Healthcare Business

Edge Therapeutics Closes in on IPO With Updated Terms

Edge Therapeutics has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO). The company is offering roughly 5.67 million shares in an expected price range of $14 to $16, with an overallotment option for an additional 850,000 shares. At the maximum price, the entire offering is valued up to $104.3 million. The company intends to file on the Nasdaq Global Market under the symbol EDGE.

The underwriters for the offering are Leerink Partners, Credit Suisse, Guggenheim Securities and JMP Securities.

This clinical-stage biotechnology company discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening conditions. Edge’s initial product candidates target rare, acute life-threatening neurological conditions for which it believes the approved existing therapies are inadequate.

EG-1962 is the lead product candidate, which the company believes can fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage (aSAH), which is bleeding around the brain due to a ruptured brain aneurysm. A single dose of EG-1962 is designed to deliver high concentrations of nimodipine, the current standard of care, directly to the brain with sustained drug exposure over 21 days. EG-1962 utilizes Edge’s proprietary, programmable, biodegradable polymer-based development platform, Precisa. In late May, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for EG-1962 for the treatment of patients with aSAH.

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In addition to EG-1962, Edge is using its Precisa platform to develop additional product candidates targeting other acute, serious conditions where limited or no current therapies exist. The company is developing its second product candidate, EG-1964, as a prophylactic treatment in the management of chronic subdural hematoma (cSDH) to prevent recurrent bleeding on the surface of the brain. EG-1964 contains aprotinin, a pancreatic trypsin inhibitor approved to reduce bleeding after cardiac surgery. The company believes that EG-1964 will deliver a high concentration of aprotinin directly to the subdural space with sustained drug exposure over 21 to 28 days. If approved, Edge expects that EG-1964 can become the standard of care as a prophylactic treatment in the management of cSDH to prevent recurrent bleeding. The company intends to submit an Investigation New Drug Application (IND) to the FDA for EG-1964 in 2016 and initiate a Phase 1/2 trial afterward.

The company plans to use the proceeds from this offering to fund its Phase 3 program and development work for EG-1962, preclinical studies and commencement trials of EG-1964, and new, ongoing discovery and development programs.