Kura Oncology Files 2023 Annual Report on Form 10-K

TL;DR

<b>Kura Oncology, Inc. has filed its 2023 annual report (10-K) detailing its financial and operational status for the year ending December 31, 2023.</b>

AI Summary

Kura Oncology, Inc. (KURA) filed a Annual Report (10-K) with the SEC on February 27, 2024. Kura Oncology, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is 12730 High Bluff Drive, Suite 400, San Diego, CA 92130. Kura Oncology's IRS number is 611547851, and it is incorporated in Delaware. The filing was submitted on February 27, 2024, under SEC file number 001-37620.

Why It Matters

For investors and stakeholders tracking Kura Oncology, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Kura Oncology's business, financial condition, and results of operations for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed financial information and risk factors disclosed in this annual report are essential for stakeholders to understand the company's strategic direction, potential challenges, and investment risks.

Risk Assessment

Risk Level: medium — Kura Oncology, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry (SIC 2834), which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, as indicated by the nature of its business and the typical risks associated with biotechnology firms.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Kura Oncology's current financial health, R&D pipeline progress, and potential market challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-02-27 — Filing Date (Filed as of date)
• 001-37620 — SEC File Number (SEC file number)
• 2834 — Standard Industrial Classification (Pharmaceutical Preparations)

Key Players & Entities

• Kura Oncology, Inc. (company) — Filer name
• 0000950170-24-021094 (other) — Accession Number
• 20231231 (date) — Conformed period of report
• 20240227 (date) — Filed as of date
• 12730 High Bluff Drive, Suite 400 (address) — Business address
• San Diego, CA (address) — Business address city and state
• 611547851 (other) — IRS Number
• DE (state) — State of incorporation

FAQ

Industry Context

Kura Oncology operates in the pharmaceutical preparations industry, focusing on the development and commercialization of targeted cancer therapies.

Regulatory Implications

As a pharmaceutical company, Kura Oncology is subject to extensive regulation by bodies such as the FDA, governing drug development, clinical trials, and marketing.

What Investors Should Do

1. Analyze the company's financial statements for revenue, expenses, and cash flow.
2. Review the 'Risk Factors' section for potential challenges and uncertainties.
3. Examine the 'Business' section for details on drug pipeline and development status.

Key Dates

• 2024-02-27: 10-K Filing — Annual report submission date

Year-Over-Year Comparison

This filing is the annual report for the fiscal year ended December 31, 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share KURA The Nasdaq Global Se
• $10.58 — 30, 2023 based on the closing price of $10.58 as reported on the Nasdaq Global Select

Filing Documents

• kura-20231231.htm (10-K) — 2751KB
• kura-ex23_1.htm (EX-23.1) — 6KB
• kura-ex31_1.htm (EX-31.1) — 14KB
• kura-ex32_1.htm (EX-32.1) — 8KB
• kura-ex97_1.htm (EX-97.1) — 60KB
• img338930_0.jpg (GRAPHIC) — 177KB
• img338930_1.jpg (GRAPHIC) — 328KB
• 0000950170-24-021094.txt (&nbsp;) — 11096KB
• kura-20231231.xsd (EX-101.SCH) — 1428KB
• kura-20231231_htm.xml (XML) — 1593KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 74 Item 1C. Cybersecurity 74 Item 2.

Properties

Properties 75 Item 3.

Legal Proceedings

Legal Proceedings 75 Item 4. Mine Safety Disclosures 75 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 76 Item 6. [ Reserved] 77 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 78 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 87 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 88 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 88 Item 9A.

Controls and Procedures

Controls and Procedures 88 Item 9B. Other Information 91 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 91 PART III Item 10. Directors, Executive Officers and Corporate Governance 92 Item 11.

Executive Compensation

Executive Compensation 92 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 92 Item 13. Certain Relationships and Related Transactions, and Director Independence 92 Item 14. Principal Accountant Fees and Services 92 PART IV Item 15. Exhibit and Financial Statement Schedules 93 Item 16. Form 10-K Summary 96

SIGNATURES

SIGNATURES 97 ii PART I

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K, or Annual Report, may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "may," "plan," "potential," "predict," "project," "targets," "likely," "will," "would," "could," "should," "continue," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our beliefs and opinions on the relevant subject and are based upon information available to us as of the date of this Annual Report. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on information that may be limited or incomplete, our projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. The sections in this Annual Report entitled "Business," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" as well as other sections in this Annual Report, discuss some of the factors th

B usiness

Item 1. B usiness. Overview We are a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes, and we intend to pair them with molecular or cellular diagnostics to identify those patients most likely to respond to treatment. We are conducting clinical trials of three product candidates: ziftomenib, tipifarnib and KO-2806. We also have additional programs that are at a discovery stage. We own global commercial rights to all of our programs and product candidates. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights. 3 Ziftomenib. Our first product candidate, ziftomenib, is a potent, selective, reversible and oral small molecule inhibitor that blocks the interaction of two proteins, menin and the protein expressed by the Lysine K-specific Methyl Transferase 2A gene, or KMT2A gene (formerly referred to as the mixed-lineage leukemia 1 gene). We received orphan drug designation for ziftomenib for the treatment of acute myeloid leukemia, or AML, from the U.S. Food and Drug Administration, or the FDA, in July 2019. We initiated our global menin-KMT2A Phase 1/2 clinical trial of ziftomenib in relapsed or refractory AML, which we call the K ura O ncology ME nin-KMT2A T rial, or KOMET-001, in September 2019. In the Phase 1a dose-escalation portion of the KOMET-001 trial, ziftomenib demonstrated a wide therapeutic window and encouraging monotherapy activity in an all-comer population of 30 patients with relapsed or refractory AML. A total of 53 patients were treated in the Phase 1b dose-validation and dose-expansion portions of the trial, which consisted of two randomized expansion cohorts, each compri

View Full Filing

View this 10-K filing on SEC EDGAR