Menlo Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results
“We are extremely pleased with the completion of our initial public offering. The funds from the IPO will provide Menlo the ability to advance the development of serlopitant as a potential once-daily therapy for pruritus and cough. We look forward to seeing the results from our Phase 2 study (ATOMIK) in atopic dermatitis which are expected in April of 2018,” stated
Fourth Quarter Business Highlights and Recent Developments
- In January, we successfully completed our initial public offering (IPO) of common stock of 8,050,000 shares of common stock at a public offering price of
$17.00 per share, which includes the exercise in full by the underwriters of their overallotment option. We raised net proceeds of approximately$125.5 million , after deducting underwriting discounts, commissions and offering expenses.
- In
November 2017 , we initiated enrollment in a 200-patient Phase 2 clinical trial evaluating serlopitant for the treatment of pruritus associated with psoriasis.
- In
October 2017 , we initiated enrollment in a 170-patient Phase 2 trial evaluating serlopitant as a treatment for refractory chronic cough.
- During 2017, we expanded our management team with key hires in finance, clinical development, medical affairs and commercial development.
Clinical Program Updates
Atopic Dermatitis
- We have completed the treatment and follow-up period for all patients in our Phase 2 study of serlopitant as a treatment for pruritus associated with atopic dermatitis, and expect to report data from this study in
April 2018 .
Psoriasis
- We expect to report data from our ongoing Phase 2 study in pruritus associated with psoriasis in late 2018 or early 2019 as previously indicated.
Prurigo Nodularis
- We plan to initiate two Phase 3 studies in pruritus associated with prurigo nodularis in the second quarter of 2018. We expect to enroll approximately 200 patients in each study. One study will be conducted in the U.S. and one in
Europe .
- We have recently started a 52-week, multicenter, open-label safety study of serlopitant for the treatment of pruritus. The objective of this study is to provide long-term safety data for serlopitant in adults with pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
Refractory Chronic Cough
- We are updating timing for data from our Phase 2 study in refractory chronic cough. We now expect to report data from this study in the fourth quarter of 2018 versus our prior guidance of late 2018 or early 2019.
Financial Results
Fourth Quarter 2017 Financial Results
Menlo reported a net loss attributable to common stockholders of $9.3 million for the fourth quarter of 2017, compared to a net loss of $4.8 million for the same period in 2016.
Collaboration and license revenue was
Research and development expenses were $10.5 million in the fourth quarter of 2017, compared to $4.1 million for the same period in 2016. The increase was primarily due to an increase in clinical trial expenses related to the development of serlopitant and higher personnel-related expenses.
General and administrative expenses were $1.7 million in the fourth quarter of 2017, compared to $1.3 million for the same period in 2016. The increase was primarily due to higher personnel-related expenses to support our expanding operations.
Full Year 2017 Financial Results
Menlo reported a net loss attributable to common stockholders of $29.1 million for the year ended
Collaboration and license revenue was
Research and development expenses were $29.0 million for the year ended
General and administrative expenses were $5.2 million for the year ended
As of December 31, 2017, Menlo had $62.5 million in cash, cash equivalents and investments, compared to $41.3 million as of December 31, 2016. In
Financial Outlook
For the full year 2018, Menlo expects operating expenses in the range of approximately
About
Forward Looking Statements
This press release contains forward-looking statements, including but not limited to the potential of serlopitant to treat pruritus associated with atopic dermatitis, psoriasis, and prurigo nodularis, or to treat refractory chronic cough, the conduct and anticipated announcement of results of Phase 2 clinical studies for pruritus associated with atopic dermatitis, refractory chronic cough and psoriasis, expectations about the start of Phase 3 clinical trials for pruritus associated with prurigo nodularis, and expected operating expenses for the full year 2018. Such forward-looking statements involve substantial risk and uncertainties that could cause Menlo Therapeutics’ development program for serlopitant, future results, achievements or performance to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks that the timing of enrollment or commencement of clinical trials may be delayed, the risk that subsequent trials do not replicate the results from completed clinical trials or do not demonstrate efficacy of serlopitant in the studied indications, the risk of adverse safety events, risks that the costs of clinical trials will exceed expectations, risks that
- 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, | ||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||
| (Unaudited) | |||||||||||||||||||
| Collaboration and license revenue | $ | 2,775 | $ | 450 | $ | 4,582 | $ | 674 | |||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 10,546 | 4,078 | 29,007 | 11,255 | |||||||||||||||
| General and administrative | 1,706 | 1,296 | 5,168 | 3,751 | |||||||||||||||
| Loss from operations | (9,477 | ) | (4,924 | ) | (29,593 | ) | (14,332 | ) | |||||||||||
| Interest income and other expense, net | 200 | 88 | 517 | 264 | |||||||||||||||
| Net loss | $ | (9,277 | ) | $ | (4,836 | ) | $ | (29,076 | ) | $ | (14,068 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.80 | ) | $ | (0.96 | ) | $ | (5.69 | ) | $ | (2.82 | ) | |||||||
| Weighted average common shares used to compute net loss per share attributable to common stockholders, basic and diluted | 5,152,087 | 5,051,111 | 5,108,121 | 4,987,133 | |||||||||||||||
| Menlo Therapeutics Inc. | |||||||
| Condensed Balance Sheet Data | |||||||
| (In thousands) | |||||||
| December 31, | |||||||
| 2017 | 2016 | ||||||
| Cash, cash equivalents and investments | $ | 62,479 | $ | 41,328 | |||
| Working capital | 56,044 | 27,637 | |||||
| Total assets | 66,867 | 42,053 | |||||
| Stockholders' deficit | (57,034 | ) | (29,441 | ) | |||
Media Contact: media@menlotx.com
Investor Contact: dsheel@menlotx.com
Source: Menlo Therapeutics Inc.