Except as set forth below, the information required by this item will be contained in our definitive proxy statement to be filed with the SEC in connection with the Annual Meeting of Stockholders within 120 days after the conclusion of our fiscal year ended December 31, 2018, or the Proxy Statement, and is incorporated in this Annual Report on Form 10-K by reference.

Aren’t generic bioequivalency studies supposed to show that alternate syntheses of the generic form of a drug create something that works the same way?

Market data and certain industry data and forecasts used throughout this annual report were obtained from internal company surveys, market research, consultant surveys commissioned by the Company, publicly available information, reports of governmental agencies and industry publications and surveys. Industry surveys, publications, consultant surveys commissioned by the Company and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable. However, this information may prove to be inaccurate because of the method by which some of the data for the estimates is obtained or because this information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. As a result, the market and industry data and forecasts included or incorporated by reference in this annual report, and estimates and beliefs based on that data, may not be reliable. We have relied on certain data from third-party sources, including internal surveys, industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry. However, we have not ascertained the underlying economic assumptions relied upon therein. Forecasts are particularly likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general economic growth were used in preparing the forecasts we cite. Statements as to our market position are based to the best of our knowledge on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this annual report, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this annual report.

3.        Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;

Results of pre-clinical studies and early clinical trials may not be predictive of results of future clinical trials.

Dragan, S., Serban, M. C. & Banach, M. Proprotein Convertase Subtilisin/Kexin 9 Inhibitors: An Emerging Lipid-Lowering Therapy? Journal of cardiovascular pharmacology and therapeutics , doi: 10.1177/1074248414539562 (2014).

        Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions; findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug; and any clinically important increase in the case of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if

Increased cGMP in platelets through action of NO released into the blood vessel lumen can decrease platelet activation and adhesion to the surface of endothelium37. NO can also regulate the cellular environment within the vessel wall by inhibiting the activity of growth factors released from cells within the vessel wall and from platelets on the endothelial surface38. Both water and hydroalcoholic extracts of boswellia serrata’s gum resin enhance PT and APTT coagulation time periods39. Extracts of boswellia serrata’s gum resin can be considered as an effective antiatherogenic resource for preventing coronary artery diseases and may serve as ideal source to isolate lead compounds of antiplatelet and anticoagulant therapeutics39. All the evidences raise the necessity to investigate the effects of β-BA on blood coagulation. As is manifested by the results, β-BA can significantly prolong TT, PT and APTT, and decrease FIB (Table 1). PT is referred to evaluate the overall efficiency of extrinsic clotting pathway, and prolonged PT indicates a deficiency in coagulation factors V, VII and X. On the other hand, APTT indicates the intrinsic clotting activity, and prolonged APTT usually represents a deficiency in factors VIII, IX, XI, XII and Von Willebrand’s factor40. According to the results, β-BA improves blood coagulation through extrinsic and intrinsic pathways. Additionally, it has been reported that β-BA induces release of arachidonic acids from platelets41, which in turn can induces endothelin-1 (ET-1) expression in endothelial cells42, Which has been identified as a key player of endothelial dysfunction. Pretreatment of β-BA results in a significant decrease of blood ET-1 level compared to model group (see Supplementary Fig. S3 online), which provides a better insight of β-BA’s protective mechanism.

We performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that information required to be disclosed in this annual report and filed with the SEC is recorded, processed, summarized and reported timely within the time period specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act, is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. There can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons within our Company to disclose information otherwise required to be set forth in our reports. Nevertheless, our disclosure controls and procedures are designed to provide reasonable assurance of achieving the desired control objectives. Based on our evaluation, our management, including our President and Chief Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15(d)-15(e) of the Exchange Act) as of the end of the period covered by this annual report are effective at such reasonable assurance level.

In addition to any healthcare reform measures that may affect reimbursement, the market acceptance and sales of Aramchol will depend on the reimbursement policies of government authorities and third-party payors. It will be difficult for us to profitably sell Aramchol if reimbursement for the product is limited by government authorities or third-party payors. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage or reimbursement will be available for Aramchol and, if coverage and reimbursement are available, of the extent of coverage and the level of reimbursement. Reimbursement may affect the demand for, or the price of, any product for which we obtain marketing approval. In addition, third-party payors are likely to impose strict requirements for reimbursement in order to limit off-label use of a higher priced drug. Reimbursement by a third-party payor may depend upon a number of factors including the third-party payor’s determination that use of a product is: 

GENFIT SA (Paris:ALGFT.PA ) is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies, including Sanofi, to address these major public health concerns and their unmet medical needs. GENFIT’s research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT’s lead proprietary compound, GFT505, that is currently in Phase IIb.

The trading market for our ordinary shares is influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who do cover, or may cover us in the future, adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, our share price would likely decline. If any analyst who cover us to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could negatively impact our share price or trading volume.