ORIC 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• Enozertinib, a brain-penetrant, orally bioavailable, irreversible inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, for which we licensed development and commercialization rights from Voronoi under the Voronoi

• 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 resulted in a substantial decrease in preclinical research, primarily from …

• For the six months ended June 30, 2026, research and development expenses were $67.7 million, compared to $55.2 million for the same period in 2025, an increase of $12.5 million. The increase was primarily driven by an increase in external expenses related to the advancement of rinzimetostat, offset…

• The following table summarizes our external and internal costs for the three and six months ended June 30, 2026 and 2025 (in thousands):

• General and administrative expenses were $9.0 million for the three months ended June 30, 2026, compared to $8.5 million for the same period in 2025, an increase of $0.5 million. The increase was primarily due to higher professional services.

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• Enozertinib, a brain-penetrant, orally bioavailable, irreversible inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, for which we licensed development and commercialization rights from Voronoi under the Voronoi License Agreement. In the fourth quarter of 2021, we filed a Clinica…

• 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…

• The following table summarizes our external and internal costs for the three months ended March 31, 2026 and 2025 (in thousands):

• General and administrative expenses were $8.2 million for the three months ended March 31, 2026, which were relatively consistent with the $8.1 million of general and administrative expenses for the same period in 2025.

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• 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.

• There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materiall…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

• biomarker-driven identification and/or highly specific criteria related to the stage of disease progression, or progression on or after certain therapies, are utilized.

• currently subject to legal challenges. While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

• Further, in June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite variou…

• Expanded access studies provide supportive safety information for regulatory review. Physicians conducting these studies may use our product candidates in a manner inconsistent with the protocol, including in children and in individuals with conditions beyond those being studied in our clinical tria…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• Further, in June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite variou…

• challenge longstanding decisions and policies, which could lead to uncertainty in the industry and disrupt federal agencies’ normal operations. Changes to the leadership of federal agencies like HHS, CMS and FDA under the current administration can lead to new policies and regulations that can have …

• Expanded access studies provide supportive safety information for regulatory review. Physicians conducting these studies may use our product candidates in a manner inconsistent with the protocol, including in children and in individuals with conditions beyond those being studied in our clinical tria…

• We have conducted and still conduct clinical trials in the United States. We may choose to conduct additional clinical trials internationally, including our current Phase 1b trials in Asia, Australia and Europe. The acceptance of study data by the FDA, EMA or other comparable foreign regulatory auth…

• the foreign countries outside the United States, the standards for clinical trials and approval may be different. There can be no assurance that any United States or foreign regulatory authority would accept data from trials conducted outside of its applicable jurisdiction. If the FDA, EMA or any ap…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• 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 May 26, 2026, Dominic Piscitelli, our Chief Financial Officer, adopted a “Rule 10b5-1 trading arrangement” providing for the sale from time to time of an aggregate of up to 200,600 shares of our common stock and any unsold shared of common stock from Mr. Piscitelli’s prior 10b5-1 trading plan. Th…

• On June 17, 2026, Mardi Dier, a member 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 114,383 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c)…

• 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.

相对上期删除的文字 · 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.