Heat Biologics Provides Corporate Update and Reports Second Quarter 2016 Financial Results

On August 15, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported a general business update and reported its financial results for the second quarter and six months ended June 30, 2016 (Filing, Q2, Heat Biologics, 2016, AUG 15, 2016, View Source [SID:1234514608]).

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"We are pleased to report a number of important scientific, clinical and financial developments at the company," said Jeff Wolf, Heat’s Founder and CEO. "First, the preclinical findings demonstrating that our ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection were published in the journal, ‘Cancer Immunology Research.’ Additionally, we reported encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer."

"We remain focused on driving shareholder value and minimizing dilution. We have implemented a number of cost-saving measures to help ensure we achieve important data readouts expected in the fourth quarter with current cash on-hand. Furthermore, I am pleased to report we have generated approximately $2.0 million in additional cash from the exercise of warrants. Significantly, we have also regained compliance with NASDAQ’s minimum closing bid price requirement, which alleviates the immediacy of effecting a reverse stock split."

"Overall, we remain encouraged by the outlook for the business and the growing interest from within the industry to utilize our platform technology with checkpoint inhibitors and other immunotherapies to activate a patient’s immune system against cancer. Importantly, our allogeneic cell-based immunotherapy has the potential to offer a broader, off-the-shelf solution that addresses many of the past challenges that have plagued the immuno-oncology market."

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Recent Developments & Second Quarter 2016 Corporate Highlights

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Heat remains on track to report topline data in the fourth quarter from its Phase 2 trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC) and its Phase 1b trial evaluating HS-110 in combination with an anti-PD-1 checkpoint inhibitor for the treatment of non-small cell lung cancer (NSCLC).

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In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments. Furthermore, the findings also showed that the ComPACT platform can be adapted to secrete other costimulatory molecules, including TL1A, 4-1BBL and ICOSL.

·
In June, Heat reported interim study findings from its Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of NSCLC. The findings suggested that the addition of HS-110 to nivolumab does not alter the nivolumab safety profile to-date. In addition, case studies of three trial patients (one non-responder and two responders) were characterized. While all three patients showed a decrease in immune cell PD-1 expression, which is consistent with nivolumab’s mechanism of action, both responders also showed a decrease in immunosuppressor cells, as well as increases in activated effector T cells in the peripheral blood. Furthermore, the two responders showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 + nivolumab. These early data appear to suggest that HS-110 in combination with nivolumab may improve response rates for patients with "cold tumors," who have historically not responded to checkpoint inhibitors alone.

·
In June, Heat presented a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting reviewing the design and endpoints for the ongoing Phase 1b trial of HS-110 in combination with nivolumab.

·
In April, Heat presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting. In the poster entitled "Phase I/II Study of Patients with NMIBC Treated with Vesigenurtacel-L (HS-410) with or without BCG," Heat reported that no additional recurrences had been reported to-date, with all patients at least 18 months out from enrollment. In another poster, Heat reported initial preclinical results from its collaboration with OncoSec Medical Incorporated. In the third poster, Heat reported positive preclinical data on its next generation ComPACT platform technology.

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In April, Heat implemented cost-saving measures and a focused corporate strategy to achieve important data readouts in the fourth quarter with its current cash on-hand.

·
In April, Heat appointed John Prendergast, Ph.D., to its Board of Directors.

Second Quarter 2016 Financial Highlights

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Research and development (R&D) expenses decreased to approximately $0.5 million in the second quarter of 2016 compared to approximately $0.6 million in the second quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in non-cash stock compensation expense related to equity grants awarded to one of our Scientific Advisory Board members in 2015.

·
Clinical and regulatory expenses decreased to approximately $1.3 million in the second quarter of 2016 compared to approximately $3.4 million in the second quarter of 2015, a decrease of approximately $2.1 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

·
General and administrative (G&A) expenses increased to approximately $1.1 million in the second quarter of 2016 compared to approximately $0.9 million in the second quarter of 2015, an increase of approximately $0.2 million. The increase is primarily attributable to separation expenses related to the departure of two of our former executive officers, as well as other incremental operating expenses.

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Net loss for the second quarter of 2016 was $3.0 million compared to a net loss of $4.9 million for the second quarter of 2015.

Six Months Ended June 30, 2016 Financial Highlights

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R&D expenses decreased to approximately $1.0 million for the six months ended June 30, 2016 compared to approximately $1.1 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as reductions in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.

·
Clinical and regulatory expenses decreased to approximately $4.5 million for the six months ended June 30, 2016 compared to approximately $5.5 million for the six months ended June 30, 2015, a decrease of approximately $1.0 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

·
G&A expenses decreased to approximately $2.1 million for the six months ended June 30, 2016 compared to approximately $2.2 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in professional services as we bring more services in-house.

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Net loss for the six months ended June 30, 2016 was $7.8 million compared to a net loss of $8.9 million for the six months ended June 30, 2015.

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Cash and cash equivalents totaled approximately $7.1 million at June 30, 2016 compared to cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015. This does not include approximately $2.0 million raised from the exercise of warrants subsequent to June 30, 2016.

AmpliPhi Biosciences Reports Second Quarter 2016 Financial Results and Provides Corporate Update

On August 15, 2016 AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, reported its financial results for the second quarter ended June 30, 2016 (Press release, AmpliPhi Biosciences, AUG 15, 2016, View Source [SID:1234514598]).

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"We have made significant progress executing on our clinical programs and look forward to presenting top-line data for both clinical trials later this year," said M. Scott Salka, CEO of AmpliPhi Biosciences. "The threat posed by drug-resistant infections is universally acknowledged. World leaders from government, medical and scientific communities continue to stress the importance of addressing this threat, and we remain confident that bacteriophage-based therapies will not only provide a potential alternative to existing broad-spectrum antibiotics, but will also be used to resensitize antibiotic-resistant infections to increasingly ineffective drugs, thereby ensuring the continued effectiveness of the drugs we currently use to treat serious, life-threatening infections."

Recent Corporate Highlights

Announced AB-SA01, our investigational phage therapy targeting Staphylococcus aureus (S. aureus) infections, was well-tolerated and caused no drug-related adverse events in the first cohort of our Phase 1 trial in patients with chronic rhinosinusitis (CRS). AmpliPhi remains on track to report final data later in 2016
Initiated the first Phase 1 phage therapy trial under a United States IND to evaluate the safety of AB-SA01 administered topically to the intact skin of 12 healthy adult volunteers in May. The trial is now fully enrolled and top-line results are expected before the end of the third quarter with the complete study report following later this year
The outstanding Series B Preferred stock was converted into common stock, streamlining AmpliPhi’s capital structure
Presented data at the European Congress of Clinical Microbiology and Infectious Diseases demonstrating that in a lung infection model, AB-PA01, our investigational phage therapy targeting Pseudomonas aeruginosa (P. aeruginosa) infections, was capable of infecting and killing 87.2% of the 429 clinical isolates in vitro, including those with multi-drug resistant strains of P. aeruginosa isolated from patients with cystic fibrosis
Strengthened our portfolio of intellectual property related to our proprietary bacteriophage platform with two new patents; one granted by the European Patent Office covering the treatment of all species of antibiotic-resistant bacterial infections through the staged use of bacteriophage preparations followed by the antibiotic to which the bacteria were initially resistant, and the second granted by the Japanese Patent Office that covers the same staged treatment regimen for P. aeruginosa infections
Completed a registered direct public offering of common stock and warrants in June, which yielded aggregate net proceeds of $4.2 million after fees and expenses
Second Quarter 2016 Financial Results

Cash and cash equivalents as of June 30, 2016 totaled $7.1 million. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations into the fourth quarter of 2016
Revenues related to sublicensing agreements from AmpliPhi’s former gene therapy program were $0.1 million for the quarter ended June 30, 2016 and for the same period in 2015
Research and development expenses for the quarter ended June 30, 2016 totaled $1.2 million compared to $1.1 in the same period of 2015. The increase was primarily attributable to an increase in personnel costs
General and administrative expenses for the quarter ended June 30, 2016 were $2.5 million compared to $1.6 million for the same period of 2015. The increase was primarily attributable to an increase in compensation costs and primarily for non-cash stock-based compensation expenses
Net cash used in operations was $6.0 million during the six month period ended June 30, 2016
There are currently 11.1 million shares of common stock outstanding
For more information, visit www.ampliphibio.com.

Syros Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Business Update

On August 15, 2016 Syros Pharmaceuticals (NASDAQ:SYRS) reported financial results for the second quarter ended June 30, 2016, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 15, 2016, View Source;p=irol-newsArticle&ID=2195352 [SID:1234514589]).

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"The first half of 2016 has been a period of tremendous growth for Syros," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We transitioned to a clinical-stage company with the FDA’s acceptance of the IND for our lead program SY-1425 and with the opening of our Phase 2 trial for patient enrollment. We also became a publicly traded enterprise with the successful completion of our IPO, which we expect to provide funding for us to drive forward our two lead programs to clinical data readouts and further enhance our gene control drug discovery and development platform through mid-2018. Importantly, we accomplished these milestones while progressing our pioneering platform to discover and develop medicines that control the expression of disease-driving genes."

Upcoming Milestones

Phase 2 trial of SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, is on track to begin dosing genomically defined relapsed or refractory AML and relapsed high-risk MDS patients with the RARA biomarker, which Syros discovered, in the third quarter of 2016. Patients are currently being screened for enrollment in the trial.
Phase 1/2 trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, remains on track to begin in the first half of 2017, with the in-life portion of the Good Laboratory Practice (GLP) toxicology studies now successfully completed.
Recent Platform and Pipeline Highlights

In June 2016, Syros presented data on its two lead programs, SY-1425 and SY-1365, at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. In preclinical studies, SY-1425 was observed to inhibit the growth of cancer cells and prolong survival in in vivo models of AML with the RARA biomarker, while SY-1365 was observed to selectively kill acute leukemia cells over non-cancerous cells and induce complete tumor regression and a significant survival benefit in in vivo models of AML.
In May 2016, the Company announced the acceptance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration to advance SY-1425 into a Phase 2 clinical trial in patients with relapsed or refractory AML and relapsed high-risk MDS with the RARA biomarker.
In April 2016, Syros presented additional preclinical data on both SY-1425 and SY-1365 at the American Association of Cancer Research Annual Meeting in New Orleans.
Recent Corporate Highlights

In July 2016, Syros completed its initial public offering, raising approximately $57.5 million in gross proceeds through the sale of 4,600,000 shares at an offering price of $12.50 per share – including 600,000 shares of common stock issued upon the full exercise by the underwriters of their option to purchase additional shares.
In June 2016, the Company expanded its Board of Directors with the appointment of industry leader Sanj K. Patel, Chief Executive Officer and Chairman of Kiniksa Pharmaceuticals and former President and Chief Executive Officer of Synageva BioPharma Corp.
Second Quarter 2016 Financial Results

Cash and cash equivalents as of June 30, 2016 were $50.1 million, compared with $35.9 million on December 31, 2015. Cash and cash equivalents as of June 30, 2016 did not include total net proceeds of approximately $49.9 million from the Company’s initial public offering of common stock, which was completed in July 2016.
For the second quarter 2016, Syros reported a net loss of $12.0 million, or $5.42 per share, compared to a net loss of $6.1 million, or $4.16 per share, for the same period in 2015.
Research and development (R&D) expenses for the second quarter 2016 were approximately $9.5 million, including stock-based compensation expense of $0.9 million, compared to $5.4 million, including stock-based compensation expense of $0.5 million, for the same period in 2015. The increase was largely due to increased external costs associated with advancing the Company’s pipeline, as well as personnel expense and stock-based compensation expense.
General and administrative (G&A) expenses for the second quarter 2016 were approximately $2.5 million, including stock-based compensation expense of $0.2 million, compared to $1.0 million, including stock-based compensation expense of $0.1 million for the same period in 2015. The increase was largely due to increased personnel expense and stock-based compensation expense, as well as increased professional fees.

Aeolus Announces Third Quarter Fiscal Year 2016 Financial Results

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, reported financial results for the nine months ended June 30, 2016 (Press release, Aeolus, AUG 15, 2016, View Source [SID:1234514588]).

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The Company reported a net loss of approximately $872,000, or $0.01 per share for the three months ended June 30, 2016. This compares to a net loss of approximately $784,000, or $0.01 per share for the three months ended June 30, 2015. For the nine months ended June 30, 2016, the Company reported a net loss of approximately $5,021,000, or $0.03 per share. This compares to a net loss of approximately $2,194,000, or $0.02 per share for the nine months ended June 30, 2015. The increase in net loss during the nine months ended June 30, 2016 was primarily attributable to a $2,486,000 non-cash expense related to a deemed dividend for the Company’s Series C Preferred Stock. The net operating loss for the nine months ended June 30, 2016 was $2,250,000 or $0.02 per share.

"With the work completed this quarter and over the term of our partnership with BARDA, we are on the brink of launching the clinical development of AEOL 10150. Thanks to the support of the BARDA Contract, we have reduced the cost of manufacturing AEOL 10150 by 90 percent, manufactured pilot scale GMP batches and, this past quarter, extended stability out to 3 years for the API and 2 years for the final drug product," stated John L. McManus, President and Chief Executive Officer. "Over the next two quarters, we anticipate filing INDs and initiating clinical studies in Idiopathic Pulmonary Fibrosis and cancer radiation therapy, which, in addition to launching our development efforts in two important commercial indications, will also provide the initial human safety data required for our Lung ARS medical countermeasure development program funded by BARDA."

Results of Operations for the Three Months Ended June 30, 2016

Revenue for the three months ended June 30, 2016 was approximately $660,000, which compares to approximately $63,000 for the three months ended June 30, 2015. The revenue is from the BARDA Contract. Higher revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules. Under the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, which is based on allowable costs incurred during the period, plus any recognizable earned fee. We consider fixed fees under cost-plus fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract.

Research and development expenses increased to approximately $904,000 for the three months ended June 30, 2016 from approximately $269,000 for the three months ended June 30, 2015. The increase is primarily attributable to the timing of work related to the BARDA Contract.

General and administrative expenses increased to approximately $628,000 for the three months ended June 30, 2016 from approximately $578,000 for the three months ended June 30, 2015. The increase is primarily attributable to increased investor relations costs and legal fees.

Results of Operations for the Nine Months Ended June 30, 2016

Revenue for the nine months ended June 30, 2016 was approximately $1,530,000, which compares to approximately $2,177,000 for the nine months ended June 30, 2015. The revenue is from the BARDA Contract. Lower revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules.

Research and development expenses decreased to approximately $1,897,000 for the nine months ended June 30, 2016 from approximately $2,539,000 for the nine months ended June 30, 2015. The decrease is primarily attributable to the timing of work related to the BARDA Contract.

General and administrative expenses increased to approximately $1,883,000 for the nine months ended June 30, 2016 from approximately $1,832,000 for the nine months ended June 30, 2015 due to higher legal fees, investor relations cost and insurance premiums.

As of June 30, 2016, the Company had approximately $3,756,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $742,000 and accounts payable of $661,000 on June 30, 2016.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company’s website, at www.aolsrx.com.

About AEOL 10150

AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Radiation-Induced Lung Fibrosis ("Lung ARS") studies in animals. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating Lung ARS and Idiopathic Pulmonary Fibrosis and has filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.

Heat Biologics Provides Corporate Update and Reports Second Quarter 2016 Financial Results

On August 15, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported a general business update and reported its financial results for the second quarter and six months ended June 30, 2016 (Press release, Heat Biologics, AUG 15, 2016, View Source [SID:1234514586]).

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"We are pleased to report a number of important scientific, clinical and financial developments at the company," said Jeff Wolf, Heat’s Founder and CEO. "First, the preclinical findings demonstrating that our ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection were published in the journal, ‘Cancer Immunology Research.’ Additionally, we reported encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer."

"We remain focused on driving shareholder value and minimizing dilution. We have implemented a number of cost-saving measures to help ensure we achieve important data readouts expected in the fourth quarter with current cash on-hand. Furthermore, I am pleased to report we have generated approximately $2.0 million in additional cash from the exercise of warrants. Significantly, we have also regained compliance with NASDAQ’s minimum closing bid price requirement, which alleviates the immediacy of effecting a reverse stock split."

"Overall, we remain encouraged by the outlook for the business and the growing interest from within the industry to utilize our platform technology with checkpoint inhibitors and other immunotherapies to activate a patient’s immune system against cancer. Importantly, our allogeneic cell-based immunotherapy has the potential to offer a broader, off-the-shelf solution that addresses many of the past challenges that have plagued the immuno-oncology market."

Recent Developments & Second Quarter 2016 Corporate Highlights

Heat remains on track to report topline data in the fourth quarter from its Phase 2 trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC) and its Phase 1b trial evaluating HS-110 in combination with an anti-PD-1 checkpoint inhibitor for the treatment of non-small cell lung cancer (NSCLC).

In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments. Furthermore, the findings also showed that the ComPACT platform can be adapted to secrete other costimulatory molecules, including TL1A, 4-1BBL and ICOSL.

In June, Heat reported interim study findings from its Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of NSCLC. The findings suggested that the addition of HS-110 to nivolumab does not alter the nivolumab safety profile to-date. In addition, case studies of three trial patients (one non-responder and two responders) were characterized. While all three patients showed a decrease in immune cell PD-1 expression, which is consistent with nivolumab’s mechanism of action, both responders also showed a decrease in immunosuppressor cells, as well as increases in activated effector T cells in the peripheral blood. Furthermore, the two responders showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 + nivolumab. These early data appear to suggest that HS-110 in combination with nivolumab may improve response rates for patients with "cold tumors," who have historically not responded to checkpoint inhibitors alone.

In June, Heat presented a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting reviewing the design and endpoints for the ongoing Phase 1b trial of HS-110 in combination with nivolumab.

In April, Heat presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting. In the poster entitled "Phase I/II Study of Patients with NMIBC Treated with Vesigenurtacel-L (HS-410) with or without BCG," Heat reported that no additional recurrences had been reported to-date, with all patients at least 18 months out from enrollment. In another poster, Heat reported initial preclinical results from its collaboration with OncoSec Medical Incorporated. In the third poster, Heat reported positive preclinical data on its next generation ComPACT platform technology.

In April, Heat implemented cost-saving measures and a focused corporate strategy to achieve important data readouts in the fourth quarter with its current cash on-hand.

In April, Heat appointed John Prendergast, Ph.D., to its Board of Directors.
Second Quarter 2016 Financial Highlights

Research and development (R&D) expenses decreased to approximately $0.5 million in the second quarter of 2016 compared to approximately $0.6 million in the second quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in non-cash stock compensation expense related to equity grants awarded to one of our Scientific Advisory Board members in 2015.

Clinical and regulatory expenses decreased to approximately $1.3 million in the second quarter of 2016 compared to approximately $3.4 million in the second quarter of 2015, a decrease of approximately $2.1 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

General and administrative (G&A) expenses increased to approximately $1.1 million in the second quarter of 2016 compared to approximately $0.9 million in the second quarter of 2015, an increase of approximately $0.2 million. The increase is primarily attributable to separation expenses related to the departure of two of our former executive officers, as well as other incremental operating expenses.

Net loss for the second quarter of 2016 was $3.0 million compared to a net loss of $4.9 million for the second quarter of 2015.
Six Months Ended June 30, 2016 Financial Highlights

R&D expenses decreased to approximately $1.0 million for the six months ended June 30, 2016 compared to approximately $1.1 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as reductions in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.

Clinical and regulatory expenses decreased to approximately $4.5 million for the six months ended June 30, 2016 compared to approximately $5.5 million for the six months ended June 30, 2015, a decrease of approximately $1.0 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

G&A expenses decreased to approximately $2.1 million for the six months ended June 30, 2016 compared to approximately $2.2 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in professional services as we bring more services in-house.

Net loss for the six months ended June 30, 2016 was $7.8 million compared to a net loss of $8.9 million for the six months ended June 30, 2015.

Cash and cash equivalents totaled approximately $7.1 million at June 30, 2016 compared to cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015. This does not include approximately $2.0 million raised from the exercise of warrants subsequent to June 30, 2016.
About Heat Biologics, Inc.