Health and Healthcare

Clearside Files for IPO

Chris Lange

Published: January 11, 2016 10:05 am

Last Updated: January 13, 2020 3:12 pm

Clearside Biomedical has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were given in the filing, but the offering is valued up to $57.5 million. The company intends to list on the Nasdaq Global Market under the symbol CLSD.

The underwriters for the offering are RBC Capital Markets, Stifel, Needham and Wedbush PacGrow.

This is a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. The current product candidates focus on diseases affecting the retina and choroid, especially diseases associated with macular edema, and are injected into the suprachoroidal space (SCS) adjacent to the choroid, using its proprietary SCS Microinjector.

With the SCS injection, the product candidates are more directly administered to the retina and choroid, as compared to other ocular drug delivery techniques, such as intravitreal injections. Clearside believes SCS injection may provide a number of benefits, including lower frequency of necessary injection and faster onset of therapeutic effect.

The company holds the exclusive rights to develop and commercialize drugs for injection into the SCS. Its most advanced product candidates, CLS-1001 and CLS-1003, are based on commonly used ophthalmic drugs, which Clearside believes will allow it to more efficiently and predictably pursue the regulatory approval of these product candidates under the U.S. Federal Food, Drug and Cosmetic Act.

If the company can establish that reliance on the Food and Drug Administration’s (FDA’s) previous findings of safety and effectiveness for an approved product is scientifically appropriate, or there is scientific literature to support the product’s safety or effectiveness, it may eliminate the need for it to conduct some of the preclinical studies or clinical trials for the new product candidate that might otherwise have been required.

Clearside estimates that there are nearly 5 million people in the United States diagnosed with its target indications and that worldwide annual sales of drugs to treat these indications were roughly $7 billion in 2014.

The company intends to use the net proceeds from this offering to complete its ongoing clinical trials and to fund continued research. The remainder will be used for working capital and general corporate purposes.