Kura Oncology(KURA) - 2022 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION ITEM 1. Condensed Financial Statements (unaudited) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's organization, accounting policies, investments, fair value measurements, balance sheet specifics, leases, stockholders' equity changes, share-based compensation, and significant subsequent events Condensed Balance Sheets | (In thousands) | September 30, 2022 (Unaudited) | December 31, 2021 | Change (2022 vs 2021) | | :-------------------------------- | :------------------------------- | :---------------- | :-------------------- | | Assets | | | | | Cash and cash equivalents | $90,937 | $90,672 | +$265 | | Short-term investments | $336,838 | $427,288 | -$90,450 | | Total current assets | $436,391 | $522,289 | -$85,898 | | Total assets | $447,988 | $534,051 | -$86,063 | | Liabilities and Stockholders' Equity | | | | | Total current liabilities | $24,745 | $22,455 | +$2,290 | | Total liabilities | $28,367 | $27,442 | +$925 | | Total stockholders' equity | $419,621 | $506,609 | -$86,988 | Condensed Statements of Operations and Comprehensive Loss | (In thousands, except per share data) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | 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 | | Interest and other income, net | $1,090 | $311 | $1,983 | $911 | | 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) | | Comprehensive Loss | $(37,105) | $(33,167) | $(110,353) | $(97,963) | Condensed Statements of Stockholders' Equity | (In thousands) | Balance at Dec 31, 2021 | Share-based compensation expense | Issuance of common stock under equity plans | Other comprehensive loss | Net loss | Balance at Sep 30, 2022 | | :----------------------------- | :---------------------- | :------------------------------- | :------------------------------------------ | :----------------------- | :------- | :---------------------- | | Common Stock (Shares) | 66,572 | — | 322 | — | — | 66,894 | | Common Stock (Par Value) | $7 | — | — | — | — | $7 | | Additional Paid-In Capital | $941,359 | $19,513 | $3,852 | — | — | $964,724 | | Accumulated Other Comprehensive Loss | $(1,789) | — | — | $(7,627) | — | $(9,416) | | Accumulated Deficit | $(432,968) | — | — | — | $(102,726) | $(535,694) | | Total Stockholders' Equity | $506,609 | $19,513 | $3,852 | $(7,627) | $(102,726) | $419,621 | Condensed Statements of Cash Flows | (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(83,532) | $(81,185) | | Net cash provided by (used in) investing activities | $79,945 | $(200,896) | | Net cash provided by (used in) financing activities | $3,852 | $(4,229) | | Net increase (decrease) in cash, cash equivalents and restricted cash | $265 | $(286,310) | | Cash, cash equivalents and restricted cash at end of period | $91,147 | $39,393 | Notes to Condensed Financial Statements (unaudited) 1. Organization and Basis of Presentation Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, developing small molecule product candidates targeting specific cancer signaling pathways. The unaudited condensed financial statements are prepared in accordance with GAAP for interim information, reflecting management's estimates and assumptions, and acknowledge the ongoing uncertainty regarding the impact of the COVID-19 pandemic - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company dedicated to precision medicines for cancer, developing small molecule product candidates[24] - The financial statements are prepared using GAAP for interim information, relying on management's estimates and assumptions, which are subject to inherent uncertainty[26][27] - The company acknowledges the highly uncertain and unpredictable impact of the COVID-19 pandemic on its business and operations[28] 2. Summary of Significant Accounting Policies This section outlines key accounting policies, including reclassifications, the treatment of restricted cash pledged for an office lease, the methodology for assessing allowance for credit losses on available-for-sale securities, and the calculation of net loss per share, noting that common stock equivalents are anti-dilutive due to net losses - Restricted cash of $0.2 million as of September 30, 2022, is pledged as collateral for an office lease[30][31] - For available-for-sale securities in an unrealized loss position, the company assesses intent/requirement to sell before recovery; credit-related losses are recorded through an allowance, while other unrealized losses are in other comprehensive income (loss)[32] - Basic and diluted net loss per share are the same for the periods presented due to net losses, with approximately 9.1 million common stock equivalents excluded from diluted EPS calculation as they would be anti-dilutive[36] 3. Investments The company invests in available-for-sale securities, primarily money market funds, U.S. Treasury, corporate debt, commercial paper, non-U.S. government, supranational debt, and U.S. Agency bonds. As of September 30, 2022, the fair value of short-term investments was $336.8 million, with $9.4 million in unrealized losses, primarily due to interest rate changes, not credit risk | (In thousands) | September 30, 2022 (Fair Value) | December 31, 2021 (Fair Value) | | :------------------------------------ | :------------------------------ | :----------------------------- | | Money market funds | $80,905 | $79,895 | | U.S. Treasury securities | $142,940 | $134,833 | | Corporate debt securities | $122,207 | $207,172 | | Commercial paper | $37,718 | $53,439 | | Non-U.S. government and supranational debt securities | $25,213 | $22,908 | | U.S. Agency bonds | $8,760 | $8,936 | | Total short-term investments | $336,838 | $427,288 | | Total investments (including cash equivalents) | $417,743 | $507,183 | - As of September 30, 2022, the company held 35 available-for-sale securities with a fair value of $299.1 million in gross unrealized loss positions, with $110.6 million in a continuous unrealized loss position for over 12 months[42] - Unrealized losses at September 30, 2022, were primarily attributed to changes in interest rates, not increased credit risks, and the company does not intend to sell these securities before recovery of their amortized cost basis[42] 4. Fair Value Measurements The company measures cash equivalents and short-term investments at fair value on a recurring basis, categorizing them into Level 1 (U.S. Treasury securities, money market funds) and Level 2 (corporate debt, commercial paper, non-U.S. government/supranational debt, U.S. Agency bonds) inputs based on the fair value hierarchy | (In thousands) | September 30, 2022 (Total Fair Value) | Level 1 | Level 2 | | :------------------------------------ | :------------------------------------ | :-------- | :-------- | | Money market funds | $80,905 | $80,905 | $— | | U.S. Treasury securities | $142,940 | $142,940 | $— | | Corporate debt securities | $122,207 | $— | $122,207 | | Commercial paper | $37,718 | $— | $37,718 | | Non-U.S. government and supranational debt securities | $25,213 | $— | $25,213 | | U.S. Agency bonds | $8,760 | $— | $8,760 | | Total | $417,743 | $223,845 | $193,898 | - Level 2 securities' fair values are determined using third-party valuations based on market pricing or prices for similar instruments, validated against a third-party pricing source[45] 5. Balance Sheet Detail This section provides a detailed breakdown of property and equipment, which increased to $2.7 million net, and accounts payable and accrued expenses, which rose to $22.4 million, primarily driven by accrued clinical trial R&D expenses | (In thousands) | September 30, 2022 | December 31, 2021 | | :------------------------------------ | :----------------- | :---------------- | | Property and equipment, net | $2,734 | $2,673 | | Accounts payable and accrued expenses | $22,441 | $20,192 | | - Accrued clinical trial R&D expenses | $5,471 | $2,619 | | - Accrued compensation and benefits | $7,966 | $7,923 | 6. Leases The company holds three operating leases for administrative and R&D space expiring between July 2024 and November 2025. Total operating lease liabilities were $5.4 million as of September 30, 2022, with a weighted-average remaining lease term of 2.6 years and a discount rate of 5.5% - The company has three operating leases for office and lab space in San Diego and Boston, expiring between July 2024 and November 2025[49] | (In thousands) | Amount | | :----------------------- | :----- | | Total operating lease liabilities (Sep 30, 2022) | $5,384 | | Weighted-average discount rate (Sep 30, 2022) | 5.5% | | Weighted-average remaining lease term (Sep 30, 2022) | 2.6 years | | Total cash paid for operating lease liabilities (Nine Months Ended Sep 30, 2022) | $1,700 | | Total operating lease expense (Nine Months Ended Sep 30, 2022) | $1,500 | 7. Stockholders' Equity In February 2022, the company established a new ATM Facility allowing the sale of up to $150.0 million in common stock, though no shares have been sold under this facility to date - A new ATM Facility was established in February 2022, enabling the company to offer and sell up to $150.0 million of common stock[51] - No shares have been sold under the ATM Facility as of the reporting date[51] 8. Share-Based Compensation Share-based compensation expense for the nine months ended September 30, 2022, increased to $19.5 million, with R&D accounting for $7.5 million and G&A for $12.0 million. Unrecognized compensation expense for stock options and restricted stock units totaled $48.4 million and $10.8 million, respectively, to be recognized over approximately 2.6 years | (In thousands) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $2,492 | $2,059 | $7,545 | $5,277 | | General and administrative | $3,863 | $4,055 | $11,968 | $11,905 | | Total share-based compensation expense | $6,355 | $6,114 | $19,513 | $17,182 | - As of September 30, 2022, unrecognized compensation expense was approximately $48.4 million for stock options and $10.8 million for restricted stock units, expected to be recognized over a weighted average period of 2.6 years[52] 9. Subsequent Events Subsequent to the quarter end, the company entered into a Loan and Security Agreement with Hercules Capital for up to $125.0 million in term loans, drawing an initial $10.0 million. Additionally, it entered a Securities Purchase Agreement with Bristol-Myers Squibb Company (BMS) for a $25.0 million registered direct offering of common stock - On November 2, 2022, the company entered a Loan Agreement with Hercules Capital, Inc. for up to $125.0 million in term loans, with an initial $10.0 million borrowed[54] - The Loan Agreement includes additional tranches of up to $115.0 million, subject to certain conditions and approvals, with a maturity date of November 2, 2027[54] - On November 2, 2022, the company also entered a Securities Purchase Agreement with BMS to sell 1,370,171 shares of common stock for approximately $25.0 million in gross proceeds[57] ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of the company's clinical-stage biopharmaceutical operations, focusing on its product candidates ziftomenib, tipifarnib, and KO-2806, and their development progress. It details the financial results, including research and development and general and administrative expenses, and discusses the company's liquidity, capital resources, contractual obligations, and critical accounting policies Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with lead product candidates ziftomenib and tipifarnib, and preclinical candidate KO-2806[62] - ziftomenib (KOMET-001 trial) received orphan drug designation for AML, completed Phase 1b enrollment, and will present updated data at ASH 2022, with Phase 2 initiation anticipated in H1 2023[65][71][73] - tipifarnib received Breakthrough Therapy Designation for HRAS mutant HNSCC, but the AIM-HN trial was closed due to feasibility challenges; new trials include KURRENT-HN (with alpelisib) and KURRENT-LUNG (with osimertinib)[79][80][81][84] - The company had $427.8 million in cash, cash equivalents, and short-term investments as of September 30, 2022, and recently secured a $125.0 million loan facility and a $25.0 million stock purchase agreement with BMS[86][87][88] Financial Operations Overview - Research and development expenses include personnel costs, clinical trial costs, manufacturing, and fees to external service providers, all expensed as incurred[90] - The timing, duration, and completion costs of preclinical studies and clinical trials are inherently unpredictable, depending on factors like trial complexity, patient enrollment, and regulatory requirements[91][93] - General and administrative expenses primarily cover executive, finance, business development, and support personnel costs, patent portfolio maintenance, and professional services[92] Results of Operations Comparison of the Three Months Ended September 30, 2022 and 2021 For the three months ended September 30, 2022, total operating expenses increased by $2.9 million to $36.6 million, primarily due to higher personnel costs and increased research activities for discovery-stage programs, partially offset by decreased tipifarnib-related clinical costs. Net loss increased to $35.5 million from $33.4 million in the prior year | (In thousands) | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Change | | :------------------------------------ | :------------------------------ | :------------------------------ | :----- | | Research and development expenses | $24,973 | $22,367 | +$2,606 | | General and administrative expenses | $11,621 | $11,310 | +$311 | | Other income (expense), net | $1,090 | $311 | +$779 | | Net Loss | $(35,504) | $(33,366) | $(2,138) | | Net loss per share, basic and diluted | $(0.53) | $(0.50) | $(0.03) | - The increase in R&D expenses was driven by higher personnel costs and increased research activities for KO-2806, partially offset by decreased clinical costs for tipifarnib[96] - Other income (expense), net increased primarily due to higher interest income[98] Comparison of the Nine Months Ended September 30, 2022 and 2021 For the nine months ended September 30, 2022, total operating expenses increased by $6.5 million to $104.7 million, primarily due to increased ziftomenib-related clinical trial costs, higher personnel expenses, and expanded discovery-stage programs, partially offset by reduced tipifarnib-related costs. Net loss increased to $102.7 million from $97.7 million in the prior year | (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Research and development expenses | $70,144 | $63,765 | +$6,379 | | General and administrative expenses | $34,565 | $34,455 | +$110 | | Other income (expense), net | $1,983 | $497 | +$1,486 | | Net Loss | $(102,726) | $(97,723) | $(5,003) | | Net loss per share, basic and diluted | $(1.54) | $(1.47) | $(0.07) | - ziftomenib-related R&D expenses increased by $3.0 million due to Phase 1/2 clinical trial costs, while tipifarnib-related R&D decreased by $9.7 million due to reduced clinical and manufacturing activities[100] - Other income (expense), net increased by $1.5 million, driven by higher interest income and a decrease in interest expense following a term loan payoff in May 2021[101] Liquidity and Capital Resources - As of September 30, 2022, the company had $427.8 million in cash, cash equivalents, and short-term investments, and an accumulated deficit of $535.7 million[86][108] - The company expects to fund operations into 2026, assuming the full draw of its $125.0 million term loan facility with Hercules Capital, entered into on November 2, 2022[103][109] | (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | Change | | :------------------------------------ | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(83,532) | $(81,185) | $(2,347) | | Net cash provided by (used in) investing activities | $79,945 | $(200,896) | +$280,841 | | Net cash provided by (used in) financing activities | $3,852 | $(4,229) | +$8,081 | Contractual Obligations and Commitments - The company has non-cancelable operating leases for office and laboratory space, with total lease payments of $5.8 million and total operating lease liabilities of $5.4 million as of September 30, 2022[50][115] - The company may be required to pay up to approximately $80.0 million in milestone payments, plus sales royalties, upon achieving regulatory and commercial milestones under its in-license agreements[118] Critical Accounting Policies and Management Estimates - There have been no material changes to the company's critical accounting policies and estimates since the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[120] ITEM 3. Quantitative and Qualitative Disclosures about Market Risk The company is exposed to interest rate risk primarily through its investment portfolio of cash, cash equivalents, and short-term investments, and its variable-rate term loans. A 10.0% change in interest rates is not expected to materially affect the fair value of the investment portfolio. Inflation has not had a material effect on the business - The company's investment portfolio, consisting of money market funds, U.S. Treasury securities, corporate debt, commercial paper, and other debt securities, is subject to interest rate risk[121] - A 10.0% change in interest rates on September 30, 2022, would not have had a material effect on the fair value of the investment portfolio[121] - The Term Loans bear interest at a variable rate (greater of prime rate minus 6.25% plus 8.65% or 8.65%), exposing the company to interest expense fluctuations[122] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during any presented periods[123] ITEM 4. Controls and Procedures The company's disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of September 30, 2022. During the quarter, a new ERP system was implemented, leading to updates in internal control over financial reporting processes, but no other material changes were identified - Disclosure controls and procedures were evaluated and concluded to be effective at the reasonable assurance level as of September 30, 2022[126] - A new ERP system was implemented during the quarter ended September 30, 2022, resulting in updated internal control over financial reporting processes[127] - No other changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the quarter[128] PART II. OTHER INFORMATION ITEM 1. Legal Proceedings The company is not currently a party to any legal proceedings that, in management's opinion, would have a material adverse effect on its results of operations or financial position - The company is not involved in any legal proceedings that would individually or in aggregate have a material adverse effect on its financial condition or results of operations[131] ITEM 1A. Risk Factors This section details the significant risks and uncertainties facing the company, encompassing challenges in product development, financial stability, reliance on third parties, regulatory compliance, intellectual property protection, commercialization, human resources, and macroeconomic conditions, all of which could materially impact its business, financial condition, and stock price Risk Factor Summary - The company's ability to conduct clinical trials has been and could continue to be adversely impacted by COVID-19[132] - High dependence on the success of lead product candidates, ziftomenib and tipifarnib, which are still in clinical development and require regulatory approval for commercialization[132] - Expectation of incurring losses for several years and the need for substantial additional capital, which may cause dilution to stockholders or restrict operations[132] - Reliance on third-party contractors for clinical trials and manufacturing increases risks of insufficient quantities, unacceptable cost, or quality issues[132] - Challenges in obtaining and maintaining intellectual property protection, as well as potential market acceptance issues and substantial competition for commercialized products[132] Risks Related to the Discovery and Development of Our Product Candidates - COVID-19 has adversely impacted and could continue to impact the company's ability to conduct clinical trials, potentially causing delays in site startup, patient enrollment, and protocol compliance[135] - The company is highly dependent on the successful development and regulatory approval of ziftomenib and tipifarnib, with no guarantee of approval or timely commercialization[136][139] - Clinical drug development is lengthy, expensive, and uncertain; preclinical and early clinical trial results may not predict later-stage outcomes, and preliminary data do not guarantee final results[155] - Product candidates may cause serious adverse events or unacceptable side effects, potentially delaying, limiting, or preventing their development or leading to trial suspension/termination[169][170] - Failure to develop, validate, and obtain regulatory approval for companion diagnostic testing platforms could harm the drug development strategy and operational results[175][177] Risks Related to Our Financial Position and Need for Additional Capital - The company expects to incur significant expenses and increasing operating losses for the foreseeable future and may never achieve or maintain profitability[181][182] - Substantial additional capital will be needed for continuing operations, which may be raised through equity offerings, debt financings, or collaborations, potentially leading to stockholder dilution or restrictive covenants[191] - The Loan Agreement with Hercules Capital includes affirmative and restrictive covenants, and a default could accelerate repayment obligations or allow lenders to take control of pledged assets[193] - The company's limited operating history makes it difficult to evaluate future success or viability, as it has not yet demonstrated the ability to successfully complete clinical trials, obtain marketing approvals, or commercialize products[188] Risks Related to Our Dependence on Third Parties - The company relies heavily on third-party contractors (CROs, data managers, medical institutions) to conduct preclinical and clinical trials, reducing control and posing risks of delays or non-compliance[195][198][199] - Dependence on third parties for manufacturing product candidates for preclinical, clinical, and commercial use increases the risk of insufficient quantities, unacceptable cost, or quality issues[204] - Manufacturing pharmaceutical products is complex, with risks including production difficulties, quality control issues, and compliance with cGMP regulations, which could lead to delays or regulatory sanctions[205][208] - Geopolitical events and the COVID-19 pandemic could negatively impact third-party manufacturers and supply chains, potentially causing interruptions in drug supply for clinical trials[210] Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters - Obtaining marketing approval from regulatory authorities (FDA, EMA) is expensive, lengthy, and uncertain, with no guarantee of success, potentially impairing revenue generation[212][213] - The company may not benefit from available regulatory exclusivity periods for tipifarnib if another company obtains approval first, potentially reducing or eliminating its exclusivity and commercial prospects[214][215] - Orphan drug exclusivity for ziftomenib (AML) may be lost if approved for a broader indication or if a competitor's different drug for the same condition is approved[218] - Fast Track and Breakthrough Therapy Designations do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[220][223] - Relationships with healthcare professionals and business operations are subject to fraud and abuse laws (Anti-Kickback, False Claims, HIPAA, Sunshine Act), privacy laws (CCPA, GDPR), and other healthcare regulations, with potential for significant penalties for non-compliance[230][232][234][235][236][240] - Recently enacted and future healthcare legislation (ACA, IRA) and governmental scrutiny over drug pricing could increase costs, restrict sales, and adversely affect revenues and profitability[241][243][244][245][247][248] Risks Related to Our Intellectual Property - Inability to obtain and maintain broad intellectual property protection for product candidates could allow competitors to commercialize similar products, impairing the company's ability to commercialize its own[255] - Patent rights for tipifarnib are limited, as composition of matter patents expired in 2016, and method of treatment patents may not prevent competitors from marketing tipifarnib for other indications[259][260] - The company depends on licensors (University of Michigan, Janssen) to prosecute and maintain material patents, and any failure by them to effectively protect these rights could adversely impact the business[264] - Breaching license agreements could lead to the loss of critical commercialization rights for product candidates, materially harming the business[266] - Changes in U.S. or foreign patent laws (e.g., Leahy-Smith Act, Unitary Patent Court) or their interpretation could diminish patent value, increase prosecution costs, and reduce protection[269][270][275][276] - Failure to protect trade secrets through non-disclosure and confidentiality agreements could result in misappropriation or independent development by competitors, harming the company's competitive position[285] Risks Related to the Commercialization of Our Product Candidates - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors, impacting revenue generation and profitability[289] - The company currently lacks internal sales and market access personnel and may struggle to establish effective capabilities or secure third-party agreements, delaying or limiting commercialization[292] - The drug development market is highly competitive, with major pharmaceutical and biotechnology companies developing competing products that may be safer, more effective, or less expensive[293][295][296] - Uncertainty regarding insurance coverage and adequate reimbursement by governmental and private payors could limit market access and decrease revenue for new products[297][298] - Product liability lawsuits related to clinical trials or commercial sales could result in substantial liabilities, reputational harm, and limitations on commercialization[304] Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions - COVID-19 precautionary measures, such as remote work, could disrupt operations, limit interaction with third parties, and negatively affect employee recruitment and engagement[306] - The company is highly dependent on its Chief Executive Officer and other key management/scientific personnel, and the inability to retain or attract qualified individuals could harm business strategy[307][308] - Anticipated significant growth in employees and operations (development, regulatory, commercial) may be difficult to manage effectively due to limited financial resources and management experience[309] - Failure to meet evolving environmental, social, and governance (ESG) expectations could negatively impact reputation, employee attraction/retention, and investment desirability[311][313] - Unfavorable global economic conditions, including volatility from COVID-19, interest rates, and inflation, could adversely affect the ability to raise capital and strain suppliers[314] - Compromised information technology systems or data, including those of third parties, could lead to security incidents, regulatory actions, litigation, and business disruptions[315][316][318][319] Risks Related to Ownership of our Common Stock - The company's stock price may fluctuate significantly due to various factors, including clinical trial results, regulatory decisions, competition, and general market conditions, making it difficult for stockholders to sell shares[324][325][326] - Future sales and issuances of common stock or rights to purchase common stock, including under equity incentive plans or the ATM Facility, could result in dilution to existing stockholders and cause the stock price to fall[332][333][337] - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change of control, limiting the market price of common stock and potentially frustrating stockholder attempts to replace management[338][340] - Changes in tax laws or regulations, such as the Tax Cut and Jobs Act or the IRA, could adversely affect the company's business, cash flow, and financial condition, and limit the use of net operating loss carryforwards[344][346] - The company does not intend to pay cash dividends on its capital stock in the foreseeable future, with any future payments dependent on financial condition and board discretion[347] General Risk Factors - If securities or industry analysts publish inaccurate or unfavorable research, the company's stock price and trading volume could decline[348] - Actions by activist stockholders could divert management's attention, incur significant costs, and negatively impact the company's reputation and stock value[349] - Securities class action litigation, common in the biotechnology industry, could divert management's attention, harm the business, and lead to significant liabilities[350] - Misconduct by employees, contractors, or other third parties, including noncompliance with regulatory standards or fraud and abuse laws, could result in significant penalties and reputational harm[351] - Non-compliance with U.S. and foreign export/import controls, sanctions, anti-corruption, and anti-money laundering laws could lead to criminal liability, fines, and harm to the business[352] ITEM 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including organizational documents, warrant agreements, securities purchase agreements, loan and security agreements, certifications, and XBRL-related documents - Key exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Warrant Agreements (including one issued to Hercules Capital, Inc. on November 2, 2022), Securities Purchase Agreement with Bristol-Myers Squibb Company, and the Loan and Security Agreement with Hercules Capital, Inc.[355] - Certifications of Principal Executive and Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included[355] - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) are provided for interactive data filing[355] Signatures The report is officially signed on behalf of Kura Oncology, Inc. by its President and Chief Executive Officer, Troy E. Wilson, Ph.D., J.D., who also serves as the Principal Executive and Financial Officer - The report was signed on November 3, 2022, by Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer, acting as the Principal Executive and Financial Officer[360]