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VerastemC
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Investor releaseQuarter not tagged2026-08-13

Verastem (VSTM) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Senior Vice President, Corporate Communications, Investor Relations and Patient Advocacy - Julissa Viana President and Chief Executive Officer - Dan Paterson Chief Commercial Officer - Dan Lyons Chief Financial Officer - Dan Calkins Doctor - Michael Kauffman Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good afternoon and welcome to Verastem Oncology's Second Quarter 2026 Earnings Conference Call. My name is Liviana and I'll be your call operator today. Please note this event is being recorded. [Operator Instructions] I will now turn the call over to Julissa Viana, Senior Vice President, Corporate Communications, Investor Relations and Patient Advocacy at Verastem Oncology. Please go ahead. Julissa Viana: Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verastem's second quarter 2026 financial results and recent business updates. This afternoon we issued a press release detailing these results along with a slide presentation that we will reference during our call today. Both are available on the investor relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we'll be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Joining me on today's call to deliver prepared remarks and take your questions are Dan Paterson, President and Chief Executive Officer; Dan Lyons, Chief Commercial Officer; and Dan Calkins, Chief Financial Officer. Dr. Michael Kauffman will be joining us for the Q&A portion of the call. I will now turn the call over to Dan. Daniel Paterson: Thank you, Julissa. Good afternoon and thank you for joining our call today. We delivered a strong second quarter with meaningful progress across both our commercial business and pipeline. For the quarter, we generated net product revenues of $25.1 million, reflecting continued execution of our commercial strategy, putting us back on track…Read full document

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Senior Vice President, Corporate Communications, Investor Relations and Patient Advocacy - Julissa Viana President and Chief Executive Officer - Dan Paterson Chief Commercial Officer - Dan Lyons Chief Financial Officer - Dan Calkins Doctor - Michael Kauffman Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good afternoon and welcome to Verastem Oncology's Second Quarter 2026 Earnings Conference Call. My name is Liviana and I'll be your call operator today. Please note this event is being recorded. [Operator Instructions] I will now turn the call over to Julissa Viana, Senior Vice President, Corporate Communications, Investor Relations and Patient Advocacy at Verastem Oncology. Please go ahead. Julissa Viana: Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verastem's second quarter 2026 financial results and recent business updates. This afternoon we issued a press release detailing these results along with a slide presentation that we will reference during our call today. Both are available on the investor relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we'll be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Joining me on today's call to deliver prepared remarks and take your questions are Dan Paterson, President and Chief Executive Officer; Dan Lyons, Chief Commercial Officer; and Dan Calkins, Chief Financial Officer. Dr. Michael Kauffman will be joining us for the Q&A portion of the call. I will now turn the call over to Dan. Daniel Paterson: Thank you, Julissa. Good afternoon and thank you for joining our call today. We delivered a strong second quarter with meaningful progress across both our commercial business and pipeline. For the quarter, we generated net product revenues of $25.1 million, reflecting continued execution of our commercial strategy, putting us back on track and reinforcing the long-term opportunity for AVMAPKI FAKZYNJA CO-PACK. We also strengthened the balance sheet with a non-dilutive royalty financing agreement with Oberland Capital to secure up to $75 million in funding, of which we expect to draw $50 million at closing. Combined with a $15 million milestone payment from Secura Bio for a COPIKTRA sales milestone, the incremental $90 million in non-dilutive funding strengthens our balance sheet and allows us to get beyond key data readouts, advance partnership discussions, and preserves strategic flexibility as we evaluate future financing opportunities. Also, as we shared previously, we continue to expect the LGSOC business will become self-sustaining by the end of 2026, meaning that commercial revenue will support both the ongoing commercial organization and the existing avutometinib and defactinib development franchise. As Dan Lyons will discuss, the commercialization of the CO-PACK is progressing well, and we're encouraged that the changes we made are having an impact. Since the first quarter, we've seen a meaningful rebound with significant quarter-over-quarter growth driven by growing physician confidence in initiating treatment for new patients, physicians prescribing to more patients in earlier lines, and increasing patient refills. In addition, our field teams are continuing to support prescribers in helping patients stay on therapy to realize the full benefit of the treatment. These trends reinforce our belief that adoption will continue to grow as physicians become increasingly comfortable using the combination at a patient's first or next recurrence. In June, we reported a positive update on the RAMP-205 pancreatic cancer data. Looking ahead, we believe the regimen of avutometinib plus defactinib in combination with chemotherapy can play an important role in the second-line treatment of PDAC following either a panRAS or KRAS G12D inhibitor to help address resistance mechanisms that are expected to emerge. Turning to VS-7375, we have an opportunity to meaningfully advance treatment for patients with KRAS G12D-driven cancers. Our goal isn't simply to extend patients' lives, but to do so with a treatment designed to specifically target the biology of these cancers without unnecessary on-target toxicities. Ultimately, we want patients to spend more time living their lives, not managing nasty side effects from their treatment. The progress we've seen across the RAS field is validation of the possibilities. At the same time, it has also made clear that there remains significant opportunity to improve both outcomes and the overall treatment experience for the approximately 60,000 patients diagnosed each year in the U.S. alone with a KRAS G12D-driven cancer. Recently, I heard about a young woman in her 30s who was participating in our trial, and her story and experience in the trial reminded me why this work matters. She was diagnosed with a KRAS G12D-mutated advanced non-small cell lung cancer. She'd never smoked and did not respond to current standard of care chemo plus immunotherapy. She was not only living with cancer, but experiencing constant symptoms of the disease that disrupted her quality of life. When she entered our study and began treatment with VS-7375 at 600 milligrams, her primary tumor shrank by more than 65% within six weeks, and her symptoms also started to improve. She remains on treatment today and continues to do well. While this is one patient's experience, it serves as a powerful reminder about what is at stake and that behind every data point is a person and family member hoping for not just more time, but more quality time. In June, we shared preliminary clinical data from the Phase I/II TARGET-D 101 study, which further strengthened our conviction that VS-7375 has the potential to not only become the best-in-class oral KRAS G12D inhibitor, but a treatment that patients can truly tolerate. We continue to be encouraged by the emerging anti-tumor activity across multiple tumor types and the favorable tolerability profile we've seen so far. Together, these data support the advancement of our three ongoing Phase II registration-directed studies in pancreatic, colorectal, and non-small cell lung cancers. Operationally, we've continued to execute the VS-7375 development program at an impressive pace. We completed target enrollment in the pancreatic, colorectal, and non-small cell lung cancer dose expansion cohorts of the TARGET-D 101 study, received FDA fast-track designation for non-small cell lung cancer, and initiated all three of our Phase II registration-directed studies with the first patients now dosed in each trial. These studies represent an important step toward generating additional data to support the potential for the accelerated approval pathway and set the stage for our upcoming frontline Phase III studies. We look forward to sharing a meaningful data update on VS-7375, including response rates across our three lead tumor types in October. With that, I'll turn the call over to Dan Lyons for our commercial update. Dan? Daniel Lyons: Thanks, Dan. We continue to make meaningful progress in the second quarter as the launch matures. We are pleased with the quarterly sales of the AVMAPKI FAKZYNJA CO-PACK, $25.1 million. Our commercialization of the CO-PACK remains focused on three priorities: driving consistent new patient demand, expanding use earlier in the treatment journey, and helping patients to stay on therapy to realize the full benefit of treatment. Across each of these areas, we are seeing encouraging signs that the changes being made are having an impact and physician experience continues to deepen. Our first commercial priority is to continue to grow new patient starts. We continue to see healthy and consistent levels of new patient starts and refills throughout the second quarter. As the new patient demand continues to build, we expect this to convert to future refills. We're seeing increasing evidence of repeat prescribing that is trending higher among existing writers and greater depth of prescribing among our existing accounts, giving us confidence that adoption continues to broaden. While our distribution model doesn't provide complete visibility into every prescription, we are pleased with the numbers of new accounts that adopted the CO-PACK in the second quarter across academic and community targets. Through the end of the second quarter, adoption continues to expand as experience with the AVMAPKI FAKZYNJA CO-PACK deepens with a meaningful addition of first-time prescribers and new accounts. Gynecologic oncologists are the primary prescribers, reflecting their central role in managing patients with LGSOC from diagnosis through the course of their disease. Adoption continues to expand across both academic and community practices. In the community setting, our site-specific alerts help identify patients, and we are already seeing early returns from that effort. We are expanding this work to more practices in the third quarter. Our second commercial priority has been to drive use in the right patients at the first or next recurrence. As we've discussed previously, the earlier months of the launch were characterized by a higher proportion of heavily pretreated and later line patients. During the second quarter, we saw multiple indicators that physicians are initiating treatment earlier. These observations are based on several inputs, including our internal prescribing data, field insights, physician discussions, and market research. As we move up in earlier lines of therapy, the patients and outcomes are beginning to mirror what we saw in our RAMP 201 trial. With this shift, we will continue to work with prescribers to help these patients stay on therapy longer. Other efforts like our reimagined recurrent LGSOC direct-to-physician and patient campaign are focused squarely on the shift of identifying the right patient. We can attribute our success in Q2 to that message resonating with prescribers. Our peer-to-peer programming are also creating opportunities for doctors to understand where the CO-PACK fits in the treatment paradigm from the respected leaders in the field. Our third commercial priority is ensuring patients remain on the CO-PACK to get the greatest benefit. As the active patient pool has grown, we saw refill consistency in Q2 that suggests patients are remaining on therapy longer. Physician feedback on the CO-PACK has been positive, with tolerability consistent with their expectations. As with any new therapy, there is a learning curve as physicians and their staff become familiar with managing patients and setting expectations around treatment. Our operational execution is strengthened with the changes that we made last quarter across all our field teams. We are working to ensure prescribers are setting appropriate expectations for patients and managing adverse events so patients can have the best outcomes while taking the AVMAPKI FAKZYNJA CO-PACK. Our reimbursement continues to not be a challenge, and patients are getting their medicines quickly. Taken together in Q2, the combination of new patient starts, increased refills, expanding physician adoption, and the appropriate patients being identified, we drove meaningful growth in the adoption of the CO-PACK, and we are seeing that momentum continue in Q3. I'll now turn the call over to Dan Calkins. Daniel Calkins: Thank you, Dan. Our full financial results are included in our press release, so I'll focus on the highlights here. For the second quarter of 2026, we recorded $25.1 million in net product revenue and $3.8 million in product cost of sales. Cost of sales increased in the quarter in line with the percent increase in net product revenue. We also recorded $15 million in license revenue from the sales-based milestone payment under the terms of our agreement with Secura Bio, which was triggered by cumulative worldwide net sales of COPIKTRA surpassing $200 million during the second quarter of 2026. Research and development expenses were $41.3 million for the second quarter, incrementally increasing as expected from the first quarter of 2026. These expenses continue to be driven by the ongoing TARGET-D 101 clinical trial in the U.S., the initiation of the three Phase II TARGET-D clinical trials, and costs associated with clinical supply and drug production activities related to our expanded VS-7375 program. SG&A expenses were $27.4 million for the second quarter of 2026, and roughly in line with the first quarter. These expenses continue to be driven by commercial activities and operations, including personnel-related costs to support the ongoing CO-PACK launch. Let me reiterate that we expect SG&A expenses to remain roughly the same on a quarterly basis throughout 2026 as we remain disciplined in our expense management, making the right investments at the right time to support the ongoing commercial launch efforts. For the second quarter of 2026, non-GAAP adjusted net loss was $30.6 million, or $0.31 per share diluted, compared to non-GAAP adjusted net loss of $41.3 million, or $0.62 per share diluted, for the second quarter of 2025. Please see our press release for reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet, we ended the second quarter of 2026 with cash equivalents and investments of $136.4 million. When you include the $50 million received at closing from the non-dilutive royalty financing with Oberland and the $15 million COPIKTRA milestone payment, our pro forma cash balance at the end of the second quarter is $201.4 million. Based on our current cash position, with expected revenues from the AVMAPKI FAKZYNJA CO-PACK sales, and access to the future tranche from our Oberland facility, we believe we have sufficient capital to fund operations into the second half of 2027 and reach meaningful value-creating inflection points before needing to access additional capital. As Dan mentioned earlier, we look forward to building on the CO-PACK's growth into 2026, and given our current trajectory, we believe the LGSOC franchise will be self-sustaining by the end of the year, with CO-PACK revenues funding both the commercial operations and our avutometinib plus defactinib clinical trials. With that, let me turn the call back over to Dan Paterson. Daniel Paterson: Thanks, Dan. Before we open the call to Q&A, I'd like to reiterate that our focus for the second half of 2026 is very clear. Drive strong execution of our commercial strategy to expand adoption of AVMAPKI FAKZYNJA CO-PACK, complete enrollment in our three Phase II registration-directed VS-7375 trials, and prepare to initiate our three Phase III trials for VS-7375. In October, we expect to provide a more comprehensive data set for VS-7375, including response rates across our three lead tumor types, pancreatic, lung, and colorectal cancers, with approximately 20 patients in each, as well as an early look at durability. The progress we've made this quarter reflects disciplined execution across the organization. We've continued to optimize our commercial business and advance our clinical programs, and this positions us well for a productive second half of the year. With that, we'll open the call for questions. Operator? Operator: [Operator Instructions] And we have a question from Cantor. Caller, please go ahead and introduce yourself and ask your question. Eric Schmidt: It's Eric Schmidt from Cantor Fitzgerald. Appreciate the opportunity and congrats on all the progress. Maybe just on 7375, can you talk perhaps in broad strokes about partnership activity in the G12D space and any updates you could provide? I know last time we spoke you had alluded to a potential collaboration with Erasca, but any other comments you want to provide on what it might take for you to form some sort of a collaboration. Thank you. Daniel Paterson: Yes, Eric, thanks for the question. We continue to work on the Erasca partnership, and we'll have more details as time goes by. We're working through details on what a first study would look like, what our respective roles would be, and really, you know, kind of when we'll be able to start the study. We still remain interested in PRMT5 and are looking at a number of different options there. And then we have had considerable inbound interest from strategics. And, you know, I think in an interesting way, you know, RevMed putting out their G12D data earlier, as well as we'll have our data coming out in October, I think will really spur additional interest. And as is always the case in these discussions, it's really a judgment call on how early or late you do a partnership. The value goes up over time, but the potential acceleration of a program that a partner can bring has a bigger impact the earlier it is. So we continue on all those fronts and, you know, the funding that we announced today I think gives us a lot more strategic flexibility to not have to rush into something nor rush into an equity financing at, you know, the current stock price. Eric Schmidt: Thank you, Dan. That's very helpful. And maybe just a quick follow-on for the other Dan. Gross margins to be running in the last couple quarters look better than at least I've been modeling. Is this a reasonable run rate going forward? Daniel Paterson: Dan C., you want to take that? Daniel Calkins: Yes, sure. Thanks, Eric. Yes, I think that is a reasonable run. I think as you look at cost of sales, the majority of that really is still continues to be royalty-based. You know, the margins on the product are relatively high. So but going forward from a modeling perspective, I think what you're seeing this quarter, which we've seen historically, should be indicative of what we should expect going forward. Operator: Thank you. Next in queue, we have a question from Guggenheim. Caller, please go ahead and introduce yourself and ask your question. Michelle Boisvert: Hi, this is Michelle on for Michael Schmidt. First of all, congrats on the strong quarter. I just wanted to ask on 7375 regarding the October update. So you cited, I think a general 30% overall response rate and six months durability as an FDA accelerated approval bar. So just heading into October, I want to know, is that still the right framing across the three of these indications? Or does, you know, the competitive landscape in PDAC, for example, shift how you might think about what's needed to establish best in class? Thanks so much. Daniel Paterson: Michael, you want to take that one? Michael Glen Kauffman: Sure. We think that's generally a very good guidepost. You probably saw the very recent approval of [ Tudriqev ] in melanoma with a 24% response rate, which got accelerated approval. Granted, we never want to go through what they went through. But 30% is a great metric in this disease. Six months is also terrific. And I would remind you, we all know that 35% is the second line response rate that we're all looking for, but 30% is very good. Let's not forget, there are drugs that are very easy to take and there are drugs that are very difficult. Having a rash that is as extensive as we've seen with some of the panRAS inhibitors is real difficult, nevermind the mucositis or stomatitis. So remember that accelerated approval looks at both activity as well as the safety and tolerability profile drug. Daniel Paterson: Thanks, Michael. Operator: Next in the queue we have a question from RBC Capital Markets. Caller, please go ahead and introduce yourself and ask your question. Joshua Wolfson: Josh on for Leo here. I was wondering whether or not like how you were feeling about the translatability of the ORR data that you've been seeing in the GenFleet China study, and whether or not that will be recapitulated in the U.S. population given the known differences in PK behavior or disease management. Thanks. Daniel Paterson: Thanks for the question. We do get compared to the GenFleet China data all the time. I would remind everybody that the most important benchmarks are going to be the U.S. data from other products and, as Michael said, really hitting a bar that we need for the U.S. accelerated approval. We are seeing quite different toxicity profile. We are showing PK that goes up as the dose goes up, and we believe, especially with an isoform-specific molecule, hitting the target really hard will translate into both depth of response and durability. I don't know, Michael, if you want to give any more color there. Michael Glen Kauffman: I think you can definitely say from the China data the drug is active. We know that. In our hands, you've seen the CA19-9 data is very active. Direct translation, probably not direct, but within the ballpark, and we're really looking forward to the October update across all three tumor types. Operator: Thank you. Next in the queue we have a question from Jefferies. Please go ahead and introduce yourself and ask your question. Faisal Khurshid: This is Faisal from Jefferies. Just wanted to ask on the CO-PACK performance, really nice to see the uptake in revenues this quarter. Can you help us understand a little bit some of the metrics around what you're seeing on like new starts and duration of therapy? Because I know in the past you had mentioned that short duration was impacting the growth. So just trying to understand the extent to which this great quarter was driven by new starts or driven by improving duration or a bit of both. Thank you. Daniel Paterson: Thanks for the question. I would say a bit of both, but maybe Dan, if you want to give... Dan Lyons, if you want to give a little more color. Daniel Lyons: Yes, thanks for the question. It's a bit of both. And so what we saw, as you know, Faisal, our three priorities are to grow new patient starts, to move up in line of therapy, and to keep patients on so they can have the best outcome with the AVMAPKI FAKZYNJA CO-PACK. What we saw in Q2 was a bit of both. We saw a meaningful increase in new prescribers and new accounts. And so that has us very encouraged what we're seeing from a new patient start perspective. We're seeing consistent new patient starts, which is what we want to see in this disease. And then from a refill perspective, we're encouraged that all the execution and focus that we had is leading to the outcomes we're looking for overall. Operator: Thank you. Next in queue, we have a question from the Mizuho group. Caller, please go ahead and introduce yourself and ask your question. Graig Suvannavejh: It's Graig Suvannavejh from Mizuho. Congrats on the quarter. Two questions if I could, just maybe on the CO-PACK, maybe piggybacking on the last question. As we think about the dynamic between new patient starts and refills and newer prescribers, is there a way to think about, is there any one particular segment that early in this launch process is going to be a bigger contributor to driving sales or is it just a combination of all three relatively equally? And then second, if I could ask a question on 7375, appreciate the color on what you're looking for in the upcoming October data. But just maybe generally speaking and in light of the comments you made about RevMed disclosing some data on their G12D, as you look at the landscape, and certainly there's a lot of excitement around the G12D inhibitor space, how do you hope to best differentiate your compound versus others that either are already out there or could be coming? Thanks. Daniel Paterson: Thanks, Graig, for the question. I'll take the second one first, and then I'll let Dan Lyons address the first one. I would say, you know, against panRAS inhibitors, we intend to show better efficacy and significantly better tolerability. With the G12D inhibitors, I think what we've said all along is, and if you look at, you know, as we've been able to escalate the dose with very little change in toxicity to hit the target hard, we believe we're going to be able to hit the target harder to have deeper response and hopefully better durability. But against the panRAS, I think the big difference is going to be tolerability. And against other G12D inhibitors, we've said we thought we have the best in class based on preclinical data. I would say where we're starting to see that in the data that we're getting clinically, and, you know, hopefully we can show that in October. Dan Lyons, you want to take the second question, and if Michael wants to add any more color, you can feel free. Daniel Lyons: Sure. I'll go first, then Michael if you want to add anything. So as you look at the question around the segments, right, whether it's new patient starts first, refills first, moving up the line of therapy, all three of those are critically important. Those new patients start to turn into refills very quickly. And as we look at the ability to keep patients on, that's where our team has been focused this last quarter, and that's where we're seeing that come through. So I think you need all three to answer your question. Now, when you look at the segmentation, I think it's important to point out that we're seeing new patient starts not just in the academics, but also in the community, right? And so we need to win in both places. And so overall, I think it's a bit of all three, but we are focused on those new patient starts as well as keeping patients on. Michael? Michael Glen Kauffman: Yes, just one last, just to add on to what Dan said. I think unlike most of the G12D inhibitors, and in fact some of the panRAS, our PK continues to climb as we go up from 400 to 600 to 900, and you guys have seen the data, we've made it public. That has not generally been seen with the other drugs. Generally they tend to threshold out and more drug doesn't deliver higher exposures. And we believe and we will assert that we're seeing that. We can get more consistent responses, deeper responses, and we believe eventually more prolonged responses because of that at very tolerable doses. I'll just add also that our main side effects which are nausea, vomiting, and diarrhea, really not much else, that are at levels that are actually below most of the panRAS inhibitors. We have no rash and no mucositis. When we go up on the dose, we don't see any increase, and this is likely due to an irritant effect of the drug rather than a particular effect of the drug when it circulates. So it irritates the stomach and causes some GI distress, but going up on the dose doesn't matter. I think we'll see all that manifest in the clinical data we'll have in October. Operator: Thank you. Next, we have a question from H.C. Wainwright. Caller, please go ahead and introduce yourself and ask your question. Andres Maldonado: It's Andres Maldonado from H.C. Wainwright. Congrats on the progress. Just a quick one on the commercial frontier. I think you guys touched upon it, but I would appreciate a little bit more color. On the, you know, how much of the prescribing is moving into first and next recurrence? And if that's happening, can you talk about if that's happening beyond the major academic centers? And then on the flip side, you know, how are the potential for dose interruptions or reductions if needed, and if they're helping patients maybe stay on treatment longer? And then a quick one from the TARGET-D developmental strategy. So particularly for CRC, I guess, you know, we just saw data recently from the KRYSTAL-10 study, obviously different inhibitor, different subset. What would justify continuing 7375 monotherapy without an EGFR inhibitor? Thank you very much. Daniel Paterson: So, just real quickly on the CRC, you know, we don't intend to develop it as a single agent. It's going to be with an EGFR inhibitor. That's really what's needed in CRC. Dan Lyons, you want to really give a little more color on the commercial question? Daniel Lyons: Thanks, Andres. So, I think there was two questions in there, line of therapy and then dose interruptions. So let me try to tackle both. We're very encouraged by what we're seeing. I mean, we do not have full visibility into our data, but what we are seeing, we're very encouraged that we are moving up in line of therapy. This is not only in the academic, but also in the community. And it goes back to our messaging around being the treatment for the first or next recurrence. And so the data we're seeing is encouraging there and we're going to continue to focus on that. In terms of dose interruptions, dose interruptions were part of our clinical trial. We expect some dose interruptions with this treatment. I think the important part is limiting that time by providing that support for practices so they understand how to manage dose interruptions and when appropriate, having patients restart at the starting dose of AVMAPKI FAKZYNJA CO-PACK. And so that's how we're seeing things. And I think the overall focus and collaboration we've seen across the teams on line of therapy, on managing AEs, managing dose interruptions, has been something that throughout Q2 continue to build. Operator: Thank you. [Operator Instructions] Next in the queue, we have a question from BTIG. Caller, please go ahead and introduce yourself and ask your question. Jeet Mukherjee: Thanks for taking the question and congrats on a great quarter. So two questions from me. When it comes to 7375 and thinking about other partner agents, PRMT5, for example, are you inclined to look to strike another partnership similar to the one that you did with Erasca or is in-licensing your own PRMT5 inhibitor something that's available as well? And then as a second question, just could you remind us what you have aligned with the FDA on in terms of the bar for approval across your various Target (sic) [ TARGET-D ] 200 trials? Daniel Paterson: Yes, I will just say on the PRMT5, we're exploring all options. There are a number available for either, you know, kind of partnerships around a clinical trial, and there are some agents that are available, and we haven't ruled anything out. Michael, you want to comment more on the accelerated approval? Michael Glen Kauffman: Yes, the FDA, and I've been through three, actually five accelerated approvals. The FDA has never told us what they need, but we can all look back at the numbers. I mean, they're always north of 20%. Typically these days they'd like to see 30, but I just mentioned on the phone call a recent approval today, I think, or yesterday in melanoma, which was 24%. I think durability really matters. But generally, I think the 30% ORR with at least six months durability is a great rule of thumb. We also know in colorectal that it's combo therapy. We know from the accelerated approval there with the combination what we need, similar numbers. And although it's not yet been done in pancreatic, certainly in lung, we've seen accelerated approvals with these kinds of numbers and even higher. And then we feel like we're in very good shape to achieve those. Daniel Paterson: And I might add, based on the accelerated approval we went through with our current product, you know, yes, response rate and durability are critically important, but it was the totality of the data, and they absolutely look at tolerability. Operator: Thank you. And our final question from Alliance Global Partners. Caller, please go ahead and introduce yourself and ask your question. Matthew Venezia: Matthew from Alliance Global Partners. Thanks for taking my questions and congrats on the progress for the Q. I had one on doctors with patients who have KRAS G12D-mutant patients. So these patients in the coming months, there's going to be a decision process for these doctors to either put them on an approved RAS inhibitor, panRAS, or to put them on a trial like yours. What does that decision process look like for each doctor, and how do you plan to differentiate your clinical trials from an approved RAS inhibitor product? Thanks. Daniel Paterson: Matthew, thanks for the question. Michael, I know that's come up specifically at the ad boards we've been having with our investigators. Maybe if you want to comment on that. Michael Glen Kauffman: Sure. The discussion is fairly straightforward with patients. Anytime you have a discussion of a new drug, particularly oncology, it's an efficacy and a tolerability discussion. So that's the discussion they'll be having. To a [ T ], I mean, I think amongst, I would say, around 30 different key opinion leaders participating in three different ad boards, colorectal, pancreatic, and lung, everyone agreed that given our tolerability profile and the data that they were privy to, they would recommend for a G12D patient that they go on to a G12D specific drug. They particularly liked ours because of what they saw. Of course, they were at our ad boards. And then they would come out with a panRAS inhibitor later, given the very significant reaction stomatitis, but also, frankly, the higher levels of even nausea, vomiting, and diarrhea, as well as other side effects. So targeted therapy for patients with a tumor that has a targeted oncogene, that's not a new concept at all. That is targeted molecular oncology, and that's what we like to do. Matthew Venezia: Got it. Great. Thanks, guys. Thanks for taking my questions. Operator: At this time, we have no further questions in the Q&A queue. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Verastem, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Verastem wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Verastem (VSTM) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-07

Verastem Q2 Earnings Call Highlights

MarketBeat
Interested in Verastem, Inc.? Here are five stocks we like better. Q2 revenue improved: Verastem reported $25.1 million in AVMAPKI FAKZYNJA CO-PACK product revenue and a $15 million COPIKTRA sales milestone from Secura Bio. Its non-GAAP net loss narrowed to $30.6 million, or $0.31 per share. CO-PACK adoption expanded: The company cited steady new patient starts, refills and repeat prescribing across academic and community practices, with growing use earlier in the LGSOC treatment journey. Verastem expects the business to become self-sustaining by the end of 2026. Pipeline and funding advanced: Verastem began three Phase II registration-directed studies of VS-7375, received FDA Fast Track designation in non-small cell lung cancer and plans an October efficacy update. Including expected financing and milestone proceeds, pro forma cash was $201.4 million, which management expects to support operations into the second half of 2027. Verastem (NASDAQ:VSTM) reported second-quarter 2026 net product revenue of $25.1 million from sales of its AVMAPKI FAKZYNJA CO-PACK, as the company said increased new patient starts, refills and physician adoption supported a rebound in commercial performance. The company also reported $15 million in license revenue from a sales-based milestone under its agreement with Secura Bio. The payment was triggered after cumulative worldwide net sales of COPIKTRA exceeded $200 million during the quarter. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Verastem’s non-GAAP adjusted net loss narrowed to $30.6 million, or $0.31 per diluted share, from $41.3 million, or $0.62 per diluted share, in the prior-year quarter. Chief Commercial Officer Dan Lyons said the commercialization strategy for AVMAPKI FAKZYNJA CO-PACK is centered on increasing new patient demand, expanding use earlier in the treatment journey and helping patients remain on therapy. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Lyons said the company saw consistent new patient starts and refills during the second quarter, along with increased repeat prescribing among existing prescribers and deeper use at existing accounts. Adoption expanded across both academic and community practices, with gynecologic oncologists serving as the primary prescribers. The company said it is seeing evidence that physicians are increasingly initiating therapy at a patient’s firs…Read full document

Interested in Verastem, Inc.? Here are five stocks we like better. Q2 revenue improved: Verastem reported $25.1 million in AVMAPKI FAKZYNJA CO-PACK product revenue and a $15 million COPIKTRA sales milestone from Secura Bio. Its non-GAAP net loss narrowed to $30.6 million, or $0.31 per share. CO-PACK adoption expanded: The company cited steady new patient starts, refills and repeat prescribing across academic and community practices, with growing use earlier in the LGSOC treatment journey. Verastem expects the business to become self-sustaining by the end of 2026. Pipeline and funding advanced: Verastem began three Phase II registration-directed studies of VS-7375, received FDA Fast Track designation in non-small cell lung cancer and plans an October efficacy update. Including expected financing and milestone proceeds, pro forma cash was $201.4 million, which management expects to support operations into the second half of 2027. Verastem (NASDAQ:VSTM) reported second-quarter 2026 net product revenue of $25.1 million from sales of its AVMAPKI FAKZYNJA CO-PACK, as the company said increased new patient starts, refills and physician adoption supported a rebound in commercial performance. The company also reported $15 million in license revenue from a sales-based milestone under its agreement with Secura Bio. The payment was triggered after cumulative worldwide net sales of COPIKTRA exceeded $200 million during the quarter. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Verastem’s non-GAAP adjusted net loss narrowed to $30.6 million, or $0.31 per diluted share, from $41.3 million, or $0.62 per diluted share, in the prior-year quarter. Chief Commercial Officer Dan Lyons said the commercialization strategy for AVMAPKI FAKZYNJA CO-PACK is centered on increasing new patient demand, expanding use earlier in the treatment journey and helping patients remain on therapy. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Lyons said the company saw consistent new patient starts and refills during the second quarter, along with increased repeat prescribing among existing prescribers and deeper use at existing accounts. Adoption expanded across both academic and community practices, with gynecologic oncologists serving as the primary prescribers. The company said it is seeing evidence that physicians are increasingly initiating therapy at a patient’s first or next recurrence, rather than predominantly among heavily pretreated later-line patients. Lyons said Verastem’s direct-to-physician and patient outreach, peer-to-peer programming and site-specific patient alerts in community practices are intended to support that shift. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling Patient refill consistency also suggested that patients are remaining on therapy longer, according to Lyons. He said physicians’ feedback on tolerability has been positive and consistent with expectations, while the company continues to work with practices on adverse-event management and appropriate use of dose interruptions and restarts. President and CEO Dan Paterson said reimbursement has not been a challenge and that patients are receiving medicines quickly. Verastem expects the low-grade serous ovarian cancer, or LGSOC, business to become self-sustaining by the end of 2026, with commercial revenue supporting the commercial organization and the existing avutometinib and defactinib development franchise. Verastem completed target enrollment in dose-expansion cohorts of the TARGET-D 101 study of VS-7375 in pancreatic cancer, colorectal cancer and non-small cell lung cancer. The company also initiated three Phase II registration-directed studies in those indications and said the first patients have been dosed in each trial. The FDA granted Fast Track designation to VS-7375 in non-small cell lung cancer, the company said. Paterson said Verastem expects to provide an October update containing response rates across pancreatic, lung and colorectal cancers, with approximately 20 patients in each of the three lead tumor types, as well as an early look at durability. The company is also preparing to initiate three Phase III studies for the candidate. Management discussed its view that VS-7375, an oral KRAS G12D inhibitor, could differentiate through efficacy and tolerability. President of Development Michael Kauffman said a roughly 30% objective response rate and at least six months of durability are useful guideposts for accelerated approval, while emphasizing that regulators evaluate the totality of efficacy, safety and tolerability data. For colorectal cancer, Paterson said Verastem does not intend to develop VS-7375 as a monotherapy and expects to use it with an EGFR inhibitor. The company also continues to explore potential partnerships involving PRMT5 and said it is working through details of a potential study collaboration with Erasca. Verastem ended the second quarter with $136.4 million in cash, cash equivalents and investments. The company entered into a non-dilutive royalty financing agreement with Oberland Capital that provides up to $75 million in funding, with Verastem expecting to draw $50 million at closing. Including the anticipated $50 million Oberland draw and the $15 million Secura Bio milestone payment, Verastem said its pro forma quarter-end cash balance was $201.4 million. Chief Financial Officer Dan Calkins said the company believes its capital, expected CO-PACK revenue and access to a future Oberland tranche should fund operations into the second half of 2027. Second-quarter product cost of sales was $3.8 million. Research and development expense was $41.3 million, reflecting the ongoing TARGET-D 101 trial, the launch of three Phase II TARGET-D trials, and clinical supply and manufacturing activities for VS-7375. Selling, general and administrative expense was $27.4 million, roughly in line with the first quarter. Calkins said Verastem expects quarterly SG&A spending to remain roughly stable through 2026 as it supports the CO-PACK launch while maintaining expense discipline. Verastem Oncology, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapies that target cancer stemness and resistance pathways. Established in 2010 and headquartered in Needham, Massachusetts, Verastem Oncology applies a precision-medicine approach to identify key signaling nodes responsible for tumor growth and relapse, with an emphasis on hematologic malignancies and solid tumors. The company’s research platform integrates insights into complex signaling networks to advance novel compounds from early discovery through clinical proof of concept. The company’s lead marketed product is COPIKTRA (duvelisib), an oral inhibitor of PI3K-delta and PI3K-gamma, which received U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Verastem Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-07

Verastem Inc (VSTM) (Q2 2026) Earnings Call Highlights: Strong Revenue Rebound and Strategic ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Verastem Inc (NASDAQ:VSTM) reported strong Q2 2026 net product revenues of $25.1 million, reflecting a meaningful rebound and continued execution of its commercial strategy for the LGSOC franchise. The company strengthened its balance sheet with a non-dilutive royalty financing agreement with Oberlin Capital for up to $75 million, plus a $15 million milestone payment from Secure Bio, providing capital to fund operations into the second half of 2027. Commercial execution is improving, with growing physician confidence, increased new patient starts, earlier lines of therapy adoption, and higher refill consistency, indicating patients are staying on treatment longer. The VS 7,375 program is advancing rapidly, with completed enrollment in dose expansion cohorts, FDA fast track designation for non-small cell lung cancer, and initiation of all three phase 2 registration-directed studies. Preliminary clinical data for VS 7,375 shows encouraging anti-tumor activity and a favorable tolerability profile, with a notable case of a patient achieving a >65% tumor shrinkage within six weeks, supporting its potential as a best-in-class KRAS G12D inhibitor. The company expects the LGSOC business to become self-sustaining by the end of 2026, with commercial revenue supporting both the commercial organization and the development franchise. Verastem Inc (NASDAQ:VSTM) continues to report significant net losses, with a non-GAAP adjusted net loss of $30.6 million in Q2 2026, though improved from the prior year. The company faces intense competition in the KRAS G12D space, with other inhibitors like PANRAS and RevMed's G12D data potentially impacting the perceived differentiation of VS 7,375. There is uncertainty regarding the translatability of clinical data from the Gen Fleet China study to the US population, given known differences in PK behavior and disease management. The commercial launch of the COPA franchise still faces challenges, including a learning curve for physicians in managing adverse events and setting patient expectations, which could impact adherence and long-term adoption. The company's ability to achieve accelerated approval for VS 7,375 is not guaranteed, as the FDA has not provided explici…Read full document

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Verastem Inc (NASDAQ:VSTM) reported strong Q2 2026 net product revenues of $25.1 million, reflecting a meaningful rebound and continued execution of its commercial strategy for the LGSOC franchise. The company strengthened its balance sheet with a non-dilutive royalty financing agreement with Oberlin Capital for up to $75 million, plus a $15 million milestone payment from Secure Bio, providing capital to fund operations into the second half of 2027. Commercial execution is improving, with growing physician confidence, increased new patient starts, earlier lines of therapy adoption, and higher refill consistency, indicating patients are staying on treatment longer. The VS 7,375 program is advancing rapidly, with completed enrollment in dose expansion cohorts, FDA fast track designation for non-small cell lung cancer, and initiation of all three phase 2 registration-directed studies. Preliminary clinical data for VS 7,375 shows encouraging anti-tumor activity and a favorable tolerability profile, with a notable case of a patient achieving a >65% tumor shrinkage within six weeks, supporting its potential as a best-in-class KRAS G12D inhibitor. The company expects the LGSOC business to become self-sustaining by the end of 2026, with commercial revenue supporting both the commercial organization and the development franchise. Verastem Inc (NASDAQ:VSTM) continues to report significant net losses, with a non-GAAP adjusted net loss of $30.6 million in Q2 2026, though improved from the prior year. The company faces intense competition in the KRAS G12D space, with other inhibitors like PANRAS and RevMed's G12D data potentially impacting the perceived differentiation of VS 7,375. There is uncertainty regarding the translatability of clinical data from the Gen Fleet China study to the US population, given known differences in PK behavior and disease management. The commercial launch of the COPA franchise still faces challenges, including a learning curve for physicians in managing adverse events and setting patient expectations, which could impact adherence and long-term adoption. The company's ability to achieve accelerated approval for VS 7,375 is not guaranteed, as the FDA has not provided explicit guidance on the required bar, and the company must rely on historical benchmarks like a 30% ORR and 6-month durability. The company's future growth depends on successful partnership discussions, particularly for PRMT5, and any delays or failures in these negotiations could limit the potential acceleration of its pipeline programs. Warning! GuruFocus has detected 7 Warning Signs with VSTM. Is VSTM fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide an update on partnership activity in the KRAS G12D space, particularly regarding the potential collaboration with Alaska, and what it might take to form a collaboration?A: Dan Patterson (President and CEO) stated that they continue to work on the Alaska Partnership, working through details on what a first study would look like, their respective roles, and when they can start the study. They remain interested in PRMT5 and are looking at options there. He noted considerable inbound interest from strategics, and believes the recent RevMed G12D data and their own October data will spur additional interest. The new non-dilutive funding provides strategic flexibility to not rush into a partnership or an equity financing at the current stock price. Q: Regarding the October update for VS 7,375, is the general 30% overall response rate with 6 months durability still the right framing across the three indications, or does the competitive landscape shift what's needed to establish best-in-class?A: Dr. Michael Kaufman noted that 30% ORR with 6 months durability is a great guidepost, citing a recent accelerated approval in melanoma with a 24% response rate. He emphasized that 30% is a very good metric in this disease and reminded that accelerated approval considers both activity and the safety/tolerability profile. Drugs with extensive rash or mucositis, as seen with some PAN-RAS inhibitors, are difficult for patients, making tolerability a key differentiator. Q: How do you feel about the translatability of the ORR data seen in the GenFleet China data to the US population, given known differences in PK behavior and disease management?A: Dan Patterson noted that while they are often compared to the GenFleet China data, the most important benchmarks are US data from other products. They are seeing a quite different toxicity profile and PK that increases with dose. Dr. Michael Kaufman added that the China data shows the drug is active, and their own CA-199 data confirms activity. While translation may not be direct, it should be within the ballpark, and they look forward to the October update across all three tumor types. Q: Can you help us understand the metrics around new patient starts and duration of therapy for COPA? Was the revenue growth driven by new starts, improving duration, or both?A: Dan Lyons (Chief Commercial Officer) confirmed it was a bit of both. In Q2, they saw a meaningful increase in new prescribers and new accounts, consistent new patient starts, and encouraging refill consistency suggesting patients are remaining on therapy longer. The execution and focus across their three commercial prioritiesnew patient demand, moving up in line of therapy, and keeping patients on therapyare leading to the desired outcomes. Q: Is there one particular segment (new patient starts, refills, or newer prescribers) that will be a bigger contributor to driving sales, and how do you hope to differentiate VS 7,375 versus other G12D inhibitors?A: Dan Lyons stated all three segments are critically important, as new patient starts quickly turn into refills. They are seeing new patient starts in both academic and community settings. Dan Patterson added that against PAN-RAS inhibitors, they intend to show better efficacy and significantly better tolerability. Dr. Michael Kaufman highlighted that unlike most G12D inhibitors, their drug's PK continues to climb with dose (400 to 600 to 900 mg) without increased toxicity, potentially leading to more consistent, deeper, and more prolonged responses. Their main side effects are manageable GI issues with no rash or mucositis. Q: Can you provide more color on how much prescribing is moving into first or next recurrence, if this is happening beyond major academic centers, and how dose interruptions are being managed?A: Dan Lyons confirmed they are encouraged by the movement up in line of therapy, which is occurring in both academic and community settings, driven by their messaging around first or next recurrence. Regarding dose interruptions, they expect some with this treatment, but the key is limiting that time by supporting practices on how to manage interruptions and restarting patients at the appropriate dose. The collaboration across teams on line of therapy and managing adverse events has been strong. Q: Regarding VS 7,375 and partner agents like PRMT5, are you inclined to strike a partnership similar to the one with Erasca, or is in-licensing your own PRMT5 inhibitor an option? Also, what bar has been aligned with the FDA for approval across the Target 200 trials?A: Dan Patterson said they are exploring all options for PRMT5, including partnerships around clinical trials and available agents, without ruling anything out. Dr. Michael Kaufman noted the FDA has never explicitly told them what's needed, but based on historical precedent, 30% ORR with at least 6 months durability is a great rule of thumb. For colorectal, it's combo therapy with an EGFR inhibitor, and they feel well-positioned to achieve these numbers. He emphasized that the totality of data, including tolerability, is critical for accelerated approval. Q: For doctors with KRAS G12D mutant patients, what does the decision process look like between choosing a PAN-RAS inhibitor or a trial like yours, and how do you plan to differentiate your clinical trials from an approved RAS inhibitor product?A: Dr. Michael Kaufman explained the discussion with patients is straightforwardit's an efficacy and tolerability discussion. Based on feedback from around 30 key opinion leaders across three advisory boards (colorectal, pancreatic, and lung), everyone agreed they would recommend a G12D-specific drug for G12D patients, particularly favoring Verastem's compound due to its tolerability profile. They would reserve PAN-RAS inhibitors for later lines given the significant rash, stomatitis, and other side effects. This targeted approach aligns with standard molecular oncology practice. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-06

Verastem Oncology Reports Second Quarter 2026 Financial Results and Highlights Recent Business Updates

Business Wire
AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $25.1 million First patients dosed in all three TARGET-D Phase 2 registration-directed clinical trials evaluating VS-7375 across 2L PDAC, 2L/3L NSCLC, and 2L+ CRC Updated clinical data for VS-7375 across pancreatic, lung, and colorectal cancers expected in October Entered into a non-dilutive royalty financing agreement with Oberland Capital providing up to $75 million in cash, including $50 million at closing Ended Q2 2026 with $136.4 million in cash, cash equivalents, and investments; proforma cash of $201.4M with Oberland and COPIKTRA sales milestone ($15M), combined with expected product revenue and future tranche from Oberland facility, expected to extend cash runway into the second half of 2027 Company to host a conference call and webcast today at 4:30 p.m. ET BOSTON, August 06, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress. "The second quarter marked meaningful progress across our commercial business and pipeline programs, with strong quarter-over-quarter growth for AVMAPKI FAKZYNJA CO-PACK driven by new patient starts and increased refills," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In the first-half clinical update for VS-7375, we demonstrated encouraging activity across multiple KRAS G12D-driven tumors, including pancreatic, colorectal, and non-small cell lung cancers. VS-7375 demonstrated dose-dependent anti-tumor activity, favorable PK supporting target exposure, and a manageable safety and tolerability profile without many of the on-target toxicities seen with panRAS approaches. With the first patients dosed across our three registration-directed Phase 2 trials, we expect to complete enrollment by year-end. We remain focused on advancing what we believe is a differentiated KRAS G12D inhibitor with the potential to fundamentally change outcomes and the treatment experience for patients with KRAS G12D-driven cancers, and we look forward to sharing additional clinical data in October." Mr. Paterson added, "The incremental $90 million in non-dilutive funding strengthens our balance sheet and allows us to get beyond key dat…Read full document

AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $25.1 million First patients dosed in all three TARGET-D Phase 2 registration-directed clinical trials evaluating VS-7375 across 2L PDAC, 2L/3L NSCLC, and 2L+ CRC Updated clinical data for VS-7375 across pancreatic, lung, and colorectal cancers expected in October Entered into a non-dilutive royalty financing agreement with Oberland Capital providing up to $75 million in cash, including $50 million at closing Ended Q2 2026 with $136.4 million in cash, cash equivalents, and investments; proforma cash of $201.4M with Oberland and COPIKTRA sales milestone ($15M), combined with expected product revenue and future tranche from Oberland facility, expected to extend cash runway into the second half of 2027 Company to host a conference call and webcast today at 4:30 p.m. ET BOSTON, August 06, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business progress. "The second quarter marked meaningful progress across our commercial business and pipeline programs, with strong quarter-over-quarter growth for AVMAPKI FAKZYNJA CO-PACK driven by new patient starts and increased refills," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In the first-half clinical update for VS-7375, we demonstrated encouraging activity across multiple KRAS G12D-driven tumors, including pancreatic, colorectal, and non-small cell lung cancers. VS-7375 demonstrated dose-dependent anti-tumor activity, favorable PK supporting target exposure, and a manageable safety and tolerability profile without many of the on-target toxicities seen with panRAS approaches. With the first patients dosed across our three registration-directed Phase 2 trials, we expect to complete enrollment by year-end. We remain focused on advancing what we believe is a differentiated KRAS G12D inhibitor with the potential to fundamentally change outcomes and the treatment experience for patients with KRAS G12D-driven cancers, and we look forward to sharing additional clinical data in October." Mr. Paterson added, "The incremental $90 million in non-dilutive funding strengthens our balance sheet and allows us to get beyond key data read outs, continue evaluating strategic partnerships, and preserve strategic flexibility as we evaluate future financing opportunities." Second Quarter 2026 and Recent Updates AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $25.1 million for the second quarter of 2026. In July, updated data from the RAMP 201 Japan study were presented at the Annual Meeting of the Japanese Society of Gynecologic Oncology (JSGO) held July 17-19, 2026, in Sapporo, Japan. As of May 29, 2026, 16 efficacy-evaluable patients with recurrent low-grade serous ovarian cancer (LGSOC) had received avutometinib plus defactinib, with a median follow up of 12.4 months. The combination achieved a 44% overall response rate and a 94% disease control rate across all patients. Response rates were 71% in patients with KRAS-mutated tumors and 22% in those with KRAS wild-type tumors, with disease control rates of 100% and 89%, respectively. Overall, 94% of patients experienced tumor shrinkage, and 11 of 16 patients remained on treatment at the data cutoff. On June 17, the Company announced positive updated results from the RAMP 205 Phase 1b/2a recommended phase 2 dose cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal carcinoma (PDAC). As of the June 5, 2026 data cutoff (median follow-up of 9.8 months) the combination achieved a 52% confirmed objective response rate (cORR), with both an 86% overall survival rate and 68% progression-free survival rate at six months. The combination demonstrated a consistent safety profile with no new safety signals. Nine patients remain on treatment, and follow-up continues as survival data matures. On May 8, the Company announced the launch of the new LGSOC Resource Guide to support people living with LGSOC. On April 30, the Company announced the launch of a new healthcare professional and patient marketing campaign, Reimagine Recurrent Low-Grade Serous Ovarian Cancer, to drive awareness of AVMAPKI FAKZYNJA CO-PACK. On April 10, the Company announced new two-year median follow-up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS-mutant and KRAS wild-type patients with recurrent LGSOC, with discontinuation rates due to adverse events consistent with the primary analysis. The data were presented at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancers. A new exposure-response analysis was also presented at SGO that demonstrated that the approved dose and schedule of avutometinib plus defactinib achieved the optimal therapeutic effect. Expected Key Milestones: Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027. Continue to pursue regulatory paths for potential expansion of recurrent LGSOC into Europe and Japan. VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor in Advanced Solid Tumors On July 28, July 22, and June 16, the Company announced the first patient was dosed in the TARGET-D 203 colorectal cancer (CRC), TARGET-D 202 non-small cell lung cancer (NSCLC), and TARGET-D 201 PDAC clinical trials, respectively, marking the initiation of patient enrollment across all three TARGET-D registration-directed Phase 2 studies. At the end of June, the Company completed target enrollment in TARGET-D 101 PDAC and NSCLC monotherapy cohorts and CRC cetuximab combination cohorts. More than 200 patients have been treated with VS-7375 in the TARGET-D 101 dose escalation and expansion study. The Company has also cleared the 1200 mg daily (QD) dose of VS-7375 with no dose-limiting toxicities (DLTs) observed. Patients will continue to be evaluated at this dose in the TARGET-D 101 dose escalation study to support Project Optimus requirements, with no changes to the current study designs for the Phase 2 TARGET-D 201, 202, and 203 clinical trials. On June 23, the Company announced a preliminary update and progress from the VS-7375 clinical development program. The data presented continued to support a differentiated profile for VS-7375, demonstrating encouraging anti-tumor activity across multiple KRAS G12D-driven tumor types, including metastatic PDAC, metastatic CRC, and advanced NSCLC, with evidence of dose-dependent activity, favorable pharmacokinetics (PK) supporting target exposure, and a favorable, manageable safety and tolerability profile. Patient follow-up continues to mature across both monotherapy and combination cohorts. On June 23, the Company announced its and Erasca, Inc.’s intent to enter into an agreement to evaluate VS-7375 with Erasca’s potential best-in-class oral pan-RAS molecular glue, ERAS-0015, across KRAS G12D mutant solid tumor models. In July, the companies executed an agreement, enabling the planned preclinical evaluation. Subject to the outcome of the preclinical evaluation and execution of a definitive agreement, the Companies intend to explore a future clinical trial collaboration to evaluate the combination in patients with advanced solid tumors. On June 3, the Company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic NSCLC who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. On May 7, the Company reported continued progress in the Phase 1/2 TARGET-D 101 trial, including advancement to the 1200 mg QD dose and PK data supporting target plasma exposure at the 900 mg QD dose. Expected Key Milestones: Report updated VS-7375 clinical data in October 2026. Complete enrollment across all three TARGET-D Phase 2 trials by the end of 2026. Meet with the FDA before the end of the year to review Phase 3 pivotal trial designs in 1L mPDAC, 1L mCRC, and 1L advanced NSCLC. Enroll the first patient in each of the Phase 3 pivotal trials in the first half of 2027. Corporate Updates On May 26, the Company announced the appointment of Michael P. Bailey to its Board of Directors. Today, the Company also reported that it has signed a non-dilutive, royalty financing agreement with Oberland Capital. Under the terms of the deal, the Company will receive up to $75 million in cash, with $50 million at closing on August 28, 2026, plus up to $25 million at the Company’s option provided that its calendar quarterly worldwide net sales of AVMAPKI FAKZYNJA CO-PACK are at least $40 million prior to May 15, 2027. Secura Bio, Inc. achieved $200 million of cumulative worldwide net sales of COPIKTRA during Q2 2026, entitling Verastem to a $15 million milestone payment, which was received in July 2026. Second Quarter 2026 Financial Results Verastem Oncology ended the second quarter of 2026 with cash, cash equivalents, and investments of $136.4 million. On a pro forma basis, inclusive of the $50.0 million non-dilutive royalty financing arrangement that is expected to close on August 28, 2026, subject to satisfaction of closing conditions, and the $15.0 million net sales milestone from Secura, cash, cash equivalents and investments were $201.4 million as of June 30, 2026. Based on Verastem’s pro forma cash position, expected revenues from AVMAPKI FAKZYNJA CO-PACK sales, and access to the future tranche from the Oberland facility, Verastem believes it has sufficient capital to fund operations into the second half of 2027. Total revenue for the three months ended June 30, 2026 (the "2026 Quarter") was $40.1 million, compared to $2.1 million for the three months ended June 30, 2025 (the "2025 Quarter"). Net product revenue for the 2026 Quarter was $25.1 million, compared to $2.1 million in net product revenue recognized for the 2025 Quarter. The Company began commercial sales of the AVMAPKI FAKZYNJA CO-PACK within the U.S. following receipt of FDA approval in May 2025. Sale of COPIKTRA license and related assets revenue for the 2026 Quarter was $15.0 million, due upon Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $200.0 million during the 2026 Quarter. Total operating expenses for the 2026 Quarter were $72.8 million, compared to $45.9 million for the 2025 Quarter. Cost of sales was $4.0 million for the 2026 Quarter, compared to $0.4 million for the 2025 Quarter. Research & development expenses for the 2026 Quarter were $41.3 million, compared to $24.8 million for the 2025 Quarter. The increase of $16.5 million, or 67%, was primarily due to increased costs for investigator fees, contract research organization costs, drug product manufacturing, and personnel costs, including non-cash stock-based compensation. Selling, general & administrative expenses for the 2026 Quarter were $27.4 million, compared to $20.7 million for the 2025 Quarter. The increase of $6.7 million, or 32%, was primarily due to higher costs for personnel, including non-cash stock-based compensation and commercial operations. Net loss (GAAP basis) for the 2026 Quarter was $34.7 million, or $0.35 per share (basic and diluted), compared to $25.9 million, or $0.39 per share (basic) for the 2025 Quarter. Non-GAAP adjusted net loss for the 2026 Quarter was $30.6 million, or $0.31 per share (basic), compared to non-GAAP adjusted net loss of $41.3 million, or $0.62 per share (basic), for the 2025 Quarter. Please refer to the GAAP to non-GAAP Reconciliation attached to this press release. Conference Call and Webcast Verastem will host a conference call and webcast today at 4:30 p.m. ET to review the second quarter 2026 financial results and recent business updates. To access the live audio webcast of the call, along with accompanying slides, please visit the "Events & Presentations" page in the Investor section of the Company's website, https://investor.verastem.com/events. A replay of the webcast will be archived and available following the event. Use of Non-GAAP Financial Measures To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2026 and 2025 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements. About AVMAPKI and FAKZYNJA Combination Therapy AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors. The U.S. Food and Drug Administration (FDA) approved AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Following a clinical update in June 2026, Verastem continues to follow patients in the Phase 1/2 RAMP 205 trial (NCT05669482), which is evaluating avutometinib plus defactinib in combination with standard-of-care chemotherapy as a first-line treatment for patients with advanced pancreatic cancer. Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use. AVMAPKI FAKZYNJA CO-PACK U.S. Indication Indication AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Important Safety Information Warnings and Precautions Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity. Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration. Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality. Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction. Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Adverse Reactions The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count. Drug Interactions Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin. Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid. Use in Specific Populations Lactation: Advise not to breastfeed. Fertility: May impair fertility in males and females. Click here for full Prescribing Information. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & the TARGET-D Clinical Program VS-7375 is a potential best-in-class, potent, and selective investigational oral KRAS G12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state. In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem has further expanded the VS-7375 clinical program with three Phase 2 registration-directed, open-label clinical trials, which are currently enrolling patients: TARGET-D 201 (NCT07644559) in second-line advanced or metastatic pancreatic ductal carcinoma (PDAC), TARGET-D 202 (NCT07659782) in second/third-line advanced or metastatic non-small cell lung cancer (NSCLC), and TARGET-D 203 (NCT07659795) in metastatic colorectal cancer (CRC). In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy. In June 2026, the FDA also granted FTD to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic NSCLC who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI® FAKZYNJA® CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company’s collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the Company’s proforma cash position, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company’s clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that we may not be successful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK; that we may not satisfy the closing conditions to receive $50.0 million from our non-dilutive royalty financing arrangement with Oberland Capital; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; risks associated with preliminary and interim data, which may not be representative of more mature data; risks associated with the regulatory and policy actions proposed and enacted by the current U.S. presidential administration that may adversely affect our business; risks associated with the current administration’s reductions to the FDA’s workforce and any subsequent reductions that may lead to disruptions and delays in the FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development programs; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 4, 2026, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806434497/en/ Contacts For Investor and Media Inquiries: Julissa VianaSenior Vice President, Corporate Communications,Investor Relations & Patient [email protected] [email protected]

Investor releaseQuarter not tagged2026-08-06

Verastem: Q2 Earnings Snapshot

Associated Press

NEEDHAM, Mass. (AP) — NEEDHAM, Mass. (AP) — Verastem Inc. (VSTM) on Thursday reported a loss of $34.7 million in its second quarter. The Needham, Massachusetts-based company said it had a loss of 35 cents per share. The drug developer posted revenue of $40.1 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VSTM at https://www.zacks.com/ap/VSTM

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 73 paragraphs
Operator

Good afternoon, and welcome to Verastem Oncology's second quarter 2026 earnings conference call. My name is Liviana, your call operator today. Please note this event is being recorded. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. I will now turn the call over to Julissa Viana, Senior Vice President of Corporate Communications, Investor Relations, and Patient Advocacy at Verastem Oncology. Please go ahead.

Julissa Viana

Thank you, operator. Welcome everyone, and thank you for joining us today to discuss Verastem's second quarter 2026 financial results and recent business updates. This afternoon, we issued a press release detailing these results, along with a slide presentation that we will reference during our call today. Both are available on the Investor Relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we'll be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today.

Julissa Viana

Joining me on today's call to deliver prepared remarks and take your questions are Dan Paterson, President and Chief Executive Officer, Dan Lyons, Chief Commercial Officer, and Dan Calkins, Chief Financial Officer. Dr. Michael Kauffman will be joining us for the Q&A portion of the call. I will now turn the call over to Dan.

Dan Paterson

Thank you, Julissa. Good afternoon, and thank you for joining our call today. We delivered a strong second quarter with meaningful progress across both our commercial business and pipeline. For the quarter, we generated net product revenues of $25.1 million, reflecting continued execution of our commercial strategy, putting us back on track and reinforcing the long-term opportunity for avutometinib defactinib CO-PACK. We also strengthened the balance sheet with a non-dilutive royalty financing agreement with Oberland Capital to secure up to $75 million in funding, of which we expect to draw $50 million at closing. Combined with a $15 million milestone payment from Secura Bio for a COPIKTRA sales milestone, the incremental $90 million in non-dilutive funding strengthens our balance sheet and allows us to get beyond key data readouts, advance partnership discussions, and preserves strategic flexibility as we evaluate future financing opportunities.

Dan Paterson

As we've shared previously, we continue to expect the LGSOC business will become self-sustaining by the end of 2026, meaning that commercial revenue will support both the ongoing commercial organization and the existing avutometinib and defactinib development franchise. As Dan Lyons will discuss, the commercialization of the CO-PACK is progressing well, and we're encouraged that the changes we made are having an impact. Since the first quarter, we've seen a meaningful rebound with significant quarter-over-quarter growth driven by growing physician confidence in initiating treatment for new patients, physicians prescribing to more patients in earlier lines, and increasing patient refills. In addition, our field teams are continuing to support prescribers in helping patients stay on therapy to realize the full benefit of the treatment. These trends reinforce our belief that adoption will continue to grow as physicians become increasingly comfortable using the combination at a patient's first or next recurrence.

Dan Paterson

In June, we reported a positive update on the RAMP 205 pancreatic cancer data. Looking ahead, we believe the regimen of avutometinib plus defactinib in combination with chemotherapy can play an important role in the second-line treatment of PDAC, following either a pan-RAS or a KRAS G12D inhibitor to help address resistance mechanisms that are expected to emerge. Turning to VS-7375, we have an opportunity to meaningfully advance treatment for patients with KRAS G12D-driven cancers. Our goal isn't simply to extend patients' lives, but to do so with a treatment designed to specifically target the biology of these cancers without unnecessary on-target toxicities. Ultimately, we want patients to spend more time living their lives, not managing nasty side effects from their treatment. The progress we've seen across the RAS field is validation of the possibilities.

Dan Paterson

It has also made clear that there remains significant opportunity to improve both outcomes and the overall treatment experience for the approximately 60,000 patients diagnosed each year in the U.S. alone with a KRAS G12D-driven cancer. Recently, I heard about a young woman in her thirties who was participating in our trial, and her story and experience in the trial reminded me why this work matters. She was diagnosed with a KRAS G12D mutated advanced non-small cell lung cancer. She'd never smoked and did not respond to current standard of care chemo plus immunotherapy. She was not only living with cancer but experiencing constant symptoms of the disease that disrupted her quality of life.

Dan Paterson

When she entered our study and began treatment with VS-7375 at 600 milligrams, her primary tumor shrank by more than 65% within six weeks, and her symptoms also started to improve. She remains on treatment today and continues to do well. While this is one patient's experience, it serves as a powerful reminder about what is at stake. That behind every data point is a person and family member hoping for not just more time, but more quality time. In June, we shared preliminary clinical data from the phase I/II TARGET-D 101 study, which further strengthened our conviction that VS-7375 has the potential to not only become the best-in-class oral KRAS G12D inhibitor, but a treatment that patients can truly tolerate. We continue to be encouraged by the emerging antitumor activity across multiple tumor types and the favorable tolerability profile we've seen so far.

Dan Paterson

Together, these data support the advancement of our three ongoing phase II registration-directed studies in pancreatic, colorectal, and non-small cell lung cancers. Operationally, we've continued to execute the VS-7375 development program at an impressive pace. We completed target enrollment in the pancreatic, colorectal, and non-small cell lung cancer dose expansion cohorts of the TARGET-D 101 study, received FDA Fast Track designation for non-small cell lung cancer, and initiated all three of our phase II registration-directed studies, with the first patients now dosed in each trial. These studies represent an important step toward generating additional data to support the potential for the accelerated approval pathway and set the stage for our upcoming frontline phase III studies. We look forward to sharing a meaningful data update on VS-7375, including response rates across our three lead tumor types, in October.

Dan Paterson

With that, I'll turn the call over to Dan Lyons for our commercial update. Dan?

Dan Lyons

Thanks, Dan. We continued to make meaningful progress in the second quarter as the launch matures. We are pleased with the quarterly sales of AVMAPKI FAKZYNJA CO-PACK, $25.1 million. Our commercialization of the CO-PACK remains focused on three priorities: driving consistent new patient demand, expanding use earlier in the treatment journey, and helping patients to stay on therapy to realize the full benefit of treatment. Across each of these areas, we are seeing encouraging signs that the changes we made are having an impact, and physician experience continues to deepen. Our first commercial priority is to continue to grow new patient starts. We continued to see healthy and consistent levels of new patient starts and refills throughout the second quarter. As the new patient demand continues to build, we expect this to convert to future refills.

Dan Lyons

We're seeing increasing evidence of repeat prescribing that is trending higher among existing writers and greater depth of prescribing among our existing accounts, giving us confidence that adoption continues to broaden. While our distribution model doesn't provide complete visibility into every prescription, we are pleased with the number of new accounts that adopted the CO-PACK in the second quarter across academic and community targets. Through the end of the second quarter, adoption continues to expand as experience with AVMAPKI FAKZYNJA CO-PACK deepens, with a meaningful addition of first-time prescribers and new accounts. Gynecologic oncologists are the primary prescribers, reflecting their central role in managing patients with LGSOC from diagnosis through the course of their disease. Adoption continues to expand across both academic and community practices. In the community setting, our site-specific alerts help identify patients, and we are already seeing early returns from that effort.

Dan Lyons

We are expanding this work to more practices in the third quarter. Our second commercial priority has been to drive use in the right patients at the first or next recurrence. As we've discussed previously, the earlier months of the launch were characterized by a higher proportion of heavily pretreated and later-line patients. During the second quarter, we saw multiple indicators that physicians are initiating treatment earlier. These observations are based on several inputs, including our internal prescribing data, field insights, physician discussions, and market research. As we move up in earlier lines of therapy, the patients and outcomes are beginning to mirror what we saw in our RAMP 201 trial. With this shift, we will continue to work with prescribers to help these patients stay on therapy longer.

Dan Lyons

Other efforts, like our reimagined recurrent LGSOC direct-to-physician and patient campaign, are focused squarely on the shift of identifying the right patient. We can attribute our success in Q2 to that message resonating with prescribers. Our peer-to-peer programming are also creating opportunities for doctors to understand where the CO-PACK fits in the treatment paradigm from the respected leaders in the field. Our third commercial priority is ensuring patients remain on the CO-PACK to get the greatest benefit. As the active patient pool has grown, we saw refill consistency in Q2 that suggests patients are remaining on therapy longer. Physician feedback on the CO-PACK has been positive, with tolerability consistent with their expectations. As with any new therapy, there is a learning curve as physicians and their staff become familiar with managing patients and setting expectations around treatment.

Dan Lyons

Our operational execution has strengthened with the changes that we made last quarter across all our field teams. We are working to ensure prescribers are setting appropriate expectations for patients and managing adverse events so patients can have the best outcomes while taking AVMAPKI FAKZYNJA CO-PACK.

Dan Paterson

Our reimbursement continues to not be a challenge. Patients are getting their medicines quickly. Taken together, in Q2, the combination of new patient starts, increased refills, expanding physician adoption, and the appropriate patients being identified, we drove meaningful growth in the adoption of the CO-PACK. We are seeing that momentum continue in Q3. I'll now turn the call over to Dan Calkins.

Dan Calkins

Thank you, Dan. Our full financial results are included in our press release, so I will focus on the highlights here. For the second quarter of 2026, we recorded $25.1 million in net product revenue and $3.8 million in product cost of sales. Cost of sales increased in the quarter in line with the percent increase in net product revenue. We also recorded $15 million in license revenue from the sales-based milestone payment under the terms of our agreement with Secura Bio, which was triggered by cumulative worldwide net sales of COPIKTRA surpassing $200 million during the second quarter of 2026. Research and development expenses were $41.3 million for the second quarter, incrementally increasing as expected from the first quarter of 2026.

Dan Calkins

These expenses continue to be driven by the ongoing TARGET-D 101 clinical trial in the U.S., the initiation of the three phase II TARGET-D clinical trials, and costs associated with clinical supply and drug production activities related to our expanded VS-7375 program. SG&A expenses were $27.4 million for the second quarter of 2026 and roughly in line with the first quarter. These expenses continue to be driven by commercial activities and operations, including personnel-related costs, to support the ongoing CO-PACK launch. Let me reiterate that we expect SG&A expenses to remain roughly the same on a quarterly basis throughout 2026 as we remain disciplined in our expense management, making the right investments at the right time to support the ongoing commercial launch efforts.

Dan Calkins

For the second quarter of 2026, non-GAAP adjusted net loss was $30.6 million or $0.31 per share diluted, compared to non-GAAP adjusted net loss of $41.3 million or $0.62 per share diluted for the second quarter of 2025. Please see our press release for a reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet, we ended the second quarter of 2026 with cash equivalents, and investments of $136.4 million. When you include the $50 million received at closing from the non-dilutive royalty financing with Oberland and the $15 million COPIKTRA milestone payment, our pro forma cash balance at the end of the second quarter is $201.4 million. Based on our current cash position, we expected revenues from the AVMAPKI FAKZYNJA CO-PACK sales and access to the future tranche from our Oberland facility.

Dan Calkins

We believe we have sufficient capital to fund operations into the second half of 2027 and reach meaningful value creating inflection points before needing to access additional capital. As Dan mentioned earlier, we look forward to building on the CO-PACK's growth into 2026, and given our current trajectory, we believe the LGSOC franchise will be self-sustaining by the end of the year, with CO-PACK revenues funding both the commercial operations and our avutometinib plus defactinib clinical trials. With that, let me turn the call back over to Dan Paterson.

Dan Paterson

Thanks, Dan. Before we open the call to Q&A, I'd like to reiterate that our focus for the second half of 2026 is very clear. Drive strong execution of our commercial strategy to expand adoption of AVMAPKI FAKZYNJA CO-PACK, complete enrollment in our three phase II registration-directed VS-7375 trials, and prepare to initiate our three phase III trials for VS-7375. In October, we expect to provide a more comprehensive data set for VS-7375, including response rates across our three lead tumor types, pancreatic, lung, and colorectal cancers, with approximately 20 patients in each, as well as an early look at durability. The progress we've made this quarter reflects disciplined execution across the organization. We've continued to optimize our commercial business and advance our clinical programs, and this positions us well for a productive second half of the year. With that, we'll open the call for questions. Operator?

Operator

Thank you. As a reminder, to ask a question, you will need to press *11 on your telephone and wait for your institution name to be announced. Please stand by while we compile the Q&A roster. We have a question from Cantor. Caller, please go ahead and introduce yourself and ask your question.

Eric Schmidt

Thanks. It's Eric Schmidt from Cantor Fitzgerald. Appreciate the opportunity and congrats on all the progress. Maybe just on VS-7375, can you talk perhaps in broad strokes about partnership activity in the G12D space and any updates you could provide? I know last time we spoke, you had alluded to a potential collaboration with Erasca, but any other comments you want to provide on what it might take for you to form some sort of a collaboration? Thank you.

Dan Paterson

Eric, thanks for the question. We continue to work on the Erasca partnership, and we'll have more details as time goes by. We're working through details on what a first study would look like, what our respective roles would be, and really when we'll be able to start the study. We still remain interested in PRMT5 and are looking at a number of different options there. We have had considerable inbound interest from strategics and I think in an interesting way, RevMed putting out their G12D data earlier as well as we'll have our data coming out in October, I think will really spur additional interest. As is always the case in these discussions, it's really a judgment call on how early or late you do a partnership.

Dan Paterson

The value goes up over time, the potential acceleration of a program that a partner can bring has a bigger impact the earlier it is. We continue on all those fronts, the funding that we announced today, I think gives us a lot more strategic flexibility to not have to rush into something nor rush into an equity financing at the current stock price.

Eric Schmidt

Thank you, Dan. That's very helpful. Maybe just a quick follow-on for the other Dan. Gross margins seem to be running in the last couple of quarters a little bit better than at least I've been modeling. Is this a reasonable run rate going forward?

Dan Paterson

Dan C., you want to take that?

Dan Calkins

Yeah, sure. Thanks, Eric. Yeah, I think that is a reasonable run rate. I think as you look at cost of sales, the majority of that really still continues to be royalty based. The margins on the product are relatively high. Going forward from a modeling perspective, I think what you're seeing this quarter, what you've seen historically should be indicative of what we should expect going forward.

Eric Schmidt

Thank you very much.

Operator

Thank you. Next in queue, we have a question from Guggenheim. Caller, please go ahead, introduce yourself, and ask your question.

Speaker 6

Hi, this is Michelle on for Michael Schmidt. First of all, congrats on the strong quarter. I just wanted to ask on 7375 regarding the October update. You've cited, I think, a general 30% overall response rate and six months durability as an FDA accelerated approval bar. Just heading into October, want to know, is that still the right framing across the three of these indications, or does the competitive landscape in PDAC, for example, shift how you might think about what's needed to establish best in class? Thanks so much.

Dan Paterson

Michael, you want to take that one?

Michael Kauffman

Sure. We think that's generally a very good guidepost. You probably saw the very recent approval of Tudriqev in melanoma with a 24% response rate, which got accelerated approval. Granted, we'd never want to go through what they went through. 30% is a great metric in this disease. Six months is also terrific. I would remind you, we all know that 35% is the second line response rate that we're all looking for, but 30% is very good. Let's not forget, there are drugs that are very easy to take, and there are drugs that are very difficult. Having a rash that is as extensive as we've seen with some of the pan-RAS inhibitors is real difficult, never mind the mucositis and stomatitis. Remember that accelerated approval looks at both activity as well as the safety and tolerability profile of the drug.

Dan Paterson

Thanks, Michael.

Operator

Thank you. Next in the queue, we have a question from RBC Capital Markets. Caller, please go ahead, introduce yourself, and ask your question.

Speaker 8

Hey, guys. Josh on for Leo here. Thanks for taking my question. I was wondering whether or not how you were feeling about the translatability of the ORR data that you've been seeing in the GenFleet China study and whether or not that'll be recapitulated in the U.S. population, given the known differences in PK behavior or disease management. Thanks.

Dan Paterson

Yeah. Thanks for the question. We do get compared to the GenFleet China data all the time. I would remind everybody that the most important benchmarks are going to be the U.S. data from other products, and as Michael said, really hitting a bar that we need for accelerated approval. We are seeing quite different toxicity profile. We are showing PK that goes up as the dose goes up, and we believe, especially with an isoform-specific molecule, hitting the target really hard will translate into both depth of response and durability. I don't know, Michael, if you want to give any more color there.

Michael Kauffman

I think you can definitely say from the China data the drug is active. We know that. In our hands, you've seen the CA19-9 data. The drug is very active. Direct translation, probably not direct, but within the ballpark, and we're really looking forward to the October update across all three tumor types.

Operator

Thank you. Next in the queue, we have a question from Jefferies. Caller, please go ahead and introduce yourself and ask your question.

Speaker 9

Hey, guys. This is Basil from Jefferies. Thank you so much for taking the question. Just wanted to ask on the CO-PACK performance, really nice to see the uptick in revenues this quarter. Can you help us understand a little bit some of the metrics around what you're seeing on new starts and duration of therapy? Because I know in the past you had mentioned that short duration was impacting the growth. Just trying to understand the extent to which this great quarter was driven by new starts or driven by improving duration or a bit of both. Thank you.

Dan Paterson

Thanks for the question. I would say a bit of both, but maybe Dan Lyons, if you want to give a little more color.

Dan Lyons

Yeah, thanks for the question. It's a bit of both. What we saw, as you know, Faisal, our three priorities are to grow new patient starts, to move up in line of therapy, and to keep patients on so they can have the best outcome with AVMAPKI FAKZYNJA CO-PACK. What we saw in Q2 was a bit of both. We saw a meaningful increase in new prescribers and new accounts, that has us very encouraged. From a new patient start perspective, we're seeing consistent new patient starts, which is what we want to see in this disease. From a refill perspective, we're encouraged that all the execution and focus that we had is leading to the outcomes we're looking for overall.

Dan Paterson

Great. Thank you.

Operator

Thank you. Next in queue, we have a question from Mizuho. Caller, please go ahead and introduce yourself and ask your question.

Graig Suvannavejh

Hey, good afternoon. It is Graig Suvannavejh, Vecha, Mizuho. Thanks for taking my question. Congrats on the quarter. Two questions if I could, just maybe on CO-PACK, maybe piggybacking on the last question. As we think about the dynamic between new patient starts and refills and newer prescribers, is there a way to think about, is there any one particular segment that early in this launch process is going to be a bigger contributor to driving sales, or is it just a combination of all three relatively equally? Second, if I could ask a question on VS-7375. Appreciate the color on what you are looking for in the upcoming October data. Just maybe generally speaking, and in light of the comments you made about RevMed disclosing some data on their G12D.

Graig Suvannavejh

As you look at the landscape, and certainly, there is a lot of excitement around the G12D inhibitor space, how do you hope to best differentiate your compound versus others that either are already out there or could be coming? Thanks.

Dan Paterson

Thanks, Graig, for the question. I will take the second one first, and then I will let Dan Lyons address the first one. I would say, against pan-RAS inhibitors, we intend to show better efficacy and significantly better tolerability. With the G12D inhibitors, I think what we have said all along is, and if you look at, as we have been able to escalate the dose with very little change in toxicity to hit the target hard, we believe we are going to be able to hit the target harder, to have deeper response, and hopefully better durability. Against the pan-RAS, I think the big difference is going to be tolerability. Against other G12D inhibitors, we have said we thought we have the best in class based on preclinical data. I would say we are starting to see that in the data that we are getting clinically, and hopefully we can show that in October.

Dan Paterson

Dan Lyons, you want to take the second question then if Michael Kauffman wants to add any more color, you can feel free.

Dan Lyons

Sure. I'll go first, then Michael, if you want to add anything. As you look at the question around the segments, right? Whether it's new patient starts first, refills first, moving up in line of therapy, all three of those are critically important. Those new patient starts turn into refills very quickly. As we look at the ability to keep patients on, that's where our team has been focused this last quarter, and that's where we're seeing that come through. I think you need all three to answer your question. Now, when you look at the segmentation, I think it's important to point out that we're seeing new patient starts not just in the academics, but also in the community, right? We need to win in both places.

Dan Lyons

Overall, I think it's a bit of all three, but we are focused on those new patient starts as well as keeping patients on. Michael?

Michael Kauffman

Yeah, just one last to add on to what Dan said. I think unlike most of the G12D inhibitors, and in fact, some of the pan-RAS, our PK continues to climb as we go up from 400 to 600 to 900, and you guys have seen the data. We've made it public. That has not generally been seen with the other drugs. Generally, they tend to threshold out and more drug doesn't deliver higher exposures. We believe, and we'll assert that we're seeing that, we can get more consistent responses, deeper responses, and we believe eventually more prolonged responses because of that at very tolerable doses. I'll just add also that our main side effects, which are nausea, vomiting, and diarrhea, really not much else that are at levels that are actually below most of the pan-RAS inhibitors. We have no rash and no mucositis.

Michael Kauffman

When we go up on the dose, we don't see any increase, and this is likely due to an irritant effect of the drug rather than a particular effect of the drug when it circulates. It irritates the stomach and causes some GI distress, but going up on the dose doesn't matter. I think we'll see all that manifest in the clinical data we'll have in October.

Dan Paterson

Thanks, Michael.

Michael Kauffman

Thank you.

Operator

Thank you. Next we have a question from H.C. Wainwright. Caller, please go ahead and introduce yourself and ask your question.

Andres Maldonado

Hi, guys. It's Andres Maldonado from H.C. Wainwright. Congrats on the progress, and of course, thanks for taking my questions. Just a quick one on the commercial frontier. I think you guys touched upon it, but would appreciate a little bit more color on the how much of the prescribing is moving into first genex recurrence, and if that's happening, can you talk about if that's happening beyond the major academic centers? And then on the flip side, how are the potential for dose interruptions or reductions if needed, and if they're helping patients maybe stay on treatment longer? And then a quick one from the TARGET-D developmental strategy. Particularly for CRC, I guess, we just saw data recently from the CRISTAL X study, obviously different inhibitor, different subset, but what would justify continuing 7375 monotherapy without an EGFR inhibitor? Thank you very much.

Dan Paterson

Just real quickly on the CRC, we don't intend to develop it as a single agent. It's going to be with an EGFR inhibitor. That's really what's needed in CRC. Dan Lyons, you want to really give a little more color on the commercial question?

Dan Lyons

Thanks, Andre. I think there was two questions in there, line of therapy, and then, dose interruptions. Let me try to tackle both. We're very encouraged by what we're seeing. We do not have full visibility into our data, but what we are seeing, we're very encouraged that we are moving up in line of therapy. This is not only in the academic, but also in the community, and it goes back to our messaging around being the treatment for the first or next recurrence. The data we're seeing is encouraging there, and we're going to continue to focus on that. In terms of dose interruptions, dose interruptions were part of our clinical trial. We expect some dose interruptions with this treatment. I think the important part is limiting that time by providing that support for practices so they understand how to manage dose interruptions.

Dan Lyons

When appropriate, having patients restart at the starting dose of AVMAPKI FAKZYNJA CO-PACK. That's how we're seeing things, and I think the overall focus and collaboration we've seen across the teams on line of therapy, on managing AEs, managing dose interruptions, has been something that throughout Q2 we saw continue to build.

Dan Paterson

Thanks, Dan.

Operator

Thank you. As a reminder to ask a question, please press star 11 on your touchtone telephone. Next in the queue, we have a question from BTIG. Please go ahead and introduce yourself and ask your question.

Speaker 12

Great. Thanks for taking the question and congrats on a great quarter. Two questions from me. When it comes to VS-7375 and thinking about other partner agents, PRMT5, for example, are you inclined to look to strike another partnership similar to the one that you did with Erasca, or is in licensing your own PRMT5 inhibitor something that's available as well? Then as a second question, just could you remind us what you have aligned with the FDA on in terms of the bar for approval across your various Target 200 trials? Thanks.

Dan Paterson

Yeah, I will just say on the PRMT5, we're exploring all options. There are a number available for either partnerships around a clinical trial, there are some agents that are available, we haven't ruled anything out. Michael, you want to comment more on the accelerated approval?

Michael Kauffman

Yeah, the FDA, I've been through three, actually five accelerated approvals. The FDA has never told us what they need, but we can all look back at the numbers. They're always north of 20%. Typically these days, they'd like to see 30%, but I just mentioned on the phone call a recent approval today, I think, or yesterday in melanoma, which was 24%. I think durability really matters, but generally, I think the 30% ORR with at least six months durability is a great rule of thumb. We also know in colorectal that it's combo therapy. We know from the accelerated approval there with the combination what we need, similar numbers, although it's not yet been done in pancreatic, certainly in lung, we've seen accelerated approvals with these kinds of numbers and even higher. Then we feel like we're in very good shape to achieve those.

Dan Paterson

I might add, based on the accelerated approval we went through with our current product, yes, response rate and durability are critically important, but it was the totality of the data, and they absolutely look at tolerability.

Speaker 12

Thank you.

Operator

Thank you. Our final question from Alliance Global Partners. Please go ahead, introduce yourself and ask your question.

Speaker 13

Hey, guys. Matthew from Alliance Global Partners. Thanks for taking my questions and congrats on the progress for the Q. I had one on doctors with patients who have KRAS G12D mutant patients. These patients in the coming months, there's going to be a decision process for these doctors to either put them on an improved RAS inhibitor, pan-RAS, or to put them on a trial like yours. What does that decision process look like for each doctor, and how do you plan to differentiate your clinical trials from an approved RAS inhibitor product? Thanks.

Dan Paterson

Matthew, thanks for the question. Michael, I know that's come up specifically at the ad boards we've been having with our investigators. Maybe if you want to comment on that.

Michael Kauffman

Sure. The discussion's fairly straightforward with patients. Anytime you have a discussion of a new drug, particularly oncology, it's an efficacy and a tolerability discussion. That's the discussion they'll be having. To a T, I think amongst, I would say around 30 different key opinion leaders participating in three different ad boards, colorectal, pancreatic, and lung, everyone agreed that given our tolerability profile on the data that they were privy to, they would recommend for a G12D patient that they go on to a G12D specific drug. They particularly liked ours because of what they saw. Of course, they were at our ad boards. Then they would come out with a pan-RAS inhibitor later, given the very significant rash and stomatitis, but also, frankly, the higher levels of even nausea, vomiting, and diarrhea, as well as other side effects.

Michael Kauffman

Targeted therapy for patients with a tumor that has a targeted oncogene, that's not a new concept at all. That is targeted molecular oncology, that's what we like to do.

Speaker 13

Got it. Great. Thanks, guys. Thanks for taking my questions.

Operator

Thank you. At this time, we have no further questions in the Q&A queue. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Investor releaseQuarter not tagged2026-08-05

Royalty Pharma (RPRX) Tops Q2 Earnings and Revenue Estimates

Zacks
Royalty Pharma (RPRX) came out with quarterly earnings of $1.32 per share, beating the Zacks Consensus Estimate of $1.27 per share. This compares to earnings of $1.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +3.94%. A quarter ago, it was expected that this company would post earnings of $1.22 per share when it actually produced earnings of $1.3, delivering a surprise of +6.56%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Royalty Pharma, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $773 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.52%. This compares to year-ago revenues of $727 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Royalty Pharma shares have added about 48.8% since the beginning of the year versus the S&P 500's gain of 13%. While Royalty Pharma has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Royalty Pharma was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1…Read full document

Royalty Pharma (RPRX) came out with quarterly earnings of $1.32 per share, beating the Zacks Consensus Estimate of $1.27 per share. This compares to earnings of $1.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +3.94%. A quarter ago, it was expected that this company would post earnings of $1.22 per share when it actually produced earnings of $1.3, delivering a surprise of +6.56%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Royalty Pharma, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $773 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.52%. This compares to year-ago revenues of $727 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Royalty Pharma shares have added about 48.8% since the beginning of the year versus the S&P 500's gain of 13%. While Royalty Pharma has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Royalty Pharma was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.12 on $852.03 million in revenues for the coming quarter and $5.18 on $3.44 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Verastem (VSTM), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This drug developer is expected to post quarterly loss of $0.46 per share in its upcoming report, which represents a year-over-year change of -18%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Verastem's revenues are expected to be $23.15 million, up 981.8% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Royalty Pharma PLC (RPRX) : Free Stock Analysis Report Verastem, Inc. (VSTM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-23

Verastem Oncology to Report Second Quarter 2026 Financial Results on August 6, 2026

Business Wire

BOSTON, July 23, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the Company will host a conference call and webcast to discuss its second quarter 2026 financial results and business updates on Thursday, August 6, 2026, at 4:30 pm ET. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website, https://investor.verastem.com/events. A replay of the webcast will be archived and available following the event. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI® FAKZYNJA® CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723238516/en/ Contacts For Investor and Media Inquiries: Julissa VianaSenior Vice President, Corporate Communications,Investor Relations & Patient [email protected] [email protected]

Investor releaseQuarter not tagged2026-06-30

Verastem (VSTM) Shares Encouraging Results from VS-7375 Phase 1/2 Trial

Insider Monkey

Verastem Inc. (NASDAQ:VSTM) is one of the 10 best stocks under $10 offering more than 50% upside. On June 24, Verastem Inc. (NASDAQ:VSTM) revealed encouraging initial findings from the ongoing TARGET-D 101 Phase 1/2 trial of VS-7375. It is an experimental oral KRAS G12D inhibitor for patients with advanced KRAS G12D-mutated tumors. The results showed encouraging clinical activity and a satisfactory tolerance and safety profile within several dosage levels and tumor types. These included metastatic colorectal cancer, advanced non-small cell lung cancer, and metastatic pancreatic ductal adenocarcinoma. Copyright: dolgachov / 123RF Stock Photo According to Verastem Oncology’s President of Development, Michael Kauffman, VS-7375 showed anti-tumor effectiveness across a range of dosages and malignancies. Data also indicated positive outcomes from combination strategies and a favorable safety profile after the first treatment cycle. It also demonstrated concordance when used alongside anti-EGFR therapy and conventional chemotherapy, encouraging its development across colorectal, pancreatic and lung malignancies. The company plans to enroll patients in three Phase 2 registration-directed trials as a follow-up to the TARGET-D 101 study, and it anticipates sharing further VS-7375 results at the end of this year. Verastem Inc. (NASDAQ:VSTM) is a development-stage biopharmaceutical company involved in developing and commercializing drugs for the treatment of cancer. Its product candidates are Avutometinib, FAKZYNJA, Defactinib, VS-7375, CO-PACK, and AVMAPKI. The company is involved in clinical studies of RAMP 301, RAMP 205, FRAME, VS-7375-101, RAMP 203, and RAMP 201. While we acknowledge the potential of VSTM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years. Disclosure: None. Follow Insider Monkey on Google News.

Investor releaseQuarter not tagged2026-06-17

Verastem Oncology Announces Positive Updated Results from RAMP 205 Evaluating Avutometinib Plus Defactinib in Combination with Standard-of-Care Chemotherapy in First-Line Metastatic Pancreatic Cancer

Business Wire
90% of patients in the study presented with metastatic (Stage IV) disease at diagnosis 6-month overall survival rate was 86%; follow-up continues and survival data continue to mature BOSTON, June 17, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a Recommended Phase 2 Dose (RP2D) cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma (PDAC). KRAS is mutated in more than 90% of pancreatic cancers, making it a key driver of tumor growth. The RAMP 205 trial was designed to evaluate whether simultaneous inhibition of KRAS-driven signaling and FAK-mediated resistance pathways, in combination with standard-of-care chemotherapy, could improve outcomes for patients living with metastatic pancreatic cancer. "The updated data from the RAMP 205 trial provide important clinical insights into the potential impact of combined RAF/MEK and FAK inhibition as a therapeutic option for pancreatic cancer. While pancreatic cancer remains one of the most challenging cancers to treat, the early survival trends and deep responses observed in this study indicate that avutometinib and defactinib are combinable with standard-of-care chemotherapy and may help overcome resistance mechanisms inherent in pancreatic cancer and support further exploration of strategies designed to address oncogenic signaling and mechanisms of treatment resistance," said John Hayslip, M.D., chief medical officer at Verastem Oncology. "We are grateful to PanCAN, the RAMP 205 investigators, and especially the patients and families who participated in the trial." In the Phase 1b/2a study, 29 patients were enrolled and treated at the RP2D with avutometinib 2.4 mg twice weekly (BIW), defactinib 200 mg twice daily (BID) for 3 weeks on and one week off, and gemcitabine (800 mg/m2) plus nab-paclitaxel (125 mg/m2) administered on Days 1, 8, and 15 of each 28-day cycle. At diagnosis, 90% of patients presented with metastatic disease. As of the June 5, 2026 data cutoff, with a median follow up of 9.8 months, the combination demonstrated encouraging clinical activity, including an 86% overall sur…Read full document

90% of patients in the study presented with metastatic (Stage IV) disease at diagnosis 6-month overall survival rate was 86%; follow-up continues and survival data continue to mature BOSTON, June 17, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a Recommended Phase 2 Dose (RP2D) cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma (PDAC). KRAS is mutated in more than 90% of pancreatic cancers, making it a key driver of tumor growth. The RAMP 205 trial was designed to evaluate whether simultaneous inhibition of KRAS-driven signaling and FAK-mediated resistance pathways, in combination with standard-of-care chemotherapy, could improve outcomes for patients living with metastatic pancreatic cancer. "The updated data from the RAMP 205 trial provide important clinical insights into the potential impact of combined RAF/MEK and FAK inhibition as a therapeutic option for pancreatic cancer. While pancreatic cancer remains one of the most challenging cancers to treat, the early survival trends and deep responses observed in this study indicate that avutometinib and defactinib are combinable with standard-of-care chemotherapy and may help overcome resistance mechanisms inherent in pancreatic cancer and support further exploration of strategies designed to address oncogenic signaling and mechanisms of treatment resistance," said John Hayslip, M.D., chief medical officer at Verastem Oncology. "We are grateful to PanCAN, the RAMP 205 investigators, and especially the patients and families who participated in the trial." In the Phase 1b/2a study, 29 patients were enrolled and treated at the RP2D with avutometinib 2.4 mg twice weekly (BIW), defactinib 200 mg twice daily (BID) for 3 weeks on and one week off, and gemcitabine (800 mg/m2) plus nab-paclitaxel (125 mg/m2) administered on Days 1, 8, and 15 of each 28-day cycle. At diagnosis, 90% of patients presented with metastatic disease. As of the June 5, 2026 data cutoff, with a median follow up of 9.8 months, the combination demonstrated encouraging clinical activity, including an 86% overall survival (OS) rate at 6 months, with the OS data continuing to mature. The progression-free survival (PFS) rate at 6 months was 68%, and the confirmed objective response rate (ORR) was 52% (15/29). At the RP2D dose, the majority (83%) of patients experienced tumor shrinkage. Nine patients remain on treatment at this dose level. Adverse events remained generally consistent with the previously reported safety and tolerability profile, with no new safety signals observed. "For patients and their families facing a pancreatic cancer diagnosis, every advance in research and understanding of the underlying biology driving this cancer matters," said Anna Berkenblit, M.D., chief scientific and medical officer of the Pancreatic Cancer Action Network (PanCAN). "We awarded Verastem the PanCAN Therapeutic Accelerator Award in 2022 to invest in research and development of novel treatment approaches. The results of the RAMP 205 trial underscore the importance of continued research in the RAS/MAPK-pathway to help improve outcomes for patients living with pancreatic cancer." "We will continue to evaluate the potential role of avutometinib plus defactinib in metastatic pancreatic cancer, including future development opportunities and potential strategic collaborations, informed by the final overall survival results from the study as well as emerging data from VS-7375, our investigational potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, currently being evaluated in metastatic pancreatic cancer as both a monotherapy and in combination regimens," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We will also assess opportunities to share these data in the future, including at a medical meeting." In May 2022, Verastem Oncology was selected by PanCAN to receive the inaugural PanCAN Therapeutic Accelerator Award, supporting evaluation of avutometinib in combination with defactinib in front-line metastatic pancreatic cancer. Designed to accelerate the development of new pancreatic cancer treatments, the award provided Verastem with $3.8M following a rigorous, competitive process involving scientific, business, and programmatic review from leading experts in the field. In parallel, a working group led by PanCAN was formed as a partnership between Verastem and the academic community to further understand the science behind and the potential of this investigational treatment combination to improve outcomes for patients. About Metastatic Pancreatic Cancer Pancreatic cancer is the third leading cause of cancer-related death in the U.S. and seventh leading cause of cancer-associated mortality worldwide. Metastatic pancreatic cancer, or stage IV disease, occurs when the cancer spreads beyond the pancreas to distant organs. More than 90% of pancreatic cancers harbor KRAS mutations, underscoring the central role of KRAS in the development and the progression of the disease. Approximately 40% of pancreatic tumors harbor a KRAS G12D mutation, the most prevalent subtype in pancreatic cancer. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. Each year, more than 30,000 people in the U.S. and over 240,000 people globally are diagnosed with metastatic pancreatic cancer. There has been minimal progress with treatment, and the five-year survival rate remains approximately 3%. Current treatment approaches may include surgery, chemotherapy, radiation therapy, targeted therapies, or a combination of these modalities. About RAMP 205 Phase 1b/2a Study RAMP 205 is a multicenter, open-label, single arm Phase 1b/2a study to evaluate the safety, tolerability, and efficacy of avutometinib and defactinib in combination with standard of care chemotherapy (gemcitabine and nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. Part A of the study evaluated varied dose and schedule combinations to determine the recommended Phase 2 dose for expansion into Part B. RAMP 205 is supported by a PanCAN Therapeutic Accelerator Award. About AVMAPKI and FAKZYNJA Combination Therapy AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors. The U.S. Food and Drug Administration (FDA) approved AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib plus defactinib with standard-of-care chemotherapy as a potential treatment in the first-line for patients with advanced pancreatic cancer (RAMP 205; NCT05669482). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use. AVMAPKI FAKZYNJA CO-PACK U.S. Indication Indication AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Important Safety Information Warnings and Precautions Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity. Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration. Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality. Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction. Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. Adverse Reactions The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count. Drug Interactions Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin. Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid. Use in Specific Populations Lactation: Advise not to breastfeed. Fertility: May impair fertility in males and females. Click here for full Prescribing Information. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI® FAKZYNJA® CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the expected outcome and benefits of the Company’s collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company’s clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as the possibility of negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that we may not be successful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; risks associated with preliminary and interim data, which may not be representative of more mature data; risks associated with the recent changes in administration policy or actions that may create regulatory uncertainty that may adversely affect our business; risks associated with the current administration’s reductions to the FDA’s workforce and any subsequent reductions that may lead to disruptions and delays in the FDA’s review and oversight of our product candidates and impact the FDA’s ability to provide timely feedback on our development programs; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" as detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 4, 2026, as well as the other information we file with the SEC, are possibly realized. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. View source version on businesswire.com: https://www.businesswire.com/news/home/20260617680929/en/ Contacts For Investor and Media Inquiries: Julissa VianaSenior Vice President, Corporate CommunicationsInvestor Relations and Patient [email protected] [email protected]

Investor releaseQuarter not tagged2026-05-11

Verastem, Inc. (NASDAQ:VSTM) Just Released Its First-Quarter Earnings: Here's What Analysts Think

Simply Wall St.
It's been a mediocre week for Verastem, Inc. (NASDAQ:VSTM) shareholders, with the stock dropping 18% to US$4.89 in the week since its latest first-quarter results. It looks like weak result overall, with ongoing losses and revenues of US$19m falling short of analyst predictions. The losses were a relative bright spot though, with a per-share (statutory) loss of US$0.37 being 21% smaller than what the analysts had presumed. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the nine analysts covering Verastem are now predicting revenues of US$106.2m in 2026. If met, this would reflect a major 114% improvement in revenue compared to the last 12 months. Losses are predicted to fall substantially, shrinking 28% to US$1.60. Before this earnings announcement, the analysts had been modelling revenues of US$114.9m and losses of US$1.71 per share in 2026. It looks like there's been a modest increase in sentiment in the recent updates, with the analysts becoming a bit more optimistic in their predictions for losses per share, even though the revenue numbers fell somewhat. View our latest analysis for Verastem There was no major change to the US$16.25average price target, suggesting that the adjustments to revenue and earnings are not expected to have a long-term impact on the business. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. The most optimistic Verastem analyst has a price target of US$18.00 per share, while the most pessimistic values it at US$14.00. The narrow spread of estimates could suggest that the business' future is relatively easy to value, or thatthe analysts have a strong view on its prospects. One way to get more context on…Read full document

It's been a mediocre week for Verastem, Inc. (NASDAQ:VSTM) shareholders, with the stock dropping 18% to US$4.89 in the week since its latest first-quarter results. It looks like weak result overall, with ongoing losses and revenues of US$19m falling short of analyst predictions. The losses were a relative bright spot though, with a per-share (statutory) loss of US$0.37 being 21% smaller than what the analysts had presumed. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the nine analysts covering Verastem are now predicting revenues of US$106.2m in 2026. If met, this would reflect a major 114% improvement in revenue compared to the last 12 months. Losses are predicted to fall substantially, shrinking 28% to US$1.60. Before this earnings announcement, the analysts had been modelling revenues of US$114.9m and losses of US$1.71 per share in 2026. It looks like there's been a modest increase in sentiment in the recent updates, with the analysts becoming a bit more optimistic in their predictions for losses per share, even though the revenue numbers fell somewhat. View our latest analysis for Verastem There was no major change to the US$16.25average price target, suggesting that the adjustments to revenue and earnings are not expected to have a long-term impact on the business. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. The most optimistic Verastem analyst has a price target of US$18.00 per share, while the most pessimistic values it at US$14.00. The narrow spread of estimates could suggest that the business' future is relatively easy to value, or thatthe analysts have a strong view on its prospects. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. One thing stands out from these estimates, which is that Verastem is forecast to grow faster in the future than it has in the past, with revenues expected to display 176% annualised growth until the end of 2026. If achieved, this would be a much better result than the 20% annual decline over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in the industry are forecast to see their revenue grow 22% per year. So it looks like Verastem is expected to grow faster than its competitors, at least for a while. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. They also downgraded Verastem's revenue estimates, but industry data suggests that it is expected to grow faster than the wider industry. Still, earnings per share are more important to value creation for shareholders. The consensus price target held steady at US$16.25, with the latest estimates not enough to have an impact on their price targets. Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. At Simply Wall St, we have a full range of analyst estimates for Verastem going out to 2028, and you can see them free on our platform here.. We don't want to rain on the parade too much, but we did also find 2 warning signs for Verastem (1 is significant!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2026-05-09

Verastem Q1 Earnings Call Highlights

MarketBeat
Interested in Verastem, Inc.? Here are five stocks we like better. Verastem reported Q1 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, bringing cumulative revenue since the May 2025 launch to nearly $50 million despite seasonal and execution headwinds. Management said it is making commercial changes after reviewing launch performance, including appointing a new chief commercial officer and focusing on earlier use at first recurrence, stronger patient persistence, and broader physician adoption. The company said its VS-7375 KRAS G12D program is advancing into registration-directed phase II trials in pancreatic cancer, non-small cell lung cancer, and colorectal cancer, while Verastem ended the quarter with $181.7 million in cash and expects runway into the first half of 2027. Verastem (NASDAQ:VSTM) reported first-quarter 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, as management said the launch of the therapy for KRAS-mutated recurrent low-grade serous ovarian cancer continued to grow despite seasonal headwinds and some early commercial execution challenges. On the company’s earnings call, President and CEO Dan Paterson said the quarter brought Verastem’s total net product revenue since the May 2025 launch to nearly $50 million. He said new patient starts remained consistent month to month, the prescriber base continued to expand and reimbursement remained favorable. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% “While we’re pleased with the growth we’ve seen, we believe there’s meaningful opportunity to build on the foundation we’ve established,” Paterson said. Paterson said Verastem conducted a focused review of launch performance and made targeted changes to its commercial organization and leadership. The company appointed Dan Lyons as chief commercial officer, citing his oncology and rare disease launch experience, including at SpringWorks. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Paterson said first-quarter results were affected by insurance turnover, re-verifications and severe weather, which disrupted patient access and affected both new patient starts and refills. The company also observed that some early patients prescribed the therapy were further along in their disease and treatment journey than expected, and in some cases discontinued treatment earlier than an…Read full document

Interested in Verastem, Inc.? Here are five stocks we like better. Verastem reported Q1 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, bringing cumulative revenue since the May 2025 launch to nearly $50 million despite seasonal and execution headwinds. Management said it is making commercial changes after reviewing launch performance, including appointing a new chief commercial officer and focusing on earlier use at first recurrence, stronger patient persistence, and broader physician adoption. The company said its VS-7375 KRAS G12D program is advancing into registration-directed phase II trials in pancreatic cancer, non-small cell lung cancer, and colorectal cancer, while Verastem ended the quarter with $181.7 million in cash and expects runway into the first half of 2027. Verastem (NASDAQ:VSTM) reported first-quarter 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, as management said the launch of the therapy for KRAS-mutated recurrent low-grade serous ovarian cancer continued to grow despite seasonal headwinds and some early commercial execution challenges. On the company’s earnings call, President and CEO Dan Paterson said the quarter brought Verastem’s total net product revenue since the May 2025 launch to nearly $50 million. He said new patient starts remained consistent month to month, the prescriber base continued to expand and reimbursement remained favorable. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% “While we’re pleased with the growth we’ve seen, we believe there’s meaningful opportunity to build on the foundation we’ve established,” Paterson said. Paterson said Verastem conducted a focused review of launch performance and made targeted changes to its commercial organization and leadership. The company appointed Dan Lyons as chief commercial officer, citing his oncology and rare disease launch experience, including at SpringWorks. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Paterson said first-quarter results were affected by insurance turnover, re-verifications and severe weather, which disrupted patient access and affected both new patient starts and refills. The company also observed that some early patients prescribed the therapy were further along in their disease and treatment journey than expected, and in some cases discontinued treatment earlier than anticipated. According to Paterson, the company has since seen a rebound in new patients through the end of the first quarter. He said physician conviction remains strong, citing a recent physician survey in which a majority indicated the CO-PACK would be their first choice at a patient’s next recurrence. → Years in the Making, AMD’s Upside Movement Has Just Begun Through April, the company had more than 400 unique prescribers to date. Prescriptions continued to be split roughly 60% from gynecologic oncologists and 40% from medical oncologists. Paterson said the active patient pool has grown in recent months, but the company is not yet providing duration of therapy or average refill metrics because those figures are still evolving. Verastem said about 65% of commercially eligible patients are using its Verastem Cares copay program, while other patients did not require assistance. The average copay for commercially insured patients is less than $30. Initial prescriptions are being filled in about 12 to 14 days, helped by rapid prior authorization approvals, and payer mix remains about half commercial and half Medicare. Management outlined three commercial priorities for the remainder of 2026: maintaining demand for new patient starts, encouraging earlier use at first recurrence and helping patients stay on therapy. Paterson said Verastem is using proxy measures in electronic health records to help identify potential low-grade serous ovarian cancer patients, including mutational status and prior AI or MEK inhibitor use. The company has also added personnel to support demand and patient adoption. He said some discontinuations appear to reflect use in patients outside the intended approved population or in patients who were significantly sicker than those enrolled in the RAMP 201 study that supported FDA approval. Paterson said this reinforces the importance of using the CO-PACK earlier, when patients are more likely to realize its full benefit. The company also launched a direct-to-physician and patient campaign called “Reimagine Recurrent LGSOC,” aimed at driving earlier use. Paterson cited recent long-term RAMP 201 data presented at the Society of Gynecologic Oncology showing durable benefit after two years of follow-up and discontinuation rates consistent with the package insert. President of Development Dr. Michael Kauffman said Verastem has renamed its VS-7375 oral KRAS G12D inhibitor trial program TARGET-D. The ongoing TARGET-D 101 phase I/II trial is evaluating dose escalation, dose expansion and combinations, with the company now testing a 1,200 mg daily dose to define the upper end of the dosing range. Verastem has also developed three phase II registration-directed trials after FDA requested separate phase II protocols for trials intended to support marketing authorization. These studies include: TARGET-D 201, a second-line pancreatic cancer study evaluating VS-7375 at 900 mg daily as monotherapy and in combination with cetuximab. TARGET-D 202, an advanced non-small cell lung cancer study evaluating VS-7375 at 900 mg daily in patients who have received one or two prior lines of therapy, including platinum chemotherapy and a PD-1 or PD-L1 blocker. TARGET-D 203, a metastatic colorectal cancer study evaluating VS-7375 at 900 mg daily as monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab. Kauffman said the primary endpoint across the three phase II trials is overall response rate by blinded independent central radiological review, with duration of response as a key secondary endpoint supporting potential accelerated approvals. He said the company anticipates first patients in each study around mid-year, “if not sooner.” Updated pharmacokinetic data show the 900 mg dose delivers serum levels at or above the company’s target level and provides clear separation from the 600 mg dose, Kauffman said. He added that the 900 mg dose has been well tolerated to date in more than 20 U.S. patients, supporting its use in phase II trials. For the first-half update from TARGET-D 101, Kauffman cautioned that efficacy data will still be limited, while safety and pharmacokinetic data will be more mature. He said the company plans to include patient cases across tumor types and combinations, with a more comprehensive data set expected later in the year. Chief Financial Officer Dan Calkins said Verastem recorded $2.8 million in product cost of sales in the first quarter. Research and development expenses were $38.2 million, driven by the global confirmatory phase III RAMP 301 trial for the CO-PACK, the VS-7375 TARGET-D 101 trial in the U.S. and higher clinical supply and drug production costs tied to the expanded VS-7375 program. Selling, general and administrative expenses were $22.3 million, reflecting commercial activities and operations supporting the CO-PACK launch. Calkins said SG&A expenses are expected to remain roughly consistent on a quarterly basis through 2026. Verastem reported a non-GAAP adjusted net loss of $42.7 million, or $0.43 per diluted share, compared with a non-GAAP adjusted net loss of $42.9 million, or $0.79 per diluted share, in the first quarter of 2025. The company ended the quarter with $181.7 million in cash, equivalents and investments. Calkins said Verastem believes its current cash, combined with future AVMAPKI FAKZYNJA CO-PACK revenue, will provide runway into the first half of 2027. Management reiterated that it expects the low-grade serous ovarian cancer franchise to become self-sustaining in the second half of 2026, with CO-PACK revenue funding commercial operations and avutometinib plus defactinib clinical trials. During the question-and-answer session, Paterson said potential partners for VS-7375 are looking for U.S. data showing the drug can be administered tolerably, combined with other agents and begin to replicate the efficacy seen in China. Kauffman said the U.S. experience has shown better tolerability than reported in China, including no significant liver dysfunction, hematologic issues or cumulative toxicities to date. Kauffman also said Verastem believes the 900 mg dose is likely the go-forward dose, while the 1,200 mg dose is being evaluated as the highest practical dose with the current 100 mg tablets. He said larger tablets are being developed. On the commercial side, Paterson said Verastem added two sales positions because two regions were too large, increased coordination with specialty pharmacies and is placing more emphasis on follow-up after initial prescriptions. He said the company expects second-quarter revenue growth over the first quarter to be larger than the growth seen from the fourth quarter to the first quarter. Verastem Oncology, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapies that target cancer stemness and resistance pathways. Established in 2010 and headquartered in Needham, Massachusetts, Verastem Oncology applies a precision-medicine approach to identify key signaling nodes responsible for tumor growth and relapse, with an emphasis on hematologic malignancies and solid tumors. The company’s research platform integrates insights into complex signaling networks to advance novel compounds from early discovery through clinical proof of concept. The company’s lead marketed product is COPIKTRA (duvelisib), an oral inhibitor of PI3K-delta and PI3K-gamma, which received U.S. The article "Verastem Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook