Verastem Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: We secured FDA approval for our lead therapy, AvmapKefaxin co-pack, for KRAS-mutated recurrent LGSOC nearly two months ahead of schedule, marking the first-ever novel drug combination approved in oncology.
  • Positive Sentiment: In the first six weeks of commercial availability, AvmapKefaxin co-pack generated $2.1 million in net product revenue, reflecting strong early market uptake and seamless payer coverage.
  • Negative Sentiment: R&D expenses rose to $24.8 million and SG&A to $20.7 million, driving a non-GAAP net loss of $41.4 million compared to $16.5 million a year ago.
  • Positive Sentiment: The balance sheet was bolstered by a private placement, ending Q2 with $164.3 million in cash and investments, supporting operations into 2026.
  • Neutral Sentiment: Multiple clinical trials remain on track, including the VS7375 G12D inhibitor and the Phase 3 RAMP-301 study, with key data readouts expected later this year.
AI Generated. May Contain Errors.
Earnings Conference Call
Verastem Q2 2025
00:00 / 00:00

There are 8 speakers on the call.

Speaker 4

Thank you for standing by. My name is Rebecca and I will 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. 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. 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. Please go ahead.

Speaker 5

Thank you, operator. Welcome everyone and thank you for joining us today to discuss Verastem Oncology'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. 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 within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 5

Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section in the company's most recent annual report on Form 10-K filed with the SEC on March 20, 2025 and the current report on Form 10-Q filed today, as well as other reports filed with the SEC. Any forward-looking statements we make represent Verastem Oncology's views as of today and we disclaim any obligations or responsibility to update.

Speaker 5

Joining me on today's call are Dan Paterson, President and Chief Executive Officer of Verastem Oncology, who will provide opening remarks and recap key highlights from the quarter, Matthew Ros, Chief Operating Officer, and Michael Crowther, Chief Commercial Officer, who will walk through the initial progress of the AVMAPKI™ FAKZYNJA™ CO-PACK commercial launch, and Dan Calkins, Chief Financial Officer, who will provide an overview of our financial results. I will now turn the call over to Dan.

Operator

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, 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 AVMAPKI™ FAKZYNJA™ CO-PACK, marking a major inflection point for the company. 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. The second quarter marked a pivotal milestone for our company with the FDA approval of AVMAPKI™ FAKZYNJA™ CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC).

Operator

This approval represents several industry firsts that underscore the significance of our achievement. 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. To our knowledge, this approval marks the first ever truly novel drug combination approved in oncology, a clear validation to our innovative approach and execution capabilities. Importantly, we received accelerated approval nearly two months ahead of schedule and our extensive prelaunch efforts over the last two years allowed us to quickly move into the market. AVMAPKI™ FAKZYNJA™ CO-PACK 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 in net product revenue, reflecting successful early traction and robust execution across all key launch priorities.

Operator

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. Matt and Mike will speak more about this in a few minutes. As we continue to build on the positive momentum thus far, we firmly believe that the AVMAPKI™ FAKZYNJA™ CO-PACK will become the new standard of care for this indication, fundamentally changing the treatment paradigm for this disease. I'll now turn the call over to Matt to discuss our commercial launch in greater detail. Matt.

Speaker 3

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. 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. 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. We are effectively targeting both academic and community-based physicians. Our experienced field and marketing teams are executing at a high level, ensuring healthcare providers understand the unique benefits and how to safely use AVMAPKI™ FAKZYNJA™ CO-PACK. We're supporting these efforts with comprehensive and complementary digital marketing efforts.

Speaker 3

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. 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. Third, we want to ensure seamless access by providing comprehensive patient support for access to AVMAPKI™ FAKZYNJA™ CO-PACK. 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. We're working closely with payers to establish appropriate coverage policies. I'm proud of what the team has accomplished since our May approval.

Speaker 3

The approval came early, and the team hit the ground running and is executing well against all three areas of the launch. As Dan said, we achieved $2.1 million in net product revenue in the first six weeks of launch. To date, reimbursement has not been a barrier to access. 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. 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 were experiencing their first recurrence. This matches our prelaunch market research and the types of patients enrolled in RAMP 201.

Speaker 3

Our sales force has been highly effective in engaging with physicians across academic community centers and large private oncology practices. Early use of AVMAPKI™ FAKZYNJA™ CO-PACK 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 team on the therapy, 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 FAK defects, engine, CO-PACK and LGSOC. Through impactful scientific exchanges with opinion leaders, we expect the recent RAMP 201 in-frame publications to drive an even deeper appreciation and understanding of the clinical relevance of MAPK defects in KRAS.

Speaker 3

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. 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, 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. 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. Looking toward the second half of the year, we will build on this momentum while staying laser focused on our strategic imperatives.

Speaker 3

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. Now I will turn the call over to Mike.

Speaker 2

Thanks Matt. It's a pleasure to be on the call today and provide some further details on the launch of the AVMAPKI™ FAKZYNJA™ CO-PACK. As you have heard, we are off to a strong start that began with our commercial team engaging prescribers immediately after we learned of the approval.

Operator

The team has been incredibly nimble.

Speaker 2

A short period of time and we are proud to be making a positive difference in the lives of people living with LGSOC. 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 ordered locations. 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. We are seeing prescriptions for patients coming from these high priority accounts, including a mix of academic and community.

Speaker 2

We are also starting to see both repeat prescriptions from physicians prescribing to multiple patients and refills for individual patients as patients receive their treatment package within a short time frame following the receipt of a prescription for AVMAPKI™ FAKZYNJA™ CO-PACK at one of the specialty pharmacies. Our medical science liaisons and oncology nurse educators have been equally busy, 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. 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 low-grade serous ovarian cancer patients.

Speaker 2

Importantly, immediately after AVMAPKI™ FAKZYNJA™ CO-PACK was approved by the FDA in May, we were immediately listed in the NCCN treatment guidelines for category 2A, a recommendation which is aligned with the approved indication. We recently submitted the RAMP 201 and FRAME publication to the NCCN to potentially expand the recommendation to include the broader LGSOC population that was enrolled and represented in both studies. The NCCN committee has informed us that they plan to review our submission in October at their 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. As Matt mentioned, we activate our digital programming and branded websites quickly to engage and support patients looking for information on the combination therapy.

Speaker 2

We also engage with the 2,500 patients who previously signed up on our disease education website before the launch. As we have shared previously, the general payer mix for our combination therapy is about half commercial and half Medicare. While it's too early to break down the mix we have seen today, thanks to the process we have in place, the payer coverage has been broad and the time to fill prescriptions has been fast. While this process will evolve and formulary coverage will build over time, we believe payers are acknowledging the unmet needs that can now be addressed by AVMAPKI™ FAKZYNJA™ CO-PACK as well as the clinical value of the combination therapy. We strongly believe that AVMAPKI™ FAKZYNJA™ CO-PACK 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 2

I'm happy with our results against our strategic 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 FDA approval support this perspective. I look forward to sharing more in the coming quarters as we progress through the launch and gain more experience and insight. With that, I'll turn the call over to Dan.

Speaker 6

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. We performed well in our initial quarter of launch, and I am pleased to report $2.1 million in net product revenue for the first six weeks. With six weeks of the launch, conquest sales were $0.4 million for the second quarter of 2025 versus $0 in the second quarter of 2024. Cost of sales did not include a significant amount of product cost as inventory produced prior to FDA approval was fully expensed at the time of production. Research and development expense was $24.8 million for the second quarter of 2025 compared to $18.1 million for the second quarter of 2024.

Speaker 6

The increase was primarily driven by higher clinical-related expenses to support the global Phase 3 RAMP 301 trial, higher drug production activities in preparation for the launch, and higher costs associated with drug product and startup activities related to the VS-7375 1:2:8 clinical trial in the U.S. 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. 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. For the second quarter of 2025, non-GAAP adjusted net loss was $41.4 million or $0.63 per share diluted compared to non-GAAP adjusted net loss of $16.5 million or $0.61 per share diluted for the 2024 quarter.

Speaker 6

Please see our press release for a reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet, we strengthened our financial position in April with a $75 million private placement, which included issuance of common stock and pre-funded warrants. We ended the second quarter of 2025 with cash, cash equivalents, and investments of $164.3 million. We believe our current cash combined with future revenues from sale and the exercise of the outstanding cash warrant provides into the second half of 2026. This is an exciting time for all of us at Verastem Oncology as we start delivering the AVMAPKI™ FAKZYNJA™ CO-PACK combination therapy to patients in the U.S. We had a solid first quarter as a commercial company, and we have sufficient capital to fund our ongoing commercial launch in the U.S. and continue advancing our current clinical development plans.

Speaker 6

With that, let me turn the call back over to Dan.

Operator

Thanks Dan. Before we open the call to Q and 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 Oncology and we've delivered on all of our milestones and are off to a great start with the commercial launch. We're in a strong position to continue executing against our plan for the second half of the year. Some of our milestones include continuing to report on the launch of AVMAPKI™ FAKZYNJA™ CO-PACK. We're advancing our potential best-in-class oral G12D inhibitor VS-7375, which our partner GenFleet shared, encouraging early results at ASCO from our study in China. We'll continue enrollment in the VS-7375-101 trial, including the monotherapy portion, and move towards initiating the dose escalation combination cohort of VS-7375 in combination with cetuximab in the fourth quarter.

Operator

In our RAMP 205 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 1

In.

Operator

Our RAMP 203 KRASG12C advanced non-small cell lung cancer trial. We plan to share an interim safety and efficacy update in the fourth quarter. Finally, we expect to complete planned enrollment in our Phase 3 RAMP 301 trial evaluating the combination in recurrent low-grade serous ovarian cancer regardless of KRAS mutation status. 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. With that, we'll open up the call for questions. Operator.

Speaker 4

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. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Michael Smitz with Guggenheim. Your line is open.

Speaker 3

Hey guys, thanks for taking our questions. This is Paul on for Michael.

Speaker 3

On the LGSOC launch, can you talk about the degree of off label use that you're currently seeing in the ARS wall type setting, what the feedback has been from providers on intended use in this setting, and what you expect in terms of prescribing and reimbursement trends leading up to the possible NCCN guideline update in October and how that could inflect once a decision is made on including the full data set?

Speaker 3

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. Reimbursement for the patient populations that we just spoke of have been an issue to date, and we'll continue to follow the reimbursement patterns as we move forward into the third quarter leading up to NCCN.

Speaker 3

Great. If I have a follow up on the KRAS program, it seems like the U.S. study is enrolling fairly well. Can you just talk about the scope of that update in the fourth quarter? Will it be roughly the same number of patients in lung and TDAC as the initial China study update at ASCO? Also, could we expect any additional updates from GenFleet from that China study at some point?

Speaker 2

Thank you.

Speaker 3

Sure.

Speaker 1

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. GenFleet has advised that they'll be presenting additional data at two different medical meetings later this year. You should expect two updates from GenFleet, and then we'll give an initial update on our phase one experience in the U.S. likely late this year on the safety side. There's a lot of interest in that, and then the efficacy early next year. Got it.

Speaker 3

Thanks very much.

Speaker 4

Your next question comes from the line of Kelly Hsieh with Jefferies. Your line is open.

Speaker 1

This is Anxi An for Kelly Shi. 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 in terms of launch momentum in the back half of the year and what could be the key drivers there? Thank you. Yeah. As it's early in the launch and as Matt had mentioned earlier, we launched with the two specialty pharmacies in place. We've now brought on the specialty distributors and the group purchasing organizations. We're just starting to track the breadth of data that we're able to get. I'll let Matt comment a little more on kind of where we'll go from here.

Speaker 1

Part of it is really starting to see the patterns we see and see what we think is repeatable and reliable and that'll then inform kind of what we're going to be tracking. Matt, I don't know if you want to.

Speaker 3

Yeah, no, I mean, Dan's absolutely right on that. I mean, 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. You can expect, I think, over time and once we see the appropriate trends, that the reporting on our performance will be anchored against those three imperatives.

Speaker 1

Got it.

Speaker 4

Thank you. Your next question comes from Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

Speaker 6

Hi, Diane. Team, congratulations on the quarter and thank you for taking our questions. First one, 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? Can you provide some color on how this traction sort of compares to your expectations?

Speaker 1

Yeah, I'll start and then I'll hand it over to Mike. I would say probably exceeds our expectations. We had a lot of inbound, and I know Mike and the salesforce don't like to hear this, but we actually had prescriptions from people who hadn't been called on yet. It was a nice mix of the high priority sites and really ones that we hadn't expected. We actually have a couple of physicians that have had multiple prescriptions that weren't on our high priority list. The team is working really hard with the larger centers to really compile lists of patients. I've said a number of times as we've been asked, is there going to be a huge bolus of patients that are just sitting out there? The nature of this disease is they need to be treated. We wouldn't advise anything different, by the way.

Speaker 1

If you're on a therapy and it's okay, this is a marathon, not a sprint. 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 cancer isn't advancing. At the point in time either of those things happen, then there's a conversation with the physician. Based on our market research and what we're seeing so far, that is what's happening. They come in, they talk, and we've been told we're the most likely thing they'll go on next. 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 gyn oncs, and that's not a surprise. The big volume would go to them. We are seeing it from net oncs, and it's rolling out kind of as we'd expected.

Speaker 1

Qualitatively, quantitatively, I'd say a little ahead of where we thought we would be. I don't know if Mike, if you want to say anything else, I'm just.

Speaker 1

Thank you, Dan. And thank you for the question. You can imagine we're very encouraged by the breadth of the initial uptake. We've certainly seen a lot of business from the top one and two tier customers that represent about 50% of the potential, but obviously about 50% are managed more broadly across the reach. We've seen encouraging uptake outside those from both community and academic physician. We've obviously got a very focused field strategy and we're going to continue broadening the reach of that in Q3. We do now expect the business to continue evolving because we've put in place those critical group purchasing organization agreements and SD contracts as well. I think overall, we're not surprised by the business from our center.

Speaker 2

But.

Speaker 2

We're very encouraged by the spontaneous use arising from those accounts, which we're supporting through our digital outreach and surround sound activities as well.

Speaker 1

Yeah, an important point that Mike just made, you know, because the approval came almost two months early, there were certain things we could accelerate. We hired the sales force. We were ready to go with our specialty pharmacies. We wanted to make sure that in the early days of the launch, this was very high touch. This is all through specialty pharmacies. Now we're bringing on the specialty distributors that are aligned with the group purchasing organizations. 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. It's really the educational programs through the group purchasing organizations that we're just bringing online now. We had no impact of that whatsoever in the first quarter.

Speaker 1

I really feel like we're going into the second half of the year with kind of all of our sails up, the wind at our back. We'll start to see the effect of everything that we were planning to bring to bear for the launch.

Speaker 6

All right, thank you for that color and that detail. Just one more question. Just curious to know what your experience has been with payers. Any pushback or perhaps you're still in the honeymoon phase with them. Any thoughts around that would be great.

Speaker 1

Yeah, I would say my market access people tell me that there's always a honeymoon phase at the beginning. Now, having said that, we're not exactly Wegovy. I don't expect that there'll be a massive pushback from payers because frankly, we have the data packets to support the reimbursement. This is kudos to our specialty pharmacies. Pharmacies to date, they've done a phenomenal job. We've seen reimbursement both with mutant, with wild type, with totally off-label uses, which again, we wouldn't promote. We're finding that the data really supports the usage of these drugs. So far, so good. We're seeing it's prior auth, of course. Medicare in particular, in that first 90 days, you get the first denial and then you have to put the appeal in. We're seeing very short periods of time indicated by the fact that we're giving away very little free drug.

Speaker 1

We're not discounting and I would say the most impactful program to date has been our $0 copay 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 for this. 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 costs. That should have minimal impact. Early days. So far so good. We're hoping to continue that and looking forward to a great second half of the year.

Speaker 6

All right, thank you for taking my questions and once again, congratulations. Great to see.

Speaker 3

It's good to see the movement forward.

Speaker 1

Thanks, Pete.

Speaker 4

Your next question comes from the line of Leonid Timashev with RBC Capital Markets. Your line is open.

Speaker 3

Hey guys, it's Anishan for Leo. Congrats on the progress this quarter and for taking our questions.

Speaker 1

Just a couple from us.

Speaker 3

First, how might the launch curve for AVMAPKI™ FAKZYNJA™ CO-PACK evolve as you switch over from specialty pharmacies to the integration of the specialty distributors you mentioned? Second, even though it's early, it would be great to get a sense on the breakdowns of AVMAPKI™ FAKZYNJA™ CO-PACK patient history based on lines of care and recurrence. If you could share some color there. Thanks so much. Sure.

Speaker 1

I would say in general, you know, I really feel like because this came early, we didn't have 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 back, 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. 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. What we will start to see is the benefit of the long duration of therapy.

Speaker 1

We would expect over time that you're going to see a big group of patients who are continuing patients and then adding more on every month. As far as the mix, I don't know, Matt, if you want to say anything or. Mike? Yeah, no, a little early, but yeah.

Speaker 3

It is a little early. We're following it as closely as you might expect us to be doing. We've seen a mix of patients with multiple lines of prior therapy. Also, encouragingly, we've seen patients that have the combination right at their first recurrence, which is quite consistent with our market research that was conducted in the prelaunch setting and remarkably consistent with what we observed in RAMP 201. The dynamics of 201 and what we've seen in our market research, as I just shared, is lining up. It's been very consistent within the first six weeks of the quarter and we're seeing those trends continue into the third.

Speaker 1

Yeah, there have been a couple of KOLs who expressed the interest in, you know, us wanting to go to Frontline and we started investigator sponsor trial in Frontline in combination with AI. We're looking into kind of more substantial programs there, obviously keeping an eye on cost. You know, there's great enthusiasm around the drug combination and we want to continue to build on that.

Speaker 3

Thanks, and congrats again.

Speaker 4

Your next question comes from the line of Craig Savanov with Mizuho. Your line is open.

Speaker 1

Great.

Speaker 1

Thanks so much for taking my questions. Congratulations on the launch so far. Wanted to ask two questions. First, just on the launch, could you just remind us, even though there was a question already on kind of how you think the uptake curve could look like, could you just remind us of your commercial efforts in terms of sizing how you expect that may or may not evolve over time. If you could comment on the role of IQVA in that. Secondly, on the NCC and 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 1

Are there certain criteria that they need to see?

Speaker 1

I guess what I'm trying to get at is trying to get a sense of how we should think about the level of confidence that you will get inclusion, although I think most people think that you will. Any color would be great.

Speaker 2

Thanks.

Operator

Yeah.

Speaker 1

Why don't I start with the NCCN and then, Mike, I'll turn it over to you. I mean, you know, they look at the totality of the data, and if you look at the publications, you know, I think anyone who's looked at the publications feels that these patients benefit. As much as I would have liked, you know, we got the 2A on the label right away, and that was kind of administrative email back and forth. As much as I would have liked the other part sooner, I think it's important to understand that in these committees, not everyone is an LGSOC expert. They're ovarian 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 1

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 know, we're not going to be in the room. It's not 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 2

And.

Speaker 2

To address the shape of the curve and the evolution of the launch, we're, as we said, very encouraged by the strength at the start, 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. Obviously, bringing the SDS and the group purchasing organizations online for 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. In terms of the evolution of our commercial organization, we held the premise that we would focus very heavily to our field teams on the top 100 accounts, and we've seen such positive results from that.

Speaker 2

I don't see any initial reason to adjust that strategy, but we'll keep a weather eye to make sure that the reaching frequency is what we'd expect. Obviously, we're supporting that through the digital programming and the group purchasing organization programming. Again, Dan spoke to for the other 50% of patients managed through those large community practices. We also obviously have a very strong medical affairs team continuing to engage at medical meetings and others to catch those customers, increase our frequency of connection with those customers.

Speaker 1

As for the IQVIA relationship, you know, a small biotech launching a drug, the ability to be able to tap into these world-class resources in an era where digital matters, data matters, you know, we never could have gotten data warehouse and all the infrastructure up two months early without a partner like IQVIA that was tapping into infrastructure they had and essentially customizing stuff for our business rules, but not building from scratch. We have been very pleased with that relationship. They worked nights and weekends just like our team and beside our team as we were getting ready to do this. That is the reason we were able to pull this off.

Speaker 1

Thank you. Congratulations again.

Speaker 4

Your next question comes from the line of Justin Zielin with BTIG. Your line is open.

Speaker 3

Thanks for taking our questions and congrats on the successful launch thus far. Given your use of specialty pharmacy, can we assume the $2.1 million in Q2 revenue largely reflects true patient demand with minimal channel stocking? Can you just talk about expectation of any inventory channel stocking moving forward? If you could share any early insights on gross to net dynamics or how the payer mix is shaping up between commercial and Medicare?

Speaker 1

Sure, I'll take part of that and then I'll hand it over to Dan Calkins. Thank you for the question. I'm surprised we didn't get it earlier because it was just two SPs, there was minimal stocking. We've been pretty adamant in our agreements that we get to limit the inventory. We want to make sure that we don't have any surprises with returns and things like that. We're keeping tight control. I will tell you each of the SPs has been restocked a number of times and that just shows that the inventory is going out the door. This isn't a bunch of inventory sitting on shelves. I'll let you speak to gross to net.

Speaker 6

Yeah, thanks Justin. Obviously it's early in the launch and we're getting everything up and running. We've been given the specifics on the gross to nets and where that will be going forward. I think as we look forward, if you look at other oncology small molecule therapeutics, typically it's around 15% to 20% which is not a bad expectation. We'll continue to monitor that. We're not giving the specific guidance or details of that at this point.

Speaker 1

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

Speaker 4

Your next question comes from the line of Shawn Lee with H.C. Wainwright. Your line is open.

Speaker 1

Hey, good afternoon.

Speaker 6

Congrats on Blake Porter.

Speaker 1

I just have two quick questions. First, you mentioned that most of these patients are switching on once they progress.

Speaker 6

From their prior therapy.

Speaker 1

I was wondering, have you noticed any noticeable differences between these patients versus what patients you've had in the clinical study? No, I think as Matt said earlier, it aligns pretty well with what we saw in the study. In the RAMP 201 study, we had patients from 1 to 10 prior lines of therapy, and we are seeing a mix of patients who had multiple prior lines as well as ones that are coming right off their first relapse. They typically come off therapy for two reasons, either progression or they can't tolerate their existing therapy. Again, that's consistent with what we saw with the patients that went on RAMP 201. Great, thanks for that. My last question is on the.

Speaker 6

7375 study.

Speaker 1

I was wondering how quickly do you expect to move on to specific indications? Because GenFleet already has, you know, quite a bit of safety data to back it up. Yeah, that's a good question. The reason we were able to start the trial at 400 milligrams, which is clearly right in an effective range, is we included the Chinese data in our IND and that probably cut, I don't know, six to nine months off the timeframe because we didn't have to start back at the lower doses. We intend to move very quickly. What we're finding is there are a lot of these patients out there and the sites we've chosen not only have a lot of patients but they're very experienced investigators. We're finding we open a cohort, the cohort gets filled and we're going to move very quickly.

Speaker 1

Once we get to the 600 milligram dose, we're going to start the cetuximab combo early. That, I think, was benefited from having some human clinical data in the IND and allowing us to really short circuit a lot of this. We intend to move very quickly. We believe that we have a best in class drug. We're excited to be able to get data out as soon as possible. There will be additional data from the GenFleet experience at least two meetings later this year. We're looking forward to getting a lot more out there to really back up what we've been saying about the drug. Great.

Speaker 6

Thank you.

Speaker 1

Thank you for that. That's all I have. Great, thanks.

Speaker 4

Your next question comes from the line of Yong Jae with B. Riley Securities. Your line is open.

Speaker 1

Thank you for taking our questions. Congrats on this initial commercial ramp up. When we think about modeling for 3Q.

Operator

For 4Q, should the free sample play.

Speaker 1

An important role in this initial ramp up?

Operator

In the 2Q, do you know?

Speaker 1

How many free samples were used by patients? To be clear, there aren't free samples as a means of bridging over until 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. The program that we've used the most is really the copay assistance and we're happy to do that.

Speaker 5

Got it.

Speaker 6

I think you've already touched on this. If the copay is covered by commercial.

Speaker 1

Insurance and Medicare, what do you expect the monthly out of pocket cost will be for the patient in this two payer 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, they have the yearly out of pocket limit for all medical costs. That kicks in for a cancer patient like the first month.

Speaker 2

Yes, got it.

Speaker 4

Your final question comes from the line of James Malloy with Alliance Global Partners. Your line is open.

Speaker 4

Hey guys. Matt on through Jim tonight. Congrats on the progress and thanks for taking our question. First on the launch, I wanted to touch on how many reps are currently on board for the salesforce and how many total planned reps you guys might add just for the launch in the KRAS-mutated population, if you could go into that. Also, what the timeline might look like for the regulatory pathway for AVMAPKI™ FAKZYNJA™ CO-PACK in Japan and the EU.

Speaker 1

I'll let you take the first part.

Operator

Mike, and then I'll address.

Operator

We launched with a very focused team of 16 individuals, and as I mentioned in earlier comments, I would keep a very close eye on that. We currently have no plans to increase beyond that.

Speaker 1

We haven't given specific guidance on Japan and the EU, but what we have said is we're doing a small bridging study in Japan that will actually wrap up accrual now, and we intend to engage with the PMDA and seek conditional approval based on the bridging study. We are already switching the sites in Japan over to be participants in 301, and we'll put enough patients on in Japan so we'll be able to get full approval. To be clear, you get full reimbursement in Japan based on conditional approval. We haven't given specific guidance on the EU. We have engaged. 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 U.S. to make sure it's recognized as a distinct disease.

Speaker 1

We'll be seeking formal scientific guidance on whether we can get approval based on RAMP 201 or whether we're going to need the randomized confirmatory study to get approval. With everything going on with MFN and the unclearness around that, I'm not sure that rushing towards that is really something that we want to do anyway. We want to make it available to patients in Europe. 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.

Speaker 3

Got it.

Speaker 2

Okay.

Speaker 2

Thank you guys for taking our questions, and congrats again.

Speaker 1

Thanks.

Speaker 4

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.

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