UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ To ________ Commission file number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 61-1547851 (Sta ...

DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER 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 ...

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, 2021 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 (State o ...

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-37620 KURA ONCOLOGY, INC. (Exact name of Registrant as specified in its Charter) Delaware 61-1547851 (State or other jurisdiction of ...

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

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