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, 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) (State or other jurisdic ...

Kura Oncology, Inc. (NASDAQ:KURA) Q2 2022 Earnings Conference Call August 3, 2022 4:30 PM ET Company Participants Pete De Spain - Senior Vice President of Investor Relations Troy Wilson - President and Chief Executive Officer Tom Doyle - Senior Vice President of Finance and Accounting Conference Call Participants Jonathan Chang - SVB Securities Tiago Fauth - Credit Suisse Peter Lawson - Barclays Roger Song - Jefferies Li Watsek - Cantor Fitzgerald Reni Benjamin - JMP Securities Eva Privitera - Cowen, Inc. O ...

Clinical Development - Kura Oncology has two clinical-stage product candidates: ziftomenib and tipifarnib, with a preclinical-stage candidate KO-2806 currently in IND-enabling studies[57]. - Ziftomenib targets approximately 35% of acute myeloid leukemia (AML), including NPM1-mutant and KMT2A-rearranged AML, with KMT2A rearrangements found in 70-80% of infant leukemias[58]. - The KOMET-001 trial for ziftomenib reported clinical activity in 6 out of 8 efficacy-evaluable patients, including 2 complete remissions[61]. - Tipifarnib has been studied in over 5,000 cancer patients, showing durable anti-cancer activity with a manageable side effect profile[67]. - The AIM-HN trial for tipifarnib in HRAS mutant head and neck squamous cell carcinoma (HNSCC) has been amended to include patients with any HRAS mutation, potentially increasing the number of evaluable patients[70]. - Tipifarnib received Breakthrough Therapy Designation from the FDA for recurrent or metastatic HRAS mutant HNSCC with variant allele frequency ≥ 20%[71]. - Kura Oncology is collaborating with Novartis to evaluate the combination of tipifarnib and alpelisib in patients with HRAS overexpression and/or PIK3CA mutations[72]. - Preclinical data suggest that tipifarnib may prevent resistance to EGFR-targeted therapies in non-small cell lung cancer (NSCLC)[74]. - Kura Oncology is developing a next-generation farnesyl transferase inhibitor, KO-2806, which has improved potency and pharmacokinetic properties compared to tipifarnib[75]. - The company plans to initiate the KURRENT-LUNG trial of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC in Q3 2022[74]. Financial Performance - As of June 30, 2022, the company had cash, cash equivalents, and short-term investments totaling $450.3 million[77]. - The company reported research and development expenses of $24.3 million for the three months ended June 30, 2022, an increase of 15.1% compared to $21.1 million for the same period in 2021[86]. - For the six months ended June 30, 2022, total research and development expenses were $45.2 million, up from $41.4 million in the same period in 2021, reflecting a 9.1% increase[90]. - The company has an accumulated deficit of $500.2 million as of June 30, 2022, indicating ongoing operating losses since inception[95]. - The company has not generated any revenues from product sales and does not have any approved products as of June 30, 2022[96]. - The company anticipates requiring significant additional financing in the future to continue operations and fund research and development activities[95]. - The company expects general and administrative expenses to increase in future periods to support planned research and development activities[88]. - The company has entered into an ATM Facility allowing for the sale of up to $150.0 million in common stock, but has not yet sold any shares under this agreement[94]. - The increase in ziftomenib-related research and development expenses for the three months ended June 30, 2022, was primarily due to costs associated with the Phase 1/2 clinical trial[86]. - The company expects its existing cash and investments to be sufficient to fund operating expenses through 2024, but future capital requirements will depend on various factors[96]. Cash Flow and Investments - Net cash used in operating activities for the six months ended June 30, 2022 was $62,522,000, an increase of $5,931,000 compared to $56,591,000 in 2021[98]. - Net cash provided by investing activities for the six months ended June 30, 2022 was $8,135,000, a significant change of $231,576,000 from a net cash used of $223,441,000 in 2021[98]. - Net cash provided by financing activities for the six months ended June 30, 2022 was $2,972,000, compared to a net cash used of $6,487,000 in 2021, reflecting a change of $9,459,000[100]. - The company may be required to pay up to approximately $80,000,000 in milestone payments plus sales royalties if regulatory and commercial milestones under in-license agreements are achieved[103]. - The increase in net cash used in operating activities was primarily due to changes of $3,000,000 in prepaid expenses and other current assets[98]. - The company does not believe that a 10.0% change in interest rates would have a material effect on the fair value of its investment portfolio as of June 30, 2022[107]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the periods presented[108]. - The company has established guidelines regarding approved investments and maturities of investments to maintain safety and liquidity[107]. - The company has short-term and cancellable agreements with clinical sites and CROs for clinical research studies, generally outstanding for periods less than one year[102]. - There have been no material changes to the company's critical accounting policies and estimates from the previous fiscal year[105].

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

Financial Data and Key Metrics Changes - Research and development expenses for Q1 2022 were $20.9 million, an increase from $20.3 million in Q1 2021, primarily due to higher clinical trial and personnel costs [14] - General and administrative expenses rose to $11.9 million in Q1 2022 from $10.6 million in Q1 2021, mainly due to increased professional fees and non-cash share-based compensation [14] - The net loss for Q1 2022 was $32.5 million, compared to a net loss of $30.7 million in Q1 2021, which included non-cash share-based compensation of $6.7 million versus $5.1 million in the prior year [15] - As of March 31, 2022, cash, cash equivalents, and short-term investments totaled $480.1 million, down from $518 million as of December 31, 2021, with a cash runway expected to fund operations through 2024 [15] Business Line Data and Key Metrics Changes - The Menin Inhibitor program, Ziftomenib, is progressing with the completion of enrollment in the Phase 1b study, with top-line data expected in Q3 2022 and a full data presentation planned for Q4 2022 [4][6] - The Farnesyl Transferase Inhibitor (FTI) programs are being developed, with ongoing trials for Tipifarnib in combination with Alpelisib targeting head and neck squamous cell carcinoma (HNSCC) [8][10] Market Data and Key Metrics Changes - The company is expanding its clinical development strategy in the U.S. and Europe, anticipating a larger patient population for Ziftomenib through combination therapies [8] - The combination of Tipifarnib and Alpelisib is expected to increase the total addressable patient population for Tipifarnib to as much as 50% of HNSCC patients [10] Company Strategy and Development Direction - The company aims to register Ziftomenib as a monotherapy while exploring combination opportunities to enhance treatment efficacy [8] - A comprehensive development strategy is being pursued for the FTI programs, focusing on both monotherapy and combination therapies to address larger patient populations [11][47] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the company's position despite a challenging market environment, highlighting a strong team and a well-designed clinical strategy [4] - The anticipated milestones for 2022 include identifying the recommended Phase 2 dose for Ziftomenib and initiating several key trials [16] Other Important Information - The company has implemented an enhanced mitigation strategy for managing differentiation syndrome associated with Ziftomenib, which is seen as a marker of clinical activity [23][60] - The company is preparing to submit an IND application for its next-generation FTI candidate, KO-2806, in Q4 2022 [13] Q&A Session Summary Question: What can investors expect in the top-line third quarter data versus the medical meeting presentation in the fourth quarter? - The top-line data will focus on safety, tolerability, and clinical activity at the recommended Phase 2 dose, while the medical meeting will provide a more comprehensive dataset including genetic subtype breakdowns [18] Question: Can you provide details on the enrollment completion and patient demographics in the Phase 1b expansion cohorts? - There is a good balance between the two populations (NPM1 mutation and KMT2A rearrangement), with no disproportionate enrollment observed [19] Question: How much safety data will be available in the Q3 update, and what is the management strategy for differentiation syndrome? - The safety data will be high-level, with an encouraging safety profile reported, and an enhanced mitigation strategy in place for differentiation syndrome [23] Question: What are the top combination studies being considered for Ziftomenib? - Venetoclax and FLT3 inhibitors are identified as attractive combination partners, with ongoing activities to support these studies [46] Question: What are the primary endpoints for the current lung trial? - The primary endpoint is progression-free survival (PFS), with safety and tolerability also being key metrics [55]

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 ...

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, 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 12730 High Bluff Drive, Suite 40 ...

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]