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By M. Marin
Advantages include expansion of the pool of potential investors & increased awareness of the company’s growth strategy
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) shares are to be included in the U.S. small cap Russell 2000® and broad-market Russell 3000® Index following the upcoming Russell annual reconstitution, based on a preliminary list of additions. The Russell index reconstitution occurs annually and inclusion is evaluated each year.
The inclusion is set to become effective upon the opening of U.S. markets on June 28, 2021. As investment managers and institutional investors use Russell indices as benchmarks for investment strategies, about $10.6 trillion in assets are benchmarked against the Russell U.S. indexes.
Versatility of the oral protein delivery platform technology…
We believe the benefits of adding ORMP to the indices increases the pool of potential investors who can acquire ORMP shares as the company continues to execute its growth strategy. The company has recently made a number of announcements to advance its various assets. Importantly, we believe the multiple studies currently being conducted underscore the potential versatility of the company’s oral protein delivery platform technology. For instance, the development of the Oravax vaccine (see below) represents a successful expansion of Oramed’s POD™ oral protein delivery platform into the vaccine development market, in our view.
… evidenced by development of COVID vaccine pill
Through a recently formed joint venture (JV), Oravax Medical, to develop a COVID-19 vaccine pill, the company and its JV partner intend to launch and commercialize an oral COVID-19 vaccine following clinical trials. In a preclinical study of its efficacy, the oral vaccine successfully produced antibodies after just one dose. It promoted systemic immunity through Immunoglobulin G (IgG), which is the most common antibody in the blood and bodily fluids protecting against viral infections, and through Immunoglobulin A (IgA), which are antibodies that are found in the lungs, sinuses, stomach, and intestines that protect the respiratory and gastrointestinal tracts against infection.
In addition to offering protection against current COVID-19 strains, Oramed also believes that the oral vaccine could protect against emerging coronavirus variants more than many other vaccines currently being administered because of its triple antigen targeting of three structural protein parts of the SARS CoV-2 virus: Spike (S), Membrane M, and coronavirus envelope E targets. Based on partner Premas’ novel technology, the Oravax pill is a virus-like particle (VLP) triple antigen vaccine. VLPs are molecules that are similar to viruses but are not infectious. According to News Medical, using VLPs is “a very effective way of creating vaccines.”
Moreover, given the difficulties involved in storing and distributing most COVID-19 vaccines currently being offered, the Oravax vaccine might also provide a more convenient way to provide wide-scale distribution and inoculation as, unlike most other vaccines that require freezing storage, the Oravax vaccine can be stored in standard refrigerators. A pill format would also enable people to fill a prescription and then take the pill vaccine in the comfort of their own homes, eliminating the inconvenience of seeking vaccine availability and then waiting at an external location to receive the dose. The company believes that a pill is probably also a greener vaccine option than a single- or double-dose injection solution that produces needles that have to be discarded. A vaccine in pill form might also help some people overcome vaccine hesitancy, or the fear of taking a relatively new vaccine.
… And Multiple Clinical Studies in 2021
50% patient enrollment in Phase 3 ORA-D-013-1 study of ORMD-0801
Simultaneously, Oramed continues to pursue opportunities in its core diabetes space, as well, including – importantly – advancing its Oral Insulin in dual concurrent Phase 3 studies. Earlier this month, the company announced that it has enrolled and randomized about 50% of the 675 patients planned for its Phase 3 ORA-D-013-1 study of ORMD-0801, its oral insulin capsule to treat type 2 diabetes (T2D). The ORA-D-013-1 trial is one of two studies being conducted simultaneously to evaluate the efficacy of the oral insulin capsule.
Oramed has also screened the first patients in its ORA-D-013-2 study, the second of the two above-noted concurrent Phase 3 studies of ORMD-0801 for the treatment of T2D. The ORA-D-013-2 study is planned to enroll 450 T2D patients.
This dual study represents the world’s first pivotal Phase 3 oral insulin trial conducted through an FDA approved protocol. Oramed also remains focused on advancing its NASH study and has also screened the first patients in this global trial. The company also is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901 for the treatment of diabetes.
Financial flexibility to develop these assets
Oramed also recently enhanced its financial flexibility by extending an agreement to sell ORMP shares from time to time under its shelf registration, depending on company needs and market conditions. Oramed has $28.0 million under the new agreement, plus also roughly $1.5 million remaining under the 2020 agreement. The flexibility of the shelf registration and extended broker agreement gives Oramed the ability to raise funds, as needed, to support its growth plans.
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