Menlo Therapeutics has registered an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). The company did not mention any pricing details in the filing, but the offering is valued up to $97.75 million, although this number tends to be just a placeholder. The company intends to list its stock on the Nasdaq under the symbol MNLO.
The underwriters for the offering are Jefferies, Piper Jaffray, Guggenheim Securities and JMP Securities.
This is a late-stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. The company is concurrently evaluating the use of serlopitant for the treatment of refractory chronic cough, a cough that persists for greater than eight weeks despite treatment of any identified underlying cause. Management believes that serlopitant has the potential to significantly alleviate pruritus and refractory chronic cough symptoms.
The company expects data from its ongoing Phase 2 clinical trial in pruritus associated with atopic dermatitis in the second quarter of 2018 and from its ongoing Phase 2 clinical trials in pruritus associated with psoriasis and refractory chronic cough by late 2018 or early 2019. Menlo plans to initiate two Phase 3 clinical trials in pruritus associated with prurigo nodularis in the first half of 2018, with results expected in the first half of 2020.
If these or future trials are successful, the firm could potentially submit a New Drug Application (NDA) for up to three indications in 2020: pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis.
Menlo intends to use the net proceeds from this offering for a few different objectives:
- To complete our ongoing Phase 2 clinical trials of serlopitant for pruritus associated with atopic dermatitis and psoriasis, and for refractory chronic cough;
- To significantly advance our planned Phase 3 development of serlopitant for pruritus associated with prurigo nodularis;
- Development and manufacturing costs primarily associated with supplying serlopitant for our clinical trials, and development and validation of our commercial manufacturing process for serlopitant in preparation for our NDA and MAA submissions;
- $3.0 million milestone payment to Merck associated with initiating a Phase 3 clinical trial;
- The remainder for personnel expenses, other development activities, including potentially commencing Phase 3 clinical trials for pruritus associated with atopic dermatitis and psoriasis and for refractory chronic cough, working capital and other general corporate purposes.