Forecasted Milestones & Financial Highlights 32 | --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER Corporate Presentation – November 2023 | | | | | * Optimum biologically active dose ** Cash, cash equivalents and short-term investments 2 All forward-looking statements contained in this presentation speak only as of the ...

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, 2023 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) Indicate by check mark w ...

PART I. FINANCIAL INFORMATION [Condensed Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(unaudited)) The company reported increased net losses for Q2 and H1 2023 due to higher operating expenses, while total assets grew to $494.7 million, bolstered by a $93.6 million public offering Condensed Balance Sheet Data (in thousands) | | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $49,124 | $51,802 | | Short-term investments | $427,855 | $386,183 | | **Total Current Assets** | **$485,646** | **$446,426** | | **Total Assets** | **$494,737** | **$456,306** | | **Liabilities & Equity** | | | | Total Current Liabilities | $23,899 | $24,057 | | **Total Liabilities** | **$35,059** | **$36,028** | | **Total Stockholders' Equity** | **$459,678** | **$420,278** | Condensed Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $28,182 | $24,258 | $53,374 | $45,171 | | General and administrative | $11,821 | $11,075 | $23,195 | $22,944 | | **Total operating expenses** | **$40,003** | **$35,333** | **$76,569** | **$68,115** | | **Net Loss** | **$(37,174)** | **$(34,769)** | **$(71,243)** | **$(67,222)** | | Net loss per share, basic and diluted | $(0.53) | $(0.52) | $(1.03) | $(1.01) | Condensed Statements of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(61,489) | $(62,522) | | Net cash (used in) provided by investing activities | $(35,197) | $8,135 | | Net cash provided by financing activities | $94,008 | $2,972 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(2,678)** | **$(51,415)** | - In June 2023, the company completed a public offering, raising net proceeds of approximately **$93.6 million** after expenses[50](index=50&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) Management highlights the company's clinical-stage pipeline, increased R&D expenses, and strengthened liquidity from a $93.6 million offering, projecting funding sufficiency until mid-2026 - The company's pipeline includes three clinical-stage product candidates: **Ziftomenib** (AML), **Tipifarnib** (HNSCC), and **KO-2806** (advanced solid tumors)[58](index=58&type=chunk)[59](index=59&type=chunk)[69](index=69&type=chunk) Research and Development Expense Breakdown (in thousands) | Expense Category | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Ziftomenib-related costs | $14,794 | $11,357 | $3,437 | | Tipifarnib-related costs | $7,595 | $10,093 | $(2,498) | | KO-2806-related costs | $4,772 | $2,017 | $2,755 | | **Total R&D Expenses** | **$53,374** | **$45,171** | **$8,203** | - As of June 30, 2023, the company held **$477.0 million** in cash, cash equivalents, and short-term investments, projected to fund operations until mid-2026[99](index=99&type=chunk) - Additional capital sources include a **$125.0 million** term loan facility (with **$10.0 million** drawn) and an unutilized **$150.0 million** at-the-market (ATM) facility[94](index=94&type=chunk)[97](index=97&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks are interest rate fluctuations affecting its investment portfolio and variable-rate debt, while inflation is not considered to have a material impact - The company faces interest rate risk from its investment portfolio and variable-rate term loans[111](index=111&type=chunk)[112](index=112&type=chunk) - Management believes inflation has not materially affected the company's business or financial results[113](index=113&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Disclosure controls and procedures were deemed effective as of the end of the reporting quarter[115](index=115&type=chunk) - No material changes to internal control over financial reporting were identified during the most recent quarter[116](index=116&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=25&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 financial position or operations - The company is not a party to any material legal proceedings as of the filing date[118](index=118&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including dependency on ziftomenib's clinical success, the high cost and uncertainty of drug development, the need for additional capital, reliance on third parties, and various operational and market challenges - **Development & Regulatory Risks:** The company's success heavily relies on ziftomenib, with drug development being a lengthy, expensive, and uncertain process prone to adverse events that could hinder approval[121](index=121&type=chunk)[137](index=137&type=chunk)[151](index=151&type=chunk) - **Financial & Capital Risks:** The company has a history of losses, requires substantial additional capital which may cause dilution, and faces financing risks from adverse economic conditions[164](index=164&type=chunk)[173](index=173&type=chunk)[178](index=178&type=chunk) - **Operational & Third-Party Risks:** Reliance on third-party contractors for clinical trials and manufacturing, along with collaborators for combination therapies, introduces risks of delays and quality issues[146](index=146&type=chunk)[181](index=181&type=chunk)[189](index=189&type=chunk) - **Commercial & Market Risks:** Approved products may not gain market acceptance, and the company faces intense competition and uncertainties regarding insurance coverage and reimbursement[273](index=273&type=chunk)[277](index=277&type=chunk)[281](index=281&type=chunk) - **Intellectual Property Risks:** Successful commercialization hinges on robust IP protection, with the company relying on licensors to maintain patents for key products like tipifarnib[238](index=238&type=chunk)[248](index=248&type=chunk) [Exhibits](index=72&type=section&id=Item%206.%20Exhibits) This section indexes all exhibits filed with the Form 10-Q, including corporate governance documents, equity plans, and Sarbanes-Oxley Act certifications - Key exhibits include the Amended and Restated Non-Employee Director Compensation Policy, 2014 Equity Incentive Plan forms, and SOX Sections 302 and 906 certifications from the Principal Executive and Financial Officer[340](index=340&type=chunk)

Financial Data and Key Metrics Changes - As of June 30, 2023, the company had cash, cash equivalents, and short-term investments of $477 million, an increase from $438 million as of December 31, 2022, which includes net proceeds of approximately $94 million from a public offering completed in June 2023 [15] - The net loss for the second quarter of 2023 was $37.2 million compared to a net loss of $34.8 million for the same period in 2022, with general and administrative expenses rising to $11.8 million from $11.1 million year-over-year [34] Business Line Data and Key Metrics Changes - The company reported a complete remission (CR) rate of 35% and an overall response rate of 45% in patients with NPM1-mutant acute myeloid leukemia (AML) treated with ziftomenib [3] - The median duration of response for all NPM1-mutant patients was 8.2 months, with a median follow-up of 8.8 months [9] Market Data and Key Metrics Changes - NPM1-mutant AML accounts for approximately 30% of new AML cases annually, representing a significant unmet medical need with no approved targeted therapies [4] - Head and neck cancer is the seventh most common cancer worldwide, with a significant unmet medical need for approved small molecule targeted therapies [5] Company Strategy and Development Direction - The company aims to establish ziftomenib as a foundational therapy that can be combined safely with various commonly used regimens, prioritizing combinations that represent the greatest unmet medical need and potential commercial value [142] - The company is evaluating the combination of tipifarnib and alpelisib in head and neck squamous cell carcinoma, with plans to initiate dose expansion in mid-2024 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the enrollment in the Phase 2 registration-directed trial of ziftomenib, noting that it continues to outperform projections due to strong interest and activity in patients who failed prior treatments [10][19] - Management believes that ziftomenib is well-positioned for the maintenance setting, with a favorable safety profile and no evidence of drug-induced myelosuppression [21][62] Other Important Information - The company plans to begin a post-transplant maintenance program for ziftomenib in the first quarter of 2024 [11] - The company has received FDA clearance for the investigational new drug application for KO-2806 for the treatment of advanced solid tumors, with plans to evaluate its safety and tolerability in a Phase 1 dose escalation study [14] Q&A Session Summary Question: Can you provide more details on enrollment progress for ziftomenib? - Management indicated that they anticipate full enrollment of 85 patients in the study by mid-next year, noting that enrollment is ahead of projections due to physician excitement and the data itself [37][90] Question: What are the expectations for initial data from the combination trial? - Management expects to have preliminary data from the COMET-007 study in the fourth quarter of 2023 or the first quarter of 2024, emphasizing the importance of gathering sufficient data before making meaningful conclusions [137][92] Question: How does the company view resistance mutations in the maintenance setting for ziftomenib? - Management does not believe resistance mutations will significantly impact the use of ziftomenib in the maintenance setting, citing a low rate of resistance mutations observed in their studies [61][62] Question: What is the strategic rationale for starting with renal cell carcinoma (RCC)? - Management explained that RCC is a more mature space with a clear understanding of the landscape, and they have conducted market research to inform their strategy [106] Question: Are there discussions with companies marketing approved drugs for combination therapies? - Management confirmed that they are exploring clinical collaboration or supply agreements to mitigate costs and expedite patient enrollment [121]

Ziftomenib (Menin Inhibitor) - Ziftomenib targets MENIN-KMT2A/MLL in acute leukemias [4] - Phase 1/2 clinical trial KOMET-001 is evaluating Ziftomenib in patients with NPM1 mutations (NPM1-m) and KMT2A rearrangements (KMT2A-r) [10] - In Phase 1a + 1b trials, the CR rate for NPM1-m patients at 600 mg was 30% (6/20), and the ORR was 40% (8/20) [14] - Ziftomenib monotherapy shows optimal clinical activity at the 600 mg daily dose [136] - Kura plans to initiate a Phase 1 combination trial of Ziftomenib (KOMET-007) with standards of care in patients with NPM1-mutant or KMT2A-rearranged AML [50] Tipifarnib & KO-2806 (Farnesyl Transferase Inhibitors) - Kura is developing next-generation FTI KO-2806 with improved potency, pharmacokinetic and physicochemical properties [77, 78] - The FDA cleared the IND application for KO-2806, and Kura is on track to initiate a Phase 1 study in 2H 2023 [94] - Kura is conducting a Phase 1/2 combination trial (KURRENT-HN) of Tipifarnib with Alpelisib for HNSCC patients with PIK3CA mutation and/or amplification [56] - Preclinical data supports the potential of Tipifarnib to prevent emergence of resistance to targeted therapies [105] Financial Highlights - Kura had $406 million in cash as of March 31, 2023 [96]

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 ...