Business Overview
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. With a focus on targeted therapies and companion diagnostics, Kura Oncology is making significant strides in developing a diverse pipeline of product candidates that aim to improve outcomes for patients with genetically defined cancers.
Kura Oncology was founded in 2014 by a team of experienced pharmaceutical industry veterans, including CEO Troy Wilson, who previously co-founded Wellspring Biosciences and Avidity Biosciences. The company's mission is to harness the power of precision medicine to transform the treatment of cancer. Kura licensed its lead product candidate, ziftomenib, from the University of Michigan in 2014. Ziftomenib is a potent, selective, reversible and oral small molecule inhibitor that blocks the interaction of two proteins, menin and the protein expressed by the KMT2A gene.
In 2019, Kura received orphan drug designation from the FDA for ziftomenib in the treatment of AML, providing important regulatory and financial incentives to support its clinical development. The company then initiated the KOMET-001 clinical trial to evaluate ziftomenib as a monotherapy in relapsed/refractory AML patients.
Kura faced a setback in 2021 when the FDA placed a partial clinical hold on the KOMET-001 trial following a reported serious adverse event potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML. However, the company successfully worked with the FDA to address their concerns, and the partial hold was lifted in early 2022, allowing the trial to resume.
In 2023, Kura reported encouraging preliminary data from the combination arm of the KOMET-007 trial, which is evaluating ziftomenib in combination with standard-of-care therapies in newly diagnosed and relapsed/refractory AML patients. The data showed a favorable safety profile and evidence of clinical activity.
In September 2019, Kura initiated the global KOMET-001 Phase 1/2 clinical trial of ziftomenib in relapsed or refractory AML. The Phase 1a dose-escalation portion of the trial demonstrated a wide therapeutic window and encouraging monotherapy activity in an all-comer population of 30 patients. The Phase 1b dose-validation and dose-expansion portions of the trial, which consisted of two randomized expansion cohorts of NPM1-mutant and KMT2A-rearranged AML patients, further validated the 600mg dose as the recommended Phase 2 dose.
In April 2024, the FDA granted ziftomenib Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory NPM1-mutant AML based on data from the KOMET-001 trial. This designation is intended to expedite the development and review of ziftomenib, recognizing its potential as an innovative medicine for this patient population.
Kura has also initiated a series of studies to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including patients with NPM1-mutant or KMT2A-rearranged AML. The KOMET-007 trial is designed to assess the safety, tolerability and preliminary efficacy of ziftomenib in combination with venetoclax and azacitidine, as well as in combination with cytarabine and daunorubicin, in newly diagnosed or relapsed/refractory NPM1-mutant or KMT2A-rearranged AML patients.
In addition to the menin-KMT2A program, Kura is developing KO-2806, a next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors. The company is currently evaluating KO-2806 as a monotherapy and in combination with other targeted therapies in the FIT-001 Phase 1 trial.
Kura's third product candidate, tipifarnib, is a potent, selective and orally bioavailable FTI that has been previously studied in more than 5,000 cancer patients. The company is currently evaluating the combination of tipifarnib and the PI3 kinase alpha inhibitor alpelisib in patients with HNSCC whose tumors have HRAS overexpression and/or PIK3CA mutation and/or amplification in the KURRENT-HN Phase 1/2 trial.
The company's pipeline consists of small molecule product candidates that target cancer signaling pathways, including ziftomenib, KO-2806, and tipifarnib. Kura has not disclosed any major scandals, short seller reports, or CEO departures.
Financials
As of June 30, 2024, Kura reported cash, cash equivalents and short-term investments of $491.5 million. The company's net loss for the second quarter of 2024 was $50.8 million, compared to a net loss of $37.2 million in the same period of 2023. Research and development expenses for the second quarter of 2024 were $39.7 million, up from $28.2 million in the prior-year period, primarily due to increases in clinical trial costs related to the ziftomenib and KO-2806 programs.
Kura has not generated any revenues from product sales to date, as the company's product candidates are still in various stages of clinical development. The company believes its current cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2027.
For the most recent fiscal year (2023), Kura reported: - Revenue: N/A - Net income: -$152,631,000 - Operating Cash Flow: -$124,824,000 - Free Cash Flow: -$124,992,000
For the most recent quarter (Q2 2024), Kura reported: - Revenue: $0 - Net income: -$50,837,000 - Operating Cash Flow: -$42,530,000 - Free Cash Flow: -$42,546,000
The company does not generate any revenue as it is a clinical-stage biopharmaceutical company that has not yet commercialized any products. The increase in net loss, operating cash outflow, and free cash outflow in Q2 2024 compared to the prior year period was primarily due to increases in research and development expenses related to the company's clinical trial activities.
Research and development expenses were $76.0 million for the six months ended June 30, 2024, up from $53.37 million in the same period of the prior year, reflecting increased costs related to the advancement of its clinical programs. General and administrative expenses were $34.86 million for the six months ended June 30, 2024, up from $23.20 million in the same period of the prior year, due to increases in personnel costs, pre-commercial planning expenses, and non-cash share-based compensation.
Liquidity
Kura Oncology maintains a strong liquidity position with its significant cash reserves. The company's cash, cash equivalents, and short-term investments of $491.5 million as of June 30, 2024, provide a substantial runway for its ongoing clinical development programs and operational expenses. This robust financial position allows Kura to fund its current operating plan into 2027, giving the company ample time to advance its pipeline and potentially reach critical milestones without immediate funding concerns.
Additional liquidity metrics include: - Debt/Equity ratio: 0.043 - Current ratio: 14.94 - Quick ratio: 14.94
In November 2022, the company entered into a loan and security agreement providing for up to $125 million in a series of term loans. Upon entering the agreement, the company borrowed $10 million of an initial $25 million tranche.
Anticipated Milestones
- Present updated data from the KOMET-007 trial of ziftomenib in combination with Ven/Aza and 7+3 at a medical meeting in Q4 2024 - Report topline data from the KOMET-001 registration-directed trial of ziftomenib in NPM1-mutant relapsed/refractory AML in early 2025 - Present preclinical data supporting the opportunity for ziftomenib in GIST at a scientific meeting in H2 2024 - Initiate a proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST in H1 2025 - Nominate a next-generation menin inhibitor development candidate targeting diabetes in early 2025 - Identify the maximum tolerated dose for KO-2806 as a monotherapy in H2 2024 - Complete enrollment of two expansion cohorts in the KURRENT-HN trial and identify the optimal biologically active dose of tipifarnib and alpelisib by the end of 2024 - Present data from the KURRENT-HN trial of tipifarnib in combination with alpelisib in PIK3CA-dependent HNSCC in H1 2025
Risks
Kura Oncology faces several risks common to clinical-stage biotechnology companies, including the uncertainty of clinical trial outcomes, regulatory approval, commercialization, and competition. The company's reliance on third-party manufacturers and service providers for the supply of materials and conduct of clinical trials also introduces risks related to potential disruptions or delays.
Additionally, Kura's success is highly dependent on the continued performance and retention of its key executives and personnel. The company operates in a competitive environment and may face challenges in attracting and retaining skilled employees.
Kura's ability to successfully develop and commercialize its product candidates, as well as its financial position, are also subject to risks related to its ability to raise additional capital as needed to fund its operations.
Industry Trends
The biopharmaceutical industry focused on oncology has seen a compound annual growth rate (CAGR) of approximately 11.5% from 2017 to 2022. This growth trend underscores the increasing demand for innovative cancer treatments and the potential market opportunity for companies like Kura Oncology.
Conclusion
Kura Oncology is a clinical-stage biopharmaceutical company with a diverse pipeline of targeted oncology therapies, led by the lead candidate ziftomenib. The company has made significant progress in advancing its clinical programs, including the recent Breakthrough Therapy Designation granted to ziftomenib for the treatment of relapsed or refractory NPM1-mutant AML.
With a strong financial position, a focus on precision medicine, and a commitment to expanding its pipeline through both internal development and strategic partnerships, Kura Oncology is well-positioned to continue its mission of realizing the promise of targeted therapies for patients with genetically defined cancers.