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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 ...
Kura Oncology(KURA) - 2022 Q3 - Earnings Call Transcript
2022-11-05 14:35
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 ...
Kura Oncology(KURA) - 2022 Q3 - Quarterly Report
2022-11-03 13:17
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(KURA) - 2022 Q2 - Earnings Call Transcript
2022-08-03 23:41
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 ...
Kura Oncology(KURA) - 2022 Q2 - Quarterly Report
2022-08-03 20:12
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].
Kura Oncology(KURA) - 2022 Q1 - Earnings Call Presentation
2022-05-06 11:26
......... 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 ...
Kura Oncology(KURA) - 2022 Q1 - Earnings Call Transcript
2022-05-05 00:22
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]
Kura Oncology(KURA) - 2022 Q1 - Quarterly Report
2022-05-04 20:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-37620 KURA ONCOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 61-1547851 12730 Hi ...
Kura Oncology (KURA) Investor Presentation - Slideshow
2022-02-25 16:16
DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER ......... Corporate Presentation – February 2022 Forward-Looking Statements This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, tipifarnib and KO-2806, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus c ...
Kura Oncology(KURA) - 2021 Q4 - Earnings Call Transcript
2022-02-25 02:06
Kura Oncology, Inc. (NASDAQ:KURA) Q4 2021 Earnings Conference Call February 24, 2022 4:30 PM ET Company Participants Troy Wilson – Chairman, Chief Executive Officer & President Tom Doyle – Senior Vice President of Finance and Accounting Pete De Spain – Vice President, Investor Relations & Corporate Communications Conference Call Participants Jonathan Chang – SVB Leerink Peter Lawson – Barclays Bank Tiago Fauth – Crédit Suisse Ren Benjamin – JMP Securities Roger Song – Jefferies Phil Nadeau – Cowen and Compa ...