Page 1

KURA ONCOLOGY Kura Oncology Provides Update on Phase 1b Study of KO - 539 in Acute Myeloid Leukemia November 24 , 2021 Management to host webcast and conference call today at 8:30 a.m. ET SAN DIEGO , Nov. 24 , 2021 ( 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 the U.S. Food and Drug Administration ( FDA ) has placed the KOMET - 001 Phase 1b study of KO - 539 in patients with relapsed or refractory acute myeloid leukemia ( AML ) on a partial clinical hold . The partial clinical hold was initiated following the Company's recent report to the FDA of a Grade 5 serious adverse event ( patient death ) potentially associated with differentiation syndrome , a known adverse event related to differentiating agents in the treatment of AML . Patients currently enrolled in the Phase 1b study may continue to receive KO - 539 , although no additional patients may be enrolled until the partial clinical hold is resolved . Kura is working closely with the FDA and the site investigators to resolve the partial clinical hold as quickly as possible . " We share the FDA's commitment to patient safety , and we appreciate our ongoing dialogue as we work diligently to address their questions , ” said Troy Wilson , Ph.D. , J.D. , President and Chief Executive Officer of Kura Oncology . “ Differentiation syndrome is known to be an on - target effect associated with therapeutic agents that induce differentiation , and we want to ensure physicians are fully informed and prepared to address these events if they occur . Based on the totality of preclinical and clinical data , we continue to believe that KO - 539 has the potential to address the significant unmet medical need of AML patients , including those with NPM1 mutations and KMT2A rearrangements . " Until the partial clinical hold is resolved , and the Company has more clarity regarding the impact on timing , Kura is suspending guidance on the completion of enrollment in the KOMET - 001 Phase 1b study and determination of the recommended Phase 2 dose of KO - 539 . Conference Call and Webcast Kura's management will host a webcast and conference call at 8:30 a.m. ET / 5 : 30 a.m. PT today , November 24 , 2021. The live call may be accessed by dialing ( 877 ) 516-3514 for domestic callers and ( 281 ) 973-6129 for international callers and entering the conference code : 2452338. 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 . KO - 539 , a potent and selective menin inhibitor , is currently in a Phase 1b clinical trial ( KOMET - 001 ) for patients with relapsed / refractory AML , including patients with NPM1 mutations or KMT2A rearrangements . Tipifarnib , a potent , selective and orally bioavailable farnesyl transferase inhibitor , has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration - directed study ( AIM - HN ) in patients with this devastating disease . In addition , Kura is pursuing the use of tipifarnib in combination with other oncology therapeutics to address larger genetic subsets of patients , including those who have HRAS- and / or PIK3CA - dependent HNSCC . The Company is also developing KO - 2806 , a next - generation farnesyl transferase inhibitor , which is intended to target innovative biology and larger oncology indications through rational combinations . 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 ability to resolve the partial clinical hold , including the timing of any such resolution , the efficacy , safety and therapeutic potential of KO - 539 , and progress and expected timing of the KO - 539 development program and clinical trial . 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 ( SEC ) , including the Company's Form 10 - Q for the quarter ended September 30 , 2021 filed with the SEC on November 4 , 2021 , 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 . Contacts Company : Pete De Spain Vice President , Investor Relations &