On November 7, 2022 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, 2022 (Press release, ORIC Pharmaceuticals, NOV 7, 2022, View Source [SID1234623338]).
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"We are pleased with the steady enrollment progress across our three ongoing Phase 1b studies and are looking forward to sharing initial clinical data for ORIC-533, ORIC-114 and ORIC-944 in the first half of 2023. Building on the strong enrollment in South Korea for ORIC-114, our brain penetrant EGFR/HER2 exon 20 program, we accelerated plans for the US IND filing and received clearance from the FDA during the third quarter," said Jacob M. Chacko, MD, chief executive officer. "We continue to be encouraged by data demonstrating ORIC-533, our oral small molecule inhibitor of CD73, has therapeutic potential in multiple myeloma and look forward to the presentation of ORIC-533 preclinical data at the 2022 ASH (Free ASH Whitepaper) Annual Meeting next month."
Third Quarter 2022 and Other Recent Highlights
ORIC-114 US IND Filing and FDA Clearance: ORIC continued to expand the clinical development of ORIC-114 by submitting and receiving clearance from the FDA of its US IND application in the third quarter of 2022. A Phase 1b trial with ORIC-114 as a single agent is already underway in South Korea and has been enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows patients with CNS metastases that are either treated or untreated but asymptomatic.
ORIC-533 Preclinical Data to be Presented at the 2022 ASH (Free ASH Whitepaper) Annual Meeting: ORIC announced a preclinical poster presentation on its CD73 inhibitor in multiple myeloma will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, LA.
Anticipated Program Milestones
ORIC anticipates the following upcoming milestones:
ORIC-533 (oral CD73 inhibitor): Initial Phase 1b data in 1H 2023
ORIC-114 (brain penetrant EGFR/HER2 exon 20 inhibitor): Initial Phase 1b data in 1H2023
ORIC-944 (allosteric PRC2 inhibitor): Initial Phase 1b data in 1H 2023
Third Quarter 2022 Financial Results
Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $218.0 million as of September 30, 2022, which the company expects will fund its current operating plan into the second half of 2024.
R&D Expenses: Research and development (R&D) expenses were $14.7 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of product candidates as well as higher personnel costs. For the nine months ended September 30, 2022, R&D expenses were $45.4 million, compared to $40.1 million for the same period of 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and other product candidates as well as higher personnel costs, including non-cash stock-based compensation of $0.8 million.
G&A Expenses: General and administrative (G&A) expenses were $6.0 million for the three months ended September 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily due to higher personnel costs. For the nine months ended September 30, 2022, G&A expenses were $19.3 million compared to $16.0 million for the same period of 2021. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million.
IPR&D Expenses: In-process research and development (IPR&D) expense of $5.0 million for the three and nine months ended September 30, 2022, was due to a development milestone payment made to Voronoi related to ORIC-114. There were no similar costs in 2021.