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VerastemD
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Earnings documents stored for VSTM.

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Investor releaseQuarter not tagged2026-05-11

Verastem, Inc. (NASDAQ:VSTM) Just Released Its First-Quarter Earnings: Here's What Analysts Think

Simply Wall St.

It's been a mediocre week for Verastem, Inc. (NASDAQ:VSTM) shareholders, with the stock dropping 18% to US$4.89 in the week since its latest first-quarter results. It looks like weak result overall, with ongoing losses and revenues of US$19m falling short of analyst predictions. The losses were a relative bright spot though, with a per-share (statutory) loss of US$0.37 being 21% smaller than what the analysts had presumed. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the nine analysts covering Verastem are now predicting revenues of US$106.2m in 2026. If met, this would reflect a major 114% improvement in revenue compared to the last 12 months. Losses are predicted to fall substantially, shrinking 28% to US$1.60. Before this earnings announcement, the analysts had been modelling revenues of US$114.9m and losses of US$1.71 per share in 2026. It looks like there's been a modest increase in sentiment in the recent updates, with the analysts becoming a bit more optimistic in their predictions for losses per share, even though the revenue numbers fell somewhat. View our latest analysis for Verastem There was no major change to the US$16.25average price target, suggesting that the adjustments to revenue and earnings are not expected to have a long-term impact on the business. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. The most optimistic Verastem analyst has a price target of US$18.00 per share, while the most pessimistic values it at US$14.00. The narrow spread of estimates could suggest that the business' future is relatively easy to value, or thatthe analysts have a strong view on its prospects. One way to get more context on th...

Investor releaseQuarter not tagged2026-05-09

Verastem Q1 Earnings Call Highlights

MarketBeat

Interested in Verastem, Inc.? Here are five stocks we like better. Verastem reported Q1 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, bringing cumulative revenue since the May 2025 launch to nearly $50 million despite seasonal and execution headwinds. Management said it is making commercial changes after reviewing launch performance, including appointing a new chief commercial officer and focusing on earlier use at first recurrence, stronger patient persistence, and broader physician adoption. The company said its VS-7375 KRAS G12D program is advancing into registration-directed phase II trials in pancreatic cancer, non-small cell lung cancer, and colorectal cancer, while Verastem ended the quarter with $181.7 million in cash and expects runway into the first half of 2027. Verastem (NASDAQ:VSTM) reported first-quarter 2026 net product revenue of $18.7 million for AVMAPKI FAKZYNJA CO-PACK, as management said the launch of the therapy for KRAS-mutated recurrent low-grade serous ovarian cancer continued to grow despite seasonal headwinds and some early commercial execution challenges. On the company’s earnings call, President and CEO Dan Paterson said the quarter brought Verastem’s total net product revenue since the May 2025 launch to nearly $50 million. He said new patient starts remained consistent month to month, the prescriber base continued to expand and reimbursement remained favorable. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% “While we’re pleased with the growth we’ve seen, we believe there’s meaningful opportunity to build on the foundation we’ve established,” Paterson said. Paterson said Verastem conducted a focused review of launch performance and made targeted changes to its commercial organization and leadership. The company appointed Dan Lyons as chief commercial officer, citing his oncology and rare disease launch experience, including at SpringWorks. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Paterson said first-quarter results were affected by insurance turnover, re-verifications and severe weather, which disrupted patient access and affected both new patient starts and refills. The company also observed that some early patients prescribed the therapy were further along in their disease and treatment journey than expected, and in some cases discontinued treatment earlier than an...

Investor releaseQuarter not tagged2026-05-08

Verastem (VSTM) Q1 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET President and Chief Executive Officer — Daniel Paterson Chief Medical Officer — Michael Glen Kauffman Chief Financial Officer — Daniel Calkins Chief Communications and Investor Relations Officer — Julissa Viana Need a quote from a Motley Fool analyst? Email [email protected] Daniel Paterson: Thank you, Julissa. Good afternoon, and thank you for joining our call today. Tomorrow marks 1 year since the accelerated approval of AVMAPKI FAKZYNJA CO-PACK, a practice-changing medicine approved for patients with KRAS-mutated recurrent low-grade serous ovarian cancer. Since our launch in May 2025, we've seen steady growth quarter-over-quarter, achieving $18.7 million in net product revenue in Q1 with nearly $50 million in total net product revenue to date. While we're pleased with the growth we've seen, we believe there's meaningful opportunity to build on the foundation we've established. New patient starts remain consistent month-over-month. Our prescriber base continues to grow and the reimbursement environment is favorable. As part of our ongoing commitment to optimize our launch, we conducted a focused review of our launch performance and execution and implemented targeted changes to our commercial organization and leadership. I'll walk through these details in a few minutes. I want to underscore that our confidence in the underlying demand and overall opportunity for the CO-PACK remains unchanged. Moving to R&D. We've made significant progress with our clinical trials for VS-7375, our potential best-in-class oral and selective KRAS G12D ON/OFF inhibitor, now branded as the VS-7375 Target-D clinical trial program. The Target-D-101 Phase I/II dose escalation and expansion trial is already underway, and we continue to enroll patients and evaluate higher dose levels. In addition, we've also initiated our Phase II registration-directed clinical trials in second-line pancreatic cancer, second and third-line non-small cell lung cancer and second-line plus metastatic colorectal cancer. Michael will share more about our progress and strategies with these trials. We continue to closely manage our expenses and remain on track for the LGSOC franchise to be self-sustaining in the second half of the year, meaning CO-PACK revenues will support both commercial operations and any ongoing clinical trials for avutometinib...

Investor releaseQuarter not tagged2026-05-08

Verastem: Q1 Earnings Snapshot

Associated Press

NEEDHAM, Mass. (AP) — NEEDHAM, Mass. (AP) — Verastem Inc. (VSTM) on Thursday reported a loss of $36.6 million in its first quarter. On a per-share basis, the Needham, Massachusetts-based company said it had a loss of 46 cents. The drug developer posted revenue of $18.7 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VSTM at https://www.zacks.com/ap/VSTM

Investor releaseQuarter not tagged2026-05-08

Verastem Oncology Reports First Quarter 2026 Financial Results and Highlights Recent Business Updates

Business Wire

AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $18.7 million Appointed Daniel Lyons as Chief Commercial Officer to lead next phase of commercial growth Initiated Phase 2 registration-directed trials "VS-7375 TARGET-D Clinical Program" in 2L PDAC, 2L/3L NSCLC and 2L+ CRC VS-7375 TARGET-D 101 early data update expected in the first half of 2026; mature data update expected in the second half of 2026 Ended Q1 2026 with $181.7 million in cash, cash equivalents and investments; expected cash runway into first half of 2027 Company to host a conference call and webcast today at 4:30 p.m. ET BOSTON, May 07, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent business progress. "As we mark the one-year anniversary of the FDA-approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, I am incredibly proud of the progress we have made to deliver a meaningful impact for people living with this rare cancer," said Dan Paterson, president and chief executive officer at Verastem Oncology. "As we build on the foundation we have established with the commercial launch, we also look to continue accelerating VS-7375, our potential best-in-class oral, KRAS G12D (ON/OFF) inhibitor, and are pleased to announce the initiation of three Phase 2 registration-directed trials in pancreatic, non-small cell lung, and colorectal cancers. In an evolving competitive landscape, we remain encouraged by the efficacy data generated by our partner and emerging in the U.S., along with the safety and tolerability profile we are seeing across multiple solid tumor cancers and look forward to sharing data updates throughout this year. Altogether, we believe we are well-positioned to drive strong execution across our commercial launch and expedite VS-7375 development while maintaining disciplined capital management." First Quarter 2026 and Recent Updates AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) U.S. Commercial Performance AVMAPKI FAKZYNJA CO-PACK generated net product revenue of $18.7 million for the first quarter of 2026. In April, the Company announced the launch of a new healthcare professional and patient marketi...

TranscriptFY2026 Q12026-05-07

FY2026 Q1 earnings call transcript

Earnings source - 112 paragraphs
Operator

Good afternoon, and welcome to Verastem Oncology's first quarter 2026 earnings conference call. My name is Daniel, and I will be your call operator today. Please note this event is being recorded. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. I will now turn the call over to Julissa Viana, Vice President of Corporate Communications, Investor Relations, and Patient Advocacy for Verastem Oncology. Please go ahead.

Julissa Viana

Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verastem's first quarter of 2026 financial results and recent business updates. This afternoon, we issued a press release detailing these results along with a slide presentation that will be referenced during our call today. Both are available on the investor relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today.

Julissa Viana

Joining me on today's call to deliver prepared remarks and take your questions are Dan Paterson, President and CEO, Dr. Michael Kauffman, President of Development, and Dan Calkins, Chief Financial Officer. I will now turn the call over to Dan.

Dan Paterson

Thank you, Julissa. Good afternoon, and thank you for joining our call today. Tomorrow marks one year since the accelerated approval of AVMAPKI FAKZYNJA CO-PACK, a practice-changing medicine approved for patients with KRAS mutated recurrent low-grade serous ovarian cancer. Since our launch in May 2025, we've seen steady growth quarter-over-quarter, achieving $18.7 million in net product revenue in Q1, with nearly $50 million in total net product revenue to date. While we're pleased with the growth we've seen, we believe there's meaningful opportunity to build on the foundation we've established. New patient starts remain consistent month-over-month, our prescriber base continues to grow, and the reimbursement environment is favorable. As part of our ongoing commitment to optimize our launch, we conducted a focused review of our launch performance and execution and implemented targeted changes to our commercial organization and leadership.

Dan Paterson

I'll walk through these details in a few minutes. I want to underscore that our confidence in the underlying demand and overall opportunity for the CO-PACK remains unchanged. Moving to R&D, we've made significant progress with our clinical trials for VS-7375, our potential best-in-class oral and selective KRAS G12D on/off inhibitor, now branded as the VS-7375 TARGET-D clinical trial program. The TARGET-D 101 phase I/II dose escalation and expansion trial is already underway, we continue to enroll patients and evaluate higher dose levels. In addition, we've also initiated our phase II registration-directed clinical trials in second-line pancreatic cancer, second and third-line non-small cell lung cancer, and second-line plus metastatic colorectal cancer. Michael will share more about our progress and strategies with these trials.

Dan Paterson

We continue to closely manage our expenses and remain on track for the LGSOC franchise to be self-sustaining in the second half of the year, meaning CO-PACK revenues will support both commercial operations and any ongoing clinical trials for avutometinib plus defactinib. As we look to the balance sheet, our focus remains on identifying value-creating, non-dilutive opportunities as we advance our pipeline and deliver for patients and shareholders. With that, let me turn to our commercial update. With almost a year into the launch, we're continually monitoring our progress. As with any launch, there's a natural evolution as we learn more about the market dynamics. We took a comprehensive look at our commercial execution and have taken decisive actions to strengthen it and position the business to the next phase of growth.

Dan Paterson

Most notably, we've appointed a new Chief Commercial Officer, Dan Lyons, who has deep and relevant experience in oncology and rare diseases. He has a strong track record of leading global commercialization strategies across solid tumor cancers, including 2 successful rare disease and oncology launches at SpringWorks. Dan's leadership will be instrumental as we evolve our launch and bring AVMAPKI FAKZYNJA CO-PACK to all patients who could benefit from this important treatment. While Dan will not be joining us on the call today, he's already actively engaged with the team driving new and existing initiatives forward. Turning to the 1st quarter results, we were impacted by the seasonal headwinds many companies experience, namely insurance turnover and re-verifications, as well as more severe weather, which affected patient access.

Dan Paterson

This impacted both new patient starts and refills. On closer examination, we also observed a specific dynamic where some patients prescribed the therapy by earlier doctors were much further along in their disease and treatment journey than we would have anticipated, and therefore discontinued the treatment earlier than expected. This is not surprising, as in many cases, these patients likely had no other alternative therapeutic options with proven clinical benefit. Since January, we've seen a rebound with a strong number of new patients through the end of the first quarter. There also continues to be strong physician conviction, with a majority of physicians surveyed at our most recent ATU indicating that the CO-PACK would be their first choice at their patient's next recurrence. Now onto the numbers. Active prescribers continue to expand, and through April, there have been more than 400 unique prescribers to date.

Dan Paterson

Consistent with previous quarters, we continue to see prescriptions split between GYN ONCs and MED ONCs at a 60/40%. Separately, our active patient pool has grown over recent months, indicating patients are staying on therapy longer, but it's too early to provide duration of therapy as it continues to evolve. It's also too early to give an average number of refills, but the trend we are seeing is consistent with what we would expect at this point in the launch. Approximately 65% of commercially eligible patients are using our Verastem Cares copay program. The remaining patients did not require copay assistance, and the average copay for commercially insured patients is less than $30.

Dan Paterson

Time to fill initial prescriptions continues to be in the range of 12-14 days due to rapid prior authorization approval, and our payer mix remains consistent with previous quarters at about half commercial and half Medicare. As we look ahead and consider our recent learnings, we focused on 3 key drivers in our business to help patients realize the full benefit of the CO-PACK. The first key driver is to maintain the consistent level of demand of new patient starts. This starts with identifying the right patient for treatment. Without an ICD-10 code specific to LGSOC, we've identified other proxy measures within EHRs, including mutational status, AI or MEK use that may indicate an appropriate patient for the CO-PACK. Our team is actively working with prescribers when these proxy measures are identified in a patient file.

Dan Paterson

Additionally, we've now added incremental personnel to continue to drive demand and support patient adoption. The second key driver is to drive earlier use at first recurrence. Over the course of the launch, we've observed discontinuations that in part reflect use outside of the attended approved patient population and in LGSOC patients who are much sicker than the patient population in RAMP 201 that was the basis for FDA approval. In fact, in some cases, patients were heading into hospice. As multiple physicians have noted, disease progression and complications can make it harder for patients to tolerate and absorb oral therapies, underscoring the importance of using the CO-PACK early at first or next recurrence when patients have the best opportunity to realize its full benefits. Our recently launched Reimagine Recurrent LGSOC direct-to-physician and patient campaign is focused squarely on this shift.

Dan Paterson

The third key driver is to help patients stay on therapy. Recent long-term data from the RAMP 201 trial presented at the Society of Gynecologic Oncology showed that after 2 years of follow-up, patients on the CO-PACK achieved durable benefit with discontinuation rates consistent with the package insert, findings that physicians view as clinically meaningful. A recent exposure response analysis also demonstrated that early side effects can be effectively managed with dose interruptions, after which patients resume at the approved dose and schedule. Setting expectations with both patients and physicians around the AE profile and how to manage through it is a key initiative for the remainder of 2026. We continue to see a substantial market opportunity for the CO-PACK, with growth potential coming from multiple directions.

Dan Paterson

Expanding reach among prescribers who haven't prescribed the CO-PACK, deepening e-experience among current prescribers by identifying additional patients in their practices, and shifting entrenched prescriber behaviors to starting CO-PACK on their first occurrence when appropriate. LGSOC is a relatively slow-growing but unrelenting cancer where patients stay on their first treatment for several years. Therefore, achieving peak share at first occurrence will take time. We believe the earlier use of the CO-PACK drives deeper adoption, produces real-world outcomes that mirror our trial experience, and establishes the CO-PACK as the new standard of care at first recurrence. We remain focused on our core product launch priorities and sustaining steady growth throughout the year. I'll now turn the call over to Michael.

Michael Kauffman

Thank you, Dan. We continue to make good progress across our pipeline programs, and I'll spend the next several minutes with an overview of our VS-7375 oral KRAS G12D inhibitor program. As Dan mentioned, we've named our VS-7375 trials TARGET-D. TARGET-D 101 is our ongoing phase I/II dose escalation, dose expansion, and combination evaluation trial. In the dose escalation portion, we are now evaluating the 1,200 milligram daily dose to fully characterize the dose range available. We will complete enrollment across the various expansion cohorts shortly, as well as the current cohorts evaluating combinations with chemotherapies. Importantly, we are moving to enroll patients into each of our phase II trials, which I'll describe in more detail. As we mentioned last quarter, the FDA requested that we develop separate phase II protocols for any trials where we are seeking marketing authorization.

Michael Kauffman

Thus, we have developed 3 phase II registration-directed trials in pancreatic cancer, or PDAC, non-small cell lung cancer, or NSCLC, and colorectal cancer, or CRC. I'll now provide some detail on each of these. TARGET-D 201 is our second-line PDAC study. This phase II open label study is designed to evaluate VS-7375 at the 900 milligram daily dose, both as monotherapy and in combination with cetuximab. Based on strong preclinical rationale showing EGFR pathway activation in pancreatic cancer and its role as a potential resistance mechanism to RAS inhibition, we are studying the combination of VS-7375 and anti-EGFR antibodies to potentially deepen and prolong responses. We're also taking the opportunity to evaluate VS-7375 and anti-EGFR antibodies in first-line pancreatic cancer, where we believe we can generate compelling data.

Michael Kauffman

It is worth noting that because VS-7375 has not been associated with skin rash to date, combination with EGFR inhibitors is expected to be clinically feasible and growing tolerability data to date support this. In addition, we are currently studying the combination of VS-7375 and gemcitabine nab-paclitaxel, or GNP, in patients with PDAC looking towards a frontline treatment regimen. TARGET-D 202 is our advanced non-small cell lung cancer study. This phase II open label study is designed to evaluate VS-7375 at the 900 milligram daily dose in patients who have received one or two prior lines of therapy, including a platinum-based chemotherapy and a PD-1 or PD-L1 blocker.

Michael Kauffman

We are currently evaluating VS-7375 at 600 milligrams daily in non-small cell lung cancer in our 101 trial. This will provide information at this lower dose. As in PDAC, we anticipate that the 900 milligram daily dose will be our go forward monotherapy dose in previously treated non-small cell lung cancer as we look towards potential marketing authorization. We are also evaluating VS-7375 monotherapy in patients with non-small cell lung cancer and asymptomatic brain metastases, where there remains a significant unmet medical need and an opportunity to improve outcomes. As previously noted, we are evaluating the combination of VS-7375 plus pembrolizumab without or with platinum pemetrexed chemotherapy in the 101 study looking towards a frontline treatment regimen. Lastly, we have our TARGET-D 203 metastatic colorectal cancer study.

Michael Kauffman

This phase II open label study is designed to evaluate VS-7375 at the 900 mg daily dose as both monotherapy and in combination with EGFR inhibitors, including cetuximab or panitumumab in patients with previously treated colorectal cancer. While we do not expect to see meaningful responses for VS-7375 as a single agent, this will be critical to showing the contribution of parts for potential combination therapy regulatory submission. We're also going to evaluate VS-7375 in combination with anti-EGFR antibodies and the modified FOLFOX6 regimen in the first-line setting, again to expand the opportunity and help us improve outcomes in patients with colorectal cancer with the goal to develop a frontline combination regimen.

Michael Kauffman

Importantly, across all three phase II trials, the primary endpoint is overall response rate by blinded independent central radiological review, or BICR, with BICR determined duration of response, or DOR, as the key secondary endpoint supporting potential accelerated approvals in each of these three indications. We anticipate the first patient in each of these studies to occur mid-year, if not sooner. We continue to enroll patients and evaluate the 1,200 milligram dose, which is the highest practical dose that we can administer to define the upper end of the dosing range. We now have updated PK data that show that the 900 milligram dose delivers serum levels of VS-7375 at or above our target level and provides clear separation from the 600 milligram dose.

Michael Kauffman

While we are seeing good responses at 600 milligrams, these data, along with good tolerability, support our enthusiasm for advancing the 900 milligram dose in our phase II trials. As additional data emerge, we expect to finalize the go forward dose across tumor types and combination settings. As we shared last quarter, our goal is to generate meaningful data sets in these tumor types, both as single agent as well as in combination with other treatments, with the goal of potential accelerated approvals in previously treated cancer, as well as developing combination strategies that position our regimens in the frontline setting across all three tumor types. Let me briefly set expectations for our first half update from the TARGET-D 101 trial. In terms of patient numbers, the safety data set will include a broad set of patients across TARGET-D 101.

Michael Kauffman

However, the number of patients available for efficacy will still be relatively small. Recall that response evaluations require a minimum of 2 baseline scans, which are typically 6 to 8 weeks apart, and not all responses occur at the first scan. Of course, duration of response requires follow-up for months after the initial response determination. We note again that meaningful response duration is typically about 6 months. As we've discussed previously, we believe that administering the highest well-tolerated dose of VS-7375 will maximize the chances for each patient to have a meaningful antitumor effect. Because the 900 milligram dose has been well tolerated to date in over 20 patients in the U.S., our results with this dose will require several additional months over what was originally projected for the 600 milligram dose.

Michael Kauffman

At this time, we can also add that the 400 and 600 milligram doses of VS-7375 in combination with cetuximab are well tolerated and that we are currently evaluating the 900 milligram dose in this combination. To reiterate, we will only be able to provide a preliminary view on activity overall because we've been able to utilize higher doses in our patients in the United States. That said, we see this first half update as an early checkpoint and believe the data set will be meaningful in terms of demonstrating our progress in enrollment, along with a more mature safety update and more PK data. We do plan to include some patient cases across tumor types and combinations in the update.

Michael Kauffman

Later this year, we expect to provide a more comprehensive data set, including tumor-specific breakdowns and more mature efficacy data as we enroll in our phase II trials for potential marketing applications. Finally, switching gears for a minute to our avutometinib plus defactinib program, we remain on track to report an update on our RAMP 205 study in first-line PDAC before the end of the second quarter of this year. Now I'll turn the call over to Dan Calkins.

Dan Calkins

Thank you, Michael. Our full financial results were included in our press release, so I'll focus on the highlights here. For the first quarter of 2026, we recorded $18.7 million in net product revenue and $2.8 million in product cost of sales. Cost of sales increased in the first quarter in line with the percent increase in net product revenue for the quarter. Research and development expenses were $38.2 million for the first quarter of 2026. R&D expenses continue to be driven by both the ongoing global confirmatory phase III RAMP 301 clinical trial with the CO-PACK and the ongoing VS-7375 TARGET-D 101 phase I-II clinical trial in the U.S., as well as higher costs associated with clinical supply and drug production activities related to our expanded VS-7375 program.

Dan Calkins

SG&A expenses were $22.3 million for the first quarter of 2026. The expenses were driven by commercial activities and operations, including personnel-related costs, to support the ongoing CO-PACK launch. I can reiterate that we expect SG&A expenses to remain roughly the same on a quarterly basis throughout 2026 as we remain disciplined in our expense management, making the right investments at the right time to support the ongoing commercial launch efforts. For the first quarter of 2026, non-GAAP adjusted net loss was $42.7 million or $0.43 per share diluted compared to non-GAAP adjusted net loss of $42.9 million or $0.79 per share diluted for the first quarter of 2025. Please see our press release for a full reconciliation of GAAP to non-GAAP measures.

Dan Calkins

Moving to the balance sheet, we ended the first quarter with 2026 with cash equivalents, and investments of $181.7 million. We believe our current cash, combined with the future revenues from the AVMAPKI FAKZYNJA CO-PACK sales will provide cash runway into the first half of 2027. We remain encouraged by the initial launch and look forward to building on the CO-PACK's growth in 2026. Given our current trajectory, I'm pleased to reiterate that we believe the LGSOC franchise will be self-sustaining in the second half of the year, with CO-PACK revenues funding both the commercial operations and our avutometinib plus defactinib clinical trials. With that, let me turn the call back over to Dan.

Dan Paterson

Thanks, Dan. Before we open the call to Q&A, our focus for the remainder of 2026 is very clear, and that's to drive strong execution across our commercial launch, move our 3 phase II trials expeditiously towards potential registrations, determine appropriate VS-7375 combinations for frontline strategies, and maintain disciplined capital management while identifying non-dilutive financial opportunities to deliver for patients and our shareholders. Overall, we believe we're well-positioned to deliver on our key milestones this year and continue building a leading oncology franchise in RAS/MAPK-driven cancers. With that, we'll open up the call for questions. Operator?

Operator

Our first question comes from Eric Schmidt with Cantor. Your line is open.

Eric Schmidt

Thanks for taking my question. Maybe, 1 on each of the 2 programs. On VS-7375, what do you think potential partners need to see from either your phase I or really phase II data sets in order to be very interested in the asset. Then, 2 for Dan in terms of the self-sustainability of the copay franchise. Can you be a little bit more granular in terms of the revenue that gets you to that sustainability? Thanks.

Dan Paterson

Sure. Eric, thanks for the question. Just to comment on potential partners, we have had a fair amount of interest and, you know, what typically happens in situations like this, it tends to come down to the competitiveness. I think if there, you know, there's one party interested, it can go on forever. I do think, you know, the fact that we've got significant data out of China that aligns well with the preclinical profile, it's really seeing enough data from the U.S. where we show that we can give it in a tolerable way, in a way that can be combined, and that we start to recapitulate efficacy. That puts us in the ballpark of still being potentially best in class.

Dan Paterson

You know, Michael, I don't know if there's anything more you wanna add there, but, you know, why don't you comment, and then we can have Dan C. talk about the expense of second half of the year and kinda what we're talking about being covered.

Michael Kauffman

I think you covered it real well, Dan.

Dan Paterson

Yeah.

Michael Kauffman

We need U.S. data, and we need a lot of detail on the patients and their prior therapy, and we're quite optimistic that we'll be able to deliver on that.

Dan Calkins

Yeah, Eric, this is Dan C. Just in terms of the self-sustaining question, obviously, we haven't given guidance in terms of the revenue for the remainder of the year. Just in terms of the expenses, if you looked at SG&A expenses from, on a quarterly basis from when we were pre-commercial to where we are now, that increase has typically been around $10 million-$15 million per quarter. From an R&D perspective, if you look specifically at the A+F related programs, that spend has typically been about $10 million-$15 million per quarter as well. The majority of that spend is really coming from the RAMP 301 trial, which we announced reached full accrual back in December of 2025.

Dan Calkins

That's now in full accrual, so don't expect that that will increase more, likely be coming down. That would give you a good sense of what it would take to be self-sustaining within that program.

Eric Schmidt

Very helpful. Thank you.

Dan Paterson

Thanks, Eric.

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Michael Schmidt

Hey, guys. Thanks for taking my questions. I had a couple on VS-7375, maybe one for Michael first. You talked about the phase I update in the first half of this year, maybe if you could just comment a little bit more about how the patients perhaps in the U.S. study compare to the GenFleet phase I study that we saw last year. Also you'd mentioned different follow-up with, you know, depending on which dose was used and, you know. How comparable will the U.S. update be perhaps to the GenFleet data from last year?

Dan Paterson

Michael, you wanna take that?

Michael Kauffman

I can. Sure. Yeah, sure, Dan. PDAC is generally treated the same way across the world, and frankly, these days, lung cancer, I mean, KEYTRUDA may or may not be the immunotherapy, but it's generally treated with a platinum agent, typically carbo. And since these are adenocarcinomas, pemetrexed. Again, colorectal cancer, it's pretty standard whether they're getting FOLFOX or FOLFIRI, and some people are getting FOLFIRINOX. It's all pretty similar. The patients are fairly similar. I think the most important difference, and the reason we wanna continue to study our drug, is because the tolerability in the U.S. has been substantially better than what was reported in China. We are not seeing any significant level at all of liver dysfunction.

Michael Kauffman

We haven't seen any significant hematologic issues at all, and we continue to see that even with patients now who are on for many months, some who are on for more than 6 months. We're just not seeing that. We're also not seeing cumulative toxicities, which is really great for a drug because giving chronically. We have really not seen anything major with this drug to date, and it's, you know, the numbers are starting to climb. The 600 milligram dose has been studied for a little bit of a while now, but across a whole bunch of different cancers. It was an open study. We'll have a little bit more specifics on it. I think the points I made in the call were that it takes a while to get responses here.

Michael Kauffman

I mean, you can't even assess the first response until six to eight weeks after initiation of dosing. Remember, when we open a trial, we don't accrue everybody at the beginning. This is staggered accrual, of course, with staggered dosing. We all wish this could happen immediately, but the first scan is six to eight weeks, and then a confirmatory scan is another six to eight weeks. If, like in PDAC, when many of your responses are going to occur in the second scan after the, you know, first scan, because these are tough tumors and they have a lot of scar tissue, it's gonna take a while, and that's okay. That's very good.

Michael Kauffman

We absolutely have responses in the first scans after dosing starts. We've seen responses at second. We've seen patients who've done really well, have shrinkage of tumors and crossed the you know, the important 30% threshold for a PR in scan 3 or 4. I don't wanna go into any detail, but we're quite pleased with what we're seeing, and we believe that 900 milligrams will be the go forward dose. That won't be the 900 milligram details will not come until the second half of the year, as we said, and we'll be able to give a little bit of data on the 600 milligram.

Michael Kauffman

We would far prefer to give you guys substantial data sets, you know, in the 20-30 patient range, with reasonable durability so that we can make some, you and we can make some intelligent decisions on how this drug is stacking up against others. All of that said, we remain very, very excited about the potential for this to be a best in class agent. I would lastly point out that this drug does not carry rash with it at all, or nor does it carry stomatitis. These are really important considerations for patients who could spend 1 year or more on these drugs.

Michael Schmidt

Okay, understood. Maybe a question on your phase II program, specifically the 201 study on slide 12 is the schematic. Yeah, just wanted to ask, so you have Part A and Part B, and I'm just curious, you know, what the decision process is for, you know, either selecting 1 of the 2 cohorts, monotherapy or combination, and then whether the Part 1 and, you know, A and B cases will be pooled at the respectively selected cohort. You know, will this be a 100-patient type, actually it's an 80-patient type registration cohort or, you know, how should we think about the decision path as you have so multiple steps in these phase II studies?

Michael Kauffman

Right. Well, beautiful way to put it, you correctly figured out what we're really doing here, which is to expect that based on what's going on right now at the 900 milligram dose currently in our phase I, we do think 900 milligrams will be good as both a monotherapy and in combination. We think both of these cohorts are going to be important, we do intend to pool parts A and B. This is sort of a 2-step. It's almost a sort of a Bayesian 2-step trial, but we're just putting it in here this way so that we can review this in case there's some unexpected findings here, which frankly would be different from what we're finding already in the 101 study.

Michael Kauffman

We don't believe that's going to happen. You know, we discussed it with our statisticians, and we thought this was the most appropriate way to do this. It doesn't really affect our timelines at all because we think both cohorts are going to go through, and we'll have both a monotherapy and a combination. I'll just add one more thing. These are important cohorts, assuming cetuximab can add efficacy. It also Remember, cetuximab brings about an 80% burden of a different kind of a rash than you see with some of the pan-RAS inhibitors. The cetuximab rash is so-called acneiform, and it's actually really well controlled with, frankly, standard acne medicines plus steroids.

Michael Kauffman

A lot of the patients will go on prophylactic minocycline or doxycycline, and that can really mitigate these rashes. It still comes with a rash, and there are patients, even with pancreatic cancer, who don't want that. We think both of these options will be important, and we think we can deliver very significant response rates, which will be correlated with durability with this kind of a drug because it doesn't have cumulative toxicities for both of these cohorts, and we'll have two different options for patients.

Michael Schmidt

Okay. you know, cetuximab is clearly an interesting choice, I think, in PDAC, but any plans to potentially evaluate combination of seventy-three, seventy-five with an investigational pan RAS inhibitor?

Michael Kauffman

We're absolutely considering that. We're in discussions with folks. We have generated and continue to generate some interesting data in that regard. We're absolutely looking into that. That said, frankly, there's a lot of different pathways that deserve study, in now that we seem to have made a dent in pancreatic cancer, and we're considering multiple other options as well.

Michael Schmidt

Thank you.

Operator

Thank you. Our next question comes from Faisal Khurshid with Jefferies. Your line is open.

Faisal Khurshid

Hey, guys. Thanks for the question. I wanted to ask about the GenFleet partnership. When you guys did the partnership, I think you had three RAS programs that you were eligible to in-license. If you look at the GenFleet pipeline, they have the G12D, the G12C, and a multi-RAS. Can you confirm if you guys are, you know, able to license the multi-RAS and what the considerations around that could be?

Dan Paterson

This is Dan. Those three molecules were not part. Well, except for the G12D, which we developed together with them and chose the lead, the other two programs were not officially part of the original collaboration. We continue to have discussions. You know, for us to jump into the pan-RAS space right now, we'd have to be convinced that it was a differentiated molecule and that, frankly, that combining G12D and pan-RAS is actually the preferred path we might wanna go down. We think we have so many other options. You know, we're still considering it, but there are a lot of other options to look at for a combination.

Faisal Khurshid

Got it. You do have two more molecules that you can get from GenFleet under the current deal?

Dan Paterson

We do, and we've not disclosed those targets yet.

Faisal Khurshid

Understood. Thank you.

Operator

Thank you. Our next question comes from Leonid Timashev with RBC. Your line is open.

Leonid Timashev

Hey, guys. Thanks for taking my question. Wanted to pivot maybe to the commercial side of A+F. Really appreciated the color on sort of how you see the commercial strategy evolving, but I guess I'm curious if you could provide more details on how you'll actually affect those changes. I mean, is there a different way the sales force is gonna message? Are the promotional materials going to be different? Are the regions going to shift? I guess, how do you actually drive towards those goals that you laid out? Thanks.

Dan Paterson

Yeah. No, that's a great question. The short answer is all except the last one. We did add two additional sales positions, and that was really driven by the fact that two of the regions were just too big. You know, we said all along we were gonna rightsize the launch. We were in the process of doing a deep dive. You know, we were about six months in. When we got to the end of the year, we had that seasonal issue, which, you know, frankly impacted refills more than initial scripts, and it was reauthorizations and things like that that would push things from January into February. We actually had some patients we had to put on free drug for a month until things got sorted out.

Dan Paterson

You know, when we talk about the focus for 2026, some of it was just additional training. Some of it is making sure that we're putting the right amount of effort into the visits after the first prescription and not putting all our effort into getting a prescription.

Dan Paterson

Implemented a number of different steps with information flow between the specialty pharmacy and really our integrated force, which is both the sales team and the Med Affairs team, to make sure that when there's a delay, and we increase the number of calls to patients so that we are in touch with what's going on with the patient, but also a very deliberate link where if there's a dose delay, somebody is calling on the practice, whether it's Med Affairs or the sales rep, to both find out what's going on and then reinforce the messaging that came out of the SGO meeting recently. We had two big events at the SGO meeting, which that and IGCS tend to be our two big meetings of the year.

Dan Paterson

We had the long-term update to RAMP 201, which showed durability and no increase in side effects with cumulative use over a long period of time. Also, we had a poster on the importance of dose intensity. One of the things that, you know, you're able to do in a clinical trial when you're interacting in a very regular basis is make sure you're reinforcing the protocol rules, which is if there's a side effect, you delay the dose, and you restart at full dose. That works really well with this drug. I think we're finding with MED ONCs in particular, who are used to the dynamics for chemotherapy are a little different, where you may get a response earlier and side effects are cumulative.

Dan Paterson

With this treatment, you tend to get early side effects, you know, they tend to be predictable things and things if a patient knows they're coming can be dealt with. The response becomes later. Really reinforcing the messaging and really the sharing of data on how important it is to get the patient through that first 3 months or so they get the benefit of the treatment. We talked about the new campaign that we rolled out. That's something that had been in the works for a little over 6 months. When you launch with accelerated approval, you're limited in what you can talk about in the early days. This was really our next wave of the promotional campaign that had been planned from the beginning and really reinforces the importance of getting on this treatment early.

Dan Paterson

I think there's another dynamic going on is also at SGO, there was an early report of a frontline LGSOC study that compared platinum-containing chemotherapy followed by, as part of the same regimen, an AI versus an AI only. The combination won out. I think you're gonna start seeing patients as standard of care based on the data that just came out that will get the platinum-based chemotherapy followed by AI as frontline therapy. I think that really sets us up very nicely to be the next therapy that patients get after that.

Operator

Thank you. Our next question comes from Graig Suvannavejh with Mizuho. Your line is open.

Speaker 13

Hi. This is Sam on for Graig. Thanks for taking our question, and congrats on the quarter. Maybe one on VS-7375. How should we be thinking about the cadence in terms of, like, timing of readouts? Is there a specific program or indication that you see has, I guess, the most likely path for a successful registration-enabled readout and data?

Dan Paterson

Sam, thanks for the question. I'll start, and then I'll turn it over to Julissa to give more specifics on what we'll have when. We believe all 3 of those indications are important for patients and places where our drug we believe will work quite well based on preclinical data. They're all moving forward in parallel. Our goal is to have those phase II studies largely accrued by the end of this year and then move forward as quickly as possible. Obviously, there's a lot of movement in PDAC we're going to have to monitor.

Dan Paterson

You know, we are in an enviable position as a company of our size that we have multiple programs in PDAC, and we're gonna have to see how both of those develop to make some decisions on how best to prioritize things while staying right on top of what's going on in the competitive space 'cause obviously there's a lot going on in PDAC. For CRC and lung cancer, again, the preclinical data is really exciting. You know, if you look at the GenFleet data in second-line lung cancer, you know, 69% response rate, you know, we're seeing, you know, unprecedented response rates as a single agent. We're starting to see that we can combine nicely with other agents. We've got a lot of choices to make around the frontline path in a very short period of time.

Dan Paterson

While we do that, and we will be doing frontline phase III studies, we will continue to push forward very aggressively on those potential accelerated approval paths.

Julissa Viana

I'll just add, this is Julissa Viana. I think just to reiterate what we said on the call about the timing, again, the update in the 1st half will show progress on enrollment. We'll share some more mature safety profile data since the 1 that we provided back in March, and we'll provide some patient cases so that you can get a sense of the efficacy that we're seeing. Then in the latter half of the year, again, the goal is more comprehensive data set, double-digit patient numbers across the tumor types, ideally at the go-forward dose, looking both at mono and combo data sets. You know, we can make some decisions at that point, looking at all of the variables that were just mentioned.

Dan Paterson

In the first half data release, we'll have more data on PK. As Michael mentioned during his prepared remarks, this is the first time we've disclosed that in the U.S., we are seeing better PK at 900 than 600, and that's both AUC, which is kind of, I guess, the standard measure folks would normally use. Because of the residence time or our time on target being about 24 hours, we actually think Cmax matters a lot. It can come out of the blood and still be actively blocking the target. Jonathan Pachter's presented some really elegant work at AACR last meeting recently.

Dan Paterson

We think by seeing that PK going up with the dose, we think it just further strengthens the case for pushing that 900 milligram dose, especially since we are seeing that it's tolerable.

Speaker 13

Thank you.

Operator

Thank you. Our next question comes from Andres Maldonado with H.C. Wainwright. Your line is open.

Andres Maldonado

Hi, guys. Thanks for taking the question and congrats on the progress. 2 for me for VS-7375. First, in the non-small cell lung cancer, you know, you're including an asymptomatic untreated brain metastases cohort. Curious there, you know, is the goal mainly to show systemic activity in a difficult subgroup, or is there a potential to, you know, do you guys think you have enough CNS exposure to support a differentiated intracranial profile that extends beyond that tissue type? Second question, kind of a macro question. You know, earlier this quarter, we saw a pan-RAS program report a grade 5 pneumonitis, you know, given the historical trends also seen with approved G12C, you know, how should we be thinking about these events, you know, through the lens of an on/off G12D or other strategies targeting G12D?

Andres Maldonado

Thank you very much.

Dan Paterson

Michael, you wanna take those?

Michael Kauffman

Sure. First, on the question of the brain mets, the systemic activity of the drug will be in lung cancer generally is being evaluated now at 600 in the ongoing phase I, we will be doing the 900 in the phase II, as you see, as you saw from the deck that we had along with the prepared remarks. There's a separate cohort because obviously when you're trying to ascertain the value of the drug, systemically, you tend not to pick patients with metastatic brain disease. That said, lung cancer frequently goes to the brain, unlike colorectal and unlike pancreatic cancer. In lung, it's especially important to try to see if there's substantial brain activity. The drug does penetrate the brain.

Michael Kauffman

I believe GenFleet reported that 2 out of the 5 patients that they had who had asymptomatic brain mets had systemic responses to the drug. We haven't been able to ascertain exactly how much the brain mets may have shrunk, but the brain mets clearly did not progress because they wouldn't have been responsive if they had. This cohort of about 25 patients will be treated at 900, which is a higher dose than GenFleet's able to obtain to see if we can control the brain mets. You all know about osimertinib and some of the other amazing therapies that also cross the blood-brain barrier and really can help these patients do very well over time by preventing or treating brain mets.

Michael Kauffman

That's a starting point for potential for this drug that may differentiate it from others. To reemphasize what Dan said, the fact that we're able to deliver such good systemic levels that are very tolerable so far with the 900 gives us a good shot at being able to drive enough of the drug into the brain and do something about this. As far as pneumonitis is concerned, we have not seen any cases of pneumonitis that were believed to be caused by the drug. I believe that we may have a treatment-unrelated pneumonitis case in a patient who already received radiation, and it was thought to be radiation associated, but it was grade 1, and it had zero impact at all on anything we've seen.

Michael Kauffman

We've certainly not seen any kind of pulmonary symptoms with our drug that give us any pause. That said, You know, we'll be treating a large number of patients with previously treated lung cancer, many of whom have received chest field irradiation, many of whom have had one or more infections, all of which predispose you to downstream lung events. We're obviously hopeful we're not gonna see that. Lastly, we do not believe, based on our tox studies, there's any drug-related risk of pneumonitis, but that remains to be seen. Nothing important so far.

Dan Paterson

Yeah. Just to amplify Michael's comments about pneumonitis, we do have access to the entire PV database at GenFleet. You know, when we heard these events with some of the other drugs, we did a deep dive. His comments are informed by that work that's been done.

Andres Maldonado

Thank you.

Operator

Thank you. Our next question comes from Yuan Zhi with B. Riley. Your line is now open.

Yuan Zhi

Thank you for taking our questions. Maybe one question on the combination of VS-7375 plus EGFR inhibitors in the PDAC indication. With this incremental addition of EGFR inhibitor, which normally patients cannot get because of baseline, you know, KRAS mutation, what kind of incremental efficacy you guys are looking to justify the addition of this agent, considering, you know, the safety liability with this EGFR inhibitor? Thank you.

Dan Paterson

Michael, you wanna take that one?

Michael Kauffman

Sure. There's two components to this. One is the overall response rate, of course. The second very important one is durability. We do believe, and we have some early data that could support that hypothesis, that we could deliver a higher response rate. It's too early yet to say whether we would have a increased durability of response. That said, the mechanism of action cetuximab is to specifically block not only a growth pathway. It's an accessory growth pathway for sure for RAS-driven cancers. It's not the primary one.

Michael Kauffman

When you block RAS in these cancers, including pancreatic and colorectal and probably some of the other gastrointestinal tumors, the EGFR pathway becomes much more important, and blockade of that can be helpful, again, upfront, but also to prevent the development of resistance and running growth pathways through the EGFR pathway. This could have impact on both sides of this. We will know fairly soon what kind of incremental we'll have. I can't give you a real number. I think what we'd like to do is say that if there are probably patients who would benefit from cetuximab from the get-go. We don't know who they are. There'll be other patients who might benefit it from down the road, you know, after, say, eight or nine or 12 months on our drug.

Michael Kauffman

If they started to develop resistance, one could imagine adding cetuximab. We think that this development plan that we expect could support accelerated approvals could lead to availability of this combination regimen, maybe not upfront in everybody, but certainly as an option for patients if they start to see progression of their tumor, as well as for some patients upfront. I think this provides a lot of flexibility. This is not an option for most of the pan-RAS inhibitors because the strong concerns about added rash here. I think for the 40% of patients who have, you know, who have PDAC that's G12D and the 20% of patients that have colorectal cancer that's G12D, that this could be a really important addition either upfront or down the road.

Yuan Zhi

Thank you.

Operator

Thank you. Our next question comes from Jeet Mukherjee with BTIG. Your line is open.

Jeet Mukherjee

Great. Thanks for taking the question. Two from me. You certainly mentioned that 900 mg is looking like a very suitable go forward dose. Was just wondering if you could elaborate a bit further on why this hits the sweet spot. Looks like 1,200 mg is certainly still under evaluation. Was there some limiting factor with that dose, perhaps? The second question was just related to the TARGET-D studies. I think you've definitely mentioned that these are designed to be supportive of approval. Have you reached some degree of alignment with the agency on what the bar for approval is? Looks like ORR is a primary endpoint across several of the studies. Is there some threshold you need to exceed? Any details there would be helpful. Thanks.

Dan Paterson

Michael, you wanna take those?

Michael Kauffman

Sure. Just to be really It's a simple answer for 1,200. The pills that we have right now are 100 mg pills. Asking patients to take nine of these to give you 900 mg is the upper limit of what they can really handle, in one swallow, if you will, or one session, if you will. For the 1,200, we're going to a split session of six and six, split by about 30 minutes because we ask people to take it with food and plenty of water and so on to make sure it gets down there and everything. It's just impractical to go much above 1,200 with the current pill size.

Michael Kauffman

That said, we are certainly in the midst of constructing larger pills, which we'll update you guys on when we have that, you know, to a point where we think it's real.

Michael Kauffman

Hopefully we won't be You know, we don't expect to be marketing this as 100 milligram pills. We expect to be marketing it with higher pill sizes so that we don't have to give people that much. It's pretty simple and straightforward. Once we have the larger pills, depending on what we see with 1,200, we may consider going higher, but right now 1,200 is it. As far as FDA's threshold, I mean, we have not had any discussions with them specifically about what this is. Thankfully, and I think the oncology division of the FDA has been superb about this, particularly for molecularly defined subsets of cancers. They have routinely approved drugs as low as 25%.

Michael Kauffman

Typically, the 25% to 30% ORR range is what's approvable as a single arm study, provided there is sufficient durability. You know, if you go to ASCO, most experts will tell you they wanna see at least 6 months duration of response. We all keep in mind that that's 6 months plus a month and a half minimum it takes to get to a response. You're talking 7.5-8 months at least on the drug which for these kinds of tumors is pretty impressive, particularly in heavily pretreated patients. I think those are kind of the thresholds you should be thinking about, 30% on the ORR number and 6 months durability. Those are general numbers, and it's always a review issue with the FDA.

Jeet Mukherjee

Thank you.

Operator

Thank you. Our final question comes from James Molloy with Leerink Partners. Your line is open.

Speaker 12

Hi, this is Matt on for Jim today. Thank you guys for taking our questions. Just two from us. In terms of the launch for A+F, the reimbursement for KRAS undefined and KRAS wild type, is that continuing at similar rates from previous quarters?

Dan Paterson

Yes, we've seen no change.

Speaker 12

Okay, excellent. Do you guys have any anecdotes from treating doctors whose patients have been on treatment for over eight or nine months at this point? If you could share, that would be very helpful.

Dan Paterson

Sure. I mean, it's anecdotal at this point, you know, given the fact, you know, we've only been out for, you know, just a year now. There are patients that have done quite well that are both wild type and mutant. We also, you know, continue to interact with the sites on RAMP 201. I recently spent some time with a patient that's been never achieved a PR with stable disease but had really transformational change in her ability to do things. She went from not being able to vacuum her living room to running a 5K and has been on our drug for, I believe, 3 to almost 4 years now. We do have a lot of anecdotal information.

Dan Paterson

Even going back to the FRAME study, we had a number of patients staying on for a long time. You know, we do think when it's the right patient that we'll recapitulate what we saw in the clinical trial. As you may recall, in RAMP 201, we had patients from anywhere from 1 prior therapy to 10 prior therapies. It tends to be less, I think. You know, of course, the more prior therapies you have, the more challenged the patient has. I think the big difference in the real world versus the clinical trial would be performance status. In most clinical trials, you're limited to performance status 0-1, and obviously in the commercial setting, you take anybody who wants to come on the drug.

Dan Paterson

Even though we did hear instances of patients going on one cycle and coming off, and then you can say, "Well, they probably shouldn't have gone on the therapy," we've also heard anecdotal stories of patients that were pulled out of hospice, put on the drug and did well for a number of months and got a number of months with good quality of life they otherwise wouldn't have had. You know, those are great stories to hear, and we continue to monitor those. You know, we're very excited about the franchise. You know, I think we've uncovered some things from seasonality. Plus, you know, you learn as you go through the launch, and I think we've made some course corrections that it may take, you know, a couple of months to see the full benefit of.

Dan Paterson

I will say with confidence, we already are sure that we will see an increase from Q1 to Q2 that was bigger than the Q4 to Q1.

Speaker 12

Great. Well, thank you guys for the color, and thanks for taking our questions. Congratulations.

Dan Paterson

Thanks for the questions.

Operator

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Investor releaseQuarter not tagged2026-04-23

Verastem Oncology to Report First Quarter 2026 Financial Results on May 7, 2026

Business Wire

BOSTON, April 23, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the Company will host a conference call and webcast to discuss its first quarter 2026 financial results and business updates on Thursday, May 7, 2026, at 4:30 pm ET. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website, https://investor.verastem.com/events. A replay of the webcast will be archived and available following the event. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKIᆴ FAKZYNJAᆴ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20260423119779/en/ Contacts For Investor and Media Inquiries: Julissa Viana Vice President, Corporate Communications, Investor Relations & Patient Advocacy [email protected] or [email protected]

Investor releaseQuarter not tagged2026-03-05

Verastem: Q4 Earnings Snapshot

Associated Press Finance

NEEDHAM, Mass. (AP) — NEEDHAM, Mass. (AP) — Verastem Inc. (VSTM) on Wednesday reported a loss of $32.9 million in its fourth quarter. On a per-share basis, the Needham, Massachusetts-based company said it had a loss of 50 cents. The drug developer posted revenue of $17.5 million in the period. For the year, the company reported a loss of $209.5 million, or $3.02 per share. Revenue was reported as $30.9 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on VSTM at https://www.zacks.com/ap/VSTM

Investor releaseQuarter not tagged2026-03-05

Verastem Oncology Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Business Updates

Business Wire

AVMAPKI™ FAKZYNJA™ CO-PACK net product revenues of $17.5 million for the fourth quarter of 2025 and $30.9 million for the full year 2025, following accelerated U.S. FDA approval in May 2025 Based on FDA guidance, Company to develop Phase 2 registration-directed protocols to evaluate VS-7375, a highly selective, oral KRAS G12D (ON/OFF) inhibitor with best-in-class potential, in 2L PDAC, 2L/3L NSCLC and 2L+ CRC in combination with cetuximab Cleared multiple dose levels of VS-7375 with no DLTs, continuing dose escalation to 1200 mg QD; cleared 600 mg QD dose level of VS-7375 in combination with cetuximab with no DLTs; continuing higher dose evaluations Company cash, cash equivalents, and investments of $205 million as of December 31, 2025; pro-forma year-end cash, cash equivalents and investments of $234 million inclusive of net proceeds from exercise of expiring cash warrants; expected cash runway into first half of 2027 BOSTON, March 04, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today reported financial results for the three months and full year ended December 31, 2025, and highlighted recent progress. "2025 was a transformative year for us, highlighted by the landmark FDA approval of AVMAPKI FAKZYNJA CO-PACK, the only medicine approved to specifically treat KRAS-mutated recurrent LGSOC. The launch is off to a strong start, and this novel-novel combination therapy is gaining positive response across the LGSOC community with gynecologic and medical oncologists in both academic and community settings increasingly turning to it when patients experience a first or subsequent recurrence. We also made considerable progress with VS-7375, our oral, KRAS G12D (ON/OFF) inhibitor with best-in-class potential for solid tumor cancers, clearing multiple dose levels across both monotherapy and cetuximab combination cohorts with no DLTs or major toxicities. Building on the insights from the China data, the tolerability profile that is emerging with VS-7375 in the U.S. has shown meaningful improvement and supports continued dose escalation," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In 2026, our priorities are to continue driving a strong launch of AVMAPKI FAKZYNJA CO-PACK to fuel sustainable growth, while we...

Investor releaseQuarter not tagged2026-03-05

Verastem Inc (VSTM) Q4 2025 Earnings Call Highlights: Transition to Commercial Stage and ...

GuruFocus.com

This article first appeared on GuruFocus. Release Date: March 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Verastem Inc (NASDAQ:VSTM) transitioned to a commercial stage company with FDA approval for the first treatment specifically for KRAS mutated recurrent low-grade serous ovarian cancer. The company reported $30.9 million in net product revenue for the launch period of May through December 2025, with $17.5 million in the fourth quarter alone. Steady growth in product adoption was observed among both academic centers and community oncologists. The combination of ivutametinib plus defactinib has shown promising anti-tumor activity in pancreatic cancer, a highly KRAS-driven cancer. Verastem Inc (NASDAQ:VSTM) has extended its cash runway into the first half of 2027, providing financial stability to advance near-term milestones. The updated NCCN ovarian cancer guidelines did not expand the recommendation for rutametinib plus defactinib to include patients without a KRAS mutation, which was disappointing for the company. The company faces challenges in securing reimbursement for KRAS wild-type patients, although they have been successful so far. Research and development expenses were high, totaling $114.6 million for the full year 2025. The company reported a non-GAAP adjusted net loss of $163.1 million for 2025, indicating financial challenges. There is a need for continued prioritization of opportunities due to limited resources, which may impact the pace of development and commercialization efforts. Warning! GuruFocus has detected 7 Warning Signs with VSTM. Is VSTM fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide insight into why the NCCN guidelines did not include wild-type patients and your confidence in reimbursement for these patients? A: Dan Patterson, CEO: We were disappointed and surprised by the NCCN's decision. We suspect it might relate to the upcoming phase 3 readout. Despite this, our team has been successful in securing reimbursement for wild-type patients, and we will continue to do so. The adoption will likely be driven by the results of the confirmatory study, which will allow us to actively promote the treatment. Q: Could you comment on the safety profile of VS 7,375 in the US study and your approach to dose selection for phase two studies? A: Dr...

TranscriptFY2025 Q42026-03-04

FY2025 Q4 earnings call transcript

Earnings source - 39 paragraphs
Operator

Good afternoon, and welcome to Verastem Oncology's Fourth Quarter and Full Year 2025 Earnings Conference Call. My name is Desiree, and I will be your call operator today. Please note this event is being recorded. [Operator Instructions] 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

Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss Verastem's Fourth Quarter and Full Year 2025 financial results and recent business updates. This afternoon, we issued a press release detailing these results along with a slide presentation that we will reference during our call today. Both are available on the Investor Relations section of our website. Before we begin, let me point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Additionally, today, we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. Joining me on today's call to deliver prepared remarks and take your questions are Dan Paterson, President and Chief Executive Officer; Mike Crowther, Chief Commercial Officer; Dr. Michael Kauffman, President of Development; and Dan Calkins, Chief Financial Officer. I will now turn the call over to Dan.

Daniel Paterson

Thank you, Julissa. Good afternoon, and thanks for joining our call today. 2025 was a truly transformative year for Verastem as we transition to a commercial stage company following our FDA approval of the first treatment specifically for KRAS-mutated recurrent low-grade serous ovarian cancer, nearly two months ahead of our PDUFA date. For the launch period of May through December 2025, we delivered $30.9 million of net product revenue and $17.5 million for the fourth quarter. I'm pleased to report that the strategies we put in place to guide our commercial launch continue to yield meaningful results. We continue to see steady growth driven by consistent adoption among both academic centers and community oncologists. Before I continue, I want to address the updated NCCN ovarian cancer guidelines that were released last week and mentioned in our press release today. The guidelines did not expand the recommendation for avutometinib plus defactinib to include patients with the recurrent LGSOC, without a KRAS mutation. This does not change our launch trajectory. Everything we've been doing for the launch has been based on the guidelines that include the combination as a category 2A recommendation for KRAS-mutated recurrent LGSOC. We're disappointed for the patients with KRAS wild-type recurrent LGSOC, who currently have no targeted FDA-approved treatment options specifically for their disease and face a particularly poor prognosis. Across three separate clinical trials, the FRAME study, RAMP 201 and RAMP 201J, we've observed what we believe are robust objective response rates for patients with recurrent LGSOC, with and without KRAS mutations. We remain committed to advancing the clinical evidence through longer-term follow-up analyses from the RAMP 201 study in 2026 and completing our ongoing confirmatory RAMP 301 Phase III clinical trial, which includes patients with and without KRAS mutations and look forward to sharing these data next year with the NCCN and the medical community to support future guideline consideration. This clinical conviction and our confidence in our data is what underpins our commercial execution. As Mike will share with you shortly, we have an opportunity to continue to drive more growth through the expansion of our prescriber base and increasing their comfort to use AVMAPKI FAKZYNJA CO-PACK at first recurrence. With this approval, we've proven that precision targeting of RAS/MAPK pathway with the combination of avutometinib and plus defactinib can deliver meaningful outcomes for patients. Cancer is highly dependent on this pathway for its growth and approaches [ that block ] just a single node in this pathway are generally insufficient for deep and durable anticancer activity. The cancer will compensate by activating other signaling proteins within the RAS pathway or in parallel pathways. This is what differentiates avutometinib plus defactinib and is defining our success in the market in the clinic. The team's execution through the early phases of the launch has enabled us to quickly deliver this medicine to patients living with a rare ovarian cancer who previously had no approved treatment options specifically for their disease. Likewise, our R&D team has made great strides in advancing key strategic clinical trials. As with LGSOC, the combination of avutometinib plus defactinib has shown promising antitumor activity in pancreatic cancer, a highly KRAS-driven cancer and our RAMP 205 trial in first-line metastatic pancreatic cancer where combining avutometinib and defactinib with standard of care chemotherapy to improve response rates and other outcomes. Avutometinib can help to inhibit tumor growth while defactinib works to inhibit FAP to reduce the stromal density in the pancreatic cancer tumor and address adaptive resistance to avutometinib. The updated data we shared at ASCO last year demonstrates the potential for this combination in treating one of the most challenging cancers. In addition to the avutometinib defactinib combination, we're targeting RAS-driven cancers with other novel therapies. This includes our other exciting pipeline program VS-7375 which has the potential best-in-class oral KRAS G12D ON/OFF inhibitor. Building on the unprecedented data from our partner in China, we moved VS-7375 into the clinic last year with a multi-indication trial strategy. Recent feedback from the FDA has given us a clear strategic path forward for clinical development. As a result, we'll be amending our existing VS-7375-101 trial protocol and separating our disease-specific Phase II registration-directed trials. This added clarity will help us move this program towards a potential accelerated approval pathway. Given the early results, we believe VS-7375 has the strong potential to be the preferred agent in treating KRAS G12D driven cancers on pancreatic, lung and colorectal. Michael will provide a more fulsome update shortly. With all our clinical studies, we've made disciplined data-driven decisions to prioritize those with the greatest potential impact for patients living with RAS-driven cancers. This was demonstrated in our decision to accelerate the VS-7375 program towards registration-directed studies and with the discontinuation of avutometinib plus defactinib program in lung cancer in light of an evolving treatment like landscape despite an interesting clinical signal. We have a wealth of opportunity but limits to our resources, and we'll continue to prioritize the opportunities with the highest value. We'll continue to closely manage our expenses and with our last financing and the exercise of the remaining cash warrants, we've extended our cash runway into the first half of 2027, giving us what we need to advance our near-term milestones. In fact, we believe the LGSOC franchise will be self-sustaining in the second half of this year with CO-PACK revenues funding both the commercial operations and any ongoing clinical trials for [ A+D ]. Our focus remains on identifying value-creating non-dilutive opportunities in this challenging environment as we advance our clinical programs and deliver for patients and shareholders alike. With that, I'll turn the call over to Mike. Mike?

Michael Crowther

Thank you, Dan. I'll cover our commercial performance for the quarter, our launch progress in 2025 since our FDA approval in May and some perspective on how we see the launch progressing in 2026. As we have shared, a diagnosis of LGSOC is a life-changing event. LGSOC can affect women as young as in their 20s and the vast majority of these women about 80% to 90% experienced recurrence highlighting the urgent need for more effective therapies. In May of 2025, AVMAPKI FAKZYNJA CO-PACK became the first ever treatment specifically approved for KRAS-mutated recurrent LGSOC, forever changing the treatment landscape for this disease. Let me give you an example of the impact of the CO-PACK therapy. Recently, we learned of a patient in her early 40s who had been diagnosed with LGSOC at age 30 and for several years, tried other systemic therapies, including chemotherapy. Following her second recurrence 4 months ago, she started in the CO-PACK and her most recent scans has shown a complete response to treatment. This incredible outcome underscores the benefit of using the CO-PACK. This is just one of many stories we are hearing from physicians treating people with this disease when other treatments were ineffective or a patient who experienced a recurrence, the doctor would give the difficult news that they have no other treatment to offer. This has all changed with the introduction of AVMAPKI FAKZYNJA CO-PACK. For the fourth quarter, we delivered a solid finish to 2025. The steady growth momentum since our launch speaks to the demand we continue to see. The team is executing well against all 3 key strategic launch imperatives, effectively reaching health care providers, ensuring seamless access to coverage and engaging and supporting patients throughout the journey. Consistent with Q3, we saw encouraging signals in Q4 in both the breadth and depth of prescribing. The number of active prescribers continues to expand. And through February, there have been nearly 300 prescribers of the CO-PACK. Let me walk you through some of the launch dynamics we saw in the fourth quarter and have continued so far through the first quarter. More than half of total prescriptions are coming from the academic setting, and we are seeing repeat prescribers write scripts for new patients. We are making good progress with our top accounts. Our top target institutions include both academic and community centers, about 75% of these organizations have either introduced or adopted AVMAPKI FAKZYNJA CO-PACK into their ecosystems, reflecting growing penetration across prescribers. The split of prescriptions between GynOncs and MedOncs remains roughly at 60-40 consistent with previous quarters. Our GPO accounts have started to incorporate the therapy second-line use into their internal EMR pathways, and we are actively partnering with their leadership on data analytics to find eligible patients within their networks. Payer coverage continues to be strong across all LGSOC prescribed patients regardless of mutational status. The tactical prescriptions continues to be in the range of 12 to 14 days due to rapid prior authorization approval and our payer mix remains consistent with previous quarters. Our Verastem Cares program has been effective in helping patients manage through insurance processes. Approximately 60% of commercially eligible patients are using our co-pay program. In our medical educational efforts, our medical science liaisons and oncology nurse educators have engaged in approximately 1,800 scientific exchanges and well over 700 educational engagements with health care providers through year-end. We saw high participation in multiple expert-led educational programs we supported for physicians to improve physicians' understanding of our treatment in the disease state. We provided a variety of tools to side effect management to help both prescribers and patients stay on the treatment and realize the benefits of the CO-PACK. This includes providing more education to prescribers as they gain experience and get more comfortable with the treatment. These resources are especially important where many community-based medical oncologists may see relatively few patients of LGSOC and appreciate support for patient management. From a patient perspective, we continue to see high engagement in our branded website. Patients are opting in to receive more information about the CO-PACK to facilitate further discussions with their doctor. This brings me to our plans for 2026. As the first company to develop and launch a treatment specifically for KRAS-mutated recurrent LGSOC, there were no well-established support systems in place for these patients and we have been working to build these systems, including providing education about the disease, increased awareness of our Verastem Cares program for insurance support and supporting patients as they learn about this new treatment option. As expected, while many physician's first experience with the CO-PACK is often in later lines, we will continue to focus on driving use of first recurrence that patients can receive the full benefits of AVMAPKI FAKZYNJA CO-PACK. In the next quarter, we will be launching a new promotional campaign to offer physicians and patients to help them reimagine how this disease can be treated. The campaign will be supported by a comprehensive digital ad campaign to generate awareness about the availability of first ever treatment specifically for KRAS-mutated recurrent LGSOC and drive traffic to our product website to access more tools. We are expanding our educational plans with additional peer-to-peer programs, including a new program that directly connects physicians with an expert in LGSOC to feel confident caring for patients with LGSOC and driving optimal outcomes. In addition, we will share support tools designed to increase depth within our active accounts while continuing to expand our reach in new patient starts. We are deploying our sales reps and those educators whenever a doctor prescribes the therapy to help them understand what to expect and use the tools we have created to manage through any adverse events. We have been focused on a fit-for-purpose launch, and as such, we've added a few additional field staff, including some sales reps, nurse educates and MSLs. Due to the nature of this disease as a slow-growing cancer where patients stay on their first treatment for several years, we know it will take time to achieve peak share of first recurrence. We remain focused on our core launch priorities and sustaining steady growth. We're encouraged by the progress we have made, and we will continue building on our momentum throughout the year. I'll now turn the call over to Michael.

Michael Glen Kauffman

Thank you, Mike. When I moved from Lead Director on the Board to Head of Development at Verastem last year, it was because I see significant promise in our pipeline and specifically believe that what we're building here with VS-7375 as the potential to significantly change outcomes for people living with KRAS-C12D-driven cancers. I'm proud of the progress our team has made in such a short amount of time. Let me start by recapping where we ended the year with avutometinib plus defactinib because 2025 was a defining year across our portfolio. Our team completed enrollment ahead of schedule in our two avutometinib and defactinib clinical trials, RAMP 301 in LGSOC and RAMP 205 in pancreatic cancer. This positions us well for the catalysts ahead. On RAMP 301, because we completed enrollment early, we expect to report the top line primary analysis in mid-2027. As a reminder, this is our randomized international Phase III trial of avutometinib plus defactinib against standard therapy in recurrent LGSOC, with or without a KRAS mutation. It will serve as a confirmatory study for the initial indication and has the potential to expand the indication regardless of KRAS mutational status and to support future regulatory filings outside of the United States. Turning now to some of our progress. For our Japan-specific RAMP 201J study in LGSOC, in collaboration with Japan's GOG, we shared an update of all 16 patients enrolled by investigator assessment that demonstrated a 57% overall response rate with KRAS mutant and a 22% overall response rate with KRAS wild-type recurrent LGSOC. This is the first ever study conducted in Japan for this disease. We look forward to sharing more data from that trial in the future. And in Europe, we received growth in drug designation in ovarian cancer last year from the European Commission. We continue working through the steps needed for our future regulatory application once we have the RAMP 301 results in hand. For RAMP 205, our first-line metastatic pancreatic cancer study of avutometinib plus defactinib in combination with [ GEM ABRAXANE ]. At ASCO last year, recall we reported a confirmed response rate in 10 of 12 patients for an overall response of 83%. We completed enrollment of the expansion cohort and expect to share an update on the additional patients enrolled in the trial in Q2 of this year. We're excited with the progress we've made with our avutometinib plus defactinib combination trials which we believe has the potential to expand the franchise into new and larger markets. Now turning to VS-7375. We moved quickly after licensing the product to secure FDA IND clearance and Fast Track designation, and we dosed our first patient in June of 2025, following the very promising early results from our partner in their trial in China and we've continued to build momentum since. Here's why the program matters so much. KRAS G12D is an important mutation in pancreatic, colorectal and lung cancers along with lower prevalences in a variety of other difficult-to-treat cancers. There are no FDA-approved therapies targeting this mutation. We have taken a broad approach to generate data not only in these larger tumor types but also across other KRAS G12D cancers, such as biliary tract cancer. We've made some exciting progress in a short time. We recently cleared the oral dose of 900 milligrams once daily in our dose escalation phase, and we're evaluating the 1,200-milligram daily dose. Our partner GenFleet selected the 600-milligram daily dose as their go-forward dose in China due to a strong efficacy signal. While we are advancing some of our cohorts using the 600-milligram dose, we're continuing on our dose escalation to the 1,200-milligram dose level to further interrogate the dose range and characterize the safety, tolerability and efficacy profile of our agent. In addition, based on a preclinical synergy with dual RAS EGFR blockade, we are evaluating the combination of VS-7375 with cetuximab. We recently cleared 600-milligram daily dose level in combination with [ secure ] dose cetuximab, and we'll continue to evaluate higher doses in this combination. I'm also pleased to share that the FDA recently provided feedback on our Phase I/II protocol. Per the agency's request, we are changing our initial Phase I/II trial, which had multiple expansion cohorts and breaking out several disease-specific Phase II registration-directed trials for KRAS G12D mutated cancers, including second-line pancreatic ductal carcinoma, second and third-line non-small cell lung cancer and with VS-7375 in combination with cetuximab in second line plus colorectal cancer. Now let me move to discuss our recent PK analysis that we did. Doses of 600-milligrams daily and above with feeding and antiemetic prophylaxis yielded similar exposures to that observed in China with faster patients. And exposures achieved cover the exposures to preclinical models necessary for maximal antitumor efficacy. From a safety perspective, we continue to be pleased with the profile we see emerging. We have the benefit of hindsight of our partners' trials in China, and we adjusted our protocols to directly address some of the tolerability issues that our partner has seen early on. As noted, the overall tolerability of VS-7375 in the United States appears to be better than that which was observed in China as we're able to escalate beyond 600-milligrams and now beyond 900-milligrams. No drug-related liver function test abnormalities have been reported in any patient across any of the dose levels to date. No drug-related neutropenia in Grade 2 has been reported. And we included in the protocol strong recommendations for standard prophylactic anti-nausea agents and rapid institution of over-the-counter antidiarrheal agents as needed. As a result, rates of nausea, vomiting and diarrhea are lower than those reported by our partner in China. The differentiation we are seeing from the data and our partner in China as well as early signals from our own trial give us strong confidence that potential of this asset to treat multiple difficult-to-treat cancers where there's a high end of medical need with a highly targeted once-a-day oral agent. Looking ahead to this year, our goal is to generate a meaningful data set in each of these tumor types, both as single agents as well as in selective cancers in combination with other treatments. Initially, we plan to share an update on preliminary data in the first half of 2026. But as I said, because of our success to date, we're able to continue with the dose escalation and also enrollment into our various tumor cohorts. And this is really important, getting the optimal dose, of course, matters greatly. We plan to share a more fulsome data at our go-forward dose in the second half of this year. Now I'll turn the call over to Dan Calkins.

Daniel Calkins

Thank you, Michael. Our full financial results are included in our press release, so I'll focus on the highlights here. I'm also pleased to reiterate that we reported $17.5 million in net product revenue for the fourth quarter of 2025 and $30.9 million for the full year, which includes the launch period of May through December. Cost of sales were $2.6 million for the fourth quarter of 2025 and $4.6 million for the full year 2025 period. Cost of sales increased in the fourth quarter in line with the increase in net product revenue for the quarter. As we've previously communicated, we're not providing detail 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 $31.7 million for the fourth quarter of 2025 and $114.6 million for the full year. R&D expenses were driven by both the ongoing global confirmatory Phase III or RAMP 301 clinical trial and the ongoing VS-7375 Phase I/II clinical trial as well as higher costs associated with drug substance production activities related to 7375. SG&A expenses were $24.4 million for the fourth quarter and $81.1 million for the full year. The expenses were driven by commercial activities and operations, including personnel-related costs to support the ongoing CO-PACK launch. Directionally, for 2026, we would expect SG&A expenses to remain roughly the same on a quarterly basis as we continue to be disciplined in our expense management, making the right investments at the right time to support the ongoing commercial launch efforts while simultaneously advancing our pipeline. For the fourth quarter of 2025, non-GAAP adjusted net loss was $39.8 million or $0.48 per share diluted compared to non-GAAP adjusted net loss of $29.3 million or $0.60 per share diluted for the fourth quarter of 2024. For the full year, non-GAAP adjusted net loss in 2025 was $163.1 million or $2.35 per share diluted compared to non-GAAP adjusted net loss in 2024 of $107.4 million or $3.01 per share diluted. Please see our press release for a full reconciliation of GAAP to non-GAAP measures. Moving to the balance sheet. We ended the fourth quarter of 2025 with cash, cash equivalents and investments of $205 million including the proceeds of the expiring cash warrants, which were exercised in January of 2026, our pro forma cash balance as of December 2025 was $234.4 million. We believe our current cash, combined with the future revenues from AVMAPKI FAKZYNJA CO-PACK sales will provide cash runway into the first half of 2027. We are very encouraged by the initial launch and look forward to building on the CO-PACK growth into 2026. Given our current trajectory, I'm pleased to reiterate that we believe the LGSOC franchise will be self-sustaining in the second half of the year, with CO-PACK revenues funding both the commercial operations and any of our avutometinib plus defactinib clinical trials. With that, let me turn the call back over to Dan.

Daniel Paterson

Thanks, Dan. Before we open the call to Q&A, I'll spend a few minutes on 2026 priorities. 2025 has given us a solid foundation for the remainder of 2026, we'll stay laser-focused on 4 key strategies: first, maximize the commercial launch execution of AVMAPKI FAKZYNJA CO-PACK for broad adoption. Second, generate monotherapy and combination data with VS-7375 to expedite the execution of our registration path in major KRAS G12D solid tumors. Third, continued execution of the RAMP 301 confirmatory Phase III trial in recurrent LGSOC. And fourth, maintain prudent capital management through our key catalysts and a strong balance sheet. In support of these strategies, we set several goals in which to measure our success. We want to maximize adoption of the CO-PACK to ensure every appropriate patient benefits from this novel treatment at their first reoccurrence. For our first-line PDAC study, RAMP 205, we plan to share an update on the expansion cohort in Q2. Finally, as we push to accelerate our VS-7375 trial, we expect to further demonstrate the breadth of our RAS/MAPK pathway driven approach and lay the path for expansion of our commercial product line. We plan to share an update on the 101 trial in the first half of this year. With the FDA's feedback in hand, we are creating Phase II registration-directed protocols for pancreatic, lung and colorectal cancers. Enrollment in the 101 trial is going well, and we anticipate being able to enroll the Phase II trials quickly. Our goal is to move forward quickly and efficiently to hopefully bring this treatment to patients who currently have no FDA-approved treatments to their KRAS G12D mutated cancers. But having said that, while speed is important, we're always cognizant that bringing the best therapy to market is more important. We're privileged to have a commercial product with growing revenue and a robust clinical pipeline that addresses larger market opportunities. We're building a sustainable multi-asset oncology company to address important unmet needs in RAS/MAPK driven cancers. As we enter 2026, we're well positioned to continue to deliver on our milestones. With that, we'll open up the call for questions. Operator?

Operator

[Operator Instructions] Our first question comes from the line of Eric Schmidt with Cantor.

Eric Schmidt

Congrats on all the progress. Maybe on the NCCN non update, do you guys have any visibility into the thought process behind why wild-type patients weren't included? And then if you could comment on your confidence that wild-type patients can continue to gain reimbursement? I know they've been a meaningful cohort for you in the commercial setting to date.

Daniel Paterson

Eric, thanks for your question. Look, we were -- it was disappointing, and we're a little surprised. We've not gotten any direct feedback. We're not really going to speculate. We suspect it might have had something to do with the imminent Phase III readout coming. We know they don't like to change things once they do add something. We don't see any difference to how we've been running our business and to the trajectory. I've said a number of times, it would be nice to have NCCN because it's kind of like air coverage and we're fighting a ground war right now on the reimbursement side. But our team has been doing a wonderful job securing reimbursement regardless of KRAS mutation status, and we'll continue to do the same thing. So our message to our team to physicians and to patients is we're going to continue to do what we've been doing before. Ultimate adoption likely to be very much driven by the results of the confirmatory study because then we can actively promote, which even with the NCCN guidelines, we can't actively promote although we are allowed to share the publications that we have and both the FRAME study and the RAMP 201 study have results in both wild-type and mutated that we believe show benefit to patients, and we'll continue to share those publications.

Operator

The next question comes from the line of Michael Schmidt with Guggenheim Partners.

Michael Schmidt

I had a couple on 7375. Obviously, the safety now looks very good in the U.S. study based on the detailed table that's included in the slide deck this quarter. Could you comment on what you've seen or if you have seen any dose modifications or perhaps discontinuations? So I'm just curious if you've seen any of those? And then question on how you're approaching dose selection. I believe you've been enrolling patients and expansion cohorts at 600 mg QD, but obviously escalating further up to 1,200 now. So how do you think about dose selection for these planned Phase II studies? And then lastly, just thinking about your combination strategy, maybe just comment on how you're thinking about the longer-term positioning of 7375 in the landscape -- in the RAS space. I know you've planned combination cohorts with approved center of care and various indications, but would it make sense perhaps to also consider combining with other novel agents, for example, pan-RAS inhibitors or other agents that are out there?

Daniel Paterson

Michael, thanks for your question. I'll let Michael Kauffman address the questions for you.

Michael Glen Kauffman

Sure. I'll try to remember all of them and come back to me if I missed something. I think -- first of all, the number of dose modifications is low and slower than typically that I expect in various trials. And remember, these are heavily pretreated refractory tumors and the patients are doing well, the drug. So the tolerability is consistent with the data you saw on the table and then consistent with any modifications, the dropout rate is very low for the patients. So we're really pleased with what we're seeing. And that includes both the 600 and the 900-milligram cohort. The second issue is how we think about escalation and evaluation of these doses because what we're really doing is kind of a 2-dimensional matrix here with dose escalation where we're increasing the dose now up to 900 and now beyond that. At the same time, we have to determine longer-term tolerability because that's the name of the game now with chronic cancer medicines and longer-term disease control and responses where we're looking for durable antitumor responses. So it's a 2-dimensional matrix for sure. We believe we can identify the proper doses evaluating 10 to 15 patients in each of these areas. And this is not going to be a long-term commitment. I mean these drugs tend to work quickly. Our drug, in particular, works quickly. and we're able to discern a lot of this stuff in several months. But the other -- just to remember, it does take -- it still takes at least two CT scans to determine if someone has a confirmed response and sometimes the responses take more than the first CT scan. So we'll be looking at multiple months. The last point on that is that the important achievements really are after 6 months because in all cases, we need to see prolonged disease control. And as you all know, thankfully, the minimum kind of numbers that we all want to see now even in these difficult-to-treat tumors is north of 6 months. So that's -- it will just take 6 months at least to affect this and understand it better, but we think we're going to be there in the not-too-distant future. The last bit is the combination strategy. Yes, I mean, there's two goals here. One is regulatory, clearly, and the second goal is where is the puck going to sort of -- Wayne Gretzky quote of how to predict the future. And we'll be looking at both. But the primary goal here is to move these drugs initially into the second and third-line setting through these accelerated approval pathways, which the FDA has helped pave the way aggressively with us to do that and then to run into frontline studies with standard of care so that we can achieve regulatory approvals but then to start to investigate -- probably through investigator-sponsored trials, some of the novel combinations.

Operator

Our next question comes from the line of Clara Dong with Jefferies.

Yuxi Dong

Congrats on all the progress. Just on the NCCN guideline update, do you have any plan to maybe reengage with the NCCN in the future with longer term data, maybe RAMP 301 data or on additional Japan data as well. And then for the FDA feedback at G12D, can you walk us through what specifically trigger feedback to separate the study into disease-specific and registration directive Phase II trials for the three indications?

Daniel Paterson

Clara, thanks for your questions. I'll take the NCCN one and then turn it over to Michael for the FDA question. Yes, we intend to continue to develop evidence on the use of this molecule in both wild-type and mutated. We have a number of activities ongoing that I won't get into details on right now. And then, obviously, as I mentioned, when we have the readout from 301, that's kind of the penultimate randomized readout that will help with both NCCN and hopefully, with the label expansion at the FDA. Michael, do you want to address the question on 7375?

Michael Glen Kauffman

Sure. We modified our protocol, our initial 101 protocol based on initial results that we were quite pleased with to expand the cohorts in each of the three major diseases as well as in a sort of tumor-agnostic cohort basically taking a page from the playbook of KEYTRUDA, where they use the Phase I trial to expand into lots of different places. The FDA since then, since the KEYTRUDA really has split the solid tumor divisions into multiple divisions. And based on that, pretty much was the driver for the FDA is saying, "Hey, we like your plan. But in general, cohorts that are going to be used for marketing authorization should be included in separate protocols." We didn't explicitly ask them for the marketing authorization, but we got the answer very clear in black and white, which was really gratifying. I mean they knew what we were trying to do. And when you put 80 to 100 patients in an expansion cohort, they know where you're going with this. And I think they were extremely supportive with us and excited about the kinds of data that we have provided both from China and the initial safety data from the U.S.

Operator

The next question comes from the line of Graig Suvannavejh with Mizuho.

Graig Suvannavejh

Congrats on continued progress. I was hoping to get maybe some color on -- a little bit more color just on the prescribing dynamics for CO-PACK right now? I might have missed it in your prepared remarks, but usage between -- in the academic center versus the community setting and color on refills? And then the second question, if I could, is just a question on financing and I'm wondering with things at your disposal, how are you thinking about future financing for the company to extend the cash runway beyond first half of 2027?

Daniel Paterson

Yes, Graig. Thanks for your question. I'll take the second one first and then ask Mike to address your question on uptake. As we've said, and we think this is really important. We believe that launch for the [ A+F ] franchise will be self-sustaining by the second half of the year and won't require additional fundraising. So any additional capital that we have to access will be based on good data coming out of the G12D program. We're looking very carefully at prioritizing what we need to do, looking at different vehicles to raise money. Obviously, going out and doing straight equity raises, creates dilution, and we like to avoid that as much as possible, especially at current stock prices and are looking at a number of different ways to stage things over time to make sure we've got enough runway, but we're being prudent in how we raise that money. Non-dilutive approaches are ones we're spending a lot of time looking at. We have had a lot of strategic interest, not saying that there's anything imminent or that we're going to go ahead and out-license the program, but there's a lot of flexibility when you have a lot of interest from folks. And I think there is a growing consensus that this is probably a best-in-class molecule, and I think that gives us a lot of degrees of freedom. And so we'll continue to look at different ways to fund it, and we'll be prudent in doing it over time. Mike, maybe if you want to address the other part of the question?

Michael Glen Kauffman

Sure, Dan. Thanks for the question. We're not giving specific guidance on patient numbers or refill rate yet since we're still early in the launch. But I can certainly give some color about the prescribers and some other factors. So we've continued to grow the number of new prescribers through February. There have been nearly 300 total new prescribers. Month over month, our field team is making some really good headway with our top accounts. Our top institutions include both academic and community centers and around 75% of these organizations have either introduced or adopted the CO-PACK reflecting growing penetration across the providers. The split of prescriptions remains roughly 60-40 between GynOncs and MedOncs, which is consistent with our previous reports. More than half the prescriptions are coming from the academic center. We expect that split to be consistent with the community over time. And importantly, as we talked about our Verastem Cares program, has continued to perform incredibly well with short times for reimbursement and fills between 12 to 14 days and about 60% of our commercially eligible patients are using our co-pay program.

Operator

The next question comes from the line of Leonid Timashev with RBC Capital Markets.

Leonid Timashev

I want to ask on 7375's safety. Just to ask you guys to elaborate a little bit more on that. I've got three questions, but hopefully, they're all related. I guess the new cut of data looked quite encouraging, but I was just trying to better understand how much we can lean on that versus what we saw coming out of China. I guess if you have any insights into what might be different across those two populations to lead to such a different safety profile. And then if you could also remind us on the kinetics of when some of these events might occur, particularly via the heme events or the liver signals just given that these patients have been followed for just -- only about 1.6 months, I think, it said. And then lastly, I know you guys were also working at some point on some potential formulation improvements that you were going to effect later on. I'm just curious how much further those could potentially improve some of the GI tolerability?

Daniel Paterson

Michael, do you want to address those questions?

Michael Glen Kauffman

Sure. The data that we provided to you that are all in the database and cleaned and all that, pretty clean, they're not completely clean, but they're representative for sure. and they're very consistent with what we're hearing ongoing now even -- these data were with a date cut off more than a month ago. So I think we've not heard of anything new and the drug is behaving very well, including at the higher dose of 900 milligrams. The cadence of these side effects are pretty straightforward. The nausea and diarrhea and vomiting, as you know, are all pretty fast, and we've really taken them down to pretty much Grade 1 and a lot of the Grade 1 goes away over the first week or two with the proper use of antinausea agents like standard Zofran or palonosetron or one of the other 5-HT3 agents. And sometimes, patients which is typical of any drug if they don't have complete cessation of nausea. I mean, nobody wants to have any nausea, then we'll -- the docs will add a second agent and really cleans it up. So those issues have been largely dealt with diarrhea is we don't prophylax against it, but we absolutely come in and the docs have been requested to come in very quickly with over-the-counter drugs to counter that, and it's very easy to get under control. We don't expect to see much in the way of emergent heme tox. We've not seen it. We have similar entry criteria to what they required in China to get onto the trial. So I don't think this is a baseline bone marrow, I should say, baseline to cell count issue. It's probably a health of the bone marrow issue. I suspect that we're using a lot more growth factors here in America than they do in China. And so when the patients who all got chemotherapy at least once and usually multiple times coming on to our trial are probably having better bone marrow support coming in. I suspect that's the major reason. I don't expect to see much in the way of liver function abnormalities. We haven't seen that. We are aware, and I think probably everybody is aware that patients in China tend to use a lot of natural products and a very inconsistent quality that have all kinds of liver abnormalities as well as other abnormalities associated with them. And we've really tried to make sure that our patients here tell their docs about any organic or general nutrition center kind of supplements they're using and really to limit all of that. So I don't know if that's the reason we're not seeing the liver signals, but we're really very comfortable with how this drug is behaving. Lastly, as far as formulation is concerned, we are looking into whether something like enteric coating could be helpful here or not. It's really important for us to get -- obviously figure out which dose we're going to use. And my gut feel is we're going to end up at the 900, but that's just a, no pun intended, my gut feel. Once we figure out the dose and we understand better the side effect profile in the setting of standard antinausea agents, we'll be able to make some decisions on formulation. But I think there is some room for a formulation to help things.

Operator

The next question comes from the line of Yuan Zhi with B.Riley Securities.

Yuan Zhi

Can you expand on the impact of this protocol update on your clinical development? What's the real impact or change there? Was it narrowed patient enrollment criteria or fewer doses to be tested there?

Daniel Paterson

Thanks for the question. I I'll let Michael elaborate, but it's essentially an administrative change where we're just breaking out into separate protocols and working to streamline things to get the new protocols in place at our current institutions. Anything more you want to say, Michael?

Michael Glen Kauffman

No, that's -- I don't think there's going to be a significant time line hit. We're going to be going -- we'll be sending the protocols in with a cover letter that basically explains is, as Dan said, this is administrative, there's no new safety change. There's no informed consent change. It's just a different protocol basically so that each of these can go to the proper part of the FDA.

Yuan Zhi

Got it. On the dose selection part, do you see a possibility to do maybe a [ titration ] meaning starting at 900 or 1200 milligrams and then using 600-milligram as maintenance dose if needed?

Daniel Paterson

Michael, do you want to address that?

Michael Crowther

Sure. Look, it's -- one thing we've learned about most cancer therapies, not all, but most, over the years is that starting high and blasting the tumor because it's really a vicious war, getting it under control and shrinking it. And as you suggest, which is sort of an induction, if you will, followed by maintenance is probably okay. Honestly, we have any reason to believe yet that we're going to need to lower the dose. It's fairly early with our U.S. experience. And I'll remind folks that in China, they were not able to get to 900 milligrams. So we have a number of patients ongoing now with 900 milligrams over many, many weeks and there doesn't seem to be a major issue. That said, of course, there will be time for patients to reduce their dose. But I'm not sure it doesn't seem like it at this point that we're going to need to reduce the dose.

Operator

[Operator Instructions] And we'll take our last question. It comes from the line of James Molloy with AGP, Alliance Global Partners.

Matthew Venezia

Matt on for Jim today. Congrats again on the continued progress. So firstly, I wanted to ask about the RAMP 201J trial. The updated data look positive to us. But can you just take us through the next steps in Japan for the [ A+D ] combo?

Daniel Paterson

Sure. There's a couple of things going on in parallel. One is all of the institutions that participated in the 201J study have now been converted over to the confirmatory study. Although we've completed accrual in the rest of the world, we do want to have enough Japanese patients on there so that we can have final approval in Japan. But the intent is to meet with the PMDA and discuss using the bridging study for conditional approval. And steps are underway for that right now. And I think we've guided that we'll probably file early next year when we have enough follow-up.

Matthew Venezia

Got it. And then in terms of the U.S. launch, is there any specific insight into the payer coverage of KRAS wild-type patients? Do you have any number or like ballpark of how many of these cases have been covered since launch?

Daniel Paterson

We don't have specific numbers on the number of cases. What I will say is our most common group of patients are of the KRAS mutant. The second biggest group is KRAS unspecified. We're seeing a lot of prior [ auths ] put in, where they're not putting the status, and those seems to be going through pretty smoothly. And then the third group is the KRAS wild type, where we've said a number of times, we're having really good success getting those paid for too. And I think it's an indication of the high unmet need. And then if you look at the totality of the data in the publications that we use and submit to the payers, these patients do appear to be benefiting where we have gotten some tightening in the last quarter or so is what I would call the totally off-label. So brain, lung, PDAC, we have seen a little pushback from payers on those. And that's not to be unexpected. I think in the early days, you sometimes get a bit of a honeymoon period. And in PDAC, we're talking the data set of 12 patients. And then in -- some of these other diseases that it was slipping through really not a lot of support. And so we're very pleased with what we're seeing to date. I think our specialty pharmacy and our hub are doing a great job, and we're hoping to see that continue.

Operator

That concludes the question-and-answer session. Thank you all for joining in. You may now disconnect. Everyone, have a great day.

Investor releaseQuarter not tagged2026-02-18

Verastem Oncology to Report Fourth Quarter and Full Year 2025 Financial Results on March 4, 2026

Business Wire

BOSTON, February 18, 2026--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the Company will host a conference call and webcast to discuss its fourth quarter and full year 2025 financial results and business updates on Wednesday, March 4, 2026, at 4:30 pm ET. To access the conference call, please dial (888) 596-4144 (U.S.) or (646) 968-2525 (international) and enter the passcode 7321921 at least 10 minutes prior to the event start time. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website, https://investor.verastem.com/events. A replay of the webcast will be archived and available following the event. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20260218134565/en/ Contacts For Investor and Media Inquiries: Julissa Viana Vice President, Corporate Communications, Investor Relations & Patient Advocacy [email protected] or [email protected]

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook