VSTM Gains FDA Accelerated Approval; At-The-Market $100M Offer
Verastem is a biopharmaceutical company that markets AVMAPKI FAKZYNJA CO-PACK (avutometinib; defactinib) in the U.S. and focuses on small molecules targeting RAS/MAPK-driven cancers. On May 8, 2025 the FDA granted accelerated approval for AVMAPKI FAKZYNJA CO-PACK for adult patients with KRAS mutant recurrent low grade serous ovarian cancer after prior systemic therapy; continued approval may be contingent on a confirmatory trial. The company holds multiple orphan drug designations for avutometinib and defactinib and plans discussions with global regulators.
Verastem filed a shelf registration to sell up to $300.0 million of various securities and an at-the-market prospectus supplement to sell up to $100.0 million of common stock through Cantor Fitzgerald & Co. The company lists on Nasdaq under VSTM (last reported sale $7.70 on August 11, 2025). As of June 30, 2025, there were 61,523,425 shares outstanding and material outstanding options and warrants that could dilute equity. Stated uses of proceeds include commercial launch, clinical development, working capital and potential acquisitions. The prospectus emphasizes a high degree of risk and contains forward-looking statements, including a note regarding ability to continue as a going concern within one year of the June 30, 2025 financial statements.
Positive
- FDA accelerated approval granted on May 8, 2025 for AVMAPKI FAKZYNJA CO-PACK for KRAS mutant recurrent LGSOC, enabling U.S. commercialization under the accelerated pathway.
- Orphan drug designations for avutometinib (alone or with defactinib) and for defactinib in ovarian cancer across the U.S., EU and Australia, supporting regulatory and market incentives.
- Financing flexibility: Shelf registration up to $300,000,000 and an at-the-market program up to $100,000,000 give the company multiple paths to raise capital for launch and development.
Negative
- The FDA approval is an accelerated approval contingent on verification in a confirmatory trial, so continued approval and commercial value depend on future trial results.
- The at-the-market program and shelf offering create potential equity dilution; the ATM may sell up to $100,000,000 of common stock through Cantor Fitzgerald & Co.
- The company has material outstanding dilutive instruments explicitly disclosed: 14,129,169 warrants at $3.50, 2,945,631 stock options, and multiple pre-funded warrants and reserved shares, which could significantly dilute existing holders if exercised or issued.
- The prospectus highlights forward-looking risks including uncertainty about cash sufficiency (referencing ability to continue as a going concern through one year from the June 30, 2025 financials).
Insights
TL;DR: FDA accelerated approval opens U.S. commercialization but sales and confirmatory-trial outcomes will determine durable value.
The FDAs accelerated approval of AVMAPKI FAKZYNJA CO-PACK for KRAS-mutant recurrent LGSOC is a material regulatory milestone explicitly tied to tumor response and duration of response. This creates a near-term commercial opportunity in a rare indication backed by multiple orphan designations, and the company has stated intent to pursue launches and regulatory discussions in other regions. However, the approval is conditional: continued approval may depend on a confirmatory trial. The prospectuss disclosure that net proceeds may fund commercial launch and clinical programs shows management plans to capitalize on approval, but success will hinge on market uptake, reimbursement and positive confirmatory data, all of which are called out as key uncertainties in the filing.
TL;DR: The $300M shelf and $100M ATM increase financing flexibility but pose dilution risk given current outstanding derivatives.
The registration provides broad funding optionality: a shelf of up to $300 million across securities and a contemporaneous at-the-market program up to $100 million with Cantor (up to 3% commission). These facilities are standard for biotech companies post-approval to fund launch and development, but the filing explicitly lists significant outstanding dilutive instruments: stock options, RSUs and >14 million warrants exercisable at $3.50 plus multiple pre-funded warrants. The prospectus quantifies outstanding common shares (61,523,425 as of June 30, 2025) and specific equity instruments, which investors should use to model potential dilution and financing runway. The filing also highlights risk factors and forward-looking uncertainties, including cash sufficiency concerns referenced in the forward-looking statements.
SECURITIES AND EXCHANGE COMMISSION
to
UNDER
THE SECURITIES ACT OF 1933
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Delaware
(State or other jurisdiction
of incorporation or organization) |
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27-3269467
(I.R.S Employer
Identification No.) |
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Needham, Massachusetts 02494
(781)292-4200
Chief Executive Officer
Verastem, Inc.
117 Kendrick Street, Suite 500
Needham, Massachusetts 02494
(781)292-4200
Thomas Danielski
Ropes & Gray LLP
Prudential Tower
800 Boylston St.
Boston, Massachusetts 02199
(617) 951-7000
(Approximate date of commencement of proposed sale to the public)
Preferred Stock
Warrants
Debt Securities
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ABOUT THIS PROSPECTUS
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ABOUT THE COMPANY
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RISK FACTORS
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FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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DESCRIPTION OF COMMON STOCK
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DESCRIPTION OF PREFERRED STOCK
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF DEBT SECURITIES
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
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LEGAL MATTERS
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EXPERTS
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Verastem, Inc.
117 Kendrick Street, Suite 500
Needham, Massachusetts 02494
(781) 292-4279
email address: investors@verastem.com
Common Stock
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ABOUT THIS PROSPECTUS SUPPLEMENT
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PROSPECTUS SUPPLEMENT SUMMARY
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THE OFFERING
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RISK FACTORS
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FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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DESCRIPTION OF COMMON STOCK
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
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Verastem, Inc.
117 Kendrick Street, Suite 500
Needham, Massachusetts 02494
(781) 292-4279
email address: investors@verastem.com
Common Stock
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Securities and Exchange Commission registration fee
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Printing and engraving expenses
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Legal fees and expenses
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Accounting fees and expenses
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Transfer Agent and Registrar fees
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Trustee’s fees and expenses
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Miscellaneous
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Total
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Exhibit
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Description
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| | 1.1 | | | Form of Underwriting Agreement* | |
| | 1.2 | | | Sales Agreement, dated August 8, 2025, by and between the Company and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 1.2 to the Registration Statement on Form S-3 filed by the Registrant with the Securities and Exchange Commission on August 8, 2025) | |
| | 3.1 | | | Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on March 12, 2019) | |
| | 3.2 | | | Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.2 to the Annual Report on Form 10-K filed by the Registrant on March 12, 2019) | |
| | 3.3 | | | Certificate of Amendment to the Restated Certificate of Incorporation of Verastem, Inc. (incorporated by reference to Exhibit 3.1 to the Form 8-K filed by the Registrant with the SEC on May 21, 2020) | |
| | 3.4 | | | Certificate of Amendment to Restated Certificate of Incorporation of Verastem, Inc. (incorporated by reference to Exhibit 3.1 to the Form 8-K filed by the Registrant with the SEC on May 31, 2023) | |
| | 3.5 | | | Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.4 to Amendment No. 3 to the Registration Statement on Form S-1 as filed with the SEC on January 13, 2012) | |
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Exhibit
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Description
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| | 3.6 | | | Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Form 8-K filed by the Registrant with the SEC on November 7, 2022) | |
| | 3.7 | | | Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Form 8-K filed by the Registrant with the SEC on January 25, 2023) | |
| | 4.1 | | | Specimen certificate evidencing shares of common stock (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Registration Statement on Form S-1 as filed with the SEC on January 13, 2012) | |
| | 4.2 | | |
Description of Securities (incorporated by reference to Exhibit 4.2 to the Annual Report on Form 10-K filed by the Registrant on March 20, 2025)
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| | 4.3 | | | Form of Pre-Funded Warrant to Purchase Common Stock (incorporated by referenced to Exhibit 10.3 to the Form 8-K filed by the Registrant with the Securities and Exchange Commission on April 25, 2025) | |
| | 4.4 | | | Registration Rights Agreement, dated April 25, 2025, by and among Verastem, Inc. and the investors party thereto (incorporated by reference to Exhibit 10.2 to Form 8-K filed by the Registrant with the Securities and Exchange Commission on April 25, 2025) | |
| | 4.5 | | | Form of Common Stock Warrant Agreement and Warrant Certificate* | |
| | 4.6 | | | Form of Preferred Stock Warrant Agreement and Warrant Certificate* | |
| | 4.7 | | | Form of Debt Securities Warrant Agreement and Warrant Certificate* | |
| | 4.8 | | | Form of Indenture (incorporated by reference to Exhibit 4.8 to the Registration Statement on Form S-3 filed by the Registrant with the Securities and Exchange Commission on August 8, 2025) | |
| | 5.1 | | |
Opinion of Ropes & Gray LLP relating to the base prospectus (filed herewith)
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Opinion of Ropes & Gray LLP relating to the at-the-market offering prospectus supplement (filed herewith)
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Consent of Ropes & Gray LLP (included in Exhibit 5.1)
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Consent of Ropes & Gray LLP (included in Exhibit 5.2)
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Consent of Ernst & Young LLP (filed herewith)
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| | 23.4 | | | Power of Attorney (incorporated by reference to the Registration Statement on Form S-3 filed by the Registrant with the Securities and Exchange Commission on August 8, 2025) | |
| | 25.1 | | |
Statement of Eligibility of Trustee Under Debt Indenture (filed herewith)
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| | 107 | | | Filing Fee Table (incorporated by reference to Exhibit 107 to the Registration Statement on Form S-3 filed by the Registrant with the Securities and Exchange Commission on August 8, 2025) | |
President and Chief Executive Officer
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SIGNATURES
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TITLE
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DATE
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/s/ Daniel W. Paterson
Daniel W. Paterson
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President, Chief Executive Officer and Director
(Principal executive officer) |
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August 12, 2025
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/s/ Daniel Calkins
Daniel Calkins
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Chief Financial Officer
(Principal financial and accounting officer) |
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August 12, 2025
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*
Brian M. Stuglik
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| | Director | | |
August 12, 2025
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*
Paul A. Bunn, M.D.
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| | Director | | |
August 12, 2025
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Robert Gagnon
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| | Director | | |
August 12, 2025
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*
John H. Johnson
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August 12, 2025
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*
Anil Kapur
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| | Director | | |
August 12, 2025
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*
Michael Kauffman, M.D., Ph.D.
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| | Director | | |
August 12, 2025
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*
Michelle Robertson
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| | Director | | |
August 12, 2025
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SIGNATURES
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TITLE
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DATE
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*
Eric Rowinsky, M.D.
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| | Director | | |
August 12, 2025
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Karin Tollefson
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| | Director | | |
August 12, 2025
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*By:
/s/ Daniel W. Paterson
Daniel W. Paterson,
Attorney-in-Fact |
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