PART I. FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(unaudited)) Kura Oncology reported a net loss of **$34.1 million** for Q1 2023, an increase from **$32.5 million** in Q1 2022, primarily due to higher research and development expenses [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$426.0 million** as of March 31, 2023, from **$456.3 million** at year-end 2022, primarily due to reduced cash and investments Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,059 | $51,802 | | Short-term investments | $378,841 | $386,183 | | Total current assets | $416,450 | $446,426 | | **Total assets** | **$425,975** | **$456,306** | | **Liabilities & Equity** | | | | Total current liabilities | $19,233 | $24,057 | | Total liabilities | $30,792 | $36,028 | | Total stockholders' equity | $395,183 | $420,278 | | **Total liabilities and stockholders' equity** | **$425,975** | **$456,306** | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$34.1 million** in Q1 2023 from **$32.5 million** in Q1 2022, primarily driven by a rise in research and development expenses to **$25.2 million** Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $25,192 | $20,913 | | General and administrative | $11,374 | $11,869 | | **Total operating expenses** | **$36,566** | **$32,782** | | Total other income, net | $2,497 | $329 | | **Net Loss** | **$(34,069)** | **$(32,453)** | | Net loss per share, basic and diluted | $(0.50) | $(0.49) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$35.9 million** in Q1 2023, while investing activities provided **$11.1 million**, a shift from prior-year usage Condensed Statement of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,872) | $(32,181) | | Net cash provided by (used in) investing activities | $11,129 | $(24,962) | | Net cash provided by financing activities | $— | $303 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(24,743)** | **$(56,840)** | [Notes to Condensed Financial Statements (unaudited)](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20(unaudited)) Key notes include a **$2.8 million** employee retention credit, **$378.8 million** in short-term investments, and **$63.9 million** in unrecognized share-based compensation expense - The company recognized a **$2.8 million** employee retention credit related to wages paid from July 2020 through September 2021, recognized as a reduction to personnel costs within operating expenses[31](index=31&type=chunk) Share-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $3,073 | $2,456 | | General and administrative | $3,765 | $4,194 | | **Total** | **$6,838** | **$6,650** | - As of March 31, 2023, unrecognized estimated compensation expense was approximately **$49.6 million** for stock options and **$14.3 million** for restricted stock units, to be recognized over a weighted average period of **2.8 years**[45](index=45&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical development progress, financial results, and liquidity, noting increased R&D expenses and **$405.9 million** in cash to fund operations into Q4 2025 [Overview](index=13&type=section&id=Overview) Kura Oncology, a clinical-stage biopharmaceutical company, is advancing ziftomenib into Phase 2 trials, supported by **$405.9 million** in liquidity and access to additional capital - The company is advancing its three main product candidates: **ziftomenib** (menin-KMT2A inhibitor), **tipifarnib** (farnesyl transferase inhibitor), and **KO-2806** (next-gen FTI)[50](index=50&type=chunk)[51](index=51&type=chunk)[59](index=59&type=chunk) - **Ziftomenib** has initiated its Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant AML, with combination studies (KOMET-007 and KOMET-008) expected to begin in 2023[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - As of March 31, 2023, the company's liquidity position was **$405.9 million** in cash, cash equivalents, and short-term investments, supported by a loan facility of up to **$125.0 million** and an ATM facility of up to **$150.0 million**[65](index=65&type=chunk)[66](index=66&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Research and development expenses increased by **$4.3 million** in Q1 2023, primarily driven by higher costs for the **ziftomenib** and **KO-2806** programs Research and Development Expenses by Program (in thousands) | Program | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Ziftomenib-related costs | $5,833 | $4,085 | $1,748 | | Tipifarnib-related costs | $4,390 | $4,861 | $(471) | | KO-2806-related costs | $2,829 | $791 | $2,038 | | Discovery stage programs | $927 | $554 | $373 | | Personnel costs and other | $8,140 | $8,166 | $(26) | | Share-based compensation | $3,073 | $2,456 | $617 | | **Total R&D Expenses** | **$25,192** | **$20,913** | **$4,279** | [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$405.9 million** in cash and investments as of March 31, 2023, expected to fund operations into Q4 2025, supplemented by access to **$125.0 million** in loans and a **$150.0 million** ATM facility - The company had cash, cash equivalents, and short-term investments of **$405.9 million** as of March 31, 2023[83](index=83&type=chunk) - Based on current plans, existing cash is expected to fund operating expenses into the **fourth quarter of 2025**[83](index=83&type=chunk) - In November 2022, the company entered into a loan agreement for up to **$125.0 million** in term loans, drawing an initial **$10.0 million**[78](index=78&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate fluctuations affecting its investment portfolio and variable-rate term loan, with inflation not deemed to have a material effect - The company's primary market risk is interest rate risk, affecting its investment portfolio and variable-rate term loan[95](index=95&type=chunk)[96](index=96&type=chunk) - Inflation is not believed to have had a material effect on the company's business, financial condition, or results of operations[97](index=97&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter - The company's principal executive and financial officer concluded that disclosure controls and procedures were effective as of the end of the quarter[99](index=99&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2023[100](index=100&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings deemed to have a material adverse effect on its operations or financial position - As of the filing date, the company is not involved in any material legal proceedings[102](index=102&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks, including high dependence on **ziftomenib**'s success, lengthy and expensive clinical development, reliance on third parties, the need for additional capital, and potential adverse events - The company is highly dependent on the success of its lead product candidate, **ziftomenib**, which is still in clinical development and has no guarantee of regulatory approval[103](index=103&type=chunk)[105](index=105&type=chunk) - Clinical drug development is a lengthy, expensive process with an uncertain outcome, and results from early trials may not predict results of later trials[103](index=103&type=chunk)[121](index=121&type=chunk) - The company expects to incur losses for the next several years, has no approved products or historical revenue, and will need to obtain substantial additional capital to continue operations[103](index=103&type=chunk)[148](index=148&type=chunk)[157](index=157&type=chunk) - The company relies on third-party contractors for clinical trials and manufacturing, and any failure by these third parties to perform satisfactorily could delay or impair development and commercialization[103](index=103&type=chunk)[165](index=165&type=chunk)[173](index=173&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and officer certifications - Lists all exhibits filed with the report, including certifications required by the Sarbanes-Oxley Act and XBRL data files[323](index=323&type=chunk)

Kura Oncology, Inc. (NASDAQ:KURA) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Pete De Spain - Senior Vice President of Investor Relations and Corporate Communications Troy Wilson - President and Chief Executive Officer Tom Doyle - Senior Vice President of Finance and Accounting Conference Call Participants Jonathan Chang - SVB Securities Roger Song - Jefferies Group LLC Peter Lawson - Barclays Li Watsek - Cantor Fitzgerald, L.P. Bradley Canino - Stifel Financial Corp. ...

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, 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 (State or other jurisdiction of ...

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

Kura Oncology, Inc. (NASDAQ:KURA) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ET Corporate 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 Peter Lawson - Barclays Roger Song - Jefferies Li Watsek - Cantor Fitzgerald Tiago Fauth - Credit Suisse Phil Nadeau - Cowen Reni Benjamin - JMP Securities Opera ...

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]