The aggregate market value of the common stock held by non-affiliates of the Registrant was approximately $226.8 million based upon the closing price of the common stock as reported on the Nasdaq Global Market on June 29, 2018, the last business day of the Registrant’s most recently completed second fiscal quarter. As of March 1, 2019, there were 42,188,517 shares of the Registrant’s common stock outstanding, $0.001 par value per share.

CombinatoRx Inc. (NasdaqGM: CRXX ) CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action striking at the biological complexities of human disease. This product portfolio is internally generated from the CombinatoRx proprietary drug discovery technology which provides a renewable and previously untapped source of novel drug candidat.

Our market is subject to intense competition. If we are unable to compete effectively, Aramchol or any other potential product candidate that we develop may be rendered suboptimal, noncompetitive or obsolete.

        Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. This could discourage, delay or prevent someone from acquiring us or merging with us, whether or not it is desired by, or beneficial to, our stockholders. This could also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in your best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock.

It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.

Han, R. Highlight on the studies of anticancer drugs derived from plants in China. Stem Cells. 12, 53–63 (1994).

In December 2018, the FDA issued the December Guidance. The December Guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic NASH with liver fibrosis, describes the FDA’s current thinking regarding the necessary components of a drug development program for noncirrhotic NASH with liver fibrosis and identifies knowledge gaps that represent important challenges in the development of drugs for the indication. According to the FDA, the ultimate goal of NASH treatment is to slow the progress of, halt, or reverse disease progression and improve clinical outcomes (i.e., prevent progression to cirrhosis and cirrhosis complications, reduce the need for liver transplantation, and improve survival). Because of the slow progression of NASH and the time required to conduct a trial that would evaluate clinical endpoints such as progression to cirrhosis or survival, the FDA recommends sponsors consider the following liver histological improvements as endpoints reasonably likely to predict clinical benefit to support accelerated approval under the regulations:

Fujitani, M. et al. P311 accelerates nerve regeneration of the axotomized facial nerve. Journal of neurochemistry. 91, 737–744 (2004).

Moosmang, S. et al. Cellular expression and functional characterization of four hyperpolarization-activated pacemaker channels in cardiac and neuronal tissues. Eur J Biochem 268, 1646–52 (2001).

We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.

Ceragenix Phamaceuticals Inc. (OTCBB: CGXP ) Ceragenix Pharmaceuticals, Inc. is a medical device company focused on infectious disease and dermatology. The Company has two base technology platforms; Ceragenins for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others.

Bachem and Debiopharm has announced the conclusion of a follow-up agreement for the long-term supply of Triptorelin Pamoate. Bachem has been supplying Triptorelin Pamoate, the active ingredient for Debiopharm’s Decapeptyl® (Trelstar® in the USA), for the treatment of prostate cancer,