Verastem Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: Second-quarter product revenue reached $25.1 million, reflecting a rebound in AVMAPKI FAKZYNJA CO-PACK demand driven by new patient starts, earlier-line prescribing, broader physician adoption, and improving refills.
  • Positive Sentiment: Verastem added up to $90 million in non-dilutive funding, including $50 million drawn from Oberland Capital and a $15 million COPIKTRA milestone, bringing pro forma cash to $201.4 million and supporting operations into the second half of 2027, according to management.
  • Positive Sentiment: The company advanced VS-7375 by completing enrollment in three TARGET-D 101 expansion cohorts and dosing the first patients in registration-directed Phase II trials for pancreatic, colorectal, and non-small cell lung cancers; management expects response-rate and early durability data across the three tumor types in October.
  • Neutral Sentiment: Management is targeting the potential accelerated-approval benchmark of roughly 30% response rates with at least six months of durability, while emphasizing that tolerability will also be important in regulatory and competitive comparisons.
  • Positive Sentiment: Verastem continues to pursue partnerships for VS-7375, including work with Erasca, but said its new funding provides flexibility to avoid rushing into a partnership or equity financing before additional clinical data become available.
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Earnings Conference Call
Verastem Q2 2026
00:00 / 00:00

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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
Julissa Viana
SVP of Corporate Communications, Investor Relations, and Patient Advocacy at Verastem Oncology

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
Julissa Viana
SVP of Corporate Communications, Investor Relations, and Patient Advocacy at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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

Dan Lyons
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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 Lyons
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Calkins
CFO at Verastem Oncology

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
Dan Calkins
CFO at Verastem Oncology

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
Dan Calkins
CFO at Verastem Oncology

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
Dan Calkins
CFO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Eric Schmidt
Analyst at Cantor Fitzgerald

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Eric Schmidt
Analyst at Cantor Fitzgerald

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 Paterson
President and CEO at Verastem Oncology

Dan C., you want to take that?

Dan Calkins
Dan Calkins
CFO at Verastem Oncology

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
Eric Schmidt
Analyst at Cantor Fitzgerald

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.

Analyst at Guggenheim

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
Dan Paterson
President and CEO at Verastem Oncology

Michael, you want to take that one?

Michael Kauffman
Michael Kauffman
President of Development at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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.

Analyst at RBC Capital Markets

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
Dan Paterson
President and CEO at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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.

Analyst at Jefferies

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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
Graig Suvannavejh
Analyst at Mizuho

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
Graig Suvannavejh
Analyst at Mizuho

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
Dan Paterson
President and CEO at Verastem Oncology

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 Paterson
President and CEO at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

Thanks, Michael.

Michael Kauffman
Michael Kauffman
President of Development at Verastem Oncology

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
Andres Maldonado
Analyst at H.C. Wainwright

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
Dan Paterson
President and CEO at Verastem Oncology

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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

Thanks, Andres. 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
Dan Lyons
Chief Commercial Officer at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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.

Analyst at BTIG

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
Dan Paterson
President and CEO at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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
Dan Paterson
President and CEO at Verastem Oncology

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.

Analyst at BTIG

Thank you.

Operator

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

Analyst at Alliance Global Partners

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
Dan Paterson
President and CEO at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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
Michael Kauffman
President of Development at Verastem Oncology

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.

Analyst at Alliance Global Partners

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.

Executives
    • Julissa Viana
      Julissa Viana
      SVP of Corporate Communications, Investor Relations, and Patient Advocacy
    • Dan Paterson
      Dan Paterson
      President and CEO
    • Dan Lyons
      Dan Lyons
      Chief Commercial Officer
    • Dan Calkins
      Dan Calkins
      CFO
    • Michael Kauffman
      Michael Kauffman
      President of Development
Analysts
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