Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases, announces the filing of its report 10Q for the second quarter, which ended June 30, 2019, and provides a business update.
“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 stock. 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,” said Hemispherx CEO Thomas K. Equels. “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.”
Balance Sheet Highlights
As of June 30, 2019, Hemispherx had cash, cash equivalents and marketable securities of $2,864,000 compared with $1,825,000 as of December 31, 2019.
Second Quarter Financial Highlights
Research and development manufacturing-related expenses for the second quarter of 2019 were $1,096,000, compared with $1,341,000 million for the second quarter of 2018. The decrease was due primarily to a general reduction of Ampligen manufacturing costs.
General and administrative expenses for the second quarter of 2019 were $1,942,000, compared with $1,733,000 for the second quarter of 2018. The increase was mainly due to an increase in stock compensation expense and an increase in public relations expenses.
The net loss from continuing operations for the second quarter of 2019 was $2,029,000, or $1.07 per share, compared with $2,415,000, or $2.38 per share, for the second quarter of 2018.
Ongoing Ampligen Clinical Studies
- Advanced Recurrent Ovarian Cancer – A Phase 1/2 clinical trial of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. Eleven patients in the Phase 1 portion have been enrolled; 10 have completed treatment and one is undergoing treatment and evaluation. An interim report from Dr. Edwards’ team was received and they are drafting a manuscript on the biological and clinical outcomes from the Phase 1 portion of the trial. Dr. Edwards’ team has issued an updated report supporting the clinical safety of using Ampligen on an intraperitoneal basis in combination therapy, thus allowing a large Phase 2 trial combining Ampligen and pembrolizumab to begin. Separately, Dr. Edwards has reported that the Phase 1/2 clinical trial generated positive survival data, to be addressed in the manuscript. See ClinicalTrials.gov.
- Advanced Recurrent Ovarian Cancer – A follow-up study to the Phase 1/2 above is a 45-patient, Phase 2 clinical trial combining Ampligen, cisplatin and pembrolizumab in the treatment of advanced recurrent ovarian cancer. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. The first patient was treated on June 11, 2019 and treatment of patients is underway. See ClinicalTrials.gov.
- Stage 4 Colorectal Cancer Metastatic to the Liver – A 12-patient, Phase 2a clinical trial combining Ampligen, Intron A and celecoxib in Stage 4 colorectal cancer. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. P. Boland. To date, seven subjects have been enrolled and completed treatment, and the trial is progressing well. Data from this trial is expected in 2020. See ClinicalTrials.gov.
- Stage 4 Metastatic Triple-Negative Breast Cancer – A Phase 1, 6-patient, open-label clinical trial combining Ampligen, Intron A, celecoxib and pembrolizumab in the treatment of Stage 4 triple-negative breast cancer. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. M. Opyrchal. Patients have been enrolled and are in early treatment. See ClinicalTrials.gov.
- Early-Stage Prostate Cancer – A 60-patient, Phase 2 randomized, three-arm clinical trial of aspirin and Ampligen with or without Intron A compared with no drug treatment in patients with early-stage prostate cancer before undergoing radical prostatectomy. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. G. Chatta. IRB and FDA approval have been received. Roswell expects first enrollment in the immediate future. See ClinicalTrials.gov.
Expanded Access Program
Advanced Pancreatic Cancer – An Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands for Stage 4 pancreatic cancer at Erasmus Medical Center has been ongoing for two years. The team at Erasmus is making progress under the supervision of Prof. Casper van Eijck, MD, a world-renowned specialist in this dread malignancy, and Diba Latifi, MD. The Dutch government has approved and extended the therapeutic program for an additional year. Early progress was reported in a published abstract from Erasmus. The abstract was part of a larger original report covering a variety of medical topics, which can be found at https://www.pancreasclub.com/wp-content/uploads/2018/06/Poster-Abstracts.pdf. The last two patients planned to be enrolled for a planned paper are nearing the end of treatment. The paper analyzing the data is expected in 2020.
Clinical trials planned for initiation in 2019/2020
- Stage 4 Brain Metastatic Breast Cancer – A multi-site Stage 4 brain metastatic breast cancer study testing Ampligen as an immunological agent increasing efficacy is awaiting funding.
- Stage 4 Refractory Metastatic Colorectal Carcinoma – Phase 2 study that will evaluate Ampligen in combination with pembrolizumab in Stage 4 refractory metastatic colorectal carcinoma at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Roswell Park is reviewing the budget and preparing it for institutional submission.
- Stage 4 Urothelial (Bladder), Melanoma and Renal Cell Carcinoma – Phase 2 study of Stage 4 urothelial (bladder), melanoma and renal cell carcinoma, resistant to checkpoint blockade, that will evaluate Ampligen in combination with a checkpoint blockade therapy at Roswell Park Comprehensive Cancer Center. Protocol design currently being finalized. Hemispherx Biopharma signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center to study Ampligen in combination with checkpoint inhibitors in a Phase 2a study in urothelial carcinoma, renal cell carcinoma and melanoma. Hemispherx is awaiting the study protocol, which is under review at Roswell Park, and confirmation of third-party funding.
- Non-Small Cell Lung Cancer – First-line therapy for non-small cell lung cancer with SOC chemotherapy that will evaluate Ampligen in combination with pembrolizumab at University of Nebraska Medical Center. Dr. V. Ernani, PI. Study design and budget being developed. However, we now anticipate an extended delay at Nebraska because we were unable to obtain funding yet for the large trial. However, we are working on a pilot trial program at Roswell Park to create sufficient data for a large, multi-site non-small cell lung cancer Phase 2 clinical study.
- Advanced Pancreatic Cancer – Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University of Nebraska Medical Center. Dr. K. Klute, PI. Protocol and budget being developed. Based upon success in the initial animal studies, an additional round of more extensive and comprehensive pre-clinical animal pancreatic cancer studies are being conducted at University of Nebraska to reconfirm results, test additional PC tumor types, examine anti-PD-1 in addition to the prior anti-PD-L1 analysis, then fine tune the focus of the proposed future pancreatic cancer clinical trial and reduce the chances of error in clinical trial design. This information will also be used to formulate proposed future combination therapy clinical activity in the Kingdom of the Netherlands.
- Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer is awaiting FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. Hemispherx’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, no assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.