– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses – – Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 – SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced clearance by the U.S. Foo ...

SAN DIEGO, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that it will report second quarter 2024 financial results after the close of U.S. financial markets on Thursday, August 8, 2024. Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate u ...

– Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases – "Despite the introduction of multiple options for the treatment of type 2 diabetes, a significant unmet need exists as a large proportion of patients do not achieve glycemic control," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are encouraged by these preclinical data for ziftomenib in diabetes, which demonstrate the potential for menin inhibitors t ...

– Kura advancing multiple, next-generation menin inhibitor drug candidates targeting diabetes and other metabolic diseases – "Despite the introduction of multiple options for the treatment of type 2 diabetes, a significant unmet need exists as a large proportion of patients do not achieve glycemic control," said Francis Burrows, Ph.D., Senior Vice President, Translational Research. "We are encouraged by these preclinical data for ziftomenib in diabetes, which demonstrate the potential for menin inhibitors t ...

Company Overview - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [7] - The company's lead investigational drug, ziftomenib (KO-539), is a menin inhibitor targeting relapsed or refractory NPM1-mutant acute myeloid leukemia (AML) [5][7] Clinical Trial Progress - Kura has completed enrollment of 85 patients in the Phase 2 portion of the KOMET-001 trial in under 16 months [1] - Topline data from the trial is expected to be reported in early 2025 [1][2] - The trial aims to assess the clinical activity, safety, and tolerability of ziftomenib, with a primary endpoint of complete response [2] Breakthrough Therapy Designation - Ziftomenib has received Breakthrough Therapy Designation from the FDA, which facilitates expedited review for its potential as an innovative treatment for R/R NPM1-mutant AML [2][5] - This designation underscores the urgent need for effective treatment options in AML, particularly for patients with NPM1 mutations, which account for approximately 30% of new AML cases annually [3][4] Market Need and Patient Prognosis - NPM1-mutant AML has a high unmet medical need, with no approved targeted therapies currently available [3][4] - Patients with R/R NPM1-mutant AML have poor survival outcomes, with only 30% overall survival at 12 months in the R/R setting [4] - The median overall survival for patients with NPM1-m AML is approximately 7.8 months in the second line, 5.3 months in the third line, and 3.5 months following the fourth line of treatment [4] Ziftomenib's Clinical Profile - In the Phase 1 study, ziftomenib demonstrated a favorable safety profile and a 35% complete remission rate at the recommended Phase 2 dose of 600 mg [5] - The drug is designed to be taken once daily and targets the menin-KMT2A/MLL protein-protein interaction [5][6]

Financial Data and Key Metrics Changes - Research and development expenses for Q1 2024 were $36.3 million, up from $25.2 million in Q1 2023, primarily due to increased clinical trial costs related to ziftomenib and KO-2806 programs [28] - General and administrative expenses for Q1 2024 were $18.2 million compared to $11.4 million in Q1 2023 [51] - Net loss for Q1 2024 was $49.5 million, reflecting an increase from the previous year's loss [51] Business Line Data and Key Metrics Changes - Ziftomenib showed a 53% overall response rate among 15 relapsed refractory patients, with a 40% overall response rate among 10 patients who had prior venetoclax treatment [4] - The complete remission rate among nine menin inhibitor naive patients was 56% [4] - The company is on track to complete enrollment of 85 patients in the KOMET-001 trial by mid-2024 [10][23] Market Data and Key Metrics Changes - The FDA granted Breakthrough Therapy Designation for ziftomenib, indicating its potential as an innovative treatment for patients with NPM1-mutant AML [3] - The company is evaluating ziftomenib in combination with current standards of care, including venetoclax/azacitidine and cytarabine plus daunorubicin [23] Company Strategy and Development Direction - The company aims to identify the recommended Phase II dose of ziftomenib in combination with venetoclax and azacitidine by mid-2024 [10] - There is a focus on developing KO-2806 as a next-generation farnesyl transferase inhibitor, with plans to evaluate it in combination with other targeted therapies [26][50] - The company is also working towards an investigational new drug application for ziftomenib in solid tumor indications in the second half of 2024 [10][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing dialogue with the FDA and the potential for accelerated timelines due to the Breakthrough Therapy Designation [12][32] - The company is optimistic about the enrollment rates across different cohorts and believes that ziftomenib has the potential to be a best-in-class menin inhibitor [90] - Management highlighted the importance of safety and tolerability in ongoing trials, noting no significant toxicities reported thus far [47][74] Other Important Information - The company is preparing to share preclinical data supporting the use of ziftomenib in solid tumors at a medical meeting later this year [49] - The company is assessing the safety and tolerability of ziftomenib in post-transplant maintenance settings [78] Q&A Session Summary Question: What are the implications of ziftomenib receiving Breakthrough Therapy Designation? - Management indicated that the designation validates the unmet need for NPM1-mutant AML and may accelerate the approval process [54][91] Question: Can you provide details on the patients who have remained in the trial? - Management clarified that as of the January data cutoff, 16 of 20 patients remained in the study, with no significant toxicities reported [36][60] Question: What is the status of the post-transplant program? - The post-transplant program is in the hands of investigators and is currently in the study startup phase [120] Question: When can we expect data from the KOMET-001 study? - Management stated that data will be available after completing enrollment and cleaning the data, with no specific timeline provided yet [108] Question: Are there plans for additional studies with KO-2806? - Management confirmed that there is a rationale for combining KO-2806 with other drug candidates, and they are exploring various options [109][130]

SAN DIEGO, May 03, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the "Company") (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on May 1, 2024, the Compensation Committee of the Company's Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 67,950 shares of common stock to six (6) new employees under the Company's 20 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20%28unaudited%29) Kura Oncology presents its unaudited condensed financial statements for Q1 2024, including balance sheets, operations, equity, cash flows, and accompanying accounting notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) - Total assets increased by **23.4%** from **$448.9 million** at December 31, 2023, to **$553.9 million** at March 31, 2024, primarily driven by an increase in short-term investments[9](index=9&type=chunk) - Total liabilities decreased by **5.5%** from **$51.7 million** to **$48.8 million**, while total stockholders' equity increased by **27.1%** from **$397.3 million** to **$505.1 million**[9](index=9&type=chunk) | Metric (in thousands) | March 31, 2024 | December 31, 2023 | Change (%) | | :-------------------- | :------------- | :---------------- | :--------- | | Total Assets | $553,908 | $448,935 | 23.4% | | Total Liabilities | $48,824 | $51,662 | -5.5% | | Total Stockholders' Equity | $505,084 | $397,273 | 27.1% | | Cash and cash equivalents | $41,506 | $37,318 | 11.2% | | Short-term investments | $485,616 | $386,639 | 25.6% | | Accumulated deficit | $(770,964) | $(721,439) | -6.9% | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) - Net loss increased by **45.4%** to **$49.5 million** for the three months ended March 31, 2024, compared to **$34.1 million** for the same period in 2023[11](index=11&type=chunk) - Research and development expenses increased by **43.9%** to **$36.3 million**, and general and administrative expenses increased by **59.9%** to **$18.2 million**[11](index=11&type=chunk) | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (%) | | :-------------------- | :-------------------------------- | :-------------------------------- | :--------- | | Research and development | $36,268 | $25,192 | 43.9% | | General and administrative | $18,184 | $11,374 | 59.9% | | Total operating expenses | $54,452 | $36,566 | 48.9% | | Interest and other income, net | $5,325 | $2,861 | 86.1% | | Net Loss | $(49,525) | $(34,069) | 45.4% | | Net loss per share, basic and diluted | $(0.59) | $(0.50) | 18.0% | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) - Total stockholders' equity increased from **$397.3 million** at December 31, 2023, to **$505.1 million** at March 31, 2024[14](index=14&type=chunk) - This increase was primarily driven by **$122.7 million** from the issuance of pre-funded warrants and **$23.1 million** from common stock issuance, net of offering costs, and **$8.5 million** in share-based compensation expense[14](index=14&type=chunk) | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Common Stock Shares Outstanding | 76,181 | 74,350 | | Additional Paid-In Capital | $1,276,856 | $1,119,976 | | Accumulated Deficit | $(770,964) | $(721,439) | | Total Stockholders' Equity | $505,084 | $397,273 | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) - Net cash used in operating activities increased to **$48.8 million** for the three months ended March 31, 2024, from **$35.9 million** in the prior year[16](index=16&type=chunk)[100](index=100&type=chunk) - Net cash used in investing activities was **$95.3 million** in Q1 2024, a significant change from **$11.1 million** provided in Q1 2023, primarily due to increased purchases of marketable securities[16](index=16&type=chunk)[101](index=101&type=chunk) - Net cash provided by financing activities was **$148.4 million** in Q1 2024, mainly from the January 2024 private placement[16](index=16&type=chunk)[102](index=102&type=chunk) | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :-------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(48,844) | $(35,872) | $(12,972) |\n| Net cash (used in) provided by investing activities | $(95,337) | $11,129 | $(106,466) |\n| Net cash provided by financing activities | $148,369 | $0 | $148,369 |\n| Net increase (decrease) in cash and cash equivalents | $4,188 | $(24,743) | $28,931 |\n| Cash and cash equivalents at end of period | $41,506 | $27,059 | $14,447 | [Notes to Condensed Financial Statements (unaudited)](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20%28unaudited%29) These notes detail Kura Oncology's financial statements, covering organization, accounting policies, investments, fair value, balance sheet items, leases, equity, and share-based compensation [Note 1. Organization and Basis of Presentation](index=7&type=section&id=Note%201.%20Organization%20and%20Basis%20of%20Presentation) - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with product candidates ziftomenib, tipifarnib, and KO-2806 in clinical trials[19](index=19&type=chunk) - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP for interim financial information and reflect normal recurring adjustments[21](index=21&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=7&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - Reclassified prior period restricted cash balance of approximately **$0.2 million** to other long-term assets[23](index=23&type=chunk) - Recognized **$2.8 million** of employee retention credits for the three months ended March 31, 2023, included within prepaid expenses and other current assets as of March 31, 2024[24](index=24&type=chunk) - No material impact is expected from recently issued accounting pronouncements on the unaudited condensed financial statements[29](index=29&type=chunk) [Note 3. Investments](index=9&type=section&id=Note%203.%20Investments) - The company invests in available-for-sale securities, including U.S. Treasury securities, corporate debt securities, money market funds, non-U.S. government debt securities, and U.S. Agency bonds[30](index=30&type=chunk) - Total investments (cash equivalents + short-term investments) increased from **$400.2 million** at December 31, 2023, to **$516.4 million** at March 31, 2024[30](index=30&type=chunk) | Investment Type (in thousands) | March 31, 2024 Fair Value | December 31, 2023 Fair Value | | :----------------------------- | :------------------------ | :--------------------------- | | Money market funds | $22,800 | $13,590 | | U.S. Treasury securities | $438,783 | $300,214 | | Corporate debt securities | $39,901 | $63,770 | | Non-U.S. government debt securities | $14,894 | $14,727 | | U.S. Agency bonds | $0 | $7,928 | | Total | $516,378 | $400,229 | [Note 4. Fair Value Measurements](index=10&type=section&id=Note%204.%20Fair%20Value%20Measurements) - Cash equivalents and U.S. Treasury securities are measured at fair value using **Level 1 inputs**[34](index=34&type=chunk)[35](index=35&type=chunk) - Corporate debt securities, non-U.S. government debt securities, and U.S. Agency bonds are measured at fair value using **Level 2 inputs**[34](index=34&type=chunk)[35](index=35&type=chunk) | Investment Type (in thousands) | March 31, 2024 Total Fair Value | March 31, 2024 Level 1 | March 31, 2024 Level 2 | | :----------------------------- | :------------------------------ | :--------------------- | :--------------------- | | Cash equivalents | $30,762 | $30,762 | $0 | | Short-term investments | $485,616 | $430,821 | $54,795 | | Total | $516,378 | $461,583 | $54,795 | [Note 5. Balance Sheet Detail](index=11&type=section&id=Note%205.%20Balance%20Sheet%20Detail) - Property and equipment, net, decreased from **$1.9 million** at December 31, 2023, to **$1.7 million** at March 31, 2024[36](index=36&type=chunk) - Accounts payable increased significantly from **$2.3 million** to **$7.5 million**, while accrued compensation and benefits decreased from **$13.2 million** to **$6.1 million**[36](index=36&type=chunk) | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Property and equipment, net | $1,709 | $1,859 | | Accounts payable | $7,529 | $2,300 | | Accrued clinical trial R&D expenses | $7,381 | $7,737 | | Accrued other R&D expenses | $6,262 | $9,265 | | Accrued compensation and benefits | $6,058 | $13,153 | [Note 6. Leases](index=11&type=section&id=Note%206.%20Leases) - The company has three operating leases for administrative and R&D office and lab space in San Diego and Boston, expiring between August 2025 and July 2031[37](index=37&type=chunk) - As of March 31, 2024, the weighted-average discount rate was **10.6%** and the weighted-average remaining lease term was **6.1 years**[41](index=41&type=chunk) | Year Ending December 31, | Total Lease Payments (in thousands) | | :----------------------- | :---------------------------------- | | 2024 (remaining) | $1,081 | | 2025 | $1,964 | | 2026 | $1,344 | | 2027 | $1,371 | | 2028 | $1,398 | | Thereafter | $3,740 | | Total lease payments | $10,898 | | Less: imputed interest | $(3,304) | | Total operating lease liabilities | $7,594 | [Note 7. Stockholders' Equity](index=13&type=section&id=Note%207.%20Stockholders%27%20Equity) - On January 26, 2024, the company completed a private placement, selling common stock and pre-funded warrants, generating approximately **$145.8 million** in net proceeds[42](index=42&type=chunk) - Proceeds from the private placement were allocated between common stock and pre-funded warrants based on their relative fair value[42](index=42&type=chunk) [Note 8. Share-Based Compensation](index=13&type=section&id=Note%208.%20Share-Based%20Compensation) - Total share-based compensation expense increased by **24.5%** to **$8.5 million** for the three months ended March 31, 2024, compared to **$6.8 million** in 2023[43](index=43&type=chunk) - Unrecognized estimated compensation expense related to stock options and restricted stock units was approximately **$49.4 million** and **$16.9 million**, respectively, as of March 31, 2024[43](index=43&type=chunk) | Expense Type (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (%) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :--------- | | Research and development | $3,885 | $3,073 | 26.4% | | General and administrative | $4,627 | $3,765 | 23.9% | | Total share-based compensation expense | $8,512 | $6,838 | 24.5% | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews Kura Oncology's business, product candidates, financial condition, operations, liquidity, and capital resources for Q1 2024 versus Q1 2023 [Overview](index=14&type=section&id=Overview) Kura Oncology is a clinical-stage biopharmaceutical company developing precision cancer medicines, with global commercial rights to its ziftomenib, tipifarnib, and KO-2806 programs - Kura Oncology, Inc. is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer[48](index=48&type=chunk) - The company is conducting clinical trials of three product candidates: ziftomenib, tipifarnib and KO-2806, and owns global commercial rights to all its programs[48](index=48&type=chunk) [Ziftomenib](index=14&type=section&id=Ziftomenib) - Ziftomenib, a menin-KMT2A inhibitor for AML, received **Orphan Drug Designation** in July 2019 and **Breakthrough Therapy Designation** for relapsed or refractory NPM1-mutant AML in April 2024[50](index=50&type=chunk)[57](index=57&type=chunk) - The KOMET-001 Phase 1b trial demonstrated a **35% complete remission (CR) rate** in NPM1-mutant AML patients treated at the 600 mg recommended Phase 2 dose (RP2D), with durable remissions observed in patients with co-mutations[52](index=52&type=chunk)[53](index=53&type=chunk) - Enrollment in the Phase 2 registration-directed portion of KOMET-001 for relapsed or refractory NPM1-mutant AML is outperforming projections and is expected to complete by **mid-2024**[56](index=56&type=chunk) - Preliminary data from the KOMET-007 study showed a **100% CR rate** in newly diagnosed AML patients treated with ziftomenib and 7+3, and a **53% overall response rate (ORR)** in relapsed or refractory patients treated with ziftomenib and venetoclax/azacitidine[61](index=61&type=chunk) - The company initiated the KOMET-008 study in February 2024 to evaluate ziftomenib in combination with gilteritinib or FLAG-IDA/LDAC in relapsed or refractory NPM1-mutant or KMT2A-rearranged AML[63](index=63&type=chunk) - A clinical collaboration with The Leukemia & Lymphoma Society (LLS) was announced to evaluate ziftomenib in pediatric patients with acute leukemias[65](index=65&type=chunk) [Tipifarnib](index=17&type=section&id=Tipifarnib) - Tipifarnib, a farnesyl transferase inhibitor (FTI), was granted **Breakthrough Therapy Designation** by the FDA in February 2021 for recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC) with high variant allele frequency[67](index=67&type=chunk)[68](index=68&type=chunk) - The KURRENT-HN trial, evaluating tipifarnib in combination with alpelisib for HNSCC, is ongoing, with enrollment of two expansion cohorts expected to complete by the **end of 2024**[69](index=69&type=chunk) - Data from the KURRENT-HN trial is anticipated to be presented at a medical meeting in the **first half of 2025**[69](index=69&type=chunk) [KO-2806](index=19&type=section&id=KO-2806) - KO-2806, a next-generation FTI, received FDA clearance for its IND for the treatment of advanced solid tumors in **January 2023**[70](index=70&type=chunk) - Preclinical data supports the development of KO-2806 in combination with TKIs in clear cell renal cell carcinoma (ccRCC) and KRAS G12C inhibitors in non-small cell lung cancer (NSCLC), demonstrating enhanced antitumor activity and tumor regressions[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - The FIT-001 Phase 1 trial is evaluating KO-2806 as monotherapy and in combination with cabozantinib in ccRCC and adagrasib in KRAS G12C-mutant NSCLC[75](index=75&type=chunk) [Liquidity Overview](index=20&type=section&id=Liquidity%20Overview) - As of March 31, 2024, the company had cash, cash equivalents, and short-term investments totaling **$527.1 million**[76](index=76&type=chunk) - Net proceeds of approximately **$145.8 million** were received from a private placement completed on January 26, 2024[77](index=77&type=chunk) - The company has an At-The-Market (ATM) Facility for up to **$150.0 million**, under which no shares have been sold to date[79](index=79&type=chunk) - A loan agreement provides for up to **$125.0 million** in term loans, with **$10.0 million** borrowed from Tranche 1; the draw period for Tranche 2 expired without additional drawdown[80](index=80&type=chunk) [Financial Operations Overview](index=20&type=section&id=Financial%20Operations%20Overview) This section outlines Kura Oncology's financial policies, including expensing R&D costs, general and administrative expenses, and income tax approach given historical net losses - The company focuses on research and development of its pipeline programs, expensing all associated costs as incurred[81](index=81&type=chunk) - General and administrative expenses primarily consist of personnel costs, patent portfolio maintenance, professional services, and pre-commercial planning expenses[83](index=83&type=chunk) - The company has incurred net losses since inception and has not recorded any U.S. federal or state income tax benefits due to valuation allowances[85](index=85&type=chunk) [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses) - Research and development expenses include salaries, benefits, share-based compensation, clinical trial costs, manufacturing costs for non-commercial products, and fees paid to external service providers[81](index=81&type=chunk) - All research and development costs are charged to expense as incurred, including payments for in-licensed technology with no alternative future uses[81](index=81&type=chunk) [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses) - General and administrative expenses primarily consist of personnel costs for executive, finance, business development, and support functions[83](index=83&type=chunk) - Other significant expenses include costs for patent portfolio, professional services (audit, legal, pre-commercial planning), investor relations, and corporate activities[83](index=83&type=chunk) [Other Income, Net](index=22&type=section&id=Other%20Income,%20Net) - Other income, net, primarily consists of interest income and interest expense[84](index=84&type=chunk) [Income Taxes](index=22&type=section&id=Income%20Taxes) - The company has incurred net losses and has not recorded any U.S. federal or state income tax benefits for these losses, as they have been offset by valuation allowances[85](index=85&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Kura Oncology's net loss significantly increased in Q1 2024 due to higher R&D and G&A expenses, partially offset by increased other income - Net loss increased to **$49.5 million** for the three months ended March 31, 2024, from **$34.1 million** for the same period in 2023[11](index=11&type=chunk)[86](index=86&type=chunk) - Total operating expenses increased by **$17.9 million**, primarily due to higher research and development and general and administrative expenses[11](index=11&type=chunk)[86](index=86&type=chunk) - Other income, net, increased by **$2.4 million**, mainly attributable to an increase in interest income[86](index=86&type=chunk)[89](index=89&type=chunk) [Comparison of the Three Months Ended March 31, 2024 and 2023](index=23&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031,%202024%20and%202023) - Research and development expenses increased by **$11.1 million (43.9%)** to **$36.3 million**, primarily due to increased costs for ziftomenib clinical trials and the KO-2806 Phase 1 trial, partially offset by decreased tipifarnib-related costs[87](index=87&type=chunk) - General and administrative expenses increased by **$6.8 million (59.9%)** to **$18.2 million**, driven by higher personnel costs, professional services, and pre-commercial planning expenses[88](index=88&type=chunk) - Other income, net, increased by **$2.4 million (97.3%)** to **$4.9 million**, primarily due to an increase in interest income[89](index=89&type=chunk) | Expense Category (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change ($) | Change (%) | | :------------------------------ | :-------------------------------- | :-------------------------------- | :--------- | :--------- | | Ziftomenib-related costs | $14,495 | $5,833 | $8,662 | 148.5% | | Tipifarnib-related costs | $1,166 | $4,390 | $(3,224) | -73.4% | | KO-2806-related costs | $3,948 | $2,829 | $1,119 | 39.6% | | Discovery stage program-related costs | $1,468 | $927 | $541 | 58.4% | | Personnel costs and other expenses | $11,306 | $8,140 | $3,166 | 38.9% | | Share-based compensation expense | $3,885 | $3,073 | $812 | 26.4% | | Total R&D expenses | $36,268 | $25,192 | $11,076 | 43.9% | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) - Since inception, operations have been funded primarily through equity and debt financings, resulting in an accumulated deficit of **$771.0 million** as of March 31, 2024[90](index=90&type=chunk)[96](index=96&type=chunk) - Net proceeds of **$145.8 million** were received from a private placement in January 2024, and **$93.6 million** from a public offering in June 2023[91](index=91&type=chunk)[92](index=92&type=chunk) - As of March 31, 2024, cash, cash equivalents, and short-term investments totaled **$527.1 million**, which is believed to be sufficient to fund operating expenses into **2027**[97](index=97&type=chunk) - Net cash used in operating activities increased by **$13.0 million** year-over-year to **$48.8 million** for the three months ended March 31, 2024[100](index=100&type=chunk) - Net cash used in investing activities was **$95.3 million** for Q1 2024, a significant change from **$11.1 million** provided in Q1 2023, primarily due to larger purchases of marketable securities[101](index=101&type=chunk) - Net cash provided by financing activities was **$148.4 million** for Q1 2024, primarily from the January 2024 private placement[102](index=102&type=chunk) [Contractual Obligations and Commitments](index=27&type=section&id=Contractual%20Obligations%20and%20Commitments) - The company has **$10.0 million** in Term Loans under a Loan Agreement, subject to variable interest rates and an end-of-term fee[103](index=103&type=chunk) - Leases office and laboratory space under non-cancelable operating leases, with total operating lease liabilities of **$7.6 million** as of March 31, 2024[104](index=104&type=chunk)[39](index=39&type=chunk) - May be required to pay up to approximately **$80.0 million** in milestone payments, plus sales royalties, under in-license agreements if regulatory and commercial milestones are achieved[106](index=106&type=chunk) [Critical Accounting Policies and Management Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Management%20Estimates) - There have been no material changes to the company's critical accounting policies and estimates from the information provided in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023[108](index=108&type=chunk) - The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section details the company's market risk exposure, focusing on interest rate risk for investments and loans, and inflation risk, with no material impact from a 10% rate change [Interest Rate Risk](index=27&type=section&id=Interest%20Rate%20Risk) - The company is exposed to interest rate risk primarily through its cash, cash equivalents, short-term investments (U.S. Treasury, corporate debt, money market funds, non-U.S. government debt, U.S. Agency bonds) and Term Loans[109](index=109&type=chunk)[110](index=110&type=chunk) - A hypothetical **10.0%** change in interest rates on March 31, 2024, would not have a material effect on the fair value of the investment portfolio or interest expense[109](index=109&type=chunk)[110](index=110&type=chunk) [Inflation Risk](index=29&type=section&id=Inflation%20Risk) - Inflation generally affects the company by increasing its clinical trial costs[111](index=111&type=chunk) - The company does not believe that inflation has had a material effect on its business, financial condition, or results of operations during any periods presented[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed the effectiveness of disclosure controls and procedures as of March 31, 2024, with no material changes in internal control over financial reporting identified [Changes in Internal Control over Financial Reporting](index=29&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - The company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2024[113](index=113&type=chunk) - No changes in internal control over financial reporting were identified during the quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[114](index=114&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) Kura Oncology is not currently a party to any legal proceedings that, in management's opinion, would have a material adverse effect on its results of operations or financial position - 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[117](index=117&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section details significant investment risks, including dependence on product candidates, drug development uncertainty, financial needs, third-party reliance, regulatory hurdles, intellectual property, commercialization, and operational challenges [Risk Factor Summary](index=30&type=section&id=Risk%20Factor%20Summary) - The company is highly dependent on the success of its lead product candidate, ziftomenib, which is still in clinical development and may not receive regulatory approval[118](index=118&type=chunk)[120](index=120&type=chunk) - Clinical drug development is a lengthy, expensive process with an uncertain outcome, and preclinical/early clinical results may not predict subsequent trial outcomes[118](index=118&type=chunk)[136](index=136&type=chunk) - The company expects to incur losses for several years, may never achieve profitability, and will require substantial additional capital[118](index=118&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[167](index=167&type=chunk) - Reliance on third-party contractors for clinical trials and manufacturing increases the risk of unsatisfactory performance or delays[118](index=118&type=chunk)[174](index=174&type=chunk)[182](index=182&type=chunk) - Failure to obtain or maintain intellectual property protection for product candidates could impair commercialization efforts[118](index=118&type=chunk)[229](index=229&type=chunk) - Product candidates may cause serious adverse events or unacceptable side effects, potentially delaying, limiting, or preventing their development[118](index=118&type=chunk)[147](index=147&type=chunk) - Failure to develop, validate, and obtain regulatory approval for a diagnostic testing platform could harm the drug development strategy[118](index=118&type=chunk)[154](index=154&type=chunk) [Risks Related to the Discovery and Development of Our Product Candidates](index=31&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) - Future success is highly dependent on obtaining regulatory approval for and successfully commercializing ziftomenib, with no guarantee of success[120](index=120&type=chunk)[121](index=121&type=chunk) - Clinical trials are lengthy, expensive, and inherently uncertain; preclinical and early clinical results may not be predictive of subsequent clinical trials[136](index=136&type=chunk) - Difficulty in enrolling patients, particularly those with specific genetic alterations, could delay or prevent clinical trials[130](index=130&type=chunk)[131](index=131&type=chunk)[134](index=134&type=chunk) - Product candidates may cause serious adverse events or unacceptable side effects, potentially leading to interruption, delay, or abandonment of development[147](index=147&type=chunk)[148](index=148&type=chunk) - Ziftomenib's on-target differentiation syndrome (DS) was manageable in the KOMET-001 trial, and no DS events were reported in the KOMET-007 trial[149](index=149&type=chunk)[60](index=60&type=chunk) - Failure by the company or its third-party collaborators to develop, validate, and obtain regulatory approval for a diagnostic testing platform could harm the drug development strategy[154](index=154&type=chunk)[156](index=156&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=41&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company expects to incur significant expenses and operating losses for the foreseeable future, with an accumulated deficit of **$771.0 million** as of March 31, 2024[160](index=160&type=chunk)[161](index=161&type=chunk) - Substantial additional funding will be needed for continuing operations, and raising capital may cause dilution to stockholders or restrict operations[167](index=167&type=chunk) - Adverse developments affecting the financial services industry could negatively impact the company's liquidity and financial performance[172](index=172&type=chunk) - As of March 31, 2024, the company had **$527.1 million** in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund operating expenses into **2027**[97](index=97&type=chunk) [Risks Related to Our Dependence on Third Parties](index=45&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) - The company relies on third-party contractors, including CROs, clinical data management organizations, and clinical investigators, to conduct its preclinical development activities and clinical trials, which increases the risk of delays or unsatisfactory performance[174](index=174&type=chunk)[175](index=175&type=chunk)[180](index=180&type=chunk) - Dependence on third parties for the manufacture of product candidates for preclinical, clinical, and commercial supply increases the risk of insufficient quantities, unacceptable cost, or quality issues[182](index=182&type=chunk) - The presence of some manufacturers and suppliers in China exposes the company to potential product supply disruption and increased costs due to geopolitical tensions or trade restrictions[184](index=184&type=chunk) - Failure of contract manufacturers to comply with cGMP regulations or other regulatory requirements could result in sanctions and supply disruptions[186](index=186&type=chunk) [Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters](index=48&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) - Failure or delays in obtaining required regulatory approvals from the FDA, EMA, and other authorities will materially impair the ability to commercialize product candidates and generate revenue[190](index=190&type=chunk)[191](index=191&type=chunk) - Breakthrough Therapy Designation does not guarantee a faster development or regulatory review or approval process, and such designations can be rescinded[197](index=197&type=chunk)[198](index=198&type=chunk) - The company may not obtain orphan drug exclusivity for its product candidates, or it may be lost, which could limit their potential profitability[194](index=194&type=chunk)[195](index=195&type=chunk) - Any product candidate that obtains marketing approval will be subject to extensive post-approval regulatory requirements and could face restrictions or withdrawal from the market if non-compliant[200](index=200&type=chunk)[202](index=202&type=chunk) - Relationships with healthcare professionals, customers, and business operations are subject to applicable fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), transparency laws, privacy laws (e.g., GDPR, CCPA), and other healthcare regulations, which could expose the company to significant penalties[205](index=205&type=chunk)[207](index=207&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[217](index=217&type=chunk) - Recently enacted and future legislation, such as the ACA and IRA, may increase the difficulty and cost of obtaining marketing approval and affect the prices the company may obtain for its products[218](index=218&type=chunk)[222](index=222&type=chunk) [Risks Related to Our Intellectual Property](index=58&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Inability to obtain or maintain sufficiently broad intellectual property protection (patents, trade secrets) for product candidates could allow competitors to develop and commercialize similar products, impairing the company's ability to commercialize its own[229](index=229&type=chunk) - Ziftomenib has issued composition of matter patents in the United States, Europe, China, Japan, and other foreign jurisdictions, but their validity or enforceability is not guaranteed[230](index=230&type=chunk) - Tipifarnib's composition of matter patents expired in 2016; its commercial strategy relies on obtaining method of use and method of treatment patents and non-patent regulatory exclusivity[234](index=234&type=chunk)[235](index=235&type=chunk) - KO-2806 has filed patent applications for composition of matter and methods of use, but there is no guarantee that patents will be granted or provide protection[238](index=238&type=chunk) - Dependence on licensors (University of Michigan, Janssen) to prosecute and maintain patents and patent applications; any failure could adversely impact business and operations[239](index=239&type=chunk) - Breach of license agreements could lead to the loss of critical commercialization rights for product candidates[240](index=240&type=chunk) - Patent terms may be inadequate to protect competitive position for a commercially meaningful length of time due to the lengthy development and regulatory review process[249](index=249&type=chunk) - Intellectual property discovered through government-funded programs may be subject to federal regulations such as 'march-in' rights and a preference for U.S.-based manufacturing companies[259](index=259&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=66&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community, which would impact revenue generation[262](index=262&type=chunk) - The company currently has no sales personnel; inability to establish effective sales capabilities or enter into agreements with third parties could hinder commercialization efforts[263](index=263&type=chunk)[264](index=264&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may develop and commercialize competing products more successfully or rapidly[265](index=265&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk) - Uncertainty regarding insurance coverage and adequate reimbursement for newly approved products and companion diagnostics could limit market access and decrease revenue generation[269](index=269&type=chunk)[274](index=274&type=chunk) - Product liability lawsuits against the company could result in substantial liabilities and limit the commercialization of any products developed[275](index=275&type=chunk) [Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions](index=70&type=section&id=Risks%20Related%20to%20Employee%20Matters,%20Managing%20Growth%20and%20Macroeconomic%20Conditions) - The company is highly dependent on its Chief Executive Officer and other key executives; the ability to attract, retain, and motivate qualified personnel is critical to success[277](index=277&type=chunk)[278](index=278&type=chunk) - Expected significant growth in employees and operations may lead to difficulties in managing growth, potentially disrupting operations and diverting management resources[280](index=280&type=chunk) - Third-party expectations relating to environmental, social, and governance (ESG) factors may impose additional costs and expose the company to new risks, potentially impacting reputation and investment desirability[281](index=281&type=chunk)[283](index=283&type=chunk) - Unfavorable global economic conditions, including those resulting from pandemics, bank failures, interest rate changes, and inflation, could adversely affect the company's ability to raise capital and its supply chain[284](index=284&type=chunk) - Information technology systems and data, both internal and those of third parties, are vulnerable to cyberattacks and system failures, which could lead to disruptions, data loss, regulatory investigations, and financial penalties[286](index=286&type=chunk)[287](index=287&type=chunk)[293](index=293&type=chunk)[295](index=295&type=chunk)[298](index=298&type=chunk) - Operations are vulnerable to interruption by natural disasters, power loss, terrorist activity, and other events beyond control, without adequate business interruption insurance[303](index=303&type=chunk) [Risks Related to Ownership of our Common Stock](index=74&type=section&id=Risks%20Related%20to%20Ownership%20of%20our%20Common%20Stock) - The company's stock price may fluctuate significantly and be volatile due to various factors, including clinical trial results, regulatory decisions, competition, and broader market conditions[305](index=305&type=chunk)[306](index=306&type=chunk) - Sales of large numbers of shares by major stockholders or the resale of shares covered by effective shelf registration statements could adversely affect the market price of common stock and the ability to raise additional equity capital[304](index=304&type=chunk)[310](index=310&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock (e.g., equity incentive plans, outstanding stock options, warrants, pre-funded warrants) could result in dilution to the percentage ownership of existing stockholders[314](index=314&type=chunk)[315](index=315&type=chunk)[319](index=319&type=chunk) - Anti-takeover provisions in the company's charter documents and Delaware law could delay or prevent a change of control, potentially limiting the market price of common stock[320](index=320&type=chunk)[321](index=321&type=chunk) - Exclusive forum provisions in charter documents could limit stockholders' ability to obtain a favorable judicial forum for disputes with the company or its directors, officers, or employees[322](index=322&type=chunk)[325](index=325&type=chunk) [General Risk Factors](index=81&type=section&id=General%20Risk%20Factors) - Inaccurate or unfavorable research published by securities or industry analysts about the company, its business, or market could cause its stock price and trading volume to decline[330](index=330&type=chunk) - Actions by activist stockholders could divert management's attention, incur significant costs, and negatively impact the business strategy and stock price[331](index=331&type=chunk) - Securities class action litigation, common in the biotechnology industry, could be expensive, time-consuming, and a distraction to management[332](index=332&type=chunk) - Employees, independent contractors, and other third parties may engage in misconduct or improper activities, including noncompliance with regulatory standards, leading to potential penalties[333](index=333&type=chunk) - The company is subject to U.S. and foreign export/import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws; violations could result in criminal liability and harm the business[334](index=334&type=chunk) - Changes in tax laws or regulations (e.g., Tax Cuts and Jobs Act, IRA) could adversely affect the business, cash flow, financial condition, or results of operations, including limitations on net operating loss carryforwards[326](index=326&type=chunk)[327](index=327&type=chunk)[328](index=328&type=chunk) - The company does not intend to pay cash dividends on its capital stock in the foreseeable future[329](index=329&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms that there were no unregistered sales of equity securities by Kura Oncology during the three months ended March 31, 2024, other than those previously reported in Current Reports on Form 8-K [Unregistered Sales of Equity Securities](index=82&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities) - There were no unregistered sales of equity securities by the company during the three months ended March 31, 2024, except as previously reported in Current Reports on Form 8-K[335](index=335&type=chunk) [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the 10-Q report, including organizational documents, warrant agreements, certifications, and XBRL-related documents - The exhibits include certifications of the Principal Executive and Financial Officer (Exhibits 31.1, 32.1) pursuant to the Sarbanes-Oxley Act of 2002[337](index=337&type=chunk) - The filing contains Inline XBRL Instance Document, Taxonomy Extension Schema With Embedded Linkbase Documents, and Cover Page Interactive Data File[337](index=337&type=chunk) [Signatures](index=85&type=section&id=Signatures) The report is duly signed on behalf of Kura Oncology, Inc. by Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer (Principal Executive and Financial Officer), on May 2, 2024 - The report was signed by Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer (Principal Executive and Financial Officer) of Kura Oncology, Inc. on May 2, 2024[344](index=344&type=chunk)

Financial Performance - Kura Oncology reported a net loss of $49.5 million for Q1 2024, compared to a net loss of $34.1 million in Q1 2023, reflecting an increase in operating expenses [15]. - Research and development expenses for Q1 2024 were $36.3 million, up from $25.2 million in Q1 2023, while general and administrative expenses rose to $18.2 million from $11.4 million [8]. - As of March 31, 2024, Kura had cash, cash equivalents, and short-term investments totaling $527 million, an increase from $424 million as of December 31, 2023 [17]. - The company expects its cash reserves to fund operations into 2027 based on its current operating plan [8]. Clinical Trials and Developments - The company is on track to complete enrollment of 85 patients in the KOMET-001 trial of ziftomenib for NPM1-mutant R/R AML by mid-2024 [4]. - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed/refractory NPM1-mutant AML, based on data from the ongoing KOMET-001 trial [3]. - In the Phase 1 trial, ziftomenib demonstrated a 35% complete response rate and a 45% overall response rate in heavily pretreated patients with NPM1-mutant AML [4]. - Preliminary data from the KOMET-007 trial showed a 100% complete remission rate in newly diagnosed patients treated with ziftomenib in combination with standard therapies [4]. - Kura plans to initiate a Phase 1b expansion study of ziftomenib in combination with standards of care in the second half of 2024 [8]. - Kura is also advancing KO-2806, with the first patient dosed in a trial for renal cell carcinoma, and plans to dose the first patient in combination with adagrasib for KRASG12C-mutated non-small cell lung cancer by mid-2024 [5].

– Ziftomenib is the first investigational treatment to be granted Breakthrough Therapy Designation for NPM1-mutant AML – – Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024 – SAN DIEGO, April 22, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that its investigational drug, ziftomenib, has been gra ...