On May 15, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the first quarter ended March 31, 2018 (Press release, Heat Biologics, MAY 15, 2018, View Source [SID1234526617]).

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”We had an eventful first quarter, with a number of positive clinical developments,” said Jeff Wolf, CEO of Heat. ”Most notably, we announced positive interim results from our Phase 2 study investigating 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) whose cancers had progressed after treatment with one or more lines of therapy. These data are especially encouraging in patients with low levels of TIL and PD-L1, who are among the most difficult-to-treat patients. Importantly, we believe the data are consistent with the mechanism of action of our T-cell Activation Platform, which has been shown to promote a robust T-cell immune response. We believe the ability of our platform to convert ”cold tumors” to ”hot tumors” will be an important component in effective immunotherapy combinations against cancer.”

”Given the strength of our recent data, we recently completed a capital raise for gross proceeds of $20.7 million. Consequently, Heat should have sufficient capital to accomplish the following key objectives over the next 5 quarters: 1) complete enrollment in our Phase 2 trial for HS-110 in NSCLC, 2) begin patient enrollment for our ComPact platform, 3) undertake our Phase I study with our first-in-class T cell costimulator antibody, PTX-35, and 4) report preliminary data for each of these trials.”

First Quarter 2018 Corporate Highlights

On March 26, 2018, the Company reported 2-year recurrence rate data from the Phase 2 trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC); achieved 100% (10 out of 10) disease free survival rate over 2 years in the subgroup of patients that generated a positive immune response to low-dose HS-410 and BCG.
On March 19, 2018, the Company announced the appointment of Anthony Tolcher, M.D., FRCPC, FACP, to the scientific advisory boards of Heat Biologics and its subsidiary, Pelican Therapeutics.
On March 12, 2018, the Board of Directors adopted a stockholder rights plan intended to ensure that all stockholders of the Company receive fair and equal treatment in the event of an attempted hostile takeover of the Company.
On February 28, 2018, the Company announced positive interim data from its Phase 2 clinical trial of HS-110 and Nivolumab in NSCLC; reported tumor shrinkage and disease control in a majority of evaluable patients; HS-110 + nivolumab combination showed durable responses in difficult-to-treat low TIL patients and low PD-L1 patients who respond poorly to checkpoint inhibitors.
On February 20, 2018, the Company reported that the Independent Data Monitoring Committee (DMC) recommended continuing patient enrollment in the ongoing Phase 2 Clinical Trial for HS-110.
On February 14, 2018, the Company announced its abstract highlighting interim results of its Phase 2 study on HS-110 had been accepted as a scientific poster presentation during the 2018 Keystone Symposia Conference XI: Immunological Memory: Innate, Adaptive and Beyond, February 25 – March 1, 2018 which took place in Austin, TX.
First Quarter 2018 Financial Results

Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased to $2.9 million for the quarter ended March 31, 2018 compared to $1.8 million for the quarter ended March 31, 2017. The $1.1 million increase is due to an increase in CMC activity in our HS-110 and PTX-35 programs as well as continued patient enrollment as we progress in our phase 2 HS-110 clinical trial.
General and administrative expense increased approximately 20% to $1.8 million for the quarter ended March 31, 2018 compared to $1.5 million for the quarter ended March 31, 2017. The $0.3 million increase is primarily attributable to the increase in personnel costs as we establish our Texas operations associated with our Pelican subsidiary.
Net loss attributable to Heat Biologics was approximately $3.5 million, or ($0.75) per basic and diluted share for the quarter ended March 31, 2018 compared to a net loss of approximately $3.2 million, or ($1.18) per basic and diluted share for the quarter ended March 31, 2017.
As of March 31, 2018, the Company had approximately $9.0 million in cash and cash equivalents. Subsequent to the end of the first quarter, the Company raised approximately $20.7 million in gross proceeds in a public offering of common shares and warrants.