Q2 2025 Verastem Inc Earnings Call

Speaker #1: Thank you for standing by. My name is Rebecca, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Verastem Oncology Second Quarter 2025 Financial Results Conference Call, all lines have been placed on mute to prevent any background noise.

Speaker #1: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad.

Speaker #1: If you would like to withdraw your question, press star one again. Thank you. I will now turn the call over to Julissa Viana, Vice President, Corporate Communications Investor Relations Patient Advocacy.

Speaker #1: Please go ahead.

Speaker #3: Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verastem's second quarter 2025 financial results and recent business updates. Earlier today, we issued a press release detailing our financial results for the second quarter of 2025.

Speaker #3: This release, along with a slide presentation that we will reference during our call today, are available on our website. Before we begin, I would like to remind you that any statements made during this call are not historical and are considered to be forward-looking statements.

Speaker #3: Within the meaning of the private securities litigation reform act of 1995, actual results may differ materially from those indicated by these statements as a result of various important factors.

Speaker #3: Including those discussed in the risk factor section in the company's most recent annual report on Form 10K, filed with the SEC on March 20th, 2025, and the current report on Form 10Q filed today as well as other reports filed with the SEC.

Speaker #3: Any forward-looking statements we make represent Verastem's views as of today, and we disclaim any obligations or responsibility to update. Joining me on today's call are Dan Patterson, President and Chief Executive Officer of Verastem, who will provide opening remarks and recap key highlights the quarter.

Speaker #3: Matt Ross, Chief Operating Officer, and Mike Crowther, Chief Commercial Officer, who will walk through the initial progress of the Avmaski-Faxenda Copac commercial launch. And Dan Caulkin, Chief Financial Officer, who will provide an overview of our financial results.

Speaker #3: I will now turn the call over to Dan.

Speaker #4: Thanks, Julissa. Good afternoon, everyone, and thank you for joining us on today's call. We're pleased to report that we delivered exceptional results in the first half of 2025.

Speaker #4: Highlighted by a particularly transformative second quarter. Our team achieved several significant milestones that position us for sustained long-term growth. We secured FDA approval for our lead program, ahead of schedule, and successfully launched Avmaski-Faxenda Copac, marking a major inflection point for the company.

Speaker #4: In addition, we advanced key clinical programs and strengthened our balance sheet to support our growth. As we look ahead to the second half of 2025, we remain highly focused on maintaining this strong momentum, bringing our new treatment option to more patients, and delivering value for our shareholders.

Speaker #4: The second quarter marked a pivotal milestone for our company with the FDA approval of Avmaski-Faxenda Copac, or KRAS mutated recurrent LGSOC. This approval represents several industry firsts that underscore the significance of our achievement.

Speaker #4: For the first time, patients with this rare ovarian cancer have access to an FDA-approved therapy specifically to address this area of high unmet need.

Speaker #4: And to our knowledge, this approval marks the first-ever truly novel novel drug combination approved in oncology, a clear validation to our innovative approach in execution capabilities.

Speaker #4: Importantly, we received accelerated approval nearly two months ahead of schedule and are extensive pre-launch efforts over the last two years allowed us to quickly move into the market.

Speaker #4: Avmaski-Faxenda Copac was available at our designated specialty pharmacies within five days of approval, demonstrating our operational excellence and commitment to patient access. In just six weeks on the market, we reported 2.1 million dollars in net product revenue reflecting successful early traction and robust execution across all key launch priorities.

Speaker #4: Our commercial and medical teams have performed exceptionally well in engaging healthcare providers, supporting patients, and ensuring seamless access. Delivering on each component of our go-to-market plan.

Speaker #4: Matt and Michael speak more about this in a few minutes. As we continue to build on the positive momentum this far, we firmly believe that the Avmaski-Faxenda Copac will become the new standard of care for this indication, fundamentally changing the treatment paradigm for this disease.

Speaker #4: I'll now turn the call over to Matt to discuss our commercial launch in greater detail. Matt?

Speaker #5: Thank you, Dan. The entire team is proud to bring this novel and breakthrough therapy to people living with KRAS mutated recurrent LGSOC. And we are encouraged by our early launch progress.

Speaker #5: This therapy addresses a critical need in LGSOC as patients face poor response rates to chemotherapy and hormone therapy which results in high recurrence rates, creating an urgent need for more effective treatment options.

Speaker #5: As the first-ever treatment approved specifically for KRAS mutated recurrent LGSOC, we can make a real difference in patients' lives. Our launch strategy focuses on three key areas: first, we want to reach all healthcare providers.

Speaker #5: We are effectively targeting both academic and community-based physicians. Our experience field and marketing teams are executing at a high level, ensuring healthcare providers understand the unique benefits and have a safely used Avmaski-Faxenda Copac.

Speaker #5: We're supporting these efforts with comprehensive and complementary digital marketing efforts. Second, we want to engage and support patients. Given the very limited treatment options available, many patients will continue to progress through other therapies and will likely be ready for a new treatment option within six to seven months.

Speaker #5: We are building upon our patient advocacy relationships and using various tools to educate patients and their caregivers about this new treatment option and supporting conversations with their doctors.

Speaker #5: And third, we want to ensure seamless access by providing comprehensive patient support for access to Avmaski-Faxenda Copac. We have seen coverage from the largest insurers in the U.S., including the three major PBMs, representing over 80% of lives in the U.S.

Speaker #5: We're ing closely with payers to establish appropriate coverage policies. I'm proud of what team has accomplished since our May approval. The approval came early, and the team hit the ground running and is executing well against all three areas of the launch.

Speaker #5: As Dan said, we achieved 2.1 million in net product revenue in the first six weeks of launch. Today, reimbursement has not been a barrier to access.

Speaker #5: While it is too early to share any trends or provide guidance on future prescriptions, we are encouraged by what we are seeing. Consistent with expectations, we have seen a variety of patient usage.

Speaker #5: Specifically, the combination therapy has been prescribed to women with advanced disease who have tried more than three prior lines of therapy. Encouragingly, we have also seen prescriptions for patients who are experiencing their first recurrence.

Speaker #5: This matches our pre-launch market research and the types of patients enrolled in RAMP201. Our sales force has been highly effective in aging with physicians across academic, community centers, and large private oncology practices.

Speaker #5: Through the use of Avmaski-Faxenda Copac, it appears to be well-balanced between these customer segments. Physician enthusiasm has been very high; in fact, some customers are reaching out to us to help educate their entire treatment teams on the therapy.

Speaker #5: Including some accounts that are historically viewed as hard to access or not known to grant access to sales representatives. In addition to our sales force efforts, our medical science liaisons are contributing to the more fulsome understanding of Avmaski-Faxenda Copac and LGSOC through impactful scientific exchanges with opinion leaders.

Speaker #5: We expect the recent RAMP201 and frame publications to drive an even deeper appreciation and understanding of the clinical relevance of Avmaski-Faxenda Copac. These studies show the combination therapy's clinically meaningful response rates, duration of treatment, long progression-free survival, favorable tolerability profile, and low treatment discontinuation rates.

Speaker #5: Moving to physician and patient education, we launched a comprehensive physician education and digital patient engagement effort immediately after approval. Our branded websites for HCPs and patients are seeing high engagement.

Speaker #5: Showing we are a trusted source of information. We quickly activated our distribution network by bringing on two independent oncology-focused specialty pharmacies to fulfill prescriptions as soon as possible.

Speaker #5: Together with the Verastem CARES patient support program, these pharmacies also provide comprehensive patient support services. Recently, we have entered into multiple agreements with specialty distributors and oncology group purchasing organizations.

Speaker #5: Looking toward the second half of the year, we will build on this momentum while staying laser-focused on our strategic imperatives. Given our early achievements, our team's effective execution, and the high unmet need for this rare form of ovarian cancer, we believe we are poised to have a strong second half of the year.

Speaker #5: Now, I will turn the call over to Mike.

Speaker #6: Thanks, Matt. It's a pleasure to be on the call today and provide some further details on the launch of the Avmaski-Faxenda Copac. As you have heard, we are off to a strong start as I began with our commercial team engaging prescribers immediately after we learned of the approval.

Speaker #6: The team has been incredibly nimble in a short period of time and we are proud to be making a positive difference in the lives of people living with LGSOC.

Speaker #6: Now, let me share some early indicators in the launch dynamics. In the second quarter, with just six weeks in the market, our field team called on 93% of the top 100 parent organizations and 84% of the top 100 office locations.

Speaker #6: We know that HCPs who treat LGSOC have a good understanding of where their patients are on their treatment journey. We are hearing from them that they are actively assessing and identifying patients when they might become appropriate candidates for the combination therapy.

Speaker #6: We are seeing prescriptions for patients coming from these high-priority accounts including a mix of academic and community. We are also starting to see both repeat prescriptions from physicians prescribing to multiple patients and refills for individual patients.

Speaker #6: As patients receive their treatment package within a short timeframe following the receipt of a prescription for Avmaski-Faxenda Copac at one of the specialty pharmacies, our medical science liaisons and oncology nurse educators have been equally busy.

Speaker #6: Having engaged in hundreds of scientific exchanges and over 30 educational forums with healthcare providers in the quarter. Feedback from customers has been very positive regarding the product profile and our Verastem care support program.

Speaker #6: It's early days, but the breadth and reach of our field engagement is critical as we raise awareness of the availability of a first-ever treatment specifically for KRAS mutated recurrent LGSOC patients.

Speaker #6: Importantly, immediately after a butamestine de facto move was approved by the FDA in May, we were immediately listed in the NCCN treatment guidelines as category 2A recommendation which is aligned with the approved indication.

Speaker #6: We recently submitted the RAMP201 and frame publications to the NCCN to potentially expand the recommendation to include the broader LGSOC population that was enrolled and represented in both studies.

Speaker #6: The NCCN committee has informed us that they plan to review our submission in October during our annual meeting. Additionally, these recent important publications are appearing in high-impact journals, which will help us to further increase awareness and understanding among physicians and medical professionals about our product and the disease state that it treats.

Speaker #6: As Matt mentioned, we activated our digital programming and branded websites quickly to engage and support patients looking for information on the combination therapy. We also engaged with the two and a half thousand patients who previously signed up on our disease education websites before the launch.

Speaker #6: As we have shared previously, the general payer mix for our combination therapy is about half commercial and half Medicare. While it's too to break down the mix we have seen to date, thanks to the process we have in place, the payer coverage has been broad and the time to fill prescriptions has been fast.

Speaker #6: While this process will evolve and form the recovery, which build over time, we believe payers are knowledging the unmet needs that can now be addressed by Avmaski-Faxenda Copac as well as the clinical value of the combination therapy.

Speaker #6: To close, we strongly believe that Avmaski-Faxenda combination therapy has the potential to make a significant impact on the lives of patients who previously had no treatment options specific to their disease.

Speaker #6: I'm happy with our results against our egic imperatives in these early days. And the team is executing well against all our launch objectives. We believe a steady adoption will occur over time and our early observations post our val support this perspective.

Speaker #6: I look forward to sharing more in the coming quarters as we progress through the launch and gain more experience and insights. With that, I'll turn the call over to Dan.

Speaker #7: Thank you, Mike. Since we issued a press release before the call today with the full financial results, I will focus on the highlights as shown on the next slide.

Speaker #7: We performed well in our initial quarter of launch and I am pleased to report 2.1 million dollars in net product revenue for the first six weeks with six weeks of the unch.

Speaker #7: Cost sales were 0.4 million for the second quarter 2025, versus zero in the second quarter of 2024. Cost of sales did not include a significant amount of product costs as inventory produced prior to FDA approval was fully expensed at the time of production.

Speaker #7: Research and development expense were 24.8 million dollars for the second quarter of 2025, compared to 18.1 million dollars for the second quarter of 2024.

Speaker #7: The increase was primarily driven by higher clinical-related expenses to support the global phase three RAMP301 trial, higher drug production activities in preparation for the launch, and higher costs associated with drug product and startup activities related to the BS7375 phase 128 clinical trial in the US.

Speaker #7: Selling, general, and administrative expenses, or SG&A, were $20.7 million for the second quarter of 2025, compared to $10.2 million for the second quarter of 2024.

Speaker #7: The increase was primarily driven by commercial readiness activities in operations, including personnel-related costs, in preparation of the approval. With that being said, we continue to be prudent in our expense management.

Speaker #7: For the second quarter of 2025, non-GAAP-adjusted net loss was 41.4 million dollars, or 63 cents per share diluted, compared to non-GAAP-adjusted net loss of 16.5 million dollars, or 61 cents per share diluted, for the 2024 quarter.

Speaker #7: Please see our press release for our reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet, we strengthened our financial position in April with a 75 million dollar private placement, which included issuance of common stock and pre-funded warrants.

Speaker #7: We ended the second quarter of 2025 with cash, cash equivalents, and investments of 164.3 million dollars. We believe our current cash combined with future revenues from Avmaski-Faxenda Copac sales and the exercise of the outstanding cash warrants provides cash runway into the second half of 2026.

Speaker #7: This is an citing time for all of us at Verastem as we start delivering the Avmaski-Faxenda Copac combination therapy to patients in the US.

Speaker #7: We had a solid first quarter as a commercial company and we had sufficient capital to fund our ongoing commercial launch in the US and continue advancing our current clinical development plans.

Speaker #7: With that, let me turn the call back over to Dan.

Speaker #8: Thanks, Dan. Before we open the call to Q&A, I'll share a few final remarks to close out today's presentation. It's been a strong first half of the year for Verastem and we've delivered on all of our milestones and are off to a great start with the commercial launch.

Speaker #8: We're in a strong position to continue executing against our plans. For the second half of the year, some of our milestones include continuing to report on the launch of Avmaski-Faxenda Copac, we're advancing our potential best-in-class oral G12D on/off inhibitor, VS7375 which our ner Genfleet shared encouraging early results at ASCO from our study in China.

Speaker #8: We'll continue enrollment in the VS7375 101 trial, including the monotherapy portion and move towards initiating the dose escalation combination cohort of VS7375 in combination with suximab in the fourth quarter.

Speaker #8: In our RAMP205 frontline metastatic pancreatic cancer trial, we demonstrated an 83% response rate with 10 of 12 patients achieving a confirmed partial response. We have moved quickly to enroll additional patients into an expansion cohort and will complete enrollment in the third quarter.

Speaker #8: In our RAMP203 KRAS G12C advanced non-small cell lung cancer trial, we plan to share an interim safety and efficacy update in the fourth quarter.

Speaker #8: Finally, we expect to complete planned enrollment in our phase three RAMP301 trial evaluating the combination and recurrent low-grade serous ovarian cancer regardless of KRAS mutation status.

Speaker #8: These milestones demonstrate the breadth of our development programs and our commitment to maximizing the potential of our platform across multiple cancer types. We have tremendous momentum heading into the second half of the year and remain confident in our ability to execute against our strategic plan and continue to help the patients we serve.

Speaker #8: With that, we'll open up the call for questions. Operator.

Speaker #1: At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad.

Speaker #1: We'll pause for just a moment. To compile the Q&A roster. Your first question comes from the line of Michael Smith with Guggenheim. Your line is open.

Speaker #9: Hey, guys. thanks for ing out questions. this is Paul on for Michael. so, just on the LGSOC launch, can you talk about the degree of off-label use that you're currently seeing in the, KRAS wall type setting?

Speaker #9: you know, what the feedback has been from providers on intended use in this setting? and then what you expect in terms of, prescribing and reimbursement trends leading up to the possible NCCN guideline update in October, and how that could reflect a once a decision is made on, on including the, full data set.

Speaker #10: Sure, thanks for the question. This is Matt. While we don't promote any off-label uses, of course, based on the current label, we have seen utilization in both the labeled population as well as in the wild-type population.

Speaker #10: Reimbursement for the patient populations that we just spoke of have not been an issue to date. And we'll continue to follow the reimbursement patterns and patterns as we move forward, into the third quarter and leading up to NCCN.

Speaker #9: Great. and then if ou have a follow-up on the, the KRAS program, so it seems like the US study is enrolling fairly well. can you just talk about the scope of that update in the fourth quarter?

Speaker #9: will it be roughly the same? You know, number of patients, in long and TDAC as, as the initial China study update? At ASCO, and also, could we expect any additional updates from, from Genfleet from, from that China study at some point?

Speaker #9: Thank ou.

Speaker #10: Sure. So thanks for the question. This is Dan. We would expect the magnitude of the update that we'll give to be roughly equivalent to what we saw in the Chinese data at ASCO.

Speaker #10: Genfleet has, advised that they'll be presenting additional data at two different medical meetings later this year. So you should expect two updates Genfleet and then we'll give an initial update on our phase one experience in the US.

Speaker #10: Likely, late this year on the safety side and there's a lot of interest in, in that. And then, the efficacy early next year.

Speaker #9: Got it. anks very much.

Speaker #1: Your next question comes from the line of Kelly Xi with Jeffries. Your line is open.

Speaker #11: This is Angie On for Kelly Xi. congrats for the quarter and thanks for taking our question. our question is, what are the key indicators you're tracking to gauge the launch performance and how should we interpret those?

Speaker #11: in terms of launch momentum, in the back half of the year, and, what could be the key drivers there? Thank ou.

Speaker #10: Yeah. I guess it's early in the launch and, and, as, Matt had mentioned earlier, we, we launched with the two specialty pharmacies in place.

Speaker #10: We've now brought on the specialty distributors, and the GPOs, and so we're just starting to track, the breadth of data that we're able to get.

Speaker #10: I'll Matt comment a little more on, you know, kind where we'll go from here. But part of it is really starting to see the patterns we see and see what we think is repeatable and reliable, and, then that'll then inform kind of what we're going to be tracking.

Speaker #10: But Matt, I don't know if you want .

Speaker #9: Yeah. No. I mean, Dan's absolutely right on that. I an, we, we mentioned on the call the importance of the three strategic imperatives around engagement with the healthcare community, ensuring that, patient access continues to be seamless, and that we're working closely with the patient population.

Speaker #9: So you expect I think over time, and once we see the appropriate trends, the reporting, on our performance will be anchored against those three imperatives.

Speaker #11: Got it. Thank ou.

Speaker #1: Your next question comes from Pete Stavropoulos with Cantor. Fitzgerald, your line is open.

Speaker #12: hi, Dan and team. Congratulations on the, quarter. and, thank you for taking our estions. first one, you ow, in terms of prescribers, do you have a sense if, these are physicians, you were targeting, what is the split between, centers of excellence and, community setting?

Speaker #12: And, can you provide some, h, color on how, this traction sort of compares to your expectations?

Speaker #10: Yeah. I'll start and then I'll hand it over to Mike. I would say it probably exceeds our expectations. You know, had a lot of inbound, and I know Mike in the sales force doesn't like to hear this, but we actually had prescriptions from people who hadn't been called on yet.

Speaker #10: but we did it was a nice mix of the high priority sites and, and really ones that we hadn't expected. And we actually have a couple of physicians that have had multiple prescriptions that weren't on our high priority list.

Speaker #10: And so, you ow, the team is working really hard. with the larger centers to really compile lists of patients, you know, I've id a number of times as we've been asked, you ow, we'll be the, is there going to be huge bolus of patients that are just sitting out there?

Speaker #10: The nature of this disease is they need to be treated. And so, and, and we wouldn't advise anything different, by the ay, you know, if you're on a therapy and it's okay, this is a marathon, not a sprint.

Speaker #10: And the best thing for the patients is to stay on what you're on, as long as you can tolerate it, and as long as the, the treat, the, cancer isn't advancing.

Speaker #10: And at the point in time, either of those things happen, then there's a conversation with the physician. And based on our market research and what we're seeing so far, that, you know, that is what's happening.

Speaker #10: They come in, they talk, and, you know, we've been told where the most likely thing they'll go on next. And so, you know, it's probably too early to give numbers on the actual breakdown, but we are seeing the majority of scripts, I would say, are from GynOncs.

Speaker #10: You know, and that's not a surprise. The big volume is, you know, would, would go to them. We are seeing it from MedOncs. and, you ow, it's, it's rolling out kind of as we'd expected, qualitatively, quantitatively, I'd say a ittle ahead of where we thought we would be.

Speaker #10: I don't know Mike, if, if you or, or. Sure. You want to say anything else?

Speaker #9: I'm just talking a little bit more color and thank you, Dan, and thank you for the estion. you can imagine we're very encouraged by the breadth of the initial uptake.

Speaker #9: We've certainly seen a lot of business from the top one- and two-tier customers that represent our 50% of the potential. But obviously, about 50% are managed more broadly across the reach, and we've seen encouraging uptake outside those from both community and academic physicians.

Speaker #9: we've obviously got a very focused field strategy. and we're going to continue broadening the reach of that in Q3. but we do now expect the business to continue evolving because we've put in place those critical GPO agreements and SD contracts as well.

Speaker #9: so I think overall, we're surprised by the business from our center. accounts. but we're very encouraged by the spontaneous user arising from those accounts, which we're supporting through our digital outreach and, surround sound activities as well.

Speaker #10: Yeah. And, and an important point that Mike just made, you know, because the, approval became, came almost two months early, there were certain things we could accelerate.

Speaker #10: We hired the sales force. We were ready to go with our specialty pharma. pharmacies. We wanted to make sure that in the early days of the launch, this was very high touch.

Speaker #10: And so this was all through specialty pharmas. Now we're bringing on the specialty distributors that are aligned with the GPOs. A big part of our strategy to reach the physicians in those large practices is not to expend a lot of effort trying to go one-on-one to those physicians because frankly, those practices don't like sales reps anyway.

Speaker #10: It's really the educational programs through the GPOs that we're just bringing online now. So, we had no impact from that whatsoever in the first quarter.

Speaker #10: And so I really feel like we're going into the second half of the year with kind all of our sales up, the wins at our back, and we'll start to see the effect of everything that we were planning to bring to bear for the launch.

Speaker #9: All right. Thank you for that color. And, h, that detail. just one more question. The system, curious to know what your, h, experience has been with payers, any pushbacks, or perhaps you're still in the honeymoon phase with them.

Speaker #9: any thoughts around that would be great.

Speaker #10: Yeah. I, I would say, you know, my market access people tell me that there's always a honeymoon phase at the beginning. Now, having said that, we're not exactly what Govee, and I don't expect that they'll be a massive pushback from payers because frankly, we have the data packets to support the reimbursement.

Speaker #10: And so, and this is kudos to our specialty pharmacies to date. They've done a phenomenal job. And we've seen reimbursement both with mutant, with wild type, with, with totally off-label uses, which, again, we wouldn't promote, but we're finding that the data really supports the usage of these drugs.

Speaker #10: And so far, so good. You know, we're seeing you ow, it's prior off, of course. You, you know, Medicare, in particular, that first 90 days, you get the first denial and then you have to put the, the, appeal in.

Speaker #10: But we're fixing very short periods of time. indicated by the fact that we're giving away very little free drug. We're not discounting. And I would say the most impactful program to date has been our zero dollar copay.

Speaker #10: Because we are committed to minimizing the burden on patients, and we are making sure that patients don't have to pay a lot out of pocket this.

Speaker #10: That's obviously on the commercial side. The benefit of IRA on the Medicare side is those patients are now capped at $2,000 out of pocket total cost.

Speaker #10: So that should have minimal impact. It's early days, so far, so good. We're hoping to continue that, and you know, looking forward to a great second half of the year.

Speaker #9: All right. thank you for taking my questions and, and once in, congratulations. Great to see, it's great to see the movement forward.

Speaker #10: Thanks, Pete.

Speaker #1: Your next question comes from the line of Leonid Tamashev with RBC Capital Markets. Your line is open.

Speaker #9: Hey, guys. It's Anisha on for Leo. Congrats on the progress this quarter and for taking our estions. Just a couple from us. First, how might the launch curve for AvFac evolve as you switch over from specialty pharmacies to the integration of the specialty distributors you ioned?

Speaker #9: And second, even though it's early, it would be great to get a sense on the breakdowns of AvFac patient history, based on lines care and recurrence, if you could are some color there.

Speaker #9: Thanks so much.

Speaker #10: Sure. I would say in general, you know, I, I really feel like because this came early, we didn't the publications. And we had, you know, part of our distribution network in place that first six weeks, we kind of had a hand tied behind our .

Speaker #10: And I really do feel like a lot of the pre-work we've done, you know, we've been out doing outreach with our MSLs for the last two plus years.

Speaker #10: I think when we have the full complement in place, we really should see an acceleration again. I don't think there's a huge bolus of patients sitting there; this will be a steady uptick.

Speaker #10: But what we will start to see is the benefit of the long-duration of therapy. And we would expect over time that you're going to see, you know, a, a big group of patients who are continuing patients, and then adding more on every month.

Speaker #10: And, you know, as far as, the mix, I don't ow, Matt, if you want to say anything or, or Mike. A

Speaker #9: Yeah. No.

Speaker #10: ittle early, but.

Speaker #9: Yeah. It, is a little early. We're, we're following it, as closely as you might as might expect us to be doing. We've seen, a mix of patients with, you know, multiple lines of prior therapy, but also encouragingly, we've seen patients at, have the combination right at their first recurrence, which is quite consistent with our market research that was conducted in the pre-launch setting.

Speaker #9: And remarkably consistent with what we observed in RAMP201. So the dynamics of 201 and what we've seen in our market research, I just shared, is lining up, and it's been very consistent within the six first weeks of, the quarter and, and we're eing those trends continue into the third.

Speaker #10: Yeah. And there have been a, a couple of KOLs who expressed the interest in, you know, us wanting to go to frontline. And 've started investigating sponsored trial in frontline in combination with AI.

Speaker #10: We're looking into kind of more substantial programs there. Obviously, keeping an eye on cost. but, you ow, there, 's great enthusiasm around the drug combination, and we want to continue to build on that.

Speaker #9: Thanks. And congrats again.

Speaker #1: Your next question comes from the line of Craig Savannah with Mizuho. Your line is open.

Speaker #9: Hi, Craig. Thanks so much for taking my questions. Congratulations on the launch so far. wanted to ask two questions if I could. First, just on the launch, could you just remind us, even though there was a question already on kind of how ou think the, uptake curve could look like, could you just ember, remind us of your, commercial efforts, in terms of sizing?

Speaker #9: how you expect that may or may not evolve over time? and then, secondly, and with that, if you could comment on the role of IQVIA in that.

Speaker #9: And then secondly, on, the NCCN guideline potential inclusion in the meeting in October. could you maybe provide some color, for me at least as to, typically what types of considerations go into, the committee that reviews this stuff?

Speaker #9: you know, are there certain criteria that they need see? I guess what 'm trying to get at is, trying to get a sense of, how we should think the level of confidence that you will get inclusion, although I think most people think that you will.

Speaker #9: But any color there would be great. Thanks.

Speaker #10: Yeah. Why 't I start with the NCCN one and then, Michael, turn it over to you. I an, you know, they look at the totality of the data.

Speaker #10: And if you look at the publications, you know, I, I ink anyone who's looked at the publications feels that these patients benefit. And, you ow, as much as I would have liked, you know, we, we got the 2A on the label, right away, and that was kind of administrative email back and forth.

Speaker #10: as much as I would have liked the other parts sooner, I think it's important to understand that in these committees, not everyone is an LGSOC expert.

Speaker #10: You know, they're, they're arian experts, but there's a handful of the LGSOC experts that are on the committee. And I think having them in a room together with our publication to advocate is our best chance of getting it done.

Speaker #10: And we have heard universally that there's the belief that this benefits patients broadly. And we think that would factor into the decision, although nothing's guaranteed and, you ow, we're not going to be in the room.

Speaker #10: It's like an FDA meeting where we get to go and advocate for ourselves. We're relying on the LGSOC experts to advocate for us at those meetings.

Speaker #9: and, and to address the, the shape of the curve and the evolution of the launch, I think, you know, we're, as we said, we're very encouraged by the strength of the start.

Speaker #9: And we continue to believe that we'll continue to see steady progression because this is not a switch market where we anticipate seeing a large bolus of patients.

Speaker #9: Obviously, bringing the SDs and the GPOs online for the Q3 and Q4 and putting those additional programs in place that Dan spoke to, I think, will continue to give us increasing breadth and opportunity to push on that.

Speaker #9: In terms of the evolution of our commercial organization, we held to the premise that we would focus very heavily through our, field teams on the top 100 accounts.

Speaker #9: And we've seen such positive results from that. I don't e any initial reason to adjust that strategy. But we'll keep a weather eye to make sure that the reach and frequency is what 'd expect.

Speaker #9: And then obviously, we're supporting that through the digital programming and the GPO programming again, Dan spoke to, for the other 50% of patients managed through those large community practices.

Control. Um, I will tell you, each of the SPs has been restocked the number of times, and that just shows that the inventory is going out the door. This isn't, um, a bunch of inventory sitting on shelves. Um, and I'll let you speak to gross the net. Um, yeah. So yeah. Thanks Justin. Um, obviously it's it's early in the launch and, um, you know, we're getting everything up and running. So we've been given the specifics on the, the gross to Nets, um, and where that will will be going forward, but I think as we look forward, if you look at other, uh, oncology small molecule Therapeutics, I think typically it's around 15 to 20%, Which is not a, not a bad expectation. So uh, we'll continue to monitor that but we're not giving the specific guidance or details of that at this point.

Any follow-ons, or are we going to move to the next question?

Your next question comes from the line of Sean Lee with HC Wang Wright. Your line is open.

Hey uh, good afternoon, congrats on the great quarter and uh, I just have 2 quick questions. Um, first, uh, you mentioned that most of these patients are switching on Wednesday progress from their prior therapy. So I was wondering, have you noticed any um, noticeable differences between these patients versus What patients you've had in the clinical study

Um relapse and they typically, you know, come off therapy for 2 Reasons, either progression or they can't tolerate their existing therapy. And again, that's consistent with what we saw with the patients that went on RAM 2011.

Uh, great, thank you for that. Um, my last question is on the, uh,

uh, 7375 study. So I was wondering, um,

What how quickly do you expect to move on to specific uh uh indications because uh gently it already has, you know, quite a bit of a safety data to back it up.

Yeah no that's a good question. Um so the reason we were able to start the trial at 400 mg which is clearly write in an effective range, is we included the Chinese data in our IND and so that probably cut

I don't know 6 to 9 months off the time frame because we didn't have to start back at the lower doses. So we intend to move very quickly. Um, what we're finding is, um, there are a lot of these patients out there, and the sites we've chosen not only have a lot of patients, but there are very experienced investigators. We're finding, um, we open a cohort, the cohort gets filled. And so we're going to move very quickly. Once we get to the 600 mg dose, we're going to start the satu map combo early, and again, that I think was.

Benefited from having some human clinical data in the IND and uh, allowing us to really short circuit a lot of this. And so we intend to move very quickly, um we believe that we have a best-in-class drug, um, we're excited to be able to get data out. Um,

As soon as possible, there will be additional data from the Gen Fleet. Um, experience it it at least 2 meetings later this year. So, um, we're looking forward to, you know, getting a lot more out there to really back up. Um, what we've been saying about the drug

Uh, great, thank you. Thank you for that and that's all I have.

Great, thanks.

Your next question comes from the line of young J with B Riley Securities. Your line is open.

Oh, thank you for taking our questions and congrats on this initial, uh, commercial ramp up of when we think about modeling for 32 and 42 sugar, free samples, play an important role in this initial ramp up. And in the 2q, do you know how many for examples were used by patients?

Um to be clear, there aren't free samples as a means of bridging over until um, Insurance gets approved. We can give a month's Supply. I mentioned a little earlier, there's been almost none, it's been very little and, and really the program that we've used the most is really the co-pay assistance and

We're happy to do that.

Got it, I think we've already touched on this, but, uh, if the code tag is covered by commercial insurance and Medicare, what do you expect the monthly out of pocket cost will be for the patients in these 2 payers group?

I think for the majority of patients, it's zero,

We have a very liberal program to support the patients.

And that's for commercial patients with the Medicare patients. Again, they have the yearly out-of-pocket limit for all medical costs and that kicks in for a cancer patient.

Like the first month.

Yep, got it.

your final question comes from the line of James Malloy with Alliance Global Partners, your line is open,

Hey guys, Matt on for Jim tonight, congrats on the progress and thanks for taking our questions. So, first on the launch, um, I wanted to touch on how many reps are currently on board for the sales force and how many total planned reps. Um, you guys might add, uh, just for the launch in uh, the ks mutated population. Um, if you could

Go into that and then as well, what the timeline might look like. For the regulatory pathway for a mapping affect ninja in Japan in the EU.

I'm going to let you take the first part, Mike, and then I'll address you in Japan. We launched with a very focused team of 16 individuals, and as I've mentioned in earlier comments, we will keep a very close eye on that. We currently have no plans to increase the honor.

It's actually wrapping up a cruel now and we intend to engage with the pmda and seek conditional and approval based on the bridging study and we are already switching the sites in Japan over to be participants in 301 and will put enough patients on Japan. So we'll be able to get full approval, but to be clear, you get full reimbursement in in, uh, Japan based on conditional approval. Well, we haven't given specific guidance. On the EU, we have engaged. Um, we recently got orphan drug designation which we think is an important part of the step. And part of what we went through here, in the US to make sure it's recognized as a distinct disease and then we'll be seeking, um, formal scientific guidance on whether we can get approval based on ramp 2011, or whether we're going to need the randomized, um, confirmatory study to get approval.

With everything going on with mfn and um, the the you know that I'm not sure you know that rushing towards that is really something that we want to do anyway. We want to make it available to patients in Europe but I do believe that even if we are able to get regulatory approval on the single arm study, most reimbursement in Europe will require the randomized study.

Got it. Okay, thank you guys for taking our questions and congrats again.

Thanks.

That is the end of the questions for today, ladies and gentlemen, that concludes today's call, thank you all for joining. You may now disconnect