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 March 31, 2022 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 12730 Hi ...

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER ......... Corporate Presentation – February 2022 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 ziftomenib, tipifarnib and KO-2806, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus c ...

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 ...