Menlo Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
“We are making solid progress in the clinical development of serlopitant for pruritus associated with prurigo nodularis (PN), our most advanced indication. Both Phase 3 PN trials are enrolling well, and we expect results from these trials in the first half of 2020,” stated
Clinical Program Updates
January 15, 2019Menlo announced that the U.S. Food and Drug Administration( FDA) granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with PN.
- Menlo is currently enrolling patients in two Phase 3 clinical trials (one in the U.S. and one in
Europe) to evaluate serlopitant as a treatment for pruritus associated with PN. Results from these trials are expected in the first half of 2020.
• At least 130 patients have been enrolled in each of the Phase 3 trials to date.
• Menlo intends to increase the target number of patients for each of the PN Phase 3 trials from 200 patients to approximately 280 patients in consideration of data from all of our completed Phase 2 pruritus trials, including the recently completed psoriasis trial. Increasing the number of patients in each trial may enable statistical significance to be achieved in a greater range of trial outcomes.
- Menlo is also currently enrolling patients in a 52-week, multicenter, open-label safety study of serlopitant for the treatment of pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis. The objective of this study is to provide long-term safety data for serlopitant in adults with pruritus, consistent with ICH and
FDAguidelines, which recommend that drugs being developed for long-term treatment be evaluated for safety in at least 100 patients treated for 12 months and 300 patients treated for 6 months. Approximately 200 patients have been enrolled in this open-label study to date.
December 10, 2018, Menlo announced that the Phase 2 clinical trial of serlopitant for the treatment of pruritus associated with psoriasis met its primary endpoint, showing a statistically significant reduction in pruritus based upon a 4-point improvement responder analysis. In this trial, 33% of patients treated with serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline (primary efficacy endpoint) vs. 21% of patients treated with placebo (p=0.028).
- The company expects to have an End of Phase 2 Meeting with the
FDAin the first half of 2019 and to begin a Phase 3 program for pruritus associated with psoriasis in 2019.
- The results of the recently completed Phase 2 trial in patients with pruritus associated with psoriasis will be presented on
March 2, 2019at the Annual Meeting of the American Academy of Dermatology.
Chronic Pruritus of Unknown Origin
- Menlo is conducting a Phase 2 clinical trial in patients with chronic pruritus of unknown origin. The company expects to enroll approximately 200 patients in this trial.
- Menlo began enrollment of patients in this Phase 2 trial in the first quarter of 2019.
- Menlo anticipates that results from this trial will be available by mid-2020.
Fourth Quarter 2018 Financial Results
Menlo reported a net loss attributable to common stockholders of $17.6 million for the fourth quarter of 2018, compared to a net loss of $9.3 million for the same period in 2017.
Collaboration and license revenue was zero in the fourth quarter of 2018 compared to $2.8 million for the same period in 2017. The decrease in collaboration and license revenue was due to the termination of the Collaboration Agreement with JT Torii in
Research and development expenses were $15.1 million in the fourth quarter of 2018, compared to $10.5 million for the same period in 2017. The increase was primarily due to an increase in clinical trial expenses, an increase in personnel expenses and stock-based compensation expense as a result of an increase in our employee headcount, and an increase in manufacturing expenses.
General and administrative expenses were $3.4 million in the fourth quarter of 2018, compared to $1.7 million for the same period in 2017. The increase was primarily due to an increase in professional fees as a result of becoming a public company as well as an increase in personnel expenses and stock-based compensation expense as a result of an increase in our employee headcount.
Full Year 2018 Financial Results
Menlo reported a net loss attributable to common stockholders of $51.4 million for the year ended
Collaboration and license revenue was
Research and development expenses were $53.0 million for the year ended
General and administrative expenses were $12.2 million for the year ended
As of December 31, 2018, Menlo had $136.3 million in cash, cash equivalents and investments, compared to $62.5 million as of December 31, 2017.
Menlo expects that its current cash, cash equivalents and investments will enable the company to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2020. Menlo expects operating expenses for the full year 2019 to be in the range of
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
- See attached financial tables –
|Menlo Therapeutics Inc.
Statement of Operations Data
(In thousands, except per share data)
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Collaboration and license revenue||$||-||$||2,775||$||10,640||$||4,582|
|Research and development||15,076||10,546||52,989||29,007|
|General and administrative||3,364||1,706||12,186||5,168|
|Loss from operations||(18,440||)||(9,477||)||(54,535||)||(29,593||)|
|Interest income and other expense, net||846||200||3,090||517|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.76||)||$||(1.80||)||$||(2.37||)||$||(5.69||)|
|Weighted average common shares used to compute net loss per share attributable to common stockholders, basic and diluted||23,166,417||5,152,087||21,668,689||5,108,121|
|Menlo Therapeutics Inc.
Condensed Balance Sheet Data
|December 31, 2018||December 31, 2017|
|Cash, cash equivalents and investments||$||136,250||$||62,479|
|Stockholders' equity (deficit)||130,377||(57,034||)|
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Source: Menlo Therapeutics Inc.