OCALA, Fla., April 01, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American: HEB) announces financial results for the fiscal year ended December 31, 2018, and provides a business update.
Highlights of 2018 included:
- Publication of a non-clinical study showing Ampligen is the only known TLR3 agonist to promote selective attraction of T-effector cells with concomitant increase in the T-effector/T-reg ratio in the tumor microenvironment
- Two cancer clinical trials underway at the University of Pittsburgh Medical Center (https://clinicaltrials.gov/ct2/show/NCT03734692) 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; the agreement expanded existing pre-clinical collaborations
- Expanded production to provide a supply of Ampligen for clinical and expanded access programs in the U.S., Canada, Europe and commercial program in Argentina
- 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 (the loan has since been renegotiated for an additional year with long-term amortization)
- Sold an under-utilized New Brunswick, N.J. warehouse for $1,050,000 and sold the New Brunswick, N.J. manufacturing facility for $4,080,000, while simultaneously entering into a favorable long-term lease with an option to repurchase the facility
Update on Cancer Clinical Trials/Programs
As of the end of 2018, two Ampligen clinical trials were underway at NCI-Designated Cancer Centers testing in humans 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, was ongoing at the Roswell Park Comprehensive Cancer Center with Dr. P. Boland as the Principal Investigator. Four of the 12 planned patients had been enrolled by the end of 2018. The second, a Phase 1/2 study to test Ampligen as a combinational therapy with intraperitoneal chemo-immunotherapy for patients with recurrent ovarian cancer was also ongoing at the University of Pittsburgh Medical Center, with Dr. R. Edwards as the Principal Investigator. Ten patients had been enrolled by the end of 2018.
Upcoming, the Company is working to initiate several additional cancer trials in collaboration with university medical/cancer research centers using Ampligen plus checkpoint blockade therapies.
In U.S. clinical trials, the Company is working with three NCI-Designated Cancer Centers — the University of Pittsburgh Medical Center, the Roswell Park Comprehensive Cancer Center and the University of Nebraska Medical Center— to study the effect of Ampligen in pre-clinical and clinical studies in the treatment of nine cancer types. The nine total cancer types are renal cell carcinoma, melanoma, non-small cell lung, ovarian, breast, colorectal, urothelial, prostate and pancreatic cancer. Additionally, the Company is supplying Ampligen to an Expanded Access Program in Europe at the Erasmus Medical Center in the Netherlands, which is treating pancreatic cancer patients with Ampligen as both a standalone therapy following FOLFIRINOX and as a post-resection adjuvant therapy. Go here for the most recent comprehensive update on the Company’s immuno-oncology work: http://ir.hemispherx.net/Hemispherx-Biopharma-Announces-Significant-Progress-in-its-Ampligen-Pancreatic-Cancer-Program-and-Mu.
Balance Sheet Highlights
As of December 31, 2018, Hemispherx had cash, cash equivalents and marketable securities of $1.825 million, compared with $2.107 million as of December 31, 2017. The Company conducted a rights offering to its stockholders in early 2019 and on March 8, 2019 received approximately $5.3 million in gross proceeds.
2018 Financial Highlights
Research and development expenses for 2018 were $4.778 million, a 17% increase compared with $4.098 million for 2017. The increase was primarily 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 2018 were $6.201 million, compared with $6.572 million for 2017. The decrease in expenses was mainly due to a favorable settlement of legal fees.
The net loss from continuing operations for 2018 was $9.813 million, or $0.22 per share, compared with $8.259 million, or $0.29 per share, for 2017. Much of this increase relates to the manufacturing expenses of the approximately 16,000 vials of Ampligen filled and finished in 2018, and to the redeemable warrants valuation which decreased in 2018 as compared to 2017.
Noncompliance Notice from NYSE American
On March 26, 2019, the Company received written notice (the “Notice”) from the NYSE American LLC (the “NYSE American”) that it is not in compliance with the continued listing standards set forth in Section 1003(f)(v) of the NYSE American Company Guide because its common stock has been selling for a low price per share for a substantial period of time. The NYSE American has determined that the continued listing of the Company’s common stock is predicated on it effecting a reverse stock split of its common stock or otherwise demonstrating sustained price improvement within a reasonable period of time. The Company has until September 26, 2019 to demonstrate compliance.
Prior to its receipt of the Notice, and based upon its significant advances in oncology, the Company had been contemplating seeking stockholder approval at its next annual meeting for a reverse stock split to raise the market price of its common stock to a range where it could allow a broader variety of institutions to invest in the common stock. Currently many funds are prohibited from buying stocks with a price below a certain threshold price. Should the Company have success in the current clinical trials, potentially increasing the trading volume and liquidity of the common stock confers major benefits. The Company believes that such a reverse stock split could help increase analyst and broker interest in the common stock, as their policies can discourage them from following or recommending companies with lower stock prices. Because of the trading volatility often associated with lower-priced stock, many brokerage houses and institutional investors have adopted internal policies and practices that either prohibit or discourage them from investing in such stocks or recommending them to their customers. Some of those policies and practices may also function to make the processing of trades in lower-priced stocks economically unattractive to brokers.
As a result of receiving the Notice, the Company now plans on holding a special meeting of its stockholders to approve a reverse stock split which it anticipates holding in late May or early June 2019.
As discussed above, there are a number of existing and planned business activities that, the Company believes, should increase stockholder value and the market price of its common stock.
There is no immediate impact on the listing of the Company’s common stock, which will continue to trade on the NYSE American, subject to the Company’s compliance with other listing standards.
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. Among other things, there can be no guarantee that the actions that the Company has taken or will take will prove successful or cure the NYSE American deficiency. In addition, no assurance can be given as to whether the trial at Roswell Park or other ongoing 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 Roswell Park or the Universities or Cancer Centers sponsoring other trials. 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.
Hemispherx Biopharma, Inc.
LHA Investor Relations
Miriam Weber Miller
Senior Vice President