Kura Oncology, Inc. (NASDAQ:KURA) Q4 2021 Earnings Conference Call February 24, 2022 4:30 PM ET Company Participants Troy Wilson – Chairman, Chief Executive Officer & President Tom Doyle – Senior Vice President of Finance and Accounting Pete De Spain – Vice President, Investor Relations & Corporate Communications Conference Call Participants Jonathan Chang – SVB Leerink Peter Lawson – Barclays Bank Tiago Fauth – Crédit Suisse Ren Benjamin – JMP Securities Roger Song – Jefferies Phil Nadeau – Cowen and Compa ...

PART I [Business Overview](index=3&type=section&id=Item%201.%20Business) Kura Oncology is a clinical-stage biopharmaceutical company focused on developing precision medicines for cancer - Kura Oncology is a clinical-stage biopharmaceutical company developing precision medicines for cancer[16](index=16&type=chunk) - The pipeline includes clinical-stage ziftomenib and tipifarnib, preclinical KO-2806, and discovery-stage programs[16](index=16&type=chunk) - The company owns global commercial rights to all programs and plans to advance them through internal development and strategic partnerships[16](index=16&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) - The report contains forward-looking statements regarding future events, financial performance, and known/unknown risks, uncertainties, and other factors[11](index=11&type=chunk) - Key forward-looking statements include the impact of COVID-19, clinical trial progress, regulatory approvals, commercialization, intellectual property, financing, and personnel[11](index=11&type=chunk) - Readers are cautioned not to unduly rely on these statements, as actual results may differ materially, particularly due to factors discussed in the 'Risk Factors' section[12](index=12&type=chunk)[13](index=13&type=chunk) [Risk Factor Summary](index=4&type=section&id=Risk%20Factor%20Summary) - Investment in common stock is speculative due to material factors summarized, including COVID-19 impact on clinical trials[14](index=14&type=chunk)[15](index=15&type=chunk) - High dependence on lead product candidates (ziftomenib and tipifarnib) which are still in clinical development and may not receive regulatory approval[15](index=15&type=chunk) - Risks include lengthy and expensive clinical development, potential for serious adverse events, need for substantial additional capital, and reliance on third-party contractors[15](index=15&type=chunk)[17](index=17&type=chunk) [Company Overview](index=5&type=section&id=Overview) - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with small molecule product candidates targeting cancer signaling pathways[16](index=16&type=chunk) - The company has two clinical-stage candidates (ziftomenib, tipifarnib), one preclinical (KO-2806), and additional discovery-stage programs, holding global commercial rights[16](index=16&type=chunk) [The COVID-19 Pandemic](index=8&type=section&id=The%20COVID-19%20Pandemic) - COVID-19 has disrupted business operations, including slower patient screening and enrollment in clinical trials, and challenges at clinical sites[35](index=35&type=chunk) - The company implemented precautionary measures like remote working and a contingency plan to minimize impact, but expects continued disruption[35](index=35&type=chunk)[37](index=37&type=chunk) [Precision Medicines in Cancer Treatment](index=9&type=section&id=Precision%20Medicines%20in%20Cancer%20Treatment) - Precision medicine aims to improve patient outcomes and reduce healthcare costs by matching targeted therapeutics to patients with specific cancers based on molecular diagnostics[38](index=38&type=chunk) - This approach offers potential for higher translatability from preclinical to clinical studies, increased response rates, and expedited clinical development[40](index=40&type=chunk) [Our Approach to Development of Precision Medicines in Oncology](index=9&type=section&id=Our%20Approach%20to%20Development%20of%20Precision%20Medicines%20in%20Oncology) - Translational research, synthesizing basic, preclinical, and clinical data, guides the company's precision medicine approach, using in vitro and in vivo experiments, including patient-derived xenograft (PDX) models[41](index=41&type=chunk) - The strategy involves using existing diagnostic tools (NGS, RNA expression profiling) to identify patient subsets and developing companion diagnostics for potential registration and marketing[42](index=42&type=chunk) - A disciplined clinical development approach evaluates product candidates in well-defined patient populations to identify early response signals and reduce development risks[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) [Clinical Programs and Pipeline](index=10&type=section&id=Clinical%20Programs%20and%20Pipeline) Kura Oncology Pipeline Status | Program | Preclinical | Phase 1 | Phase 2 | Registration Directed | | :--- | :--- | :--- | :--- | :--- | | Ziftomenib (KO-539) Menin Inhibitor | Acute Myeloid Leukemia (AML) KOMET-001 Trial | Enrollment in Phase 1b expansion cohorts ongoing | | | | Tipifarnib Farnesyl Transferase Inhibitor (FTI) | | HRAS mutant Head and Neck Squamous Cell Carcinoma (HNSCC) AIM-HN Trial (Enrollment ongoing) | PIK3CA/HRAS Dependent HNSCC KURRENT Trial (Enrollment ongoing) | | | KO-2806 Next-Generation FTI | Solid Tumors (IND enabling studies ongoing) | | | | [Ziftomenib (KO-539) – A Selective Inhibitor of the Menin-KMT2A Interaction](index=10&type=section&id=Ziftomenib%20%28KO-539%29%20%E2%80%93%20A%20Selective%20Inhibitor%20of%20the%20Menin-KMT2A%20Interaction) - Ziftomenib is an orally bioavailable small molecule inhibitor of the menin-KMT2A interaction, developed for genetically defined subsets of acute leukemias (AML, ALL)[46](index=46&type=chunk) - Preclinical data supports anti-tumor activity in KMT2A-rearranged and NPM1-mutant acute leukemias, potentially addressing **~35% of AML cases**[18](index=18&type=chunk)[49](index=49&type=chunk) - The KOMET-001 Phase 1/2 trial for relapsed/refractory AML reported preliminary clinical activity in **6 of 8 evaluable patients** (including **2 complete remissions**) and a manageable safety profile as of Nov 2020[20](index=20&type=chunk)[51](index=51&type=chunk) - The KOMET-001 trial was placed on a partial clinical hold in Nov 2021 due to a Grade 5 adverse event, but the hold was lifted in Jan 2022 after agreement on a mitigation strategy for differentiation syndrome[25](index=25&type=chunk)[56](index=56&type=chunk) - Preclinical data from Dec 2021 showed synergistic activity of ziftomenib in combination with the BCL2 inhibitor venetoclax in AML cells[26](index=26&type=chunk)[57](index=57&type=chunk) [Tipifarnib – An Oral Farnesyl Transferase Inhibitor](index=11&type=section&id=Tipifarnib%20%E2%80%93%20An%20Oral%20Farnesyl%20Transferase%20Inhibitor) - Tipifarnib is a potent, selective, orally bioavailable farnesyl transferase inhibitor, previously studied in over **5,000 cancer patients** with a manageable side effect profile[27](index=27&type=chunk)[58](index=58&type=chunk) - The company is evaluating tipifarnib in HRAS mutant HNSCC (AIM-HN registration-directed trial) and in combination with alpelisib (PI3 kinase alpha inhibitor) in the KURRENT trial (collaboration with Novartis)[28](index=28&type=chunk)[32](index=32&type=chunk)[74](index=74&type=chunk)[78](index=78&type=chunk) - Tipifarnib received Breakthrough Therapy Designation from the FDA in Feb 2021 for recurrent or metastatic HRAS mutant HNSCC (variant allele frequency **≥ 20%**) after platinum-based chemotherapy[30](index=30&type=chunk)[73](index=73&type=chunk) - Clinical data from a Phase 2 study in relapsed/refractory PTCL showed an overall response rate of **56%** and median overall survival of **32.8 months** in advanced AITL patients[33](index=33&type=chunk)[84](index=84&type=chunk) - The company is collaborating with Illumina, Inc. to develop and commercialize a companion diagnostic test for HRAS mutations in HNSCC patients for use with tipifarnib[81](index=81&type=chunk) [Next-Generation Farnesyl Transferase Inhibitor](index=15&type=section&id=Next-Generation%20Farnesyl%20Transferase%20Inhibitor) - Kura Oncology is developing KO-2806, a next-generation farnesyl transferase inhibitor, which has advanced into IND-enabling studies[34](index=34&type=chunk)[86](index=86&type=chunk) - KO-2806 is intended for innovative biology and larger disease indications in combination with other targeted therapies, with an IND submission expected by the end of 2022[34](index=34&type=chunk)[86](index=86&type=chunk) [License Agreements](index=15&type=section&id=License%20Agreements) - The company holds exclusive worldwide rights for its menin-KMT2A program (including ziftomenib) from the University of Michigan, involving upfront fees, annual maintenance, and milestone/royalty payments[87](index=87&type=chunk) - Exclusive global rights for tipifarnib (excluding virology) were licensed from Janssen Pharmaceutica NV, with obligations for development, commercialization, regulatory/sales milestone payments (up to **$75 million aggregate**), and tiered royalties[89](index=89&type=chunk)[90](index=90&type=chunk) [Competition](index=16&type=section&id=Competition) - The cancer treatment market is intensely competitive, with Kura Oncology facing major pharmaceutical, specialty pharmaceutical, and biotechnology companies globally[92](index=92&type=chunk) - Competitors for menin-KMT2A inhibitors include Syndax, Biomea, Janssen, Sumitomo Dainippon, and Daiichi Sankyo, with other products in clinical development for KMT2A-r or NPM1 leukemias[97](index=97&type=chunk) - For farnesyl transferase inhibitors (

Financial Data and Key Metrics Changes - Research and development expenses for Q3 2021 were $22.4 million, up from $16.6 million in Q3 2020, primarily due to increased clinical trial costs and personnel expenses [30] - General and administrative expenses for Q3 2021 were $11.3 million, compared to $7.6 million in Q3 2020, driven by higher personnel costs and professional fees [31] - Net loss for Q3 2021 was $33.4 million or $0.50 per share, compared to a net loss of $23.8 million or $0.42 per share in Q3 2020 [31] - As of September 30, 2021, cash, cash equivalents, and short-term investments totaled $543.4 million, down from $633.3 million as of December 31, 2020 [32] Business Line Data and Key Metrics Changes - KO-539 showed encouraging single-agent activity in relapsed and/or refractory AML, with a favorable safety profile and no evidence of QTC prolongation [9][10] - The Phase 1b study of KO-539 is currently enrolling two expansion cohorts, with preliminary results indicating activity at both doses [12][13] - Tipifarnib has been awarded breakthrough therapy designation from the FDA for HRAS mutant HNSCC, based on data from the Phase 2 RUN-HN trial [20][21] Market Data and Key Metrics Changes - The overall response rate for tipifarnib in patients with angioimmunoblastic T-cell lymphoma was reported at 56.3%, with a median overall survival of 32.8 months [20] - The company is preparing for a Phase 1/2 study of tipifarnib in combination with alpelisib in HNSCC, with the first clinical site activated [24][25] Company Strategy and Development Direction - The company remains focused on three main programs: KO-539 in acute leukemia, tipifarnib in head and neck squamous cell carcinoma, and KO-2806 in solid tumors [8] - The development strategy for KO-539 aims to register it as a monotherapy while exploring combination therapies to expand treatment options [16][75] - The company is actively preparing for combination trials and is exploring partnerships to enhance development opportunities [63][75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of clinical trials and the potential of their drug candidates to create significant value for patients and shareholders [8][16] - The company anticipates sufficient cash reserves to fund operations into 2024, despite the increase in operating expenses [32][33] - Management remains optimistic about the clinical activity of KO-539 and the potential for registration in both NPM1 and KMT2A populations [46] Other Important Information - The company plans to provide updates on the Phase 1 study results at future medical meetings, pending the determination of the recommended Phase 2 dose [15] - The company has identified opportunities for farnesyl transferase inhibitors in combination with other targeted therapies in large solid tumor indications [27] Q&A Session Summary Question: Can you provide more details on the evidence of activity and safety profile? - Management indicated that they are encouraged by the clinical activity observed in both dose cohorts but could not provide more granular details at this stage due to the nature of the Phase 1b study [38][39] Question: What is the latest thinking on KO-539's activity in different genetic subtypes? - Management stated that they have not observed any significant differences in activity between NPM1 and KMT2A populations and expect the recommended Phase 2 dose to support efficacy in both [41][43] Question: How do you interpret competitor data in the context of the relapsed/refractory patient population? - Management noted that while competitor data showed lower response rates, it is early in the study, and they remain optimistic about their own data and the potential for longer duration of response [52][54] Question: What are the go/no-go criteria for moving forward with KO-539? - Management confirmed that they have established go/no-go criteria based on achieving a sufficient level of CR/CRH to support confidence in a properly powered trial [70] Question: How will the company approach combination trials once the recommended Phase 2 dose is established? - Management indicated a desire to maintain control over trial design and execution while exploring opportunities for investigator-sponsored trials (ISTs) [64][75] Question: Have global supply chain issues impacted the company's activities? - Management reported no significant impact from supply chain issues, attributing their resilience to the nature of their drug candidates being small molecules that can be administered on an outpatient basis [85] Question: How is duration of response measured in trials, particularly regarding transplant? - Management clarified that duration of response is tracked until the point of transplant, at which data are censored to avoid confounding results [91]

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q3 2021 financial statements reflect decreased assets and increased net loss driven by higher R&D and G&A expenses [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheets Data | | September 30, 2021 (Unaudited, $ in thousands) | December 31, 2020 ($ in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,183 | $325,493 | | Short-term investments | $504,262 | $307,827 | | Total current assets | $548,905 | $637,292 | | Total assets | $561,141 | $647,212 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $27,385 | $36,307 | | Total stockholders' equity | $533,756 | $610,905 | | Total liabilities and stockholders' equity | $561,141 | $647,212 | - Total assets decreased from **$647.2 million** at the end of 2020 to **$561.1 million** as of September 30, 2021, while total liabilities also decreased from **$36.3 million** to **$27.4 million** in the same period[10](index=10&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Statements of Operations and Comprehensive Loss Data | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | **(In thousands, except per share data)** | **2021 ($ in thousands)** | **2020 ($ in thousands)** | **2021 ($ in thousands)** | **2020 ($ in thousands)** | | Research and development | $22,367 | $16,601 | $63,765 | $42,873 | | General and administrative | $11,310 | $7,593 | $34,455 | $22,694 | | **Net Loss** | **$(33,366)** | **$(23,769)** | **$(97,723)** | **$(63,466)** | | Net loss per share, basic and diluted | $(0.50) | $(0.42) | $(1.47) | $(1.24) | - Net loss for the nine months ended September 30, 2021, increased to **$97.7 million** from **$63.5 million** in the same period of 2020, primarily due to a significant rise in both Research and Development and General and Administrative expenses[13](index=13&type=chunk) [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) - Total stockholders' equity decreased from **$610.9 million** at December 31, 2020, to **$533.8 million** at September 30, 2021. The decrease was primarily driven by a net loss of **$97.7 million**, partially offset by **$17.2 million** in share-based compensation and **$3.6 million** from stock option exercises[16](index=16&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows Data | (In thousands) | Nine Months Ended Sep 30, 2021 ($ in thousands) | Nine Months Ended Sep 30, 2020 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(81,185) | $(51,522) | | Net cash used in investing activities | $(200,896) | $(39,746) | | Net cash (used in) provided by financing activities | $(4,229) | $142,298 | | **Net (decrease) increase in cash, cash equivalents and restricted cash** | **$(286,310)** | **$51,030** | - Cash used in operating activities increased to **$81.2 million** for the first nine months of 2021, compared to **$51.5 million** in the prior-year period. Financing activities used **$4.2 million** in cash, a stark contrast to the **$142.3 million** provided by financing in the same period of 2020, which included proceeds from a common stock issuance[22](index=22&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with a pipeline of small molecule product candidates[25](index=25&type=chunk) - In May 2021, the company repaid all amounts owed under its Term Loan with Silicon Valley Bank, resulting in a loss on extinguishment of debt of approximately **$0.2 million**[47](index=47&type=chunk) - Share-based compensation expense for the nine months ended September 30, 2021, was **$17.2 million**, a significant increase from **$9.1 million** in the same period of 2020[57](index=57&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased R&D and G&A expenses, strong liquidity, and future funding needs for clinical development [Overview](index=15&type=section&id=Overview) - Kura Oncology is a clinical-stage biopharmaceutical company with two primary product candidates: tipifarnib (for HNSCC and other tumors) and KO-539 (for acute leukemia)[61](index=61&type=chunk) - Tipifarnib received Breakthrough Therapy Designation from the FDA for treating recurrent or metastatic HRAS mutant HNSCC[66](index=66&type=chunk) - The company initiated a clinical collaboration with Novartis to evaluate tipifarnib in combination with alpelisib in HNSCC patients, with a Phase 1/2 trial (KURRENT) planned for Q4 2021[67](index=67&type=chunk) - For KO-539, the company amended the KOMET-001 trial to include Phase 1b expansion cohorts to determine the recommended Phase 2 dose (RP2D), with a determination expected by Q1 2022[74](index=74&type=chunk)[75](index=75&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) Three Months Ended September 30, 2021 vs 2020 | (In thousands) | Three Months Ended Sep 30, 2021 ($ in thousands) | Three Months Ended Sep 30, 2020 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $22,367 | $16,601 | $5,766 | | General and administrative | $11,310 | $7,593 | $3,717 | Nine Months Ended September 30, 2021 vs 2020 | (In thousands) | Nine Months Ended Sep 30, 2021 ($ in thousands) | Nine Months Ended Sep 30, 2020 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $63,765 | $42,873 | $20,892 | | General and administrative | $34,455 | $22,694 | $11,761 | - The increase in R&D expenses for the nine months ended Sep 30, 2021 was primarily due to a **$10.6 million** increase in KO-539-related costs for its Phase 1/2 clinical trial and manufacturing, and a **$4.8 million** increase in tipifarnib-related costs[88](index=88&type=chunk) - The increase in G&A expenses for the nine months ended Sep 30, 2021 was primarily due to a **$5.5 million** increase in non-cash share-based compensation and a **$4.1 million** increase in personnel costs from additional headcount[89](index=89&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2021, the company had **$543.4 million** in cash, cash equivalents, and short-term investments[94](index=94&type=chunk) - Management believes existing cash is sufficient to fund operating expenses and capital expenditure requirements into 2024[94](index=94&type=chunk) - The company has an at-the-market (ATM) facility to sell up to **$75.0 million** of common stock, but no shares have been sold under this facility to date[92](index=92&type=chunk) - The company anticipates needing substantial additional funding for its continuing operations, particularly for clinical trials, seeking marketing approval, and potential commercialization[93](index=93&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Primary market risk is interest rate fluctuations on investments, with no material impact from a 10% change or inflation - The company's main market risk is interest rate risk on its cash and investment portfolio, which consists of money market funds, corporate debt, U.S. Treasury securities, and other high-quality instruments[106](index=106&type=chunk) - Management does not believe that a hypothetical **10%** change in interest rates would have a significant impact on the company's financial statements[106](index=106&type=chunk) - Inflation is not believed to have had a material effect on the company's business, financial condition, or results of operations[107](index=107&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective with no material changes to internal controls during the quarter - The company's CEO and CFO concluded that disclosure controls and procedures were effective at a reasonable assurance level as of the end of the quarter[110](index=110&type=chunk) - No material changes to internal control over financial reporting were identified during the most recent quarter[111](index=111&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings adversely affecting its financial position - The company is not currently a party to any material legal proceedings[114](index=114&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks, including clinical success dependency, COVID-19 impacts, funding needs, and third-party reliance - The company's ability to conduct clinical trials has been and could continue to be adversely impacted by the COVID-19 pandemic, potentially causing delays in site startup and patient enrollment[117](index=117&type=chunk) - The company is highly dependent on the success of its lead product candidates, tipifarnib and KO-539, which are still in clinical development and may never receive regulatory approval[119](index=119&type=chunk) - The company will need to obtain substantial additional capital to continue operations, and raising capital may cause dilution to stockholders or restrict operations[170](index=170&type=chunk) - The company relies on third-party contractors for manufacturing and conducting clinical trials, and any failure by these third parties to perform satisfactorily could delay or impair development efforts[173](index=173&type=chunk)[180](index=180&type=chunk) [Exhibits](index=65&type=section&id=Item%206.%20Exhibits) This section indexes exhibits filed with the Form 10-Q, including officer certifications and XBRL data - Lists exhibits filed with the report, including officer certifications (**31.1**, **31.2**, **32.1**) and Inline XBRL documents[315](index=315&type=chunk)

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER 0 0 Corporate Presentation – September 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, KO-539 and KO-2806, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competitiv ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides key financial data, management's analysis, market risk disclosures, and internal controls for Kura Oncology, Inc [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Kura Oncology's unaudited condensed financial statements, including balance sheets, statements of operations, and cash flows, for the period ended June 30, 2021 Condensed Balance Sheet Data (in thousands) | | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $38,974 | $325,493 | | Short-term investments | $528,520 | $307,827 | | Total current assets | $573,632 | $637,292 | | Total assets | $584,891 | $647,212 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $21,290 | $26,024 | | Total liabilities | $26,340 | $36,307 | | Total stockholders' equity | $558,551 | $610,905 | Condensed Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | Research and development | $21,074 | $13,697 | $41,398 | $26,272 | | General and administrative | $12,573 | $7,476 | $23,145 | $15,101 | | **Total operating expenses** | **$33,647** | **$21,173** | **$64,543** | **$41,373** | | **Net Loss** | **$(33,663)** | **$(20,487)** | **$(64,357)** | **$(39,697)** | | Net loss per share, basic and diluted | $(0.51) | $(0.40) | $(0.97) | $(0.82) | Condensed Statements of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2021** | **2020** | | Net cash used in operating activities | $(56,591) | $(34,556) | | Net cash (used in) provided by investing activities | $(223,441) | $5,774 | | Net cash (used in) provided by financing activities | $(6,487) | $137,615 | | **Net (decrease) increase in cash, cash equivalents and restricted cash** | **$(286,519)** | **$108,833** | - In May 2021, the company repaid all amounts owed under its Term Loan with Silicon Valley Bank, paying **$6.6 million** This transaction was accounted for as an extinguishment of debt, resulting in a recorded loss of approximately **$0.2 million** for the three and six months ended June 30, 2021[44](index=44&type=chunk) - Share-based compensation expense increased significantly to **$11.1 million** for the six months ended June 30, 2021, compared to **$5.7 million** for the same period in 2020[54](index=54&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Kura Oncology's business, financial condition, and operational results, highlighting clinical program advancements and increased operating expenses [Overview](index=15&type=section&id=Overview) Kura Oncology is a clinical-stage biopharmaceutical company focused on precision cancer medicines, with lead candidates tipifarnib and KO-539 advancing in clinical trials - Tipifarnib received **Breakthrough Therapy Designation** from the FDA for treating recurrent or metastatic HRAS mutant HNSCC[64](index=64&type=chunk) - KO-539, a menin-KMT2A inhibitor, is in a **Phase 1/2 trial (KOMET-001)** for relapsed or refractory AML The trial was amended to include **Phase 1b expansion cohorts** to determine the recommended Phase 2 dose (RP2D)[67](index=67&type=chunk)[68](index=68&type=chunk)[70](index=70&type=chunk) - A clinical collaboration was announced with Novartis to evaluate the combination of tipifarnib and alpelisib in HNSCC patients, with the KURRENT trial planned to start in **Q4 2021**[65](index=65&type=chunk) - A next-generation farnesyl transferase inhibitor, KO-2806, was nominated for development, with an Investigational New Drug (IND) application expected **by the end of 2022**[73](index=73&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) This section details the operating results for the three and six months ended June 30, 2021, showing increased net loss driven by higher Research and Development and General and Administrative expenses R&D Expense Breakdown (Six Months Ended June 30, in thousands) | Category | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Tipifarnib-related costs | $17,723 | $12,863 | $4,860 | | KO-539-related costs | $8,062 | $1,444 | $6,618 | | Discovery stage programs | $1,835 | $854 | $981 | | Personnel costs and other expenses | $10,560 | $9,496 | $1,064 | | Share-based compensation expense | $3,218 | $1,615 | $1,603 | | **Total R&D expenses** | **$41,398** | **$26,272** | **$15,126** | - The **increase** in R&D expenses for the six months ended June 30, 2021, was primarily driven by **higher costs** for the Phase 1/2 clinical trial of KO-539 and **increased activities** for the registration-directed trial of tipifarnib, including companion diagnostics development[85](index=85&type=chunk) - General and administrative expenses for the six months ended June 30, 2021, **increased by $8.0 million** compared to the same period in 2020, primarily due to a **$3.8 million** increase in non-cash share-based compensation and a **$3.2 million** increase in personnel costs from additional headcount[87](index=87&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) This section details Kura Oncology's financial position, including $567.5 million in cash and investments, and discusses future funding needs for ongoing operations and clinical development - As of June 30, 2021, the company had cash, cash equivalents, and short-term investments of **$567.5 million**[74](index=74&type=chunk)[93](index=93&type=chunk) - Management believes that existing cash reserves are sufficient to fund operating expenses and capital expenditure requirements **into 2024**[93](index=93&type=chunk) Summary of Net Cash Flow Activities (Six Months Ended June 30, in thousands) | | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(56,591) | $(34,556) | $(22,035) | | Net cash (used in) provided by investing activities | $(223,441) | $5,774 | $(229,215) | | Net cash (used in) provided by financing activities | $(6,487) | $137,615 | $(144,102) | - The company anticipates needing **substantial additional funding** for its continuing operations, including R&D, clinical trials, and potential commercialization efforts[92](index=92&type=chunk)[94](index=94&type=chunk) [Contractual Obligations](index=22&type=section&id=Contractual%20Obligations) The company's significant contractual obligations as of June 30, 2021, primarily consist of operating leases, with potential additional milestone payments under in-license agreements Contractual Obligations as of June 30, 2021 (in thousands) | | Total | Less than 1 Year | 1-3 Years | 3-5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | :--- | | Operating leases | $8,578 | $2,242 | $4,751 | $1,585 | $— | - The company may be required to pay up to approximately **$80.2 million** in milestone payments under in-license agreements, which are contingent upon achieving certain regulatory and commercial milestones and are excluded from the table[101](index=101&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate risk on its investments, with management believing a 10% change would not materially affect portfolio fair value - The company's main market risk is interest rate risk on its portfolio of cash, cash equivalents, and short-term investments, which include money market funds, corporate debt, and government securities[106](index=106&type=chunk) - Management believes that a hypothetical **10%** change in interest rates as of June 30, 2021, would not have had a material effect on the fair value of its investment portfolio[106](index=106&type=chunk) - Inflation is not believed to have had a material effect on the company's business, financial condition, or results of operations[107](index=107&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** at the reasonable assurance level as of June 30, 2021[109](index=109&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[110](index=110&type=chunk) [PART II. OTHER INFORMATION](index=24&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, key risk factors, and a list of exhibits filed with the report [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, Kura Oncology is not a party to any legal proceedings expected to have a material adverse effect on its financial position or results of operations - The company is **not currently a party** to any legal proceedings that would have a material adverse effect on its results of operations or financial position[113](index=113&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including dependence on clinical success, COVID-19 impacts, funding needs, reliance on third parties, and intellectual property challenges, particularly for tipifarnib - The company is **highly dependent** on the success of its lead product candidates, tipifarnib and KO-539, which are still in clinical development and require regulatory approval[114](index=114&type=chunk)[118](index=118&type=chunk) - The COVID-19 pandemic has **adversely impacted** and could continue to adversely impact clinical trials through delays in site startup, patient enrollment, and supply chain disruptions[114](index=114&type=chunk)[116](index=116&type=chunk) - The company will need to obtain **substantial additional capital** to fund its operations, and raising capital may cause dilution to stockholders or restrict operations[114](index=114&type=chunk)[169](index=169&type=chunk) - The company **relies on third-party contractors** for clinical trials and manufacturing, increasing risks related to performance, quality, and supply continuity[114](index=114&type=chunk)[172](index=172&type=chunk)[179](index=179&type=chunk) - Intellectual property risks are significant, as the composition of matter patents for tipifarnib **have expired**, increasing reliance on method-of-use patents and regulatory exclusivity which may not provide sufficient protection[115](index=115&type=chunk)[189](index=189&type=chunk)[226](index=226&type=chunk) [Exhibits](index=63&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the 10-Q report, including corporate governance documents, warrants, and newly filed agreements - The report includes a list of all exhibits filed, such as corporate governance documents, warrants, and newly filed agreements[315](index=315&type=chunk) - New exhibits filed with this report include a lease agreement dated May 11, 2021, and a first amendment to an executive employment agreement for Bridget Martell[315](index=315&type=chunk) [Signatures](index=64&type=section&id=Signatures) This section contains the official signatures of the company's President, CEO, CFO, and Chief Business Officer, certifying the report's submission - The report was duly signed on **August 5, 2021**, by Troy E Wilson, Ph.D., J.D. (President and Chief Executive Officer) and Marc Grasso, M.D. (Chief Financial Officer and Chief Business Officer)[318](index=318&type=chunk)

Financial Data and Key Metrics Changes - Research and development expenses for Q1 2021 were $20.3 million, up from $12.6 million in Q1 2020, primarily due to increased clinical trial costs and personnel expenses [15] - General and administrative expenses for Q1 2021 were $10.6 million, compared to $7.6 million in Q1 2020, mainly due to higher personnel costs and noncash share-based compensation [16] - Net loss for Q1 2021 was $30.7 million, or $0.46 per share, compared to a net loss of $19.2 million, or $0.42 per share, in Q1 2020 [16] - As of March 31, 2021, cash, cash equivalents, and short-term investments totaled $603.9 million, down from $633.3 million as of December 31, 2020, with sufficient funds projected to last into 2024 [16] Business Line Data and Key Metrics Changes - The KO-539 program is positioned as a potentially best-in-class menin inhibitor, with ongoing clinical trials aimed at optimizing Phase II dosing [6][7] - The company is also advancing the farnesyl transferase inhibitor program, with a focus on HRAS mutant head and neck squamous cell carcinoma, which received breakthrough designation from the FDA [10][11] Market Data and Key Metrics Changes - The menin inhibitor space is experiencing heightened activity, with new developments from competitors validating the therapeutic target in acute myeloid leukemia (AML) [5] - The company aims to expand its market presence by exploring additional genetic subtypes and indications, including acute lymphocytic leukemia and myelodysplastic syndrome [8] Company Strategy and Development Direction - The company plans to conduct a comprehensive clinical development plan for KO-539, including both monotherapy and combination studies [6] - The strategy includes a focus on identifying optimal dosing and expanding into additional genetic subtypes once the recommended Phase II dose is established [30] - The company is also preparing a Phase I/II proof-of-concept study for tipifarnib in combination with a PI3 kinase alpha inhibitor [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the KO-539 program's potential, citing a favorable safety profile and wide therapeutic window [6][24] - The company is optimistic about the potential for tipifarnib to become the first approved small molecule targeted therapy in head and neck cancer [10] - Management highlighted the importance of defining the optimal Phase II dose and the potential for increased response rates in AML treatment [21][63] Other Important Information - The company is actively engaging with key opinion leaders and a global steering committee to refine its clinical development plans [7] - The anticipated milestones for 2021 include the initiation of genetically enriched Phase Ib expansion for KO-539 and the nomination of a development candidate for the next-generation farnesyl transferase inhibitor [17] Q&A Session Summary Question: Thoughts on Amgen's KRAS G12C inhibitor disclosures - Management discussed the FDA's initiative to define the optimum Phase II dose and the importance of identifying the lowest dose with maximum pharmacologic and clinical activity [19][21] Question: Confidence in KO-539 compared to competitors - Management highlighted the advantages of KO-539, including a wide therapeutic window and no dependence on CYP3A4, unlike competitors [22][24] Question: Data readouts and Phase Ib expansion - Management confirmed that updates on Phase Ib data will be provided later in the year, focusing on determining the recommended Phase II dose [27][28] Question: Expansion opportunities and genetic subtypes - Management indicated ongoing efforts to explore additional genetic subtypes and the potential for KO-539 to benefit MDS patients [30][31] Question: Financial guidance and R&D spending - Management acknowledged that Q1 expenses were higher due to one-off costs but anticipated continued increases in R&D spending throughout the year [45] Question: Properties of next-generation farnesyl transferase inhibitors - Management expressed the goal of improving pharmacokinetic properties and reducing dosing frequency compared to existing therapies [46] Question: Status of AIM study and site readiness - Management noted that patient reluctance due to COVID-19 has impacted enrollment but emphasized ongoing efforts to identify and screen eligible patients [49][50] Question: Pharmacokinetic and pharmacodynamic goals for Phase Ib - Management clarified that the focus will be on understanding interpatient variability and optimizing efficacy rather than targeting specific pharmacokinetic markers [52][53] Question: Comparison of combatant versus non-covalent inhibitors - Management discussed the decision to pursue a reversible inhibitor approach for KO-539, citing concerns over potential off-target toxicity with covalent inhibitors [56] Question: Targeting NPM1 versus MLLr populations - Management highlighted the negative prognosis associated with NPM1 mutations in relapsed/refractory settings and the potential for menin inhibitors to drive MRD-negative responses [60][63]

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER ......... Corporate Presentation – May 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 competitive therapi ...

[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].