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Heat Biologics Posts Wider Loss Y/Y, Focus on Pipeline

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Heat Biologics, Inc. reported a loss of $1.83 per share in 2014, wider than the year-ago loss of $1.81 per share.

In 2014, research and development expenses were $2.9 million, up 5% from the year-ago quarter. The increase was primarily driven by increased patent legal fees associated with licenses.

General and administrative expenses shot up 63.7% from the year-ago quarter to $4 million primarily driven by an increase in personnel costs.

Additionally, the company incurred clinical and regulatory expenses of $5.3 million in 2014 compared to $1.4 million in the year-ago period. This increase was primarily due to an increase in payments to investigators, specimen management and other clinical trial expenses, pipeline development and manufacturing expenses.

Pipeline Update

Heat Biologics is currently evaluating two lead candidates – HS-410 and HS-110 – for non-small cell lung cancer and non-muscle invasive bladder cancer, respectively. During the fourth quarter of 2014, the company completed patient enrollment in a phase I study on HS-410 for non-muscle invasive bladder cancer. An immune response analysis of the first 10 patients is expected in the first half of 2015. Meanwhile, patient dosing in a phase II study on HS-410 (for the same indication) is ongoing. Heat Biologics expects to complete patient enrollment in the first three arms of the phase II study in combination with bacillus Calmette–Guérin (BCG) by the third quarter of 2015. Top-line results should be out in the second half of 2016. HS-410 (in combination with BCG) enjoys fast track status in the U.S. for the treatment of non-muscle invasive bladder cancer.

Meanwhile, HS-110 is being evaluated in a phase II study for non-small cell lung cancer. Patient enrollment is expected to be completed by the fourth quarter of 2015. Interim data on immune response in the phase II study should be out in 2015.

Our Take

Being a development-stage company, Heat Biologics may face an increase in its operating expenses. However, we are pleased with the company’s pipeline progress so far. With several data readouts coming up, including the announcement of immune response data from the phase I study on HS-410 and the phase II study on HS-110, we believe 2015 will be a data-rich year for the company.

Heat Biologics carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Cytokinetics, Incorporated (CYTK - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Horizon Pharma plc (HZNP - Free Report) . All these stocks carry a Zacks Rank #1 (Strong Buy).




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