Item 4.01 Changes in Registrant's Certifying Accountant.
On April 2, 2020, the audit committee (the "Audit Committee") of the board of
directors (the "Board") of Menlo Therapeutics Inc. (the "Company") appointed
Kesselman & Kesselman ("Kesselman"), a member firm of PricewaterhouseCoopers
International Limited, as the Company's independent registered public accounting
firm for the year ending December 31, 2020, and dismissed Mayer Hoffman McCann
P.C. ("Mayer Hoffman") as the Company's independent registered public accounting
firm. Kesselman served as the independent registered public accounting firm for
Foamix Pharmaceuticals Ltd. ("Foamix") prior to its merger with the Company on
March 9, 2020 (the "Merger").
During the years ended December 31, 2019 and December 31, 2018, and the
subsequent interim period through the date hereof, neither the Company nor
anyone acting on its behalf consulted with Kesselman regarding any of the
matters set forth in Item 304(a)(2)(i) or (ii) of Regulation S-K.
Mayer Hoffman's report on the Company's financial statements as of and for the
years ended December 31, 2019 and 2018 did not contain an adverse opinion or a
disclaimer of opinion, nor were they qualified or modified as to uncertainty,
audit scope, or accounting principles.
During the two years ended December 31, 2019 and December 31, 2018, and for the
subsequent interim period through the date hereof, there were no: (i)
disagreements as that term is defined in Item 304(a)(1)(iv) of Regulation S-K,
between the Company and Mayer Hoffman on any matter of accounting principles or
practices, financial statement disclosure, or auditing scope or procedures
which, if not resolved to the satisfaction of Mayer Hoffman, would have caused
Mayer Hoffman to make reference thereto in their reports; or (ii) reportable
events as described in Item 304(a)(1)(v) of Regulation S-K.
The Company provided Mayer Hoffman with a copy of the foregoing disclosures and
requested that Mayer Hoffman provide a letter addressed to the U.S. Securities
and Exchange Commission stating whether it agrees with such disclosures in
accordance with Item 304(a)(3) of Regulation S-K. A copy of Mayer Hoffman's
letter dated April 6, 2020 is filed herein as Exhibit 16.1.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal
Year.
On April 2, 2020, the Board approved an amendment (the "Amendment") to the
Company's Amended and Restated Bylaws (the "Bylaws"), effective as of April 2,
2020, to add a federal forum selection provision as a new Section 7.13 of the
Bylaws.
Section 7.13 provides that unless the Company consents in writing to the
selection of an alternative forum, the federal district courts of the United
States of America will be the sole and exclusive forum for the resolution of any
complaint asserting a cause of action arising under the Securities Act of 1933,
as amended. In addition, Section 7.13 provides that any person or entity
purchasing or otherwise acquiring or holding any interest in shares of capital
stock of the Company will be deemed to have notice of and consented to this
provision.
The foregoing description of the Amendment does not purport to be complete and
is qualified in its entirety by reference to the full text of the Amendment, a
copy of which is attached as Exhibit 3.1 hereto and is incorporated herein by
reference.
Item 8.01. Other Events.
On April 6, 2020, the Company issued a press release entitled "Menlo
Therapeutics Announces Results from Two Phase 3 Clinical Trials of Serlopitant
for the Treatment of Pruritus Associated with Prurigo Nodularis." A copy of the
press release is attached hereto as Exhibit 99.1.
Contingent Stock Rights
As further explained in the press release referred to above, each of the
Company's Phase 3 clinical trials evaluating the safety and efficacy of once
daily oral serlopitant for the treatment of pruritus (itch) associated with
prurigo nodularis (PN) (study MTI-105 and study MTI-106) did not meet their
respective primary endpoint of demonstrating statistically significant reduction
in pruritus in patients treated with serlopitant compared to placebo based upon
a 4-point improvement responder analysis.
As previously disclosed in the Company's Current Report on Form 8-K filed on
March 10, 2020 , each shareholder of Foamix as of March 9, 2020, the effective
date of the Merger, received 0.5924 of a share of the Company's common stock
("Common Stock") and one contingent stock right (a "CSR") for each Foamix
ordinary share ("Foamix Share") owned. The CSRs are subject to the Contingent
Stock Rights Agreement (the "CSR Agreement"), dated as of March 9, 2020, by and
between the Company and American Stock Transfer & Trust Company, LLC ("AST").
In light of the results of the clinical trials and pursuant to the terms of the
CSR Agreement, each CSR will be converted into 1.2082 shares of Common Stock,
resulting in an effective exchange ratio in the Merger of 1.8006 shares of
Common Stock for each Foamix Share. AST will promptly deliver the additional
shares of Common Stock to legacy Foamix shareholders, along with any cash
payable in lieu of fractional shares. Following the distribution of the
additional shares of Common Stock, it is expected that legacy Foamix
shareholders and their transferees and legacy Menlo stockholders and their
transferees will own approximately 82% and 18% of the outstanding shares of the
Company, respectively.
In addition, each holder of Foamix restricted stock unit awards that were
outstanding immediately prior to the Merger will receive a number of additional
restricted stock units, and each holder of Foamix options that were outstanding
immediately prior to the Merger will be adjusted, in each case, to reflect the
value of the Common Stock issuable in respect of the CSR such that the Foamix
equity awards will settle into equity awards for Common Stock as follows.
Each Foamix restricted stock unit award that was outstanding immediately prior
to Merger will be converted into a restricted stock unit award relating to
Common Stock (an "Adjusted RSU Award") that has the same terms and conditions as
applied to the Foamix restricted stock unit award immediately prior to the
Merger. The Adjusted RSU Award will settle in the number of shares of Common
Stock (rounded down to the nearest whole number of shares) equal to the product
obtained by multiplying (i) the number of Foamix Shares subject to the Foamix
restricted stock unit award immediately prior to the Merger by (ii) 1.8006.
Additionally, on April 5, 2020, the Board determined, pursuant to the terms of
the merger agreement, that each Foamix option will be converted into an option
to purchase Common Stock (an "Adjusted Option") with the same terms and
conditions as applied to the Foamix option immediately prior to the Merger;
however, the Adjusted Option will cover a number of shares of Common Stock
(rounded down to the nearest whole number of shares) equal to the product of (i)
the number of Foamix Shares subject to the Foamix option immediately prior to
the Merger and (ii) 1.8006, and has an exercise price per share equal to the
quotient of (i) the exercise price per Foamix Share subject to such Foamix
option immediately prior to the Merger divided by (ii) 1.8006, with any
fractional cents rounded up to the next higher number of whole cents.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are filed herewith.
Exhibit No. Description
Amendment to Amended and Restated Bylaws of Menlo Therapeutics
3.1 Inc.
16.1 Letter from Mayer Hoffman McCann P.C. dated April 2, 2020
99.1 Press release, entitled "Menlo Therapeutics Announces Results from
Two Phase 3 Clinical Trials of Serlopitant for the Treatment of
Pruritus Associated with Prurigo Nodularis"
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