[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for Kura Oncology, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with accompanying notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Balance Sheet Highlights (In thousands) | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $110,835 | $325,493 | | Short-term investments | $493,038 | $307,827 | | Total current assets | $610,705 | $637,292 | | Total assets | $620,263 | $647,212 | | Total current liabilities | $25,139 | $26,024 | | Total liabilities | $34,276 | $36,307 | | Total stockholders' equity | $585,987 | $610,905 | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenues, expenses, net loss, and comprehensive loss over specific periods Condensed Statements of Operations and Comprehensive Loss Highlights (In thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development expenses | $20,324 | $12,575 | | General and administrative expenses | $10,572 | $7,625 | | Total operating expenses | $30,896 | $20,200 | | Total other income | $202 | $990 | | Net Loss | $(30,694) | $(19,210) | | Net loss per share, basic and diluted | $(0.46) | $(0.42) | | Weighted average shares (basic and diluted) | 66,218 | 45,411 | | Comprehensive Loss | $(30,822) | $(18,980) | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in the company's equity, reflecting share transactions, comprehensive income/loss, and accumulated deficit Changes in Stockholders' Equity (In thousands) | Metric | Balance at Dec 31, 2020 | Share-based Comp Expense | Stock Issuance from Options | Other Comp Loss | Net Loss | Balance at Mar 31, 2021 | | :-------------------------------- | :---------------------- | :----------------------- | :-------------------------- | :-------------- | :------- | :---------------------- | | Common Stock Shares | 66,194 | — | 69 | — | — | 66,263 | | Additional Paid-In Capital | $913,354 | $5,075 | $829 | — | — | $919,258 | | Accumulated Other Comprehensive | $46 | — | — | $(128) | — | $(82) | | Income (Loss) | | | | | | | | Accumulated Deficit | $(302,502) | — | — | — | $(30,694) | $(333,196) | | Total Stockholders' Equity | $610,905 | $5,075 | $829 | $(128) | $(30,694) | $585,987 | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Statements of Cash Flows Highlights (In thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(28,517) | $(19,822) | | Net cash (used in) provided by investing activities | $(186,220) | $27,461 | | Net cash provided by financing activities | $79 | $247 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(214,658) | $7,886 | | Cash, cash equivalents and restricted cash at end of period | $111,045 | $34,021 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed financial statements, including accounting policies and significant estimates - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with small molecule product candidates targeting cancer signaling pathways. The company aims to pair these candidates with molecular or cellular diagnostics to identify responsive patients[22](index=22&type=chunk) - The preparation of financial statements involves management estimates and assumptions, which are continuously evaluated. The COVID-19 pandemic introduces additional uncertainty, potentially impacting business operations, clinical trials, and financial results, though the full scope cannot be predicted[25](index=25&type=chunk)[26](index=26&type=chunk) Cash, Cash Equivalents, and Restricted Cash Reconciliation (In thousands) | Metric | March 31, 2021 | December 31, 2020 | March 31, 2020 | December 31, 2019 | | :------------------------ | :------------- | :---------------- | :------------- | :---------------- | | Cash and cash equivalents | $110,835 | $325,493 | $33,811 | $26,135 | | Restricted cash | $210 | $210 | $210 | — | | Total | $111,045 | $325,703 | $34,021 | $26,135 | - The company invests in available-for-sale securities (money market funds, commercial paper, corporate debt, U.S. Treasury securities) and manages credit risk by diversifying its portfolio and investing with high credit quality institutions. As of March 31, 2021, **16 debt securities with a fair value of $149.5 million** were in unrealized loss positions, but none were considered credit losses[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) Fair Value Measurements of Cash Equivalents and Short-Term Investments (In thousands) | Category | March 31, 2021 Total | March 31, 2021 Level 1 | March 31, 2021 Level 2 | | :------------------------ | :------------------- | :--------------------- | :--------------------- | | Money market funds | $105,195 | $105,195 | $— | | Commercial paper | $169,353 | $— | $169,353 | | Corporate debt securities | $163,032 | $— | $163,032 | | U.S. Treasury securities | $160,653 | $160,653 | $— | | **Total** | **$598,233** | **$265,848** | **$332,385** | | Category | December 31, 2020 Total | December 31, 2020 Level 1 | December 31, 2020 Level 2 | | :------------------------ | :-------------------- | :---------------------- | :---------------------- | | Money market funds | $311,239 | $311,239 | $— | | Commercial paper | $5,998 | $— | $5,998 | | Corporate debt securities | $113,020 | $— | $113,020 | | U.S. Treasury securities | $88,457 | $88,457 | $— | | **Total** | **$625,064** | **$399,696** | **$225,368** | Accounts Payable and Accrued Expenses (In thousands) | Category | March 31, 2021 | December 31, 2020 | | :------------------------------------ | :------------- | :---------------- | | Accounts payable | $958 | $2,753 | | Accrued clinical trial R&D expenses | $6,789 | $4,080 | | Accrued other R&D expenses | $6,661 | $5,581 | | Accrued compensation and benefits | $3,858 | $7,016 | | Operating lease liability, current | $2,102 | $2,089 | | Other accrued expenses | $1,771 | $1,505 | | **Total** | **$22,139** | **$23,024** | - The company has several operating lease agreements for office and lab space, with **total lease liabilities of $7.3 million** as of March 31, 2021, and a weighted-average remaining lease term of **3.8 years**. Total operating lease expense for the three months ended March 31, 2021, was approximately **$0.5 million**[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) Share-Based Compensation Expense (In thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,371 | $1,170 | | General and administrative | $3,704 | $1,983 | | **Total** | **$5,075** | **$3,153** | - Unrecognized estimated compensation expense related to stock options and RSUs was approximately **$61.4 million** and **$5.7 million**, respectively, as of March 31, 2021, to be recognized over weighted average periods of **2.9 years** and **3.8 years**[48](index=48&type=chunk) - The company recorded management fee income of **$8,000** and **$15,000** for the three months ended March 31, 2021 and 2020, respectively, from a related party, Araxes Pharma LLC[49](index=49&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=13&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Kura Oncology's business, its clinical-stage product candidates, and a detailed analysis of its financial condition and results of operations for the three months ended March 31, 2021, compared to the same period in 2020 [Overview](index=13&type=section&id=Overview) This section introduces Kura Oncology's core business, lead product candidates, and strategic financial position as a clinical-stage biopharmaceutical company - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision cancer medicines, with two lead clinical-stage product candidates: tipifarnib and KO-539. The company owns global commercial rights for both and has additional discovery-stage programs[54](index=54&type=chunk) - Tipifarnib, a farnesyl transferase inhibitor, is being evaluated in HRAS mutant HNSCC. The AIM-HN registration-directed trial is ongoing, and tipifarnib received **FDA Breakthrough Therapy Designation in February 2021** for recurrent/metastatic HRAS mutant HNSCC with variant allele frequency ≥ 20%. The company plans a Phase 1/2 study for tipifarnib in combination with a PI3 kinase alpha inhibitor in HNSCC in H2 2021[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) - KO-539, a menin-KMT2A inhibitor, is in a Phase 1/2 clinical trial (KOMET-001) for relapsed or refractory AML. Preliminary results from December 2020 showed clinical or biological activity in **six of eight efficacy-evaluable patients**, including **two complete remissions**. The trial protocol was amended in May 2021 to include two Phase 1b expansion cohorts enriched with NPM1-mutant and KMT2A-rearranged AML patients, with enrollment expected to begin mid-2021[62](index=62&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - As of March 31, 2021, the company had **$603.9 million in cash, cash equivalents, and short-term investments**. It has an at-the-market (ATM) issuance sales agreement for up to **$75.0 million** but has not yet sold any shares under it. The company anticipates needing significant additional financing as it has not generated product sales revenue[67](index=67&type=chunk) [Financial Operations Overview](index=15&type=section&id=Financial%20Operations%20Overview) This section describes the key components of the company's operating expenses, other income, and tax position - Research and development expenses include personnel costs, clinical trial costs, manufacturing for non-commercial products, and fees to external service providers. These costs are expensed as incurred, and the timing and completion costs of future studies are uncertain due to the unpredictable nature of preclinical and clinical development[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) - General and administrative expenses primarily cover executive, finance, business development, and support personnel costs, patent portfolio maintenance, professional services (audit, legal, investor relations), and allocated facilities. Other income (expense) includes management fee income, interest income, and interest expense[71](index=71&type=chunk)[72](index=72&type=chunk) - The company has incurred net losses and has not recorded U.S. federal or state income tax benefits due to valuation allowances[73](index=73&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) This section analyzes the changes in key financial metrics, including research and development, general and administrative expenses, and other income, for the reported periods Operating Results Comparison (Three Months Ended March 31, In thousands) | Metric | 2021 | 2020 | Change | | :-------------------------------- | :----- | :----- | :----- | | Research and development expenses | $20,324 | $12,575 | $7,749 | | General and administrative expenses | $10,572 | $7,625 | $2,947 | | Other income, net | $202 | $990 | $(788) | - Research and development expenses increased by **$7.7 million**, primarily due to higher tipifarnib-related costs (**$4.4 million** increase for companion diagnostics and clinical activities) and KO-539-related costs (**$1.8 million** increase for clinical trial and manufacturing development). KO-947 costs decreased due to program termination[75](index=75&type=chunk) - General and administrative expenses rose by **$2.9 million**, driven by a **$1.7 million** increase in non-cash share-based compensation and a **$1.6 million** increase in personnel costs, partially offset by a **$0.4 million** decrease in pre-commercial planning expenses[76](index=76&type=chunk) - Net other income decreased by **$0.8 million**, mainly due to a reduction in interest income[77](index=77&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and future capital requirements, highlighting its reliance on external financing - Since inception, operations have been funded primarily through equity and debt financings, focusing on R&D. As of March 31, 2021, cash, cash equivalents, and short-term investments totaled **$603.9 million**, expected to fund operations into **2024**[78](index=78&type=chunk)[83](index=83&type=chunk) - The company has an ATM facility for up to **$75.0 million** in common stock sales, but no shares have been sold yet. A **$7.5 million** term loan from Silicon Valley Bank, entered in November 2018, is due May 1, 2023, with principal payments commencing December 1, 2020[79](index=79&type=chunk)[80](index=80&type=chunk) - Future capital requirements are substantial and depend on factors like clinical trial progress, regulatory review, commercialization costs, manufacturing, and intellectual property. The company expects to incur significant operating losses and will need additional funding through stock offerings, debt, or collaborations[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) Net Cash Flow Activities (Three Months Ended March 31, In thousands) | Activity | 2021 | 2020 | Change | | :------------------------------------ | :--------- | :--------- | :---------- | | Net cash used in operating activities | $(28,517) | $(19,822) | $(8,695) | | Net cash (used in) provided by investing activities | $(186,220) | $27,461 | $(213,681) | | Net cash provided by financing activities | $79 | $247 | $(168) | - The increase in net cash used in operating activities was primarily due to a higher net loss and changes in prepaid expenses, partially offset by increased share-based compensation and changes in accounts payable. Investing activities shifted from a net cash provider to a net cash user, mainly due to increased purchases of marketable securities[86](index=86&type=chunk)[87](index=87&type=chunk) [Contractual Obligations](index=19&type=section&id=Contractual%20Obligations) This section confirms that there were no material changes to the company's contractual obligations since the last annual report - There were no material changes in contractual obligations from the amounts disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2020[89](index=89&type=chunk) [Off-Balance Sheet Arrangements](index=19&type=section&id=Off-Balance%20Sheet%20Arrangements) This section states that the company had no off-balance sheet arrangements as of the reporting date - As of March 31, 2021, the company did not have any off-balance sheet arrangements[90](index=90&type=chunk) [Critical Accounting Policies and Management Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Management%20Estimates) This section highlights the company's reliance on management estimates for financial reporting and confirms no material changes to these policies - The company's financial statements rely on management's estimates and judgments, particularly for accrued expenses and share-based compensation. There have been no material changes to these critical accounting policies and estimates since the December 31, 2020, Annual Report on Form 10-K[91](index=91&type=chunk)[92](index=92&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section assesses the company's exposure to market risks, specifically interest rate risk and inflation risk, concluding no material impact - The company is exposed to interest rate risk through its cash, cash equivalents, short-term investments (money market funds, corporate debt, U.S. Treasury securities, commercial paper), and a term loan. A **10% change in interest rates** as of March 31, 2021, would not have a material effect on the fair value of the investment portfolio or interest expense[93](index=93&type=chunk)[94](index=94&type=chunk) - Inflation generally affects the company by increasing clinical trial costs, but it has not had a material effect on the business, financial condition, or results of operations during the periods presented[95](index=95&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures and reports no material changes in internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2021[98](index=98&type=chunk) - There have been no material changes in internal control over financial reporting during the quarter ended March 31, 2021. The company continues to monitor and assess the impact of the COVID-19 pandemic on its internal controls[99](index=99&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) [ITEM 1. LEGAL PROCEEDINGS](index=22&type=section&id=Item%201.%20Legal%20Proceedings) This section states that Kura Oncology, Inc. is not currently involved in any legal proceedings that would materially adversely affect its operations or financial position - The company is not a party to any legal proceedings that would individually or in aggregate have a material adverse effect on its results of operations or financial position[102](index=102&type=chunk) [ITEM 1A. RISK FACTORS](index=22&type=section&id=Item%201A.%20Risk%20Factors) This comprehensive section outlines the significant risks associated with investing in Kura Oncology's common stock, covering various aspects from drug development to financial and regulatory challenges [Risk Factor Summary](index=22&type=section&id=Risk%20Factor%20Summary) This section provides a high-level overview of the primary risks, including clinical trial impacts, product candidate dependence, financial needs, and regulatory challenges - Key risks include potential adverse impacts of COVID-19 on clinical trials, high dependence on the success of lead product candidates (tipifarnib and KO-539) which are still in clinical development, and the uncertain outcome of targeted therapeutics development for genetically defined cancers[105](index=105&type=chunk) - Other significant risks involve the lengthy and expensive clinical drug development process, the need for combination therapies with third-party drugs, potential serious adverse events or unacceptable side effects, and the critical reliance on third-party collaborators for diagnostic testing platforms[105](index=105&type=chunk) - Financial risks include expected losses, the need for substantial additional capital which may cause dilution, and reliance on third-party contractors for clinical trials and manufacturing. Regulatory risks encompass obtaining and maintaining approvals, post-approval requirements, and intellectual property protection[105](index=105&type=chunk) [Risks Related to the Discovery and Development of Our Product Candidates](index=23&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) This section details the inherent risks in developing new drug candidates, including clinical trial challenges, regulatory uncertainties, and potential adverse effects - The COVID-19 pandemic has and could continue to adversely impact the ability to conduct clinical trials, potentially causing delays in site startup, patient enrollment, and compliance with protocols due to resource prioritization and travel restrictions[106](index=106&type=chunk)[107](index=107&type=chunk) - The company's future success is highly dependent on tipifarnib and KO-539, which require further clinical development, regulatory approval, and substantial investment. There is no guarantee of timely completion of trials or regulatory approval, and preliminary results may not predict final outcomes[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[114](index=114&type=chunk)[125](index=125&type=chunk) - Developing targeted therapeutics for genetically defined cancers is a rapidly evolving area with uncertain outcomes. Identifying and enrolling patients with specific genetic alterations is challenging, and failure to do so or to validate biomarkers could delay development and regulatory approval[116](index=116&type=chunk)[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - Product candidates may cause serious adverse events or unacceptable side effects, potentially leading to development delays, abandonment, or limitations to narrower uses. Tipifarnib has a known side effect profile, and KO-539's safety profile is still being evaluated[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) - Reliance on third-party collaborators for developing and commercializing diagnostic tests is critical. Failure to develop, obtain approval for, or achieve widespread adoption of these companion diagnostics could harm the ability to commercialize product candidates[144](index=144&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=32&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section addresses the company's ongoing financial losses, substantial capital requirements, and the potential for dilution or restrictive debt covenants - The company expects to incur significant operating losses for the foreseeable future and may never achieve or maintain profitability, requiring substantial additional funding through equity or debt financings. This could lead to stockholder dilution or restrictive covenants[151](index=151&type=chunk)[152](index=152&type=chunk)[154](index=154&type=chunk)[161](index=161&type=chunk) - As a clinical-stage company with no approved products or historical product revenue, financial and operating results are expected to fluctuate significantly due to factors like clinical trial success, collaborations, funding availability, and competition[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - The company has a **$7.5 million** term loan with Silicon Valley Bank, secured by most assets (excluding IP). Defaulting on this loan could accelerate repayment obligations and harm the business[163](index=163&type=chunk)[164](index=164&type=chunk) [Risks Related to Our Dependence on Third Parties](index=35&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section highlights the risks associated with relying on external contractors for clinical trials, manufacturing, and other critical operations - The company relies heavily on third-party contractors (CROs, clinical data managers, medical institutions) to conduct preclinical and clinical trials. Failure of these third parties to perform satisfactorily, meet deadlines, or comply with regulations could delay product development and commercialization[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - 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, which could delay or impair development efforts. Compliance with cGMP regulations by manufacturers is critical[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[176](index=176&type=chunk) - The COVID-19 pandemic could limit the ability of third-party operations, including clinical site monitoring and supply chain, potentially causing delays or disruptions in drug supply to clinical sites[171](index=171&type=chunk)[178](index=178&type=chunk) [Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters](index=37&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) This section details the extensive regulatory hurdles, compliance requirements, and legal risks involved in bringing product candidates to market and maintaining operations - Obtaining regulatory approvals (FDA, EMA, etc.) is expensive, lengthy, and uncertain. Failure or delays in approval would materially impair revenue generation. The COVID-19 pandemic could also delay regulatory reviews[179](index=179&type=chunk)[181](index=181&type=chunk)[194](index=194&type=chunk) - The company's commercial strategy for tipifarnib relies on non-patent regulatory exclusivity. If another company (e.g., EB Pharma) obtains regulatory approval for tipifarnib in a different indication first, the exclusivity period could be reduced or eliminated, harming commercial prospects[183](index=183&type=chunk)[184](index=184&type=chunk) - Obtaining and maintaining orphan drug exclusivity is difficult and not guaranteed. While KO-539 has orphan drug designation for AML, it could be lost if approved for a broader indication or if a competitor's drug is deemed safer/more effective[185](index=185&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) - Fast Track and Breakthrough Therapy Designations (granted for tipifarnib in HRAS mutant HNSCC) do not guarantee faster development, review, or approval, nor do they increase the likelihood of marketing approval[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk)[193](index=193&type=chunk) - Any approved product candidates will be subject to extensive post-approval regulatory requirements, including safety reporting, manufacturing compliance (cGMP), and marketing restrictions. Non-compliance or unforeseen problems could lead to sanctions, product withdrawal, or significant penalties[195](index=195&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) - Relationships with healthcare professionals and customers are subject to fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Physician Payments Sunshine Act). Non-compliance could result in significant civil and criminal penalties, reputational harm, and exclusion from healthcare programs[200](index=200&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - Healthcare reform measures (like the ACA) and governmental scrutiny over drug pricing could increase the difficulty and cost of obtaining marketing approval, restrict post-approval activities, and negatively affect product pricing and reimbursement, impacting profitability[205](index=205&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[214](index=214&type=chunk) [Risks Related to Our Intellectual Property](index=45&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section discusses the challenges and uncertainties in protecting the company's intellectual property, including patent reliance, licensing risks, and potential litigation - The company relies on regulatory exclusivity, patents, trade secrets, and license agreements to protect its intellectual property. The composition of matter patents for tipifarnib expired in **2016**, making the company reliant on method-of-use patents and regulatory exclusivity, which may not provide sufficient protection against competitors[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) - Dependence on licensors (Janssen, University of Michigan) to prosecute and maintain patents carries risks, as their actions may not align with the company's interests or may be insufficient to protect licensed intellectual property[224](index=224&type=chunk)[225](index=225&type=chunk) - Breaching license agreements could lead to the loss of critical commercialization rights for product candidates like tipifarnib and KO-539, materially harming the business. Disputes over intellectual property rights in license agreements are also a risk[226](index=226&type=chunk)[227](index=227&type=chunk)[228](index=228&type=chunk) - The patent position in biotechnology is highly uncertain, involving complex legal and factual questions. Patent applications may not result in issued patents, or issued patents may be challenged, narrowed, or invalidated, allowing competitors to commercialize similar products[229](index=229&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk) - Changes in patent laws (e.g., Leahy-Smith Act) or their interpretation could diminish patent value and increase prosecution/enforcement costs. Patent terms may also be inadequate to protect competitive positions for a sufficient duration[230](index=230&type=chunk)[231](index=231&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Failure to comply with procedural requirements for patent maintenance can lead to loss of patent rights. Involvement in patent litigation (to protect or defend against infringement claims) is expensive, time-consuming, and uncertain, potentially resulting in adverse outcomes or significant liabilities[238](index=238&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk) - Inability to acquire or in-license necessary third-party intellectual property rights for development programs or companion diagnostics could hinder business growth, especially given competition from larger companies[242](index=242&type=chunk)[243](index=243&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk) - Failure to protect trade secrets through non-disclosure agreements and other measures could harm the company's competitive position if proprietary information is disclosed or independently developed by competitors[246](index=246&type=chunk) - Intellectual property from government-funded programs may be subject to federal regulations, including 'march-in' rights and U.S.-based manufacturing requirements, which could limit exclusive rights or ability to contract with non-U.S. manufacturers[247](index=247&type=chunk)[248](index=248&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=51&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) This section outlines the challenges in bringing approved product candidates to market, including market acceptance, competition, sales capabilities, and reimbursement uncertainties - Even with marketing approval, product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors due to competition from established treatments, other novel products, pricing, convenience, or side effects[249](index=249&type=chunk)[250](index=250&type=chunk) - The company currently lacks sales and market access personnel. Failure to establish effective sales and marketing capabilities, either internally or through third-party collaborations, could prevent successful commercialization and revenue generation[251](index=251&type=chunk) - The drug development market is highly competitive, with numerous pharmaceutical and biotechnology companies developing cancer treatments. Competitors may develop safer, more effective, or less expensive products, or obtain regulatory approval faster, reducing the company's commercial opportunity[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk) - Uncertainty regarding insurance coverage and adequate reimbursement by governmental and private payors is a significant risk. Failure to obtain sufficient coverage or favorable reimbursement rates could limit market access and revenue potential, especially given increasing cost-containment initiatives[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) - Product liability lawsuits related to clinical trials or commercial sales could result in substantial liabilities, reputational harm, and limitations on commercialization, potentially exceeding current insurance coverage[264](index=264&type=chunk)[265](index=265&type=chunk) [Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions](index=54&type=section&id=Risks%20Related%20to%20Employee%20Matters%2C%20Managing%20Growth%20and%20Macroeconomic%20Conditions) This section covers risks related to human capital, organizational growth, and external economic factors, including the impact of the COVID-19 pandemic - The COVID-19 pandemic and related precautionary measures (e.g., remote work) could negatively affect business operations, recruitment, and management of third-party partners[266](index=266&type=chunk) - The company is highly dependent on its Chief Executive Officer and key management/scientific teams. Failure to retain these individuals or attract qualified new personnel in a competitive market could impede research, development, and commercialization objectives[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk) - Anticipated significant growth in employees and operations (development, regulatory, sales, marketing) may be difficult to manage effectively due to limited financial resources and management experience, potentially disrupting business plans[270](index=270&type=chunk) - Unfavorable global economic conditions, including volatility from the COVID-19 pandemic, could adversely affect the ability to raise capital, strain suppliers, and harm overall business operations[271](index=271&type=chunk) - The business is vulnerable to cybersecurity threats and system failures, especially with increased reliance on technology due to remote work during the pandemic. Such incidents could disrupt operations, lead to data loss, liabilities, and delays in drug development[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) - Operations are vulnerable to natural disasters, power loss, and other uncontrollable events, particularly in California. The lack of business interruption insurance for such events could materially harm the business[275](index=275&type=chunk) [Risks Related to Ownership of our Common Stock](index=56&type=section&id=Risks%20Related%20to%20Ownership%20of%20our%20Common%20Stock) This section addresses risks pertinent to investors, including stock price volatility, dilution, anti-takeover provisions, and potential litigation - The company's stock price may fluctuate significantly and be volatile due to various factors, including clinical trial results, regulatory decisions, competition, market conditions, and the impact of the COVID-19 pandemic. Large sales by substantial stockholders could also adversely affect trading price[276](index=276&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk) - Management has broad discretion in using cash, and ineffective allocation could adversely affect operating results and stock value. Investments in short-term securities may not yield favorable returns[279](index=279&type=chunk) - FINRA sales practice requirements for speculative or low-priced securities may limit broker-dealers' ability to recommend the stock, potentially affecting trading volume and price[280](index=280&type=chunk) - The resale of shares covered by the effective shelf registration statement could adversely affect the market price of common stock and impair the ability to raise additional equity capital[281](index=281&type=chunk) - Complying with public company laws and regulations (e.g., Sarbanes-Oxley Act) incurs significant legal, accounting, and other expenses, and failure to maintain effective internal controls could harm operating results and investor confidence[282](index=282&type=chunk)[283](index=283&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock (including through equity incentive plans, options, warrants) could result in dilution to existing stockholders and cause the stock price to fall[284](index=284&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk) - 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[289](index=289&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk) - The exclusive forum provisions in charter documents for certain disputes could limit stockholders' ability to choose a favorable judicial forum, potentially discouraging lawsuits or increasing costs if found unenforceable[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk) - Changes in tax laws or regulations (e.g., Tax Cuts and Jobs Act, CARES Act) could adversely affect the business, cash flow, and financial condition. The ability to use net operating loss carryforwards may be limited by ownership changes or state-level suspensions[295](index=295&type=chunk)[297](index=297&type=chunk) - The company does not intend to pay cash dividends on its capital stock in the foreseeable future, as future payments depend on financial condition, contractual restrictions, and board discretion[298](index=298&type=chunk) - Negative research or cessation of coverage by securities analysts could cause the stock price and trading volume to decline. Actions by activist stockholders could divert management's attention and impact stock value[299](index=299&type=chunk)[300](index=300&type=chunk) - Securities class action litigation, common in the biotechnology industry, could divert management's attention, harm the business, and lead to significant liabilities. Misconduct by employees or third parties could result in regulatory sanctions and criminal liability[301](index=301&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk) [ITEM 6. EXHIBITS](index=63&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, warrant agreements, collaboration agreements, executive employment agreements, and certifications required by the Sarbanes-Oxley Act - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Form of Common Stock certificate, Warrant to Purchase Stock, Master Collaboration Agreement with Illumina, Inc., various Executive Employment Agreements, and certifications under the Sarbanes-Oxley Act[306](index=306&type=chunk) - XBRL (eXtensible Business Reporting Language) documents are also included, such as the Inline XBRL Instance Document, Taxonomy Extension Schema Document, Calculation Linkbase Document, Definition Linkbase Document, and Presentation Linkbase Document[307](index=307&type=chunk) [SIGNATURES](index=65&type=section&id=Signatures) This section contains the official signatures of Kura Oncology, Inc.'s President and Chief Executive Officer, and Chief Financial Officer and Chief Business Officer, certifying the submission of the Quarterly Report on Form 10-Q - The report is duly signed on behalf of Kura Oncology, Inc. by **Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer (Principal Executive Officer)**, and **Marc Grasso, M.D., Chief Financial Officer and Chief Business Officer (Principal Financial and Accounting Officer)**, both dated **May 6, 2021**[311](index=311&type=chunk)

Financial Data and Key Metrics Changes - Research and Development (R&D) expenses for Q4 2020 were $17.5 million, up from $13.5 million in Q4 2019. Full year R&D expenses for 2020 were $16.4 million compared to $47.8 million in 2019 [25]. - General and Administrative (G&A) expenses for Q4 2020 were $8.8 million, compared to $5.5 million in Q4 2019. Full year G&A expenses for 2020 were $31.5 million, up from $19.7 million in 2019 [26]. - Net loss for Q4 2020 was $26.2 million, compared to a net loss of $17.9 million in Q4 2019. The full year net loss for 2020 was $89.6 million, compared to $63.1 million in 2019 [27][28]. - Cash, cash equivalents, and short-term investments were $633.3 million as of December 31, 2020, compared to $236.9 million as of December 31, 2019 [29]. Business Line Data and Key Metrics Changes - The menin inhibitor KO-539 showed promising preliminary clinical data in patients with relapsed or refractory acute myeloid leukemia, demonstrating single-agent activity and a favorable safety profile [7][8]. - The farnesyl transferase inhibitor tipifarnib received breakthrough therapy designation from the FDA for treating recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma, with an objective response rate of approximately 50% [14][15][17]. Market Data and Key Metrics Changes - The breakthrough therapy designation for tipifarnib acknowledges the significant unmet need for patients with HRAS mutant head and neck squamous cell carcinoma [16]. - The total addressable population for tipifarnib may be as high as 50% of head and neck squamous cell carcinoma patients [19]. Company Strategy and Development Direction - The company is focused on advancing its clinical-stage oncology drug candidates through an accelerated development and fast-to-market strategy [5]. - Plans include initiating genetically enriched Phase 1 expansion cohorts for KO-539 and a Phase 1/2 proof-of-concept study for tipifarnib in combination with a PI3 kinase alpha inhibitor [31]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position, with over $600 million in cash to support ongoing programs into 2024 [6][29]. - The company aims to refine its clinical development plans based on FDA feedback, focusing on identifying a minimum safe and efficacious dose for KO-539 [50][52]. Other Important Information - The company is exploring the development of a next-generation farnesyl transferase inhibitor with improved properties compared to tipifarnib [22]. - The anticipated milestones for 2021 include the initiation of Phase 1 expansion cohorts for KO-539 and the combination study for tipifarnib [31]. Q&A Session Summary Question: What drove the decision to dose escalate to 800 milligrams? - Management indicated that the decision was based on the lack of observed toxicity and the potential for good safety and tolerability, allowing for continued dose escalation [34][35]. Question: Will the 600 milligram dose be used in the expansion cohorts? - Management stated that they are evaluating both lower and higher doses in the expansion cohorts to determine the optimal dose for efficacy [37][39]. Question: What is the rationale for the change in protocol? - The change was driven by discussions with the FDA, focusing on identifying a minimum safe and efficacious dose to maximize therapeutic benefit [46][50]. Question: When will the recommended Phase 2 dose be determined? - Management indicated that the timing for determining the recommended Phase 2 dose is still pending further data from the ongoing studies [61][63]. Question: What is the expected timeline for filing for tipifarnib? - Management expressed optimism about the ongoing registrational study and the potential for future combination studies, but did not provide specific timelines for filing [64].

[Part I](index=3&type=section&id=PART%20I) [Business](index=6&type=section&id=Item%201.%20Business) Kura Oncology is a clinical-stage biopharmaceutical company developing precision cancer medicines, with lead candidates tipifarnib and KO-539 in advanced clinical trials [Overview and Pipeline](index=6&type=section&id=Overview%20and%20Pipeline) Kura Oncology is a clinical-stage biopharmaceutical company with lead candidates tipifarnib for HRAS mutant HNSCC and KO-539 for AML, plus a next-generation FTI in discovery - Kura Oncology is a clinical-stage biopharmaceutical company developing small molecule product candidates targeting cancer signaling pathways, paired with molecular diagnostics[23](index=23&type=chunk) Clinical Development Pipeline as of December 31, 2020 | Program | Indication | Stage | | :--- | :--- | :--- | | **Tipifarnib (FTI)** | HRAS mutant HNSCC | Registration-Directed Trial (AIM-HN) Ongoing | | | PI3Kα mutant and HRAS overexpressed HNSCC | PI3Kα inhibitor combination study expected in 2H 2021 | | **KO-539 (Menin Inhibitor)** | Acute Myeloid Leukemia (AML) | Phase 1 expansion cohorts expected to begin mid-2021 | | **Next-Generation FTI** | Solid tumors | Development candidate nomination expected mid-2021 | [Clinical Programs](index=10&type=section&id=Clinical%20Programs) Clinical development focuses on tipifarnib for HRAS mutant HNSCC (Breakthrough Therapy Designation) and KO-539 for AML, with a next-generation FTI program initiated - The FDA granted **Breakthrough Therapy Designation** to tipifarnib for recurrent or metastatic HRAS mutant HNSCC with variant allele frequency ≥ 20% after progression on platinum-based chemotherapy, based on data from the Phase 2 RUN-HN trial[27](index=27&type=chunk)[60](index=60&type=chunk) - The AIM-HN registration-directed trial for tipifarnib was amended in July 2020 to enroll patients with any HRAS mutation and to reflect evolving standards of care, which will require enrolling an increased number of patients; timelines are uncertain due to COVID-19[26](index=26&type=chunk)[59](index=59&type=chunk) - Preliminary data from the KOMET-001 trial of KO-539 in AML, presented at ASH 2020, showed clinical or biological activity in **6 of 8 evaluable patients**, including two complete remissions; the drug was well tolerated[31](index=31&type=chunk)[75](index=75&type=chunk) - The company is advancing its KO-539 KOMET-001 trial, having completed the 600 mg dose cohort and currently evaluating an 800 mg dose, with plans to initiate Phase 1 expansion cohorts at lower doses in parallel with dose escalation[32](index=32&type=chunk)[76](index=76&type=chunk) - A discovery-stage program for a next-generation Farnesyl Transferase Inhibitor (FTI) has commenced, with a development candidate expected to be nominated in mid-2021, aiming for improved pharmacokinetic and physicochemical properties[77](index=77&type=chunk)[78](index=78&type=chunk) [License and Asset Purchase Agreements](index=15&type=section&id=License%20and%20Asset%20Purchase%20Agreements) Kura Oncology holds exclusive global rights for tipifarnib from Janssen and KO-539 from the University of Michigan, involving milestone and royalty payment obligations - Kura licensed exclusive global rights for tipifarnib from Janssen, with obligations to pay up to **$25.0 million** in regulatory milestones and up to **$50.0 million** in sales milestones, plus tiered royalties in the low teens percentages of net sales[79](index=79&type=chunk)[80](index=80&type=chunk) - The company licensed exclusive worldwide rights for its menin-KMT2A program (including KO-539) from the University of Michigan, with obligations to pay up to **$3.4 million** in development and regulatory milestones, plus tiered royalties in the low single-digit percentages of net sales[82](index=82&type=chunk) [Competition](index=16&type=section&id=Competition) The company faces significant competition for tipifarnib from established HNSCC therapies and for KO-539 from other menin-KMT2A inhibitors - While no farnesyl transferase inhibitors are currently approved for cancer, tipifarnib will compete with established therapies for HNSCC, including cetuximab (Erbitux®), nivolumab (Opdivo®), and pembrolizumab (Keytruda®)[87](index=87&type=chunk)[88](index=88&type=chunk) - In the menin-KMT2A inhibitor space, Kura faces competition from other companies developing similar targeted therapies, including Syndax and Biomea[89](index=89&type=chunk) [Intellectual Property](index=17&type=section&id=Intellectual%20Property) Kura's IP strategy combines licensed and owned patents, focusing on method-of-use patents for tipifarnib (composition-of-matter expired) and composition-of-matter patents for KO-539 - The composition-of-matter patents for tipifarnib expired in the U.S. and Europe in 2016, making the company's protection strategy reliant on method-of-use patents for specific patient populations, such as those with HRAS mutant HNSCC[99](index=99&type=chunk) - The company has issued U.S. patents covering the composition of matter for KO-539 and related compounds, as well as methods for their use in treating cancers[99](index=99&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) The company's products are subject to extensive FDA and global regulation, utilizing expedited programs like Fast Track and Breakthrough Therapy Designation to accelerate development - The FDA drug approval process involves preclinical testing, submitting an Investigational New Drug (IND) application, and conducting three sequential phases of clinical trials (Phase 1, 2, and 3) to establish safety and efficacy before submitting a New Drug Application (NDA)[108](index=108&type=chunk)[111](index=111&type=chunk)[113](index=113&type=chunk) - The company leverages FDA's expedited programs, with tipifarnib having received **Fast Track Designation**, which allows for more frequent FDA interaction and rolling review of the NDA[121](index=121&type=chunk)[122](index=122&type=chunk) - Tipifarnib has also received **Breakthrough Therapy Designation**, designed to expedite the development and review of drugs for serious conditions where preliminary clinical evidence shows substantial improvement over available therapies[125](index=125&type=chunk)[126](index=126&type=chunk) - KO-539 has received **Orphan Drug Designation** for AML, which provides incentives such as tax credits and eligibility for seven years of market exclusivity in the U.S. upon approval for that indication[127](index=127&type=chunk)[128](index=128&type=chunk) [Human Capital](index=28&type=section&id=Human%20Capital) As of December 31, 2020, Kura Oncology employed 89 people, with a focus on R&D, and established a Culture and Inclusion Leadership Committee in 2020 - As of December 31, 2020, the company had **89 employees**, with **59** in R&D and supply chain and **30** in commercial and G&A roles[166](index=166&type=chunk) - In 2020, the company established a Culture and Inclusion Leadership Committee to obtain employee feedback and focus on corporate culture, diversity, and inclusion[169](index=169&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Kura Oncology faces significant risks including clinical trial success dependency, COVID-19 impacts, financial losses, reliance on third parties, and limited intellectual property protection for tipifarnib - The COVID-19 pandemic could continue to adversely impact clinical trial conduct, including delaying site startups, slowing patient enrollment, and disrupting the supply of product candidates[175](index=175&type=chunk) - The company is highly dependent on the success of its two lead product candidates, tipifarnib and KO-539, which are still in clinical development and may never receive regulatory approval[176](index=176&type=chunk) - The company has a history of losses, expects to incur losses for the foreseeable future, and will need to obtain substantial additional capital, which may cause dilution to stockholders or restrict operations[216](index=216&type=chunk)[225](index=225&type=chunk) - The company relies on third-party contractors for manufacturing and to conduct clinical trials, which reduces control over these activities and introduces risks related to performance, quality, and timelines[229](index=229&type=chunk)[235](index=235&type=chunk) - The composition of matter patents for tipifarnib expired in 2016, making the company reliant on method-of-use patents, which may provide weaker protection and expose it to competition from generic versions for other indications[245](index=245&type=chunk)[280](index=280&type=chunk) [Properties](index=69&type=section&id=Item%202.%20Properties) Kura Oncology leases corporate office spaces in San Diego (**13,420 sq. ft.**) and Boston (**16,541 sq. ft.**), deemed sufficient for current operations - The company leases **13,420 sq. ft.** for its headquarters in San Diego, CA (lease expires Nov 2025) and **16,541 sq. ft.** in Boston, MA (lease expires July 2024)[366](index=366&type=chunk) [Legal Proceedings](index=69&type=section&id=Item%203.%20Legal%20Proceedings) Kura Oncology is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[367](index=367&type=chunk) [Part II](index=70&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=70&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Kura Oncology's common stock trades on Nasdaq under "KURA"; the company has never paid and does not intend to pay cash dividends - The company's common stock has been listed on the Nasdaq Global Select Market under the symbol "**KURA**" since November 5, 2015[371](index=371&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, with future earnings to be retained for business growth[373](index=373&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=72&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Kura Oncology's net loss increased to **$89.6 million** in 2020 due to higher R&D and G&A expenses, but its financial position was strengthened by **$459.0 million** in public offerings, providing liquidity into 2024 [Results of Operations](index=75&type=section&id=Results%20of%20Operations) In 2020, R&D expenses increased to **$60.4 million** due to KO-539 and discovery programs, while G&A expenses rose to **$31.5 million** from higher personnel and professional costs Results of Operations (in thousands) | | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses | $60,397 | $47,826 | $12,571 | | General and administrative expenses | $31,502 | $19,653 | $11,849 | | Other income, net | $2,274 | $4,339 | $(2,065) | Research and Development Expenses Breakdown (in thousands) | Category | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Tipifarnib-related costs | $26,025 | $26,517 | $(492) | | KO-539-related costs | $6,629 | $2,496 | $4,133 | | KO-947-related costs | $2,301 | $3,416 | $(1,115) | | Discovery stage programs | $2,255 | $318 | $1,937 | | Personnel costs and other expenses | $19,227 | $11,652 | $7,575 | | Share-based compensation expense | $3,960 | $3,427 | $533 | | **Total R&D Expenses** | **$60,397** | **$47,826** | **$12,571** | - The increase in R&D expenses was primarily due to higher costs for the Phase 1/2 clinical trial of KO-539, which began in September 2019, and increased activities for new discovery stage programs[402](index=402&type=chunk) - The increase in G&A expenses was driven by rises of **$2.9 million** each in share-based compensation, pre-commercial planning, and personnel costs, plus a **$2.3 million** increase in professional and legal services[403](index=403&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2020, Kura Oncology held **$633.3 million** in cash and investments, secured through **$459.0 million** in public offerings, expected to fund operations into 2024 - The company ended 2020 with **$633.3 million** in cash, cash equivalents, and short-term investments[394](index=394&type=chunk)[412](index=412&type=chunk) - In 2020, the company completed two public offerings, raising net proceeds of approximately **$324.1 million** in December and **$134.9 million** in May[406](index=406&type=chunk)[407](index=407&type=chunk) - Management believes that existing cash, cash equivalents, and short-term investments are sufficient to fund operating expenses and capital expenditure requirements into 2024[412](index=412&type=chunk) Summary of Net Cash Flow (in thousands) | | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(69,830) | $(54,760) | $(15,070) | | Net cash used in investing activities | $(99,936) | $(46,325) | $(53,611) | | Net cash provided by financing activities | $469,334 | $111,101 | $358,233 | [Quantitative and Qualitative Disclosures About Market Risk](index=80&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Kura Oncology's primary market risk is interest rate risk on its investments and term loan, though a 10% rate change is not expected to be material - The company's main market risk is interest rate risk on its cash, cash equivalents, short-term investments, and its term loan facility with SVB[427](index=427&type=chunk)[428](index=428&type=chunk) - Management does not believe a hypothetical **10%** change in interest rates as of December 31, 2020, would have a material effect on the fair value of its investment portfolio or its interest expense[427](index=427&type=chunk)[428](index=428&type=chunk) [Financial Statements and Supplementary Data](index=80&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents Kura Oncology's audited financial statements for 2020, including the independent auditor's report, detailing financial position, operations, equity, and cash flows [Report of Independent Registered Public Accounting Firm](index=82&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued unqualified opinions on Kura Oncology's 2020 financial statements and internal controls, identifying accrued clinical trial R&D expenses as a Critical Audit Matter - The independent auditor, Ernst & Young LLP, issued an unqualified opinion on the company's financial statements and the effectiveness of its internal control over financial reporting as of December 31, 2020[441](index=441&type=chunk)[475](index=475&type=chunk) - The audit identified "**Clinical Trial Research and Development Expenses and Accruals**" as a Critical Audit Matter due to the challenging and subjective judgments required to estimate the progress and stage of completion of R&D activities[478](index=478&type=chunk)[480](index=480&type=chunk) [Financial Statements](index=93&type=section&id=Financial%20Statements) Kura Oncology's 2020 financial statements show total assets grew to **$647.2 million**, with a net loss of **$89.6 million** (or **$1.69** per share), driven by increased expenses Balance Sheet Highlights (in thousands) | | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $325,493 | $26,135 | | Short-term investments | $307,827 | $210,756 | | **Total Assets** | **$647,212** | **$241,972** | | Total Liabilities | $36,307 | $23,191 | | **Total Stockholders' Equity** | **$610,905** | **$218,781** | Statement of Operations Highlights (in thousands, except per share data) | | 2020 | 2019 | | :--- | :--- | :--- | | Total operating expenses | $91,899 | $67,479 | | **Net Loss** | **$(89,625)** | **$(63,140)** | | Net loss per share, basic and diluted | $(1.69) | $(1.51) | Statement of Cash Flows Highlights (in thousands) | | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(69,830) | $(54,760) | | Net cash used in investing activities | $(99,936) | $(46,325) | | Net cash provided by financing activities | $469,334 | $111,101 | [Controls and Procedures](index=80&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2020, management and auditors concluded Kura Oncology's disclosure controls and internal control over financial reporting were effective, with no material changes - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[433](index=433&type=chunk) - Management concluded that internal control over financial reporting was effective as of December 31, 2020, based on the COSO framework; this assessment was audited by Ernst & Young LLP, which issued an unqualified opinion[434](index=434&type=chunk)[436](index=436&type=chunk) - There were no changes in internal control over financial reporting during the fourth quarter of 2020 that materially affected, or are reasonably likely to materially affect, such controls[437](index=437&type=chunk) [Part III](index=84&type=section&id=PART%20III) [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accounting Fees](index=84&type=section&id=Items%2010-14) Information for Items 10-14, covering governance, compensation, and related matters, is incorporated by reference from the company's forthcoming 2021 Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accounting Fees and Services (Item 14) is incorporated by reference from the company's forthcoming 2021 Proxy Statement[451](index=451&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk)[455](index=455&type=chunk)[456](index=456&type=chunk) [Part IV](index=85&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=85&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists filed financial statements and provides a comprehensive index of all exhibits, including corporate documents and material contracts - This item contains the list of financial statements filed with the annual report and an index of all exhibits, including material contracts and corporate governance documents[458](index=458&type=chunk)[460](index=460&type=chunk) [Form 10-K Summary](index=89&type=section&id=Item%2016.%20Form%2010-K%20Summary) No summary is provided for the Form 10-K - No summary is provided for the Form 10-K[464](index=464&type=chunk)

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER J.P. Morgan Healthcare Conference – January 11-14, 2021 Forward-Looking Statements This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for tipifarnib and KO-539, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competi ...

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Virtual Investor Event – December 5, 2020 Forward-Looking Statements | --- | --- | |-------|-------| | | | | | | Today's Agenda Topic Speaker | --- | --- | |------------------------------------------------|----------------------------------------------------------------| | | | | Program overview / KO-539 development timeline | Troy Wilson, Ph.D., J.D. President and Chief Executive Officer | | Introduction of KOMET-001 investigators | Stephen Dale, M ...

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Stifel Healthcare Conference – November 16, 2020 Forward-Looking Statements This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for tipifarnib and KO-539, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competitive th ...

Kura Oncology, Inc. (NASDAQ:KURA) Q3 2020 Earnings Conference Call November 5, 2020 8:00 AM ET Company Participants Pete De Spain - Investor Relations Troy Wilson - President and Chief Executive Officer Marc Grasso - Chief Financial Officer Stephen Dale - Chief Medical Officer Jim Basta - Chief Legal Officer Kirsten Flowers - Chief Commercial Officer Kathy Ford - Chief Operating Officer Conference Call Participants Peter Lawson - Barclays Marty Auster - Credit Suisse Ren Benjamin - JMP Securities Alexander ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ To ________ Commission file number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 61-1547851 (Sta ...

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – August 2020 Forward-Looking Statements This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for tipifarnib and KO-539, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competitive therapies, and ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ To ________ Commission file number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction ...