Verastem
VSTM
conference date: March 13, 2018
for quarter ending: December 31, 2017 (Q4, fourth quarter 2017)
No conference was held, this is a summary of the press release. Verastem did make a live presentation at the Roth Conference on March 12.
Forward-looking
statements
Overview: Clincal stage company may be going commercial if FDA approves duvelisib for CLL.
Basic data (GAAP):
There was no revenue.
The net loss for the full year 2017 was $67.8 million or $1.76 per share.
Guidance:
Cash is sufficient to last into the second half of 2018.
Conference Highlights:
Robert Forrester, CEO of Verastem. "The last year has been marked by significant achievement for Verastem with the reporting of positive data from the pivotal Phase 3 DUO study and culminating in the recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking full approval for duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). As we await the potential acceptance and approval of the duvelisib NDA, we are diligently working to build our commercial infrastructure and preparing for our first potential product launch."
In February an NDA was submitted to the FDA for duvelisib, a P13K inhibitor, for treatment of relapsed or refractory CLL/SLL, and for accelerated approval for relapsed or refractory FL. The supporting Phase 3 study met its primary endpoint and had a manageable safety profile. The data had been presented at ASH.
Defactinib preclinical data was also presented at ASH for AML.
In December Verastem raised $25 million with a public stock offering. In January the loan facility was increased from $25 million to $50 million. In October a $6 million milestone payment was made to Infinity Pharmaceucals for the duvlelisib license.
Cash and equivalents ended Q4 at $86.7 million.
Full year 2017 R&D expense was $46.4 million. G&A was $21.4 million. Total operating expense was $67.8 million.
Q&A:
none
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