On May 14, 2015 Heat Biologics reported its financial results for the first quarter ended March 31, 2015.
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First Quarter 2015 Highlights & Recent Developments
· Presented positive immunological data on HS-410 (vesigenurtacel-L) in non-muscle-invasive bladder cancer (NMIBC)
o At the 7th Annual Phacilitate Immunotherapy Forum, data were presented showing a strong immune response, that correlated with a clinical response, in a HS-410 treated patient, supporting the mechanism of action of ImPACT therapy
o At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, provided an update on immune responder and non-responder phenotypes from the phase I clinical trial of HS-410 in NMIBC.
· Received US FDA "Fast-Track" designation for HS-410 in combination with BCG for the treatment of non-muscle invasive bladder cancer
· Presented preclinical data on a novel approach to combination immunotherapy at the Keystone Symposia on Tumor Immunology
o Data presented demonstrate strategy for vaccine and co-stimulation in a single-cell based product
· Announced collaboration with OncoSec Medical to evaluate
combination immunotherapy platforms
· Announced initiation of a new Phase 1b trial of Viagenpumatucel-L (HS-110) in non-small cell lung cancer (NSCLC)
oTrial will explore combination of HS-110 with various immune checkpoint agents
· Raised net proceeds of approximately $11.1 million in an underwritten public offering
"We are pleased to report continued positive momentum with our lead clinical programs in NMIBC and NSCLC," said Jeff Wolf, Heat’s CEO. "We look forward to achieving several additional clinical milestones this year, including interim immune response data from the ongoing Phase 2 trial in NSCLC and completion of enrollment in the Phase 2 trial in NMIBC. The successful public financing we completed in March of this year puts us in a stronger financial position to execute on our development activities."
Quarter Ended March 31, 2015 vs. Quarter Ended March 31, 2014
Research and development expenses for the first quarter of 2015 decreased 6% compared to the first quarter of 2014. Clinical and regulatory expenses were $2.2 million compared to $0.8 million for the first quarter of 2014. The increase was attributable to increases in clinical trial execution costs, increased investigator payments, and other costs related to the manufacturing of vaccines for clinical trials.
General and administrative expenses for the quarter were $1.3 million compared to $1.0 million for the first quarter of 2014. The increase from the first quarter of 2014 was attributable to increases related to professional services, personnel costs as well as an increase in non-cash stock compensation.
Net loss attributable to common stockholders was $3.9 million, or ($0.57) per basic and diluted share for the first quarter of 2015. This compares to a net loss of $2.3 million, or ($0.36) per basic and diluted share for the first quarter of 2014.
As of March 31, 2015, the Company had approximately $21.1 million in cash, cash equivalents, and short-term investments. This balance includes the $11.1 million net proceeds from the March 2015 offering and subsequent over-allotment option.