On March 16, 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 and year ended December 31, 2022 (Press release, ORIC Pharmaceuticals, MAR 16, 2023, View Source [SID1234628910]).

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"We had a productive 2022, during which we made significant progress across our clinical pipeline, advanced multiple preclinical discovery programs, and further strengthened the balance sheet," said Jacob M. Chacko, MD, chief executive officer. "We commenced dosing for all three Phase 1b trials in 2022 and selected a drug candidate for our potential first-in-class PLK4 inhibitor. We are pleased with the ongoing enrollment across our three Phase 1b trials and are looking forward to sharing initial clinical data for ORIC-533, ORIC-114, and ORIC-944 in the second half of 2023."

Fourth Quarter 2022 and Other Recent Highlights

ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Enrolling a Phase 1b trial of ORIC-533 as a single-agent, in patients with relapsed/refractory multiple myeloma.
Presented preclinical data supporting the potential of ORIC-533 in multiple myeloma at ASH (Free ASH Whitepaper).
Established a clinical development collaboration with Pfizer for a potential Phase 2 combination study of ORIC-533 and elranatamab, Pfizer’s investigational B-cell maturation antigen (BCMA) CD3 targeted bispecific antibody.
Filed and received clearance for a Clinical Trial Application (CTA) for ORIC-533 by the Canadian regulatory authority.
Expect to report initial Phase 1b data for ORIC-533 in second half of 2023.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

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 or HER2 amplifications, including patients with CNS metastases that are either treated or untreated but asymptomatic.
Initiated the first US site of the Phase 1b trial of ORIC-114 in EGFR/HER2-mutated cancers.
Expect to report initial Phase 1b data for ORIC-114 in second half of 2023.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Enrolling a Phase 1b trial of ORIC-944 as a single-agent, in patients with advanced prostate cancer.
Ongoing preclinical evaluation of combinations in prostate cancer and other potential indications.
Expect to report initial Phase 1b data for ORIC-944 in second half of 2023.
Discovery Pipeline:

Selected a novel, potent, selective, orally bioavailable PLK4 inhibitor as a development candidate.
Corporate Highlights:

The Company sold 5,376,344 shares of common stock at a price of $4.65 per share to Pfizer for proceeds of approximately $25.0 million.
In conjunction with the investment from Pfizer, Jeff Settleman, Ph.D., Chief Scientific Officer, Oncology Research & Development, Pfizer, joined the Company’s Scientific Advisory Board.
Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with multiple myeloma in the second half of 2023.
ORIC-114: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with EGFR/HER2-mutated cancers in the second half of 2023.
ORIC-944: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with prostate cancer in the second half of 2023.
Fourth Quarter and Full year 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $228.2 million as of December 31, 2022, which the company expects will be sufficient to fund its operating plan into the first half of 2025.
R&D Expenses: Research and development (R&D) expenses were $16.3 million for the three months ended December 31, 2022, compared to $16.7 million for the three months ended December 31, 2021, a decrease of $0.5 million. The decrease was primarily due to the discontinuation of ORIC-101. For the year ended December 31, 2022, R&D expenses were $61.7 million compared to $56.9 million for the same period of 2021, an increase of $4.8 million. The increase was driven by a net increase in external expenses related to the advancement of product candidates as well as higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.
G&A Expenses: General and administrative (G&A) expenses were $5.8 million for the three months ended December 31, 2022, compared to $6.1 million for the three months ended December 31, 2021, a decrease of $0.2 million. For the year ended December 31, 2022, G&A expenses were $25.1 million compared to $22.0 million for the same period in 2021, an increase of $3.1 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.9 million.
IPR&D Expenses: In-process research and development (IPR&D) expense of $5.0 million for the year ended December 31, 2022, was due to a development milestone payment made to Voronoi related to ORIC-114. There were no similar costs in 2021.