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Oric(ORIC) - 2025 Q2 - Quarterly Report
2025-08-12 20:20
[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's unaudited financial statements, management's analysis, and market risk disclosures [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Provides the unaudited balance sheets, statements of operations, stockholders' equity, and cash flows for the reporting period [Balance Sheets](index=6&type=section&id=Balance%20Sheets) Details the company's assets, liabilities, and stockholders' equity at the end of the reporting period Balance Sheet Summary | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change (2025 vs 2024) | Percentage Change | | :-------------------- | :------------ | :---------------- | :-------------------- | :------------------ | | Cash and cash equivalents | $75,864 | $59,406 | +$16,458 | +27.7% | | Short-term investments | $206,649 | $196,554 | +$10,095 | +5.1% | | Total current assets | $291,124 | $262,250 | +$28,874 | +11.0% | | Total assets | $346,857 | $274,142 | +$72,715 | +26.5% | | Total current liabilities | $18,050 | $24,846 | -$6,796 | -27.4% | | Total liabilities | $22,862 | $31,020 | -$8,158 | -26.3% | | Total stockholders' equity | $323,995 | $243,122 | +$80,873 | +33.3% | [Statements of Operations and Comprehensive Loss](index=7&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Summarizes revenues, expenses, and the resulting net loss over the reporting periods Operating Results Summary | Metric (in thousands) | 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) | | Net loss per share, basic and diluted | $(0.47) | $(0.45) | $(0.89) | $(0.83) | - **Net loss increased by $4.392 million (13.7%)** for the three months ended June 30, 2025, and by **$9.402 million (16.5%)** for the six months, primarily due to higher operating expenses and lower other income[19](index=19&type=chunk)[92](index=92&type=chunk) [Statements of Stockholders' Equity](index=8&type=section&id=Statements%20of%20Stockholders'%20Equity) Outlines the changes in the company's equity accounts over the reporting period Stockholders' Equity Summary | Metric (in thousands, except shares) | December 31, 2024 | March 31, 2025 | June 30, 2025 | | :----------------------------------- | :---------------- | :------------- | :------------ | | Common Stock Shares | 71,021,855 | 71,078,511 | 86,187,328 | | Common Stock Amount | $7 | $7 | $9 | | Additional Paid-in Capital | $805,510 | $812,317 | $952,949 | | Accumulated Deficit | $(562,774) | $(592,795) | $(629,150) | | Total Stockholders' Equity | $243,122 | $219,738 | $323,995 | - **Total stockholders' equity increased to $323.995 million** at June 30, 2025, primarily driven by the issuance of common stock and pre-funded warrants totaling **$133.267 million**[22](index=22&type=chunk) [Statements of Cash Flows](index=9&type=section&id=Statements%20of%20Cash%20Flows) Details the sources and uses of cash from operating, investing, and financing activities Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(63,375) | $(55,811) | | Net cash used in investing activities | $(54,480) | $(43,588) | | Net cash provided by financing activities | $134,313 | $125,846 | | Net increase in cash, cash equivalents and restricted cash | $16,458 | $26,447 | - **Net cash used in operating activities increased by $7.564 million YoY**, while net cash from financing activities increased by **$8.467 million YoY** from private placements and ATM offerings[25](index=25&type=chunk)[107](index=107&type=chunk)[111](index=111&type=chunk) [Notes to Unaudited Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) Provides supplementary information and disclosures related to the company's financial statements [1. Description of the Business](index=10&type=section&id=1.%20Description%20of%20the%20Business) ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company focused on overcoming cancer resistance - ORIC Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on overcoming resistance in cancer, operating as a single segment[28](index=28&type=chunk) - The company has an **accumulated deficit of $629.2 million** as of June 30, 2025, and has historically funded operations through stock issuances[30](index=30&type=chunk) - Management believes it has **sufficient working capital to fund operations for at least the next twelve months** from the financial statement issuance date[31](index=31&type=chunk) [2. Basis of Presentation and Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) The financial statements are prepared in accordance with GAAP for interim reporting - The unaudited financial statements are prepared in accordance with GAAP for interim financial information and SEC Form 10-Q instructions[35](index=35&type=chunk) - The company operates as one segment, focusing on cancer research and development[38](index=38&type=chunk)[39](index=39&type=chunk) - The company is currently evaluating the impact of ASU 2024-03, which requires enhanced expense disclosures effective after December 15, 2026[40](index=40&type=chunk) [3. License Agreements and Clinical Development Collaborations](index=11&type=section&id=3.%20License%20Agreements%20and%20Clinical%20Development%20Collaborations) The company has entered into several key collaborations for its clinical programs - ORIC entered into clinical supply agreements with Johnson & Johnson to evaluate ORIC-114 and ORIC-944 in combination with their respective drugs[41](index=41&type=chunk)[42](index=42&type=chunk) - A collaboration with Bayer was established to evaluate ORIC-944 in combination with Nubeqa® (darolutamide)[43](index=43&type=chunk) - The Voronoi License Agreement grants ORIC exclusive rights for ORIC-114 with potential **milestone payments up to $336.0 million** and royalties[44](index=44&type=chunk)[46](index=46&type=chunk) - The Mirati License Agreement grants ORIC worldwide exclusive rights to ORIC-944 for an upfront payment of **588,235 shares of common stock**[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) [4. Property and Equipment, net](index=15&type=section&id=4.%20Property%20and%20Equipment%2C%20net) Details the composition and value of the company's property and equipment Property and Equipment Breakdown | Category (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Lab equipment | $7,709 | $7,386 | | Leasehold improvements | $2,065 | $2,043 | | Computer hardware and software | $287 | $274 | | Furniture and fixtures | $697 | $697 | | Total property and equipment, gross | $10,758 | $10,400 | | Less accumulated depreciation | $(7,996) | $(7,476) | | Total property and equipment, net | $2,762 | $2,924 | - **Net property and equipment decreased by $162 thousand** from December 31, 2024, to June 30, 2025, due to depreciation offsetting new acquisitions[54](index=54&type=chunk) [5. Accrued Liabilities](index=15&type=section&id=5.%20Accrued%20Liabilities) Provides a breakdown of the company's short-term financial obligations Accrued Liabilities Breakdown | Category (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Accrued clinical and manufacturing costs | $5,365 | $11,808 | | Accrued compensation | $5,175 | $7,648 | | Operating lease liabilities - short-term | $3,273 | $3,183 | | Other accruals | $1,107 | $659 | | Total accrued liabilities | $14,920 | $23,298 | - **Total accrued liabilities decreased by $8.378 million (36.0%)** from December 31, 2024, mainly due to lower clinical, manufacturing, and compensation costs[55](index=55&type=chunk) [6. Investments](index=15&type=section&id=6.%20Investments) Outlines the composition and fair value of the company's investment portfolio Investment Portfolio | Investment Type (in thousands) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :----------------------------- | :------------------------- | :----------------------------- | | Short-term U.S. treasury securities | $206,649 | $196,554 | | Long-term U.S. treasury securities | $45,216 | — | | Total Investments | $251,865 | $196,554 | - The company's investments consist primarily of U.S. treasury securities, with no material declines in fair value due to credit-related factors[56](index=56&type=chunk)[57](index=57&type=chunk) [7. Fair Value Measurements](index=17&type=section&id=7.%20Fair%20Value%20Measurements) Details the methodology for measuring the fair value of financial assets Assets Measured at Fair Value | Asset Category (in thousands) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :---------------------------- | :------------------------- | :----------------------------- | | Money market funds | $75,864 | $59,406 | | U.S. treasury securities | $251,865 | $196,554 | | Total | $327,729 | $255,960 | - All major categories of assets measured at fair value are classified as **Level 1**, indicating observable inputs such as quoted prices in active markets[59](index=59&type=chunk)[63](index=63&type=chunk) [8. Stockholders' Equity and Stock-Based Compensation](index=17&type=section&id=8.%20Stockholders'%20Equity%20and%20Stock-Based%20Compensation) Discloses information on equity transactions and stock-based compensation expenses Stock-Based Compensation Expense | Stock-Based Compensation (in thousands) | 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 | $2,919 | $2,131 | $5,811 | $4,276 | | General and administrative | $3,655 | $2,865 | $7,317 | $5,678 | | Total stock-based compensation expense | $6,574 | $4,996 | $13,128 | $9,954 | - **Total stock-based compensation expense increased by 31.6%** for the three months and **31.9%** for the six months ended June 30, 2025, compared to 2024[62](index=62&type=chunk) - As of June 30, 2025, **14,249,525 stock options were outstanding** with a weighted-average exercise price of $6.37[64](index=64&type=chunk)[65](index=65&type=chunk) - In May 2025, the company completed a private placement, selling **14,130,313 shares of common stock** and pre-funded warrants for 5,100,532 shares[67](index=67&type=chunk)[68](index=68&type=chunk) [9. Subsequent Events](index=20&type=section&id=9.%20Subsequent%20Events) Describes significant events that occurred after the balance sheet date - From July 1 to August 12, 2025, the company raised approximately **$108.7 million in net proceeds** through an At-the-Market (ATM) sales agreement[70](index=70&type=chunk) - On August 12, 2025, ORIC announced a strategic pipeline prioritization to focus on ORIC-944 and ORIC-114, resulting in an **approximately 20% workforce reduction**[71](index=71&type=chunk) - The workforce reduction is expected to incur a **one-time cost of approximately $1.9 million**, primarily for termination benefits in Q3 2025[71](index=71&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on the company's financial condition, operational results, and future outlook [Overview](index=21&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm focused on overcoming cancer resistance - ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company focused on overcoming resistance in cancer through its specialized pipeline[74](index=74&type=chunk) - ORIC-944 showed a **59% PSA50 response rate** in mCRPC patients, with updated data expected in H2 2025 and Phase 3 initiation in H1 2026[75](index=75&type=chunk) - ORIC-114 demonstrated systemic and intracranial activity in advanced solid tumors, with comprehensive data updates expected in H2 2025[75](index=75&type=chunk)[76](index=76&type=chunk) - A strategic pipeline prioritization was announced on August 12, 2025, to focus resources on ORIC-944 and ORIC-114, leading to a **20% workforce reduction**[77](index=77&type=chunk) - ORIC incurred a **net loss of $66.4 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$629.2 million**[78](index=78&type=chunk) [Components of Operating Results](index=23&type=section&id=Components%20of%20Operating%20Results) This section breaks down the key drivers of the company's operating expenses [Research and Development Expenses](index=23&type=section&id=Research%20and%20Development%20Expenses) R&D expenses consist of external and internal costs related to advancing the product pipeline - R&D expenses are a significant portion of operating costs, comprising external (CROs, CMOs) and internal (personnel) expenses[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - **R&D expenses are expected to increase substantially** as ORIC-944 and ORIC-114 advance into later-stage clinical trials[83](index=83&type=chunk)[85](index=85&type=chunk) - The August 2025 strategic prioritization will decrease preclinical research and incur a **one-time cost of $1.9 million** from a 20% workforce reduction[88](index=88&type=chunk) [General and Administrative Expenses](index=25&type=section&id=General%20and%20Administrative%20Expenses) G&A expenses include costs for personnel, facilities, and professional services - G&A expenses primarily include personnel costs, allocated facilities, depreciation, and professional fees[89](index=89&type=chunk) - **G&A expenses are expected to increase** in the foreseeable future due to increased headcount supporting R&D and business growth[89](index=89&type=chunk) [Other Income, Net](index=26&type=section&id=Other%20Income%2C%20Net) Other income primarily consists of interest earned on cash and investments - Other income, net, primarily consists of interest income from interest-bearing money market accounts and investments[91](index=91&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Compares the company's operating results for the current and prior-year periods Comparison of Operating Results | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | :----------------------------- | :----------------------------- | :----- | | Research and development | $30,549 | $28,940 | $1,609 | $55,189 | $50,900 | $4,289 | | General and administrative | $8,515 | $7,077 | $1,438 | $16,593 | $14,107 | $2,486 | | Total operating expenses | $39,064 | $36,017 | $3,047 | $71,782 | $65,007 | $6,775 | | Other income, net | $2,709 | $4,054 | $(1,345) | $5,406 | $8,033 | $(2,627) | | Net loss | $(36,355) | $(31,963) | $(4,392) | $(66,376) | $(56,974) | $(9,402) | - **Research and development expenses increased by $4.3 million (8.4%)** for H1 2025 YoY, driven by higher personnel costs and ORIC-114 advancement[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) - **General and administrative expenses increased by $2.5 million (17.6%)** for H1 2025 YoY, primarily due to higher personnel and professional services costs[96](index=96&type=chunk)[97](index=97&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's financial position, cash flows, and funding sources - On May 23, 2025, ORIC completed a private placement of common stock and pre-funded warrants, generating **gross proceeds of $125.0 million**[98](index=98&type=chunk) - The company raised approximately **$8.9 million through an ATM offering** as of June 30, 2025, with an additional **$108.7 million** raised through August 12, 2025[99](index=99&type=chunk) - As of June 30, 2025, ORIC had **$327.7 million in cash, cash equivalents, and investments**, projected to fund operations into the second half of 2028[143](index=143&type=chunk) Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(63,375) | $(55,811) | | Net cash used in investing activities | $(54,480) | $(43,588) | | Net cash provided by financing activities | $134,313 | $125,846 | | Net increase in cash, cash equivalents and restricted cash | $16,458 | $26,447 | [Critical Accounting Policies and Significant Judgments and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Outlines the accounting policies that require significant management judgment and estimation - The company's financial statements are prepared in accordance with US GAAP, with no significant changes to critical accounting policies since December 31, 2024[113](index=113&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=30&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Describes the company's reporting status and its implications under securities laws - ORIC is an 'emerging growth company' and 'smaller reporting company,' electing not to use the extended transition period for new accounting standards[114](index=114&type=chunk)[115](index=115&type=chunk) - The company will transition to **'large accelerated filer' status on December 31, 2025**, requiring shorter filing deadlines and auditor attestation[116](index=116&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses the company's exposure to market risks, primarily interest rate and inflation risk - The company's primary investment objective is to preserve principal and liquidity, investing in high-quality marketable debt instruments[117](index=117&type=chunk) - As of June 30, 2025, cash, cash equivalents, and investments totaled **$327.7 million**; a 100 basis point change in interest rates would not have a material effect[117](index=117&type=chunk) - The company does not believe inflation, interest rate changes, or exchange rate fluctuations significantly impacted results for the periods presented[118](index=118&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of the company's disclosure controls and internal financial reporting controls - As of June 30, 2025, management concluded that the company's **disclosure controls and procedures were effective** at a reasonable assurance level[119](index=119&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended June 30, 2025, that materially affected internal controls[120](index=120&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part contains other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) States the company is not currently a party to any material litigation or legal proceedings - ORIC is not currently involved in any material litigation or legal proceedings expected to have a material adverse effect on its business[123](index=123&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Outlines various risks that could materially harm the company's business and financial condition - Key risk categories include financial position, product development, regulatory compliance, intellectual property, and dependence on third parties[125](index=125&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) - The company has a limited operating history, has incurred **significant net losses**, and expects to continue incurring losses, requiring substantial additional capital[132](index=132&type=chunk)[135](index=135&type=chunk)[140](index=140&type=chunk) - **Success is highly dependent on ORIC-944 and ORIC-114**, which are subject to significant clinical, regulatory, and commercial uncertainties[147](index=147&type=chunk)[148](index=148&type=chunk)[155](index=155&type=chunk)[188](index=188&type=chunk) - The company faces risks related to **protecting its intellectual property** and operating without infringing third-party rights[314](index=314&type=chunk)[321](index=321&type=chunk)[327](index=327&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=129&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) States there were no unregistered sales of equity securities during the reporting period - No unregistered sales of equity securities occurred during the period[440](index=440&type=chunk) - No proceeds from registered securities were used during the period[440](index=440&type=chunk) [Item 3. Defaults Upon Senior Securities](index=129&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Confirms that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[441](index=441&type=chunk) [Item 4. Mine Safety Disclosures](index=129&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that there are no mine safety disclosures to report - No mine safety disclosures are applicable or required[442](index=442&type=chunk) [Item 5. Other Information](index=129&type=section&id=Item%205.%20Other%20Information) Details Rule 10b5-1 trading arrangements adopted by certain directors and executive officers - The CEO, Jacob M. Chacko, adopted a Rule 10b5-1 trading arrangement on June 21, 2025, for the sale of up to **251,000 shares**[443](index=443&type=chunk) - The CFO, Dominic Piscitelli, adopted a Rule 10b5-1 trading arrangement on June 24, 2025, for the sale of up to **140,000 shares**[444](index=444&type=chunk) - Board member Mardi C. Dier adopted a Rule 10b5-1 trading arrangement on June 27, 2025, for the sale of up to **114,383 shares**[445](index=445&type=chunk) [Item 6. Exhibits](index=130&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of the Form 10-Q report - Key exhibits include the Form of Pre-Funded Warrant, Securities Purchase Agreement, and certifications of the Principal Executive and Financial Officers[447](index=447&type=chunk) [SIGNATURES](index=131&type=section&id=SIGNATURES) Contains the required signatures from the registrant's authorized officers - The report is signed by Jacob M. Chacko, M.D., President and CEO, and Dominic Piscitelli, CFO, on August 12, 2025[451](index=451&type=chunk)
Oric(ORIC) - 2025 Q2 - Quarterly Results
2025-08-12 20:10
ORIC Pharmaceuticals Q2 2025 Report Overview [Executive Summary](index=1&type=section&id=ORIC%C2%AE%20Pharmaceuticals%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Operational%20Updates) 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](index=1&type=chunk) - 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](index=1&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) [Second Quarter 2025 and Other Recent Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Other%20Recent%20Highlights) The company detailed progress on key clinical programs, completed financing, prioritized its pipeline, and extended its cash runway [ORIC-944 Clinical and Preclinical Data](index=1&type=section&id=ORIC-944%3A%20a%20potent%20and%20selective%20allosteric%20inhibitor%20of%20PRC2) 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](index=3&type=chunk)[6](index=6&type=chunk) * PSA responses were observed across all ORIC-944 dose levels, with similar response rates when combined with apalutamide and darolutamide[3](index=3&type=chunk)[6](index=6&type=chunk) * 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](index=3&type=chunk)[6](index=6&type=chunk) - 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](index=6&type=chunk) [Enozertinib (ORIC-114) Updates](index=2&type=section&id=Enozertinib%20(formerly%20ORIC-114)%3A%20a%20brain%20penetrant%20inhibitor%20that%20selectively%20targets%20EGFR%20exon%2020%2C%20HER2%20exon%2020%20and%20EGFR%20atypical%20mutations) 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](index=6&type=chunk) - Continued enrollment of 1L NSCLC patients with EGFR exon 20 mutations in the enozertinib combined with subcutaneous (SC) amivantamab Phase 1b trial[6](index=6&type=chunk) - The World Health Organization International Nonproprietary Names (INN) Expert Committee has approved "enozertinib" as the nonproprietary (generic) name for ORIC-114[6](index=6&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights%3A) 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](index=6&type=chunk) - 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](index=6&type=chunk) - Anticipates approximately **$1.9 million** in one-time charges in Q3, primarily related to termination benefits, including severance and health-related benefits[6](index=6&type=chunk) - 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](index=6&type=chunk) [Anticipated Program Milestones](index=3&type=section&id=Anticipated%20Program%20Milestones%3A) 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](index=10&type=chunk) * **Q1 2026:** Dose optimization data with AR inhibitor combination[10](index=10&type=chunk) - **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](index=10&type=chunk) * **Mid-2026:** 1L EGFR atypical data and 1L EGFR exon 20 with SC amivantamab combination data[10](index=10&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) 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](index=10&type=chunk) 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](index=10&type=chunk) [Company Information & Disclosures](index=3&type=section&id=Company%20Information%20%26%20Disclosures) [About ORIC Pharmaceuticals, Inc.](index=3&type=section&id=About%20ORIC%20Pharmaceuticals%2C%20Inc.) 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](index=9&type=chunk) - Clinical-stage lead product candidates include: * **ORIC-944:** An allosteric inhibitor of PRC2 (EED subunit) for prostate cancer[9](index=9&type=chunk)[11](index=11&type=chunk) * **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](index=9&type=chunk)[11](index=11&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) [Contact Information](index=5&type=section&id=Contact%3A) Provides contact information for investor and media inquiries - Contact: **Dominic Piscitelli**, Chief Financial Officer[14](index=14&type=chunk) - Email: dominic.piscitelli@oricpharma.com, info@oricpharma.com[14](index=14&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Balance Sheets](index=6&type=section&id=CONDENSED%20BALANCE%20SHEETS) 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](index=7&type=section&id=STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) 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 |
ORIC® Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Updates
Globenewswire· 2025-08-12 20:05
Core Insights - ORIC Pharmaceuticals reported promising clinical efficacy and safety data from the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors for treating metastatic castration-resistant prostate cancer (mCRPC) [1][5] - The company strengthened its cash position with $244 million in gross proceeds from a $125 million private placement and $119 million from at-the-market (ATM) issuances, extending its cash runway into the second half of 2028 [1][9] - ORIC has revised its operating plan to focus on advancing its lead clinical programs, ORIC-944 and enozertinib, while significantly reducing investment in discovery research [2][9] Financial Highlights - As of June 30, 2025, ORIC reported cash, cash equivalents, and investments totaling $327.7 million, which increased to $436.4 million after additional fundraising [9][15] - Research and development (R&D) expenses for Q2 2025 were $30.5 million, up from $28.9 million in Q2 2024, reflecting higher personnel costs and advancement of enozertinib [9][15] - General and administrative (G&A) expenses for Q2 2025 were $8.5 million, compared to $7.1 million in Q2 2024, primarily due to increased personnel costs and professional services [9][15] Clinical Development Updates - ORIC-944 demonstrated a 59% PSA50 response rate and a 24% PSA90 response rate in patients with mCRPC, indicating its potential as a best-in-class PRC2 inhibitor [5] - Enozertinib continues to enroll patients in a Phase 1b trial targeting advanced non-small cell lung cancer (NSCLC) with specific EGFR and HER2 mutations [4][10] - The company anticipates initiating registrational trials for ORIC-944 and enozertinib in 2026, with key data milestones expected in late 2025 and mid-2026 [7][9]
Oric Pharmaceuticals, Inc. (ORIC) Now Trades Above Golden Cross: Time to Buy?
ZACKS· 2025-07-15 14:56
Core Viewpoint - Oric Pharmaceuticals, Inc. (ORIC) is showing potential for a bullish breakout as it has reached a key support level and experienced a "golden cross" in its moving averages [1][4]. Technical Analysis - A "golden cross" occurs when a short-term moving average (50-day) crosses above a long-term moving average (200-day), indicating a potential bullish trend [2]. - The formation of a golden cross involves three stages: a downtrend that bottoms out, a crossover of moving averages, and subsequent upward momentum in stock prices [3]. Performance Metrics - Over the past four weeks, ORIC's stock has increased by 15.3% [4]. - The company currently holds a 1 (Strong Buy) rating on the Zacks Rank, suggesting strong bullish sentiment [4]. - Earnings expectations have improved, with two upward revisions in estimates for the current quarter and no downward revisions, indicating positive investor sentiment [4]. Investment Outlook - The combination of favorable earnings estimate revisions and the technical "golden cross" suggests that investors should monitor ORIC for potential further gains [5].
Oric Pharmaceuticals, Inc. (ORIC) is a Great Momentum Stock: Should You Buy?
ZACKS· 2025-07-11 17:01
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Oric Pharmaceuticals, Inc. (ORIC) - ORIC currently holds a Momentum Style Score of B, indicating a positive momentum outlook [2] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [3] Performance Metrics - Over the past week, ORIC shares increased by 4.75%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 2.88% [5] - In the last quarter, ORIC shares surged by 140.04%, and over the past year, they gained 19.27%, while the S&P 500 only increased by 19.67% and 12.87%, respectively [6] - The average 20-day trading volume for ORIC is 896,080 shares, indicating a bullish sentiment as the stock is rising with above-average volume [7] Earnings Outlook - In the past two months, three earnings estimates for ORIC have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$1.98 to -$1.74 [9] - For the next fiscal year, two estimates have also moved upwards, with no downward revisions during the same period [9] Conclusion - Given the positive performance metrics and earnings outlook, ORIC is positioned as a promising investment opportunity with a Momentum Score of B and a Zacks Rank of 2 (Buy) [11]
All You Need to Know About Oric Pharmaceuticals (ORIC) Rating Upgrade to Buy
ZACKS· 2025-06-19 17:01
Core Viewpoint - Oric Pharmaceuticals, Inc. (ORIC) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for Oric Pharmaceuticals reflects an optimistic earnings outlook, likely leading to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, influencing their buying and selling actions, which subsequently affects stock prices [5]. Recent Performance of Oric Pharmaceuticals - For the fiscal year ending December 2025, Oric Pharmaceuticals is expected to earn -$1.75 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 15.7% over the past three months [9]. Zacks Rank System Overview - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. - Oric Pharmaceuticals' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].
Does Oric Pharmaceuticals (ORIC) Have the Potential to Rally 104.99% as Wall Street Analysts Expect?
ZACKS· 2025-06-19 14:56
Core Viewpoint - Oric Pharmaceuticals, Inc. (ORIC) has seen a significant stock price increase of 57.1% over the past four weeks, closing at $9.22, with analysts suggesting a potential upside of 105% based on a mean price target of $18.9 [1][11]. Price Targets and Analyst Estimates - The mean estimate consists of 10 short-term price targets with a standard deviation of $4.04, indicating variability among analysts [2]. - The lowest price target is $12.00, suggesting a 30.2% increase from the current price, while the highest target is $25.00, indicating a potential surge of 171.2% [2]. - A low standard deviation signifies a strong agreement among analysts regarding the stock's price movement [9]. Earnings Estimates and Analyst Agreement - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price increases [11]. - Over the last 30 days, two earnings estimates for ORIC have been revised upward, leading to a 7.8% increase in the Zacks Consensus Estimate [12]. - ORIC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [13]. Conclusion on Price Movement - While consensus price targets may not be entirely reliable, the direction indicated by these targets appears to be a useful guide for potential price movement [14].
What Makes Oric Pharmaceuticals, Inc. (ORIC) a Strong Momentum Stock: Buy Now?
ZACKS· 2025-06-13 17:01
Company Overview - Oric Pharmaceuticals, Inc. (ORIC) currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3] - The company has a Zacks Rank of 2 (Buy), suggesting favorable market performance expectations [4] Performance Metrics - Over the past week, ORIC shares have increased by 14.08%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 5.43% [6] - In a longer time frame, ORIC's monthly price change is 104.01%, significantly higher than the industry's 7.54% [6] - Over the last quarter, ORIC shares have risen by 28.76%, and over the past year, they are up 25.91%, while the S&P 500 has only moved 8.33% and 12.92%, respectively [7] Trading Volume - ORIC's average 20-day trading volume is 1,988,020 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, 5 earnings estimates for ORIC have been revised upwards, while only 1 has been revised downwards, leading to an increase in the consensus estimate from -$2.06 to -$1.75 [10] - For the next fiscal year, 3 estimates have moved upwards, with 1 downward revision during the same period [10] Conclusion - Given the strong performance metrics and positive earnings outlook, ORIC is positioned as a promising investment opportunity with a Momentum Score of A [12]
Oric Pharmaceuticals (ORIC) FY Conference Transcript
2025-06-10 15:00
Summary of Oric Pharmaceuticals (ORIC) FY Conference Call Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Industry**: Clinical stage oncology, focusing on small molecule treatments for solid tumors, specifically prostate cancer, lung cancer, and breast cancer [2][3] Key Programs and Pipeline - **ORIC-944**: An allosteric PRC2 inhibitor in combination with AR inhibitors for prostate cancer [3][4] - **ORC-114**: A brain-penetrant EGFR HER2 exon 20 inhibitor for non-small cell lung cancer mutations [4][63] Clinical Development and Data - **Upcoming Studies**: Plans to initiate two Phase III studies in 2026 for ORIC-944 and ORC-114 [4][88] - **Recent Data**: Initial data from a Phase 1b study showed a PSA 50 response of 47% and a PSA 90 response of 24% in combination with AR inhibitors, which is favorable compared to Pfizer's data [18][20] - **Safety Profile**: ORIC-944 demonstrated a lower incidence of treatment-related adverse events compared to Pfizer's PRC2 inhibitor, with a diarrhea rate of 53% and only one grade three event [19][20] Competitive Landscape - **Market Opportunity**: Prostate cancer represents a significant market with approximately 40,000 to 50,000 patients in metastatic CRPC annually [34] - **Comparison with Competitors**: ORIC-944 aims to differentiate itself from Pfizer's mebrometostat by having a longer half-life (20 hours vs. 2 hours) and a potentially better safety profile [12][33][34] - **Other Competitors**: Awareness of several other PRC2 inhibitors in development, including those from Novartis and various companies in China, which may not be optimized for prostate cancer [40][41] Future Expectations and Updates - **Next Updates**: Anticipated updates on ORIC-944 in the second half of 2025, with a focus on PSA response and safety [51][56] - **Phase III Study Timeline**: Expected to start the Phase III study for ORIC-944 in the first half of 2026 [57][88] Financial Position - **Recent Financing**: Raised $125 million in a PIPE financing, extending cash runway into the second half of 2027 [88] - **Cash Management**: The cash runway includes funding for both assets and assumes no strategic partnerships, covering all costs associated with the upcoming Phase III studies [88] Additional Insights - **Combination Studies**: ORIC-114 is being studied in combination with amivantamab, which may provide synergistic effects due to its unique mechanism of action [80][84] - **Patient Population**: ORIC's studies allow for patients with active metastases, which is a differentiating factor compared to other trials that have stringent inclusion criteria [67][72] This summary encapsulates the key points discussed during the conference call, highlighting Oric Pharmaceuticals' strategic focus, clinical advancements, competitive positioning, and financial outlook.
Oric Pharmaceuticals (ORIC) 2025 Conference Transcript
2025-06-04 17:50
Summary of Oric Pharmaceuticals (ORIC) 2025 Conference Call Company Overview - **Company Name**: Oric Pharmaceuticals (ORIC) - **Focus**: Development of small molecule drugs targeting solid tumors, specifically in lung cancer, prostate cancer, and breast cancer [4][5] Key Programs - **ORIC-944**: A PRC2 inhibitor for prostate cancer, currently in combination studies with two androgen receptor inhibitors (apalutamide and darolutamide) [5][6] - **ORIC-114**: A brain-penetrant inhibitor targeting lung cancer populations, including EGFR exon 20, EGFR atypicals, and HER2 exon 20 [6] Clinical Data and Comparisons - **Prostate Cancer Data**: - ORIC-944 showed a confirmed PSA 50 response rate of 47% compared to Pfizer's mevremetostat at 34% [10][13] - Confirmed PSA 90 response rate for ORIC-944 was 24% versus Pfizer's 12% [11][13] - Safety profile of ORIC-944 demonstrated lower rates of gastrointestinal toxicity compared to Pfizer's drug [14][15] Safety and Efficacy - **Toxicity Comparison**: ORIC-944 exhibited significantly lower rates of GI toxicity and anemia compared to Pfizer's data, which reported high rates of diarrhea and dysgeusia [14][15] - **Dosing Strategy**: ORIC-944 has a longer half-life allowing for once-daily dosing, while Pfizer's drug requires twice-daily dosing [26][27] Future Development Plans - **Phase III Study**: Planned to start in the first half of 2026, focusing on both post-abiraterone and post-AR inhibitor populations [33][44] - **Data Updates**: Two additional data updates expected later in 2025, focusing on dose escalation and optimization [34][36] Market Position and Strategy - **Competitive Landscape**: ORIC aims to close the timeline gap with Pfizer, emphasizing that being a second entrant in a large market can still yield significant commercial opportunities [60][61] - **Partnerships**: Strong relationships with Janssen and Bayer for drug supply and insights into clinical development [51][52] Financial Position - **Cash Position**: As of March, ORIC reported a pro forma cash position of $349 million, providing a runway into the second half of 2027 [73] Additional Insights - **ctDNA as a Biomarker**: ORIC is exploring ctDNA as a potential better marker for long-term durability compared to PSA activity [40][41] - **Focus on Frontline Opportunities**: ORIC is prioritizing frontline strategies for ORIC-114, aiming for robust data in competitive populations [63][64] Conclusion - ORIC Pharmaceuticals is positioned to advance its clinical programs with promising early data, a strong financial position, and strategic partnerships, while navigating a competitive landscape in oncology.