Form 8-K - Current report

false000179628000017962802024-08-122024-08-12

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 12, 2024

 

ORIC Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-39269		47-1787157
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

240 E. Grand Ave, 2nd Floor

South San Francisco, CA 94080

(Address of principal executive offices, including zip code)

 

[phone]

(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:

☐	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
Common stock, par value $0.0001 per share		ORIC		The Nasdaq Global Select Market

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. ☒

 

 

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Item 2.02 Results of Operations and Financial Condition.

On August 12, 2024, ORIC Pharmaceuticals, Inc. issued a press release announcing its financial results for the fiscal quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 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 (the “Securities Act”), 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		Press Release dated August 12, 2024
104		Cover Page Interactive Data File (embedded with the Inline XBRL document)

 

 

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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: August 12, 2024				By:		/s/ Dominic Piscitelli
						Dominic Piscitelli Chief Financial Officer

 

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	Exhibit 99.1

 

ORIC Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Updates

 

Initiated dosing of ORIC-944 in combinations with NUBEQA® (darolutamide) and ERLEADA® (apalutamide) in the ongoing Phase 1b trial for prostate cancer

 

Entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support the ongoing Phase 1b trial of ORIC-944 in combination with NUBEQA® and in combination with ERLEADA®

 

Expanded leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs

 

Cash and investments of $308.5 million expected to fund operating plan into late 2026

 

SOUTH SAN FRANCISCO and SAN DIEGO, CA – August 12, 2024 – 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 June 30, 2024.

 

“We have made strong progress on advancing the pipeline, deepening strategic relationships, and growing the leadership team to add new functional capabilities,” said Jacob M. Chacko, M.D., president and chief executive officer. “We are making good progress on the expansion cohorts for ORIC-114 in three different selected patient populations in NSCLC and have initiated combination dosing for ORIC-944 in prostate cancer. The clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson are pivotal steps in supporting those combination cohorts. Finally, we bolstered our leadership team to add commercial and medical affairs capabilities in advance of the potential initiation of multiple registrational trials in 2025. We look forward to sharing further clinical updates in 2025.”

 

Second Quarter 2024 and Other Recent Highlights

 

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

•

Announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 and the selection of two provisional recommended phase 2 doses.

•

Announced first patients dosed across three expansion cohorts in the Phase 1b trial of ORIC-114 in patients with mutated non-small cell lung cancer (NSCLC), including EGFR exon 20 insertion (EGFR exon 20 inhibitor naïve), HER2 exon 20 insertion, and EGFR atypical mutations.

•

Initiated an extension cohort to evaluate ORIC-114 for the treatment of patients with first-line, treatment-naïve EGFR exon 20 insertion NSCLC.

•

Expect to report updated Phase 1b data in the first half of 2025.

 

 

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ORIC-944: a potent and selective allosteric inhibitor of PRC2

•

Initiated dosing of ORIC-944 in combination with NUBEQA® (darolutamide) and in combination with ERLEADA® (apalutamide) in the ongoing Phase 1b trial for prostate cancer in first half of 2024.

•

Entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support the ongoing Phase 1b trial of ORIC-944 in combinations with AR inhibitors for the treatment of prostate cancer.

•

Presented preclinical data at the 2024 AACR Annual Meeting demonstrating superior drug properties and synergy data in prostate cancer models, reinforcing the promise of ORIC-944 as a potential best-in-class treatment for combination with AR inhibitors.

 

Discovery Pipeline:

•

Presented at the 2024 AACR annual meeting the first preclinical data on ORIC-613, a potential first- and best-in-class development candidate selectively inhibiting PLK4.

 

Corporate Highlights:

•

Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs.

 

Second Quarter 2024 Financial Results

 

•

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $308.5 million as of June 30, 2024, which the company expects will be sufficient to fund its operating plan into late 2026.

 

•

R&D Expenses: Research and development (R&D) expenses were $28.9 million for the three months ended June 30, 2024, compared to $18.8 million for the three months ended June 30, 2023, an increase of $10.2 million. For the six months ended June 30, 2024, R&D expenses were $50.9 million, compared to $38.3 million for the six months ended June 30, 2023, an increase of $12.6 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.6 million and $1.2 million for the three and six months ended June 30, 2024, respectively.

 

•

G&A Expenses: General and administrative (G&A) expenses were $7.1 million for the three months ended June 30, 2024, compared to $6.2 million for the three months ended June 30, 2023, an increase of $0.9 million. For the six months ended June 30, 2024, G&A expenses were $14.1 million, compared to $12.4 million for the six months ended June 30, 2023, an increase of $1.7 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.6 million and $1.3 million for the three and six months ended June 30, 2024, respectively.

About ORIC Pharmaceuticals, Inc.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates

 

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include (1) 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, (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-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. Beyond these three 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 X 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-114 and ORIC-944; ORIC-114 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-114, ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational studies; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; 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’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts 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 and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; 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

 

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conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2024, 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

[e-mail]

[e-mail]

 

 

 

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ORIC PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 

	June 30, 2024				December 31, 2023
	(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term investments	$	286,406			$	208,187
Prepaid expenses and other current assets		8,193				4,410
Total current assets		294,599				212,597
Long-term investments		22,126				26,852
Property and equipment, net		2,878				2,862
Other assets		9,303				9,696
Total assets	$	328,906			$	252,007
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	2,309			$	944
Accrued liabilities		17,230				19,514
Total current liabilities		19,539				20,458
Other long-term liabilities		6,967				7,461
Total liabilities		26,506				27,919
Total stockholders' equity		302,400				224,088
Total liabilities and stockholders' equity	$	328,906			$	252,007

 

 

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ORIC PHARMACEUTICALS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share and per share amounts)

 

	Three Months Ended June 30,								Six Months Ended June 30,
	2024				2023				2024				2023
Operating expenses:
Research and development	$	28,940			$	18,787			$	50,900			$	38,303
General and administrative		7,077				6,205				14,107				12,367
Total operating expenses		36,017				24,992				65,007				50,670
Loss from operations		(36,017	)			(24,992	)			(65,007	)			(50,670	)
Other income, net		4,054				2,048				8,033				3,781
Net loss	$	(31,963	)		$	(22,944	)		$	(56,974	)		$	(46,889	)
Other comprehensive (loss) income:
Unrealized (loss) gain on investments		(94	)			(68	)			(514	)			724
Comprehensive loss	$	(32,057	)		$	(23,012	)		$	(57,488	)		$	(46,165	)
Net loss per share, basic and diluted	$	(0.45	)		$	(0.50	)		$	(0.83	)		$	(1.03	)
Weighted-average shares outstanding, basic and diluted		70,348,414				45,654,208				68,848,981				45,373,745

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Document and Entity Information	Aug. 12, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001796280
Document Type	8-K
Document Period End Date	Aug. 12, 2024
Entity Registrant Name	ORIC Pharmaceuticals, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-39269
Entity Tax Identification Number	47-1787157
Entity Address, Address Line One	240 E. Grand Ave
Entity Address, Address Line Two	2nd Floor
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(650)
Local Phone Number	388-5600
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common stock, par value $0.0001 per share
Trading Symbol	ORIC
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	true

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