KURA Kura Oncology Inc.

32.28
+2  (+7%)
Previous Close 30.28
Open 30.25
52 Week Low 6.35
52 Week High 35.25
Market Cap $1,816,817,790
Shares 56,283,079
Float 55,915,010
Enterprise Value $1,360,384,723
Volume 621,345
Av. Daily Volume 684,498
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Upcoming Catalysts

Drug Stage Catalyst Date
KO-539
Relapsed or refractory acute myeloid leukemia (AML)
Phase 1
Phase 1
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Tipifarnib
Chronic myelomonocytic leukemia (CMML) - cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC) with HRAS Mutations
Phase 2
Phase 2
Phase 2 mature data presented at ASCO May 29, 2020 - Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC
KO-947
Solid tumors
Phase 1
Phase 1
Phase 1 development terminated - May 4, 2020.
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Phase 2
Registration-directed trial to be initiated in 2H 2020.
Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
Phase 2
Phase 2 enrolling.

Latest News

  1. – Preclinical data support potential to expand therapeutic utility of tipifarnib to HRAS/PI3K dependent tumors representing up to 50% of HNSCC –

    – Company plans to conduct a Phase 1/2 proof-of-concept study of tipifarnib in combination with a PI3Kα inhibitor in relapsed/refractory HNSCC –

    SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported new preclinical data demonstrating the Company's late-stage drug candidate, tipifarnib, shows compelling activity when combined with a PI3Kα inhibitor in models of HRAS/PI3K-dysregulated head and neck squamous cell carcinoma (HNSCC), including tumors…

    – Preclinical data support potential to expand therapeutic utility of tipifarnib to HRAS/PI3K dependent tumors representing up to 50% of HNSCC –

    – Company plans to conduct a Phase 1/2 proof-of-concept study of tipifarnib in combination with a PI3Kα inhibitor in relapsed/refractory HNSCC –

    SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported new preclinical data demonstrating the Company's late-stage drug candidate, tipifarnib, shows compelling activity when combined with a PI3Kα inhibitor in models of HRAS/PI3K-dysregulated head and neck squamous cell carcinoma (HNSCC), including tumors with PIK3CA mutations or amplifications as well as HRAS overexpression.

    These preclinical data were presented at the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics on Saturday. A copy of the poster is available on Kura's website at www.kuraoncology.com/pipeline/publications.

    "In addition to conducting our ongoing registration-directed trial of tipifarnib in recurrent or metastatic HRAS mutant HNSCC (AIM-HN), we are also pioneering new approaches to expand the use of tipifarnib into larger patient populations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The compelling preclinical data underscore the potential to combine tipifarnib with a PI3Kα inhibitor to treat HNSCC patients and support our rationale to prioritize a Phase 1/2 study of tipifarnib in combination with a PI3Kα inhibitor in advanced or unresectable relapsed/refractory HNSCC harboring PIK3CA mutations or amplifications and/or HRAS overexpression."

    HRAS, both in the mutant and overexpressed form, acts as a key node at the center of HNSCC tumor biology, while PIK3CA represents the most commonly dysregulated oncogene in HNSCC tumors. As concluded in the presentation, Kura's preclinical data support the observation that the HRAS and PI3K pathways are complementary in HNSCC, each providing compensatory mechanisms of resistance to single agent inhibition of the other. Specifically, additive or synergistic activity was observed with administration of the combination of tipifarnib and a PI3Kα inhibitor in a panel of 16 patient-derived xenograft models representative of these HNSCC genotypes.

    It is estimated that up to 20% of HNSCC patients have tumors that overexpress HRAS, and an additional 35% have PIK3CA-dependent tumors. Although the precise overlap between the HRAS overexpressed and PI3K-dysregulated HNSCC populations is still being evaluated, the Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.

    About HNSCC

    Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 885,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

    About Tipifarnib

    Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Tipifarnib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with HRAS mutant HNSCC, which represents 4-8% of HNSCC patients. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

    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 two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia (AML). For additional information about Kura, please visit the Company's 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, Kura's potential for growth. 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 Oncology 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," "anticipated," "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 Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke Partners, LLC

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

    Primary Logo

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  2. SAN DIEGO, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, today announced that an abstract reporting preliminary data from KOMET-001, an ongoing clinical trial of the Company's oral, potent and selective menin inhibitor, KO-539, has been accepted for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

    The following abstract will be posted on the ASH website at 9:00 a.m. ET on November 5, 2020. Updated data will be presented at the meeting.

    Title: Preliminary Data on a Phase 1/2A First in Human Study of the Menin-KMT2A (MLL) Inhibitor KO-539 in Patients…

    SAN DIEGO, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, today announced that an abstract reporting preliminary data from KOMET-001, an ongoing clinical trial of the Company's oral, potent and selective menin inhibitor, KO-539, has been accepted for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

    The following abstract will be posted on the ASH website at 9:00 a.m. ET on November 5, 2020. Updated data will be presented at the meeting.

    Title: Preliminary Data on a Phase 1/2A First in Human Study of the Menin-KMT2A (MLL) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

    Publication Number: 115

    Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel promising therapies for relapsed/refractory AML

    Session Date: Saturday, December 5, 2020

    Session Time: 9:30 AM - 11:00 AM

    Presentation Time: 10:30 AM

    About KOMET-001

    KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2A study to determine the safety, tolerability and recommended Phase 2 dose of KO-539 in patients with refractory or relapsed acute myeloid leukemia (AML). A planned expansion phase in specific genetic subgroups, including NPM1 mutant AML and KMT2A rearranged AML, is expected to further evaluate anti-leukemic activity and tolerability of KO-539. Additional information about the Phase 1/2A study of KO-539 can be found at kuraoncology.com/clinical-trials-komet.

    About KO-539

    KO-539, an oral investigational drug candidate, is a novel compound targeting the menin-KMT2A (MLL) interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, KO-539 inhibits the KMT2A (MLL) protein complex and has downstream effects on HOXA9/MEIS1 expression. KO-539 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

    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 two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company's pipeline is also highlighted by KO-539, a potent and selective menin inhibitor currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke Partners, LLC

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

     

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  3. SAN DIEGO, Sept. 08, 2020 (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 announced that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming virtual investor conferences: 

    • A fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020 at 11:30 a.m. ET / 8:30 a.m. PT; and

    • A fireside chat at the 2020 Cantor Virtual Global Healthcare Conference on September 16, 2020 at 4:00 p.m. ET / 1:00 p.m. PT.

    Live audio webcasts of the fireside chats will be available in the Investors section of Kura's website at www.kuraoncology.com

    SAN DIEGO, Sept. 08, 2020 (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 announced that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming virtual investor conferences: 

    • A fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020 at 11:30 a.m. ET / 8:30 a.m. PT; and



    • A fireside chat at the 2020 Cantor Virtual Global Healthcare Conference on September 16, 2020 at 4:00 p.m. ET / 1:00 p.m. PT.

    Live audio webcasts of the fireside chats will be available in the Investors section of Kura's website at www.kuraoncology.com, with an archived replay available for 30 days following the events.

    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 two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke ICR

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

    Primary Logo

    View Full Article Hide Full Article
  4. SAN DIEGO, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, today announced the appointment of Stephen Dale, M.D., as Chief Medical Officer. Dr. Dale joins Kura most recently from Kyowa Kirin, where he served as Senior Vice President and Global Head of Medical Science with a primary focus in oncology.

    "I am delighted that Stephen is joining Kura to lead our clinical development organization," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "His extensive background in medical oncology, including the successful development of multiple targeted therapies coupled…

    SAN DIEGO, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, today announced the appointment of Stephen Dale, M.D., as Chief Medical Officer. Dr. Dale joins Kura most recently from Kyowa Kirin, where he served as Senior Vice President and Global Head of Medical Science with a primary focus in oncology.

    "I am delighted that Stephen is joining Kura to lead our clinical development organization," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "His extensive background in medical oncology, including the successful development of multiple targeted therapies coupled with his leadership skills and experience at leading late-stage drug development teams, will be invaluable as we continue to advance the development of tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)."

    Dr. Dale is a recognized R&D leader with expertise in oncology and immuno-oncology across both early and late-stage clinical development. As Global Head of Medical Sciences for Kyowa Kirin, he was responsible for pan-therapy areas, including Oncology, Neuroscience, Immunology and Rare Diseases, and was a significant contributor to both FDA and EMA approvals in oncology and neurosciences. Previously, he held a series of roles of increasing responsibility at AstraZeneca, most recently as Global Clinical Vice President and Clinical Head of Oncology - GMed, where he oversaw the development of Tagrisso® (osimertinib) for metastatic EGFR-T790M mutation-positive non-small cell lung cancer (NSCLC). He also worked with the Iressa® (gefitinib) team on the IPASS study in patients with EGFR activating mutations, which evoked a paradigm shift in the way NSCLC is treated. Dr. Dale earned his MD from the University of Manchester Medical School.

    "I'm delighted to join Kura and truly honored to serve the organization as Chief Medical Officer," said Dr. Dale. "I'm highly impressed with their proven scientific rigor and commitment to bringing new cancer medicines to patients in areas of high unmet medical need. This is an exciting time for the company, with the registration-directed study of tipifarnib well underway, the potential to expand the utility of tipifarnib into HRAS and PI3K-dependent head and neck squamous cell carcinomas (HNSCC) as well as preliminary data from the emerging menin inhibitor program, KO-539, in AML anticipated later this year. I look forward to working with this talented team to drive these clinical programs through registration-directed trials and potential regulatory approval."

    Bridget Martell, M.A., M.D., Kura's acting Chief Medical Officer, will transition to the role of Senior Scientific Advisor, where she will continue to advise Kura on initiatives in research and development and corporate strategy.

    "I'd like to take this opportunity to thank Bridget for stepping up and leading the clinical development organization as acting Chief Medical Officer through this period of transition," continued Dr. Wilson. "She has been instrumental in positioning both tipifarnib and KO-539 for success in the clinic and I am pleased that we will continue to benefit from her experience and leadership going forward."

    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 two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory AML. For additional information about Kura, please visit the Company's 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, Kura's potential for growth. 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 Oncology 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," "anticipated," "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 Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke Partners, LLC

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

    Primary Logo

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  5. – Anticipate preliminary data presentation of menin inhibitor program, KO-539, at ASH –

    – Continued progress in registration-directed trial of tipifarnib in HRAS mutant HNSCC –

    – Opportunity to expand to HRAS and PI3K dependent tumors with potential to target up to 50% of HNSCC –

    – $338.9 million in cash, cash equivalents and investments provide runway into 2023 –

    – Management to host webcast and conference call today at 4:30 p.m. ET –

    SAN DIEGO, Aug. 06, 2020 (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 second quarter 2020 financial results and provided a corporate update.

    "Last…

    – Anticipate preliminary data presentation of menin inhibitor program, KO-539, at ASH –

    – Continued progress in registration-directed trial of tipifarnib in HRAS mutant HNSCC –

    – Opportunity to expand to HRAS and PI3K dependent tumors with potential to target up to 50% of HNSCC –

    – $338.9 million in cash, cash equivalents and investments provide runway into 2023 –

    – Management to host webcast and conference call today at 4:30 p.m. ET –

    SAN DIEGO, Aug. 06, 2020 (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 second quarter 2020 financial results and provided a corporate update.

    "Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe tipifarnib and KO-539 provide opportunities to address large proportions of head and neck cancers and acute leukemias, respectively. Now, following a successful public offering this past quarter, we are well-positioned to advance each of these programs toward important upcoming catalysts."

    Corporate Update

    • Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the American Society of Hematology Annual Meeting in December 2020, and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.

       
    • Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program in May 2020. The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company's efforts in HRAS mutant HNSCC, a disease of high unmet need.

       
    • Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.

       
    • Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.

    Financial Results

    • Research and development expenses for the second quarter of 2020 were $13.7 million, compared to $11.4 million for the second quarter of 2019.

       
    • General and administrative expenses for the second quarter of 2020 were $7.5 million, compared to $4.5 million for the second quarter of 2019.

       
    • Net loss for the second quarter of 2020 was $20.5 million, compared to a net loss of $14.9 million for the second quarter of 2019.

       
    • Cash, cash equivalents and short-term investments totaled $338.9 million as of June 30, 2020, including net proceeds of approximately $134.9 million from a public offering completed in May 2020, compared with $236.9 million as of December 31, 2019.

       
    • Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.

    Conference Call and Webcast

    Kura's management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (866) 278-7953 for domestic callers and +1 (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast of the call will be available from the Investors and Media section of the Company's website at www.kuraoncology.com, and will be archived there for 30 days.

    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 two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory AML. For additional information about Kura, please visit the Company's 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, tipifarnib and KO-539, 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 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, applications and other interactions with regulatory bodies, the risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, 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, 
      2020  2019  2020  2019 
    Operating Expenses:                
    Research and development $13,697  $11,440  $26,272  $21,822 
    General and administrative  7,476   4,451   15,101   9,020 
    Total operating expenses  21,173   15,891   41,373   30,842 
    Other income, net  686   948   1,676   1,959 
    Net loss $(20,487) $(14,943) $(39,697) $(28,883)
    Net loss per share, basic and diluted $(0.40) $(0.38) $(0.82) $(0.75)
    Weighted average number of

      shares used in computing net loss

      per share, basic and diluted
      51,633   38,928   48,522   38,550 
                     



    KURA ONCOLOGY, INC. 
    Balance Sheet Data 
    (unaudited) 
    (in thousands) 
             
      June 30,  December 31, 
      2020  2019 
    Cash, cash equivalents and short-term investments $338,869  $236,891 
    Working capital  323,635   224,039 
    Total assets  353,000   241,972 
    Long-term liabilities  12,075   7,627 
    Accumulated deficit  (252,574)  (212,877)
    Stockholders' equity  322,374   218,781 



    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke ICR

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

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