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): May 7, 2019

 

KURA ONCOLOGY, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

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):

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. ☒

Securities registered pursuant to Section 12(b) of the Act:

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 7, 2019, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the first quarter ended March 31, 2019 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.

 

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SIGNATURE

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.

 

 

Exhibit 99.1

 

Kura Oncology Reports First Quarter 2019 Financial Results and Highlights Upcoming Milestones

 

– Registration-directed trial of tipifarnib in HRAS mutant HNSCC continues on track –

 

– Data from ongoing Phase 2 trial of tipifarnib in CXCL12-driven PTCL accepted for oral presentations at EHA and ICML next month –

 

– Data from ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other SCCs anticipated in second half 2019 –

 

– $165.5 million in cash, cash equivalents and investments provide runway into 2021 –

 

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

 

SAN DIEGO, May 7, 2019 – 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 first quarter 2019 financial results and highlighted upcoming milestones.

 

“We have made considerable progress over the past quarter, as we continue to execute against our first registration-directed trial for tipifarnib in patients with HRAS mutant squamous head and neck cancers,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Meanwhile, our elucidation of the CXCL12 pathway as a therapeutic target of tipifarnib, coupled with identification of associated farnesylated proteins, offers the potential to significantly expand the population of patients who may benefit from treatment with tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers could enable registrational strategies for tipifarnib in multiple hematologic and solid tumor indications.”

 

“Now, we look forward to a series of important milestones,” continued Dr. Wilson, “beginning with an update from our ongoing Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which was accepted for oral presentation at both the European Hematology Association (EHA) Annual Congress and the International Conference on Malignant Lymphoma (ICML) next month. This will be followed by additional data from our ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including head and neck squamous cell carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as well as an update from our ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) later in the year.”

 

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Recent Highlights

 

 

 

 

 

Financial Results

 

 

 

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Upcoming Milestones

 

 

 

 

 

 

 

Conference Call and Webcast

 

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 7, 2019, to discuss the financial results for the first quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 4436235. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

 

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 where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, for which the Company has initiated a registration-directed trial of tipifarnib in recurrent or metastatic patients with HRAS

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mutant HNSCC. In addition, tipifarnib is being evaluated in multiple other Phase 2 clinical trials in solid tumor and hematologic indications. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 dose-escalation trial, and KO-539, a menin-MLL inhibitor, which has been cleared to begin a Phase 1 clinical trial. 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-947 and KO-539, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the potential expansion of tipifarnib to additional indications, 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 and applications, 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 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