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Our operations may be disrupted as a result of the obligation of Israeli citizens to perform military service.

        In addition to the programs described above, we also have discovery and pre-clinical programs targeting selective inhibition of various complement factors for other indications. For example, we are also developing a Factor D inhibitor program designed to reduce C3 fragment coating on PNH red blood cells and subsequent spleen phagocytosis, which could potentially increase the risk of infection and limit investigator interest, but which we also believe has the potential to serve as an efficacious treatment method.

Any of the risk factors referred to above could significantly and negatively affect our business, results of operations or financial condition, which may reduce our ability to pay dividends and lower the trading price of our ordinary shares. The risks referred to above are not the only ones that may exist. Additional risks not currently known by us or that we deem immaterial may also impair our business operations.

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Ma, X. et al. Hypoxia/Aglycemia-induced endothelial barrier dysfunction and tight junction protein downregulation can be ameliorated by citicoline. PLoS One. 8, e82604 (2013).

On September 22, 2016, we entered into an investigator initiated clinical trial agreement, or the UCSD Agreement, with the Regents of the University of California on behalf of its San Diego campus, or UCSD, to conduct a Phase 1/2A study, or the ARTISAN Study, entitled: “A Phase I-IIa Study to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics of Aramchol in a NAFLD Juvenile Population”, or the Protocol. The ARTISAN Study (ARamchol Trial to Improve Steatosis in Adolescent NAFLD) will be led by Jeffrey Schwimmer, MD, professor of pediatrics, UC San Diego School of Medicine and Director, Fatty Liver Clinic, Rady Children’s Hospital, San Diego. We expect patient enrolment of the ARTISAN Study to commence during 2019.

        In addition to the protection afforded by patents, we also rely on trade secret protection for certain aspects of our intellectual property. For example, a majority of the patents underlying our proprietary peptide chemistry technology expire by 2022. As a result, we anticipate that we will rely on trade secrets as the primary protection for the know-how behind our proprietary platform. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, consultants, independent contractors, advisors, contract manufacturers, suppliers and other third parties. We also enter into confidentiality and invention or patent assignment agreements with employees and certain consultants. Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary

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As used in this summary, the term “U.S. Holder” means a beneficial owner of our ordinary shares that is, for U.S. federal income tax purposes, (i) an individual citizen or resident of the United States, (ii) a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state thereof, or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its source, or (iv) a trust with respect to which a court within the United States is able to exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of its substantial decisions, or that has a valid election in effect under applicable Treasury Regulations to be treated as a “United States person.”

Either party may terminate the OWL License Agreement (i) upon the other party’s breach if such party fails to cure such breach within 60 days after receiving written notice thereof; or (ii) upon customary events such as the granting of a winding up order or upon the appointment of a temporary or permanent liquidator or receiver if such order or act is not cancelled within 60 days. We may terminate the OWL License Agreement for any reason upon 30 days’ prior written notice. Further, OWL may terminate the OWL License Agreement upon 30 days’ prior written notice, in the event that within 18 months of receipt of the required regulatory approval to market and sell the first Licensed Technology Product in the U.S, there has not been a first commercial sale, unless such failure or delay is caused by (i) force majeure; or (ii) the requirements of a regulatory or other governmental authority, any contract manufacturer, or due to any market shortage; or (iii) a significant technological and/or scientific barrier. 

(*) Retroactively adjusted to reflect the 729:1 share split, which occurred upon the consummation of the Reorganization (as defined below).

As far as metformin is concerned, the incidence of lactic acidosis is so rare that we’re wondering if it’s even from the metformin.


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