On November 6, 2023 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 ended September 30, 2023 (Press release, ORIC Pharmaceuticals, NOV 6, 2023, View Source [SID1234637042]).

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"We continued making strong progress across our pipeline in the third quarter of 2023 with steady enrollment across our three clinical trials and the first presentation of clinical data for ORIC-114," said Jacob M. Chacko, MD, chief executive officer. "Initial data for ORIC-114 demonstrated clinical activity across multiple dose levels, including the first reported CNS complete response by an EGFR exon 20 inhibitor in a patient with untreated brain metastases, and a favorable safety profile. We are eager to continue advancing ORIC-114, and we also look forward to presenting initial clinical data for ORIC-533 in multiple myeloma and for ORIC-944 in prostate cancer over the coming quarters."

Third Quarter 2023 and Other Recent Highlights:

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Presented initial data from the ongoing 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.
CNS activity was observed at multiple dose levels, including the first reported CNS complete response by an EGFR exon 20 inhibitor in a patient with documented untreated brain metastases.
Systemic responses were observed at multiple dose levels in heavily pre-treated NSCLC patients, characterized by 81% having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline.
At the potential RP2D of 75 mg QD, responses were observed in 2 of 3 EGFR exon 20 patients previously treated with amivantamab, including a confirmed complete response.
Responses were observed at multiple dose levels in HER2 exon 20 patients, including a confirmed partial response with 100% regression of all target lesions.
ORIC-114 demonstrated a favorable safety profile with mainly Grade 1 and 2 treatment related adverse events.
Presented preclinical data for ORIC-114 at ESMO (Free ESMO Whitepaper) Congress 2023 demonstrating potent activity across atypical mutations in EGFR.
The Phase 1b trial of ORIC-114 is ongoing to determine the candidate RP2Ds for dose optimization and the selection of the final RP2D. Expansion cohorts will enroll patients with EGFR exon 20 insertion mutations that are EGFR exon 20 inhibitor-naïve and that have been previously treated with amivantamab, as well as patients with HER2 exon 20 insertion mutations and atypical EGFR mutations. The company expects to report updated Phase 1b data in the first half of 2025.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Ongoing enrollment in a Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma.
The company will report initial safety, PK/PD, and preliminary antitumor activity data at the 65th ASH (Free ASH Whitepaper) Annual Meeting taking place December 9-12, 2023, in San Diego, CA.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Ongoing enrollment in a Phase 1b trial of ORIC-944 in patients with advanced prostate cancer.
Expect to report initial safety, PK/PD, and preliminary antitumor activity data in the first quarter of 2024.
Third Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of September 30, 2023, which the company expects will be sufficient to fund its current operating plan into late 2025.
R&D Expenses: Research and development (R&D) expenses were $22.4 million for the three months ended September 30, 2023, compared to $14.7 million for the three months ended September 30, 2022, an increase of $7.7 million. For the nine months ended September 30, 2023, R&D expenses were $60.7 million, compared to $45.4 million for the nine months ended September 30, 2022, an increase of $15.3 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 $6.3 million for the three months ended September 30, 2023, compared to $6.0 million for the three months ended September 30, 2022, an increase of $0.3 million. For the nine months ended September 30, 2023, G&A expenses were $18.7 million, compared to $19.3 million for the nine months ended September 30, 2022, a decrease of $0.6 million. The decrease was primarily due to a decrease in professional fees.

IPR&D Expenses: Acquired in-process research and development (IPR&D) expenses of $5.0 million for the three and nine months ended September 30, 2022, were due to a development milestone payment related to ORIC-114. There were no such expenses for the three and nine months ended September 30, 2023.