UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 2, 2020

 

 

 

Menlo Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 001-38356 45-3757789

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

 

520 U.S. Highway 22, Suite 204

Bridgewater, New Jersey 08807

(Address of principal executive offices, including Zip Code)

 

(800) 755-7936

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨       Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨        Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨        Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨        Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s) 		 

Name of each exchange

on which registered

Common Stock, $0.0001 par value   MNLO   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company  x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x

 

 

 

 

 

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
3.1   Amendment to Amended and Restated Bylaws of Menlo Therapeutics 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”

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  MENLO THERAPEUTICS INC.
     
Date: April 6, 2020 By:

/s/ Mutya Harsch

    Mutya Harsch
    Chief Legal Officer and General Counsel

 

 

 

Exhibit 3.1

 

AMENDMENT NO. 1 TO

THE AMENDED AND RESTATED BYLAWS OF

MENLO THERAPEUTICS INC.

 

Dated April 2, 2020

 

The Amended and Restated Bylaws of Menlo Therapeutics Inc. (the “Corporation”) are hereby amended by adding the following Section 7.13 in Article 7 thereof:

 

“7.13 FEDERAL FORUM SELECTION

 

Unless the Corporation consents in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933. Any person or entity purchasing or otherwise acquiring or holding any interest in shares of capital stock of the Corporation shall be deemed to have notice of and consented to this provision.”

 

The foregoing is certified as an amendment to the Amended and Restated Bylaws of the Corporation, as approved by the Board of Directors by unanimous written consent, and effective as of April 2, 2020.

 

  By: /s/ David Domzalski
  Name: David Domzalski
  Title: President and Chief Executive Officer

 

 

 

 

Exhibit 16.1

 

April 6, 2020

 

Securities and Exchange Commission

100 F Street N.E.

Washington, DC 20549

 

Commissioners:

 

We have read Item 4.01 of Menlo Therapeutics Inc.’s Form 8-K dated April 6, 2020, and we agree with the statements set forth in Item 4.01, insofar as they relate to our firm.  We have no basis to agree or disagree with other statements made by the registrant contained in Item 4.01.

 

Very truly yours,

 

/s/ Mayer Hoffman McCann P.C.

 

San Diego, California

 

 

 

 

Exhibit 99.1

 

 

 

Menlo Therapeutics Announces Results from Two Phase 3 Clinical Trials of Serlopitant for the Treatment of Pruritus Associated with Prurigo Nodularis

 

Conference call today at 8.30am EDT

 

BRIDGEWATER, New Jersey, April 06, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced top line results from two 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), studies MTI-105 and MTI-106. Study MTI-105 enrolled 285 patients in the US and study MTI-106 enrolled a total of 295 patients from Germany, Poland and Austria. Patients were randomized 1:1 to either serlopitant 5mg or placebo treatment.

 

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. In study MTI-105, 26.45% of patients in the serlopitant group achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10 compared to baseline (primary efficacy endpoint) vs. 20.31% of patients treated with placebo (p=0.229). In study MTI-106, 25.90% of patients in the serlopitant group achieved a 4-point or greater improvement on the WI-NRS at week 10 compared to baseline (primary efficacy endpoint) vs. 18.95% of patients treated with placebo (p=0.158). Results for all supportive sensitivity analyses for the primary endpoint were comparable to the primary analyses for both studies.

 

“Menlo undertook a robust Phase 3 program to investigate serlopitant as a potential treatment for pruritis associated with PN. While the data showed a numerical advantage for serlopitant compared with placebo on the primary endpoint, the difference was not statistically significant,” said David Domzalski, Chief Executive Officer of Menlo Therapeutics Inc. “We will thoroughly analyze these data to better understand the outcome but, at this point, we do not intend to further pursue serlopitant. I would like to thank the patients and their families, as well as physicians and other healthcare professionals, who participated in these studies.”

 

“Despite this news, we remain focused on building a successful franchise in dermatology and leveraging our infrastructure to expand our pipeline,” added Mr. Domzalski. “We launched AMZEEQ as a treatment for moderate-to-severe acne at the beginning of the year and are very encouraged by positive reception so far from both physicians and patients. FMX103, which is our 1.5% minocycline foam for the treatment of papulopustular rosacea, is currently under review at the FDA and has been assigned a target PDUFA action date of June 2, 2020. If approved, this product will be our second commercial launch in 2020. Additionally, our Phase 2 study for FCD 105, our combination product containing minocycline plus the retinoid adapalene remains on track for the data readout later this quarter.”

 

 

 

 

 

 

On March 9, 2020, Menlo completed its merger transaction with Foamix Pharmaceuticals Ltd. (“Foamix”) pursuant to which Foamix became a wholly-owned subsidiary of Menlo. In the merger, Foamix shareholders received 0.5924 shares of Menlo common stock for each share of Foamix held at the closing, plus a contingent stock right (CSR) that would convert into additional shares of Menlo common stock if both results of the Phase 3 trials of serlopitant for pruritus associated with PN were not positive. In the case of mixed results where one trial was positive but the other trial was not, each CSR would convert into an additional 0.6815 shares of Menlo stock, such that the legacy Foamix shareholders would own approximately 76% of Menlo’s outstanding stock as of the closing. If both Phase 3 clinical trials were not positive, each CSR would convert into an additional 1.2082 shares of Menlo, such that the legacy Foamix shareholders would own approximately 82% of the outstanding Menlo shares as of the closing. If both results of the Phase 3 trials were positive, each CSR would automatically be terminated, and its holder would not be entitled to any additional shares of Menlo. The CSRs were not transferable and are payable only to the holders of Foamix shares at the closing of the merger.

 

If you were a shareholder of Foamix at the time of the closing, you will automatically receive for each Foamix share you held at the closing, an additional 1.2082 shares of Menlo common stock through your bank or broker plus cash in lieu of fractional shares and there is no need to take any further action. If you did not hold Foamix shares at the closing, you will not receive the additional merger consideration.

 

CSR and Exchange Agent

Shareholders with questions about their shares can contact our CSR and Exchange Agent, American Stock Transfer & Trust Company, LLC at (877) 248-6417.

 

About Studies MTI-105 and MTI-106

Studies MTI-105 and MTI-106 were identical Phase 3 multicenter, placebo-controlled double-blind clinical trials that enrolled patients with PN who experienced pruritus for at least six months prior to enrollment where the underlying cause for the pruritus was directly associated with PN. All patients reported a WI-NRS score of 7 or higher at screening and a minimum weekly average WI-NRS of 6.5 for each of two weeks prior to randomization. These trials compared treatment with serlopitant 5 mg orally once daily versus placebo for 10 weeks, with an additional post-treatment safety assessment period. For more information, refer to ClinicalTrials.gov Identifiers: NCT03546816 and NCT03677401.

 

Conference call details

There will be a conference call and webcast, at 8:30 a.m. Eastern Time today April 6th to discuss the top line Phase 3 results and provide a corporate update.

 

Toll free: 877-407-0784
International: 201-689-8560
Conference ID: 13701710

 

Webcast:  http://public.viavid.com/index.php?id=139032

 

 

 

 

 

 

About AMZEEQ™

 

Indication

 

AMZEEQ is a topical form of the antibiotic minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in adults and children 9 years of age and older. AMZEEQ is available by prescription only.

 

AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in the mouth, eyes or vagina.

 

Important Safety Information

 

· AMZEEQ should not be used in people who are allergic to AMZEEQ or any tetracycline medicine. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs.
· AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
· AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ.
· People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ should be stopped if skin is sunburned.
· When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

 

AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes; bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.

 

The most common side effect of AMZEEQ is headache.

 

These are not all of the possible side effects with AMZEEQ. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ.

 

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see full Prescribing Information.

 

 

 

 

 

 

About Menlo Therapeutics

Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. (“Foamix”) to form a different type of biopharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

 

With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for the world’s first topical minocycline, AMZEEQ™ (minocycline) topical foam, 4%.

 

For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

 

Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of Menlo’s products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, any adverse effects related to the global COVID-19 pandemic; the achievement of certain expected cost synergies; the outcome of any legal proceedings related to the merger; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from our clinical trials are not sufficient to support registration or marketing approval of product candidates; adverse events associated with the commercialization of AMZEEQ™; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ™ or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ™ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ™ or any of Menlo’s other product or product candidates; risks that Menlo’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo’s patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo’s patent applications may not be granted and potential competitors may also seek to design around Menlo’s granted patents or patent applications; additional competition in the acne and dermatology markets; inability to raise additional capital on favorable terms or at all; Menlo’s ability to recruit and retain key employees; and Menlo’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo’s actual results to differ from those contained in the forward-looking statements, see the sections titled “Risk Factors” in (i) Menlo’s most recent annual report on Form 10-K, (ii) Foamix’s most recent annual report on Form 10-K and (iii) Menlo’s definitive joint proxy statement/prospectus filed with the U.S. Securities and Exchange Commission under Rule 424(b)(3) on January 7, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Menlo’s subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

 

 

 

 

 

 

Media Relations:
Bridgette Potratz

Zeno Group

312-755-5462, x5516

bridgette.potratz@zenogroup.com

 

Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com