] Second Quarter 2025 Financial Results The company reported its financial position, cash, investments, and year-over-year changes in R&D and G&A expenses for Q2 2025 Cash, Cash Equivalents, and Investments | Metric | As of June 30, 2025 | As of June 30, 2025 (Proforma) | | :-------------------------------- | :------------------ | :------------------------------ | | Cash, cash equivalents and investments | $327.7 million | $436.4 million | | Proceeds from private placement (May 2025) | $125.0 million | N/A | | Proceeds from ATM offering (Q2 2025) | $8.9 million | N/A | | Net proceeds from ATM (post Q2 2025) | N/A | $108.7 million | | Expected cash runway | Into 2H 2028 | Into 2H 2028 | Research and Development (R&D) Expenses | Period | 2025 (in millions) | 2024 (in millions) | Change (YoY) | | :-------------------- | :----------------- | :----------------- | :----------- | | Three months ended June 30 | $30.5 | $28.9 | +$1.6 million | | Six months ended June 30 | $55.2 | $50.9 | +$4.3 million | - The increase in R&D expenses was due to higher personnel costs (including non-cash stock-based compensation) and increased costs for advancing the enozertinib program, partially offset by reduced costs from terminated programs[10] General and Administrative (G&A) Expenses | Period | 2025 (in millions) | 2024 (in millions) | Change (YoY) | | :-------------------- | :----------------- | :----------------- | :----------- | | Three months ended June 30 | $8.5 | $7.1 | +$1.4 million | | Six months ended June 30 | $16.6 | $14.1 | +$2.5 million | - The increase in G&A expenses was primarily due to higher personnel costs and professional service fees, including additional non-cash stock-based compensation[10] Company Information & Disclosures About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company focused on overcoming cancer resistance with key candidates ORIC-944 and enozertinib - A clinical-stage biopharmaceutical company dedicated to improving patient lives by overcoming cancer resistance[9] - Clinical-stage lead product candidates include: * ORIC-944: An allosteric inhibitor of PRC2 (EED subunit) for prostate cancer[9][11] * Enozertinib (ORIC-114): A brain-penetrant inhibitor selectively targeting EGFR exon 20, HER2 exon 20, and EGFR atypical mutations for various genetically defined cancers[9][11] Cautionary Note Regarding Forward-Looking Statements This standard disclaimer informs readers that forward-looking statements are subject to risks and uncertainties, and actual results may differ materially - Statements in this press release that are not purely historical are forward-looking statements as defined by Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934[12] - Forward-looking statements are based on ORIC's current expectations and involve assumptions that may not be realized or prove incorrect, with actual results potentially differing materially due to numerous risks and uncertainties[12] - Risks include those related to drug discovery, development, and commercialization; clinical trial results potentially differing from expectations; financing needs; regulatory developments; reliance on third parties; intellectual property; loss of key personnel; industry competition; and macroeconomic and market conditions[12] Contact Information Provides contact information for investor and media inquiries - Contact: Dominic Piscitelli, Chief Financial Officer[14] - Email: dominic.piscitelli@oricpharma.com, info@oricpharma.com[14] Financial Statements Condensed Balance Sheets Presents the company's financial position, assets, liabilities, and equity as of June 30, 2025, compared to December 31, 2024 Condensed Balance Sheets (in thousands of dollars) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :------------------------------------ | :------------------------ | :------------------ | | Assets | | | | Cash, cash equivalents and short-term investments | $282,513 | $255,960 | | Prepaid expenses and other current assets | $8,611 | $6,290 | | Total current assets | $291,124 | $262,250 | | Long-term investments | $45,216 | — | | Property and equipment, net | $2,762 | $2,924 | | Other assets | $7,755 | $8,968 | | Total assets | $346,857 | $274,142 | | Liabilities and Stockholders' Equity | | | | Accounts payable | $3,130 | $1,548 | | Accrued liabilities | $14,920 | $23,298 | | Total current liabilities | $18,050 | $24,846 | | Other long-term liabilities | $4,812 | $6,174 | | Total liabilities | $22,862 | $31,020 | | Total stockholders' equity | $323,995 | $243,122 | | Total liabilities and stockholders' equity | $346,857 | $274,142 | Statements of Operations and Comprehensive Loss Details the company's financial performance, operating expenses, loss, and net loss for the three and six months ended June 30, 2025 and 2024 Statements of Operations and Comprehensive Loss (in thousands of dollars, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $30,549 | $28,940 | $55,189 | $50,900 | | General and administrative | $8,515 | $7,077 | $16,593 | $14,107 | | Total operating expenses | $39,064 | $36,017 | $71,782 | $65,007 | | Loss from operations | $(39,064) | $(36,017) | $(71,782) | $(65,007) | | Other income, net | $2,709 | $4,054 | $5,406 | $8,033 | | Net loss | $(36,355) | $(31,963) | $(66,376) | $(56,974) | | Unrealized loss on investments | $(22) | $(94) | $(192) | $(514) | | Comprehensive loss | $(36,377) | $(32,057) | $(66,568) | $(57,488) | | Net loss per share, basic and diluted | $(0.47) | $(0.45) | $(0.89) | $(0.83) | | Weighted-average shares outstanding, basic and diluted | 78,126,257 | 70,348,414 | 74,602,994 | 68,848,981 |