Kura Oncology Reports First Quarter 2022 Financial Results
– Enrollment completed in Phase 1b expansion cohorts for ziftomenib; topline data expected in third quarter, full data presentation in fourth quarter –
– Enrollment in PIK3CA-dependent cohort in KURRENT-HN trial of tipifarnib plus alpelisib continues; first patient in HRAS overexpression cohort expected by third quarter –
– First patient in Phase 1 KURRENT-LUNG trial of tipifarnib plus osimertinib expected in third quarter –
–
– Management to host webcast and conference call today at
“We continue to operate from a position of strength, armed with three independent drug development programs, near-term clinical milestones and cash runway through 2024,” said
Recent Highlights
- Enrollment completed in Phase 1b expansion cohorts for ziftomenib – Kura has completed enrollment of the patients in the Phase 1b portion of KOMET-001 required to identify a recommended Phase 2 dose for ziftomenib. The Phase 1b portion was designed to enroll two expansion cohorts – 200 mg and 600 mg – with each cohort comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed and/or refractory acute myeloid leukemia (AML). The goal of the Phase 1b portion is dose optimization, and the two doses were selected based on the encouraging clinical activity, safety profile and tolerability demonstrated in the Phase 1a portion of KOMET-001. Kura remains on track to identify the recommended Phase 2 dose for ziftomenib and report topline data from the Phase 1b portion of KOMET-001 in the third quarter of 2022, with a more complete dataset reserved for presentation at a medical meeting in the fourth quarter of 2022.
- Expanded opportunity for tipifarnib in head and neck squamous cell carcinoma – Enrollment continues in the Phase 1/2 clinical trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC, and Kura expects to dose the first patient in an HRAS overexpression cohort in the third quarter of 2022. The Company believes the combination with alpelisib has the potential to drive deeper and more durable responses than either agent as monotherapy and to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.
- Preclinical data support use of tipifarnib to prevent relapse to osimertinib – In
April 2022 , preclinical data supporting the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR mutant non-small cell lung cancer (NSCLC) were reported at theAmerican Association for Cancer Research Annual Meeting. Kura is now preparing to initiate a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC and expect to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, Kura’s next-generation farnesyl transferase inhibitor (FTI), through investigational new drug (IND)-enabling studies.
Financial Results
- Research and development expenses for the first quarter of 2022 were
$20.9 million , compared to$20.3 million for the first quarter of 2021. The increase in R&D expenses was primarily due to increases in ziftomenib clinical trial and personnel costs. - General and administrative expenses for the first quarter of 2022 were
$11.9 million , compared to$10.6 million for the first quarter of 2021. The increase in G&A expenses was primarily due to increases in professional fees and non-cash share-based compensation. - Net loss for the first quarter of 2022 was
$32.5 million , compared to a net loss of$30.7 million for the first quarter of 2021. This included non-cash share-based compensation expense of$6.7 million , compared to$5.1 million for the same period in 2021. - Cash, cash equivalents and short-term investments totaled
$480.1 million as ofMarch 31, 2022 , compared with$518.0 million as ofDecember 31, 2021 . Based on its current plans, management expects that current cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones
- Identify the recommended Phase 2 dose of ziftomenib and report topline data from the Phase 1b study in the third quarter.
- Present updated data from KOMET-001 at a medical meeting in the fourth quarter.
- Dose the first patient in the HRAS overexpression cohort of the KURRENT-HN trial by the third quarter.
- Dose the first patient in the KURRENT-LUNG trial in the third quarter.
- Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at
About
Forward-Looking Statements
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 | ||||||||
(unaudited) | ||||||||
(in thousands, except per share data) | ||||||||
Three Months Ended | ||||||||
2022 | 2021 | |||||||
Operating Expenses: | ||||||||
Research and development | $ | 20,913 | $ | 20,324 | ||||
General and administrative | 11,869 | 10,572 | ||||||
Total operating expenses | 32,782 | 30,896 | ||||||
Other income, net | 329 | 202 | ||||||
Net loss | $ | (32,453 | ) | $ | (30,694 | ) | ||
Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (0.46 | ) | ||
Weighted average number of shares used in computing net loss per share, basic and diluted |
66,607 | 66,218 | ||||||
Balance Sheet Data | ||||||||
(unaudited) | ||||||||
(in thousands) | ||||||||
2022 | 2021 | |||||||
Cash, cash equivalents and short-term investments | $ | 480,075 | $ | 517,960 | ||||
Working capital | 469,309 | 499,834 | ||||||
Total assets | 498,585 | 534,051 | ||||||
Long-term liabilities | 4,610 | 4,987 | ||||||
Accumulated deficit | (465,421 | ) | (432,968 | ) | ||||
Stockholders’ equity | 476,250 | 506,609 |
Contacts
Company:
Senior Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
pete@kuraoncology.com
Investors:
Managing Director
ICR Westwicke
(858) 356-5932
robert.uhl@westwicke.com
Media:
Managing Director
(619) 849-6005
jason@canalecomm.com
Source: Kura Oncology, Inc.