Oric Pharmaceuticals, Inc.

Previous wording

ORIC-944, an allosteric inhibitor of the PRC2 via the embryonic ectoderm development (EED) subunit, for which we licensed development and commercialization rights from Mirati with the Mirati License Agreement. We filed and cleared an Investigational New Drug (IND) with the Food and Drug Administration (FDA) for ORIC-944 in the fourth quarter of 2021. We completed a Phase 1b trial of ORIC-944 as a single-agent, in patients with advanced prostate cancer and reported initial Phase 1b data from this trial in January 2024, demonstrating potential best-in-class drug properties, including an approximate 20-hour clinical half-life, robust target engagement and a favorable safety profile. In July 2024, we announced that in the first half of 2024 we initiated dosing of ORIC-944 in combination with apalutamide as well as in combination with darolutamide, as part of the ongoing Phase 1b trial in patients with metastatic castration resistant prostate cancer (mCRPC). We also announced that we entered into clinical trial collaboration and supply agreements with Janssen Research & Development, LLC, a Johnson and Johnson company (Johnson & Johnson) and Bayer Consumer Care AG (Bayer), to evaluate ORIC-944 in combination with Erleada® (apalutamide), Johnson & Johnson’s androgen receptor (AR) inhibitor and Nubeqa® (darolutamide), Bayer’s AR inhibitor. In January 2025, we reported early Phase 1b combination data from the dose escalation cohort of ORIC-944 in combination with 240 mg (QD) apalutamide in patients with mCRPC. In May 2025, we reported additional data which included ORIC-944 in combination with 600 mg (BID) darolutamide in patients with mCRPC, in addition to the previously reported data from January 2025. The combined May 2025 data set demonstrated a 59% PSA50 response rate (confirmed response rate of 47%) and 24% PSA90 response rate (all confirmed) in patients with mCRPC. The PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide. As of May 9, 2025, the data cutoff date for the May 2025 data set, the majority of patients were still ongoing with multiple patients approaching one year or more on therapy. Both combination regimens demonstrated a safety profile compatible with long term dosing, with the vast majority of adverse events Grade 1 or Grade 2 in severity. We expect to report updated data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in the second half of 2025. We expect to report dose optimization data in the first quarter of 2026, and we expect to initiate our first Phase 3 trial for ORIC-944 in mCRPC in the first half of 2026.

Current wording

ORIC-944, an allosteric inhibitor of the PRC2 via the embryonic ectoderm development (EED) subunit, for which we licensed development and commercialization rights from Mirati with the Mirati License Agreement. We filed and cleared an Investigational New Drug (IND) with the Food and Drug Administration (FDA) for ORIC-944 in the fourth quarter of 2021. We completed a Phase 1b trial of ORIC-944 as a single-agent, in patients with advanced prostate cancer and reported initial Phase 1b data from this trial in January 2024, demonstrating potential best-in-class drug properties, including an approximate 20-hour clinical half-life, robust target engagement and a favorable safety profile. In July 2024, we announced that in the first half of 2024 we initiated dosing of ORIC-944 in combination with apalutamide as well as in combination with darolutamide, as part of the ongoing Phase 1b trial in patients with metastatic castration resistant prostate cancer (mCRPC). We also announced that we entered into clinical trial collaboration and supply agreements with Janssen Research & Development, LLC, a Johnson and Johnson company (Johnson & Johnson) and Bayer Consumer Care AG (Bayer), to evaluate ORIC-944 in combination with Erleada® (apalutamide), Johnson & Johnson’s androgen receptor (AR) inhibitor and Nubeqa® (darolutamide), Bayer’s AR inhibitor. In the first half of 2025, we reported Phase 1b combination data from the dose exploration cohort of ORIC-944 in combination with apalutamide and with darolutamide in 17 patients with mCRPC. In November 2025, we announced the completion of the dose exploration portion of the Phase 1b trial and the selection of provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg QD of ORIC-944 in combination with 600 mg BID of darolutamide; and 600 mg, 800 mg and 1,200 mg QD of ORIC-944 in combination with 240 mg QD of apalutamide. Also, in November 2025, we reported Phase 1b dose exploration data in 20 patients with mCRPC, which included the 17 patients reported earlier this year, who were treated with ORIC-944 in combination with 240 mg QD of apalutamide or with 600 mg BID of darolutamide. The November 2025 data set (cutoff date of September 22, 2025) demonstrated PSA responses and circulating tumor DNA (ctDNA) reductions across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide. Broad and deep PSA responses were demonstrated, with 55% of patients achieving a PSA50 response rate (confirmed in 40%), and 20% of patients achieving a PSA90 response rate (all confirmed). Rapid and deep ctDNA responses were observed in patients across a breadth of AR mutations and other gene alterations, with 76% of patients achieving greater than 50% ctDNA reduction, and 59% of patients achieving ctDNA clearance. Both combination regimens demons…

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Previous wording

ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, for which we licensed development and commercialization rights from Voronoi with the Voronoi License Agreement. In the fourth quarter of 2021, we filed a Clinical Trial Application (CTA) in South Korea for ORIC-114, which was cleared in the first quarter of 2022. We also filed and cleared an IND with the FDA for ORIC-114 in the third quarter of 2022. We are enrolling a Phase 1b trial of ORIC-114 as a single-agent, in patients with advanced solid tumors with EGFR and HER2 exon 20 insertion mutations, EGFR atypical mutations or HER2 amplifications, which allows enrollment of patients with CNS metastases that are either treated or untreated but asymptomatic. We reported initial Phase 1b data from this trial at the European Society for Medical Oncology Congress in October 2023, which demonstrated both systemic and intracranial activity across multiple dose levels in a heavily pre-treated patient population. In April 2024, we announced the selection of two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg daily QD. We expect to report a comprehensive data update during the second half of 2025 that will include ORIC-114 in the first-line EGFR exon 20 monotherapy cohort, the 2L+ EGFR atypical cohort and cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20. In January 2025, we announced that we entered into a clinical trial and supply agreement with Johnson & Johnson, to evaluate ORIC-114 in combination with subcutaneous (SC) amivantamab for the first line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, and we initiated a Phase 1b trial in the first quarter of 2025. Initial data from this trial in addition to ORIC-114 data as a monotherapy in first-line EGFR atypical mutations are expected in mid-2026. We also expect to initiate Phase 3 trial(s) for ORIC-114 in first-line NSCLC in 2026, in EGFR exon 20, HER2 exon 20, and/or atypical EGFR mutations.

Current wording

Enozertinib (formerly ORIC-114), a brain-penetrant, orally bioavailable, irreversible inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, for which we licensed development and commercialization rights from Voronoi with the Voronoi License Agreement. In the fourth quarter of 2021, we filed a Clinical Trial Application (CTA) in South Korea for enozertinib, which was cleared in the first quarter of 2022. We also filed and cleared an IND with the FDA for enozertinib in the third quarter of 2022. We are enrolling a Phase 1b 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 reported initial Phase 1b data from this trial at the European Society for Medical Oncology Congress in October 2023, which demonstrated both systemic and intracranial activity across multiple dose levels in a heavily pre-treated patient population. In April 2024, we announced the selection of two provisional recommended Phase 2 dose (RP2D) levels of enozertinib at 80 mg and 120 mg daily QD. We expect to report a comprehensive data update during the fourth quarter of 2025 that will include enozertinib in the first-line EGFR exon 20 monotherapy cohort, the 2L+ EGFR atypical cohort and cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20. In January 2025, we announced that we entered into a clinical trial and supply agreement with Johnson & Johnson, to evaluate enozertinib in combination with subcutaneous (SC) amivantamab for the first line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, and we initiated a Phase 1b trial in the first quarter of 2025. Initial data from this trial in addition to enozertinib data as a monotherapy in first-line EGFR atypical mutations are expected in mid-2026. We also expect to initiate Phase 3 trial(s) for enozertinib in first-line NSCLC in 2026, in EGFR exon 20, EGFR atypical, and/or HER2 exon 20 mutations.

Previous wording

Beyond these clinical stage product candidates, we have historically engaged in the research and development of multiple discovery stage precision medicines targeting other hallmark cancer resistance mechanisms. 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 ORIC-114. This initiative will result in a substantial decrease in preclinical research, primarily from the elimination of our discovery research group.

Current wording

Beyond these clinical stage product candidates, we have historically engaged in the research and development of multiple discovery stage precision medicines targeting other hallmark cancer resistance mechanisms. 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 the elimination of our discovery research group.

Previous wording

We have incurred significant losses since the commencement of our operations. Our net loss for the six months ended June 30, 2025, was $66.4 million and we had an accumulated deficit of $629.2 million as of June 30, 2025. Our losses and accumulated deficit have resulted primarily from costs incurred in connection with research and development activities including in-licensing and to a lesser extent from general and administrative costs associated with our operations. We expect to incur significant losses for the foreseeable future, and we anticipate these losses will increase significantly as we continue our development of ORIC-944 and ORIC-114 and any future product candidates through preclinical development and into clinical trials as we seek regulatory approval for these product candidates. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

Current wording

We have incurred significant losses since the commencement of our operations. Our net loss for the nine months ended September 30, 2025, was $99.0 million and we had an accumulated deficit of $661.7 million as of September 30, 2025. Our losses and accumulated deficit have resulted primarily from costs incurred in connection with research and development activities including in-licensing and to a lesser extent from general and administrative costs associated with our operations. We expect to incur significant losses for the foreseeable future, and we anticipate these losses will increase significantly as we continue our development of ORIC-944 and enozertinib and any future product candidates through preclinical development and into clinical trials as we seek regulatory approval for these product candidates. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

Previous wording

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 ORIC-114. This initiative will result in a substantial decrease in preclinical research, primarily from the elimination of our discovery research group. This will result in an approximately 20% workforce reduction and we expect to incur a one-time cost of approximately $1.9 million primarily related to termination benefits, including severance and healthcare-related benefits. We estimate that the workforce reduction will be substantially complete in the third quarter of 2025 and that the majority of the related charges will be recognized in our financial results of operations for the third quarter of 2025.

Current wording

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 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-related benefits. The workforce reduction was substantially completed in the third quarter of 2025.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Previous wording

Research and development expenses were $30.5 million for the three months ended June 30, 2025, compared to $28.9 million for the same period in 2024, an increase of $1.6 million. The increase was driven by higher personnel costs of $2.5 million, including additional non-cash stock-based compensation of $0.8 million, offset primarily by lower costs from discontinued programs.

Current wording

Research and development expenses were $28.8 million for the three months ended September 30, 2025, compared to $31.2 million for the same period in 2024, a decrease of $2.4 million. The decrease was driven by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs of $2.7 million, including additional non-cash stock-based compensation of $0.3 million, and costs related to the advancement of enozertinib.

Previous wording

For the six months ended June 30, 2025, research and development expenses were $55.2 million, compared to $50.9 million for the same period in 2024, an increase of $4.3 million. The increase was driven by higher personnel costs of $4.9 million, including additional non-cash stock-based compensation of $1.5 million, and costs related to the advancement of ORIC-114, offset primarily by lower costs from discontinued programs.

Current wording

For the nine months ended September 30, 2025, research and development expenses were $84.0 million, compared to $82.1 million for the same period in 2024, an increase of $1.9 million. The increase was driven by higher personnel costs of $7.6 million, including additional non-cash stock-based compensation of $1.9 million, and costs related to the advancement of enozertinib, offset by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs.

Previous wording

The following table summarizes our external and internal costs for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our external and internal costs for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

General and administrative expenses were $8.5 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024, an increase of $1.4 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $0.8 million.

Current wording

General and administrative expenses were $7.9 million for the three months ended September 30, 2025, compared to $7.1 million for the same period in 2024, an increase of $0.8 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $0.2 million.

Previous wording

For the six months ended June 30, 2025, general and administrative expenses were $16.6 million, compared to $14.1 million for the same period in 2024, an increase of $2.5 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $1.6 million.

Current wording

For the nine months ended September 30, 2025, general and administrative expenses were $24.5 million, compared to $21.2 million for the same period in 2024, an increase of $3.3 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $1.9 million.

Previous wording

We previously entered into an ATM sales agreement with Jefferies LLC as our sales agent, to sell shares of our common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, we filed a Form S-3ASR and prospectus supplement, to allow us to sell from time to time up to $200.0 million of shares of our common stock in negotiated transactions or transactions deemed to be an ATM offering. As of June 30, 2025, we raised approximately $8.9 million through the sale of 850,000 shares in an ATM offering, with participation from a healthcare specialist fund, at a purchase price of $10.50. As of June 30, 2025, $191.1 million remained available for sale under the ATM sales agreement. Subsequent to June 30, 2025, from July 1, 2025, through August 12, 2025, we raised aggregate net proceeds of approximately $108.7 million under the ATM sales agreement.

Current wording

We previously entered into an ATM sales agreement with Jefferies LLC as our sales agent, to sell shares of our common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, we filed a Form S-3ASR and prospectus supplement, to allow us to sell from time to time up to $200.0 million of shares of our common stock in negotiated transactions or transactions deemed to be an ATM offering. During the three months ended September 30, 2025, we raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $108.7 million through the sale of 10,930,032 shares at a weighted average purchase price of $10.10. During the nine months ended September 30, 2025, we raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $117.6 million through the sale of 11,780,032 shares at a weighted average purchase price of $10.13.

Previous wording

Net cash used in operating activities during the six months ended June 30, 2024, of $55.8 million was attributable to our net loss of $57.0 million and $4.8 million in changes to working capital, offset by non-cash expenses of $6.0 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2025, of $88.5 million was attributable to our net loss of $99.0 million and $7.1 million in changes to working capital, offset by non-cash expenses of $17.6 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Previous wording

Net cash used in operating activities during the six months ended June 30, 2025, of $63.4 million was attributable to our net loss of $66.4 million and $9.3 million in changes to working capital, offset by non-cash expenses of $12.3 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2024, of $84.6 million was attributable to our net loss of $91.5 million and $2.4 million in changes to working capital, offset by non-cash expenses of $9.3 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Previous wording

Net cash used in investing activities during the six months ended June 30, 2025, of $54.5 million was primarily attributable to purchases of investments, net of maturities.

Current wording

Net cash used in investing activities during the nine months ended September 30, 2025, of $165.0 million was primarily attributable to purchases of investments, net of maturities.

Previous wording

Net cash used in investing activities during the six months ended June 30, 2024, of $43.6 million was primarily attributable to purchases of investments, net of maturities.

Current wording

Net cash used in investing activities during the nine months ended September 30, 2024, of $20.5 million was primarily attributable to purchases of investments, net of maturities.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2025, of $134.3 million was attributable to net proceeds received from our private placement in May 2025, the ATM offering in June 2025 and proceeds received from common stock issued under our ESPP and stock option exercises.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2025, of $243.8 million was attributable to net proceeds received from our private placement in May 2025 of $124.4 million, net proceeds from our ATM offerings of $117.6 million and proceeds received from stock option exercises and common stock issued under our ESPP.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2024, of $125.8 million was attributable to net proceeds received from our private placement in January 2024 and proceeds received from common stock issued under our ESPP and stock option exercises.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2024, of $126.0 million was attributable to net proceeds received from our private placement in January 2024 of $124.8 million and proceeds received from stock option exercises and common stock issued under our ESPP.

Previous wording

We are also a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended (Exchange Act). We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies.

Current wording

We are also a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended (Exchange Act). We may take advantage of certain of the scaled disclosures available to smaller reporting companies.

Previous wording

We will remain an emerging growth company and a smaller reporting company until December 31, 2025. We will transition to “large accelerated filer” status on December 31, 2025 because the aggregate market value of our common stock held by non-affiliates exceeded $700 million as of June 30, 2025. Beginning with our Annual Report on Form 10-K for the year ending December 31, 2025, we will be subjected to shorter filing deadlines and be required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, which will require additional time and expense. In addition, beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2026, we will no longer be permitted to take advantage of the reduced reporting requirements applicable to smaller reporting companies.

Current wording

We will remain an emerging growth company and a smaller reporting company until December 31, 2025. Beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2026, we will no longer be permitted to take advantage of the reduced reporting requirements applicable to smaller reporting companies, but will remain a non-accelerated filer through 2026.