Q2 2026 Verastem Inc Earnings Call

August 6, 2026

Operator: Good afternoon, and welcome to Verastem Oncology Second Quarter 2026 Earnings Conference Call. My name is Olivia, and I'll be 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, 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 Q2 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.

Speaker #2: 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. are available on the Investor Relations section of our website.

Speaker #2: reference during our call today. Both begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. are subject to certain risks and uncertainties, and actual results may differ materially.

Speaker #2: expectations and beliefs. These statements 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. today's call to deliver prepared remarks and take your questions are Dan Patterson, President and Chief Executive Officer.

Speaker #2: Joining me on the call is Dr. Michael Kaufman, who will be joining us for the Q&A portion. I will now turn the call over to Dan.

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.

Speaker #3: 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.

Dan Paterson: Thank you, Julissa. Good afternoon, and thank you for joining our call today. We delivered a strong Q2 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 preserve strategic flexibility as we evaluate future financing opportunities.

Speaker #3: 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 AVMAP GFEX India COPAC.

Speaker #3: We also strengthened the balance sheet with a non-dilutive royalty financing agreement with Oberlin Capital, to secure up to $75 million in funding, of which we expect to draw $50 million at closing.

Speaker #3: Combined with a $15 million milestone payment from Secura Bio for a copectra 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.

Speaker #3: Also, 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 Avutametnab and Difactinab development franchise.

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 Q1, 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.

Speaker #3: As Dan Lyons will discuss, the commercialization of the COPAC is progressing well, and we're encouraged that the changes we made are having an impact.

Speaker #3: Since the first quarter, we've seen a meaningful rebound with significant quarter-over-quarter growth, driven by growing physician confidence and initiating treatment for new patients. Physicians are prescribing to more patients in earlier lines and increasing patient refills.

Speaker #3: 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.

Speaker #3: In June, we reported a positive update on the RAMP 205 pancreatic cancer data, looking ahead we believe the regimen of Avutametnab plus Difactinab in combination with chemotherapy can play an important role in the second-line treatment of PDAC following either a PanRAS or a KRAS G12D inhibitor to help address resistance mechanisms that are expected to emerge.

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.

Speaker #3: Turning to VS7375, 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.

Speaker #3: 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.

Speaker #3: At the same time, it has also made clear that there remain significant opportunity to improve both outcomes and the overall treatment experience for the approximately 60,000 patients diagnosed each year in the U.S.

Dan Paterson: 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 US 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 mg, her primary tumor shrank by more than 65% within 6 weeks, and her symptoms also started to improve.

Speaker #3: alone with a KRAS G12D-driven cancer. Recently, I heard about a young woman in her 30s who is participating in our trial, and her story and experience in the trial reminded me why this work matters.

Speaker #3: 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.

Speaker #3: She was not only living with cancer but disease that disrupted her quality of life. When she entered our study and began treatment with VS7375 at 600 milligram, her primary tumor shrank by more than 65% within 6 weeks, and her symptoms also started to improve.

Speaker #3: 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.

Dan Paterson: She remains on treatment today and continues to do well. 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 that 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.

Speaker #3: 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 1, 2 target D101 study, which further strengthened our conviction that VS7375 has the potential to not only become the best-in-class oral KRAS G12D inhibitor, but a treatment that patients can truly tolerate.

Speaker #3: 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 2 registration-directed studies in pancreatic, colorectal, and non-small cell lung cancers.

Speaker #3: Operationally, we've continued to execute the VS7375 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 D101 study, received FDA fast-track designation for non-small cell lung cancer, and initiated all three of our phase 2 registration-directed studies with the first patients now dosed in each trial.

Dan Paterson: 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?

Speaker #3: 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 front-line phase 3 studies.

Speaker #3: We look forward to sharing a meaningful data update on VS7375, 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.

Speaker #3: Dan?

Speaker #2: Thanks, Dan. We continue to make meaningful progress in the second quarter as the launch matures. We are pleased with the quarterly sales of Avumat Difactinab and COPAC, 25.1 million dollars.

Dan Lyons: Thanks, Dan. We continued to make meaningful progress in the Q2 as the launch matures. We are pleased with the quarterly sales of avutometinib defactinib 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 Q2. As the new patient demand continues to build, we expect this to convert to future refills.

Speaker #2: Our commercialization of COPAC remains focused on three priorities: driving consistent new patient demand, expanding use earlier in the treatment journey, and helping patients stay on therapy to realize the full benefit of treatment.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: As a 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.

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 Q2 across academic and community targets. Through the end of the Q2, adoption continues to expand as experience with avutometinib defactinib 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.

Speaker #2: 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 COPAC in the second quarter across academic, and community targets.

Speaker #2: Through the end of the second quarter, adoption continues to expand as experience with Avumat Difactinib and COPAC deepens, with a meaningful addition of first-time prescribers and new accounts.

Speaker #2: 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.

Speaker #2: 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.

Dan Lyons: We are expanding this work to more practices in the Q3. 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 pre-treated and later-line patients. During the Q2, 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.

Speaker #2: 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 pre-treated and later-line patients.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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-directed physician and patient campaign, are focused squarely on the shift of identifying the right patient.

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 CoPak fits in the treatment paradigm from the respective leaders in the field. Our third commercial priority is ensuring patients remain on the CoPak 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 CoPak 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.

Speaker #2: And we can attribute our success in Q2 to that message resonating with prescribers. Our peer-to-peer programming, and also creating opportunities for doctors to understand where COPAC fits in the treatment paradigm, from the respected leaders in the field.

Speaker #2: Our third commercial priority is ensuring patients remain on the COPAC 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.

Speaker #2: Physician feedback on the COPAC 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.

Speaker #2: Our operational execution has strengthened, with the changes that we made at 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 Avumat Difactinab and COPAC.

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. 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 CoPak. We are seeing that momentum continue in Q3. I'll now turn the call over to Dan Calkins.

Speaker #2: 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, expanded physician adoption, and the appropriate patients being identified drove meaningful growth in the adoption of the COPAC, and we are seeing that momentum continue in Q3.

Speaker #2: I'll now turn the call over to Dan Calkins.

Speaker #3: 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.

Dan Calkins: Thank you, Dan. Our full financial results are included in our press release. I'll focus on the highlights here. For Q2 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 a 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 Q2 2026. Research and development expenses were $41.3 million for Q2, incrementally increasing as expected from Q1 2026.

Speaker #3: 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 Cropictra surpassing 200 million dollars during the second quarter of 2026.

Speaker #3: Research and development expenses were 41.3 million dollars for the second quarter, incrementally increasing as expected from the first quarter of 2026. These expenses continue to be driven by the ongoing target D101 clinical trial in the US, the initiation of the three-phase two target D clinical trials, and costs associated with clinical supply and drug production activities related to our expanded VS-7375 program.

Dan Calkins: These expenses continue to be driven by the ongoing TARGET-D 101 clinical trial in the US, 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 Q2 2026, roughly in line with Q1. These expenses continue to be driven by commercial activities and operations, including personnel-related costs, to support the ongoing CoPak 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.

Speaker #3: 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 COPAC launch.

Speaker #3: Let me reiterate that we expect SG&A expenses to remain roughly the same on a quarterly basis throughout 2026, as we've remained disciplined in our expense management, making the right investments at the right time to support the ongoing commercial launch efforts.

Speaker #3: For the second quarter of 2026, non-GAAP adjusted net loss was 30.6 million, or 31% per share diluted, compared to non-GAAP adjusted net loss of 41.3 million, or 62 cents per share diluted, for the second quarter of 2025.

Dan Calkins: For Q2 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 Q2 2025. Please see our press release for a reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet, we ended Q2 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 Q2 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.

Speaker #3: 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, cash equivalents, and investments of $136.4 million.

Speaker #3: When you include the 50 million dollars received at closing from the non-dilutive royalty financing with Overland and the 15 million dollar Cropictra milestone payment, our pro forma cash balance at the end of the second quarter is 201.4 million dollars.

Speaker #3: Based on our current cash position, we expected revenues from the Avumat Difactinab and COPAC sales and access to the future tranche from our Overland 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.

Dan Calkins: We believe we have sufficient capital to fund operations into H2 2027 and reach meaningful value creating inflection points before needing to access additional capital.

Speaker #3: As Dan mentioned earlier, we look forward to building on COPAC'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 COPAC revenues funding both the commercial operations and our Abutametnib plus Tofacitinib clinical trials.

Dan Calkins: 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.

Speaker #3: With that, let me turn the call back over to Dan Paterson.

Speaker #1: 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.

Dan Paterson: Thanks, Dan. Before we open the call to Q&A, I'd like to reiterate that our focus for H2 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 H2 of the year. With that, we'll open the call for questions. Operator?

Speaker #1: Drive strong execution of our commercial strategy to expand adoption of Avumat Difactinab and COPAC. Complete enrollment in our three-phase two registration-directed VS-7375 trials and prepare to initiate our three-phase three trials for VS-7375.

Speaker #1: In October, we expect to provide a more comprehensive dataset for VS-7375, including response rates across our three lead tumor types: pancreatic, lung, and colorectal cancers.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: With that, we'll open the call for questions. Operator?

Speaker #4: Thank you. As a reminder, to ask a question, you will need to press star, 11 on your telephone, and wait for your institution name to be announced.

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.

Speaker #4: Please stand by while we compile the Q&A roster. And we have a question from Cantor. Caller, please go ahead and introduce yourself and ask your question.

Eric Schmidt: Well, thanks. 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.

Speaker #1: Well, thanks. 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?

Speaker #1: I know last time we spoke, you had alluded to a potential collaboration with Araska. But are there any other comments you want to provide on what it might take for you to form some sort of collaboration?

Speaker #1: Thank you.

Speaker #2: Yes. Eric, thanks for the question. We continue to work on the Araska 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 kind of when we'll be able to start the study.

Dan Paterson: Yeah. 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.

Speaker #2: 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 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.

Speaker #2: I think we'll 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.

Speaker #2: The value goes up over time, but the potential acceleration of a program and that a partner can bring has a bigger impact the earlier it is.

Dan Paterson: 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. We continue on all those fronts, and 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.

Speaker #2: So we continue on all those fronts, and 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.

Speaker #1: Thank you, Dan. That's very helpful. And maybe just a quick follow-on for the other Dan. Gross margin CV running in the last couple of quarters—a little bit better than, at least, I've been modeling.

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?

Speaker #1: Is this a reasonable run rate going forward?

Speaker #2: Dan, do you want to take that?

Dan Paterson: Dan C, you want to take that?

Speaker #3: Yeah, sure. Thanks, Eric. Yeah, I think that that is a reasonable run rate. I think as you look at cost of sales, the majority of that really is still continues to be royalty-based.

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're seeing historically should be indicative of what we should expect going forward.

Speaker #3: The margins on the product are relatively high. So but going forward from a modeling perspective, I think what you're seeing this quarter and what you've seen historically should be indicative of what we should expect going forward.

Speaker #1: Thank you very much.

Eric Schmidt: Thank you very much.

Speaker #4: Thank you. Next in the queue, we have a question from Guggenheim. Caller, please go ahead, introduce yourself, and ask your question.

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

[Analyst] (Cantor Fitzgerald): Hi, this is Michelle on for Michael Schmidt. First of all, congrats on the strong quarter. I just wanted to ask on VS-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.

Speaker #5: 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.

Speaker #5: So you've cited, I think, a general 30% overall response rate in 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?

Speaker #5: 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.

Speaker #2: Michael, you want to take that one?

Dan Paterson: Michael, you want to take that one?

Speaker #3: Sure. We think that's generally a very good guidepost to probably saw the recent very recent approval of two DRICEV in melanoma with a 24% response rate, which got accelerated approval.

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%'s 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

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: And 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 really difficult.

Michael Kauffman: There are drugs that are very easy to take, 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.

Speaker #3: Never mind the mucositis and stomatitis. So remember that accelerated approval looks at both activity as well as the safety and tolerability profile of the drug.

Speaker #2: Thanks, Michael.

Dan Paterson: Thanks, Michael.

Speaker #4: Thank you. Next in the queue, we have a question from RBC Capital Markets. Caller, please go ahead and introduce yourself and ask your question.

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

Speaker #6: Hey, guys. Josh on for Leo here. Thanks for taking my question. I was wondering whether or not how you were feeling about the translateability of the ORR data that you've been seeing in the Gen Fleet China study.

Josh Anfalio: Hey, guys. Josh Anfalio 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 US population given the known differences in PK behavior or disease management. Thanks.

Speaker #6: And whether or not that'll be recapitulated in the US population given the known differences and PK behavior or disease management. Thanks.

Speaker #2: Yeah. Thanks for the question. We do get compared to the Gen Fleet China data all the time. I would remind everybody that the most important benchmarks are going to be the US data from other products.

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 US 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 do not know, Michael, if you want to give any more color there.

Speaker #2: And as Michael said, we're really hitting the bar that we need for accelerated approval. We are seeing quite a different toxicity profile. We are showing PK that goes up as the dose increases, and we believe—especially with an isoform-specific molecule—that hitting the target really hard will translate into both depth of response and durability.

Speaker #2: I don't know, Michael, if you want to give any more color there.

Speaker #3: Yeah, 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.

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

Speaker #3: 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.

Speaker #4: Thank you. Next in the queue, we have a question from Jeffries. Caller, please go ahead and introduce yourself and ask your question.

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] (Jefferies): Hey, guys. This is Faisal 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 are 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.

Speaker #6: Hey, guys. This is Vessel from Jeffries. Thank you so much for taking the question. I just wanted to ask on the COPAC performance, really nice to see the uptake in revenues this quarter.

Speaker #6: Can you help us understand a little bit about 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.

Speaker #6: 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.

Speaker #6: Thank you.

Speaker #2: Thanks. Thanks for the question. I would say a bit of both, but maybe Dan, if you want to give Dan Lions, if you want to give a little more color.

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.

Speaker #3: Yeah, thanks for the question. It's a bit of both. And so what we saw, as you know, Vessel, 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 that MAP defects into COPAC.

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 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. 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.

Speaker #3: 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.

Speaker #3: 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 at all the execution and focus that we had is leading to the outcomes we're looking for overall.

Speaker #6: Great. Thank you.

[Analyst] (Jefferies): Great. Thank you.

Speaker #4: Thank you. Next in queue, we have a question from Mizuho Group. Caller, please go ahead and introduce yourself and ask your question.

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

Speaker #7: Hey, good afternoon. It's Greg Savanovich at Mizuho. Thanks for taking my question and congrats on the quarter. Two questions if I could. Just maybe on COPAC, maybe piggybacking on the last question as we think about the dynamic between new patient starts and refills and newer prescribers.

Greg Savana: Hey, good afternoon. It's Greg Savana, vet at Mizuho. Thanks for taking my question, and 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're looking for in the upcoming October data.

Speaker #7: Is there a way to think about whether any one particular segment 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?

Speaker #7: And then second, if I could ask a question on 73, 75. Appreciate the color on what you're looking for in the upcoming October data.

Speaker #7: 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 inhibitors space, how do you hope to best differentiate your compound versus others that either already out there or could be coming?

Greg Savana: 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.

Speaker #7: Thanks.

Speaker #2: Thanks, Greg, for the question. I'll take the second one first and then I'll let Dan Lions address the first one. I would say against pan-RAS inhibitors, we intend to show better efficacy and significantly better tolerability.

Dan Paterson: Thanks, Greg, for the question. I'll take the second one first, then I'll 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've said all along is, and if you look at 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. Against the pan-RAS, I think the big difference is going to be tolerability. Against other G12D inhibitors, we've said we thought we have the best in class based on preclinical data.

Speaker #2: With the G12D inhibitors, I think what we've said all along is, if you look at how 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.

Speaker #2: But against the pan-RAS, 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.

Speaker #2: I would say what we're starting to see that in the data that we're getting clinically and hopefully we can show that in October. Dan Lions, do you want to take the second question then if Michael wants to add any more color?

Dan Paterson: I would say we're starting to see that in the data that we're getting clinically. Hopefully we can show that in October. Dan Lyons, you want to take the second question? If Michael wants to add any more color, you can feel free.

Speaker #2: You can feel free.

Speaker #3: Sure. I'll go first, then Michael, if you want to add anything. So, as you look at the question around the segment—whether it's new patient starts versus refills versus moving up in line of therapy—all three of those are critically important.

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 versus 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.

Speaker #3: Those new patient starts turn into refills very quickly. And as we look at as we look at the ability to keep patients on, that's where our team has been focused this last quarter.

Speaker #3: 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?

Speaker #3: 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.

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?

Speaker #3: Michael?

Speaker #6: Yeah, just one last point to add on to what Dan said. I think, unlike most of the G12D inhibitors and in fact some of the pan-RAS, RPK continues to climb.

Michael Kauffman: 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 pan-RAS, our PK continues to climb as we go up from 400 to 600 to 900. 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.

Speaker #6: 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.

Speaker #6: Generally, they tend to threshold out and more drug doesn't deliver higher exposures. And 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.

Speaker #6: 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.

Speaker #6: We have no rash and no mucositis. When we go up on the dose, we don't see any increase. This is likely due to an irritant effect of the drug rather than a particular effect of the drug when it circulates.

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.

Speaker #6: 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 of that manifest in the clinical data.

Speaker #6: We'll have in October.

Speaker #2: Thanks, Michael.

Dan Paterson: Thanks, Michael.

Speaker #7: Thank you.

Michael Kauffman: Thank you.

Speaker #4: Thank you. Next, we have a question from HC Wenright. Caller, please go ahead and introduce yourself and ask your question.

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

Speaker #8: Hi guys, this is Andre Salvinato from HC Wenright. Congrats on the progress and of course, thanks for taking my questions. Just a quick one on the commercial frontier.

Andres Maldonado: Hi, guys. This is 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 front here. 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? If that's happening, can you talk about if that's happening beyond the major academic centers? 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? A quick one from the TARGET-D developmental strategy. Particularly for CRC, I guess we just saw data recently from the KRYSTAL-10 study, obviously different inhibitor, different subset, but what would justify continuing VS-7375 monotherapy without an EGFR inhibitor? Thank you very much.

Speaker #8: 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 or next recurrence?

Speaker #8: 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?

Speaker #8: And then a quick one from the Target D developmental strategy. So particularly for CRC, I guess we just saw data recently from the Crystal 10 study.

Speaker #8: Obviously different inhibitor, different subset. But what would justify continuing 73, 75 monotherapy without any GFR inhibitor? Thank you very much.

Speaker #2: So just real quickly on the CRC, we don't intend to develop it as a single agent. It's going to be with any GFR inhibitor.

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?

Speaker #2: That's really what's needed in CRC. Dan Lions, you want to really give a little more color on the commercial question?

Speaker #3: Thanks, Andre. So I think there was two questions in there. Line of therapy. And then dose interruption. So let me try to tackle both.

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.

Speaker #3: 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.

Speaker #3: This is not only in the academic setting, but also in the community. And it goes back to our messaging around being the treatment for the first or next recurrence.

Speaker #3: 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.

Speaker #3: 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 those interruptions.

Dan Lyons: 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 avutometinib defactinib 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.

Speaker #3: And when appropriate, having patients restart at the starting dose of a MAP defects and Gecko 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 we saw continue to build.

Speaker #2: Thanks, Dan.

Andres Maldonado: Thanks, Dan.

Speaker #4: Thank you. And as a reminder to ask a question, please press star 11 on your touchdown telephone. Next in the queue, we have a question from BTIG.

Operator: Thank you. As a reminder to ask a question, please press * one one on your touchtone telephone. Next in the queue, we have a question from BTIG. Caller, please go ahead and introduce yourself and ask your question.

Speaker #4: Caller, please go ahead and introduce yourself and ask your question.

Speaker #7: Great. Thanks for taking the question and congrats on a great quarter. So two questions from me. When it comes to 73, 75 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 the RASCA, or is in-licensing your own PRMT5 inhibitor something that's available as well?

[Analyst] (BTIG): Great. Thanks for taking the question. 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? 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-D 200 trials? Thanks.

Speaker #7: 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 200 trials?

Speaker #7: Thanks.

Speaker #2: Yeah, I will just say on the PRMT5, we're exploring all options. There are a number available for either kind of partnerships around a clinical trial.

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, 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?

Speaker #2: And there are some agents that are available, and we haven't ruled anything out. Michael, do you want to comment more on the accelerated approval?

Speaker #6: Yeah, 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.

Michael Kauffman: The FDA, I've been through three, actually five accelerated approvals. The FDA has never told us what they need. 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 6 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. We feel like we're in very good shape to achieve those.

Speaker #6: I mean, there are 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.

Speaker #6: 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.

Speaker #6: 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.

Speaker #6: And then we feel like we're in very good shape to achieve those.

Speaker #2: And 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.

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 #2: And they absolutely look at tolerability.

Speaker #7: Thank you.

Michael Kauffman: Thank you.

Speaker #4: Thank you. And a final question from Alliance Global Partners. Caller, please go ahead and introduce yourself and ask your question.

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

Speaker #7: Hey guys, Matthew from Alliance Global Partners. Thanks for taking my questions and congrats on the progress for the queue. I had one on doctors with patients who have KRAS G12D mutant patients.

[Analyst] (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.

Speaker #7: So these patients in the coming months, there's going to be 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.

Speaker #7: 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?

Speaker #7: Thanks.

Speaker #2: Oh, 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.

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.

Speaker #6: 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.

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 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. 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.

Speaker #6: 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 put they would recommend for G12D patients that they go on to a G12D specific drug.

Speaker #6: They particularly like DARS because of what they saw. Of course, they were at our ad boards, and 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.

Speaker #6: So targeted therapy for patients with a tumor that has a targeted oncogene. That's not a new concept at all. That is targeted that is targeted molecular oncology.

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, and that's what we like to do.

Speaker #6: And that's what we like to do.

Speaker #7: Got it. Great. Thanks, guys. Thanks for taking my questions.

[Analyst] (Alliance Global Partners): Got it. Great. Thanks, guys. Thanks for taking my questions.

Operator: Thank you. At this time, we have no further que-

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