Clearside Biomedical Inc. (NASDAQ: CLSD) has filed an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding a secondary offering. The company did not give any pricing details in the filing, but it values the offering up to $86.25 million, with an overallotment option valued up to $11.25 million.
The underwriters for this offering are JPMorgan, Cowen, Stifel and Wedbush PacGrow.
This late-stage clinical biopharmaceutical company is 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 the proprietary SCS Microinjector.
With the SCS injection, Clearside’s product candidates are more directly administered to the retina and choroid, as compared to other ocular drug delivery techniques, such as intravitreal injections. The company believes SCS injection may provide a number of benefits, including lower frequency of necessary injection and faster onset of therapeutic effect.
Clearside 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 it 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.
It is estimated that there are nearly 5 million people in the United States diagnosed with these target indications, and that worldwide annual sales of drugs to treat these indications were roughly $7 billion in 2015.
In the filing, the company said:
We anticipate that the majority of the net proceeds from this offering will be used to complete our pivotal Phase 3 clinical trial of Zuprata for the treatment of macular edema associated with non-infectious uveitis, to initiate our Phase 3 clinical program of Zuprata for the treatment of macular edema associated with RVO, to complete our ongoing Phase 1/2 clinical trial of Zuprata for the treatment of DME and to initiate and complete a planned Phase 1/2 clinical trial of axitinib for the treatment of wet AMD. The remainder may be used to fund continued research and development of our earlier-stage programs, including drug discovery for potential new applications for our suprachoroidal microinjection technology, and for working capital and other general corporate purposes.
Shares were trading down more than 10% at $16.50, with a consensus analyst price target of $25.00 and a post-IPO trading range of $5.65 to $25.08.