Latest news with #KuraOncologyInc
Yahoo
02-05-2025
- Business
- Yahoo
Kura Oncology Inc (KURA) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Rising Costs
Collaboration Revenue: $14.1 million for Q1 2025, compared to no revenue in Q1 2024. Research and Development Expenses: $56 million for Q1 2025, up from $36.3 million in Q1 2024. General and Administrative Expenses: $22.8 million for Q1 2025, compared to $18.2 million in Q1 2024. Net Loss: $57.4 million for Q1 2025, compared to $49.5 million in Q1 2024. Cash, Cash Equivalents, and Short-term Investments: $658.2 million as of March 31, 2025, compared to $727.4 million as of December 31, 2024. Pro Forma Cash Position: $703.2 million as of March 31, 2025, adjusted for a $45 million milestone payment. Warning! GuruFocus has detected 3 Warning Signs with KURA. Release Date: May 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kura Oncology Inc (NASDAQ:KURA) has submitted a New Drug Application (NDA) for ziftomenib, a menin inhibitor, for the treatment of relapsed or refractory NPM1-mutant acute myeloid leukemia (AML), marking a significant regulatory milestone. The company has achieved a $45 million milestone payment from its collaboration with Kyowa Kirin, enhancing its financial position. Kura Oncology Inc (NASDAQ:KURA) has a strong cash position with $703.2 million in cash, cash equivalents, and short-term investments, providing sufficient capital to fund its ziftomenib AML program through commercialization. The company is advancing its FTI program, with plans to share preliminary clinical data from multiple Phase 1 cohorts later this year, indicating potential for FTIs as combination therapies. Kura Oncology Inc (NASDAQ:KURA) has announced the appointment of Samir Vattompadam as Senior Vice President, Global Program Leadership, bringing over 20 years of experience in the biotech and pharmaceutical industry to the team. Research and development expenses increased to $56 million in Q1 2025 from $36.3 million in Q1 2024, indicating rising costs. The company reported a net loss of $57.4 million for Q1 2025, compared to a net loss of $49.5 million in Q1 2024, reflecting ongoing financial challenges. General and administrative expenses rose to $22.8 million in Q1 2025 from $18.2 million in the same period in 2024, suggesting increased operational costs. Despite progress, the competitive landscape for menin inhibitors in the relapsed/refractory AML setting remains challenging, with other companies also advancing in this space. The company faces potential uncertainties in the regulatory approval process, although it has not experienced any disruptions or delays so far. Q: Can you set expectations for the combo data coming later this year, especially the aza/ven cohort? What do you need to show to be competitive? A: We are primarily focused on safety in these preliminary data presentations. We want to establish the ability to safely combine ziftomenib with venetoclax in the frontline. We aim to demonstrate the combinability of ziftomenib without added toxicity or adverse events. We remain on track to start the study in the second half of 2025. - Mollie Leoni, Chief Medical Officer Q: How have changes at the regulatory agency impacted the potential approval process and timelines for ziftomenib? A: We have not seen any impact from changes at the FDA. The agency has been responsive and collaborative. We requested priority review and expect to receive notification on the application acceptance and PDUFA date in the second quarter. - Troy Wilson, CEO Q: What is your strategy for capturing market share in the NPM1 setting, given the competitive landscape? A: We emphasize safety, tolerability, and clinical activity. We believe ziftomenib will be competitive in the relapsed/refractory setting. We are working with Kyowa Kirin to bring resources and focus to compete for every patient, aiming for use in earlier lines of therapy and in combination. - Troy Wilson, CEO and Brian Powl, Chief Commercial Officer Q: How do you envision the long-term development of KO-2806 in combination with VEGF TKIs in RCC? A: KO-2806 is seen as highly synergistic with current treatments, potentially offering deeper, longer, and higher response rates. We aim to augment current treatment paradigms, providing additional therapeutic options in RCC. - Mollie Leoni, Chief Medical Officer Q: What are the gating steps before initiating the Phase 3 KOMET-017 trial, and how is the reception from trial investigators? A: We are in study startup, focusing on contracting, budgeting, and site initiation. Investigators are positive about ziftomenib, noting that patients feel the same or better on the therapy. We anticipate excitement to build as more data is shared. - Troy Wilson, CEO and Mollie Leoni, Chief Medical Officer For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
27-02-2025
- Business
- Yahoo
Kura Oncology Inc (KURA) Q4 2024 Earnings Call Highlights: Strategic Advances and Financial Growth
Collaboration Revenue: $53.9 million for Q4 2024, compared to none for Q4 2023. Research and Development Expenses: $52.3 million for Q4 2024, up from $32.5 million for Q4 2023. General and Administrative Expenses: $24.1 million for Q4 2024, compared to $14.2 million for Q4 2023. Net Loss: $19.2 million for Q4 2024, compared to a net loss of $42.8 million for Q4 2023. Non-Cash Share-Based Compensation Expense: $8.6 million for Q4 2024, compared to $7.2 million for Q4 2023. Cash, Cash Equivalents, and Short-Term Investments: $727.4 million as of December 31, 2024, including a $330 million upfront payment from Kyowa Kirin, compared to $424 million as of December 31, 2023. Warning! GuruFocus has detected 2 Warning Sign with KURA. Release Date: February 26, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kura Oncology Inc (NASDAQ:KURA) is poised to submit its first NDA for ziftomenib, a potentially best-in-class menin inhibitor for relapsed/refractory NPM1-mutant AML. The company has reached alignment with both the FDA and EMA on potential accelerated approval pathways for ziftomenib in frontline AML. Kura Oncology Inc (NASDAQ:KURA) reported positive top-line results from the KOMET-001 Phase II trial, achieving its primary endpoint with a 20% to 30% CR/CRh rate. The company is well-financed, with cash, cash equivalents, and short-term investments totaling $727.4 million, sufficient to fund operations into 2027. Kura Oncology Inc (NASDAQ:KURA) has a strong pipeline with multiple clinical data updates expected throughout the year, including the initiation of the KOMET-015 trial in GIST and the KOMET-017 trials in AML. The anticipated top-line results for the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting are not expected until 2028, which may be seen as a long timeline for investors. Research and development expenses increased significantly to $52.3 million in Q4 2024 from $32.5 million in Q4 2023, indicating rising costs. General and administrative expenses also rose to $24.1 million in Q4 2024 from $14.2 million in Q4 2023, reflecting higher operational costs. Despite positive developments, the net loss for Q4 2024 was $19.2 million, although this was an improvement from a $42.8 million loss in Q4 2023. There is potential uncertainty regarding the acceptance of MRD-negative CR as a surrogate endpoint by global health authorities, which could impact regulatory approval timelines. Q: Troy, you guided to the Phase III top-line in frontline intensive AML setting in 2028. Just curious what assumptions went into that guidance? And anything you can share on the trial size, that plan or enrollment timeline? A: Yes, Li, thanks for the question. We thought it was important because we've been getting questions from both analysts and investors to give people some idea of the timeline, particularly now that we've gained alignment with both FDA and EMA, but specifically with FDA on pathways to accelerated approval in the U.S. and we feel comfortable. We think we're being conservative, but we feel comfortable saying that we think we can have top-line results for that accelerated approval endpoint in 2028. We'll give you more detail on the trial size, the powering, et cetera, as we get a little bit closer to the trials actually going live and being posted on Q: And then just wondering what the remaining items that you may need to work through before the NDA submission. Any notable feedback from the pre-NDA meeting? A: No. I mean, that's -- thank you for the question. I don't know if at the time we made that announcement a few weeks ago, if that -- if people sort of read over that. We were deliberate actually in not saying anything until after we've had the pre-NDA meeting. And the team -- Mollie and the team did a phenomenal job of again gaining alignment with the agency on all the aspects of the submission. Clearly, the clinical data is always the long pole in the tent, and that's what is driving the timing of the submission at this point. But given that we have BTD and given that we've had pretty constructive engagements not only on the monotherapy, but now in the combination setting with FDA, we feel like we're in good shape. And again, we're guiding to a second quarter submission. The team is doing everything in its power to accelerate those timelines. But so far, I think we have everything we need and we've gotten very -- it's been a very constructive series of interactions with the agency. Q: So the first question I have is that when we look at the commercial opportunities for ziftomenib, I guess, the most important variable is the treatment duration. Could you share the reason behind your confidence that frontline AML patients will be able to stay on the treatment for more than a year? A: Yes. Let me actually -- Yen-Der, thank you for the question. I'm actually going to do this in 2 parts. Maybe Mollie can speak to how we've informed the duration of treatment from our experience with KOMET-007. And then I'll ask -- after she answers, I'll ask Brian to comment on how does that translate into our assumptions around the commercial potential in the frontline. Mollie, if you would? Sure. As Troy alluded to, the 007 trial has been highly informative to how we handle designing and our expectations for the 017 trial and for use in the frontline in general. I think initially, we thought that, especially with the intensive chemo setting, the use would be some induction, some consolidation, then the patient will go off to transplant and potentially some proportion would come back after transplant, post consolidation maintenance. What we're seeing is incredibly different, especially for the NPM1 patients that make up such a large majority of the patient population. These patients are coming on doing induction, consolidation and post-continuation consolidation immediately with few trips to transplant, except for the KMT2As who get to transplant whenever possible and then almost universally either have returned or intend to return to post-consolidation, post-transplant maintenance. Similarly, with the ven/aza, we have patients that are staying on for very prolonged periods of time on treatment in the frontline even when -- or if the backbone drops away or is decreased in intensity or used a little bit differently from when it's used prior to gaining control of disease. So we're seeing good prolonged use in each of these that was probably more significant than what we initially thought. But with that, Brian, I'll turn it over to you to how you see that translating. Sure. And based on the assumptions that we are observing -- or what we've observed in the trial, like Mollie said, we do think there's a tremendous potential that menin inhibitors could transform the treatment of AML with patients being able to get on therapy, stay on therapy for a long period of time. When you think about our opportunities with -- and as we've stated that we think this could be -- as Troy said, it could be a $7 billion potential market. If you're able to get patients to receive menin inhibitor for 18 to 24 months, and there could be potential for longer than that, but if you think between that 18 to 24 months in the FIT intensive chemo population and then 18 months plus within the non-intensive, that gives you a significant duration that we think really could reflect that transformative potential and really kind of align with what we've seen in some other markets like multiple myeloma where long duration of treatments with IMiDs have really transformed the market and also the outcomes for patients. Q: Congrats on the progress. I was curious, as you look to the additional dose expansion data from the 007 study, what in your view would be encouraging from the 7+3 combo as you start to expand into the non-adverse risk group? Specifically in terms of MRD negativity, what gives you -- what would give you confidence that addition of zifto would ultimately give you a survival benefit? A: Yes. Jason, thanks for the question. I'm going to ask Mollie to speak to it. But Molly, maybe you can take a minute and help folks understand how we think about the MRD negativity and sort of what the standard is as you answer Jason's question. Absolutely. So what we understand, obviously, we're part of a consortium of a large amount of pharmaceutical companies that are really looking into this MRD negativity for this patient population. And we have access, therefore, to both published and unpublished data from those other pharmaceutical companies as well as from some of the key opinion leaders that are really advancing the MRD as an endpoint in AML. So we understand that a good outcome for these patients with the current treatments available would be to see about a 40% to 45% MRD negativity in the bone marrow. And that's for the better performing patients, so your NPM1s, for instance. So we would expect that any incremental increase in that would be due to the influence of having a targeted agent in the mix as well and maybe getting into the 50s and 60% MRD negativity rate would be encouraging for translation into the overall survival as well. So that's the way we're thinking about our data as we continue to look at these patients enrolling. Obviously, you've seen the patients do very well from a response perspective. So I wouldn't expect to see much difference in that. They're going to continue to do well. But it's -- as you're pointing to, the MRD that is what we're looking at to make sure we're headed in the right For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Washington Post
26-02-2025
- Business
- Washington Post
Kura Oncology: Q4 Earnings Snapshot
SAN DIEGO — SAN DIEGO — Kura Oncology Inc. (KURA) on Wednesday reported a loss of $19.2 million in its fourth quarter. On a per-share basis, the San Diego-based company said it had a loss of 22 cents. The results topped Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 63 cents per share.
