OCALA, Fla., Nov. 15, 2018 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE American: HEB) announces financial results for the three and nine months ended September 30, 2018, and provides a business update.
Highlights of the 2018 third quarter include:
- Successful animal studies in immuno-oncology
- Two cancer clinical trials underway, with subjects being treated at the University of Pittsburgh Medical Center (https://clinicaltrials.gov/ct2/show/NCT02432378) and Roswell Park Comprehensive Cancer Center (https://clinicaltrials.gov/ct2/show/NCT03403634)
- Signed agreement with Roswell Park Comprehensive Cancer Center to study Ampligen plus checkpoint inhibitors in bladder cancer, melanoma, and renal cell carcinoma
- New agreement expands existing pre-clinical collaboration
- Announced distribution of second lot of Ampligen for multiple uses in Argentina, the United States and Europe
- Issued letter to stockholders that provided comprehensive overview of the strategy in immuno-oncology, the pipeline and manufacturing capabilities
- Completed bridge financing of $3 million under terms favorable to the Company
- Six additional cancer clinical trials expected to commence over the next twelve months
Detailed Cancer Clinical Trials Updates
Currently, two Ampligen clinical trials are underway at university cancer centers testing in humans on whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint blockade. The first, a Phase 2A study evaluating a chemokine modulatory regimen in patients with colorectal cancer metastatic to the liver, is ongoing at the Roswell Park Comprehensive Cancer Center with Dr. P. Boland as the Principal Investigator. Four of the twelve planned patients have been enrolled. The second, a Phase 1/2 study of autologous αDC1 vaccines and intraperitoneal chemo-immunotherapy for patients with recurrent ovarian cancer, is ongoing at the University of Pittsburgh Medical Center, with Dr. R. Edwards as the Principal Investigator. Ten Phase 1 patients have been enrolled. An interim report is expected in Q1 of 2019.
Upcoming, we are working to initiate six additional cancer trials in collaboration with university medical/cancer research centers using Ampligen plus checkpoint blockade therapies, as follows below:
- Advanced ovarian carcinoma using cisplatin, pembrolizumab (anti-PD-1) plus Ampligen: Dr. R. Edwards, Principal Investigator (PI), the University of Pittsburgh Medical Center plans on enrolling up to 45 subjects in this single arm Phase 2 study. (https://clinicaltrials.gov/ct2/show/NCT03734692)
- Refractory metastatic colorectal carcinoma using pembrolizumab (anti-PD-1) plus Ampligen: Dr. P. Boland, PI, Roswell Park Comprehensive Cancer Center will lead this single arm Phase 2 study.
- Metastatic triple negative breast cancer using chemokine modulation therapy including Ampligen and pembrolizumab (anti-PD-1): Dr. M. Opyrchal, PI, Roswell Park Cancer Center with IRB approval pending.
- Ampligen in combination with checkpoint inhibitors in three advanced solid tumors, urothelial (bladder), melanoma, and renal cell carcinoma, resistant to checkpoint blockade: Dr. M. Opyrchal, PI, Roswell Park Comprehensive Cancer Center is currently working on the study design details.
- First line therapy for non-small cell lung cancer (NSCLC) with standard of care including pembrolizumab (anti-PD-1) plus Ampligen: Dr. V. Ernani, PI, the University of Nebraska Medical Center is currently working on the study design and budget details.
- Advanced pancreatic carcinoma using atezolizumab (anti-PD-L1) plus Ampligen: Dr. K. Klute, PI, the University of Nebraska Medical Center is currently working on the study design and budget details.
Management Commentary
“We have been working hard to move quickly and effectively on the eight cancer clinical trials we expect to have fully underway over the next year,” said Hemispherx CEO Thomas K. Equels. “Success here, in my opinion, has the potential to be a highly effective driver for increased stockholder value.”
Balance Sheet Highlights
As of September 30, 2018, Hemispherx had cash, cash equivalents and marketable securities of $4.075 million, compared with $2.107 million as of December 31, 2017.
Third Quarter Financial Highlights
Research and development manufacturing-related expenses for the third quarter of 2018 were $1.595 million, a 103% increase compared with $0.787 million for the third quarter of 2017. The increase was due to the manufacture of 7,907 Ampligen vials and to the initial costs for the production of polymers.
General and administrative expenses for the third quarter of 2018 were $1.273 million, compared with $1.556 million for the third quarter of 2017.
The net loss from continuing operations for the third quarter of 2018 was $3.078 million, or $0.07 per share, compared with $1.252 million, or $0.04 per share, for the third quarter of 2017.
Nine Month Financial Highlights
Research and development expenses for the first nine months of 2018 were $3.791 million, a 15% increase compared with $3.284 million for the first nine months of 2017. The increase was due to the production of the two Ampligen lots of 8,484 vials and 7,907 vials, and initial costs for the production of polymer.
General and administrative expenses for the first nine months of 2018 were $4.569 million, compared with $4.839 million for the first nine months of 2017.
The net loss from continuing operations for the first nine months of 2018 was $8.206 million, or $0.19 per share, compared with $6.266 million, or $0.23 per share, for the first nine months of 2017. Much of this increase relates to the manufacturing expenses of the approximately 16,000 vials of Ampligen filled and finished in 2018.
Forward Looking Statement
Some of the statements included in this document may be forward-looking statements that involve a number of risks and uncertainties. For example, possible initiation of new oncology clinical trials may not occur due to many factors including lack of IRB or regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring universities or cancer centers. Even if the clinical trials are initiated, we cannot assure that the clinical studies will be completed, will be considered successful or will yield any useful data.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those 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