Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage
biopharmaceutical company focused on the development of serlopitant
for the treatment of pruritus (itch), today announced financial
results for the fourth quarter and year ended December 31, 2019 and
reviewed business highlights.
“In February, our shareholders approved our upcoming merger with
Foamix. We look forward to the prospects and outlook for the
combined organization, which will have a compelling pipeline of
dermatology products and product candidates,” said Steve Basta,
chief executive officer of Menlo Therapeutics. “We believe the
combined organization will be a stronger dermatology focused
company, well positioned to serve the needs of patients while
enhancing stockholder value.”
Foamix Merger Approved by Menlo
Shareholders
On February 6, 2020, in the special meeting of Menlo
stockholders, Menlo’s merger with Foamix was approved. On the same
date, shareholders of Foamix Pharmaceuticals Ltd. also approved all
shareholder proposals necessary to complete the merger. Pending the
expiration of a 30-day waiting period required by Israeli law and
satisfaction of closing conditions set forth in the merger
agreement, the merger is expected to close on or about March 9,
2020. The combined biopharmaceutical company will be focused on the
commercialization and development of therapeutics to serve patients
in the dermatology space.
The combined company will have a diversified portfolio including
an approved product and three late-stage product candidates focused
on dermatologic indications.
Recent pipeline highlights from both
organizations:
- Foamix recently received U.S. Food and Drug Administration
(FDA) approval for AMZEEQTM (minocycline) topical foam, 4%, for the
treatment of inflammatory lesions of non-nodular moderate-to-severe
acne vulgaris in adults and pediatric patients nine years of age
and older. AMZEEQTM is the first approved topical formulation of
minocycline to be approved by the FDA for any condition. Foamix
commercially launched AMZEEQTM in the U.S. in January 2020.
- Foamix has submitted a New Drug Application to the FDA for
FMX103 (minocycline) topical foam, 1.5%, for the treatment of
moderate-to-severe papulopustular rosacea in adults. The FDA set a
Prescription Drug User Fee Act (PDUFA) action date of June 2, 2020.
If approved, FMX103 would be the first minocycline product
available for rosacea patients. Foamix is also conducting a Phase 2
trial for FCD105, a topical combination foam of minocycline and
adapalene, currently being evaluated for the treatment of
moderate-to-severe acne vulgaris.
- Menlo’s serlopitant is being evaluated in two Phase 3 clinical
trials for the treatment of pruritus associated with prurigo
nodularis. The studies are fully enrolled, with results expected in
March or April 2020.
Expected upcoming catalysts for the combined company:
- Phase 3 clinical trial results in the U.S. and Europe for
serlopitant for the treatment of pruritus in prurigo nodularis in
March or April 2020
- PDUFA action date of June 2, 2020 for FMX103 (minocycline)
topical foam, 1.5%, for the treatment of moderate-to-severe
papulopustular rosacea in adults
- Phase 2 clinical trial results for FCD105 for treatment of
moderate-to-severe acne with top-line data expected in Q2 2020
- Assuming successful completion of the Phase 3 clinical trials,
a New Drug Application submission for serlopitant for the treatment
of pruritus in prurigo nodularis is expected in the second half of
2020.
Financial Results
Fourth Quarter 2019 Financial Results
Menlo reported a net loss of $21.5 million for the fourth
quarter of 2019, compared to a net loss of $17.6 million for the
same period in 2018.
Research and development expenses were $11.8 million in the
fourth quarter of 2019, compared to $15.1 million for the same
period in 2018. The decrease was primarily due to decreases in
manufacturing and clinical trial expenses.
General administrative expenses were $10.2 million in the fourth
quarter of 2019, compared to $3.4 million for the same period in
2018. The increase was primarily due to increases in stock-based
compensation expense, legal expenses, and transaction-related
expenses in connection with negotiating and executing the merger
agreement with Foamix.
Full Year 2019 Financial Results
Menlo reported a net loss of $73.7 million for the year ended
December 31, 2019, compared to a net loss of $51.4 million for the
year ended December 31, 2018.
Collaboration and license revenue was zero for the year ended
December 31, 2019, compared to $10.6 million for the year ended
December 31, 2018. The decrease in collaboration and license
revenue was due to the termination of Menlo’s collaboration
agreement with JT Torii in June 2018.
Research and development expenses were $53.8 million for the
year ended December 31, 2019, compared to $53.0 million for the
year ended December 31, 2018. The increase was primarily due to an
increase in clinical trial expenses, an increase in stock-based
compensation expense, and an increase in manufacturing expenses
offset by a $3.0 million milestone expense to Merck in May
2018.
General administrative expenses were $22.5 million for the year
ended December 31, 2019, compared to $12.2 million for the year
ended December 31, 2018. The increase was primarily due to
increases in stock-based compensation expense, legal expenses, and
transaction-related expenses in connection with negotiating and
executing the merger agreement with Foamix.
As of December 31, 2019, Menlo had $76.9 million in cash, cash
equivalents and investments, compared to $136.3 million as of
December 31, 2018.
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 two
ongoing Phase 3 clinical trials for the treatment of pruritus
associated with prurigo nodularis and a Phase 3-ready clinical
program for the treatment of pruritus associated with psoriasis. On
November 11, 2019, Menlo announced that it had signed a definitive
merger agreement with Foamix Pharmaceuticals Ltd. to create a
combined biopharmaceutical company focused on the commercialization
and development of therapeutics to serve patients in the
dermatology space. On February 6, 2020, the
shareholders/stockholders of Menlo and Foamix both approved the
merger. For more information about Menlo and its impending merger
with Foamix, please visit our website at
www.menlotherapeutics.com.
Important Additional Information and Where to Find
It
On December 4, 2019, Menlo filed an initial Registration
Statement on Form S-4, Menlo filed a Registration Statement on Form
S-4 containing a joint proxy statement/prospectus of Menlo and
Foamix and other documents concerning the proposed merger with the
Securities and Exchange Commission (the “SEC”). The registration
statement has been declared effective by the SEC. The registration
statement was amended by Amendment No. 1 on January 6, 2020,
supplemented on January 15, 2020 by Menlo’s 8-K and amended on
January 28, 2020 by Menlo’s 8-K. Foamix and Menlo may also file
other relevant documents with the SEC regarding the proposed
merger. This communication is not a substitute for the joint proxy
statement/prospectus or Registration Statement or any other
document which Menlo or Foamix may file with the SEC. MENLO’S AND
FOAMIX’S RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS IN ITS ENTIRETY AND ANY OTHER DOCUMENTS FILED
BY EACH OF MENLO AND FOAMIX WITH THE SEC IN CONNECTION WITH THE
PROPOSED MERGER OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER AND
THE PARTIES TO THE PROPOSED MERGER. Security holders may obtain a
free copy of the joint proxy statement/prospectus and other
documents filed by Menlo and Foamix with the SEC at the SEC’s
website at www.sec.gov. Investors and stockholders will also be
able to obtain a free copy of the joint proxy statement/prospectus
and other documents containing important information about Menlo
and Foamix through the website maintained by the SEC at
www.sec.gov. Menlo and Foamix make available free of charge at
www.menlotherapeutics.com and www.foamix.com, respectively (in the
“Investor Relations” section), copies of materials they file with,
or furnish to, the SEC.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of the federal securities law that are subject to
various risks and uncertainties that could cause our actual results
to differ materially from those expressed or implied in such
statements. Words such as “anticipate,” “expect,” “project,”
“intend,” “believe,” and words and terms of similar substance used
in connection with any discussion of future plans, actions or
events identify forward-looking statements. Such factors include,
but are not limited to: (i) conditions to the closing of the
merger may not be satisfied; (ii) the merger may involve
unexpected costs, liabilities or delays; (iii) the effect of
the announcement of the merger on the ability of Menlo or Foamix to
retain and hire key personnel and maintain relationships with
customers, suppliers and others with whom Menlo or Foamix does
business, or on Menlo’s or Foamix’s operating results and business
generally; (iv) Menlo’s or Foamix’s respective businesses may
suffer as a result of uncertainty surrounding the merger and
disruption of management’s attention due to the merger;
(v) the outcome of any legal proceedings related to the
merger; (vi) Menlo or Foamix may be adversely affected by
other economic, business, and/or competitive factors;
(vii) the occurrence of any event, change or other
circumstances that could give rise to the termination of the merger
agreement; (viii) risks that the merger disrupts current plans
and operations and the potential difficulties in employee retention
as a result of the merger; (ix) the risk that Menlo or Foamix
may be unable to obtain governmental and regulatory approvals
required for the transaction, or that required governmental and
regulatory approvals may delay the transaction or result in the
imposition of conditions that could reduce the anticipated benefits
from the proposed transaction or cause the parties to abandon the
proposed transaction; and (x) other risks to consummation of
the merger, including the risk that the merger will not be
consummated within the expected time period or at all. Additional
factors that may affect the future results of Menlo and Foamix are
set forth in their respective filings with the SEC, including
each of Menlo’s or Foamix’s most recently filed Annual Report on
Form 10-K, subsequent Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K and
other filings with the SEC, which are available on the SEC’s
website at www.sec.gov. See in particular Item 1A of Part II
of Menlo’s Annual Report on Form 10-K for the year
ended December 31, 2019 under the heading “Risk Factors”
and Item 1A of Part II of Foamix’s Quarterly Report
on Form 10-Q for the quarter ended September
30, 2019 under the heading “Risk Factors.” The risks and
uncertainties described above and in Menlo’s most recent SEC
filings and Foamix’s most recent SEC filings are not exclusive and
further information concerning Menlo and Foamix and their
respective businesses, including factors that potentially could
materially affect its business, financial condition or operating
results, may emerge from time to time. Readers are urged to
consider these factors carefully in evaluating these
forward-looking statements. Readers should also carefully review
the risk factors described in other documents that Menlo and Foamix
file from time to time with the SEC. The forward-looking
statements in this press release speak only as of the date of this
press release. Except as required by law, Menlo and Foamix assume
no obligation to update or revise these forward-looking statements
for any reason, even if new information becomes available in the
future.
Additional 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, include, but
are not limited to, statements regarding the potential safety and
efficacy of serlopitant for the treatment of various conditions,
expectations with respect to the anticipated announcement of
results of its clinical trials for pruritus associated with prurigo
nodularis, the timing of potential regulatory filings, expected
cash needs and sufficiency of cash on hand, and the relative
success of the launch of AMZEEQ. 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 relating to the ongoing
securities class action litigation, risks relating to the planned
merger with Foamix and risks resulting from the unpredictability of
the regulatory process and regulatory developments in the United
States and foreign countries. These factors, together with those
that are described in greater detail in Menlo Therapeutics’ Annual
Report on Form 10-K filed on March 3, 2020, in the Joint Proxy
Statement/Prospectus filed with the SEC on January 7, 2020,
including any amendments or supplements, 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.Statement of
Operations Data(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
| Collaboration and license
revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
10,640 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
11,758 |
|
|
|
15,076 |
|
|
|
53,761 |
|
|
|
52,989 |
|
|
General and administrative |
|
10,173 |
|
|
|
3,364 |
|
|
|
22,481 |
|
|
|
12,186 |
|
| Loss from operations |
|
(21,931 |
) |
|
|
(18,440 |
) |
|
|
(76,242 |
) |
|
|
(54,535 |
) |
| Interest income and other
expense, net |
|
433 |
|
|
|
846 |
|
|
|
2,539 |
|
|
|
3,090 |
|
| Net loss |
$ |
(21,498 |
) |
|
$ |
(17,594 |
) |
|
$ |
(73,703 |
) |
|
$ |
(51,445 |
) |
| Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.89 |
) |
|
$ |
(0.76 |
) |
|
$ |
(3.09 |
) |
|
$ |
(2.37 |
) |
| Weighted average common shares
used to compute net loss per share attributable to common
stockholders, basic and diluted |
|
24,050,872 |
|
|
|
23,166,417 |
|
|
|
23,818,691 |
|
|
|
21,668,689 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Menlo
Therapeutics Inc.Condensed Balance Sheet
Data(In thousands) |
| |
|
|
|
|
|
|
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
|
|
|
|
| Cash, cash equivalents and
investments |
|
$ |
76,944 |
|
$ |
136,250 |
| Working capital |
|
|
67,666 |
|
|
129,956 |
| Total assets |
|
|
79,169 |
|
|
139,928 |
| Stockholders' equity |
|
|
68,508 |
|
|
130,377 |
| |
|
|
|
|
|
|
Media Contact: media@menlotx.com
Investor Contact: IR@menlotx.com
Menlo Therapeutics (NASDAQ:MNLO)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Menlo Therapeutics (NASDAQ:MNLO)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
