MicroCap Review Spring 2019

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“Success in any of these trials has the potential to light a path to a new and more effective way of fighting cancer and dramatically change the immuno-oncology landscape. This is all about R&D to develop therapies aimed for those fighting lethal malignancies who currently have no real hope,” said Equels. “There can be no higher calling.” 2 investigator-sponsored trial being conducted in advanced recurrent ovarian cancer at the University of Pittsburgh Medical Center that will evaluate Ampligen in combination with pembrolizumab. Patient enrollment has been initiated in this study designed for 45 subjects. Dr. Robert Edwards, world renowned expert in ovarian cancer is the lead investigator. In addition, five Ampligen clinical trials are planned for initiation in 2019, subject to funding: 1. Phase 2 study that will evaluate Ampligen in combination with pembrolizumab in refractory metastatic colorectal carcinoma at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Study design and budget being developed. 2. Phase 2 study of advanced 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. Dr. M. Opyrchal, PI. 3. 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. 4. Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University of Nebraska Medical Center. Dr. K. Klute, PI. Protocol

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and budget being developed. 5. 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. An Independent New Drug application has been filed and is under review by the FDA. These ten trials/programs include nine different solid tumor types: pancreatic, ovarian, colorectal, prostate, lung, bladder, breast, melanoma and renal cell carcinoma. These are what Equels is referring to when he talks about Hemispherx’s “ten shots on goal.” “Success in any of these trials has the potential to light a path to a new and more effective way of fighting cancer and dramatically change the immuno-oncology landscape. This is all about R&D to develop therapies aimed for those fighting lethal malignancies who currently have no real hope,” said Equels. “There can be no higher calling.”

years served as a court-appointed receiver turning around businesses in a number of different fields. Equels received his J.D. with high honors from Florida State University. He is also a summa cum laude graduate of Troy University and obtained his Masters’ Degree in Management from Troy. Equels is also a highly decorated combat aviator, twice awarded the Distinguished Flying Cross and awarded the Purple Heart, the Bronze Star and 15 Air Medals, including three for extraordinary valor. In 2012 he was knighted by Pope Benedict as a knight of the Papal States. David R. Strayer, M.D. — Chief Scientific & Medical Officer Dr. Strayer was appointed Chief Scientific Officer in February 2016 and has acted as Hemispherx’s Medical Director since 1986. With this background and experience, he is the world’s foremost medical expert on both Ampligen and Alferon. He served as Professor of Medicine at the Medical College of Pennsylvania and Hahnemann University from 1987 to 1998. Dr. Strayer is Board Certified in Medical Oncology and Internal Medicine, with research interests in the fields of cancer and immune system disorders. He has served as principal investigator in studies funded by the Leukemia Society of America, the American Cancer Society, and the National Institutes of Health. Dr. Strayer received his M.D. in 1972 from the School of Medicine at the University of California at Los Angeles. n www.hemispherx.net

MANAGEMENT Thomas K. Equels, M.S., J.D. — Chief Executive Officer Equels was named Chief Executive Officer in February 2016 and has served as President since August 2015, having first joined Hemispherx in 2010 as General Counsel from 2010 to 2016. Prior to that, Equels’ successful legal career included extensive experience in the pharma sector. He has over the The company paid consideration to SNN or its affiliates for this article.

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