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Menlo Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update ~ Phase 2 Data in Psoriasis Expected December 2018 ~ ~ New Phase 2 Clinical Trial in Chronic Pruritus of Unknown Origin Expecte

Key Takeaway: Menlo Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update ~ Phase 2 Data in Psoriasis Expected December 2018 ~ ~ New Phase 2 Clinical Trial in Chronic Pruritus of Unknown Origin Expected to Start in Q4 2018 ~ ~ Prurigo Nodularis Phase 3 Clini

Full Press Release Details

Menlo Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update
~ Phase 2 Data in Psoriasis Expected December 2018 ~
~ New Phase 2 Clinical Trial in Chronic Pruritus of Unknown Origin Expected to Start in Q4 2018 ~
~ Prurigo Nodularis Phase 3 Clinical Trials Enrolling in U.S. and Europe ~
REDWOOD CITY, Calif., November 7, 2018 -- Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus associated with various conditions, today announced financial results for the third quarter ended September 30, 2018 and provided an update on its clinical development programs.
Clinical Program Updates
Refractory Chronic Cough
Third Quarter 2018 Financial Results
Menlo reported a net loss attributable to common stockholders of $12.8 million, or $0.56 per share for the third quarter of 2018, compared to a net loss of $8.2 million, or $1.60 per share for the same period in 2017.
Collaboration and license revenue for the third quarter of 2018 was zero compared to $0.9 million for the corresponding period in 2017. The decrease in collaboration and license revenue was due to the termination of the Collaboration Agreement with JT Torii in June 2018.
Research and development expenses for the third quarter of 2018 increased to $10.7 from $8.0 million for the corresponding period in 2017. The increase was primarily due to an increase in clinical trial expenses, an increase in personnel expenses as a result of an increase in our employee headcount, and an increase in manufacturing expenses.
General and administrative expenses for the third quarter of 2018 increased to $3.0 million from $1.2 million for the corresponding 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 as a result of an increase in our employee headcount.
As of September 30, 2018, Menlo had $152.7 million in cash, cash equivalents and investments, compared to $62.5 million as of December 31, 2017.
Updated 2018 Operating Expense Guidance
Menlo is lowering operating expense guidance for the full year 2018 to a range of $62.0 to $67.0 million, including approximately $4.0 million in stock-based compensation, from its prior projection of a range of $68.0 to $78.0 million. 2018 operating expenses are primarily driven by development activities related to serlopitant and Menlo's general and administrative infrastructure.
About Menlo Therapeutics
Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, for the treatment of pruritus. The Company's clinical development program for serlopitant includes ongoing Phase 3 studies for the treatment of pruritus associated with prurigo nodularis, an ongoing Phase 2 study for the treatment of pruritus associated with psoriasis, and a planned Phase 2 study for the treatment of chronic pruritus of unknown origin.
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Menlo Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including, but not limited to, statements regarding the timing of the anticipated announcement of results of its Phase 2 clinical trial for pruritus associated with psoriasis, expectations about the start and conduct of a Phase 2 clinical trial for chronic pruritus of unknown origin, the conduct and timing of data from its Phase 3 clinical trials in the United States and Europe for pruritus associated with prurigo nodularis, the objectives for the multicenter, open-label safety study of serlopitant for the treatment of pruritus 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 results, 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 Menlo Therapeutics will need to raise additional capital and will be unable to do so on favorable terms or at all, risks of competition and the risk that Menlo Therapeutics is not able to successfully defend or protect its intellectual property. These factors, together with those that are described in greater detail in Menlo Therapeutics' Annual Report on Form 10-K filed on March 28, 2018 and its Quarterly Report on Form 10-Q that it expects to file on November 7, 2018, as well as any reports that it may file with the SEC in the future, may cause Menlo Therapeutics' actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Menlo Therapeutics undertakes no obligation to update or revise any forward-looking statements.
- See attached financial tables -
Menlo Therapeutics Inc.
Condensed Statements of Operations
(In thousands, except per share data, unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2018 2017 2018 2017
Collaboration and license revenue $ - $ 909 $ 10,640 $ 1,807
Operating expenses:
Research and development 10,667 8,008 37,913 18,461
General and administrative 3,035 1,236 8,822 3,462
Loss from operations (13,702 ) (8,335 ) (36,095 ) (20,116 )
Interest income and other expense, net 855 163 2,243 316
Net loss $ (12,847 ) $ (8,172 ) $ (33,852 ) $ 19,800
Net loss per share attributable to common stockholders, basic and diluted $ (0.56 ) $ (1.60 ) $ (1.60 ) $ (3.89 )
Weighted average common shares used to compute net loss per share attributable to common stockholders, basic and diluted 22,977,793 5,116,165 21,164,069 5,093,418
Menlo Therapeutics Inc.
Condensed Balance Sheet Data
September 30, 2018 December 31, 2017 (1)
(unaudited)
Cash, cash equivalents and investments $ 152,657 $ 62,479
Working capital 146,406 56,044
Total assets 154,958 66,867
Stockholders' equity (deficit) 146,884 (57,034 )
Media Contact: media@menlotx.com
Investor Contact: dsheel@menlotx.com
Last updated: Nov 7, 2018