Ding, Y. et al. Neuroprotection by Acetyl-11-Keto-β-Boswellic Acid, in Ischemic Brain Injury Involves the Nrf2/HO-1 defense Pathway. Scientific Reports. 4, 7002 (2014).

We have invested almost all of our efforts and financial resources in the research and development (clinical and pre-clinical) of our product candidate, Aramchol. We recently completed our Phase 2b ARREST Study, or the ARREST Study and are planning to initiate the ARMOR Study of Aramchol in 2019. As a result, our business is largely dependent on the commencement of and success of the ARMOR Study and our ability to complete the development of, obtain regulatory approval for and successfully commercialize Aramchol in a timely manner. The commencement of the ARMOR Study is dependent, in part, upon the success of our end of Phase 2b meeting that we plan to hold with the FDA during March 2019 and agreement on an IND for the ARMOR Study that, dependent on the outcome of that meeting, we plan to file with the FDA. There can be no assurance regarding the outcome of the planned end of Phase 2b meeting with the FDA or the IND. The process to develop, obtain regulatory approval for and commercialize Aramchol is long, complex, costly and uncertain as to its outcome.

Wang, Y. Y., Qu, Y. L., Gong, P., Wang, P., Man, Y. & Li, J. D. Preparation and in vitro evaluation of chitosan bioelectret membranes for guided bone regeneration. J. Bioact. Compat. Pol. 25, 622–633 (2010).

Eddy, A. A. Progression in chronic kidney disease. Advances in chronic kidney disease. 12, 353–365 (2005).

        If we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our products. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other foreign regulatory authorities.

Lv, S. et al. Effect of QiShenYiQi Pill on Myocardial Collagen Metabolism in Rats with Partial Abdominal Aortic Coarctation. Evid Based Complement Alternat Med 2015, 415068, 10.1155/2015/415068 (2015).

Our remuneration committee also oversees the administration of the Company’s various compensation plans and arrangements, in particular, the incentive compensation, deferred compensation and equity based plans of the Company (and to the extent appropriate, of the subsidiaries of the Company) and assists the Board in fulfilling its responsibilities relating to the compensation of directors, the Chief Executive Officer and other Office Holders of the Company. In carrying out these duties, our remuneration committee meets on an ad hoc basis. Under the Companies Law, our remuneration committee may need to seek the approval of the Board and the shareholders for certain compensation decisions as described above. Each member of our remuneration committee is an “independent director” in accordance with the Nasdaq Capital Market corporate governance requirements, as affirmatively determined by our Board. Mr. Nir, Ms. Yaron-Eldar and Dr. Sidransky are the current members of our remuneration committee, with Ms. Yaron-Eldar serving as chairperson.

Backup withholding is not an additional tax. Amounts withheld as backup withholding from a payment may be credited against a U.S. Holder’s U.S. federal income tax liability and such U.S. Holder may obtain a refund of any excess amounts withheld by filing the appropriate claim for refund with the IRS and furnishing any required information in a timely manner.

P311, also known as PTZ17, is primarily expressed in the mouse embryonic brain and persists at a high level in the cerebellum, hippocampus and olfactory bulb during adulthood1. The P311 gene has been mapped to the chromosome 5 in humans and the chromosome 18 in mice, and it encodes an 8-kDa intracellular protein that contains 68 amino acids and does not belong to any known protein family. The protein’s N-terminus contains a PEST domain (rich in Pro, Glu, Ser and Thr), which is highly conserved among humans, mice and chickens. The PEST domain functions in targeting proteins for degradation via the ubiquitin/proteasome pathway and in protein-protein interactions and activation. The PEST domain was originally identified in short-lived proteins, such as transcription factors, cytokines and signaling molecules2,3. The half-life of P311 protein is approximately 5 minutes; it is rapidly degraded by Met-HGF/SF, the lactacystin-sensitive ubiquitin/proteasome system and an unidentified metalloprotease1. P311 functions in nerve and lung regeneration4,5, glioblastoma invasion6,7, blood pressure homeostasis8, myofibroblast differentiation and amoeboid-like migration9,10,11. P311-deficient mice have no overt abnormalities, but they exhibit altered behavioral responses in learning and memory12. Additionally, P311 is involved in the affective, not the sensory, component of pain13, which is consistent with P311 expression in the nervous system.

I agree that the purpose of biotech companies is to make money, whether they have a useful drug or not. From time to time, a few turn out to have a useful drug. For example, I am thinking of CAR-T (Kite, Juno). But no doubt there are lots of scam out there.

Tu, L. et al. Astragaloside IV protects heart from ischemia and reperfusion injury via energy regulation mechanisms. Microcirculation 20, 736–747, 10.1111/micc.12074 (2013).

The Physician Payment Sunshine Act, enacted in 2010 as part of the Affordable Care Act, requires manufacturers of pharmaceuticals and medical devices to annually report certain payments and other transfers of value to physicians and teaching hospitals, as well as investment interests held by physicians and their immediate family members. In recent years, several states in the United States have also enacted legislation requiring pharmaceutical companies to file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as establish marketing compliance programs. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. Failure to meet these requirements, to the extent they are applicable to our activities, also could result in a variety of governmental sanctions that could have a material adverse effect on our business.