On November 5, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results for the quarter ended September 30, 2020 (Press release, ORIC Pharmaceuticals, NOV 5, 2020, View Source [SID1234570060]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In just over six months since our initial public offering we have made substantial progress in advancing our internally developed pipeline and also successfully executed two highly strategic business development deals to augment our pipeline with additional novel programs," said Jacob Chacko, M.D., president and chief executive officer. "These efforts have put us in position for multiple upcoming milestones in 2021, including two top line interim Phase 1b clinical readouts for our lead program, ORIC-101, as well as three IND/CTA filings for ORIC-533, -944 and -114."
Third Quarter 2020 and Other Recent Highlights
Licensed Exclusive Rights to EGFR/HER2 Exon 20 Inhibitor Program, ORIC-114: In October 2020, ORIC licensed from Voronoi, Inc. exclusive rights worldwide excluding the People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC Territory) for the development and commercialization of a potential best-in-class 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 against exon 20 insertion mutations. ORIC expects to file a Clinical Trial Application (CTA) and initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers for ORIC-114 in the second half of 2021.
Licensed Exclusive Worldwide Rights to PRC2 Inhibitor, ORIC-944: In August 2020, ORIC licensed from Mirati Therapeutics, Inc. exclusive worldwide development and commercialization rights to a potential best-in-class small molecule allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2), a validated oncogenic target across several cancers with promising therapeutic potential in prostate cancer, among other indications. ORIC expects to file an IND for ORIC-944 in the second half of 2021.
Preclinical Data on ORIC-101 Presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper): In October 2020, ORIC presented a poster and oral discussion at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium 2020 that demonstrated ORIC-101 reversed glucocorticoid receptor (GR) mediated resistance to an androgen receptor (AR) degrader. Key findings of the presentations included:
Upon treatment of prostate cancer cell lines with an AR degrader, GR mRNA and protein levels were significantly upregulated, similar to the GR upregulation seen after dosing with enzalutamide;
GR upregulation translated into GR activation that conferred resistance to the AR degrader, permitting prostate cancer cells to continue to grow;
ORIC-101 was shown to reverse these effects and block tumor cell growth and androgen-regulated gene expression; and
These data demonstrate that GR may be a mechanism of resistance to AR degraders and that in vitro, ORIC-101 overcomes GR-driven resistance to AR degradation.
Anticipated Milestones
ORIC expects to:
Select the recommended Phase 2 dose for its two ongoing ORIC-101 combination trials in the second half of 2020 and to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.
File an Investigational New Drug (IND) Application for ORIC-533 with the Food and Drug Administration (FDA) in the first half of 2021.
File an IND Application for ORIC-944 with the FDA in the second half of 2021.
File a CTA and initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers for ORIC-114 in the second half of 2021.
Third Quarter 2020 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $186.6 million as of September 30, 2020. The company expects its current cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the second half of 2022.
R&D Expenses: Research and development (R&D) expenses were $8.8 million for the three months ended September 30, 2020, compared to $5.6 million for the three months ended September 30, 2019, an increase of $3.2 million. For the nine months ended September 30, 2020, R&D expenses were $23.8 million compared to $15.9 million for the same period of 2019, an increase of $7.9 million. The increases for the 2020 periods were primarily driven by an increase in external expenses related to the advancement of ORIC-101, ORIC-533 and exploratory research programs, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.5 million and $1.2 million for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, respectively.
IPR&D Expenses: In-process research and development (IPR&D) expense of $13.0 million for the three and nine months ended September 30, 2020 related to the non-cash charge the company recorded for the fair value of the 588,235 shares issued to Mirati for the development and commercialization rights to ORIC-944. There were no similar costs incurred in 2019.
G&A Expenses: General and administrative (G&A) expenses were $3.8 million for the three months ended September 30, 2020, compared to $1.5 million for the three months ended September 30, 2019, an increase of $2.3 million. For the nine months ended September 30, 2020, G&A expenses were $9.1 million compared to $3.9 million for the same period in 2019, an increase of $5.2 million. These increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.9 million and $1.8 million for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, respectively, higher professional services and related costs to operate as a public company.