Kura Oncology, Inc. (NASDAQ:KURA) Q4 2023 Earnings Call Transcript
Kura Oncology, Inc. (NASDAQ:KURA) Q4 2023 Earnings Call Transcript February 27, 2024
Kura Oncology, Inc. beats earnings expectations. Reported EPS is $-0.55, expectations were $-0.56. Kura Oncology, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon, ladies and gentlemen, and welcome to the Q4 2023 Kura Oncology, Inc. Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Tuesday, February 27, 2024. I would now like to turn the conference over to Pete De Spain, Head of Investor Relations. Please go ahead.
Pete De Spain: Great, thank you, Eric. Good afternoon and welcome to Kura Oncology's fourth quarter and full-year 2023 conference call. Joining me on the call are Dr. Troy Wilson, our President and CEO 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. Let's jump right in. Last month we reported preliminary clinical data from the first 20 patients in KOMET-007, a Phase 1 dose escalation trial of our Menin inhibitor, Ziftomenib in combination with standards of care in patients with NPM1 mutant and KMT2A rearranged acute myeloid leukemia. The first 20 patients were enrolled in fewer than four months from July to November of last year, including five newly diagnosed patients with adverse risk AML and 15 patients with relapsed refractory AML. Ziftomenib demonstrated a highly encouraging safety and tolerability profile in combination with cytarabine plus daunorubicin or 7+3 as well as with Venetoclax plus Azacitidine enabling continuous administration of Ziftomenib while effectively mitigating the risk of differentiation syndrome.
In fact, no differentiation syndrome events of any grade were reported among the first 20 patients. Furthermore, no dose limiting toxicities, QTc prolongation, drug, drug interactions or additive myelosuppression were observed. As of the data cutoff on January 11, all five newly diagnosed patients with adverse risk NPM1 mutant or KMT2A rearranged AML treated with Ziftomenib in 7+3 achieved a complete remission with full count recovery for a CR rate of 100%. The overall response rate among the 15 relapsed refractory patients treated with Ziftomenib and Ven/Aza was 53%, including a 40% ORR among the 10 patients who had received prior Venetoclax, a setting with very limited effective treatment options. Notably, the CR/CRh rate among the nine relapsed refractory patients who were Menin inhibitor naive was 56%.
As of the data cutoff, 16 of the first 20 patients remained on trial, including all 11 NPM1 mutant patients. Continuous daily dosing of Ziftomenib at 200 milligrams QD was well tolerated and the safety profile was consistent with features of underlying disease and backbone therapies. As we reported on January 30, the 200 milligram dose of Ziftomenib has been cleared in both relapsed refractory Ven/Aza cohorts and enrollment at the 400 milligram dose continues. In the meantime, I'm pleased to report we've also escalated to the 400 milligram dose of Ziftomenib in the frontline adverse risk NPM1 mutant 7+3 cohort and we anticipate clearing the 200 milligram dose in the frontline KMT2A rearranged 7+3 cohort shortly. At this rate, we expect to determine the recommended Phase 2 dose for Ziftomenib in combination with Ven/Aza and in combination with 7+3 by the middle of this year.
After determination of the recommended Phase 2 dose, we plan to initiate a Phase 1b dose validation expansion with Ziftomenib in Ven/Aza in newly diagnosed with patients with NPM1 mutant and KMT2A rearranged AML. In the meantime, we're now dosing patients in our KOMET-008 study of Ziftomenib in combination with additional standards of care, including the FLT3 inhibitor, Gilteritinib, FLAG-IDA or LDAC, all for the treatment of relapsed refractory NPM1 mutant or KMT2A rearranged AML, roughly half of patients with relapsed or refractory NPM1 mutant AML have cooccurring FLT3 mutations and the prognosis for these patients is particularly poor. Preclinical data for Ziftomenib in combination with FLT3 inhibitors demonstrates strong synergistic effects compared to either single agent alone.
We believe a best-in-class safety and activity profile and optimum pharmaceutical properties will enable Ziftomenib to become a cornerstone of therapy for patients with acute leukemias. This belief is supported by growing investigator enthusiasm as evidenced by rapid enrollment across all of our ongoing Ziftomenib studies. We continue to be encouraged by the rate of enrollment in KOMET-001, our Phase 2 registration directed trial of Ziftomenib in patients with relapsed refractory NPM1 mutant AML and we remain on pace to complete enrollment of all 85 patients in the trial by the middle of this year. Our mission is to develop Ziftomenib across the continuum of care for all patients with acute leukemias whose disease is driven by the Menin pathway, including pediatrics where poor outcomes unfortunately remain.
In December, we announced Ziftomenib was selected for the Leukemia and Lymphoma Society's Pediatric Acute Leukemia Master Clinical Trial commonly known as PedAL. As part of the study, Ziftomenib will be evaluated in combination with chemotherapy in pediatric patients with relapsed refractory, KMT2A rearranged, NUP98-rearranged or NPM1-mutant acute leukemia. In addition, we recently began dosing patients with KMT2A rearranged acute lymphoblastic leukemia, a relatively small group of patients, but with a very large unmet medical need, as well as a cohort of patients who have neither NPM1 mutant nor KMT2A rearranged AML. We also have a growing body of preclinical data that supports attractive opportunities for Menin inhibitors beyond acute leukemias.
We're now preparing to initiate a proof-of-concept study in an undisclosed solid tumor indication later this year. Meanwhile, we continue to make progress toward a next generation Menin inhibitor, which we intend to direct to an additional soon to be disclosed indication. And with our recent financing, we remain in a strong financial position, which enables us to invest aggressively in research, development and precommercial activities to maximize the value of Ziftomenib and support our other pipeline assets. Now let's turn our attention to our Farnesyl Transferase Inhibitor Programs beginning with KO-2806. Despite success of targeted cancer drugs such as Tyrosine Kinase inhibitors and KRAS inhibitors, a considerable need remains to drive enhanced antitumor activity while addressing mechanisms of innate and adaptive resistance.
We are developing our next generation Farnesyl Transferase Inhibitor KO-2806 to address this need. 2806 was designed to improve upon the potency, pharmacokinetic and physio chemical properties of earlier FTI drug candidates. Last year, we presented compelling preclinical data supporting the rationale for combining KO-2806 with distinct classes of targeted therapies, including Tyrosine Kinase inhibitors and KRAS inhibitors. In October, we began dosing patients with KO-2806 as a monotherapy in a Phase 1 dose escalation trial that we call FIT-001. FIT-001 uses an innovative design that enables us to begin dose escalation of KO-2806 in combination cohorts very early on in the study while continuing to dose escalate concurrently as a monotherapy.
We're now preparing to dose the first patients with KO-2806 in combination with Cabozantinib in clear cell renal cell carcinoma and in combination with Adagrasib in KRAS G12C mutated non-small cell lung cancer by the middle of this year. Recall in November, we announced a clinical collaboration and supply agreement with Mirati Therapeutics, now Bristol Myers Squibb to support that latter study. We're encouraged that the strong operational execution seen in the Ziftomenib trials has carried over to the FIT-001 study and look forward to realizing the promise of the combinations. If successful, we believe KO-2806 could become an ideal combination partner for multiple targeted therapies in large solid tumor indications. Meanwhile, we continue to evaluate our first generation FTI Tipifarnib in combination with the targeted therapy Alpelisib, building on impressive clinical benefit we observed with Tipifarnib alone in head and neck cancer.
We continue to evaluate patients in the dose escalation study of Tipifarnib and Alpelisib, which we call KURRENT-HN. Given encouraging clinical activity observed at multiple dose levels, we're adding additional patients to help inform selection of the optimal biologically active dose for the combination. Once we determine the OBAD later this year, we'll determine the next steps for the program. Importantly, we are encouraged that Tipifarnib continues to demonstrate a favorable safety and tolerability profile at its full dose in combination with Alpelisib. We believe this significantly derisks development of our next generation FTI KO-2806 as we begin to evaluate it in combination with other targeted therapies. And with that, I'll now turn the call over to Tom Doyle for a discussion of our financial results.
Tom?
Tom Doyle: Thank you, Troy, and good afternoon everyone. I'm happy to provide a brief overview of our financial results for the fourth quarter and full-year 2023. Research and development expenses for the fourth quarter of 2023 were $32.5 million compared to $22.7 million for the fourth quarter of 2022. R&D expenses for the full-year 2023 were $115.2 million compared to $92.8 million for the prior year. The increase in R&D expenses was primarily due to increases in clinical trial costs related to our Ziftomenib and KO-2806 programs. General and administrative expenses for the fourth quarter of 2023 were $14.2 million compared to $12.5 million for the fourth quarter of 2022. G&A expenses for the full-year of 2023 were $50.6 million compared to $47.1 million for the prior year.
Net loss for the fourth quarter of 2023 was $42.8 million compared to a net loss of $33.1 million for the fourth quarter of 2022. Net loss for the full-year of 2023 was $152.6 million compared to a net loss of $135.8 million for the prior year. Net loss for the fourth quarter and full-year of 2023 included non-cash share based compensation expense of $7.2 million, and $28.1 million respectively. This compares to $6.8 million and $26.3 million for the same periods in 2022. As of December 31, 2023 we had cash, cash equivalents and short-term investments of $424 million compared to $438 million as of December 31, 2022. Subsequently, on January 26, 2024 we completed an oversubscribed private placement with a select group of institutional and accredited healthcare specialist investors.
As adjusted for the approximately $146 million in net proceeds resulting from this private placement, Kura had on a pro form basis $570 million in cash, cash equivalents and short-term investments. We believe that our cash, cash equivalents and short term investments will be sufficient to fund our current operating plan into 2027. With that, I'd now like to 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 upcoming milestones. For Ziftomenib, initiate the post-transplant maintenance program in the first quarter of 2024, complete enrollment of 85 patients in the KOMET-001 registration directed trial in NPM1 mutant AML by mid-2024, determine the recommended Phase 2 dose in combination with Ven/Aza and initiate dose validation expansion in frontline AML by mid-2024 and determine the recommended Phase 2 dose in combination with 7+3 by mid-2024. For KO-2806 dose the first patients in combination with Cabozantinib in clear cell renal cell carcinoma by 2024 and dose the first patients in combination with Adagrasib in KRAS G12C mutated non-small cell lung cancer by mid-2024.
And for Tipifarnib, complete enrollment of two expansion cohorts to support determination of the optimal biologically active dose in combination with Alpelisib by the end of 2024. With that Eric, we are now ready for questions.
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