Any delay in obtaining or failure to obtain required approvals could negatively impact our ability or that of any future collaborators to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.

Third parties may assert that we are employing their proprietary technology without authorization. If a court held that any third-party patents are valid, enforceable and cover Aramchol and any future product candidates or their use, the holders of any of these patents may be able to block our ability to commercialize Aramchol and any future product candidates unless we obtained a license under the applicable patents, or until the patents expire. In addition to litigation proceedings which may be filed against us, we may not be able to enter into licensing arrangements or make other arrangements at a reasonable cost or on reasonable terms. Any inability to secure licenses or alternative technology could result in delays in the introduction of Aramchol or any future product candidates or lead to prohibition of the manufacture or sale of products by us.

Our strategy is to build a specialized biopharmaceutical company that develops, in a cost-effective manner, novel molecules from clinical stage to market readiness. We seek to create global partnerships with academic institutions and biotechnology or pharmaceutical companies to effectively collaborate in developing a portfolio and ultimately out-license Aramchol. Through this approach, we have successfully advanced Aramchol into various stages of clinical development. Key elements of our strategy include:

Hypoxia regulates the expression of a specific set of miRNAs previously termed hypoxamirs. Some hypoxamirs, such as miR-210, have a similar expression pattern in ubiquitous types of cells23, whereas others act as hypoxamirs only in specific types of tissues and cells. Caruso et al. have identified a number of hypoxamirs in rat lungs that are also affected by monocrotaline (MCT) treatment. Among these, miR-322 was found to be significantly upregulated during the course of development of PH18. Ghosh et al. have demonstrated that the human homolog of miR-322, has-miR-424, specifically increased in endothelial and vascular smooth muscle cells, but not in tumor cell lines, in response to hypoxia23. Here, we confirmed the hypoxia-induced increase in expression of miR-322 in rat PASMCs, highlighting miR-322 as the functional hypoxamirs in PASMCs.

The primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by magnetic resonance spectroscopy, or MRS (Aramchol 600mg vs. placebo). Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis. Other secondary endpoints included improvement (2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination in ALT (U/L).

Treatment of CHO-K1 cells expressing human HCN1 channels by MβCD resulted in reduced current density compared to untreated control cells (Fig. 1A,B). To verify that this effect was specific to the effects of membrane cholesterol, and not due to unspecific effects of MβCD, we also examined the effect of 30 μM mevastatin, which blocks cholesterol synthesis. Similar to the effect of MβCD, current densities were also reduced in cells treated with mevastatin. While there was a trend towards an increase in the current density with the enrichment of cellular cholesterol by MβCD/cholesterol (P = 0.12), statistical significance could not be resolved. Both depletion and enrichment had no effect on the steady-state activation properties of HCN1 channels (Fig. 1C; Table 1). HCN1 activation currents can be described by a dual-exponential function, whose fast time component (τfast) was unchanged by modulation of membrane cholesterol (Fig. 1D), however, cholesterol depletion reduced the slow component of activation (τslow) by 2-fold (Fig. 1E). No observable effect on HCN1 deactivation kinetics could be discerned.

Extraordinary Transactions, including private placement transactions, with a controlling shareholder or in which a controlling shareholder has a personal interest, and engagements with a controlling shareholder or his or her relative, directly or indirectly, including through a corporation under his or her control, regarding the company’s receipt of services from the controlling shareholder, and if such controlling shareholder is also an office holder or an employee of the company, regarding his or her terms of service or employment, require the approval of the audit committee or remuneration committee, the board of directors and the shareholders of a company by a Special Majority, in that order.

We rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to oversee most of the operations of our clinical trials and to perform data collection and analysis. As a result, we may face additional delays outside of our control if these parties do not perform their obligations in a timely fashion or in accordance with regulatory requirements. If these third parties do not successfully carry out their contractual duties or obligations and meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our financial results and the commercial prospects for Aramchol or any other potential product candidates could be harmed, our costs could increase and our ability to obtain regulatory approval and commence product sales could be delayed.

Loscalzo, J. Nitric oxide insufficiency, platelet activation, and arterial thrombosis. Circ Res. 88, 756–762 (2001).

Bachem is continuously expanding and updating its extensive range of products for your research purposes. We are pleased to present our latest product additions, which include human C5a Anaphylatoxin, the deuterium-labelled octreotide analog ([ring-D5]Phe³) – Octreot

        Competition that our products may face from generic versions of our products could negatively impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments in those product candidates.

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