DEVELOPING PRECISION MEDICINES FOR THE TREATMENT OF CANCER
Corporate Presentation - May 2023
FORWARD-LOOKING STATEMENTS
This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, tipifarnib and KO-2806, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competitive therapies, and our expectations regarding the therapeutic and commercial potential of our product candidates. The words "believe," "may," "should," "will," "estimate," "promise," "plan", "continue," "anticipate," "intend," "expect," "potential" and similar expressions (including the negative thereof), are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: our preclinical studies and clinical trials may not be successful; the U.S. Food and Drug Administration (FDA) may not agree with our interpretation of the data from clinical trials of our product candidates; we may decide, or the FDA may require us, to conduct additional clinical trials or to modify our ongoing clinical trials; we may experience delays in the commencement, enrollment, completion or analysis of clinical testing for our product candidates, or significant issues regarding the adequacy of our clinical trial designs or the execution of our clinical trials may arise, which could result in increased costs and delays, or limit our ability to obtain regulatory approval; the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; our product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates could delay or prevent regulatory approval or commercialization; and we may not be able to obtain additional financing. Additional risks and uncertainties may emerge from time to time, and it is not possible for Kura's management to predict all risk factors and uncertainties.
All forward-looking statements contained in this presentation speak only as of the date on which they were made. Other risks and uncertainties affecting us are described more fully in our filings with the Securities and Exchange Commission. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
This presentation also contains statistical and clinical data obtained from and prepared by third parties. The recipient is cautioned not to give undue weight to such disclosures. Neither the Company nor any other person makes any representation as to the accuracy or completeness of such data or undertakes any obligation to update such data after the date of this presentation.
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INVESTMENT HIGHLIGHTS
Targeted | Advancing a pipeline of novel therapies, forging new scientific and clinical paths to give patients a |
Oncology | better chance for long-term durable remissions |
Menin Inhibitor Program (ziftomenib) | |
• Potential to address 35% or more of acute leukemias | |
• Encouraging safety, tolerability and clinical activity observed in relapsed/refractory AML patients | |
• 30% CR rate among 20 patients with NPM1 mutations treated at RP2D | |
Proprietary | • Enrollment ongoing in Phase 2 registration-directed trial in NPM1-mutant AML |
• First combination study with standards of care expected to begin in 1H 2023 | |
Pipeline |
Farnesyl Transferase Inhibitor Programs (tipifarnib & KO-2806)
- Durable responses as a monotherapy in recurrent/metastatic HRAS-mutant HNSCC patients
- Proof of mechanism demonstrated in combination with alpelisib in PIK3CA-dependent HNSCC
- Preclinical data support potential to prevent emergence of resistance to targeted therapies
- FDA clearance of IND for KO-2806,next-generation FTI; on track to initiate Phase 1 study in 2H 2023
Strong | • | $25 million strategic equity investment from Bristol Myers Squibb |
Financials | • | $406 million in cash as of March 31, 2023* provides runway into Q4 2025 |
* Cash, cash equivalents and short-term investments
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KURA LEADERSHIP TEAM AND BOARD OF DIRECTORS
Leadership Team
Troy Wilson, Ph.D., J.D. | Teresa Bair, J.D. | Stephen Dale, M.D. | Kathy Ford |
President & | Chief Legal Officer | Chief Medical Officer | Chief Operating Officer |
Chief Executive Officer |
Francis Burrows, Ph.D. | Pete De Spain | Tom Doyle | Mollie Leoni, M.D. |
Senior Vice President, | Senior Vice President, Investor | Senior Vice President, | Senior Vice President, |
Translational Research | Relations & Corporate | Finance & Accounting | Clinical Development |
Communications | |||
Board of Directors |
Troy Wilson, Ph.D., J.D. | Faheem Hasnain | Helen Collins, M.D. | Thomas Malley | ||||
Chairman | Lead Independent Director | ||||||
Carol Schafer | Steven Stein, M.D. | Diane Parks | Mary Szela | 4 | |||
DRUG CANDIDATE PIPELINE
PROGRAM | CLINICAL TRIAL | PLANNED |
STUDY STARTUP
PHASE 1
REGISTRATION DIRECTED
KOMET-001 | NPM1-mutant acute myeloid leukemia (AML) | |
Monotherapy | Non-NPM1-m /Non-KMT2A-r AML | |
(Relapsed/ | ||
refractory) | KMT2A-rearranged ALL | |
KOMET-007 | ||
ZIFTOMENIB | Combinations | NPM1-mutant AML |
Menin Inhibitor | with ven/aza, 7+3 | |
(Relapsed/ | KMT2A-rearranged AML | |
refractory, | ||
frontline) | ||
KOMET-008 | ||
Combinations | NPM1-mutant AML | |
with gilteritinib, | ||
FLAG-IDA, LDAC | KMT2A-rearranged AML | |
(Relapsed/ | ||
refractory) | ||
TIPIFARNIB | KURRENT-HN | |
Farnesyl | ||
Combination with PIK3CA-dependent HNSCC | ||
Transferase | ||
alpelisib | ||
Inhibitor (FTI) | ||
KO-2806 | FIT-001 | Clear Cell Renal Cell Carcinoma |
Next-Generation | Combinations | Non-Small Cell Lung Cancer |
with targeted | ||
FTI | ||
therapies | Other Solid Tumors | |
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Disclaimer
Kura Oncology Inc. published this content on 10 May 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 May 2023 20:32:18 UTC.