UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of principal executive offices, including zip code) |
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On March 21, 2022, ORIC Pharmaceuticals, Inc. (the “Company”) hosted a conference call and webcast to discuss the Company’s fourth quarter and full year 2021 financial results and provide an operational update. A copy of the Company’s corporate presentation used during the conference call and webcast is attached hereto as Exhibit 99.1, which is incorporated herein by reference.
All of the information furnished in this Item 7.01 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Corporate Presentation dated March 21, 2022 | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ORIC PHARMACEUTICALS, INC. | ||||
| Date: March 21, 2022 | By: | /s/ Dominic Piscitelli | ||
| Dominic Piscitelli Chief Financial Officer | ||||
Fourth Quarter and Full Year 2021 Financial Results and Operational Update March 21, 2022 Exhibit 99.1
Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding ORIC Pharmaceuticals, Inc.’s (“ORIC”, “we”, “us” or “our”) future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will” or the negative of these terms or other similar expressions. Forward-looking statements contained in this presentation also include, but are not limited to, statements regarding: our development plans and timelines; the potential advantages of our product candidates and programs; plans for the clinical trials and development of ORIC-533, ORIC-944 and ORIC-114; the expected timing of reporting data from multiple clinical trials; our anticipated milestones and clinical updates; and the period over which we estimate our existing cash, cash equivalents and investments will be sufficient to fund our current operating plan. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and results of our preclinical studies and clinical trials; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use in humans and operating as an early clinical stage company; negative impacts of the COVID-19 pandemic on our operations, including clinical trials; the potential for current or future clinical trials of product candidates to differ from preclinical, initial, interim, preliminary or expected results; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; changes in our plans to develop and commercialize our product candidates; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; potential benefits and costs of strategic arrangements, licensing and/or collaborations; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of our license agreements; our estimates regarding expenses, future revenue, capital requirements and needs for financing and our ability to obtain capital; the sufficiency of our existing cash, cash equivalents and investments to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified professionals; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, product candidates and our pipeline; our ability to contract with third-party contract research organizations, suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; general economic and market conditions; and the other risks, uncertainties and assumptions discussed in the public filings we have made and will make with the Securities and Exchange Commission (“SEC”). These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Except as required by law, we undertake no obligation to update any statements in this presentation for any reason after the date of this presentation. We have filed Current Reports on Form 8-K, Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, and other documents with the SEC. You should read these documents for more complete information about us. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This presentation discusses our product candidates that are under preclinical or clinical study, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of our product candidates for the therapeutic use for which they are being studied.
Fourth Quarter and Full Year 2021 Financial Results and Operational Update Executive Summary Update on ORIC-101 + Enzalutamide Update on ORIC-101 + Nab-paclitaxel Pipeline Update and Summary Agenda Participants Jacob Chacko, Chief Executive Officer Pratik Multani, Chief Medical Officer Dominic Piscitelli, Chief Financial Officer
Executive Summary Recently completed interim analyses from the two Phase 1b combination studies of ORIC-101 + nab-paclitaxel in solid tumors and ORIC-101 + enzalutamide in mCRPC We believe that further development of ORIC-101 should be discontinued due to a lack of sufficient efficacy signal to meet our benchmarks Well Designed Trials Tested GR Hypothesis Efficiently and Thoroughly Pipeline Continues to be One of the Most Robust and Differentiated in Small Cap Biotech Well Capitalized; Cash Runway Extended into 2H 2024 Late line patient populations with limited treatment options Extensive translational effort and thoughtful study design enabled rapid, data driven decision, allowing for prudent resource prioritization Three single agent trials initiating in 2022, with initial data expected in 1H23: ORIC-533 (CD73): orally bioavailable, superior potency and first-in-class for multiple myeloma ORIC-114 (EGFR/HER2 exon20): selective and brain penetrant for EGFR/HER2 cancers ORIC-944 (PRC2): favorable drug properties and allosteric inhibitor via EED subunit for prostate cancer Cash and investments of $280.4 million as of December 31, 2021 Runway into 2H 2024 assumes advancement of all pipeline programs Discontinued Development of ORIC-101
Update on ORIC-101 + Enzalutamide
Phase 1b Study of ORIC-101 + Enzalutamide in Metastatic Prostate Cancer: Interim Analysis Key Eligibility Metastatic prostate cancer progressing on enzalutamide ECOG 0-1 Independent of baseline GR status Screening / Enrollment RP2D Determined Screening / Enrollment RP2D: 240 mg ORIC-101 QD + 160 mg enzalutamide QD (N=28) Dose Level 3 (n=3) 240 mg ORIC-101 + 160 mg enzalutamide Dose Level 2 (n=3) 160 mg ORIC-101 + 160 mg enzalutamide Dose Level 1 (n=4) 80 mg ORIC-101 + 160 mg enzalutamide Note: ClinicalTrials.gov identifier: NCT04033328. Dose Expansion (Part II) Dose Escalation (Part I) Primary endpoints: Part I: recommended Phase 2 dose (RP2D); Part II: disease control rate (DCR) at 12 weeks Key secondary endpoints: Part I: PK; Part II: safety, PSA50 response rate, progression-free survival (PFS), overall survival Target patient population: Absence of AR resistance variants or markers of lineage plasticity with moderate-to-high GR expression Phase 1b, Multicenter, Open-Label Study
Phase 1b Interim Analysis Results Summary Safety: The combination regimen was generally well tolerated at the RP2D Translational: PK data confirmed ORIC-101 achieved exposures necessary for GR target coverage PD data demonstrated downregulation of GR target genes, confirming target engagement Majority of patient tumors demonstrated moderate-to-high GR expression at baseline Efficacy: No PSA50 responses observed DCR at 12 weeks in target patient population: 33.3% (80%, CI: 4.3, 77.7) Median PFS in target patient population: 3.7 months (95% CI: 1.9, 7.1) No meaningful differences in DCR and PFS versus the unselected patient population DCR and PFS insufficient to support continued development
Update on ORIC-101 + Nab-paclitaxel
Phase 1b Study of ORIC-101 + Nab-Paclitaxel in Advanced Solid Tumors: Interim Analysis Note: ClinicalTrials.gov identifier: NCT03928314. Key Eligibility Advanced or metastatic solid tumors Received prior standard therapies ECOG 0-1 Independent of baseline GR status Dose Expansion (Part II) Dose Escalation (Part I) Screening / Enrollment RP2D (160 mg ORIC-101 + 75 mg/m2 nab-pac) Screening / Enrollment Patients previously treated with and progressed on a taxane-based therapy (N = 61) PDAC (n=21) Ovarian Cancer (n=13) Other Solid Tumors (n=20) TNBC (n=7) ORIC-101 + nab-paclitaxel 3+3 design Once daily intermittent and continuous dosing explored 21 patients enrolled Primary endpoints: Part I: recommended Phase 2 dose (RP2D); Part II: objective response rate (ORR) Key secondary endpoints: Part I: PK; Part II: safety, duration of response, progression-free survival (PFS), overall survival Exploratory endpoints: GR / GR pathway by immunohistochemistry, disease- and GR-related molecular markers in tissue and blood Phase 1b, Multicenter, Open-Label Study
Phase 1b Interim Analysis Results Summary Safety: The combination regimen was generally well tolerated at the RP2D Translational: PK data confirmed ORIC-101 achieved exposures necessary for GR target coverage PD data demonstrated downregulation of GR target genes, confirming target engagement High GR expression at baseline across all tumor types, especially PDAC and ovarian cancer Efficacy: One confirmed partial response in ovarian cancer cohort; no responses in PDAC cohort Median PFS in cohorts of interest: PDAC: 1.9 months (95% CI: 1.1, 3.1) Ovarian cancer: 2.2 months (95% CI: 0.9, NE) Note: NE = not estimable. ORR and PFS insufficient to support continued development
Potential Reasons for Lack of Clinical Benefit Suboptimal exposure of ORIC-101 Unlikely: PK data demonstrate exposures sufficient for target coverage Insufficient target engagement Unlikely: Extensive PD data demonstrate target engagement with inhibition of GR signaling genes Tumor heterogeneity Possible: Intra/inter-lesion heterogeneity in resistance mechanism may mean GR is only relevant in a portion of cells within or between tumors in a patient Resistance redundancy Possible: Other co-existing resistance pathways beyond GR may drive tumor progression GR pathway not a key tumor dependency in the clinic Possible: Novel target We conducted two well designed Phase 1b clinical studies that enabled an efficient data driven decision
Pipeline Update and Summary
Broad Pipeline Targeting Multiple Resistance Mechanisms Program Lead Identification Lead Optimization IND Enabling Phase 1 Phase 2 Phase 3 Indication Multiple Myeloma PRODUCT CANDIDATES DISCOVERY RESEARCH PROGRAMS Multiple programs targeting resistance mechanisms ORIC-533 CD73 inhibitor Breast cancer Solid tumors Solid tumors NSCLC, Breast & Tumor agnostic ORIC-114 EGFR/HER2 exon 20 inhibitor ORIC-944 PRC2 inhibitor Prostate Cancer PLK4 Program Phase 1b: ORIC-533 single agent Phase 1b: ORIC-944 single agent Phase 1b: ORIC-114 single agent Key Differentiation Orally bioavailable Superior potency First-in-class for myeloma Brain penetrant Allosteric inhibitor First-in-class potential
Financial Highlights As a result of the discontinuation of ORIC-101, cash runway extended from 1H 2024 to 2H 2024 4Q 2021 and 2021 Financial Results Represents cash, cash equivalents and investments as of December 31, 2021.
ORIC Pharmaceuticals: Dedicated to Overcoming Resistance In Cancer Broad Pipeline of Potential First-in-Class and Best-in-Class Programs Dual Engines for Pipeline Expansion Strong Financial Position and Multiple Upcoming Milestones Experienced Management Team Three ongoing potential best-in-class Phase 1b clinical programs focused on validated targets Heritage of discovering and developing multiple approved oncology medicines at Ignyta, Medivation, Aragon and Genentech Track record of building pipeline via internal discovery and business development Three IND/CTAs filed in 2021 and targeting one new IND every 18 months Three clinical updates expected in 1H 2023 Cash, cash equivalents & investments expected to fund company into 2H 2024 2022 and 1H 2023 Anticipated Milestones and Clinical Updates ORIC-101: Updates from two Phase 1b combination trials in 1H 2022 New program and/or indication to be announced in 2022 ORIC-533: Initial Phase 1b data in 1H 2023 ORIC-114: Initial Phase 1b data in 1H 2023 ORIC-944: Initial Phase 1b data in 1H 2023 Precision Oncology Expertise Enables Accelerated Clinical Timelines Rapid timelines enabled by biomarker-driven, patient-selected clinical trials and translational expertise