March 10, 2016
By Mark Terry, BioSpace.com Breaking News Staff
With one piece of bad news after another, Cambridge, Mass.-based Eleven Biotherapeutics Inc. filed a Form 8-K with the U.S. Securities and Exchange Commission, addressed a delisting notification it received from the Nasdaq on Mar. 3.
The Nasdaq informed the company that its stock dropped below $1 a share, and that the stockholder equity didn’t comply with the $5,000,000 minimum stockholders’ equity requirement. As a result, it has 180 days to comply with Nasdaq rules.
On Jan. 10, the company announced that its Phase III clinical trial of EBI-005 (isunakinra) for severe allergic conjunctivitis did not meet its primary endpoint.
In May 2015, the company reported that its drug, EBI-005, for moderate to severe dry eye disease, failed to prevent damage to the cornea or reduce eye pain in comparison to the control group.
In a January statement, Abbie Celniker, president and chief executive officer of Eleven Biotherapeutics, said, “We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis. Our efforts will be focused on submitting an investigational new drug application (IND) for EBI-031 in diabetic macular edema in the first half of 2016.”
EBI-031 was designed for intravitreal delivery using the company’s AMP-Rx platform. The drug blocks both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). The compound is being developed to treat diabetic macular edema (DME) and uveitis.
The company made its initial public offering (IPO) in February 2014 for $10 per share. Company rose to $13.56 on May 12, 2015, then dropped to $2.34 on May 19, 2015 and never really recovered. Shares rose briefly on Aug. 13, 2015 to $5 per share, then dropped back to $3.61 on Aug. 19. Shares are currently trading for $0.32.
On Jan. 26, 2016, Eleven Biotherapeutics announced that it was selling its proprietary Supermin albumin variant assets to Copenhagen, Denmark-based Albumedix. Eleven has used its AMP-Rx platform to develop recombinant albumin variants that extend the systemic concentrations of drugs. Albumedix is a leader in albumin engineering and protein manufacturing. Albumedix’s proprietary drug delivery platform, Veltis, is a good fit with Eleven’s albumin technology.
“Albumedix has a credible track record in the innovation and supply of commercial recombinant albumin,” said Peter Rosholm, vice president of Albumedix, in a statement. “The acquisition of Eleven’s exciting albumin platform, which will be incorporated without our proven Veltis technology portfolio, will strengthen our existing offering and mean we are able to provide customers with an even more comprehensive solution to improve the therapeutic impact of their products.”
The terms of the deal have not been disclosed, although there was an upfront fee and a cut of profits.
The company has indicated that it has enough cash and cash equivalents to operate into this year’s fourth quarter. As of Dec. 31, 2015, the company reported $36.1 million in cash and equivalents. However, because of the outcome of the most recent clinical trial, Eleven Biotherapeutics has to fund a cash collateral account with Silicon Valley Bank for about $15.1 million, which is the outstanding amount under its current loan agreement with the bank.
“Despite this outcome,” Michael Goldstein, Eleven Biotherapeutics’ chief medical officer, said in an earlier statement, “we plan to continue to assess interleukin-1 (IL-1) genotyping in ocular surface diseases by evaluating data from patient subsets in this clinical trial identified to be higher producers of IL-1.”
