ORIC Oric Pharmaceuticals Inc.

14.33
-0.67  -4%
Previous Close 15
Open 14.66
52 Week Low 11.91
52 Week High 40.81
Market Cap $564,342,140
Shares 39,381,866
Float 20,085,487
Enterprise Value $303,006,990
Volume 88,039
Av. Daily Volume 310,776
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Drug Pipeline

Drug Stage Notes
ORIC-101 and ABRAXANE (nab-paclitaxel)
Solid tumors
Phase 1b
Phase 1b
Phase 1b data presented at ASCO June 4, 2021.
ORIC-533
Multiple myeloma
Phase 1
Phase 1
Phase 1b trial to be initiated 4Q 2021.
ORIC-114
Tumors - EGFR/HER2 Exon 20 Inhibitor
Phase 1/2
Phase 1/2
Phase 1/2 trial planned. Preclinical data demonstrated compelling brain exposure and antitumor activity in preclinical studies of HER2-positive breast cancer, noted November 8, 2021.
ORIC-101 and XTANDI (Enzalutamide)
Prostate cancer
Phase 1b
Phase 1b
Phase 1b initial results showed that the dose was well tolerated, with no substantial added toxicity. PK showed no evidence of drug-drug interaction. Within the key patient population (8), 75% of patients' tumors expressed moderate to high GR and 25% of patients' tumors expressed low GR, noted October 7, 2021.

Latest News

  1. SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 11, 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 management will participate in the following investor conferences:

    • Jefferies London Health Conference – Participating in a virtual fireside chat on Thursday, November 18, 2021, at 8:00 a.m. GMT.

    • Evercore ISI 4th Annual HealthconX Conference – Participating in a virtual fireside chat on Thursday, December 2, 2021, at 3:55 p.m. ET.

    Webcasts of the fireside chats will be available through the investor section of the company's website at www.oricpharma.com. Replays of the webcasts will be…

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 11, 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 management will participate in the following investor conferences:

    • Jefferies London Health Conference – Participating in a virtual fireside chat on Thursday, November 18, 2021, at 8:00 a.m. GMT.



    • Evercore ISI 4th Annual HealthconX Conference – Participating in a virtual fireside chat on Thursday, December 2, 2021, at 3:55 p.m. ET.

    Webcasts of the fireside chats will be available through the investor section of the company's website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the events.

    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, being developed for multiple myeloma, (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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  2. SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 10, 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 the appointment of Angie You, Ph.D., to its board of directors. Dr. You currently serves as chief executive officer of Amunix Pharmaceuticals, Inc.

    "We are delighted to welcome Angie to ORIC's board of directors," said Jacob Chacko, M.D., president and chief executive officer. "Angie's broad experience spanning venture capital, a variety of business development transactions, and public company leadership will bring valuable expertise and insight to ORIC as we continue to build and advance our…

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 10, 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 the appointment of Angie You, Ph.D., to its board of directors. Dr. You currently serves as chief executive officer of Amunix Pharmaceuticals, Inc.

    "We are delighted to welcome Angie to ORIC's board of directors," said Jacob Chacko, M.D., president and chief executive officer. "Angie's broad experience spanning venture capital, a variety of business development transactions, and public company leadership will bring valuable expertise and insight to ORIC as we continue to build and advance our pipeline of novel oncology candidates toward potential clinical proof of concept and commercialization."

    Dr. You joined Amunix Pharmaceuticals as chief executive officer of in 2018. Prior to joining Amunix, Dr. You served as chief business & strategy officer and head of commercial at Sierra Oncology (NASDAQ:SRRA), where she led the company's strategic and transactional business and commercial efforts, including building its robust pipeline through acquisition and licensing of several product assets. Prior to Sierra Oncology, Dr. You served as chief business officer of Aragon Pharmaceuticals. In previous roles, Dr. You served as chief business officer at Synosia Therapeutics and Ren Pharmaceuticals. Before joining Ren Pharmaceuticals, Dr. You focused on new company formation at Venrock Ventures. Dr. You earned a Ph.D. in Biochemistry from Harvard University and a B.A. in Chemistry from Harvard College.

    Dr. You added, "I have watched with interest as Jacob and the highly experienced ORIC leadership team have used both cutting-edge internal drug discovery and targeted business development to build an impressive pipeline of promising oncology candidates to treat a range of cancers. I am excited to join the board and look forward to working with the leadership team to support the next phase of growth and evolution of the company."

    Concurrent with the appointment of Dr. You, Carl L. Gordon, Ph.D., CFA, founding and managing partner at OrbiMed, resigned from ORIC's board. Dr. Chacko stated, "I would like to thank Carl for his guidance, support, and partnership during his tenure on the ORIC board dating back to his initial investment in our Series B in 2015. On behalf of the entire ORIC Board and leadership team, we are incredibly grateful to Carl for his many contributions to ORIC that have positioned us well to achieve our mission of improving patients' lives by overcoming resistance in 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, being developed for multiple myeloma, (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 development of the Company's product candidates and statements by the company's president and chief executive officer or board members. 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 November 8, 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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  3. Initial clinical data from Phase 1b trial of ORIC-101 in combination with enzalutamide and preclinical data on ORIC-114 presented at AACR-NCI-EORTC

    Update on oral CD73 inhibitor program to be presented at the American Society of Hematology (ASH) Annual Meeting and Phase 1 trial initiation of single agent ORIC-533 in patients with multiple myeloma expected in 4Q 2021

    CTA filing submitted for ORIC-114 and IND filing for ORIC-944 expected in 4Q 2021

    Strengthened board of directors with addition of Steven L. Hoerter

    Cash and investments of $296.5 million expected to fund current operating plan into 2024

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 08, 2021 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology…

    Initial clinical data from Phase 1b trial of ORIC-101 in combination with enzalutamide and preclinical data on ORIC-114 presented at AACR-NCI-EORTC

    Update on oral CD73 inhibitor program to be presented at the American Society of Hematology (ASH) Annual Meeting and Phase 1 trial initiation of single agent ORIC-533 in patients with multiple myeloma expected in 4Q 2021

    CTA filing submitted for ORIC-114 and IND filing for ORIC-944 expected in 4Q 2021

    Strengthened board of directors with addition of Steven L. Hoerter

    Cash and investments of $296.5 million expected to fund current operating plan into 2024

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 08, 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 September 30, 2021.

    "We are proud of the ongoing steady advancement of our broad pipeline" said Jacob Chacko, M.D., president and chief executive officer. "In October, we announced initial trial data from our ORIC-101 combination with enzalutamide in prostate cancer, which demonstrated a safe and tolerable profile and encouraging early antitumor activity in a key patient population; in November, we submitted a CTA filing for ORIC-114, our brain penetrant EGFR/HER2 exon 20 inhibitor. In the fourth quarter, we also expect to initiate a Phase 1 trial with our CD73 inhibitor ORIC-533 as a single agent in multiple myeloma and to file an IND for ORIC-944, our allosteric PRC2 inhibitor."

    Third Quarter 2021 and Other Recent Highlights

    • Data Presentations at AACR-NCI-EORTC:



      ORIC-101: The Phase 1b clinical trial of ORIC-101 in combination with enzalutamide 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 of the combination when administered in patients with metastatic prostate cancer progressing on enzalutamide. Following the completion of the Part I dose escalation portion of the trial, the RP2D was determined to be 240 mg of ORIC-101 and 160 mg of enzalutamide once daily. In the Part II dose expansion portion of the trial, up to 48 patients with metastatic prostate cancer progressing on enzalutamide are expected to be enrolled and treated with the combination at the RP2D. Patients are enrolled independent of GR status, with retrospective analysis of AR variants and GR expression and other potentially predictive biomarkers. Enrollment continues in the Part II dose expansion cohorts at nine clinical sites across the United States.



      As of the August 20, 2021, data cut-off date, the key findings of the initial data presented included:



      Preliminary Safety Analyses:
    • 25 patients were enrolled across Parts I/II of the study, which included 7 patients treated at non-RP2D doses and 18 patients treated at the RP2D.
    • RP2D was well tolerated; treatment-related adverse events were primarily Grade 1 or 2, with only four Grade 3 events, which all resolved with dose interruption.
    • Tolerability profile for the combination was generally consistent with that of single agent enzalutamide.



      Preliminary PK and Biomarker Analyses:
    • Plasma concentrations exceeded the threshold for GR inhibition at all dose levels, with GR target gene suppression observed after one dose of ORIC-101 in peripheral blood mononuclear cells from 22 of 23 patients.
    • ORIC-101 exposure increased with dose.
    • No evidence observed of drug-drug interaction impacting enzalutamide levels.
    • Translational efforts identified a key patient population, in line with published literature, consisting of the ~60% of patients with tumors lacking biomarkers of AR resistance (e.g., ARv7 splice variant, AR L702H point mutation) and AR independence (e.g., lineage switching).



      Preliminary Antitumor Activity:
    • Within the key patient population (n=8), 75% (6 of 8) of patients' tumors expressed moderate to high GR and 25% (2 of 8) of patients' tumors expressed low GR.
    • The two patients with low GR came off treatment at less than two months. In contrast, the six patients with moderate to high GR demonstrated prolonged time on treatment (with two patients on treatment for over seven months, and another four patients still ongoing at varying durations at the time of the data cut).



      ORIC-114: A brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. Key findings of the preclinical presentation included:
    • ORIC-114 demonstrated greater cell potency on HER2-positive breast cancer cell lines relative to non-amplified cell lines and was more potent than lapatinib and tucatinib, two approved tyrosine kinase inhibitors for the treatment of HER2-positive breast cancer.
    • ORIC-114 demonstrated robust tumor regressions in a HER2-positive breast cancer in vivo model without significant body weight loss.
    • ORIC-114 demonstrated superior brain exposure compared to other EGFR exon 20 and HER2 targeted agents.

    • Corporate: In August 2021, the company appointed Steven L. Hoerter to its board of directors. Mr. Hoerter is currently CEO of Deciphera Pharmaceuticals and has more than twenty-five years of experience in sales, marketing, commercial and public company leadership roles.

    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 fourth quarter of 2021:
      • ORIC-533:
        • Present update on oral CD73 inhibitor program at the ASH Annual Meeting
        • Initiate single agent Phase 1 trial in patients with multiple myeloma
      • ORIC-944: File IND

    Third Quarter 2021 Financial Results

    • Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents, and investments totaled $296.5 million, which the company expects will fund its current operating plan into 2024.



    • R&D Expenses: Research and development expenses were $12.9 million for the three months ended September 30, 2021, compared to $8.8 million for the three months ended September 30, 2020, an increase of $4.1 million. For the nine months ended September 30, 2021, R&D expenses were $40.1 million compared to $23.8 million for the same period of 2020, an increase of $16.3 million. The increases for the 2021 periods were primarily driven by an increase in external expenses related to the advancement of ORIC-101 and other product candidates of $2.8 million and $12.8 million for the three and nine months ended September 30, 2021, respectively, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.7 million and $2.2 million for the three and nine months ended September 30, 2021, as compared to the same periods in 2020, respectively.

    • G&A Expenses: General and administrative expenses were $5.6 million for the three months ended September 30, 2021, compared to $3.8 million for the three months ended September 30, 2020, an increase of $1.8 million. For the nine months ended September 30, 2021, G&A expenses were $16.0 million compared to $9.1 million for the same period of 2020, an increase of $6.8 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million and $3.6 million for the three months and nine months ended September 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.

    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, being developed for multiple myeloma, (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 and ORIC-533 clinical trials and development, including expectations regarding patient enrollment and the expected timing of initiating a Phase 1 clinical trial of ORIC-533; plans underlying ORIC-944, ORIC-114 or any other programs and the planned IND filing for ORIC-944; ORIC's anticipated fourth quarter 2021 milestones; the period over which ORIC estimates its existing cash, cash equivalents and available-for-sale 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, 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 November 8, 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)

     September 30, 2021  December 31, 2020 
     (unaudited)    
    Assets 
    Current assets:     
    Cash, cash equivalents and short-term investments$289,519  $293,600 
    Prepaid expenses and other current assets 3,330   3,097 
    Total current assets 292,849   296,697 
          
    Investments, available-for-sale 6,956    
    Property and equipment, net 1,825   1,981 
    Other assets 12,550   319 
    Total assets$314,180  $298,997 
          
    Liabilities and Stockholders' Equity 
          
    Current liabilities:     
    Accounts payable$419  $757 
    Accrued liabilities 11,484   8,245 
    Total current liabilities 11,903   9,002 
          
    Other long-term liabilities 10,741   219 
    Total liabilities 22,644   9,221 
          
    Total stockholders' equity 291,536   289,776 
    Total liabilities and stockholders' equity$314,180  $298,997 



    ORIC PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
     2021  2020  2021  2020 
    Operating expenses:           
    Research and development$12,899  $8,831  $40,113  $23,808 
    Acquired in-process research and development    12,971      12,971 
    General and administrative 5,557   3,800   15,953   9,125 
    Total operating expenses 18,456   25,602   56,066   45,904 
    Loss from operations (18,456)  (25,602)  (56,066)  (45,904)
                
    Other income:           
    Interest income, net 30   10   107   276 
    Other income    44   15   184 
    Total other income 30   54   122   460 
    Net loss$(18,426) $(25,548) $(55,944) $(45,444)
    Other comprehensive gain (loss):           
    Unrealized (loss) gain on available-for-sale investments (5)  (29)  29   (29)
    Comprehensive loss$(18,431) $(25,577) $(55,915) $(45,473)
    Net loss per share, basic and diluted$(0.47) $(0.84) $(1.49) $(2.52)
    Weighted-average shares outstanding, basic and diluted 39,008,114   30,314,904   37,471,740   18,022,068 
                


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  4. CD73 inhibition overcomes immune suppression and demonstrates activity in autologous ex vivo cell assays derived from relapsed or refractory multiple myeloma patients, offering the potential for single agent activity in the clinic

    Phase 1 trial of single agent ORIC-533, a highly potent, orally bioavailable small molecule inhibitor of CD73, in patients with multiple myeloma expected to initiate in 4Q 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 04, 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 a preclinical poster presentation at the American Society of Hematology (ASH) Annual…

    CD73 inhibition overcomes immune suppression and demonstrates activity in autologous ex vivo cell assays derived from relapsed or refractory multiple myeloma patients, offering the potential for single agent activity in the clinic

    Phase 1 trial of single agent ORIC-533, a highly potent, orally bioavailable small molecule inhibitor of CD73, in patients with multiple myeloma expected to initiate in 4Q 2021

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 04, 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 a preclinical poster presentation at the American Society of Hematology (ASH) Annual Meeting to be held December 11-14, 2021, in Atlanta, GA.

    Details of the poster presentation are as follows:

    Title: CD73 inhibition overcomes immunosuppression and triggers autologous T-cell mediated multiple myeloma cell lysis in the bone marrow milieu
    Abstract #:  2675
    Date & Time: Sunday, December 12, 2021, 6:00 - 8:00 pm ET
    Session:651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational:
      Poster II in Hall B5, Georgia World Congress Center

    The presentation, in collaboration with Dr. Kenneth Anderson's research laboratory at Dana-Farber Cancer Institute, will focus on the role of adenosine signaling in immunosuppression in patients with multiple myeloma and the ability of single agent CD73 inhibition to restore antitumor immune activity.

    Key points of the abstract include:

    • In bone marrow aspirates from patients with relapsed or refractory multiple myeloma, an autologous ex vivo assay system comprising the multiple myeloma bone marrow milieu demonstrated that CD73-mediated adenosine activity suppressed the cytolytic activity of T-cells against tumor cells.
    • CD73 inhibition triggered activation of plasmacytoid dendritic cells and stimulated T-cell activation in ex vivo assays of multiple myeloma bone marrow microenvironment.
    • ORIC's small molecule inhibitor of CD73 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells by autologous T-cells in the bone marrow microenvironment.

    Full abstracts are available for online viewing via the ASH Annual Meeting website at www.hematology.org/meetings/annual-meeting. The Phase 1 trial of single agent ORIC-533 in patients with multiple myeloma is expected to initiate in 4Q 2021.

    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, as well as other small molecule inhibitors of CD73 and adenosine receptor antagonists. Preclinical data demonstrated that ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment, reflective of AMP levels observed in tumors. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, as well as in ex vivo bone marrow aspirates from relapsed or refractory multiple myeloma patients.

    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, being developed for multiple myeloma, (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 potential advantages ORIC-533 may have over other approaches and therapies; the expected timing of initiation of the Phase 1 trial of ORIC-533 in patients with multiple myeloma; and the potential benefits of ORIC-533 or the company's other product candidates. 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 August 10, 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. ORIC-101 and enzalutamide combination regimen at the recommended Phase 2 dose was well tolerated; adverse events generally consistent with single agent enzalutamide

    ORIC-101 plasma concentrations provided excellent target coverage, consistent suppression of key glucocorticoid receptor (GR) biomarkers, and no evidence of drug-drug interaction impacting enzalutamide

    The addition of ORIC-101 after progression on single agent enzalutamide enabled continued enzalutamide treatment, with preliminary evidence of longer time on treatment demonstrated in a key patient population with tumors having moderate to high GR versus low GR expression

    ORIC-114 demonstrated compelling brain exposure and antitumor activity in preclinical studies of HER2-positive

    ORIC-101 and enzalutamide combination regimen at the recommended Phase 2 dose was well tolerated; adverse events generally consistent with single agent enzalutamide

    ORIC-101 plasma concentrations provided excellent target coverage, consistent suppression of key glucocorticoid receptor (GR) biomarkers, and no evidence of drug-drug interaction impacting enzalutamide

    The addition of ORIC-101 after progression on single agent enzalutamide enabled continued enzalutamide treatment, with preliminary evidence of longer time on treatment demonstrated in a key patient population with tumors having moderate to high GR versus low GR expression

    ORIC-114 demonstrated compelling brain exposure and antitumor activity in preclinical studies of HER2-positive breast cancer

    Conference call and webcast today at 9:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Oct. 07, 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 multiple presentations, including initial clinical data from an ongoing Phase 1b study evaluating ORIC-101, a glucocorticoid receptor antagonist, in combination with enzalutamide, in patients with metastatic prostate cancer progressing on enzalutamide. The abstracts and presentations are available for on-demand viewing via the online platform for AACR-NCI-EORTC as of October 7, 2021, at 9 a.m. ET.

    Presentations:

    "We are pleased to share initial data from our ORIC-101 clinical program in patients with metastatic prostate cancer. The combination was well tolerated without evidence of drug-drug interaction affecting enzalutamide dosing and has demonstrated preliminary evidence of antitumor activity in the relevant patient population," said Pratik S. Multani, MD, chief medical officer. "Given the tumor heterogeneity in metastatic prostate cancer, we've made significant progress in identifying a key patient population that may benefit from ORIC-101 and, within these patients, seen preliminary evidence of more pronounced clinical benefit in patients whose tumors express higher GR levels. Patients are continuing to enroll in the expansion cohort and we look forward to reporting an update from the Phase 1b trial in 2022."

    ORIC-101: Glucocorticoid Receptor (GR) Antagonist

    The Phase 1b clinical trial of ORIC-101 in combination with enzalutamide 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 in patients with metastatic prostate cancer progressing on enzalutamide.

    In the Part I dose escalation portion of the trial, three cohorts of patients were enrolled to evaluate daily dosing of ORIC-101 with doses ranging from 80 to 240 mg, in combination with 160 mg of enzalutamide once daily dosing. Following the completion of the dose escalation portion of the study, the RP2D was determined to be 240 mg of ORIC-101 and 160 mg of enzalutamide once daily.

    In the Part II dose expansion portion of the trial, up to 48 patients with metastatic prostate cancer progressing on enzalutamide are expected to be enrolled and treated with the combination at the RP2D. Patients are enrolled independent of GR status, with retrospective analysis of GR expression and other potentially predictive biomarkers. Enrollment continues in the Part II dose expansion cohorts at nine clinical sites across the United States.

    As of the August 20, 2021, data cut-off date:

    Preliminary Safety Analyses:

    • 25 patients were enrolled across Parts I/II of the study, which included 7 patients treated at non-RP2D doses and 18 patients treated at the RP2D of 240 mg of ORIC-101 and 160 mg of enzalutamide once daily.
    • RP2D was well tolerated; treatment-related adverse events were primarily Grade 1 or 2, with only four Grade 3 events, which all resolved with dose interruption.
    • Tolerability profile for the combination was generally consistent with that of single agent enzalutamide.

    Preliminary PK Analysis:

    • Plasma concentrations exceeded the threshold for GR inhibition at all dose levels.
    • ORIC-101 exposure increased with dose.
    • No evidence observed of drug-drug interaction impacting enzalutamide levels.

    Preliminary Biomarker Analyses:

    • GR pathway suppression, evaluated using GR target gene expression, was observed after one dose of ORIC-101 in peripheral blood mononuclear cells from 22 of 23 patients.
    • Moderate to high GR expression (IHC H-score ≥ 100) in prostate tumor cells was observed in 76% of pretreatment biopsies.
    • Translational efforts identified a key patient population, in line with published literature, consisting of the ~60% of patients with tumors lacking biomarkers of AR resistance (e.g., ARv7 splice variant, AR L702H point mutation) and AR independence (e.g., lineage switching).

    Preliminary Antitumor Activity:

    • Within the key patient population (n=8), 75% (6 of 8) of patients' tumors expressed moderate to high GR and 25% (2 of 8) of patients' tumors expressed low GR.
    • The two patients with low GR came off treatment at less than two months. In contrast, the six patients with moderate to high GR demonstrated prolonged time on treatment (with two patients on treatment for over seven months, and another four patients still ongoing at varying durations at the time of the data cut).

    ORIC-101 is also being evaluated in a Phase 1b trial in combination with nab-paclitaxel in up to 132 patients across four cohorts, including pancreatic ductal adenocarcinoma, ovarian cancer, triple negative breast cancer, and other advanced solid tumors. Enrollment continues in this study at 12 clinical sites across the United States and an additional update is expected in 2022.

    ORIC-114: EGFR/HER2 Inhibitor

    ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. These are the first publicly disclosed preclinical data with ORIC-114 demonstrating compelling activity in HER2-positive breast cancer models.

    Key Findings of the Presentation:

    • ORIC-114 demonstrated greater cell potency on HER2-positive breast cancer cell lines relative to non-amplified cell lines and was more potent than lapatinib and tucatinib, two approved tyrosine kinase inhibitors for the treatment of HER2-positive breast cancer.
    • ORIC-114 demonstrated robust tumor regressions in a HER2-positive breast cancer in vivo model without significant body weight loss.
    • ORIC-114 demonstrated superior brain exposure compared to other EGFR exon 20 and HER2 targeted agents.

    Separately, today the company disclosed head to head in vivo preclinical data in an EGFR exon 20 NSCLC xenograft model demonstrating good tolerability and improved efficacy, including a 90% complete response rate, versus multiple clinical stage exon 20 inhibitors.

    Webcast and Conference Call

    ORIC will host a conference call and webcast today at 9:00 a.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 3575856. 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 enzalutamide; 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 trials in combination with nab-paclitaxel and enzalutamide; the potential benefits of ORIC-101, ORIC-114 or the company's other product candidates; and statements by the company's chief medical 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 August 10, 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 enzalutamide, 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



     



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