Oric Pharmaceuticals, Inc.

Previous wording

ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, for which we licensed development and commercialization rights from Mirati Therapeutics, Inc. (Mirati) in August 2020 (Mirati License Agreement). We filed and cleared an IND with the 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 darolutamide as well as in combination with apalutamide, as part of the ongoing Phase 1b trial in patients with metastatic prostate cancer. We also announced that we entered into clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-944 in combination with Nubeqa® (darolutamide), Bayer’s androgen receptor (AR) inhibitor, and Erleada® (apalutamide), Johnson & Johnson’s AR inhibitor.

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 IND with the 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. We expect to report dose escalation data of ORIC-944 both in combination with apalutamide and in combination with darolutamide in the first half of 2025, followed by an additional update in the second half of 2025. We also expect to report dose optimization data in combination with AR inhibitor(s) in the fourth quarter of 2025 or first quarter of 2026. We expect to initiate our first Phase 3 trial for ORIC-944 in mCRPC in the first half of 2026.

Previous wording

ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency towards exon 20 insertion mutations, for which we licensed development and commercialization rights from Voronoi Inc. (Voronoi) in October 2020 (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 Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (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 alterations, atypical EGFR mutations or HER2 amplifications, and that trial allows 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 (ESMO) 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 QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or atypical EGFR mutations. We also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC. We expect to report updated Phase 1b data in the first half of 2025.

Current 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 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.

Previous wording

We have incurred significant losses since the commencement of our operations. Our net loss for the nine months ended September 30, 2024 was $91.5 million and we had an accumulated deficit of $526.5 million as of September 30, 2024. 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-114 and ORIC-944 and any future product candidates from discovery 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 three months ended March 31, 2025, was $30.0 million and we had an accumulated deficit of $592.8 million as of March 31, 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 from discovery 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

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Current wording

Comparison of the Three Months Ended March 31, 2025 and 2024

Previous wording

Research and development expenses were $31.2 million for the three months ended September 30, 2024, compared to $22.4 million for the same period in 2023, an increase of $8.8 million. The increase was driven by a net increase in external expenses of $7.2 million and higher personnel costs of $1.7 million, including additional non-cash stock-based compensation of $0.5 million. The net increase in external expenses was related to the advancement of ORIC-114 and ORIC-944, offset by lower ORIC-533 costs and lower preclinical, other unallocated and discontinued costs.

Current wording

Research and development expenses were $24.6 million for the three months ended March 31, 2025, compared to $22.0 million for the same period in 2024, an increase of $2.7 million. The increase was driven by a net increase in external expenses of $0.3 million and higher personnel costs of $2.4 million, including additional non-cash stock-based compensation of $0.7 million. The net increase in external expenses was related to the advancement of ORIC-944 and ORIC-114, offset primarily by lower costs from discontinued programs.

Previous wording

The following table summarizes our external and internal costs for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our external and internal costs for the three months ended March 31, 2025 and 2024 (in thousands):

Previous wording

General and administrative expenses were $7.1 million for the three months ended September 30, 2024, compared to $6.3 million for the same period in 2023, an increase of $0.8 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

Current wording

General and administrative expenses were $8.1 million for the three months ended March 31, 2025, compared to $7.0 million for the same period in 2024, an increase of $1.0 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.8 million.

Previous wording

We expect our current cash, cash equivalents and investments will be sufficient to fund our current operating plan into late 2026. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts.

Current wording

We expect our current cash, cash equivalents and investments will be sufficient to fund our current operating plan into 2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts.

Previous 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 and accretion of discount on investments.

Current wording

Net cash used in operating activities during the three months ended March 31, 2025, of $32.5 million was attributable to our net loss of $30.0 million and $8.5 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.

Previous wording

Net cash used in operating activities during the nine months ended September 30, 2023, of $61.4 million was attributable to our net loss of $72.4 million, offset by non-cash expenses of $8.0 million, which were primarily driven by stock-based compensation and accretion of discount on investments, and $2.9 million in changes to working capital.

Current wording

Net cash used in operating activities during the three months ended March 31, 2024, of $30.2 million was attributable to our net loss of $25.0 million and $8.2 million in changes to working capital, offset by non-cash expenses of $3.0 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 nine months ended September 30, 2023, of $64.4 million was primarily attributable to purchases of investments, net of maturities.

Current wording

Net cash provided by investing activities during the three months ended March 31, 2025, of $22.5 million was primarily attributable to maturities of investments, net of purchases.

Previous 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.

Current wording

Net cash used in investing activities during the three months ended March 31, 2024, of $61.9 million was primarily attributable to purchases of investments, net of maturities.

Previous wording

Net cash provided by financing activities during the nine months ended September 30, 2024, of $126.0 million was primarily 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.

Current wording

Net cash provided by financing activities during the three months ended March 31, 2024, of $125.0 million was primarily attributable to proceeds received from our private placement in January 2024.