SEC Filing — Kura Oncology, Inc.

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8-K

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): November 3, 2022

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On November 3, 2022, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the third quarter ended September 30, 2022 and providing a corporate update. A copy of this press release is furnished herewith as Exhibit 99.1.

On November 3, 2022, the Company filed with the Securities and Exchange Commission (the “SEC”) a prospectus supplement (the “Prospectus Supplement”) pursuant to Rule 424(b) under the Securities Act of 1933, as amended, relating to its Registration Statement on Form S-3ASR (File No. 333-251172) filed with the SEC on December 7, 2020, in connection with a registered direct offering. In the Prospectus Supplement, the Company disclosed that its net tangible book value of its common stock as of September 30, 2022 was approximately $419.6 million, or approximately $6.27 per share of common stock, based upon 66,893,757 shares outstanding. These amounts are unaudited and do not present all information necessary for an understanding of the Company’s financial condition as of September 30, 2022.

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 November 3, 2022

104		Cover Page Interactive Data File (embedded within 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 thereunto duly authorized.


	KURA ONCOLOGY, INC.

Date: November 3, 2022	By:	/s/ Teresa Bair
		Teresa Bair
		Chief Legal Officer

EX-99.1

Exhibit 99.1

Kura Oncology Reports Third Quarter 2022

Financial Results

– Abstract reporting updated data from KOMET-001 accepted for oral presentation at ASH –

– First demonstration of durable clinical response with tipifarnib plus alpelisib in HNSCC –

– AIM-HN trial of tipifarnib in HRAS mutant HNSCC closed to further enrollment –

– $25 million equity investment from Bristol Myers Squibb and $125 million term loan facility from Hercules Capital –

– $428 million in cash plus equity investment and term loan facility, if fully drawn, provide runway into 2026 –

– Management to host webcast and conference call today at 8:00 a.m. ET –

SAN DIEGO, Nov. 3, 2022– 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 third quarter 2022 financial results and provided a corporate update.

“We are very proud to announce that our abstract reporting updated data from the KOMET-001 trial of ziftomenib has been accepted for oral presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in December,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We continue to have strong conviction in ziftomenib and its potential to be a best-in-class menin inhibitor. Our confidence is supported by a growing body of clinical data, and we look forward to sharing a comprehensive update on the program at ASH.”

“Earlier this morning, we also announced a $25 million equity investment from Bristol Myers Squibb and a $125 million term loan facility from Hercules Capital,” Dr. Wilson continued. “If the term loan facility is fully drawn, proceeds from these two transactions, together with our existing cash, are expected to fund our current operating plan into 2026, enabling us to advance ziftomenib as well as our farnesyl transferase inhibitor programs through important, clinical-stage inflection points that we believe will create meaningful value for patients and shareholders.”

Recent Highlights

•

Updated data from KOMET-001 accepted for oral presentation at ASH – An abstract reporting updated data from the KOMET-001 trial of ziftomenib has been accepted for oral presentation at the ASH Annual Meeting on December 10, 2022. The abstract, which will be published on the ASH website later today, highlights the encouraging safety profile and clinical activity of ziftomenib in patients with relapsed/refractory acute myeloid leukemia (AML). It includes 30 all-comer AML patients from the Phase 1a dose-escalation portion of the trial and 24 NPM1-mutant or KMT2A-rearranged AML patients from the Phase 1b portion – 12 patients at 200 mg and 12 patients at 600 mg.

•

Additional 18 patients enrolled in KOMET-001 Phase 1b extension – Kura enrolled an additional 18 patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory AML in a Phase 1b extension as the Company prepares to transition into the Phase 2 registration-directed portion of the KOMET-001 trial and initiate a series of combination studies in the relapsed and frontline settings, pending FDA review of the recommended Phase 2 dose (RP2D) and protocols. Kura anticipates sharing a more mature dataset, including preliminary data from the additional 18 patients in the Phase 1b extension, during its oral presentation at ASH.

•

Preliminary proof of mechanism of tipifarnib plus alpelisib in HNSCC – Last week, at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, Kura reported the first demonstration that the combination of tipifarnib and alpelisib can induce a durable clinical response in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC). A patient with stage III squamous cell carcinoma of the tonsil with a PIK3CA mutation and HRAS overexpression has achieved a durable partial remission in KURRENT-HN. As of mid-September, the patient has experienced an 84% reduction in target lesions and continued on-study for more than 27 weeks. Treatment-related adverse events in KURRENT-HN have been consistent with the known safety profiles of each drug and are manageable, with no dose-limiting toxicities reported to date.

•

AIM-HN registration-directed trial closed to further enrollment – Kura continues to observe evidence of meaningful clinical activity in its AIM-HN registration-directed trial of tipifarnib as a monotherapy in recurrent and metastatic HRAS mutant HNSCC but has elected to close the trial to further enrollment due to significant feasibility challenges. The Company is currently evaluating the best way to harvest and use the clinical data from AIM-HN, along the with the data from the RUN-HN trial, which formed the basis of the Breakthrough Therapy Designation for tipifarnib, to inform future development of the program. Given the significant overlap between patients with HRAS overexpression and mutation, HRAS mutant HNSCC patients in the U.S. may be eligible to enroll in the KURRENT-HN study.

•

Initiation of KURRENT-LUNG trial of tipifarnib plus osimertinib – Kura has initiated a Phase 1 KURRENT-LUNG trial of tipifarnib in combination with osimertinib in EGFR-mutated non-small cell lung cancer (NSCLC) and expects to dose the first patient this quarter. Preclinical data, generated through a collaboration with INSERM (the French National Institute of Health and Medical Research), support the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR-mutant NSCLC. The Company intends to perform initial clinical evaluation with tipifarnib in combination with osimertinib while advancing its next-generation FTI, KO-2806, through investigational new drug (IND)-enabling studies.

•

$25 million equity investment from Bristol Myers Squibb – Kura has agreed to sell 1,370,171 shares to Bristol Myers Squibb at a price of $18.25 per share for gross proceeds of $25 million. In connection with the equity investment, Bristol Myers Squibb will appoint a member to Kura’s Global Steering Committee. The equity investment further strengthens the relationship between the two organizations and enables Bristol Myers Squibb, a leader in the discovery and development of transformational cancer treatments, to provide valuable strategic input into Kura’s global development strategy.

•

$125 million term loan facility from Hercules Capital – Under the terms of the loan agreement, $10 million will be drawn immediately after closing and an additional $15 million is immediately available to Kura at its sole discretion. Kura may draw an additional $75 million in two separate tranches upon achievement of near-term clinical milestones. An additional $25 million may be drawn in a fourth tranche, subject to the approval of Hercules Capital. The term loan facility augments Kura’s already strong balance sheet and gives the Company significant financial strength and flexibility to invest across its three programs to drive meaningful value for both patients and shareholders.

Financial Results

•

Research and development expenses for the third quarter of 2022 were $25.0 million, compared to $22.4 million for the third quarter of 2021. The increase in R&D expenses was primarily due to increases in personnel costs and discovery stage programs.

•

General and administrative expenses for the third quarter of 2022 were $11.6 million, compared to $11.3 million for the third quarter of 2021. The increase in G&A expenses was primarily due to increases in personnel costs.

•

Net loss for the third quarter of 2022 was $35.5 million, compared to a net loss of $33.4 million for the third quarter of 2021. This included non-cash share-based compensation expense of $6.4 million, compared to $6.1 million for the same period in 2021.

•

Cash, cash equivalents and short-term investments totaled $427.8 million as of September 30, 2022, compared with $518.0 million as of December 31, 2021.

•

As adjusted for the $25 million equity investment from Bristol Myers Squibb and the $10 million initial draw from the Hercules term loan facility, Kura had, on a pro forma basis, $462.8 million in cash, cash equivalents and short-term investments at September 30, 2022.

•

Management believes that cash, cash equivalents and short-term investments, plus cash from the term loan facility from Hercules, if fully drawn, will be sufficient to fund its current operating plan into 2026.

Forecasted Milestones

•

Oral presentation of the Phase 1 data from KOMET-001, including preliminary data from additional 18 patients in the Phase 1b extension, at ASH in December

•

Initiation of the Phase 2 registration-directed portion of KOMET-001 in the first half of 2023, pending FDA review of the RP2D and protocol

•

Initiation of a Phase 1 combination study of ziftomenib in front line and relapsed/refractory AML in the first half of 2023, pending FDA review of the RP2D and protocol

•

First patient dosed in the Phase 1 KURRENT-LUNG study of tipifarnib plus osimertinib in the fourth quarter of 2022

•

Determination of the optimal biologically active dose (OBAD) for the PIK3CA cohort in the Phase 1 KURRENT-HN study of tipifarnib plus alpelisib in mid-2023

•

Submission of the IND application for KO-2806 in the fourth quarter of 2022

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 3, 2022, to discuss the financial results for the third quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (888) 394-8218 for domestic callers and (323) 994-2093 for international callers and entering the conference ID: 2251807. 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. Ziftomenib (KO-539), a potent and selective menin inhibitor, is currently in a Phase 1b clinical trial (KOMET-001) for patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. Tipifarnib, a potent, selective and orally bioavailable FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC. Kura is conducting a Phase 1/2 trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients, including those whose tumors are dependent on HRAS and/or PI3Kα pathways. The Company has also initiated a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutant NSCLC. Kura intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, the Company’s next-generation FTI, through IND-enabling studies. For additional information, please visit Kura’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, ziftomenib, tipifarnib 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 sufficiency of cash, cash equivalents and short-term investments, plus cash from the term loan facility from Hercules, if fully drawn, to fund its current operating plan into 2026. 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 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, including the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2022, 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.


KURA ONCOLOGY, INC.
Statements of Operations Data
(unaudited)
(in thousands, except per share data)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2022			2021			2022			2021
Operating Expenses:
Research and development	$	24,973		$	22,367		$	70,144		$	63,765
General and administrative		11,621			11,310			34,565			34,455
Total operating expenses		36,594			33,677			104,709			98,220
Other income (expense), net		1,090			311			1,983			497
Net loss	$	(35,504	)	$	(33,366	)	$	(102,726	)	$	(97,723	)
Net loss per share, basic and diluted	$	(0.53	)	$	(0.50	)	$	(1.54	)	$	(1.47	)
Weighted average number of shares used in computing net loss per share, basic and diluted		66,889			66,353			66,723			66,285


KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)

	September 30,			December 31,
	2022			2021
Cash, cash equivalents and short-term investments	$	427,775		$	517,960
Working capital		411,646			499,834
Total assets		447,988			534,051
Long-term liabilities		3,622			4,987
Accumulated deficit		(535,694	)		(432,968	)
Stockholders’ equity		419,621			506,609

Contacts

Company:

Pete De Spain

Senior Vice President, Investor Relations &

Corporate Communications

(858) 500-8803

pete@kuraoncology.com

Investors:

Robert H. Uhl

Managing Director

ICR Westwicke

(858) 356-5932

robert.uhl@westwicke.com

Media:

Jason Spark

Managing Director

Evoke Canale

(619) 849-6005

jason.spark@evokegroup.com