ORIC Oric Pharmaceuticals Inc.

15.9
-0.09  -1%
Previous Close 15.99
Open 15.75
52 Week Low 15.67
52 Week High 40.81
Market Cap $624,768,526
Shares 39,293,618
Float 19,997,239
Enterprise Value $377,952,739
Volume 149,242
Av. Daily Volume 232,919
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Upcoming Catalysts

Drug Stage Catalyst Date
ORIC-101 and XTANDI (Enzalutamide)
Prostate cancer
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
ORIC-533
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 2021.
ORIC-101 and ABRAXANE (nab-paclitaxel)
Solid tumors
Phase 1b
Phase 1b
Phase 1b data presented at ASCO June 4, 2021.
ORIC-114
Tumors - EGFR/HER2 Exon 20 Inhibitor
Phase 1/2
Phase 1/2
Phase 1/2 trial planned.

Latest News

  1. ORIC expects to initiate single agent clinical trial in an undisclosed tumor type in 2H21

    ORIC-533 IND filing is the first of three IND/CTA filings expected in 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, June 28, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's 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…

    ORIC expects to initiate single agent clinical trial in an undisclosed tumor type in 2H21

    ORIC-533 IND filing is the first of three IND/CTA filings expected in 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, June 28, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's 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.

    "The FDA clearance of our IND application for ORIC-533 is a significant milestone for ORIC as we move into the clinic with a second novel, internally discovered oncology drug candidate," said Jacob Chacko, M.D., president and chief executive officer. "In preclinical studies, ORIC-533 has demonstrated higher potency within a high AMP environment compared to all CD73 and adenosine receptor inhibitors against which it was compared. Furthermore, in addition to the potential best-in-class properties of ORIC-533, we are excited about its differentiated clinical development plan that will explore its single agent activity in contrast to the combination studies that dominate the CD73 field today."

    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.

    This is the first of three planned IND/CTA filings for 2021, with the IND filing for ORIC-944 and CTA filing for ORIC-114 expected in the second half of the year.

    About ORIC-533

    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. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, other small molecule CD73 inhibitors and inhibitors of adenosine receptors. Preclinical data suggest ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment. In preclinical studies, 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.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer. ORIC's other product candidates include (1) ORIC-533, an 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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on Twitter or LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the clinical development of ORIC-533 in an undisclosed tumor type and its potential best-in-class nature; the expected timing of initiation of the Phase 1 clinical trial of ORIC-533; the expected timing of an IND filing for ORIC-944 and a CTA filing for ORIC-114; the potential benefits of ORIC-533 or the company's other product candidates; and statements by the company's chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-101, ORIC-533, ORIC-944, ORIC-114 or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license agreements; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 6, 2021, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Contact:

    Dominic Piscitelli, Chief Financial Officer





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  2. Initial safety data showed combination regimen at the recommended Phase 2 dose was well tolerated; treatment-related adverse events primarily Grade 1 or 2, with no treatment-related discontinuations

    ORIC-101 plasma concentrations provided excellent target coverage; no evidence of drug-drug interaction with nab-paclitaxel

    Translational data showed pharmacodynamic modulation of GR biomarkers and high rates of GR expression in tumor types of interest

    Antitumor activity demonstrated across multiple advanced solid tumors in heavily pretreated patients, including those previously treated with a taxane-based therapy

    Extended PFS observed in patients with late-line relapsed pancreatic cancer who had previously progressed on or after nab-paclitaxel

    Initial safety data showed combination regimen at the recommended Phase 2 dose was well tolerated; treatment-related adverse events primarily Grade 1 or 2, with no treatment-related discontinuations

    ORIC-101 plasma concentrations provided excellent target coverage; no evidence of drug-drug interaction with nab-paclitaxel

    Translational data showed pharmacodynamic modulation of GR biomarkers and high rates of GR expression in tumor types of interest

    Antitumor activity demonstrated across multiple advanced solid tumors in heavily pretreated patients, including those previously treated with a taxane-based therapy

    Extended PFS observed in patients with late-line relapsed pancreatic cancer who had previously progressed on or after nab-paclitaxel

    Conference call and webcast today at 5:00 p.m. ET

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced initial data from an ongoing Phase 1b study evaluating ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel, in advanced solid tumors. The data will also be presented in two posters at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4 – 8, 2021.

    "We are excited to share initial data from our ORIC-101 clinical program in patients with advanced solid tumors. We are pleased that the combination was well tolerated without evidence of drug-drug interaction and has demonstrated both tumor regression and prolonged stable disease in multiple heavily pretreated tumors," said Pratik S. Multani, MD, chief medical officer. "Although early, we are particularly intrigued by the potential benefit seen in patients with late-line relapsed pancreatic cancer previously treated with nab-paclitaxel, as any retreatment benefit in such patients would not be expected. We are continuing to enroll patients in the expansion cohorts and look forward to reporting updated data from the Phase 1b trial in 2022."

    "Having been involved with this study from its design stage, I feel we have developed an optimal combination for this heavily pretreated patient population," said Professor Pamela Munster, MD, Director of the University of California San Francisco's Early Phase Clinical Trials Unit, and trial investigator and senior author of the ASCO poster. "I'm impressed by the extended time on treatment we've seen in patients with late-line pancreatic cancer; seeing clinical activity in these patients is quite remarkable."

    Trial Design and Initial Results from Phase 1b Clinical Trial

    The Phase 1b clinical trial of ORIC-101 in combination with nab-paclitaxel 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.

    In the Part I dose escalation portion of the study, five cohorts of patients across multiple solid tumors were enrolled to evaluate ORIC-101 doses ranging from 80 to 240 mg administered orally in both intermittent and continuous once daily dosing regimens, in combination with either 75 or 100 mg/m2 nab-paclitaxel. Following the completion of the dose escalation portion of the study, the RP2D was determined to be 160 mg of ORIC-101 continuous once daily dosing and 75 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle, 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.

    Safety Analyses:

    • As of March 31, 2021, a total of 31 patients were enrolled across Parts I/II of the study, which included 12 patients treated at non-RP2D doses and 19 patients treated at the RP2D of 160 mg of ORIC-101 continuous once daily dosing and 75 mg/m2 of nab-paclitaxel.
    • 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.

    The poster presentations will be on the ORIC website on June 4, 2021.

    ORIC-101 is also being evaluated in a Phase 1b trial in combination with Xtandi (enzalutamide) in metastatic prostate cancer, which is also currently enrolling to the dose expansion portion of the study, and initial interim safety, efficacy, and translational data are expected in the second half of 2021.

    Webcast and Conference Call

    ORIC will host a conference call and webcast, today at 5:00 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 4783288. A live webcast and audio archive of the conference call will be available through the investor section of the company's website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

    About ORIC-101

    ORIC-101 is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. Preclinical in vitro and in vivo data suggest ORIC-101 is able to address key resistance mechanisms of multiple classes of cancer treatments, including taxanes and androgen receptor modulators. Based on preclinical and clinical studies, ORIC-101 is expected to have reduced drug-drug interaction liabilities than other glucocorticoid receptor antagonists. Currently, there are no glucocorticoid receptor antagonists approved by the FDA for the treatment of cancer. Following the successful completion of two Phase 1a trials in over 50 healthy volunteers, ORIC initiated two separate Phase 1b trials of ORIC-101 in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer. ORIC's other product candidates include (1) ORIC-533, an 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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on Twitter or LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-101 in combination with nab-paclitaxel; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the expected timing of reporting updated data from the ORIC-101 clinical trial in combination with nab-paclitaxel; the expected timing of reporting the initial data from the ORIC-101 clinical trial in combination with enzalutamide; the potential benefits of ORIC-101 or the company's other product candidates; and statements by the company's chief medical officer and Dr. Munster. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-101, ORIC-533, ORIC-944, ORIC-114 or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license agreements; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 6, 2021, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.  

    This press release contains interim results based on initial data from the ORIC-101 clinical trial in combination with nab-paclitaxel, including preliminary safety and antitumor activity analyses, as of the data cutoff date.  These initial data, results and related findings and conclusions are subject to change materially based on patient data subsequent to the cutoff date or as patient enrollment continues.  

    Investor Contact:

    Dominic Piscitelli, Chief Financial Officer

    do



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  3. SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 26, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that Jacob Chacko, M.D., chief executive officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021, at 1:30 p.m. ET.

    A live webcast of the fireside chat will be available through the investor section of the company's website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to…

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 26, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that Jacob Chacko, M.D., chief executive officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021, at 1:30 p.m. ET.

    A live webcast of the fireside chat will be available through the investor section of the company's website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer. ORIC's other product candidates include (1) ORIC-533, an 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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on Twitter or LinkedIn.

    Investor Contact:

    Dominic Piscitelli, Chief Financial Officer





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  4. SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 25, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the company will host a conference call and webcast to review initial data from the ongoing Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in advanced solid tumors. On the conference call, management will be joined by trial investigator and senior author, Professor Pamela Munster, M.D., Director of the Early Phase Clinical Trials Unit and Co-Leader of the Center for BRCA Research at the University of California San Francisco. The data…

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 25, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the company will host a conference call and webcast to review initial data from the ongoing Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in advanced solid tumors. On the conference call, management will be joined by trial investigator and senior author, Professor Pamela Munster, M.D., Director of the Early Phase Clinical Trials Unit and Co-Leader of the Center for BRCA Research at the University of California San Francisco. The data will also be presented in two posters at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4 – 8, 2021.

    Webcast and Conference Call

    ORIC will host a conference call and webcast, Wednesday, June 2, 2021, at 5:00 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 4783288. A live webcast and audio archive of the conference call will be available through the investor section of the company's website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer. ORIC's other product candidates include (1) ORIC-533, an 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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on Twitter or LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the expected timing of reporting initial data from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel and plans underlying any of ORIC's other programs. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-101, ORIC-533, ORIC-944, ORIC-114 or any other product candidates to differ from preclinical, interim, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license agreements; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 6, 2021, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Contact:

    Dominic Piscitelli, Chief Financial Officer





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  5. Lead program ORIC-101 on track for two initial Phase 1b data readouts in 2021

    Three IND/CTA filings for ORIC-533, -944, and -114 expected in 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 06, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter ended March 31, 2021.

    "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…

    Lead program ORIC-101 on track for two initial Phase 1b data readouts in 2021

    Three IND/CTA filings for ORIC-533, -944, and -114 expected in 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 06, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter ended March 31, 2021.

    "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 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: 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) Annual Meeting, to be held June 4 - 8, 2021. The ASCO 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: In April 2021, ORIC presented posters on four programs at the 2021 American Association for Cancer Research (AACR) 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
      • 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.

    About ORIC Pharmaceuticals, Inc.

    ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials in combination with (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer. ORIC's other product candidates include (1) ORIC-533, an 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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on Twitter or LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding ORIC's development plans and timelines; the potential advantages of ORIC's product candidates and programs; plans underlying ORIC-101 clinical trials and development; the expected timing of reporting interim data from the ORIC-101 clinical trials; plans underlying ORIC-533, ORIC-944, ORIC-114 or any other programs; the planned IND filings for ORIC-533 and ORIC-944 and CTA filing for ORIC-114; ORIC's anticipated 2021 milestones; the period over which ORIC estimates its existing cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan; and statements by the company's president and chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC-101, ORIC-533, ORIC-944, ORIC-114 or any other product candidates to differ from preclinical, interim, preliminary or expected results; negative impacts of the COVID-19 pandemic on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license agreements; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 6, 2021, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Contact:

    Dominic Piscitelli, Chief Financial Officer





    ORIC PHARMACEUTICALS, INC.

    CONDENSED BALANCE SHEETS

    (in thousands, except share and per share amounts)

     March 31, 2021 December 31, 2020
     (unaudited)  
    Assets
    Current assets:   
    Cash, cash equivalents and short-term investments$278,141 $293,600
    Prepaid expenses and other current assets 1,960  3,097
    Total current assets 280,101  296,697
        
    Property and equipment, net 1,969  1,981
    Other assets 1,890  319
    Total assets$283,960 $298,997
        
    Liabilities and Stockholders' Equity
        
    Current liabilities:   
    Accounts payable$606 $757
    Accrued liabilities 7,070  8,245
    Total current liabilities 7,676  9,002
        
    Other long-term liabilities 209  219
    Total liabilities 7,885  9,221
        
    Total stockholders' equity 276,075  289,776
    Total liabilities and stockholders' equity$283,960 $298,997
        





    ORIC PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended March 31, 
     2021  2020 
    Operating expenses:       
    Research and development$11,697  $7,254 
    General and administrative 4,856   1,925 
    Total operating expenses 16,553   9,179 
    Loss from operations (16,553)  (9,179)
            
    Other income:       
    Interest income, net 44   241 
    Other income    66 
    Total other income 44   307 
    Net loss$(16,509) $(8,872)
    Other comprehensive loss:       
    Unrealized gain on available-for-sale securities 48    
    Comprehensive loss$(16,461) $(8,872)
    Net loss per share, basic and diluted$(0.45) $(4.46)
    Weighted-average shares outstanding, basic and diluted 36,679,684   1,988,861 



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