ORIC 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• enozertinib in the third quarter of 2022. Enozertinib is being evaluated in Phase 1b trials in EGFR exon 20 insertion and P-loop and alpha C-helix compressing (PACC) mutated non-small cell lung cancer (NSCLC), which allow enrollment of patients with CNS metastases that are either treated or untreate…

• We expense research and development costs in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been…

• On August 12, 2025, we announced a strategic pipeline prioritization to focus operational and financial resources on the continued advancement of our two lead clinical programs, rinzimetostat and enozertinib. This initiative has resulted in a substantial

• decrease in preclinical research, primarily from the elimination of our discovery research group. This resulted in an approximately 20% workforce reduction and we have incurred a one-time cost of approximately $1.9 million primarily related to termination benefits, including severance and healthcare…

• General and administrative expenses consist primarily of salaries, related benefits and stock-based compensation expense for personnel in executive, finance and administrative functions. General and administrative expenses also include allocated facilities, depreciation and other expenses, which inc…

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• trial of enozertinib as a single-agent, in patients with advanced solid tumors with EGFR exon 20 insertion mutations, EGFR atypical mutations, or HER2 exon 20 insertion mutations, which allows enrollment of patients with CNS metastases that are either treated or untreated but asymptomatic. We report…

• We expense research and development costs in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our

• estimate of the level of service that has been performed at each reporting date. We track external costs by program, clinical or preclinical. We do not track internal costs by program because these costs are deployed across multiple programs and, as such, are not separately classified.

• On August 12, 2025, we announced a strategic pipeline prioritization to focus operational and financial resources on the continued advancement of our two lead clinical programs, ORIC-944 and enozertinib. This initiative has resulted in a substantial decrease in preclinical research, primarily from t…

• General and administrative expenses consist primarily of salaries, related benefits and stock-based compensation expense for personnel in executive, finance and administrative functions. General and administrative expenses also include allocated facilities, depreciation and other expenses, which inc…

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the SEC's rules and forms, and that such i…

• Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2026.

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time period specified in

• the SEC's rules and forms, and that such information is accumulated and communicated to management including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. As of September 30, 2025, we carried out an evaluation under …

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• limitations on our ability to use overseas vendors and service providers;

• of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the pe…

• Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase i…

• For enozertinib, we are aware that Johnson & Johnson and Dizal Pharmaceuticals have FDA-approved products for patients with EGFR exon 20 insertion mutations. We are also aware of several companies developing small molecule inhibitors against EGFR exon 20 insertion mutations and EGFR atypical mutatio…

• addition, we are facing increasing competition from companies utilizing artificial intelligence, or AI, in their research and development efforts or other business processes, which could create a competitive advantage that we would find difficult to match. While our current use of AI-based platforms…

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• limitations related to our status as an emerging growth company and our status as a smaller reporting company and our transition after we no longer meet the requirements of such statuses;

• Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since

• For enozertinib, we are aware that Johnson & Johnson and Dizal Pharmaceuticals have FDA-approved products for patients with EGFR exon 20 insertion mutations, Daiichi Sankyo in collaboration with AstraZeneca has an FDA-approved product for patients with HER2 mutations, including HER2 exon 20 insertio…

• invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements w…

• third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment, or at all. If we are unable to successfully license or acquire additional product candidates to expand our portfolio, our pipeline, competitive position, business, financial conditi…

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• No officers or directors, as defined in Rule 16a-1(f) of the Exchange Act, adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Regulation S-K Item 408, during the last fiscal quarter.

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• During the last fiscal quarter, certain directors and officers, as defined in Rule 16a-1(f) of the Exchange Act, adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408, as follows:

• On September 26, 2025, Richard Heyman, Ph.D., Chairman of our board of directors, adopted a “Rule 10b5-1 trading arrangement” providing for the sale from time to time of an aggregate of up to 89,400 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in…

• Except as described above, no officers or directors, as defined in Rule 16a-1(f) of the Exchange Act, adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Regulation S-K Item 408, during the last fiscal quarter.