Kura Oncology Reports Second Quarter 2019 Financial Results and Provides Corporate Update
- Registration-directed trial of tipifarnib in HRAS mutant HNSCC ongoing –
– Positive Phase 2 trial of tipifarnib in AITL and CXCL12-driven PTCL support potential paths to registration –
– Additional Phase 2 data in HRAS mutant HNSCC, other SCCs and AITL anticipated in fourth quarter of 2019 –
– Strengthened balance sheet with
– Management to host webcast and conference call today at
“The past quarter was highlighted by impressive data from our ongoing Phase 2 trial of tipifarnib in peripheral T-cell lymphoma (PTCL),” said
“As we look toward the second half of this year and early next year, we anticipate a number of milestones across our pipeline programs,” continued Dr. Wilson, “including an update from our ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other squamous cell carcinomas (SCCs), additional Phase 2 data in AITL, completion of the dose-escalation portion of the Phase 1 trial of our ERK inhibitor, KO-947, and initiation of the Phase 1 trial of our menin-MLL inhibitor, KO-539. With our successful public offering in June, we have greater resources and flexibility to continue to create value across our pipeline.”
- Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura continues to execute on its initial registration-directed trial of tipifarnib in HRAS mutant HNSCC. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in
November 2018and is expected to take approximately two years to fully enroll.
- Positive Phase 2 trial of tipifarnib in AITL and CXCL12-driven PTCL – In
June 2019, Kura reported positive data from its ongoing Phase 2 trial of tipifarnib in patients with relapsed or refractory PTCL, including clinical proof-of-concept in the trial’s two expansion cohorts: 1) patients with AITL, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression, and 2) patients with PTCL who lack a single nucleotide variation in the 3’-untranslated region of the CXCL12 gene. The Company believes these data could support the potential registration of tipifarnib in both the AITL and PTCL-NOS patient populations and intends to seek regulatory feedback on next steps for this program. In addition, Kura plans to continue enrolling AITL patients in the trial and expects to provide additional data from this cohort at a medical meeting later this year.
- Expanded patent protection for tipifarnib in the U.S. and
Europe– The U.S. Patent and Trademark Office recently issued two new patents further protecting tipifarnib, including a method of treating patients with HRAS mutant HNSCC with any farnesyl transferase inhibitor and a method of treating patients with HRAS mutant non-small cell lung carcinoma with tipifarnib. In addition, the European Patent Office granted a patent directed to the use of tipifarnib as a method of treating patients with HRAS mutant HNSCC. The new patents have an expiration date of August 2036, excluding any possible patent term extension.
- Dose escalation in Phase 1 trial of KO-947 advancing – Kura continues to evaluate dosing regimens for KO-947, its potent and selective small molecule inhibitor of ERK, in an ongoing Phase 1 trial, with a goal of reaching a recommended Phase 2 dose or maximum tolerated dose. The Company expects to complete the dose-escalation portion of the trial by the end of 2019.
- Orphan Drug Designation to KO-539 for treatment of AML – Last week, the
U.S. Food and Drug Administration( FDA) granted Orphan Drug Designation to KO-539, Kura’s menin-MLL inhibitor for the treatment of AML. The FDAcleared the investigational new drug application for KO-539 in March 2019, and the Company is in the final stages of study startup for a Phase 1 clinical trial of KO-539 in relapsed or refractory AML.
- Successful public offering strengthens cash position – In
June 2019, Kura completed a public offering in which the Company sold an aggregate of 6,785,000 shares of common stock at a price of $17.00per share. Net proceeds from the public offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $108.1 million.
- Research and development expenses for the second quarter of 2019 were
$11.4 million, compared to $11.5 millionfor the second quarter of 2018.
- General and administrative expenses for the second quarter of 2019 were
$4.5 million, compared to $3.8 millionfor the second quarter of 2018.
- Net loss for the second quarter of 2019 was
$14.9 million, or $0.38per share, compared to a net loss of $14.7 million, or $0.45per share, for the second quarter of 2018.
- Cash, cash equivalents and short-term investments totaled
$261.4 millionas of June 30, 2019, which includes net proceeds of approximately $108.1 millionfrom a public offering completed in June 2019, compared with $179.0 millionas of December 31, 2018.
- Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2021.
- Initiation of the Phase 1 trial of KO-539 in relapsed or refractory AML in the second half of 2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other SCCs in the fourth quarter of 2019
- Additional data from the AITL expansion cohort in the ongoing Phase 2 trial of tipifarnib in the fourth quarter of 2019
- Completion of the dose-escalation portion of the Phase 1 trial of KO-947 by the end of 2019
- Additional data from the ongoing Phase 2 trial of tipifarnib in chronic myelomonocytic leukemia (CMML) in the first half of 2020
- Initiation of a proof-of-concept study of tipifarnib in pancreatic cancer in the first half of 2020
Conference Call and Webcast
Kura’s management will host a webcast and conference call today 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, tipifarnib, KO-947 and KO-539, progress and expected timing of Kura’s drug development programs and clinical trials and submission of regulatory filings, the potential expansion of tipifarnib to additional indications, 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 and applications, 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
|KURA ONCOLOGY, INC.|
|Statements of Operations Data|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||11,440||$||11,476||$||21,822||$||23,042|
|General and administrative||4,451||3,800||9,020||7,225|
|Total operating expenses||15,891||15,276||30,842||30,267|
|Other income, net||948||537||1,959||924|
|Net loss per share, basic and diluted||$||(0.38||)||$||(0.45||)||$||(0.75||)||$||(0.91||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||38,928||32,971||38,550||32,403|
|KURA ONCOLOGY, INC.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||261,413||$||178,985|
Vice President, Investor Relations &
Westwicke Partners, LLC
Source: Kura Oncology, Inc.