Hemispherx Reports 2019 First Quarter Financial Results

OCALA Fla., May 16, 2019 (GLOBE NEWSWIRE) -- 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 financial results for the first quarter ended March 31, 2019, and provides a business update.

Highlights 2019 through May 14, 2019 include:

• Our stockholders participated in a Rights Offering and we raised $5.3 million. Further, subsequent to the end of the quarter steps were taken to increase stockholder equity by an additional $4.4 million.
• Initiated a 45-patient clinical study in ovarian cancer at University of Pittsburgh Medical Center combining Ampligen, cisplatin and pembrolizumab, data expected by 2021. See full details of the study at ClinicalTrials.gov.
• Initiated 12-patient clinical study in colorectal cancer at Roswell Park Comprehensive Cancer Center combining Ampligen, Intron A, and celecoxib, data expected by 2020. See full details of the study at ClinicalTrials.gov.
• Initiated 6-patient clinical study in triple negative breast cancer at Roswell Park Comprehensive Cancer Center combining with Ampligen, Intron A, celecoxib and pembrolizumab, data expected by 2020. See full details of the study at ClinicalTrials.gov.
• Extended the Early Access Program (EAP) at the Erasmus Medical Center in the Netherlands using Ampligen in the treatment of patients with pancreatic cancer. The EAP is approved by the Dutch Health Inspectorate until March 9, 2020 to treat pancreatic cancer patients diagnosed with any stage of the serious disease. Patients receive Ampligen as a maintenance therapy after completing standard care. Read the full release.
• An additional round of more extensive and comprehensive pre-clinical animal pancreatic cancer studies were initiated at the University of Nebraska to reconfirm the successful results seen in the initial animal studies. Two pancreatic cancer tumor types will be examined using both anti-PD-1 in addition to the prior anti-PD-L1 in order to fine tune the focus of the proposed future pancreatic cancer clinical trial and reduce the chances of error in clinical trial design.
• Received an interim report from Dr. Edwards’ team on recurrent Ovarian Cancer Phase 1/2 study of intraperitoneal chemo-immunotherapy at University of Pittsburgh Medical Center. See full details of the study at ClinicalTrials.gov.
• The Phase 2 study of neoadjuvant conditioning of prostate cancer using Ampligen as a component of chemokine modulation at Roswell Park Comprehensive Cancer Center. Dr. G. Chatta, PI has received authorization to proceed by the FDA. See full details of the study at ClinicalTrials.gov.

Detailed Cancer Clinical Trials Updates

Hemispherx recently announced significant progress in multiple Ampligen-plus-checkpoint-blockade immuno-oncology programs, including additional planned trials at major research institutes, subject to obtaining funding. For a detailed discussion of our ongoing immuno-oncology clinical trials, see our most recent quarterly update.

Management Commentary

"When our management team began three years ago, Hemispherx identified four significant steps we needed to take to make our company a success,” said Hemispherx CEO Thomas K. Equels. “First, raise the funds necessary to produce our drug candidate, Ampligen, for use in immuno-oncology clinical trials and other programs. Second, produce adequate supplies of Ampligen to conduct such trials. Third, initiate multiple immuno-oncology clinical trials. We have now accomplished each of these steps and are using Ampligen to treat cancers in clinical trials. Now is the time for us to seek out big pharma partners who share our excitement and enthusiasm for the potential of Ampligen. We believe that success in these trials will create the environment for that goal. Accomplishing success in R&D is based on such progress."

Balance Sheet Highlights

As of March 31, 2019, Hemispherx had cash, cash equivalents and marketable securities of $4.9 million, compared with $1.8 million as of December 31, 2018.

First Quarter Financial Highlights

Research and development manufacturing-related expenses for the first quarter of 2019 were $0.93 million, an 8% increase compared with $0.86 million for the first quarter of 2018. The increase was due to Ampligen related stability testing and maintenance.

General and administrative expenses for the first quarter of 2019 were $1.76 million, compared with $1.56 million for the first quarter of 2018. The increase was due to increased salaries, equity based compensation and stock market fees.

The net loss from continuing operations for the first quarter of 2019 was $3.36 million, or $0.07 per share, compared with $2.71 million, or $0.07 per share, for the first quarter of 2018.

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 generate 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.

Cautionary Statement

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.

Contacts:
Hemispherx Biopharma, Inc.
Phone: 800-778-4042
Email: IR@hemispherx.net

Or

LHA Investor Relations
Miriam Weber Miller
Senior Vice President
Phone: +1-212-838-3777
Email: mmiller@lhai.com