On March 11, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter and year ended December 31, 2023 (Press release, ORIC Pharmaceuticals, MAR 11, 2024, View Source [SID1234641021]).
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"We’ve made significant progress over the past year as we presented initial positive data readouts across our three clinical programs, ORIC-114, ORIC-944 and ORIC-533, demonstrating their potential as best-in-class cancer therapeutics," said Jacob M. Chacko, M.D., president and chief executive officer. "We strengthened our balance sheet with the completion of two PIPE financings totaling $210 million from top-tier healthcare specialist funds and prioritized our clinical pipeline around ORIC-114 and ORIC-944. We are building on the momentum generated in 2023 with multiple clinical milestones planned through the first half of 2025 as we advance two programs towards the initiation of registrational studies in the second half of 2025."
Fourth Quarter 2023 and Other Recent Highlights
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor
Presented initial data from the Phase 1b dose escalation trial for patients with EGFR or HER2 exon 20 mutated non-small cell lung cancer (NSCLC) at the ESMO (Free ESMO Whitepaper) Congress 2023. Initial data demonstrated potential best-in-class profile in heavily pretreated patients, with 81% of patients having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline. Data from 50 patients showed favorable safety and both systemic and CNS responses, including the first reported systemic and CNS confirmed complete response in a patient with active brain metastases.
Presented preclinical data for ORIC-114 at ESMO (Free ESMO Whitepaper) Congress 2023, demonstrating potent activity across atypical mutations in EGFR, thus expanding the potential eligible patient population.
Expect to initiate dose expansion of Phase 1b trial in multiple cohorts in the first half of 2024 and expect to report updated Phase 1b data in the first half of 2025.
ORIC-944: a potent and selective allosteric inhibitor of PRC2
In January 2024, reported initial Phase 1b monotherapy data in metastatic prostate cancer demonstrating the potential of ORIC-944 as a best-in-class therapeutic, including half-life greater than 10 hours, robust target engagement and well tolerated safety profile, supporting advancement for combination development.
Expect to initiate combination study with AR inhibitor(s) in the first half of 2024 and provide a program update in mid-2024.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73
Presented initial data from the Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma at the 2023 ASH (Free ASH Whitepaper) Annual Meeting. Initial data demonstrated preliminary evidence of clinical antimyeloma activity and predicted immune effects from preclinical models, as well as a clean safety profile, with only grade 1 and 2 treatment-related events in heavily pre-treated patients.
Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024, and the company plans to pursue strategic partnership for combination studies.
Discovery Pipeline:
Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibitors as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Advanced ORIC-613, a novel, highly selective PLK4 inhibitor, through IND enabling studies.
Corporate Highlights:
Strengthened cash position with $85 million and $125 million private placement financings from new and existing healthcare specialist funds in June 2023 and January 2024, respectively.
Fourth Quarter and Full Year 2023 Financial Results
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $235.0 million as of December 31, 2023. Including the $125.0 million private placement in January 2024, as of January 31, 2024 the Company had $351.8 million (unaudited) in cash, cash equivalents and investments, which is expected to fund the current operating plan into late 2026.
R&D Expenses: Research and development (R&D) expenses were $24.5 million for the three months ended December 31, 2023, compared to $16.3 million for the three months ended December 31, 2022, an increase of $8.2 million. For the year ended December 31, 2023, R&D expenses were $85.2 million compared to $61.7 million for the same period of 2022, an increase of $23.5 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs.
G&A Expenses: General and administrative (G&A) expenses were $6.9 million for the three months ended December 31, 2023, compared to $5.8 million for the three months ended December 31, 2022, an increase of $1.1 million. The increase was primarily due to higher professional fees and personnel costs. For the year ended December 31, 2023, G&A expenses were $25.6 million compared to $25.1 million for the same period of 2022, an increase of $0.5 million. The increase was primarily due to higher personnel costs.
IPR&D Expenses: Acquired in-process research and development (IPR&D) expenses of $5.0 million for the year ended December 31, 2022, were due to a development milestone payment related to ORIC-114. There were no such expenses for the year ended December 31, 2023.