Kura Oncology Reports Third Quarter 2024 Financial Results
Kura Oncology has released its Q3 2024 financial results and corporate updates. Key highlights include the expected topline results from the registration-directed trial of ziftomenib in R/R NPM1-mutant AML in early 2025. Additionally, data from 100 patients in the Phase 1a study of ziftomenib will be presented at the ASH Annual Meeting. The Phase 1b expansion study of ziftomenib is now enrolling at 600 mg across all cohorts. Preclinical data supports the potential of ziftomenib in GIST, with a proof-of-concept study expected in 1H 2025. The first patient has been dosed in the study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC. Financially, Kura reported a net loss of $54.4 million for Q3 2024, compared to $38.6 million in Q3 2023. R&D expenses rose to $41.7 million from $29.3 million, and G&A expenses increased to $18.2 million from $13.1 million. The company holds $455.3 million in cash, cash equivalents, and investments, expected to fund operations into 2027.
Kura Oncology ha pubblicato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono i risultati attesi topline dalla sperimentazione registrativa di ziftomenib in AML NPM1-mutante R/R all'inizio del 2025. Inoltre, i dati provenienti da 100 pazienti nello studio di Fase 1a di ziftomenib saranno presentati all'ASH Annual Meeting. Lo studio di espansione di Fase 1b di ziftomenib è attualmente in fase di reclutamento a 600 mg in tutti i gruppi. I dati preclinici supportano il potenziale di ziftomenib nel GIST, con uno studio proof-of-concept previsto per la prima metà del 2025. Il primo paziente ha ricevuto il trattamento nello studio di KO-2806 e adagrasib nel NSCLC mutato KRASG12C. Dal punto di vista finanziario, Kura ha riportato una perdita netta di 54,4 milioni di dollari per il terzo trimestre 2024, rispetto ai 38,6 milioni di dollari nel terzo trimestre 2023. Le spese per ricerca e sviluppo sono aumentate a 41,7 milioni di dollari rispetto ai 29,3 milioni di dollari, e le spese generali e amministrative sono salite a 18,2 milioni di dollari da 13,1 milioni di dollari. L'azienda detiene 455,3 milioni di dollari in contante, equivalenti di cassa e investimenti, previsti per finanziare le operazioni fino al 2027.
Kura Oncology ha publicado sus resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. Los aspectos destacados incluyen los resultados topline esperados del ensayo dirigido a la registración de ziftomenib en AML NPM1-mutante R/R a principios de 2025. Además, se presentarán datos de 100 pacientes en el estudio de Fase 1a de ziftomenib en la Reunión Anual de ASH. El estudio de expansión de Fase 1b de ziftomenib está actualmente reclutando a 600 mg en todos los grupos. Los datos preclínicos respaldan el potencial de ziftomenib en GIST, con un estudio de prueba de concepto esperado para la primera mitad de 2025. El primer paciente ha sido dosificado en el estudio de KO-2806 y adagrasib en NSCLC mutado KRASG12C. Desde el punto de vista financiero, Kura informó una pérdida neta de 54,4 millones de dólares para el tercer trimestre de 2024, en comparación con 38,6 millones de dólares en el tercer trimestre de 2023. Los gastos de I+D aumentaron a 41,7 millones de dólares desde 29,3 millones de dólares, y los gastos generales y administrativos aumentaron a 18,2 millones de dólares desde 13,1 millones de dólares. La compañía tiene 455,3 millones de dólares en efectivo, equivalentes de efectivo e inversiones, que se espera financien las operaciones hasta 2027.
Kura Oncology는 2024년 3분기 재무 결과와 회사 업데이트를 발표했습니다. 주요 하이라이트에는 2025년 초에 R/R NPM1 변이 AML에 대한 ziftomenib의 등록 지향 시험에서 기대되는 톱라인 결과가 포함됩니다. 또한 ziftomenib의 1a상 연구에서 100명의 환자 데이터가 ASH 연례 회의에서 발표될 예정입니다. ziftomenib의 1b상 확대 연구는 모든 그룹에서 600mg로 등록 중입니다. GIST에서 ziftomenib의 잠재력을 뒷받침하는 전임상 데이터가 있으며, 2025년 상반기에 개념 증명 연구가 예상됩니다. KO-2806 및 adagrasib의 연구에서 첫 번째 환자가 투여되었습니다KRASG12C 변이 NSCLC에서. 재무 측면에서 Kura는 2024년 3분기에 5,440만 달러의 순손실을 보고했으며, 이는 2023년 3분기의 3,860만 달러에 비해 증가한 것입니다. 연구 개발 비용은 2,930만 달러에서 4,170만 달러로 증가하였고, 일반 관리 비용은 1,310만 달러에서 1,820만 달러로 증가하였습니다. 이 회사는 현금, 현금성 자산, 투자의 규모가 4억 5,530만 달러에 달하며, 2027년까지 운영을 지원할 것으로 보입니다.
Kura Oncology a publié ses résultats financiers du troisième trimestre 2024 et des mises à jour de l'entreprise. Les points saillants incluent les résultats topline attendus de l'essai dirigé vers l'enregistrement de ziftomenib dans l'AML muté NPM1 R/R prévu pour début 2025. De plus, des données provenant de 100 patients de l'étude de phase 1a de ziftomenib seront présentées lors de la réunion annuelle de l'ASH. L'étude d'expansion de phase 1b de ziftomenib est actuellement en cours de recrutement à 600 mg dans tous les groupes. Des données précliniques soutiennent le potentiel de ziftomenib dans le GIST, avec une étude de preuve de concept prévue pour le premier semestre 2025. Le premier patient a été traité dans l'étude de KO-2806 et adagrasib dans le NSCLC muté KRASG12C. Sur le plan financier, Kura a rapporté une perte nette de 54,4 millions de dollars pour le troisième trimestre 2024, par rapport à 38,6 millions de dollars au troisième trimestre 2023. Les dépenses de R&D ont augmenté à 41,7 millions de dollars contre 29,3 millions de dollars, et les dépenses générales et administratives ont augmenté à 18,2 millions de dollars contre 13,1 millions de dollars. L'entreprise détient 455,3 millions de dollars en liquidités, équivalents de liquidités et investissements, prévus pour financer ses opérations jusqu'en 2027.
Kura Oncology hat seine finanziellen Ergebnisse für das 3. Quartal 2024 sowie Unternehmensaktualisierungen veröffentlicht. Zu den wichtigsten Punkten gehört die erwarteten Topline-Ergebnisse aus der registrierungsgerichteten Studie zu ziftomenib bei R/R NPM1-mutiertem AML Anfang 2025. Darüber hinaus werden Daten von 100 Patienten aus der Phase-1a-Studie zu ziftomenib auf dem ASH-Jahrestreffen präsentiert. Die Phase-1b-Erweiterungsstudie zu ziftomenib wird derzeit mit 600 mg in allen Kohorten rekrutiert. Präklinische Daten unterstützen das Potenzial von ziftomenib bei GIST, wobei eine Machbarkeitsstudie im ersten Halbjahr 2025 erwartet wird. Der erste Patient erhielt die Dosis in der Studie zu KO-2806 und adagrasib bei KRASG12C-mutiertem NSCLC. Finanziell meldete Kura einen Nettoverlust von 54,4 Millionen US-Dollar für das 3. Quartal 2024, verglichen mit 38,6 Millionen US-Dollar im 3. Quartal 2023. Die F&E-Ausgaben stiegen auf 41,7 Millionen US-Dollar von 29,3 Millionen US-Dollar, und die allgemeinen und Verwaltungskosten stiegen auf 18,2 Millionen US-Dollar von 13,1 Millionen US-Dollar. Das Unternehmen verfügt über 455,3 Millionen US-Dollar an Bargeld, cash-ähnlichen Mitteln und Investitionen, die voraussichtlich die Operationen bis 2027 finanzieren werden.
- $455.3 million in cash, expected to fund operations into 2027.
- Phase 1a dose-escalation data of ziftomenib to be presented at ASH.
- Preclinical data supports ziftomenib's potential in GIST.
- Net loss increased to $54.4 million from $38.6 million in Q3 2023.
- R&D expenses increased to $41.7 million from $29.3 million.
- G&A expenses rose to $18.2 million from $13.1 million.
Insights
The Q3 2024 report reveals significant financial strength with
The pipeline progress is particularly compelling with ziftomenib's breakthrough therapy designation in NPM1-mutant AML. The upcoming ASH presentation featuring data from over 100 patients, combined with The Lancet Oncology publication, signals strong clinical validation. The expansion into GIST treatment and positive preclinical diabetes data suggest significant market opportunity beyond AML. The advancement of all Phase 1b expansion cohorts to 600mg dosing and rapid enrollment of 45 patients since August indicate strong clinical momentum and investigator confidence.
– Topline results from registration-directed trial of ziftomenib in R/R NPM1-mutant AML expected in early 2025; Phase 1 results published in The Lancet Oncology –
– Data from 100 patients in Phase 1a dose-escalation study of ziftomenib combined with ven/aza in R/R AML and 7+3 in 1L adverse risk AML to be presented at ASH –
– Phase 1b expansion study of ziftomenib in combination with standards of care now enrolling at 600 mg in all cohorts –
– Preclinical data support opportunity for ziftomenib in GIST; proof-of-concept study expected to begin in 1H 2025 –
– First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC –
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– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- 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 third quarter 2024 financial results and provided a corporate update.
“We approach the end of 2024 in a strong position, with a series of important catalysts ahead,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “First, we look forward to sharing a robust dataset from more than 100 patients in our Phase 1a dose-escalation study of ziftomenib in combination with standards of care in acute myeloid leukemia (AML) at the upcoming American Society of Hematology (ASH) Annual Meeting, followed by topline results from our registration-directed trial of ziftomenib in relapsed/refractory (R/R) NPM1-mutant (NPM1-m) AML early next year. In the meantime, we continue to enroll rapidly across all our ziftomenib studies, further supporting the broad development of our menin inhibitor programs.”
Recent Highlights
- Topline results from registration-directed trial of ziftomenib in early 2025 – 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-m AML. Ziftomenib is the first and only investigational therapy to be granted Breakthrough Therapy Designation (BTD) for the treatment of R/R NPM1-m AML, which accounts for approximately
30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists. Results from the Phase 1 portion of KOMET-001 were recently published in the leading clinical oncology journal, The Lancet Oncology. - Data from Phase 1a dose-escalation study of ziftomenib at ASH – Two abstracts reporting preliminary data from the Phase 1a dose-escalation study of ziftomenib in combination with standards of care in patients with NPM1-m and KMT2A-rearranged (KMT2A-r) AML have been accepted for presentation at the ASH Annual Meeting in December. As of the June 21, 2024 data cutoff, the abstracts continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care, including venetoclax plus azacitidine (ven/aza) as well as cytarabine plus daunorubicin (7+3). Kura expects to present a more mature dataset from more than 100 patients in the Phase 1a dose-escalation study in the presentations at ASH.
- Phase 1b expansion study of ziftomenib now enrolling in all cohorts – All four cohorts in the Phase 1a dose-escalation study have cleared the highest dose and advanced into the Phase 1b expansion study at 600 mg. The Phase 1b expansion study includes multiple combination cohorts, including ziftomenib plus ven/aza in newly diagnosed NPM1-m or KMT2A-r AML and ziftomenib plus 7+3 in newly diagnosed NPM1-m or KMT2A-r AML without qualification for high-risk disease. Each of the seven combination cohorts is expected to enroll at least 20 patients. A total of 45 patients have already enrolled in the study since the first dose-expansion cohort opened in August 2024. The Company anticipates sharing preliminary data from the Phase 1b expansion study at a medical meeting in 2025.
- Preclinical data support opportunity for ziftomenib in GIST – Last month, at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Kura reported preclinical data supporting the combination of ziftomenib and imatinib for the treatment of advanced gastrointestinal stromal tumors (GIST). The combination showed unexpectedly robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST patient-derived xenograft models, and in all cases was significantly superior to imatinib monotherapy. The Company received FDA clearance of its Investigational New Drug application for ziftomenib for the treatment of advanced GIST in August and expects to initiate a proof-of-concept study in the first half of 2025 evaluating ziftomenib and imatinib in patients with advanced GIST who have failed imatinib.
- First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC – In August 2024, Kura 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.
- 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 Scientific Sessions in Orlando. The Company expects to nominate a next generation menin inhibitor candidate targeting diabetes in the first half of 2025.
Financial Results
- Research and development expenses for the third quarter of 2024 were
$41.7 million , compared to$29.3 million for the third quarter of 2023. - General and administrative expenses for the third quarter of 2024 were
$18.2 million , compared to$13.1 million for the third quarter of 2023. - Net loss for the third quarter of 2024 was
$54.4 million , compared to a net loss of$38.6 million for the third quarter of 2023. This included non-cash share-based compensation expense of$8.3 million , compared to$7.1 million for the same period in 2023. - As of September 30, 2024, Kura had cash, cash equivalents and short-term investments of
$455.3 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 ASH in December 2024.
- Report topline results from the KOMET-001 registration-directed trial of ziftomenib in NPM1-mutant R/R AML in early 2025.
- Present preliminary data from the Phase 1b expansion portion of KOMET-007 at a medical meeting in 2025.
- 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 targeting diabetes in the first half of 2025.
- Identify the maximum tolerated dose for KO-2806 as a monotherapy in the second half of 2024.
- Initiate one or more expansion cohorts for the combination of KO-2806 and cabozantinib in renal cell carcinoma in the first half of 2025.
- 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, November 7, 2024, to discuss the financial results for the third quarter 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 225-9448 for domestic callers and (203) 518-9708 for international callers and entering the conference ID: KURAQ3. 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.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received BTD for the treatment of R/R NPM1-m AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. Kura is evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC (KURRENT-HN). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.
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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 41,705 | $ | 29,328 | $ | 117,700 | $ | 82,702 | ||||||||
| General and administrative | 18,179 | 13,145 | 53,040 | 36,340 | ||||||||||||
| Total operating expenses | 59,884 | 42,473 | 170,740 | 119,042 | ||||||||||||
| Other income, net | 5,480 | 3,871 | 15,974 | 9,197 | ||||||||||||
| Net loss | $ | (54,404 | ) | $ | (38,602 | ) | $ | (154,766 | ) | $ | (109,845 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.63 | ) | $ | (0.50 | ) | $ | (1.80 | ) | $ | (1.53 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 86,950 | 77,241 | 85,834 | 71,845 | ||||||||||||
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and short-term investments | $ | 455,297 | $ | 423,957 | ||||
| Working capital | 422,817 | 397,218 | ||||||
| Total assets | 478,837 | 448,935 | ||||||
| Long-term liabilities | 14,694 | 16,399 | ||||||
| Accumulated deficit | (876,205 | ) | (721,439 | ) | ||||
| Stockholders’ equity | 423,771 | 397,273 | ||||||
Contacts
Investors:
Pete De Spain
Executive Vice President, Investor Relations &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com
Media:
Cassidy McClain
Vice President
Inizio Evoke Comms
(619) 849-6009
cassidy.mcclain@inizioevoke.com
FAQ
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