Menlo Therapeutics Reports First Quarter 2019 Financial Results
“2019 is a year of execution for us as we prepare for multiple data events and a potential NDA filing for serlopitant next year,” said
Clinical Program Updates
January 2019, Menlo announced that the U.S. Food and Drug Administration( FDA) granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (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. Each trial will enroll approximately 280 patients. More than 160 patients have been enrolled in each trial to date. Results from these trials are expected in the first half of 2020.
- Menlo is also currently enrolling patients in a 52-week, multicenter, open-label safety study of serlopitant for the treatment of pruritus associated with PN, 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 300 patients have been enrolled in this open-label study to date.
- Menlo has completed an initial end of Phase 2 meeting with the
FDAand is in ongoing communications with the FDAregarding the planned Phase 3 program for pruritus associated with psoriasis, which is anticipated to begin in 2019.
Chronic Pruritus of Unknown Origin
- Menlo is conducting a Phase 2 clinical trial in patients with chronic pruritus of unknown origin and 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.
First Quarter 2019 Financial Results
Menlo reported a net loss attributable to common stockholders of $18.9 million for the first quarter of 2019, compared to a net loss of $12.7 million for the same period in 2018.
Collaboration and license revenue was zero in the first quarter of 2019 compared to $0.5 million for the same period in 2018. 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 $15.9 million in the first quarter of 2019, compared to $11.0 million for the same period in 2018. The increase was primarily due to an increase in manufacturing expenses, clinical trial expenses, an increase in personnel expenses as a result of an increase in our employee headcount and stock-based compensation expense, and an increase in medical affairs related costs.
General and administrative expenses were $3.7 million in the first quarter of 2019, compared to $2.7 million for the same period in 2018. The increase was primarily due to an increase in personnel expenses as a result of an increase in our employee headcount and stock-based compensation expense and an increase in professional and insurance fees.
As of March 31, 2019, Menlo had $121.5 million in cash, cash equivalents and investments, compared to $136.3 million as of December 31, 2018. In
Updated Cash Runway Guidance
Menlo expects that its current cash, cash equivalents and investments will enable the company to fund its anticipated operating expenses and capital expenditure requirements through the end of 2020.
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 potential safety and efficacy of serlopitant for the treatment of various conditions, expectations with respect to the timing of enrollment and the anticipated announcement of results of its clinical trials for pruritus associated with prurigo nodularis, psoriasis, and chronic pruritus of unknown origin, the timing of potential regulatory filings, the regulatory process and regulatory approvals and the potential utility of Breakthrough Therapy designation. Such forward-looking statements involve substantial risk and uncertainties that could cause Menlo Therapeutics’ development program for serlopitant, future financial 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 are unsuccessful, despite prior successfully 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 resulting from the unpredictability of the regulatory process and regulatory developments in the
- See attached financial tables –
|Menlo Therapeutics Inc.
Condensed Statements of Operations
(In thousands, except share per share data, unaudited)
|Three Months Ended|
|Collaboration and license revenue||$||-||$||497|
|Research and development||15,923||11,020|
|General and administrative||3,746||2,697|
|Loss from operations||(19,669||)||(13,220||)|
|Interest income and other expense, net||796||563|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.81||)||$||(0.72||)|
|Weighted average common shares used to compute net loss per share attributable to common stockholders, basic and diluted||23,286,282||17,583,377|
|Menlo Therapeutics Inc.
Condensed Balance Sheet Data
|Cash, cash equivalents and investments||$||121,516||$||136,250|
- Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2018.
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Source: Menlo Therapeutics Inc.