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Kura Oncology(KURA) - 2023 Q3 - Earnings Call Presentation
2023-11-03 01:38
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 ...
Kura Oncology(KURA) - 2023 Q3 - Quarterly Report
2023-11-02 20:05
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 ...
Kura Oncology(KURA) - 2023 Q2 - Quarterly Report
2023-08-09 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) 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 June 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 ________ (State or other jurisdiction ...
Kura Oncology(KURA) - 2023 Q2 - Earnings Call Transcript
2023-08-06 14:41
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]
Kura Oncology (KURA) Investor Presentation - Slideshow
2023-05-18 15:25
INVESTMENT HIGHLIGHTS Francis Burrows, Ph.D. Senior Vice President, Translational Research Teresa Bair, J.D. Chief Legal Officer Tom Doyle Senior Vice President, Finance & Accounting Mollie Leoni, M.D. Senior Vice President, Clinical Development Thomas Malley PROGRAM CLINICAL TRIAL PLANNED STUDY STARTUP PHASE 1 REGISTRATION DIRECTED | --- | --- | --- | --- | --- | --- | --- | |-------------|------------------------------------|-------|-------|-----------|-------|-------| | | | | | | | | | | | | | | | | | ZI ...
Kura Oncology(KURA) - 2023 Q1 - Earnings Call Transcript
2023-05-11 02:13
Kura Oncology, Inc. (NASDAQ:KURA) Q1 2023 Earnings Conference Call May 10, 2023 5:00 PM ET Company Participants Pete De Spain - SVP, IR & Corporate Communications Troy Wilson - Chairman, CEO & President Thomas Doyle - SVP, Finance & Accounting Conference Call Participants Jonathan Chang - SVB Securities Roger Song - Jefferies Bradley Canino - Stifel, Nicolaus & Company Li Watsek - Cantor Fitzgerald & Co. Philip Nadeau - TD Cowen Operator Good afternoon, ladies and gentlemen, and welcome to the Q1 2023 Kura ...
Kura Oncology(KURA) - 2023 Q1 - Quarterly Report
2023-05-10 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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) (State or other jurisdiction ...
Kura Oncology(KURA) - 2022 Q4 - Earnings Call Transcript
2023-02-24 03:11
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. ...
Kura Oncology(KURA) - 2022 Q4 - Annual Report
2023-02-23 21:11
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 ...
Kura Oncology (KURA) Investor Presentation - Slideshow
2022-12-02 14:18
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 ...