On March 28, 2019 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 fourth quarter and year ended December 31, 2018 (Press release, Heat Biologics, MAR 28, 2019, View Source [SID1234534693]).

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Jeff Wolf, Heat’s CEO, commented, "We are making excellent progress advancing HS-110 and recently reported interim Phase 2 non-small cell lung cancer (NSCLC) data on HS-110 plus nivolumab at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. Importantly, we observed a survival benefit in patients with low CD8+ "cold" tumors at baseline compared to high CD8+ patients. This Cohort B data was especially encouraging, as all of the enrolled patients had previously experienced disease progression while receiving an immune checkpoint inhibitor. Preliminary data suggest the addition of HS-110 to Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab), may restore responsiveness to treatment after tumor progression on prior checkpoint inhibitor therapy. We believe we are the first company to present clinical data in advanced NSCLC with patients whose prior checkpoint inhibitor treatment has failed. The results have generated significant interest within the industry and oncology community."

"We also expanded our Phase 2 trial to dose patients with HS-110 in combination with Merck’s anti-PD1 checkpoint inhibitor, KEYTRUDA (pembrolizumab) with or without ALIMTA (pemetrexed), in patients receiving front-line maintenance therapy for advanced NSCLC."

"We look forward to filing our Phase 1 Investigational New Drug (IND) for our next-generation therapy (HS-130) in the first half of 2019. HS-130 in combination with HS-110 combines T-cell activation and co-stimulation, potentially providing superior immune activation at reduced treatment costs. Further, we also plan to submit an IND for a CPRIT-funded 70 patient Phase 1 clinical program of PTX-35 in the first half of 2019. PTX-35 is our novel co-stimulatory antibody designed to harness the body’s natural antigen-specific T cell immune activation mechanisms. We remain encouraged by the preliminary pre-clinical efficacy and safety data, which show a lack of adverse effects across a wide range of doses."

"We ended 2018 with approximately $28 million of cash, cash equivalents and short-term investments. We also are on track to receive an additional $6.9 million in Cancer Prevention Research Institute of Texas (CPRIT) grant funds for PTX-35 in the coming months. As a result, we believe we are well funded beyond completion of our Phase 2 HS-110 trial. As previously disclosed, we have been efficient in our use of funds, which has allowed us to operate under budget, further extending our runway on primarily clinical development programs."

Full Year 2018 Financial Results

Recognized $5.8 million of grant revenue for qualified expenditures under the CPRIT grant.

Research and development expenses were $16.2 million for the year ended December 31, 2018 compared to $8.3 million for the year ended December 31, 2017. The increase was primarily due to the increase enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial as well as the PTX expense as we continue pre-clinical development of the PTX-35 program.

General and administrative expenses were $7.0 million for the year ended December 31, 2018 compared to $6.4 million for the year ended December 31, 2017.

Net loss attributable to Heat Biologics was $15.7 million, or ($0.90) per basic and diluted share for the year ended December 31, 2018 compared to a net loss of $11.8 million, or ($3.08) per basic and diluted share for the year ended December 31, 2017.

As of December 31, 2018, the Company had approximately $28 million in cash, cash equivalents and short term investments.