We protect our intellectual property rights related to the Extreme Diversity program through a combination of licensed patents, trade secrets, and know-how. For more information, see the section titled "Intellectual Property."

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        Identifying potential product candidates and conducting pre-clinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

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Financial instruments which potentially subject us to credit risk consist primarily of cash, cash equivalents, and marketable securities. We hold these investments in highly-rated financial institutions, and, by policy, limit the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. We have not experienced any credit losses in such accounts and do not believe we are exposed to any significant credit risk on these funds. We have no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements.

ChIP assays were carried out using the EZ ChipTM Assay kit (Millipore) according to the manufacturer’s instructions. Briefly, cells were crosslinked with 1% formaldehyde at room temperature for 15 min, washed twice in PBS and lysed in SDS lysis buffer. Chromatin fragments were prepared by sonicating lysates on ice. Then, lysates were incubated with antibodies against HIF-1α, HIF-2α (Novus Biologicals), RNA polymerase II, or IgG (Millipore). Immunoprecipitated complexes were collected using protein G-agarose beads. The pellets were washed with Elution buffer and incubated at 65 °C for 4 h to reverse the cross-link by formaldehyde. They were then digested with 50 μg/ml proteinase K for 1 h. Dissociative DNA were purified using the Cycle Pure Kit (Omega) and subjected to PCR amplification. The primers used for amplification of the HRE and negative control segments of the promoter were as follows: HRE, 5 -AGG AAA TGA ATC AAT GTA AC -3 (forward) and 5- TAA GCA ACT CCA CCA AAA -3 (reverse); negative control, 5- TCC GCT CTT CTT CCC TCA -3 (forward) and 5– TGC GAA GCT GCT CAG TCG -3 (reverse).

In 2019, we completed a PK study involving 16 healthy subjects to assess whether dose splitting of Aramchol 600mg to twice daily 300mg will significantly increase plasma levels. The treatment in both dosing regimens was similar in terms of safety and was well tolerated.

During 2016, the Company issued a total of 78,750 RSUs. Upon vesting, each RSU will settle by the issuance of one ordinary share. The RSUs vest over four years. As of December 31, 2018, a total of 41,462 ordinary shares were issued upon vesting of 45,309 RSUs and a total of 13,869 RSUs were outstanding, while as of December 31, 2017, a total of 30,932 ordinary shares were issued upon vesting of 30,932 RSUs and a total of 32,348 RSUs were outstanding.

Zhejiang approved a process change in the manufacture of valsartan API in November 2011, but “failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process,” FDA noted in the letter. The company also failed to evaluate the need for additional analytical methods to detect impurities prior to making the process change.

In addition, under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee in the course and as a result of or arising from his or her employment with a company are regarded as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, or the Committee, a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his inventions. Recent case law clarifies that the right to receive consideration for “service inventions” can be waived by the employee and that in certain circumstances, such waiver does not necessarily have to be explicit. The Committee will examine, on a case-by-case basis, the general contractual framework between the parties, using interpretation rules of the general Israeli contract laws. Further, the Committee has not yet determined one specific formula for calculating this remuneration (but rather uses the criteria specified in the Patent Law). Although we generally enter into assignment-of-invention agreements with our employees pursuant to which such individuals assign to us all rights to any inventions created in the scope of their employment or engagement with us, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current and former employees, or be forced to litigate such claims, which could negatively affect our business.

        We are an "emerging growth company," as defined in the JOBS Act, and may remain an emerging growth company for up to five years following our initial public offering. For so long as we remain an