Kura Oncology Reports Fourth Quarter and Full Year 2021 Financial Results
– Patient enrollment continues in KOMET-001 Phase 1b study of ziftomenib (KO-539) in AML –
– Multiple milestones and data readouts from KOMET-001 expected in 2022 –
– First patients dosed in Phase 1/2 study of tipifarnib plus alpelisib in HNSCC –
– Abstract supporting next-generation FTI program accepted for presentation at AACR –
– Management to host webcast and conference call today at
“We have made meaningful advancements across our programs during the past year, and we begin 2022 with significant momentum, resources and enthusiasm,” said
- Patient enrollment continues in KOMET-001 Phase 1b study of ziftomenib (KO-539) – In
January 2022, Kura received authorization from the U.S. Food and Drug Administration(FDA) to proceed with its KOMET-001 trial of ziftomenib (formerly KO-539) in patients with relapsed or refractory acute myeloid leukemia (AML), following agreement with the FDA on an enhanced mitigation strategy for differentiation syndrome. Differentiation syndrome is known to be an on-target effect associated with a number of therapeutic agents, including menin inhibitors, which may induce differentiation of leukemic blasts. Patients already enrolled in the Phase 1b expansion cohorts were eligible to remain on study during the partial clinical hold and enrollment of new patients has resumed.
- Multiple milestones and data readouts from KOMET-001 expected in 2022 – Kura expects to complete enrollment of 24 patients in the Phase 1b study of ziftomenib by the second quarter of 2022, after which it will assess the patients in each expansion cohort for safety and tolerability, pharmacokinetics and exposure, as well as efficacy. The Company expects to identify the recommended Phase 2 dose for ziftomenib and report top-line data from the Phase 1b study by the third quarter of 2022, with updated data from KOMET-001 reserved for a medical meeting in the fourth quarter of 2022. Meanwhile, Kura continues to add sites in the
U.S.and Europein anticipation of the subsequent Phase 2 registration-enabling portion of KOMET-001.
- First patients dosed in Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC – Last year, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The Company believes this combination has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC. In
December 2021, the first patient was dosed in a Phase 1/2 clinical trial (KURRENT) of tipifarnib in combination with alpelisib. The initial cohort includes patients who have PIK3CA-dependent HNSCC. The Company expects to initiate an HRAS overexpression cohort in KURRENT by the third quarter of 2022.
- Preclinical data supporting next-generation FTI program at AACR – Kura’s next-generation farnesyl transferase inhibitor (FTI) program is designed to target novel farnesylated targets and address large solid tumor indications of high unmet need through combination regimens, with a focus on delaying the onset of drug resistance. An abstract from one of the Company’s academic collaborators, with preclinical data supporting the first opportunity in non-small cell lung cancer (NSCLC), has been accepted for presentation at the upcoming
American Association for Cancer ResearchAnnual Meeting in April 2022. Kura plans to perform initial clinical evaluation with tipifarnib in NSCLC while continuing its IND-enabling studies of KO-2806, the lead development candidate in the Company’s next-generation FTI program.
- Research and development expenses for the fourth quarter of 2021 were
$21.0 million, compared to $17.5 millionfor the fourth quarter of 2020. Research and development expenses for the full year 2021 were $84.7 million, compared to $60.4 millionfor the prior year.
- General and administrative expenses for the fourth quarter of 2021 were
$12.1 million, compared to $8.8 millionfor the fourth quarter of 2020. General and administrative expenses for the full year 2021 were $46.5 million, compared to $31.5 millionfor the prior year.
- Net loss for the fourth quarter of 2021 was
$32.7 million, compared to a net loss of $26.2 millionfor the fourth quarter of 2020. Net loss for the full year 2021 was $130.5 million, compared to a net loss of $89.6 millionfor the prior year. Net loss for the fourth quarter and full year 2021 included non-cash share-based compensation expense of $6.4 millionand $23.6 million, respectively, $3.7 millionand $12.8 millionfor the same periods in 2020.
- Cash, cash equivalents and short-term investments totaled
$518.0 millionas of December 31, 2021, compared with $633.3 millionas of December 31, 2020. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2024.
- Complete enrollment of 24 patients in the KOMET-001 Phase 1b expansion cohorts by the second quarter.
- Identify the recommended Phase 2 dose of ziftomenib (KO-539) and report top-line data from the Phase 1b expansion cohorts by the third quarter.
- Present updated data from KOMET-001 at a medical meeting in the fourth quarter.
- Initiate the HRAS overexpression cohort in the KURRENT trial of tipifarnib plus alpelisib by the third quarter.
- Report preclinical data supporting the use of a FTI to delay the onset of drug resistance in NSCLC in the second quarter.
- Submit an IND application for KO-2806 by the end of the year.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura’s product candidates, ziftomenib, tipifarnib and KO-2806, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, the strength of Kura’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the
|Statements of Operations Data|
|(in thousands, except per share data)|
|Three Months Ended||Year Ended|
|Research and development||$||20,956||$||17,524||$||84,721||$||60,397|
|General and administrative||12,082||8,808||46,537||31,502|
|Total operating expenses||33,038||26,332||131,258||91,899|
|Other income (expense), net||295||173||792||2,274|
|Net loss per share, basic and diluted||$||(0.49||)||$||(0.45||)||$||(1.97||)||$||(1.69||)|
|Weighted average number of
shares used in computing net loss
per share, basic and diluted
|Balance Sheet Data|
|Cash, cash equivalents and short-term investments||$||517,960||$||633,320|
Senior Vice President, Investor Relations &
Source: Kura Oncology, Inc.