Business Update and Apple iOS Stocks Advisory
OCALA, Fla., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American: HEB) announces that Thomas K. Equels, President and Chief Executive Officer, has issued a Letter to Stockholders providing a business update. The full text of the Letter, which has also been posted to the Company's website, is as follows.
To My Fellow Stockholders,
As we move into the final weeks of 2018, we are excited about the progress we have made this year and eagerly look forward to seeing how this will translate into clinical outcomes in 2019. We appreciate the support of each of our stockholders as we have worked hard to establish a clear path forward for Ampligen. I believe the clinical trials now underway, and those in our short-term pipeline, will be powerful long-term drivers for our stock.
Due to the importance of transparent communication, I want to let all our stockholders know that some of you who use the Apple Stocks app may not have a current and accurate idea of all that Hemispherx is doing to reach our goals with Ampligen if they depend solely on Apple’s default Stocks app for stock news.
We have learned that the Apple iOS12 Stocks app, as a result of a recent update, has a software “glitch” affecting numerous public companies, including Hemispherx. It inaccurately informs certain iPhone and Apple portable device users that there are “No Recent Stories” related to Hemispherx, as well as several other companies. This “No Recent Stories” statement is simply wrong as to Hemispherx. In addition to filing all financial and regulatory documents in a timely manner, Hemispherx has provided several periodic public updates in the form of press releases on our ongoing and material progress in Ampligen immuno-oncology clinical work, manufacturing and R&D progress.
We have formally notified Apple and demanded they fix this software “glitch” on an expedited basis. Thus far, Apple has not corrected the problem and, while we have every hope that they will cure this “glitch” on an expedited basis, we feel an advisory is required.
We encourage our stockholders and potential investors who are using the defective Apple Stocks app to also use other popular stock news resources — such as Bloomberg, Google Finance and Yahoo Finance — to get the latest and accurate information on Hemispherx. You can also go to our website at www.hemispherx.net to see our progress.
To ensure that our stockholders get a full picture of our most recent progress and announcements, I’ve included certain milestones achieved this year and also a link to the full body of our Q3 press release. (http://ir.hemispherx.net/profiles/investor/ResLibraryView.asp?ResLibraryID=89181&BzID=2265&g=980&Nav=0&LangID=1&s=0)
Highlights of Hemispherx’ 2018 announcements through the third quarter include:
- Numerous highly successful immuno-oncology animal studies of Ampligen in combination with checkpoint blockade therapies.
- Two cancer clinical trials underway, a Phase 1/2 with subjects being treated at the University of Pittsburgh Medical Center in Ovarian Cancer (https://clinicaltrials.gov/ct2/show/NCT02432378) and a Phase 2a Roswell Park Comprehensive Cancer Center in Colorectal Cancer (https://clinicaltrials.gov/ct2/show/NCT03403634).
- One new study in collaboration with University of Pittsburgh Medical Center and Merck Sharp & Dohme Corp. is a Phase 2 on advanced ovarian carcinoma using cisplatin, pembrolizumab (Keytruda) as an anti-PD-1 therapy plus Ampligen, and is expected to commence in January 2019 (https://clinicaltrials.gov/ct2/show/NCT03734692).
- Signed clinical trial agreement with Roswell Park Comprehensive Cancer Center to commence new clinical studies with Ampligen plus checkpoint inhibitors in bladder cancer, melanoma, and renal cell carcinoma. This new agreement expands existing pre-clinical collaborations.
- Progress at the Buffett Cancer Center toward 2019 clinical trials with Ampligen and checkpoint blockade therapy in non-small cell lung and pancreatic cancers.
- The successful production of two commercial-sized lots of Ampligen, totaling ~16,000 vials.
- Expansion of our ME/CFS Early Access Program (“EAP”), known as AMP-511, utilizing part of the above-mentioned Ampligen lots.
- Continuation of the Ampligen EAP in pancreatic cancer at Erasmus, M.C., Netherlands.
- Completed bridge financing of $3 million under terms favorable to the Company.
- Additional cancer clinical trials are expected to commence over the next twelve months.
We will continue to keep you apprised of our progress in these efforts as we move forward, accomplishing our milestones. Thank you for your continued support of Hemispherx Biopharma.
Thomas K. Equels
President and Chief Executive Officer
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.
Hemispherx Biopharma, Inc.
LHA Investor Relations
Miriam Weber Miller
Senior Vice President