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Kura Oncology Reports Second Quarter 2024 Financial Results – Topline data from registration-directed trial of ziftomenib in R/R NPM1-mutant AML expected in early 2025 – – Breakthrough Therapy Design

Key Takeaway: Kura Oncology reported its second-quarter 2024 financial results, highlighting significant advancements in its clinical programs. Ziftomenib received Breakthrough Therapy Designation for treating relapsed/refractory NPM1-mutant AML, with topline data expected in early 2025 from trials indicating promising efficacy. The company also announced the start of a Phase 1b expansion study for ziftomenib, alongside positive financial status with $491.5 million in cash reserves. However, the increase in net losses and rising operational costs point to ongoing financial challenges as the company moves forward.

Market Sentiment Analysis

POSITIVE FACTORS

  • Ziftomenib received Breakthrough Therapy Designation from the FDA for R/R NPM1-mutant AML, indicating significant clinical potential.
  • The completion of enrollment in the pivotal KOMET-001 trial reflects strong organizational execution and progress towards critical milestones.
  • Kura has $491.5 million in cash reserves, providing a financial runway into 2027 for ongoing development.
  • The upcoming topline data from the registration-directed trial in early 2025 highlights forward momentum in Kura's drug development pipeline.

CONCERNS & RISKS

  • The net loss for Q2 2024 increased to $50.8 million compared to $37.2 million in Q2 2023, indicating growing financial pressures.
  • Higher research and development expenses suggest increased operational costs during the development phases.
  • The continued reliance on achieving future milestones exposes Kura to risks associated with clinical outcomes and regulatory approvals.

Full Press Release Details

Kura Oncology Reports Second Quarter 2024
Topline data from registration-directed trial of ziftomenib in R/R NPM1-mutant AML expected in early 2025
Breakthrough Therapy Designation granted for ziftomenib in R/R NPM1-mutant AML
Data from 100 patients in KOMET-007 trial of ziftomenib in combination with ven/aza and 7+3 expected in Q4; Phase 1b expansion study in 1L AML now enrolling
Investigational New Drug (IND) application cleared for ziftomenib in GIST
Preclinical data at ADA support potential for menin inhibitor in diabetes
First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC
$491.5 million in cash, cash equivalents and investments provide runway into 2027
Management to host webcast and conference call today at 4:30 p.m. ET
SAN DIEGO, Aug. 8, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2024 financial results and provided a corporate update.
This past quarter was highlighted by strong execution across the organization, said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. We completed enrollment in our KOMET-001 registration-directed trial of ziftomenib in patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML), and we were delighted to have ziftomenib receive Breakthrough Therapy Designation from the FDA in that indication. In the KOMET-007 study, the safety, tolerability and clinical activity of ziftomenib continue to support advancement of ziftomenib into the frontline (1L) population, and the Phase 1b expansion study in combination with venetoclax and azacitidine (ven/aza) and cytarabine plus daunorubicin (7+3) is now open for enrollment. We are generating a robust clinical data package to support the broad development of ziftomenib, including enrollment of more than 100 patients in the KOMET-007 study, and we look forward to providing an update on this study at a medical meeting later this year, followed by topline data from our registration-directed trial in early 2025.
-Completion of enrollment in pivotal trial of ziftomenib in R/R NPM1-mutant AML In May 2024, Kura completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of its menin inhibitor, ziftomenib, in patients with R/R NPM1-mutant AML. NPM1-mutant AML accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists. The Company expects to report topline data from the trial in early 2025.
-Breakthrough Therapy Designation for ziftomenib in NPM1-mutant AML In April 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to ziftomenib for the treatment of R/R NPM1-mutant AML. FDA granted BTD based on data from the KOMET-001 trial of ziftomenib in patients with R/R NPM1-mutant AML. BTD is awarded for a drug that treats a serious or life-threatening condition and may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
-Phase 1b expansion portion of KOMET-007 open for enrollment Kura recently began dosing patients in the Phase 1b expansion portion of its KOMET-007 combination study of ziftomenib. The Phase 1b expansion study includes multiple combination cohorts, including ven/aza in newly diagnosed NPM1-mutant or KMT2A-rearranged AML and 7+3 in newly diagnosed NPM1-mutant or KMT2A-rearranged AML without qualification for high-risk disease. Each combination cohort is expected to enroll approximately 20 patients at 600 mg. The Company expects to present updated data from the KOMET-007 study at a medical meeting in the fourth quarter of 2024.
-IND for ziftomenib in GIST; proof-of-concept study to begin in early 2025 Earlier today, Kura announced FDA clearance of its IND application for ziftomenib for the treatment of advanced gastrointestinal stromal tumors (GIST) in combination with imatinib. Preclinical data suggest ziftomenib has potential to resensitize patients to imatinib and induce deep, durable responses. The Company expects to present the preclinical data for the combination at an upcoming scientific meeting, followed by a proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.
-Preclinical data support potential for menin inhibitor in diabetes In June 2024, Kura reported data showing that ziftomenib induces insulin production, improves insulin sensitivity and reduces insulin resistance in a preclinical in vivo model of type 2 diabetes. Ziftomenib demonstrated meaningful levels of glycemic control, including reduced fasting blood glucose levels and %HbA1C within 27 days, as well as consistent improvement in both insulin sensitivity and insulin production. The data were presented at the American Diabetes Association (ADA) Scientific
Sessions in Orlando. The Company expects to nominate the first in a series of next-generation development candidates targeting diabetes in early 2025.
-First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC Kura recently began dosing patients in its study of KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in combination with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC). The Company's findings suggest that combining KO-2806 with adagrasib may drive tumor regressions and enhance both duration and depth of antitumor response in preclinical models of KRASG12C-mutated NSCLC. The study of KO-2806 and adagrasib is supported by a clinical collaboration and supply agreement with Mirati, now a Bristol Myers Squibb company.
-Research and development expenses for the second quarter of 2024 were $39.7 million, compared to $28.2 million for the second quarter of 2023.
-General and administrative expenses for the second quarter of 2024 were $16.7 million, compared to $11.8 million for the second quarter of 2023.
-Net loss for the second quarter of 2024 was $50.8 million, compared to a net loss of $37.2 million for the second quarter of 2023. This included non-cash share-based compensation expense of $8.4 million, compared to $7.0 million for the same period in 2023.
-As of June 30, 2024, Kura had cash, cash equivalents and short-term investments of $491.5 million, compared to $424.0 million as of December 31, 2023.
-Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations into 2027.
Forecasted Milestones
-Present updated data from the KOMET-007 trial of ziftomenib in combination with ven/aza and 7+3 at a medical meeting in the fourth quarter of 2024.
-Report topline data from the KOMET-001 registration-directed trial of ziftomenib in NPM1-mutant R/R AML in early 2025.
-Present preclinical data supporting opportunity for ziftomenib in GIST at a scientific meeting in the second half of 2024.
-Initiate proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.
-Nominate a next generation menin inhibitor development candidate in early 2025.
-Identify the maximum tolerated dose for KO-2806 as a monotherapy in the second half of 2024.
-Complete enrollment of two expansion cohorts in KURRENT-HN 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 head and neck squamous cell carcinoma (HNSCC) in the first half of 2025.
Conference Call and Webcast
Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 8, 2024, to discuss the financial results for the second quarter 2024 and to provide a corporate update. The live call may be accessed by dialing (877) 300-8521 for domestic callers and (412) 317-6026 for international callers and entering the conference ID: 10190278. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.
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, KO-2806 and tipifarnib, 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 strength of Kura's balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund its current operating plan into 2027. 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 Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
KURA ONCOLOGY, INC.
Statements of Operations Data
(unaudited)
(in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2024 2023 2024 2023
Operating Expenses:
Research and development $ 39,727 $ 28,182 $ 75,995 $ 53,374
General and administrative 16,677 11,821 34,861 23,195
Total operating expenses 56,404 40,003 110,856 76,569
Other income, net 5,567 2,829 10,494 5,326
Net loss $ (50,837 ) $ (37,174 ) $ (100,362 ) $ (71,243 )
Net loss per share, basic and diluted $ (0.59 ) $ (0.53 ) $ (1.18 ) $ (1.03 )
Weighted average number of shares used in computing net loss per share, basic and diluted 86,635 69,795 85,270 69,103
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
June 30, December 31,
2024 2023
Cash, cash equivalents and short-term investments $ 491,519 $ 423,957
Working capital 466,317 397,218
Total assets 515,116 448,935
Long-term liabilities 15,595 16,399
Accumulated deficit (821,801 ) (721,439 )
Stockholders' equity 466,070 397,273
Executive Vice President, Investor Relations & Corporate Communications

Frequently Asked Questions

What is ziftomenib used for?

Ziftomenib is being investigated for treating R/R NPM1-mutant AML.

When are results expected from the KOMET-001 trial?

Topline data from the KOMET-001 trial is expected in early 2025.

What designation did ziftomenib receive from the FDA?

Ziftomenib received Breakthrough Therapy Designation for R/R NPM1-mutant AML.

What is the focus of the KOMET-007 expansion study?

The KOMET-007 expansion study focuses on ziftomenib in combination therapies.

What financial resources does Kura currently have?

Kura has $491.5 million in cash and equivalents, funding operations into 2027.

Last updated: Aug 8, 2024