Hemespherx Biopharma HEB Stock News

Hemispherx BioPharma, Inc. (NASDAQ: HEB) issued its financial results and corporate update for the second quarter of fiscal year 2019 early this morning. The report outlined strong results, including impressive balance sheet growth and progress along the path of development for Ampligen. Here’s what we saw:

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HEB Stock Is Attractive After A Strong Q2

As mentioned above, Hemispherx BioPharma issued its second quarter results this morning. First and foremost, balance sheet growth proved to be impressive. On June 30, 2019, the end of the second quarter, the company had cash, cash equivalents and marketable securities of $2,864,000. That’s more than a million in cash growth over the $1,825,000 reported as of December 31, 2019. 

Research and development costs are dropping dramatically. With a general reduction in the cost of manufacturing Ampligen leading the charge, these costs fell from $1,341,000 in Q2 18 to $1,096,000 in Q2 19. 

The company spent $1,942,000 in general and administrative expenses, up from $1,733,000 year over year. HEB said that the increase in cost was largely the result of an increase in stock compensation expenses as well as public relations expenses. 

Net losses came to $2,029,000, down from $2,415,000 year over year. That works out to a net loss of $1.07 per share in the second quarter, compared to $2.38 per share in the same quarter last year. 

Clinical Updates

In the report, HEB also provided an update with regard to its multiple ongoing clinical studies. The company said that 11 patients have been enrolled and 10 have completed or are undergoing treatment in the Phase 1 part of a Phase 1/2 clinical trial of Ampligen in advanced recurrent ovarian cancer. 

The trial is being conducted at the University of Pittsburgh Medical Center (UPMC) by Dr. R. Edwards. So far, the company has received an interim report from Dr. Edward’s team and is awaiting a manuscript on the biological and clinical outcomes from the Phase 1 portion of the trial. 

Moreover, the company said that Dr. Edwards’ team has issued an updated final report with regard to the clinical safety of using Ampligen as a combination therapy. The report will allow for a large, Phase 2 trial of Ampligen in combination with pembrolizumab to be initiated. Also, the company said that Dr. Edwards has reported positive survival data from the trial. 

In another trial taking place at UPMC, Dr. Edwards and his team are assessing the potential of combining Ampligen, cisplatin and pembrolizumab in the treatment of advanced recurrent ovarian cancer. The trial is a 45-patient, follow up trial to the clinical development program mentioned above. 

In the release, HEB said that the first patient was treated on June 11, 2019. Treatment of additional patients is currently underway. 

In yet another trial, 12 patients with Stage 4 colorectal cancer metastatic to the liver are being provided a combination treatment, including Ampligen, Intron A and celecoxib. This particular trial is taking place at Roswell Park Comprehensive Cancer Center and is being performed by a team led by Dr. P. Boland. 

So far, 7 patients have been enrolled and completed treatment in this Phase 2a trial. The company said that the trial is progressing well, with data expected in 2020. 

Hemispherx BioPharma is also conducting a 6-patient Phase 1 study in Stage 4 Metastatic Triple-Negative Breast Cancer. In this study, Ampligen is being combined with Intron A, celecoxib and pembrolizumab as a potential treatment options. All patients have been enrolled and are in early treatment. 

In a Phase 2 clinical trial, 60-patients are being treated with aspirin and Ampligen, with or without Intron A or randomized into a no-treatment arm. The goal is to assess the combination in comparison to no drug treatment in patients with early-stage prostate cancer before undergoing radical prostatectomy. 

This trial is also being conducted at Roswell Park Comprehensive Cancer Center. Dr. G. Chatta is leading the charge. At this stage, IRB and FDA approvals have been received with enrollment expected to begin shortly. 

Early Access In The Netherlands

HEB also provided an update with regard to the Expanded Access Program in the Netherlands. The program provides early access to patients in the Netherlands with Stage 4 pancreatic cancer, with treatment taking place at Erasmus Medical Center. 

So far, the program has been active for about two years, with the team at Erasmus making progress. As a result, the government in the Netherlands has approved an extension of the program for an additional year. 

Hemispherx said that the last two patients planned to be enrolled for a planned paper are nearing the end of the treatment. As such, a paper analyzing the data is expected to be released in the year 2020. 

Clinical Trials Ahead

HEB also outlined that it plans on initiating five clinical trials through the rest of 2019 and into 2020. These trials include indications like Stage 4 brain metastatic breast cancer, Stage 4 refractory metastatic colorectal carcinoma, Stage 4 urothelial cancer, melanoma and renal cell carcinoma, non-small cell lung cancer, advanced pancreatic cancer and early-stage triple negative breast cancer. 

In a statement, Thomas K. Equels, CEO at HEB, had the following to offer:

“The company’s stockholder equity increased by $2,618,000 during the second quarter to $6,548,000 and we expect to continue on this positive trajectory. We look forward to the results from our ongoing clinical trials over the next 18 months, seeing them as strong value drivers for the stuck. Thus far, we have had strong, steady and consistent clinical progress in immuno-oncology. I believe this is critical to creating long-term stockholder value, as success in any one of our ongoing or upcoming clinical trials has the potential to be a strong market catalyst. 

Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial combining Ampligen and pembrolizumab. All our trials are paid for by third parties without Hemispherx conceding any rights for development. I believe that third parties’ fronting of trial costs shows that it’s not just Hemispherx that believes in Ampligen, but that major cancer research centers, governmental grantors and the pharmaceutical industry grantors also see the potential of Ampligen as a combination therapy. “

The Takeaway

There’s a simple message to take away from the HEB quarterly report, and that is one of progress. The company is firing on all cylinders, reducing costs associated with production of its lead drug and moving forward with multiple clinical trials that have the potential to drive strong catalysts ahead. All in all, Hemispherx is headed in the right direction and seems to be on track toward creating further shareholder value ahead. 

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CNA Finance, parent company to Alpha Stock News, has a monetary relationship with Hemispherx Biopharma.

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