Kura Oncology, Inc. (NASDAQ:KURA) Q1 2023 Earnings Call Transcript
Kura Oncology, Inc. (NASDAQ:KURA) Q1 2023 Earnings Call Transcript May 10, 2023
Kura Oncology, Inc. beats earnings expectations. Reported EPS is $-0.5, expectations were $-0.54.
Operator: Good afternoon, ladies and gentlemen, and welcome to the Q1 2023 Kura Oncology, Inc. Earnings Conference Call. [Operator Instructions]. This call is being recorded on Wednesday, May 10, 2023. I would now like to turn the conference over to Pete De Spain, Senior Vice President of Investor Relations and Communications. Please go ahead.
Pete De Spain: Great. Thank you, Julie. Good morning, and welcome to Kura Oncology's First Quarter 2023 Conference Call. Joining me on the call are Dr. Troy Wilson, our President and Chief Executive Officer; and Tom Doyle, our Senior Vice President of Finance and Accounting. Before I turn the call over to Dr. Wilson, I'd like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I'll now turn the call over to Troy.
Troy Wilson: Thank you, Pete, and thank you all for joining us. Our strong conviction in ziftomenib and its potential to be the best-in-class menin inhibitor continues to increase. This confidence is supported by one of the highest complete response rates reported for a targeted therapy in the setting of relapsed/refractory leukemia and is reinforced by the rapid pace of enrollment in our registration-directed trial. More on that in just a moment. We're also encouraged by the durable remissions in our Phase I trial, driven primarily by single-agent activity of ziftomenib, and we look forward to sharing an update at the European Hematology Association Congress next month. You've got a glimpse of these data in our recently released abstract, which showed that ziftomenib continues to demonstrate significant clinical activity in patients with heavily pretreated and co-mutated relapsed refractory NPM1 mutant AML.
As of January 31 data cutoff, 6 of the 20 NPM1 patients treated at the recommended Phase 2 dose achieved complete responses with full count recovery. The abstract showed a median duration of response of 8.2 months with a median follow-up of approximately 8 months. 4 patients were still ongoing at the time of data cutoff. Ziftomenib is well tolerated and the on-target effect of differentiation syndrome is manageable. We are excited by these evolving data, and we look forward to reporting updated data as of an early April data cutoff. Now building on the momentum generated by our positive Phase 1 data, we announced in February that the first patients were dosed in our Phase 2 registration-directed trial of ziftomenib in NPM1 mutant relapsed or refractory AML.
Site activation and enrollment in our registration-directed study are outperforming our projections, an indication of the continued enthusiasm surrounding ziftomenib among investigators and patients. As a reminder, 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. Once the disease becomes relapsed or refractory, the prognosis for NPM1 mutant AML patients is particularly poor, with an overall survival of approximately 6 months after initial chemotherapy. NPM1 mutant AML is further compounded with co-mutations such as IDH or FLT3, notably in our Phase I trial for ziftomenib, 2/3 of NPM1-mutant AML patients who achieved a CR at 600 milligrams had IDH and/or FLT3 co-mutations, all of whom have failed prior treatment with IDH and/or FLT3 targeted inhibitors.
A complete response rate with full count I'm sorry, a 30% complete response rate with full count recovery after prior failure of these targeted therapies makes the clinical activity of Ziftomenib even more striking. We're also impressed with the potential for ziftomenib to drive durable remissions as a monotherapy, and additional NPM1 mutant patient who entered the trial with multiple code mutations, including DNMT3A, following 2 prior stem cell transplants achieved a CR with no evidence of minimal residual disease and remains on Ziftomenib for more than 32 cycles as of our January 31 data cutoff. In parallel with our efforts to advance Ziftomenivisim monotherapy, we're preparing to initiate a series of combination studies to significantly broaden the addressable patient population.
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We believe Ziftomenib is uniquely positioned for these combination strategies. This belief is driven by several key competitive advantages, including no evidence of drug-induced QTC prolongation, no predicted adverse drug-drug interactions and once-daily oral dosing that should enable convenient administration with current standards of care. Our team is working diligently to initiate the COMET 007 and COMT008 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including both NPM1 mutant and KMT2A-rearranged AML. We've designed the Phase 1 studies to assess safety, tolerability and antileukemic activity of ziftomenib in combination with key regimens such as venetoclax and azacitidine, the FLT3 inhibitor gilteritinib and the chemotherapy regimen of 7 plus 3.
Our approach to combinations is to establish ziftomenib as a foundational therapy that can be combined safely with various commonly used regimens and then prioritize those combinations that represent the largest unmet medical need and the greatest potential commercial value, namely venetoclax and FLT3 inhibitor containing regimens. Notably, up to half of NPM1 mutant AML patients also exhibit co-mutations in the FLT3 gene. Given the safety profile of ziftomenib, we believe it may be the ideal menin inhibitor to combine with FLT3 inhibitors to address this population, a difficult-to-treat group that represents approximately 15% of AML. We also believe that rational combination approaches will help to mitigate differentiation syndrome in the KMT2A rearranged population as has previously been demonstrated in the development of IDH inhibitors in combination with azacitidine.
We're very excited about the potential for our combination studies to further unlock the value of ziftomenib for patients with acute leukemias. We've begun site activation in the first of these studies, COMET-007, and we're on track to dose first patients this quarter. We're very proud of our team's execution and grateful for the continued support of our studies investigators. Their enthusiasm, coupled with a growing body of clinical data and multiple emerging lines of evidence reinforce our confidence in ziftomenib as the best-in-class menin inhibitor. We look forward to sharing more at our upcoming presentation at EHA. Now let's turn our attention to our farnesyl transferase inhibitor program. Over the past several years, we've pioneered the development of FTIs as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy in large solid tumor indications.
Although targeted therapies have demonstrated meaningful clinical activity across a range of solid tumors, adaptive resistance almost invariably emerges over time, which limits the ability of targeted therapies to drive sustained clinical benefit. We have generated a growing body of preclinical and clinical data that support the combination of SDIs with multiple classes of targeted therapies, including EGFR inhibitors as well as PI3-kinase inhibitors. In April, we presented encouraging preclinical data at the American Association for Cancer Research Annual Meeting, which supports the potential use of FTIs in combination with 2 additional distinct classes of targeted therapy. The first of 2 posters revealed robust synergy between tipifarnib and the standard of care anti-angiogenic TKI, axitinib in cell and patient-derived xenograft models of clear cell renal cell carcinoma.
The second poster reported regression of multiple models of KRAS inhibitor resistant non-small cell lung cancer through the addition of tipifarnib either to adagrasib or sotorasib therapy. These promising preclinical data illustrate the potential for FDIs to drive enhanced antitumor activity as well as address mechanisms of both innate and adaptive resistance to targeted therapies. In addition, we believe these data strongly support our rationale to combine our next-generation FTI, KO-2806 with TKIs in clear cell renal cell carcinoma as well as KRAS G12C mutant inhibitors in non-small cell lung cancer. In January, we were pleased to announce FDA clearance of our investigational new drug application for KO-2806 for the treatment of advanced solid tumors, an important next step for this program.
Now we intend to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 dose escalation study, which we're calling FIT-001. We're now in study startup, and we look forward to dosing the first patients in FIT-001 later this year. Concurrent with the dose escalation as monotherapy, we also plan to evaluate KO2806 in dose escalation combination cohorts in advanced solid tumors. Meanwhile, we continue to evaluate tipifarnib in combination with the PI3 kinase alpha inhibitor, alpelisib, a combination that has potential to address up to half of all patients with recurrent and metastatic HNSCC. We're encouraged by the preliminary activity observed in our ongoing current HN trial, including a durable partial response in a patient with PIK3CA mutated squamous cell carcinoma of the tonsil.
We're also very pleased by our ability to combine tipifarnib with another targeted therapy, in this case, alpelisib with no dose-limiting toxicities reported to date. We remain on track to determine the optimal biologically active dose in mid-2023. We continue to unlock the potential therapeutic and commercial value of farnesyl transferase inhibition, the challenging, but we believe increasingly substantial opportunity that has potential to address large solid tumor indications such as renal cell carcinoma as well as cancers of the lung and colorectal system. As with our menin inhibitor program, we believe FTI programs have potential to create significant value for patients, health care providers and our shareholders. We're confident we have the leadership, experience and operational and financial resources to realize that value.
With that, I'll now turn the call over to Tom Doyle for a discussion of our financial results.
Thomas Doyle: Thank you, Troy, and good afternoon, everyone. I'm happy to provide a brief overview of our financial results for the first quarter of 2023. Research and development expenses for the first quarter of 2023 were $25.2 million compared to $20.9 million for the first quarter of 2022. The increase in R&D expenses was primarily due to increases in clinical trial costs related to our ziftomenib and KO2806 programs, offset by decreases in clinical trial costs related to our tipifarnib program. General and administrative expenses for the first quarter of 2023 were $11.4 million compared to $11.9 million for the first quarter of 2022. Net loss for the first quarter of 2023 was $34.1 million compared to a net loss of $32.5 million for the first quarter of 2022.
This included noncash share-based compensation expense of $6.8 million compared to $6.7 million for the same period in 2022. As of March 31, 2023, we have cash, cash equivalents and short-term investments of $405.9 million compared to $438 million as of December 31, 2022. We believe that our cash, cash equivalents and short-term investments will be sufficient to fund our current operating plan into the fourth quarter of 2025. With that, I now turn the call back over to Troy.
Troy Wilson: Thank you, Tom. Before we jump into the question-and-answer session, let me lay out our anticipated milestones for the remainder of this year. For ziftomenib, dosed the first patients in the COMET-007 combination trial in the first half, present updated data from our Phase 1 trial in NPM1 mutant AML at EHA in June and dose first patients in the COMMET-008 combination trial in the second half. For tipifarnib, determine the optimal biologically active dose in the current HN trial in combination with alpelisib in mid-2023. And for KO-2806, dose first patients in the FIT-001 dose escalation trial in the second half of 2023. With that, operator, we're now ready for questions.
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