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Jun 30, 2020
Verastem Q2 2020 Earnings Report
Verastem Oncology announced the sale of COPIKTRA® rights to Secura Bio and a focus on development of VS-6766 and Defactinib.
Key Takeaways
Verastem Oncology entered into a definitive agreement to sell its global commercial and development rights to COPIKTRA to Secura Bio for $70 million up-front, with a total deal value up to $311 million plus royalties. Verastem will focus on developing VS-6766 and Defactinib in KRAS mutant solid tumors, with current programs funded until at least 2024.
Verastem will receive $70 million up-front with a total deal value up to $311 million from Secura Bio.
Verastem will focus on the development of VS-6766 and Defactinib in KRAS mutant solid tumors.
Phase 2 registration-directed trials are expected to commence by year end 2020 in low-grade serous ovarian cancer and KRAS mutant non-small cell lung cancer.
Enrollment in the ongoing investigator-initiated Phase 1/2 FRAME study of VS-6766 and Defactinib is expanding to include pancreatic, KRAS mutant endometrial and KRAS-G12V non-small cell lung cancer cohorts.
Verastem
Verastem
Forward Guidance
Verastem Oncology provides forward-looking statements about its strategy, future plans, and prospects, including the expected sale of COPIKTRA and the potential clinical value of RAF/MEK/FAK combination.
Positive Outlook
- The transaction with Secura Bio is expected to close in the third quarter of 2020.
- The FDA was supportive of the Company’s development strategy and adaptive design for LGSOC.
- Verastem expects to commence registration-directed clinical trials for potential accelerated approval in LGSOC and KRASmt NSCLC by the end of 2020.
- The FRAME study is expanding in August 2020 to include new cohorts in pancreatic, KRASmt endometrial and KRAS-G12V NSCLC.
- With the sale of COPIKTRA, Verastem will become a focused development company with reduced annual expenses of approximately $50 million and is in a position of financial strength with a cash runway expected to fund the clinical and regulatory milestones and development of VS-6766 and defactinib in LGSOC and KRASmt NSCLC until at least 2024.
Challenges Ahead
- The satisfaction of closing conditions with respect to the sale of the COPIKTRA assets to Secura Bio.
- The ability of Secura Bio to achieve the clinical and sales milestones necessary to result in additional consideration payable to Verastem.
- The inherent uncertainty in forecasting expected funding needs of the Company in advancing its product candidates.
- The success in the development and potential commercialization of product candidates, including defactinib in combination with VS-6766.
- The occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis or result in unmanageable safety profiles compared to their levels of efficacy.