BiolineRx announced both a $15 million ADS offering and a new Orphan Drug Designation by the FDA for its lead oncology product, BL-8040 for the treatment of pancreatic cancer. The company's value has increased to $197M
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Summary of Highlights
Pancreatic cancer has a very poor five year survival rate. Despite advances in the treatment of various cancers with immune checkpoint inhibitors, pancreatic cancer is refractory to these treatment options, and remains an area of significant unmet medical need. Today the pancreatic cancer therapeutics market is valued at approximately $2 billion and is growing at an exponential rate.
Bioline announced (5 Feb, 2018) that it has priced an underwritten public offering of 28,000,000 American Depositary Shares ("ADSs"), at a public offering price of $0.55. The gross proceeds of the offering to the Company are expected to be $15.4 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioLineRx, and excluding the exercise of any warrants. The closing of the offering is expected to occur on or about February 7, 2019, subject to customary closing conditions. BioLineRx anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials. The offering was conducted at a discount of 30% on tיe 6 months average ADS price ($0.8).
In addition, one of BiolineRX's leading products, BL-8040 received Orphan Drug Designation in pancreatic cancer. This is a very important milestone in the development plan of BL-8040 and joins the BL-8040 previously FDA approved orphan designations for AML and stem-cell mobilization. BL-8040 has gained a lot of interest and is currently being investigated in clinical studies for the treatment of pancreatic cancer under two separate immuno-oncology collaborations – one with Merck (known as MSD outside the US and Canada), and the other with Genentech, a member of the Roche Group.
Orphan Drug Designation by the FDA entitles BiolineRx to the following: seven years of market exclusivity for the use of BL-8040 in the treatment of pancreatic cancer (in the case of marketing approval), development incentives such as tax credits related to clinical trial expenses, an exemption from the FDAuser fee, and FDA assistance in clinical trial design.
BiolineRX is becoming a leader in the development of novel therapeutics for the treatment of cancer. Financially, this designation increases our estimation for the market share the company will have. Thus, we are updating our valuation of the company to $197M / NIS 715M (previously $166M / NIS 612M); Target price decreased to a mean of NIS 4.95 (previously, NIS 5.67) due to dilution because of the new offering.
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About the company - BioLineRx Ltd. (hereinafter: "BioLineRx" or "the Company") is an Israeli clinical-stage biopharmaceutical company focused on oncology and immunology. In 2007, the company was listed on the Tel Aviv Stock Exchange. In July 2011, the company registered American Depositary Shares (ADSs) with the NASDAQ. The Company in-licenses compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
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