Is the 30% overall response rate and six months durability still the right framing for FDA accelerated approval for VS-7375 across indications, considering the competitive landscape?

30% ORR with six months durability is a very good guidepost for accelerated approval, noting recent approvals with lower response rates. Tolerability is also a critical factor, and VS-7375's favorable profile is a key differentiator. “30% is a great metric in this disease. Six months is also terrific. And I would remind you, we all know that 35% is the second line response rate that we're all looking for, but 30% is very good.”

To what extent was the strong COPAQ revenue growth driven by new patient starts versus improved duration of therapy?

The growth was driven by a combination of both new patient starts and improved duration of therapy. There was a meaningful increase in new prescribers and accounts, consistent new patient starts, and improved refill consistency due to focused execution. “What we saw in Q2 was a bit of both. We saw a meaningful increase in new prescribers and new accounts. And so that has us very encouraged what we're seeing from a new patient start perspective.”

Which segment (new starts, refills, earlier line) is a bigger contributor to COPAQ sales? How does VS-7375 differentiate itself against pan-RAS and other G12D inhibitors?

All three factors (new patient starts, refills, moving up in line of therapy) are critically important and contribute to COPAQ growth. For VS-7375, differentiation against pan-RAS is better efficacy and significantly better tolerability. Against other G12D inhibitors, the goal is deeper and more durable responses due to its PK profile allowing higher target engagement with low toxicity. “Against other G12D inhibitors, we've said we thought we have the best in class based on preclinical data. I would say where we're starting to see that in the data that we're getting clinically and, you know, Hopefully we can show that in October.”

VSTM

Verastem (VSTM) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Verastem, Inc. Q2 FY26 — Strong Commercial Rebound and Pipeline Advancement

Verastem delivered a strong second quarter, marked by a significant commercial rebound for AvMap Gifex India Copac, driven by increased physician confidence and earlier treatment initiation. The company also substantially strengthened its balance sheet through non-dilutive financing and a milestone payment, providing strategic flexibility. Progress in the VS-7375 pipeline, including fast-track designation and initiation of Phase II studies, positions the company for key data readouts and future development.

Highlights

Generated net product revenues of $25.1 million, reflecting continued execution and a meaningful rebound with significant quarter-over-quarter growth.
Strengthened the balance sheet with a non-dilutive royalty financing agreement for up to $75 million, with $50 million expected at closing.
Received a $15 million milestone payment from Securibio for Copictra sales, contributing to $90 million in incremental non-dilutive funding.
Completed target enrollment in the VS-7375 Phase 1-2 Target D-101 study and initiated three Phase II registration-directed studies.
Received FDA fast-track designation for VS-7375 in non-small-cell lung cancer.

Concerns

Competitive landscape in KRAS G12D space
Need for additional capital
Physician learning curve for new therapy (COPAQ)

Guidance & targets

Category	Target	Timeline	Confidence
LGSOC franchise self-sustainability	Self-sustaining high materiality	FY26	High
Capital runway	Sufficient capital to fund operations into the second half of 2027 high materiality	H2 FY27	High
SG&A expenses	Remain roughly the same on a quarterly basis medium materiality	FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
AvMap Gifex India Copac (Product) Commercialization focused on driving new patient demand, expanding earlier use, and helping patients stay on therapy. Seeing encouraging signs that changes are having an impact and physician experience is deepening. Reimbursement is not a challenge. New patient demand: healthy and consistent levelsRefills: healthy and consistent levelsRepeat prescribing: increasing among existing writersDepth of prescribing: greater among existing accountsNew accounts: meaningful addition across academic and community targetsLine of therapy: physicians initiating treatment earlierRefill consistency: suggests patients remaining on therapy longer	$25.1 million	—	significant quarter-over-quarter growth	—

Deals & partnerships

Oberland Capital Non-dilutive royalty financing agreement up to $75 million

Agreement to secure funding, with an initial draw of $50 million expected at closing.

Securibio Milestone payment for Copictra sales $15 million

Payment triggered by cumulative worldwide net sales of Copictra surpassing $200 million during Q2 FY26.

ARASCA Potential collaboration for G12D space

Ongoing discussions about a first study, respective roles, and start date.

Various (unnamed) Exploring options for PRMT5 inhibitors

Exploring all options for PRMT5, including clinical trial partnerships and available agents for in-licensing.

Risks & headwinds

Competitive landscape in KRAS G12D space ongoing

RevMed putting out their G12D data and earlier

Mitigation:Upcoming VS-7375 data in October expected to spur additional interest and differentiate the compound based on efficacy and tolerability.

Need for additional capital beyond H2 FY27

After second half of 2027

Mitigation:Current capital runway extends into H2 2027, allowing the company to reach meaningful value-creating inflection points before needing to access additional capital.

Physician learning curve for new therapy (COPAQ) ongoing

Managing patients and setting expectations around treatment

Mitigation:Field teams are working to ensure prescribers set appropriate expectations and manage adverse events, with focus on limiting time off therapy through support for practices.

What to watch in Q3 FY26

VS-7375 comprehensive data update

October

Current Preliminary Phase 1-2 data showed emerging antitumor activity and favorable tolerability

Target Comprehensive data set including response rates across pancreatic, lung, and colorectal cancers (~20 patients each) and early durability data

Why it matters

This data will be crucial for validating VS-7375's potential as a best-in-class KRAS G12D inhibitor and supporting accelerated approval pathways.

In October, we expect to provide a more comprehensive data set for VS7375, including response rates across our three lead tumor types, pancreatic, lung, and colorectal cancers, with approximately 20 patients in each, as well as an early look at durability.

Find out whether VSTM delivers this. Inve re-checks your case every morning.

Q&A highlights

Can you provide an update on partnership activity for VS-7375 in the G12D space, including ARASCA and PRMT5, and comment on the sustainability of current gross margins?

The company is working on ARASCA partnership details and exploring all options for PRMT5. Inbound interest from strategics is high, and upcoming data will spur more. New funding provides strategic flexibility to avoid rushing into partnerships or equity financing. Gross margins are expected to remain a reasonable run rate, being royalty-based and relatively high.

“The funding that we announced today I think gives us a lot more strategic flexibility to not have to rush into something nor rush into an equity financing at, you know, the current stock price.”

asked by Eric Schmidt · answered by Daniel Paterson

2 min read 5 chapters

Detailed narrative

Commercial Strategy and AvMap Gifex India Copac Performance

Verastem reported net product revenues of $25.1 million for AvMap Gifex India Copac in Q2 FY26, demonstrating a significant quarter-over-quarter rebound. The commercial strategy focuses on driving new patient demand, expanding earlier line use, and improving patient adherence. The company observed healthy and consistent new patient starts and refills, increasing repeat prescribing, and broader adoption across academic and community practices.

Physicians are initiating treatment earlier, aligning with the RAMP201 trial outcomes, and refill consistency has improved, indicating longer patient therapy duration.

VS-7375 Clinical Development and Differentiation

The VS-7375 program, targeting KRAS G12D-driven cancers, showed significant progress. Preliminary Phase 1-2 data from the TARGET-D101 study demonstrated emerging antitumor activity and a favorable tolerability profile. Target enrollment was completed for dose expansion cohorts in pancreatic, colorectal, and non-small-cell lung cancers.

The FDA granted fast-track designation for NSCLC, and all three Phase II registration-directed studies have initiated dosing. Management believes VS-7375 has the potential to be a best-in-class oral K-RAS G12D inhibitor due to its ability to achieve deeper and more durable responses with superior tolerability compared to pan-RAS inhibitors.

Financial Strength and Capital Allocation

Verastem ended Q2 FY26 with $136.4 million in cash, cash equivalents, and investments. This was significantly bolstered by a non-dilutive royalty financing agreement with Oberland Capital for up to $75 million ($50 million expected at closing) and a $15 million milestone payment from Securibio.

The pro forma cash balance, including these funds, stands at $201.4 million. This capital is expected to fund operations into the second half of 2027, allowing the company to reach key value-creating inflection points before needing additional capital. The LGSOC franchise is projected to be self-sustaining by the end of 2026.

Pipeline Outlook and Upcoming Milestones

The company is preparing to initiate three Phase III trials for VS-7375. A comprehensive data update for VS-7375 is expected in October, including response rates across pancreatic, lung, and colorectal cancers (approximately 20 patients each), along with an early look at durability.

Discussions are ongoing for a potential collaboration with ARASCA and exploring options for PRMT5 inhibitors. The strengthened balance sheet provides strategic flexibility for these partnership discussions and future financing opportunities.

Physician Adoption and Patient Management

Physician feedback on AvMap Gifex India Copac has been positive, with tolerability consistent with expectations. The company's field teams are actively supporting prescribers in managing adverse events and setting appropriate patient expectations to maximize treatment benefits. Reimbursement for COPAQ remains unchallenging, ensuring quick patient access to medication.

Efforts like site-specific alerts and peer-to-peer programming are expanding adoption and deepening physician experience across both academic and community settings.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.