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This Day That Year : Menlo Therapeutics


Shares of Menlo Therapeutics Inc. (MNLO) are down 86% from their 52-week high of $39.86 recorded on February 6, 2018.

It was on this day last year, i.e. on January 25, 2018, that Menlo Therapeutics debuted on the NASDAQ Global Select Market by setting a public offering at $17.00 per share.

Menlo is a late-stage biopharmaceutical company developing Serlopitant for the treatment of pruritus, or itch, associated with various conditions like prurigo nodularis, psoriasis, and atopic dermatitis.

Serlopitant is currently in two phase III clinical trials (one in the U.S. and one in Europe) as a treatment for pruritus associated with prurigo nodularis.

Prurigo nodularis (PN) is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, causing people to scratch themselves to the point of bleeding or pain. (Source: NIH).

It is estimated that there are approximately 350,000 people with prurigo nodularis in the United States. Currently, there is no approved treatment in the U.S. to treat this skin disease.

The phase III U.S. trial of Serlopitant is over 50% enrolled, and the European trial is over 30% enrolled. Data from each trial is expected by the first quarter of 2020.
Last month, the Company successfully completed a phase II clinical trial of Serlopitant for the treatment of pruritus associated with psoriasis. An End of Phase 2 Meeting with the FDA is expected to be held in the first half of 2019, and a phase III program for pruritus associated with psoriasis might be initiated this year.

Menlo was one of the worst IPO performers last year, losing nearly 80% of its stock value, as two of its clinical trials of Serlopitant failed to meet the endpoints.

In April 2018, the Company's phase II clinical trial of Serlopitant for the treatment of pruritus in adults and adolescents with a history of atopic dermatitis, dubbed ATOMIK, did not meet its primary or key secondary efficacy endpoints.

Another phase II study that failed last year was TUSSIX, which evaluated Serlopitant for the treatment of refractory chronic cough.

Menlo is also exploring the potential of Serlopitant in patients with chronic pruritus of unknown origin, and expects to enroll the first patient in a phase II trial this month.

Key Numbers:

In the nine months ended September 30, 2018, net loss attributable to common stakeholders was $33.85 million or $1.60 per share on collaboration & license revenue of $10.64 million. This compared with a net loss attributable to common stakeholders of $19.80 million or $3.89 per share and collaboration & license revenue of $1.81 million in the year-ago period.

The Company ended September 30, 2018, with $152.7 million in cash, and 23.23 million shares outstanding.

Shares of Menlo have traded in a range of $3.74 to $39.86 over the last 1 year. The stock closed Thursday's (Jan.24, 2019) trading at $5.48, up 0.55%.

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