Verastem Oncology
VSTM
conference date: May 3, 2018 (press release only)
for quarter ending: March 31, 2018 (Q1, first quarter 2018)
No conference was held, this is a summary of the press release.
Forward-looking
statements
Overview: Clincal stage company may be going commercial if FDA approves duvelisib for CLL.
Basic data (GAAP):
There was no revenue.
Net income was negative $21.1 million, down from negative $13.0 million year-earlier.
EPS, diluted, was negative $0.41, down from negative $0.35 year-earlier.
Guidance:
Cash is sufficient to last into 2019.
Conference Highlights:
Robert Forrester, CEO of Verastem. "We’ve had a strong start to 2018, highlighted foremost by the acceptance of our duvelisib New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA), including the receipt of Priority Review with an assigned target action date of October 5, 2018."
In February an NDA was submitted to the FDA for duvelisib, a P13K inhibitor, for treatment of relapsed or refractory CLL/SLL and FL, 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.
Buildout of the commercial team for duvelisib is led by Joseph Lobaki, former CCO of Medivation.
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 at $64.2 million, down sequentially from $86.7 million. In Q2 sold shares ATM to generate an additional $21.9 million. Verastem has a $50.0 million line of credit available.
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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