What Verastem, Inc. told the SEC could break it.

Verastem sells its newly approved AVMAPKI FAKZYNJA CO-PACK to a limited number of U.S. specialty pharmacies and specialty distributors, and for 2025 two customers each individually accounted for more than 10% of total revenue ($27.4 million combined); in 2024 a single customer (Secura) was essentially all revenue. This narrow distribution channel concentrates credit and demand risk, so loss or reduced ordering by one of these few intermediaries would materially affect revenue.

“For the year ended December 31, 2025, there were two customers who each individually accounted for greater than 10% of the Company's total revenues, for a total of $ 27.4 million.”

Verastem expects continued operating losses as it launches its first product, and it carries secured debt: its obligations under the Note Purchase Agreement (and prior Oxford loan) are secured by a security interest on substantially all of its and its subsidiaries' assets, including the intellectual property for avutometinib and defactinib (plus a negative pledge on GenFleet-collaboration IP), and the debt restricts dividends, stock repurchases and investments; it had ~$205.0M cash at year-end and has relied on repeated equity raises (a November 2025 offering, Series B preferred, ATM programs), creating dilution and refinancing/covenant risk.

“Our obligations under the Note Purchase Agreement are secured by a security interest on substantially all of our and our subsidiaries' assets, including our intellectual property related to avutometinib and defactinib”

Verastem depends on FDA and foreign regulatory approvals that are not guaranteed and do not transfer across jurisdictions, and faces specific uncertainty over whether the FDA will accept data from clinical trials conducted outside the U.S. — including GenFleet's Phase 1/2 VS-7375 trial in China — as applicable to U.S. patients and practice; its commercial product is also subject to Medicare Part B/D coverage and out-of-pocket-cap dynamics, Inflation Reduction Act inflation-rebate and price-negotiation provisions, and discounted Federal Supply Schedule pricing, all of which affect realized pricing and reimbursement.

“we and our collaboration partners are currently conducting clinical trials, and may in the future conduct additional clinical trials, outside the U.S., including the Phase 1/2 clinical trial evaluating VS-7375 by GenFleet in China. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to conditions imposed by the FDA.”

Verastem has no manufacturing capacity and obtains all of its AVMAPKI FAKZYNJA CO-PACK commercial supply and its product-candidate clinical/commercial supply from third-party manufacturers or collaborators, and relies on third parties for various formulation development and on CROs and clinical sites to conduct all of its trials; this dependence creates risk of inadequate or untimely supply, quality failures or loss of a manufacturer that could disrupt commercialization and delay development.

“obtain all of our AVMAPKI FAKZYNJA CO-PACK commercial supply and supply of our product candidates for clinical development and commercial requirements from third-party manufacturers or third-party collaborators, and we expect to continue to rely on third parties for the manufacture of clinical and commercial quantities of our product candidates.”