In 2016, we performed a PK study involving 66 Chinese subjects, or the Chinese PK Study, who are domiciled in the United States, consisting of two parts. Overall treatment with Aramchol 400 mg and 600 mg was well tolerated, all adverse events were mild, and no safety signal was identified. No serious adverse events or deaths were reported. We deemed no changes were required in the enrollment of Chinese patients into the ARREST Study

Leave-one-out sensitivity analysis for the impact of statin therapy on plasma concentrations of ADMA.

We may experience rapid and substantial growth in order to achieve our operating plans, which will place a strain on our human and capital resources. Successful implementation of our business plan will require management of growth, which will result in an increase in the level of responsibility for management personnel. Although we have a relatively small number of employees, as we prepare for the ARMOR Study we have been increasing our operations, including expanding our employee base of managerial, operational, clinical and financial personnel. Any future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. To that end, we must be able to, among other things:

a Representative myocardium sections stained by HE showing cadiomyocyte hypertrophy (Bar = 50 μm) with sections stained for F-actin by rhodamine phalloidin showing below to illustrate cardiomyocyte rupture (Bar = 100  m) in different groups. b Representative images of MBF acquired by Laser Scanning Doppler Perfusion Imager in each group. c Statistical results of MBF in each group. The data are presented as mean ± S.E. *p < 0.05 vs. Sham, #p < 0.05 vs. AAS1M, †p < 0.05 vs. AAS2M, ‡p < 0.05 vs. QSYQ, $p < 0.05 vs. ASIV, §p < 0.05 vs. DLA, €p < 0.05 vs. R1, Ψp < 0.05 vs. DO. n = 6.

For several years, I have have been attracted to the idea that aging is essentially an evolved epigenetic program.  The holy grail would be to take cells that are programmed to be old and epigenetically reprogram them to be young.  The hitch in this plan is that to do this directly requires changing methylation at millions of separate sites, in addition to re-programming dozens of other kinds of epigenetic markers (besides methylation), some of which are just being discovered.  These sites are specific to cell type, introducing further complexity.  We have neither the knowledge of where all these sites are, and only rudimenteray ability to alter them with CRISPR and allied techniques.

As is shown in Table 1, thrombin time (TT), prothrombin (PT) and activated partial thromboplastin time (APTT) were shortened, and fibrinogen (FIB) level was significantly increased in the model group. β-BA significantly prolonged TT, PT and APTT, and decreased FIB level compared with the model group, which demonstrated β-BA’s role to modulate plasma coagulation parameters in a dose-dependent manner.

In this study, using rat ascending aortic stenosis (AAS) model and proteomic and biochemical analyses, we investigated the holistic mechanisms underlying the therapeutic effect of QSYQ on CH. By comparing the efficacies and mechanisms of QSYQ, its single ingredient ASIV, DLA, R1, DO and various ingredient combinations we showed the rationality of QSYQ formula design, supporting that a regime containing multiple components is more effective than individual treatment for complex diseases16.

We are a clinical-stage biopharmaceutical company focused on the development of the liver targeted stearoyl-coenzyme A desaturase-1, or SCD1, modulator Aramchol, a first in class, novel, oral therapy for the treatment of NASH for variable populations, as well as other liver associated disorders. We believe that our product candidate, Aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that constitutes a large unmet medical need.

Raising additional capital may be costly or difficult to obtain and will dilute current shareholders’ ownership interests, potentially substantially.

        In addition, increasingly, third-party payors are requiring higher levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged. We cannot be sure that coverage will be available for any product candidate that we, or any future collaborator, commercialize and, if available, that the reimbursement rates will be adequate. Further, the net reimbursement for drug products may be subject to additional reductions if there are changes to laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S. An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any of our product candidates for which we, or any future collaborator, obtain marketing approval could significantly harm our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Antoniades, C. et al. Association of plasma asymmetrical dimethylarginine (ADMA) with elevated vascular superoxide production and endothelial nitric oxide synthase uncoupling: implications for endothelial function in human atherosclerosis. European heart journal 30, 1142-1150 , doi: 10.1093/eurheartj/ehp061 (2009).

We had negative cash flow from operating activities of approximately $9.0 million for the year ended December 31, 2018 as compared to a negative cash flow from operating activities of approximately $12.1 million for the year ended December 31, 2017. The negative cash flow from operating activities for the year ended December 31, 2018 was mainly attributable to our net loss of approximately $9.9 million.