XTL Biopharmaceuticals Ltd. (Nasdaq:XTLB); TASE:XTL) has filed a registration statement with the US Securities and Exchange Commission (SEC) to raise up to a gross $40 million on Nasdaq. The company will offer up to 3,216,331 American Depository Receipts (ADRs), each representing 20 ordinary shares, at $3.23 per ADR (NIS 0.60 per share on the TASE).
XTL's share price fell 5% on Nasdaq, the day after the filing, to $3.81, giving a market cap of $52 million, and fell 1% by midday on the TASE today to NIS 0.695.
A month ago, XTL CEO Joshua Levine told "Globes" that the company would focus on its treatment for Lupus, which had previously been developed by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), but returned to the Weizmann Institute of Science after the failure of a clinical trial.
"I devoted my first two days as XTL's CEO to purchasing the rights to this Lupus drug," said Levine, who was familiar with the drug from his work at Teva's innovative drugs R&D department. "The drug failed in the 2007 clinical trial under US Food and Drug Administration (FDA) protocols, but it has since redefined success in a clinical trial for the disease. If we use the new measurements for the data achieved in Teva's study, the drug achieved good results. If we can replicate Teva's results, we can register the product."
1.5 million people suffer from chronic Lupus, and the market exceeds $1 billion. There is one treatment on the market, Banlysta, but it is not suitable for all patients. XTL has a second product under development: recombinant Human Erythropoietin (rHuEPO), a known agent for anemia, to prolong the survival of patients with advanced Multiple Myeloma.
XTL plans to initiate a large Phase IIb clinical study of its hCDR1 compound for the treatment of Lupus in late 2014 or early 2015, and expects interim results 1-2 years later. It plans to initiate Phase II clinical trial of its Multiple Myeloma treatment by mid-2014 in Israel and selected foreign medical centers. The company will need a partner for its Lupus treatment, as it will find it difficult to finance a Phase III clinical trial on its own. Further independent development of the Myeloma treatment is possible.
$40 million is a reasonable to finance these activities, although XTL might not raise the full amount in a single offering. It had $3.3 million in cash at the end of September 2013.
Published by Globes [online], Israel business news - www.globes-online.com - on March 9, 2014
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