Kura Oncology Reports Third Quarter 2019 Financial Results and Provides Corporate Update
– Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC support enrichment strategy in ongoing registration-directed trial –
– Data from Phase 2 trial of tipifarnib in AITL accepted for oral presentation at ASH 2019 –
– Initiation of first-in-class menin-MLL inhibitor KO-539 gives Company three wholly owned, clinical-stage oncology assets –
– Management to host webcast and conference call today at
“We continue to be very encouraged by our growing body of data that support the potential of tipifarnib, highlighted recently by impressive results from our ongoing Phase 2 trial in HRAS mutant head and neck squamous cell carcinomas (HNSCC),” said
“Meanwhile, we continue to make steady and encouraging progress with our emerging pipeline programs,” Dr. Wilson continued, “including continued dose escalation of our ERK inhibitor, KO-947, and the initiation of a Phase 1 trial of our first-in-class menin-MLL inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). We believe both of our early-stage drug candidates represent differentiated approaches that could potentially address large indications with high unmet need, and we look forward to sharing updates on all of our progress in the months ahead."
- Durable anti-tumor activity in Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Last week, Kura reported updated data from its RUN-HN Phase 2 trial of tipifarnib in HNSCC patients with high HRAS mutant variant allele frequency at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeuticsin Boston. The preliminary results showed that 10 of the 18 efficacy-evaluable patients achieved a confirmed partial response (PR), for an objective response rate of 56%. In addition, eight patients experienced disease stabilization, including two who achieved an unconfirmed PR, one of whom was awaiting a confirmatory response assessment as of the data cutoff date. The median progression-free survival (PFS) of the 18 evaluable patients treated with tipifarnib was 6.1 months, compared to 2.8 months on their last prior therapy, including 8.3 months among patients who achieved a PR on tipifarnib and 4.5 months for those with stable disease. Patients had a median of two prior lines of therapy (range 0-6), with no responses observed on their last prior therapy.
- Updated Phase 2 data support enrichment strategy in ongoing registration-directed trial – Of the eight efficacy-evaluable patients in the RUN-HN Phase 2 trial who were prospectively enrolled with high HRAS mutant variant allele frequency, three achieved a confirmed PR and five had stable disease, including two who achieved an unconfirmed PR, one of whom is awaiting a confirmatory response assessment. Kura’s registration-directed trial, AIM-HN, is designed to enroll at least 59 evaluable HNSCC patients with high HRAS mutant variant allele frequency who have received prior platinum-based therapy. AIM-HN was initiated in
November 2018and is now open in more than 75 clinical sites worldwide. The trial is expected to require approximately two years for full enrollment. Based upon the statistical assumptions, AIM-HN could be positive as soon as 15 responses are confirmed.
- Positive Phase 2 trial of tipifarnib in HRAS mutant urothelial carcinoma – In
September 2019, Kura reported that an investigator-sponsored Phase 2 trial of tipifarnib in HRAS mutant urothelial carcinomas met its primary efficacy endpoint prior to completion of enrollment. The trial is being conducted at the Samsung Medical Centerin Seoul, South Korea. Five of the 13 evaluable patients experienced confirmed objective responses, with four patients having experienced PFS of greater than 6 months. Further analyses of the trial are ongoing, and data are expected to be presented at a medical meeting next year.
- Data from Phase 2 trial of tipifarnib in AITL accepted for oral presentation at ASH. In
June 2019, Kura announced that the primary endpoint was achieved in both expansion cohorts in its Phase 2 trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Additional data, including new patients from the AITL expansion cohort, have been accepted for oral presentation at the upcoming American Society of Hematology(ASH) Annual Meeting in December 2019.
- Expanded patent exclusivity for tipifarnib – In
September 2019, the U.S. Patent and Trademark Office issued a new patent further extending Kura’s exclusivity to the use of any farnesyl transferase inhibitor (FTi) for the treatment of CXCL12-expressing PTCL and AML. This adds to the Company’s growing portfolio of patents involving CXCL12 pathway biomarkers and follows the issuance of another patent earlier this year that covers the use of any FTi for the treatment of HRAS mutant HNSCC. These new patents expire in 2037 and 2036, respectively, excluding any possible patent term extension. The Company continues to aggressively pursue additional intellectual property protection, both in the U.S. and abroad.
- Initiated Phase 1 trial of KO-539 in relapsed or refractory AML – In
September 2019, the first patient was dosed in a Phase 1 trial of KO-539, Kura’s first-in-class, potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Phase 1, open-label, dose-escalation trial is designed to determine the recommended Phase 2 dose or maximum tolerated dose of KO-539 in patients with relapsed or refractory AML. Upon completion of the dose-escalation portion of the trial, expansion cohorts are planned to further assess the safety and activity of KO-539 in specific genetic subgroups, such as patients with MLL fusions or partial tandem duplications and patients with mutations in the NPM1 oncogene.
- Strengthened senior leadership team and board of directors – Kura recently added
Kathleen Fordas Chief Operating Officer, James Bastaas Chief Legal Officer and Diane Parksas a member of the board of directors. Previously, Ms. Ford was Senior Vice President, Head of Global Clinical Operations at Merck Serono, a division of Merck KGaA, Mr. Basta was Senior Vice President, Chief Corporation Counsel at Biogen, and Ms. Parks was most recently Senior Vice President, Head of U.S. Commercial at Kite Pharma. All three are valuable additions to Kura, as the Company continues to advance its three clinical-stage oncology assets and begins to focus on commercial readiness.
- Research and development expenses for the third quarter of 2019 were
$12.5 million, compared to $11.7 millionfor the third quarter of 2018.
- General and administrative expenses for the third quarter of 2019 were
$5.1 million, compared to $4.3 millionfor the third quarter of 2018.
- Net loss for the third quarter of 2019 was
$16.4 million, or $0.36per share, compared to $15.0 million, or $0.40per share, for the third quarter of 2018.
- Cash, cash equivalents and short-term investments totaled
$250.1 millionas of September 30, 2019, compared with $179.0 millionas of December 31, 2018.
- Management continues to expect that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2021.
- Additional data from the AITL expansion cohort in the ongoing Phase 2 trial of tipifarnib in PTCL at ASH in
- Regulatory feedback from the Phase 2 trial of tipifarnib in AITL in the first half of 2020
- 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 2020
- Data from the Phase 2 investigator-sponsored trial of tipifarnib in urothelial carcinoma in 2020
- Potential for full enrollment in the AIM-HN registration-directed trial of tipifarnib in HRAS mutant HNSCC by the end of 2020
- Completion of the dose-escalation portion of the Phase 1 trial of KO-947 by the end of 2019 or early 2020
- Initiation of tumor-specific extension cohort(s) in the Phase 1 trial of KO-947 in 2020
- Achievement of a recommended Phase 2 dose in the Phase 1 dose-escalation trial of KO-539 in 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||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||12,540||$||11,661||$||34,362||$||34,703|
|General and administrative||5,134||4,321||14,154||11,546|
|Total operating expenses||17,674||15,982||48,516||46,249|
|Other income, net||1,282||975||3,241||1,899|
|Net loss per share, basic and diluted||$||(0.36||)||$||(0.40||)||$||(1.11||)||$||(1.30||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||45,241||37,789||40,805||34,218|
|KURA ONCOLOGY, INC.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||250,126||$||178,985|
Vice President, Investor Relations &
Source: Kura Oncology, Inc.