On August 10, 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 June 30, 2021 (Press release, ORIC Pharmaceuticals, AUG 10, 2021, View Source [SID1234586224]).
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"We executed well in the first half of the year, achieving multiple milestones, including the initial data readout for ORIC-101 in combination with nab-paclitaxel in solid tumors and the clearance of the IND application for ORIC-533, our small molecule CD73 inhibitor," said Jacob Chacko, M.D., president and chief executive officer. "In the second half of the year, we expect to present preliminary safety, pharmacokinetic, and translational data, as well as preliminary antitumor activity from our ongoing Phase 1 trial of ORIC-101 in combination with enzalutamide in prostate cancer. In addition, we look forward to dosing our first patient with ORIC-533 and to filing an IND for ORIC-944, our allosteric PRC2 inhibitor, and a CTA for ORIC-114, our brain penetrant EGFR/HER2 exon 20 inhibitor. Furthermore, the proceeds from our recent financing have bolstered our balance sheet with funding for the continued development of ORIC-101 and our other three product candidates through multiple data readouts expected in the 2022 and 2023 timeframe."
Second Quarter 2021 and Other Recent Highlights
Initial ORIC-101 Clinical Data Presented at ASCO (Free ASCO Whitepaper): In June 2021, ORIC presented initial clinical data from the Phase 1b trial of ORIC-101 in combination with nab-paclitaxel. The trial is a single arm, multicenter, open-label study conducted in two parts, intended to establish the recommended Phase 2 dose (RP2D), safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity when administered to patients with advanced or metastatic solid tumors. Following the completion of the Part I dose escalation portion of the study, the RP2D was determined to be 160 mg of ORIC-101 continuous once daily dosing in combination with 75 mg/m2 of nab-paclitaxel, without requirement for prophylactic granulocyte-colony stimulating factor (G-CSF). For the Part II dose expansion portion of the study, up to 132 patients are expected to be enrolled across four cohorts, including pancreatic ductal adenocarcinoma (PDAC), ovarian cancer, triple negative breast cancer, and other advanced solid tumors. Enrollment continues in the Part II dose expansion cohorts at 12 clinical sites across the United States. Patients in the dose expansion portion of the study are required to have previously progressed on a taxane-based therapy, with retrospective analysis of GR expression and other potentially predictive biomarkers. Key findings of the initial data presented included:
Safety Analyses:
As of March 31, 2021, a total of 31 patients were enrolled across Parts I and II of the study, which included 12 patients treated at non-RP2D doses and 19 patients treated at the RP2D. Patients treated at the RP2D were heavily pretreated, with a median of four prior therapies, and all had previously received a taxane-based therapy.
As of the database cutoff date of April 21, 2021, the RP2D was well tolerated; treatment-related adverse events were primarily Grade 1 or 2, with only three Grade 3 events, which all resolved with dose interruption.
There were no treatment-related discontinuations and no requirement for prophylactic G-CSF at the RP2D.
Preliminary Antitumor Activity (as of the database cutoff date of April 21, 2021):
The efficacy evaluable population included a total of 23 patients who had an opportunity for at least one on-treatment tumor assessment.
Five partial responses were observed, one confirmed and four unconfirmed, including in heavily pretreated patients with PDAC, endometrial and breast cancers, who previously progressed on or after a taxane-based therapy.
Further evidence of antitumor activity was demonstrated by prolonged disease stabilization across multiple solid tumors, including PDAC, breast, gastric, esophageal, and testicular cancers.
Notably, three of the four efficacy evaluable patients with late-line relapsed PDAC treated at the RP2D demonstrated extended progression free survival ranging from 3.6 months to 5.3+ months in the third-line or later setting, despite having already previously progressed on nab-paclitaxel.
ORIC-533 IND Cleared by FDA: In June 2021, ORIC announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug Application (IND) for ORIC-533 to proceed into a first-in-human clinical trial. ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. Based on a preclinical collaboration with an academic key opinion leader that generated compelling single agent activity in patient derived model systems in an undisclosed tumor type, the company plans to pursue a single agent clinical development plan in this indication. ORIC plans to initiate the Phase 1 clinical trial with ORIC-533 in the second half of 2021 to evaluate safety, PK and preliminary efficacy in cancer patients.
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.
Corporate: In July 2021, ORIC raised gross proceeds of $50.0 million through the sale of approximately 2.6 million shares under its ATM offering, with participation based on unsolicited interest received from a healthcare specialist fund. The company sold the shares at a purchase price per share of $19.25, a premium to the market price at the time of the sale.
Anticipated Milestones
ORIC anticipates the following milestones in the second half of 2021:
ORIC-101: Report interim safety, pharmacokinetics, translational data, and preliminary antitumor activity from the ongoing combination trial with enzalutamide
ORIC-533: Initiate Phase 1 study
ORIC-944: File IND
ORIC-114: File CTA
Present additional preclinical data at scientific conferences
Second Quarter 2021 Financial Results
Cash, Cash Equivalents and Short-term Investments: Cash, cash equivalents, and short-term investments totaled $261.1 million as of June 30, 2021. Along with the July 2021 ATM offering gross proceeds of $50.0 million, the company expects its cash, cash equivalents, and short-term investments of $305.9 million as of July 31, 2021, will be sufficient to fund its current operating plan into 2024.
R&D Expenses: Research and development expenses were $15.5 million for the three months ended June 30, 2021, compared to $7.7 million for the three months ended June 30, 2020, an increase of $7.8 million. For the six months ended June 30, 2021, R&D expenses were $27.2 million compared to $15.0 million for the same period of 2020, an increase of $12.2 million. The increases for the 2021 periods were primarily driven by an increase in external expenses related to the advancement of ORIC-101 and our other product candidates of $6.4 million and $10.0 million for the three and six months ended June 30, 2021, respectively, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.7 million and $1.5 million for the three and six months ended June 30, 2021, as compared to the same periods in 2020, respectively.
G&A Expenses: General and administrative expenses were $5.5 million for the three months ended June 30, 2021, compared to $3.4 million for the three months ended June 30, 2020, an increase of $2.1 million. For the six months ended June 30, 2021, G&A expenses were $10.4 million compared to $5.3 million for the same period of 2020, an increase of $5.1 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million and $2.5 million for the three months and six months ended June 30, 2021, as compared to the same periods in 2020, respectively, as well as higher professional services and related costs to operate as a public company.