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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 5, 2021

 

KURA ONCOLOGY, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware	001-37620	61-1547851
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
12730 High Bluff Drive, Suite 400, San Diego, CA		92130
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 500-8800

N/A

(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 Instructions 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
Common Stock, par value $0.0001 per share	KURA	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 5, 2021, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the second quarter ended June 30, 2021 and providing a corporate update. A copy of this press release is furnished herewith as Exhibit 99.1.

The information contained in this Current Report on Form 8-K under Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit Number		Description
99.1		Press release dated August 5, 2021
104		Cover Page Interactive Data File (embedded within 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 thereunto duly authorized.

 

		KURA ONCOLOGY, INC.
Date: August 5, 2021		By:	/s/ Marc Grasso, M.D.
			Marc Grasso
			Chief Financial Officer and Chief Business Officer

 

 

 

 

Exhibit 99.1

 

 

 

Kura Oncology Reports Second Quarter 2021

Financial Results

 

– First patients dosed in Phase 1b expansion cohorts with menin inhibitor KO-539 –

 

– Clinical collaboration with Novartis to evaluate tipifarnib in combination with the PI3Kα inhibitor alpelisib in HNSCC –

 

– KO-2806 nominated as lead development candidate in next-generation farnesyl transferase inhibitor program –

 

– $567.5 million in cash, cash equivalents and investments provide runway into 2024 –

 

– Management to host webcast and conference call today at 4:30 p.m. ET –

 

SAN DIEGO, August 5, 2021 – Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2021 financial results and provided a corporate update.

 

“I am extremely proud of the progress our team has made over the past several months, underscoring our focus on operational execution,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We continue to have strong conviction in KO-539 and its potential to be both a first-in-class and a best-in-class menin inhibitor. This confidence is supported by clinical data from KOMET-001, our Phase 1/2 trial of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). Given the wide therapeutic window KO-539 demonstrated in the Phase 1a dose escalation portion of the trial, we have now advanced into the Phase 1b expansion cohorts in patients with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML. The Phase 1b enables us to refine the selection of a recommended Phase 2 dose while maintaining an aggressive development timeline for the program.”

 

“Although it is early and the results are still preliminary,” continued Dr. Wilson, “we are encouraged by observations of early signs of clinical activity in the Phase 1b expansion cohorts. We are also encouraged by the rate of patient screening and enrollment, an indication of the enthusiasm of the investigators as well as the strong execution of our clinical operations team. We intend to provide an update on both the Phase 1a and the Phase 1b at a future medical meeting, pending determination of the recommended

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Phase 2 dose. In the meantime, we look forward to providing qualitative updates on the progress of the Phase 1b in the months ahead.”

 

Recent Highlights

 

 

 

 

 

 

 

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Financial Results and Guidance

 

 

 

 

 

 

 

 

Upcoming Milestones

 

 

 

 

 

Conference Call and Webcast

 

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 5, 2021, to discuss the financial results for the second quarter 2021 and provide a corporate update. The live call may be accessed by dialing (877) 516-

 

 

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3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 3171857. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

 

About Kura Oncology

 

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. KO-539, a potent and selective menin inhibitor, is currently in a Phase 1/2 clinical trial (KOMET-001) and targeting patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. Tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed study (AIM-HN) in patients with this devastating disease. In addition, Kura is pursuing the use of tipifarnib in combination with other oncology therapeutics to address larger genetic subsets of patients, including those who have HRAS- and/or PIK3CA-dependent HNSCC. The Company is also developing a next-generation farnesyl transferase inhibitor, which is intended to target innovative biology and larger oncology indications through rational combinations. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.

 

Forward-Looking Statements

 

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s product candidates, tipifarnib, KO-539 and KO-2806, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, the strength of Kura’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the

 

 

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negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

 

 

 

 

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Contacts

 

Company:

Pete De Spain

Vice President, Investor Relations &

Corporate Communications

(858) 500-8803

pete@kuraoncology.com

 

Investors:

Robert H. Uhl

Managing Director

Westwicke Partners, LLC

(858) 356-5932

robert.uhl@westwicke.com

 

Media:

Jason Spark

Managing Director

Canale Communications

(619) 849-6005

jason@canalecomm.com