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stock-based compensation expense; partially offset by a decrease in net operating losses and a lower U.S. federal tax rate due to the TJCA.

American Oriental Bioengineering Inc. (NYSE:AOB ) is a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter products.

bioMmune Technologies Inc. (TSX:IMU.V) is a biopharmaceutical company headquartered in Vancouver, Canada. BioMmune is developing three technologies discovered at The University of British Columbia. They include, discovery of compounds that will be active in restoring immune-recognition of cancer cells resulting in the body’s immune system to fight the cancer cells. A discovery relating to Calcium Channels, whose activities regulate the concentration of calcium (Ca) in different compartments in cells, which is very important for the activity of cells involved in the immune system to improve their ability to combat cancers, infections and also autoimmunities. Furthermore, the company is pursuing the modulation of CD74, a protein involved in the immune system and its ability to fight foreign antigens. Finding ways or compounds that regulate its activity will improve the immune system to combat infections, cancers and autoimmune diseases.

For hypoxia experiments, cells were placed in a special hypoxia incubator infused with a gas mixture of 5% CO2 and nitrogen to obtain 3% oxygen concentration. To chemically stabilize HIFs, cells were treated with 200 μM CoCl2 (Sigma-Aldrich) or an equivalent volume of deionized water (dissolvent control) for 24 h.

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The process required by the FDA before a drug may be marketed in the United States generally involves the following:

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ¨ No x

        We, or any future collaborators, may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent clinical development, marketing approval or commercialization of our product candidates, including:

        In April 2013, we entered into a multi-target collaboration and license agreement with Merck, or the Merck Agreement, to use its proprietary drug discovery technology platform to identify orally available cyclic peptides for non-complement program targets nominated by Merck and provide specific research and development services. Under the Merck Agreement, we granted Merck licenses under certain of our intellectual property rights to manufacture, develop, and commercialize compounds and products directed to selected program targets. The agreement consists of a research phase, where we and Merck collaborated on identifying and pre-clinically developing orally available cyclic peptides suitable for further development by Merck, and a development and commercialization phase pursuant to which Merck has sole discretion and responsibility, including financial responsibility, for further development and commercialization of these peptides, on a program-by-program basis, from the collaboration. The research term ended in April 2016.

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Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to ordinary shares. Ordinary shares issuable under share options, warrants or other conversion rights currently exercisable or that are exercisable within 60 days after February 28, 2019 are deemed outstanding for the purpose of computing the percentage ownership of the person holding the options, warrants or other conversion rights, but are not deemed outstanding for the purpose of computing the percentage ownership of any other person. Percentage of shares beneficially owned is based on 21,113,066 ordinary shares outstanding on February 28, 2019. 

The results of our Phase 2a clinical trial of Aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal were published in December 2014. The trial manuscript, entitled “The Fatty Acid-Bile Acid Conjugate Aramchol Reduced Liver Fat Content in Patients with Nonalcoholic Fatty Liver Disease,” provides the full report of the Phase 2a trial, which was completed in January 2012 and presented at the 47th Annual Meeting of the European Association for the Study of the Liver in 2012. Based on this Phase 2a proof-of-concept results, we established a development plan that we believe may confirm: (i) the good safety profile of Aramchol, (ii) the optimal dose of Aramchol, and (iii) efficacy on steatosis as well as fibrosis in patients with NASH. 


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