On November 13, 2017 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2017 (Press release, Heat Biologics, NOV 13, 2017, View Source [SID1234521963]).
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"We had a very productive third quarter, as we achieved a number of important milestones," said Jeff Wolf, CEO of Heat. "We signed a critical manufacturing agreement to further advance our co-stimulatory programs, and we were also granted a Type C meeting with the FDA to review our Phase 2 clinical trial using our HS-110 for the treatment for non-small cell lung cancer."
Results for the third quarter of 2017 are summarized below.
Third Quarter 2017 Financial Highlights
Research and development expenses increased eight percent, to approximately $1.8 million, for the quarter ended September 30, 2017, compared to Q3 2016. The HS-110 program expense increased $0.4 million primarily due to Chemistry, Manufacturing and Control (CMC) activities, as well as continued patient enrollment for our HS-110 Phase 2, multi-arm trial for non-small cell lung cancer (NSCLC). R&D expenses related to the HS-410 Phase 2 trial decreased $0.4 million, as currently enrolled patients are now in long-term follow-up for recurrence-free survival. Additional R&D pre-clinical costs were associated with our Zika program, Pelican Therapeutics, Inc. ("Pelican") T-cell co-stimulatory programs, and laboratory supplies. Unallocated expenses included personnel-related expenses, professional and consulting fees, travel, and other costs. These costs increased approximately $0.1 million, primarily related to an increase in consultant fees and travel, offset by a decrease in personnel costs.
General and administrative expenses increased 45 percent, to $1.2 million, for the quarter ended September 30, 2017, compared to $0.8 million for the quarter ended September 30, 2016. The $0.4 million increase was primarily attributable to the increase in personnel costs as we establish Texas operations for our Pelican Therapeutics subsidiary.
Net loss attributable to Heat for the third quarter of 2017 was $2.3 million ($0.06) per basic and diluted share for the third quarter; compared to a net loss of $1.6 million, or ($0.08) per basic and diluted share for the quarter ended September 30, 2016.
Cash and cash equivalents totaled approximately $4.3 million, as of September 30, 2017. This amount does not include an additional $6.5 million of CPRIT funds received October 3, 2017.
Third Quarter 2017 Corporate Highlights
Heat’s subsidiary, Pelican Therapeutics, entered into a manufacturing agreement with KBI Biopharma, Inc. to advance its cancer-targeting immunotherapies. Under the agreement, KBI will offer comprehensive development and manufacturing services for cGMP production of Pelican’s PTX-35 antibody and PTX-15 fusion protein.
Heat was granted a Type C meeting with the FDA to discuss its registrational pathway and development plan for its NSCLC trial with HS-110 in combination with Bristol Myers-Squibb’s nivolumab (Opdivo).
Heat expanded its leadership team with two new hires: Lori McDermott, VP of Clinical Development; and Gary Vinson, VP of CMC.