In March 2016, Omega Pharma received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal of warts. The commercial product launch of this first OTC indication (warts/verrucas) commenced in the second quarter of 2016 and it is already being sold in a number of countries in the EU, as described in “Clinical-Stage Pipeline” above.
In August 2016, we signed an exclusive, worldwide agreement with Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for the in-licensing of a drug candidate for the treatment of liver fibrosis, and in particular, non-alcoholic steatohepatitis (NASH). This drug candidate, to be called BL-1210, is the first project to be in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates. The pre-clinical project, developed by Prof. Rifaat Safadi, Head of the Liver Unit, Department of Medicine at Hadassah Medical Center, Jerusalem, Israel, offers a novel mechanism for controlling liver fibrosis through modulation of the immune system. BioLineRx will address the novel drug target that will modulate the immune system to ultimately reduce the liver fibrogenesis and therefore reduce liver scarring. Limiting the fibrosis process this way will potentially control the disease progression.
On July 20, 2016, we received written notice (the “Notification Letter”) from The Nasdaq Stock Market (“Nasdaq”) stating that we are not in compliance with the minimum bid price requirement set forth in Nasdaq’s rules for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of our American Depositary Shares (“ADSs”), each representing one ordinary share, for the 30 consecutive business days from June 3, 2016, we no longer met the minimum bid price requirement as of the date of the Notification Letter, and such non-compliance continues as of the date of this review. The Notification Letter has no immediate effect on the listing of the ADSs, and they will continue to trade on The Nasdaq Capital Market under the symbol “BLRX” at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a grace period of 180 calendar days, or until January 17, 2017 (the “Compliance Period”), to regain compliance with the minimum bid price requirement. To regain compliance, the bid price of our ADSs must meet or exceed $1.00 per share for at least ten consecutive business days during the Compliance Period.
If we do not regain compliance with the minimum bid price requirement by January 17, 2017, Nasdaq may provide written notification to us that our securities will be subject to delisting. At that time, we may have alternatives to obtain an extension and/or avoid delisting, including an appeal of Nasdaq’s delisting determination to the Nasdaq Listing Qualifications Panel.
We intend to monitor the bid price of our ADSs between now and January 17, 2017 and intend to cure the deficiency within the prescribed grace period.
The receipt of the Notification Letter does not affect our business operations or the listing of our ordinary shares on the Tel Aviv Stock Exchange.