Verastem - Earnings Call - Q3 2025

Executive Summary

• First full commercial quarter delivered $11.2M net product revenue from AVMAPKI FAKZYNJA CO-PACK, materially above S&P Global consensus, with broad payer coverage and rapid time-to-fill; management said results “exceeded expectations” and adoption is “consistent” across academic and community oncologists.
• Non-GAAP EPS of $(0.54) beat consensus; GAAP loss widened on a large non-cash warrant liability mark, while gross margin expanded versus Q2 given limited COGS recognition from pre-approval inventory accounting.
• RAMP 301 confirmatory Phase 3 completed planned enrollment; IDMC requested a modest one-time ~29-patient increase across KRAS mutational strata, with timelines intact; management remains blinded and cited fewer-than-expected events due to rapid accrual.
• VS-7375 (KRAS G12D ON/OFF) cleared 400/600 mg monotherapy cohorts without DLTs and with no GI AEs > Grade 1; early anti-tumor activity observed; cetuximab combo cohort opened; multiple readouts guided for 1H26.
• Near-term stock catalysts: commercial ramp durability and payer breadth, RAMP 203 interim (Q4 25), plus 1H26 VS-7375 interim and RAMP 205 update; confirmatory outcomes and NCCN scope remain watch items.

What Went Well and What Went Wrong

• What Went Well

  • Commercial launch traction: “net revenue of over $11 million” in Q3 on “consistent adoption” across academic and community settings; 133 prescribers; covered lives >80%; time-to-fill ~12–14 days.
  • RAMP 301 execution: planned enrollment completed early; only a “modest” sample-size increase (~29 patients) across KRAS mutant and wild-type arms per IDMC, with timelines maintained.
  • KRAS G12D program momentum: VS-7375 cleared 400/600 mg without DLTs; “no nausea, vomiting, or diarrhea greater than Grade 1,” with early tumor reductions; cetuximab combination initiated.

• What Went Wrong

  • Earnings quality/noise: GAAP net loss widened to $(98.5)M, driven largely by a $(55.9)M unfavorable warrant liability fair value change; OpEx elevated on launch and pipeline investment.
  • Limited visibility: management declined to provide gross-to-net or detailed new vs. refill metrics; patient retention commentary still “too early” (trial DOR ~18 months, but commercialization nascent).
  • External uncertainties: outcome/timing of NCCN review for potential broader listing (KRAS wild-type) not yet known; off-label use exists, but data visibility limited via distributor channels.

Transcript

Operator (participant)

Good morning, and welcome to Verastem Oncology's Third Quarter 2025 Earnings Conference Call. My name is Liz, and I'll be your call operator for 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, Vice President of Corporate Communications, Investor Relations, and Patient Advocacy at Verastem Oncology. Please go ahead.

Julissa Viana (Head of Investor Relations)

Thank you, operator. Welcome, everyone. Thank you for joining us today to discuss Verastem's third quarter 2025 financial results, and recent business updates. This morning, we issued a press release detailing our financial results for the quarter and year-to-date. This release, along with the 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.

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 20th, 2025 and the current report on Form 10-Q that will be filed later today, as well as other reports filed with the SEC. Any forward-looking statements we make represent Verastem's views as of today, and we disclaim any obligations or responsibilities to update.

Joining me on today's call are Dan Paterson, President and Chief Executive Officer of Verastem, who will provide opening remarks and recap key highlights from the quarter, Matt Ros, Chief Operating Officer, and Mike Crowther, Chief Commercial Officer, who will walk through the continued 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.

Dan Paterson (President and CEO)

Thank you, Julissa. Good morning, and thank you for joining us today to discuss our third-quarter financial results and business update. In Q2, we shared our excitement about achieving FDA approval for AVMAPKI FAKZYNJA CO-PACK in KRAS-mutated recurrent low-grade serous ovarian cancer or LGSOC, and reported our first six weeks of commercial performance. Today, I'm pleased to share that the strength we saw in those initial weeks has accelerated. With a full quarter of commercial operations now complete, the fundamentals we put in place to guide our commercial launch are translating into meaningful results. Our third-quarter net product revenue of $11.2 million surpassed our expectations, and was driven by consistent adoption among both academic centers and community oncologists. We set three key objectives to support our commercial execution and drive sustainable growth, physician engagement, patient initiation and retention, and streamlined reimbursement, all three are trending positively.

We're simultaneously advancing our broader strategic priorities, specifically expanding the opportunity set for AVMAPKI FAKZYNJA CO-PACK and accelerating the clinical path of VS-7375, our KRAS G12D on/off inhibitor program. Let me highlight a few achievements. We completed the enrollment of our expansion cohort in RAMP 205, our first-line pancreatic cancer trial, evaluating ibrutinib plus defactinib and standard of care chemotherapy. We completed the planned enrollment of our confirmatory phase III clinical trial, RAMP 301, in recurrent LGSOC and will be making a modest increase in enrollment per the IDMC's recommendation. This does not have a meaningful impact on our expected timelines. We shared initial safety and tolerability data from our G12D program with VS-7375. We cleared two monotherapy doses with no dose-limiting toxicities. We reported that we did not observe nausea, vomiting, or diarrhea above grade 1.

Importantly, these dose levels included the phase II go-forward dose that was chosen by our partner in China. We're now moving ahead, opening the combination cohort with cetuximab. These are exciting developments that add to our continued success. In the fourth quarter, we remain focused on our three key launch objectives and maintaining our execution discipline across all commercial, clinical, and operational functions. Let me now turn the call over to Matt to review some specific highlights from the third quarter.

Matt Ros (COO)

Thank you, Dan. The strong AVMAPKI FAKZYNJA CO-PACK growth reflects the high-end medical need, and physician enthusiasm for this first-ever treatment option. The team has achieved significant results since our May approval, and we continue to execute well against all three strategic launch imperatives. Dan touched upon these, and they are, first, to effectively reach healthcare providers, remembering that the top 100 commercial healthcare organizations comprise about 50% of the sales opportunity. Second, to engage and support patients throughout their journey, as we know that as patients progress through other therapies, many will be ready for a new treatment option. Third, to ensure seamless access, so we can support patients, and ensure any barriers to reimbursement are removed. Our approach is highly targeted, and we're utilizing a deliberate mix of one-on-one meetings, group discussions, and conference engagements to maximize the impact of every interaction in this rare disease market.

Thus far, each element of this approach has proven to be successful. As Dan shared, we generated $11.2 million in net product revenue in the third quarter, which was our first full quarter of launch. We've leveraged the momentum from the first six weeks of launch, and uptake has been strong. With 133 prescribers of AVMAPKI FAKZYNJA CO-PACK, physician excitement is palpable, and our field teams continue to do an excellent job in engaging with healthcare providers to ensure they understand the unique benefits of the CO-PACK and how to administer it. Consistent with Q2, we continue to see prescriptions generated by gynecological oncologists and medical oncologists. This well-rounded base of prescribers reinforces the touchpoints our teams are making across our top 100 organizations and tier one and tier two targets.

We are experiencing high levels of engagement within community practices that are either large affiliated practices or are associated with group purchasing organizations. We are directly contracting with the GPOs and conducting educational programming. We are also having meaningful success in accounts that are typically closed to sales representatives. We continue to engage and support patients with outreach efforts to help educate them about the treatment and support their conversations with their doctors. While we won't be speaking to future trends or prescriptions at this time, we are encouraged by specific insights, following our first full quarter of launch. Approximately 65% of prescriptions written have been generated by our top 100 organizations. What's great about this is that we are making strong headway in our tier one and tier two accounts, but we are also seeing prescriptions coming from other accounts as well.

We believe that speaks to the strength of the data and brand awareness. More than half of total prescriptions are coming from the academic setting, and we expect the split to be consistent between the community and academic setting providers over time. 60% of the prescriptions written are coming from GYN oncologists, and 40% written from medical oncology. Our specialty distributors are now fully on board, and we see a good mix between the two specialty pharmacies on board in Q2 and the four specialty distributors we added this quarter. The initial orders across our specialty distributors were managed closely, and have been consistent with the initial orders from our two specialty pharmacies at launch. For these reasons, we believe inventory stocking has been minimized, and we plan to continue to manage this closely through year-end.

Lastly, reimbursement has not been a barrier to any access, and Mike will provide more specifics in that regard shortly. Looking at the fourth quarter, we aim to continue to build on our momentum while staying laser-focused on our strategic imperatives, to ensure every appropriate patient benefits from this novel treatment. The key opinion leader community continues to reinforce our thesis, that every KRAS-mutated LGSOC patient should not only receive this treatment, but should do so at their first recurrence. Given our early achievements, our team's effective execution and the high unmet need in this rare form of ovarian cancer, we believe we are well-positioned for continued growth. Now, I will turn the call over to Mike to speak further about the launch dynamics. Mike.

Mike Crowther (Chief Commercial Officer)

Thanks, Matt. Let's get right into the specifics of our AVMAPKI FAKZYNJA CO-PACK launch. I'm extremely pleased with how well the launch is going as net product revenue growth accelerates in the third quarter. While we consider ourselves still in the early days of launch, the underpinning success is built upon the breadth and reach of our field engagement to raise awareness of the availability of a first-ever treatment, specifically for people living with KRAS-mutated recurrent LGSOC. These impressive results are driven by a few key factors, high unmet need, increased engagement with both academic and community oncology practices, expanding reach and removing barriers to access through specialty distributors and their GPO Partners, and continued efforts to ensure seamless access.

From an engagement standpoint in the third quarter, we have had high engagement among our top 100 organizations and top 100 offices, which includes a mix of academics and community providers. These efforts have resulted in approximately 65% of prescriptions coming from them, and specifically within our tier one and tier two accounts. We continue to see both repeat prescriptions from physicians prescribing to multiple patients, and refills for patients given the CO-PACK's favorable safety profile. An important insight we have gained is that HCPs treating LGSOC have a good understanding of where their patients are in the treatment journey, and are keeping CO-PACK top of mind for when their patient's current therapy fails due to either intolerability or clinical progression.

Doctors continue to share that they are actively assessing and identifying patients that may become appropriate candidates for this targeted combination therapy, demonstrating that our efforts with HCPs are creating visibility into new patients becoming available for treatment. Additionally, the awareness of AVMAPKI FAKZYNJA CO-PACK is high. Our medical science liaisons and oncology nurse educators have engaged in 800 scientific exchanges, and well over 100 educational forums with healthcare providers within this quarter alone. We believe payers are acknowledging the unmet need that can now be addressed by the CO-PACK, as well as the clinical value of the combination therapy. The payer coverage continues to be broad, and the time to fill prescriptions has been fast, within approximately 12-14 days. We can also confidently share that covered lives has now exceeded 80%, and that the payer mix for our combination therapy is about half commercial and half Medicare.

From a patient perspective, we continue to see high engagement in our branded website. Our digital campaign is effectively driving traffic to this resource, and patients are downloading our patient brochure and opting in to receive more details associated with how the CO-PACK can be appropriate for them. To close, we strongly believe that the AVMAPKI FAKZYNJA 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.

With several months now under our belt, the team is executing well against all our launch objectives. We continue to believe a steady adoption will occur over time, and our early observations post-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 insights. With that, I'll turn the call over to Dan Calkins to provide an update on our financials.

Dan Calkins (CFO)

Thank you, Mike. We issued a press release before the call today with the full financial results, so I'll focus on the highlights for the third quarter. In our first full quarter of launch, I'm also pleased to report $11.2 million of net product revenue for the third quarter. Cost of sales were $1.7 million for the third quarter of 2025, and did not include a significant amount of product costs as inventory produced prior to FDA approval was fully expensed at the time of production. Currently, we're not providing guidance on gross to net, other than to say that expectations should be consistent with other oncology small molecule therapeutics. Turning to research and development expenses, they were $29.0 million for the third quarter of 2025.

R&D expenses were driven by both the ongoing global confirmatory phase III RAMP 301 clinical trial, and the ongoing VS-7375 phase I-VIII clinical trial, as well as higher costs associated with drug substance production activities related to VS-7375. SG&A expenses were $21.0 million for the third quarter. The expenses were driven by commercial activities in operations, which included personnel-related costs to support the ongoing CO-PACK launch. We continue to be prudent in our expense management, making the right investment at the right time to support the ongoing commercial launch efforts, while simultaneously advancing our pipeline. For the third quarter of 2025, non-GAAP adjusted net loss was $39.4 million or $0.54 per share diluted, compared to non-GAAP adjusted net loss of $35.3 million or $0.88 per share diluted for the 2024 quarter. Please refer to our press release for a reconciliation of GAAP to non-GAAP measures.

Moving to the balance sheet, we ended the third quarter of 2025 with cash, cash equivalents, and investments of $137.7 million. We believe our current cash combined with future revenues from AVMAPKI FAKZYNJA CO-PACK sales and the exercise of the outstanding cash warrants, provides runway into the second half of 2026. We had a solid first full quarter as a commercial company. We have sufficient capital to fund our ongoing commercial launch in the U.S., and continue advancing our current clinical development plans. With that, I'll turn the call back over to Dan.

Dan Paterson (President and CEO)

Thanks, Dan. Before we open the call to Q&A, I'll share a few final remarks to close out today's presentation. We've seen another strong quarter of execution at Verastem, as we continue to deliver on all our strategic priorities, meeting our key milestones and delivering a strong commercial launch. As we're in the final quarter of 2025 and look to 2026, I want to reaffirm our strong confidence in our growth trajectory and the significant value creation opportunities ahead for our company and shareholders. Commercial execution remains a top priority. The fundamentals are driving AVMAPKI FAKZYNJA CO-PACK adoption, and the launch is progressing as planned. Our clinical pipeline continues to advance on multiple fronts. We expect several important data readouts in the first half of 2026, that will further demonstrate the breadth of our RAS/MAPK pathway-driven approach.

We expect to share safety and efficacy results from our RAMP 205 expansion cohort in first-line advanced pancreatic cancer in the first half of 2026. We also plan to share initial results from our phase I-VIII trial evaluating VS-7375 in advanced G12D mutant solid tumors in the first half of 2026. We'll continue to advance our trial of VS-7375 in both monotherapy and combination expansion cohorts in pancreatic, lung, and colorectal cancers. Importantly, we believe VS-7375 has demonstrated significant and best-in-class potential among KRAS G12D inhibitors to date, in both advanced pancreatic cancer and lung cancer. We're committed to moving quickly to registration-enabling studies in these and other high-potential priority indications. This is an active area of focus for the company, and we plan to engage with the FDA in the first half of 2026 to discuss our path forward.

This would include seeking their input on how to harmonize the abundance of existing data generated by our partner in China, to advance the program efficiently on behalf of patients who currently have no FDA-approved treatments for their KRAS G12D-mutated cancers. We now have a commercial product generating growing revenue, and a robust clinical pipeline with multiple near-term catalysts that will determine the future development plans. We're building a sustainable, multi-asset oncology company to address important unmet needs in RAS/MAPK pathway-driven cancers. With that, we'll open up the call for questions. Operator?

Operator (participant)

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 will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Michael Smith with Guggenheim Securities. Please go ahead.

Michael Schmidt (Analyst)

On the LGSOC launch, yeah, just wondering if you could provide a few more comments on how the product is being used in the market in terms of patients having had prior lines of therapy. I'm just thinking about some of the market dynamics around incidence of new patients that relapse versus that sort of existing prevalence pool. How is the product being utilized in that context? What are you seeing in terms of KRAS mutant versus wild-type use?

Dan Paterson (President and CEO)

Yeah. I mean, we're early in the launch, and so you do end up seeing some patients with later lines of therapy, but we're also seeing patients that are first recurrence. It is a mix of wild-type and mutant, as well as some just off-label totally. We don't have exact numbers on that. Again, we don't see total visibility of that through the distribution channel that goes through the distributors as opposed to specialty pharmacy. We don't always have a good view into total number of lines of therapy. I don't know Mike, if you wanted to give it a little more color.

Mike Crowther (Chief Commercial Officer)

Sure, Dan. I mean, consistent with what you've said, we've seen a variety of patients across a range of lines of therapy. We're not always given the information about what prior therapies they've been on, but obviously, they've seen most of the classical mix of chemotherapy, AI, bevacizumab, plus or minus a MAC inhibitor. Since we're promoting just on-label, the vast majority of our patients that we've seen so far are KRAS mutant LGSOC.

Michael Schmidt (Analyst)

Great, thanks. A question on the RAMP 301 study update. Just curious if you could comment on what type of analysis the IDMC did. Was this just looking at event rates and adjusting for event rates, or did they perhaps look at additional information in terms of effect size? Yeah, any comments there would be helpful. Thanks so much.

Dan Paterson (President and CEO)

Yeah, great question. I mean, to be clear, we're blinded by what the IDMC did. We had put this interim analysis in place because, and we've mentioned this before, there wasn't perfect information on the comparators. There weren't prior studies with, prospectively broken out KRAS mutant and wild-type. We tried to keep the sample size as low as possible, but also have the ability to be able to upsize that if needed.

I'm optimistic because the number of recommended additional patients was relatively small, about 30. It was across both wild-type and mutant, which again, I think speaks to them being within the range. What I was told is, because the study accrued faster than we had projected, there were less events than one normally would have had. I think part of the reason for adding a couple more patients is, there just aren't enough events yet really to draw any definitive conclusion and we want to make sure we have enough patients to be in the range.

Michael Schmidt (Analyst)

Great. Thanks so much. Congrats again on that great quarter.

Dan Paterson (President and CEO)

Thanks.

Operator (participant)

Your next question comes from the line of Justin Zelin with BTIG. Please go ahead.

Justin Zelin (Analyst)

Thanks for taking our questions, and congrats on the strong quarter. I want to ask about the [NTCN] committee review in October, if you had heard back on a recommendation for the labels to be expanded to include KRAS wild-type patients and had some follow-ups.

Dan Paterson (President and CEO)

Yeah, that's a great question. To be clear, had we heard, we would have told people. We don't know. We know the committee met. We don't know the outcome of that yet.

Justin Zelin (Analyst)

Got it. Do you have an expectation on any timelines on when you might expect to hear back?

Dan Paterson (President and CEO)

We actually don't. We've heard it can be as long as early next year, could be earlier. I think different committees operate differently. We've not been given a lot of guidance. It's a relatively opaque, and what I would say, a secret process. They've all signed NDAs and things. As much as I would love to know the outcome of the meeting, we just don't know yet.

Justin Zelin (Analyst)

Understood. Maybe just one additional question just on the commercial launch. Do you have any color on new patient starts versus patients who are refilling prescriptions as far as contribution to your strong quarter?

Dan Paterson (President and CEO)

Matt, you want to take that one?

Matt Ros (COO)

Yeah, sure. Great question. We aren't providing that level of detail or specificity on new to RX refills. However, we are continuing to see significant new prescriptions come in for patients. Patients that have started on therapy, particularly in the beginning of the third quarter, have continued to receive refills. We are seeing that dynamic in the marketplace, but providing that level of granularity at this point is a bit too premature for us. We wanted to just see another full quarter or two underneath our belts before we provide that level of detail.

Justin Zelin (Analyst)

Thanks for taking our questions and congrats again.

Matt Ros (COO)

Thanks.

Operator (participant)

Again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from the line of Sean Lee with H.C. Wainwright. Please go ahead.

Sean Lee (Analyst)

Hey. Good morning, guys. Congrats on a good quarter, and thanks for taking my questions. I just have two quick ones. First, on the LGSOC market, I was wondering whether you could provide some details on, what are you seeing in terms of patient retention? Correct me if I'm wrong, I think on the clinical study, the average treatment duration was about 10 months, so it's a little bit early for that. Maybe if you can provide some color on the patient dropout rates, has that been in line with what you expect?

Dan Paterson (President and CEO)

Yeah. I would say it's really early to tell. Actually, average duration was about 18 months in the clinical trial. I don't know, Matt or Mike if you want to provide any more color. It is really too early to tell.

Mike Crowther (Chief Commercial Officer)

Yeah. I mean, it's a great question. Dan's right. The performance of the CO-PACK in the clinical program, the DOR, was around 18 months. We're seeing patients that are coming in at first recurrence. We would expect if they're coming in an earlier line of treatment, that the benefit would be prolonged. It is still fairly early to provide specific commentary.

Sean Lee (Analyst)

I see, yeah. Thanks for that. My second question is on the VS-7375 study. I was wondering whether there are any significant differences between how you're treating the patients compared to the study that your partner is running in China, because I think I recall that you were discussing some prophylactic antiemetics and such. Are there any notable differences?

Dan Paterson (President and CEO)

Yes. Thanks, Sean. That was a great question. Yeah. One of the things that we've said we were doing differently is, and this was based on experience with the G12C inhibitors being developed, and a number of our investigators participated in those studies, is really the differences where the patients in China were fasted. This first couple of cohorts we treated in the U.S. were fed. They were also mandated to have prophylactic antiemetics, which is not part of the protocol in China.

Part of the reason we released the information on the first two cohorts is, A, we thought it was important that we cleared those first two cohorts, which included the recommended phase II dose in China without any DLTs. Also, the early data that we're seeing is that those interventions are making a difference. As we said earlier, we didn't see any GI toxicities, nausea, vomiting, diarrhea that were graded in grade one, which we were very happy to see, and we hope that carries forward.

Sean Lee (Analyst)

Great. Thanks for that. That's all the questions I have.

Dan Paterson (President and CEO)

Great. Thanks, Sean.

Operator (participant)

Your next question comes from the line of UNZ with B. Reilly Securities. Please go ahead.

Congratulations on the commercial launch. Maybe my first question is, for your confirmatory trial, can you remind us, what was the enrollment plan for the KRAS mutant patient population and KRAS wild-type patient population separately?

Dan Paterson (President and CEO)

The total enrollment was planned for 270, and there were guardrails set up to keep the amount somewhere between 1/2 and 1/3 KRAS mutant to mirror the population. The accrual has come out that way. As I mentioned, the data monitoring committee recommended that we put a couple more patients on both of those groups. We were glad to see, A, that it was a small number of patients. It actually could have gone up quite a bit, and that it was both arms, which tells us that we're in play with both of them.

Got it. My second question is, what is your next step or priority in the commercial launch? Do you plan to target more prescribers or just make sure a higher number of prescription [per doctor]?

I would say both. We're not going to change what we're doing. We feel that between our direct calling on individual doctors, the programmatic work we're doing with the organizations and our digital work, as well as reaching out to patients, that we're covering the waterfront. We're not planning on changing what we're doing, but it's really a matter of making sure existing prescribers continue to prescribe. New prescribers come on because in any launch, you've got early adopters, mid-adopters, late adopters, and we're working through that chain and then importantly, that when patients go on, they stay on.

Got it. Maybe before I come back to the queue, my last question is on the patient's journey. Let's say a patient got their prescription. How long do they have to refill? How often do they have to visit the doctors to check either symptoms or any side effects? Additional color will be very helpful. Thank you.

Yeah. Mike, do you want to take that one?

Mike Crowther (Chief Commercial Officer)

Sure. Prescription is for a month's supply, three weeks out of four. In terms of doctor's visits, there is a small amount of visits to begin with, just to make sure they're being monitored closely for early toxicities, but that rapidly goes down to every three to six months.

Got it. Thank you.

Operator (participant)

Your next question comes from the line of Eric Schmidt with Cantor Fitzgerald. Please go ahead.

Eric Schmidt (Analyst)

Thanks for taking my question. Apologies I hopped on a little bit late. With regard to the RAMP 301 IDMC recommendation to moderately upsize the study, can you talk about what the potential outcomes could have been through that look and what data the committee had access to in order to make the decision? Thank you.

Dan Paterson (President and CEO)

Yes. The committee had the full data set, and the outcomes could have ranged from everything from futility, adding, I believe up to 100 patients, they could have added none. Again, we're blinded to the actual results, but our understanding was, there were less events than one would have anticipated given the rapid accrual. That may have led to the small number of patients being added on. They are being added on to both KRAS wild-type and mutant, and it's about 30 across the two groups.

Eric Schmidt (Analyst)

That's helpful. Thank you. There wasn't any pre-specified criteria for adding the 29 patients. It was just what the IDMC chose to do, that number?

Dan Paterson (President and CEO)

My understanding is it was within their purview, and they made a recommendation to us and we followed it. Again, we do not have full transparency into exactly what they were doing.

Eric Schmidt (Analyst)

Okay. Maybe switching to the 7675, the G12D and your ongoing study. Very clear that GI tolerability was good in the first dose, with no more than grade one cases of GI issues. Were there any other side effects to report in that initial cohort? Anything at all of grade two or three?

Dan Paterson (President and CEO)

I believe there were some grade two or three in very, very small numbers, but no signal that we had not expected based on the Chinese data. I think the only thing that was really different was the level of GI tox. We'll give a more full release of the full efficacy once we've got a few more patients on. I think we've guided early next year, we'll give an update on both efficacy and safety.

Eric Schmidt (Analyst)

Great. Thank you, Dan.

Dan Paterson (President and CEO)

Thank you, Eric.

Operator (participant)

Your next question comes from the line of James Molloy with Alliance Global Partners. Please go ahead.

James Molloy (Analyst)

Hey, guys. Thank you very much for taking my questions. I was wondering, could you share any sort of anecdotal updates from the launch, talking to the usage, any potential off-label usage on the wild-type versus mutant, and sort of any feedback you're getting early stages of the launch? I have a couple other questions as well.

Dan Paterson (President and CEO)

Sure. Mike, Matt, you guys want to give a little more color?

Mike Crowther (Chief Commercial Officer)

Sure. I mean, I think as we shared in our scripted remarks and earlier question, we're promoting obviously our labeled indication. The vast majority of use we've seen thus far has been within the KRAS mutant LGSOC population. That doesn't mean there haven't been wild-type patients because there have. Those have also seen coverage through the payers as well thus far.

James Molloy (Analyst)

Okay, great. Maybe a follow-up. It looks like there's been some M&A in the oncology space recently. You guys are obviously after an excellent launch year. Any thoughts you care to discuss? Any inbound interest you may or may not have from other partners?

Dan Paterson (President and CEO)

Yeah. I mean, obviously, we wouldn't talk about any specifics. Given the launch trajectory to date, and I'd say even more so the excitement around G12D and how the molecules perform both preclinically and clinically, we do get a fair amount of inbound interest and entertain those discussions all the time. We've got some very exciting plans to take these forward, but we're always evaluating, could we do more with more resources?

James Molloy (Analyst)

Okay. Thank you for taking the questions.

Operator (participant)

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.