On May 6, 2021 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 March 31, 2021 (Press release, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579351]).
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"We continue to make steady progress in advancing our robust pipeline of novel oncology candidates," said Jacob Chacko, M.D., president and chief executive officer. "As planned, we will present preliminary safety, pharmacokinetic, and translational data, as well as early efficacy data from our ongoing Phase 1 trial of ORIC-101 in combination with nab-paclitaxel in solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, we expect to achieve multiple other milestones throughout the remainder of 2021, including reporting preliminary data from our second trial for ORIC-101 in combination with enzalutamide in prostate cancer, and IND/CTA filings for ORIC-533, our oral small molecule CD73 inhibitor, ORIC-944, our allosteric PRC2 inhibitor, and ORIC-114, our brain penetrant EGFR/HER2 exon 20 inhibitor."
First Quarter 2021 and Other Recent Highlights
Acceptance of Two Abstracts at ASCO (Free ASCO Whitepaper): Two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021. The ASCO (Free ASCO Whitepaper) presentations will highlight interim safety, pharmacokinetic, efficacy, and translational data from the ongoing Phase 1b study of ORIC-101 in combination with nab-paclitaxel.
Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2021, ORIC presented posters on four programs at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting. Key findings of the presentations included:
ORIC-101: Glucocorticoid Receptor (GR) Antagonist
GR upregulation and activation, an established preclinical resistance mechanism for antiandrogens, may drive resistance when antiandrogens are combined with AKT inhibitors.
ORIC-101 was able to overcome this resistance and restore antitumor activity in preclinical prostate cancer cell lines.
ORIC-533: Oral Small Molecule CD73 Inhibitor
Nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, reflective of AMP levels observed in tumors.
Inhibitors of adenosine receptors were only able to rescue CD8+ T-cell function in the context of low AMP, and were ineffective in moderate or high AMP levels.
ORIC-533 has potential best-in-class properties in inhibiting adenosine production and reversing immunosuppression in tumors.
ORIC-944: Allosteric PRC2 Inhibitor
ORIC-944 has potential best-in-class drug properties compared to first generation PRC2 inhibitors, including a clean CYP profile.
ORIC-944 demonstrated superior activity compared to an EZH2 inhibitor in an in vivo DLBCL model.
ORIC-944 demonstrated strong tumor growth inhibition as a single agent with once daily oral dosing in both enzalutamide-responsive and enzalutamide-resistant in vivo prostate cancer models.
ORIC-114: Brain Penetrant EGFR/HER2 exon 20 Inhibitor
ORIC-114 is highly selective for the EGFR family of receptors with superior kinome selectivity compared to other exon 20 inhibitors.
ORIC-114 demonstrated low nanomolar potency across exon 20 insertion variants in biochemical and cell-based assays.
Significant tumor regression was observed in multiple EGFR exon 20 patient-derived xenograft models using once daily oral administration of ORIC-114.
ORIC-114 displayed superior brain exposure relative to other compounds targeting exon 20 insertion mutations, and greater activity compared to other EGFR inhibitors in an intracranial NSCLC EGFR mutant xenograft model.
Anticipated Milestones
ORIC anticipates the following milestones in 2021:
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with nab-paclitaxel at ASCO (Free ASCO Whitepaper)
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with enzalutamide in the second half of 2021
ORIC-533: File an IND in the second quarter of 2021
ORIC-944: File an IND in the second half of 2021
ORIC-114: File a CTA in the second half of 2021
Present additional preclinical data at scientific conferences in 2021
First Quarter 2021 Financial Results
Cash, Cash Equivalents and Short-term Investments: Cash, cash equivalents, and short-term investments totaled $278.1 million as of March 31, 2021. The company expects its current cash, cash equivalents, and short-term investments will be sufficient to fund its current operating plan into the second half of 2023.
R&D Expenses: Research and development expenses were $11.7 million for the three months ended March 31, 2021, compared to $7.3 million for the three months ended March 31, 2020, an increase of $4.4 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-101 and our other product candidates of $3.6 million, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.8 million for the three months ended March 31, 2021, as compared to the same period in 2020.
G&A Expenses: General and administrative expenses were $4.9 million for the three months ended March 31, 2021, compared to $1.9 million for the three months ended March 31, 2020, an increase of $3.0 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.4 million for the three months ended March 31, 2021, as compared to the same period in 2020, and higher professional services and related costs to operate as a public company.