On November 15, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2018 (Press release, Heat Biologics, NOV 15, 2018, View Source [SID1234531356]).

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Jeff Wolf, Heat’s CEO, commented, "We continue to advance our Phase 2 trial investigating our lead candidate HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC). We intend to announce updates regarding interim Phase 2 data in the fourth quarter of 2018 and plan to complete patient enrollment in Q2 2019. Given the positive interim results we reported earlier this year, which included durable responses to HS-110 in difficult-to-treat low TIL and low PD-L1 patients, we have seen increased interest from within the industry for improving outcomes for those patients least likely to respond to checkpoint inhibitors alone.

"We have completed a Pre-IND Type B meeting with FDA for our next-generation ComPACT product and plan to file our Phase 1 Investigational New Drug (IND) in the first quarter of 2019. Our ComPACT therapy combines T-cell activation and co-stimulation within a single treatment, simplifying combination immunotherapy while potentially providing superior immune activation at reduced treatment costs.

"Finally, we are also on track to submit an IND for PTX-35, our novel co-stimulatory antibody designed to harness the body’s natural antigen-specific immune activation mechanisms, in the first quarter of 2019. We are encouraged by the preliminary pre-clinical efficacy and safety data which shows a positive toxicity profile across a wide range of doses.

"Importantly, we ended the quarter with a strong cash balance of $21.0 million and expect to receive an additional $6.9 million in CPRIT grant funds for PTX-35 within the next few months. Combined, these funds should provide us with sufficient capital to significantly advance our clinical programs through a number of key milestones, including completion of our Phase 2 trial of HS-110, which holds the potential to drive significant value for shareholders."

Third Quarter 2018 Financial Results

Recognized $1.8 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased approximately 144.4% to $4.4 million for the three months ended September 30, 2018 compared to $1.8 million for the three months ended September 30, 2017.
General and administrative expense increased approximately 33.3% to $1.6 million for the three months ended September 30, 2018 compared to $1.2 million for the three months ended September 30, 2017. The $0.4 million increase consists of professional services/consulting fees associated with our 2018 Annual Meeting of Shareholders as well as an increase in investor relations and new business development fees during the three months ended September 30, 2018.
Net loss attributable to Heat Biologics was $3.7 million, or ($0.16) per basic and diluted share for the three months ended September 30, 2018 compared to a net loss of $2.3 million, or ($0.64) per basic and diluted share for the three months ended September 30, 2017.
As of September 30, 2018, the Company had approximately $21.0 million in cash and cash equivalents.