dispensing, dispensing only under certain circumstances, special monitoring, or the use of patient registries. The FDA may require a REMS before approval or post-approval if it becomes aware of a serious risk associated with use of the product. The requirement for a REMS can materially affect the potential market and profitability of a product.

The following table summarizes the Company’s marketable debt securities as of December 31, 2018 and 2017.

        If we further expand our operations outside of the U.S., we will be required to dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

The Company’s financial assets are measured at fair value on a recurring basis by level within the fair value hierarchy. All of the Company’s marketable securities are classified as Level 1. Other than the marketable debt securities, the Company doesn’t have any other financial assets or financial liabilities marked to market at fair value.

Young, J. M. et al. Effect of atorvastatin on plasma levels of asymmetric dimethylarginine in patients with non-ischaemic heart failure. European journal of heart failure 10, 463–466, doi: 10.1016/j.ejheart.2008.03.010 (2008).

In 2016, the U.S. Congress enacted the 21st Century Cures Act. The law contains several provisions aimed at accelerating drug approval. In particular, it directs FDA to implement a formal review pathway to qualify biomarkers and other drug development tools. It is unclear when this new pathway will be implemented or whether using this pathway would have any impact on our clinical program.

In the event of a merger or consolidation of our company subsequent to which we would no longer exist as a legal entity, or a sale of all, or substantially all, of our ordinary shares or assets or other transaction having a similar effect on us, or a Transaction, any unexercised options then outstanding will be cancelled. Notwithstanding the foregoing, the Board, or the relevant committee of the Board, may determine that the options will not be cancelled but will be assumed or substituted for an appropriate number of the same type of shares or other securities of the successor company as were distributed to the Company or the shareholders in connection with the Transaction. In addition, the Board, or the relevant committee of the Board, may determine to include in certain option agreements either a clause that provides for acceleration of vesting of all or part of the unvested options in the event of a Transaction or the occurrence of another event or a clause which provides that if the optionee’s employment with the successor company is terminated by the successor company without cause within a certain period, not to exceed two years from the closing of such Transaction, all or part of the unvested options shall be accelerated.

Even if we, or any future collaborators, are able to commercialize any product candidate that we, or they, develop, the product may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies, any of which could harm our business.

The SEC maintains an Internet website that contains reports and other information regarding issuers that file electronically with the SEC. You may read and copy this annual report, including the related exhibits and schedules, and any document we file with the SEC at http://www.sec.gov.

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Lu, T.-M. et al. Effect of<i>rosuvastatin</i>on plasma levels of asymmetric dimethylarginine in patients with hypercholesterolemia. The American journal of cardiology 94, 157–161 (2004).

For the years 2018, 2017 and 2016, with respect to the above-mentioned RSUs, the Company recorded stock-based compensation expenses in the amount of $94 thousand, $105 thousand and $124 thousand, respectively. All of the above-mentioned stock-based compensation expenses are recorded under the G&A expenses.