Copyright © 2020 Menlo Therapeutics. This press release 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. Serlopitant is a small molecule, highly selective NK1 receptor antagonist. Foamix’s mission is to improve the lives of patients by developing and commercializing proprietary, innovative and differentiated drugs in dermatology, and plans to leverage its infrastructure to efficiently commercialize a portfolio of products while continuing to develop new therapies. The Boards of Directors of both Foamix and Menlo … The company’s clinical development program for serlopitant covers three indications and includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a Phase 3-ready clinical program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Menlo Therapeutics Inc. (Nasdaq: MNLO) announced today the completion of its merger with Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) following the satisfaction of all closing conditions required by the merger agreement. Ilan Hadar, CFO BRIDGEWATER, N.J., March 09, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. ( MNLO) (“Menlo” or the “Company”) announced today the completion of its merger with Foamix Pharmaceuticals Ltd. ( FOMX) (“Foamix”) following the satisfaction of all closing conditions required by the merger agreement. Additional Information and Where to Find It. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. The board of the combined company will consist of five members designated by Foamix (including Mr. Domzalski) and two members designated by Menlo (including Steve Basta, its CEO). 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 merger values Urovant at $16.25 per share, a 96% premium on the biotech’s closing price of $8.28 on Thursday. Skadden, Arps, Slate, Meagher & Flom, LLP and Meitar | Law Offices acted as Foamix’s legal counsel in connection with the transaction. Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. The merged company is called and trades under Menlo Therapeutics. Such factors include, but are not limited to: (i) Menlo or Foamix may be unable to obtain stockholder approval as required for the merger; (ii) other conditions to the closing of the merger may not be satisfied; (iii) the merger may involve unexpected costs, liabilities or delays; (iv) 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; (v) 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; (vi) the outcome of any legal proceedings related to the merger; (vii) Menlo or Foamix may be adversely affected by other economic, business, and/or competitive factors; (viii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (ix) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (x) 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 (xi) 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. http://public.viavid.com/index.php?id=138439. Media Relations:Vusi MoyoZeno Group312-396-9703vusi.moyo@zenogroup.com, Investor Relations:Joyce AllaireLifeSci Advisors, LLC646-889-1200jallaire@lifesciadvisors.com, Exchange Agent: American Stock Transfer & Trust Company, LLC (877) 248-6417. The exchange ratio or CSR may result in the delivery of additional shares of Menlo common stock to Foamix shareholders dependent upon the Phase III trial results for serlopitant for the treatment of pruritus in PN. LifeSci Advisors, LLC 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 expectations with respect to the anticipated announcement of results of Menlo’s clinical trials for pruritus associated with prurigo nodularis, 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. Further, Foamix’s drug development platform will continue to bring novel dermatology product candidates into the clinic, including FCD105, which recently began enrollment in its Phase II trial. Zeno Group Combination Creates a Differentiated Dermatology-Focused Company. With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ. Menlo Therapeutics Announces Completion of Corporate Name Change to VYNE Therapeutics, Menlo Therapeutics Announces Corporate Name Change to VYNE Therapeutics, Menlo Reports Second Quarter 2020 Financial Results and Provides Business Update, Menlo Therapeutics to Report Second Quarter 2020 Financial Results on August 6, Menlo Therapeutics Announces Pricing of Offering of Common Stock, Phase II clinical trial results for serlopitant for the treatment of CPUO in January or February 2020, Phase III clinical trial results in the U.S. and Europe for serlopitant for the treatment of pruritus in PN in March or April 2020, Phase II clinical trial results for FCD105 for treatment of moderate to severe acne with top-line data expected in mid-2020, NDA submission, assuming Phase III success for serlopitant for the treatment of pruritus in PN, in H2 2020, Commercial leverage: Foamix’s dermatology sales and marketing organization can more effectively launch Menlo’s near-term potential breakthrough product for pruritus associated with PN, Cost savings: by utilizing Foamix’s commercial organization and G&A infrastructure, the companies could save approximately $50 million per year versus the stand-alone estimated duplicate organization costs in future years, Reduced financing need: the combined cash from the companies provides runway through H1 2021, Creates a leading dermatology company with multiple products, If one of the Phase III PN trials fails to meet its primary endpoint at or before May 31, 2020, Foamix shareholders will receive an additional 0.6815 of a share of Menlo common stock for each Foamix share, increasing pro forma ownership of the combined company by Foamix shareholders to 76%, If both Phase III PN trials fail to meet their primary endpoints at or before May 31, 2020, Foamix shareholders will receive 1.2082 additional Menlo shares for each Foamix share, increasing pro forma ownership of the combined company by Foamix shareholders to 82%, If both the Phase III PN trials are successful with results announced by May 31, 2020, then no additional Menlo shares will be issued to Foamix shareholders and pro forma ownership by Foamix shareholders will remain 59%. Under the terms of the merger agreement, each share of Foamix stock will be exchanged for 0.5924 of a  share of Menlo common stock and a contingent stock right (“CSR”). Jan. 17, 2020, 02:00 PM. By way of background MNLO merged with Foamix Inc. on March 7, 2020. Menlo’s lead late stage product candidate, serlopitant, is being developed as a novel treatment for pruritus (itch). The combined company already has an approved, commercial-stage product, AMZEEQ™, and several late-stage product candidates with several meaningful near-term catalysts,” said David Domzalski, who became the Chief Executive Officer of Menlo upon the closing of the merger. Menlo Therapeutics and Foamix Pharmaceuticals Complete Merger, Creating a Combined Company Focused on the Development and Commercialization of Therapeutics for Dermatologic Indications. This press release does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov,Menlo’s website at http://ir.menlotherapeutics.com/financials/sec-filings and Foamix’s website at https://www.foamix.com/investors/sec-filings. BEFORE MAKING ANY VOTING DECISION, MENLO’S AND FOAMIX’S RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE 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 TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. jallaire@lifesciadvisors.com. BRIDGEWATER, N.J., March 09, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”) announced today the completion of its merger with Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix”) following the satisfaction of all closing conditions required by the merger agreement. 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. Serlopitant has received Breakthrough Therapy Designation by the FDA for the treatment of pruritus associated with PN and has the potential to be the first approved therapy for this indication. Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs. In addition, the Company is focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, as a novel potential treatment option for pruritus associated with prurigo nodularis. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. The Boards of Directors of both Foamix and Menlo have unanimously approved the transaction. The initial launch intends to focus on 6,000 high-prescribing dermatologists. The FDA set a Prescription Drug User Fee Act action date of June 2nd, 2020. “Our new corporate branding, VYNE Therapeutics, reflects an evolution of our business which combines the strengths and traditions of our legacy companies ─ Menlo Therapeutics and Foamix Pharmaceuticals ─ with our ambition to build a sustainable, fully … These risks and uncertainties include, but are not limited to, Menlo’s ability to successfully integrate the two companies; 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, including those for serlopitant; determination by the FDA that results from Menlo’s 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. March 09, 2020 08:00 ET. Readers should also carefully review the risk factors described in other documents that Menlo and Foamix file from time to time with the SEC. With every problem we take on, our approach is the same: question traditional assumptions and find a better solution. Menlo plans to file 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”). Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”) announced today the completion of its merger with Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix”) following the satisfaction of all closing conditions required by the merger agreement. These contingent stock rights potentially allow Foamix shareholders to receive additional shares of Menlo common stock based on the results of Menlo’s Phase 3 trials of serlopitant for the treatment of pruritus associated with prurigo nodularis, as more fully described in the companies’ joint proxy statement/prospectus on Form S-4. As part of the transaction, Foamix has designated five of its pre-closing directors, David Domzalski, Sharon Barbari, Rex Bright, Anthony Bruno and Stanley Hirsch to serve as members of the Menlo Board of Directors. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Foamix recently submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for FMX103 (minocycline) topical foam, for the treatment of moderate-to-severe papulopustular rosacea. To the extent the holdings of Menlo securities by Menlo’s directors and executive officers or the holdings of Foamix securities by Foamix’s directors and executive officers have changed since the amounts set forth in Menlo’s or Foamix’s respective proxy statement for its 2019 annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. There are certain adjustments to the ownership levels for each company’s shareholders as follows that result from an adjustment to the exchange ratio under the Merger Agreement prior to closing or post-closing through the issuance of CSRs to Foamix shareholders: The adjustments to ownership levels were designed with the intent of providing protection to Foamix shareholders in the event that either of these important serlopitant clinical trials were not successful. “We are encouraged by the initial performance and activities in support of the launch of AMZEEQ,” continued Mr. Domzalski. 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. A replay of the call will be archived on the Company’s website at www.menlotherapeutics.com promptly after the conference call. The commercialization plans for FMX103 and serlopitant for pruritus associated with PN, if approved, will utilize the established sales force and commercial infrastructure for AMZEEQTM requiring minimal additional investment. In the event that the results of the Phase III PN trials are received prior to closing (or if the results of neither trial has been announced by May 31, 2020 and the closing occurs thereafter), then the exchange ratio will be amended based on the clinical trial results and no CSRs will be issued. The transaction is subject to approval of the merger by Foamix shareholders, approval of the share issuance to Foamix shareholders by Menlo stockholders, as well as regulatory approvals and satisfaction of other customary closing conditions. Tachykinins have a broad range of functions in the nervous and immune systems. Additional information regarding the interests of such individuals in the proposed merger will be included in the joint proxy statement/prospectus relating to the proposed merger when it is filed with the SEC. On November 10, 2019, Menlo Therapeutics Inc., a Delaware corporation (“Menlo”), Foamix Pharmaceuticals Ltd., a company organized under the laws of the State of Israel (“Foamix”) and Giants Merger Subsidiary Ltd., a company organized … For more information, visit www.menlotherapeutics.com. Upon completion of the merger, pursuant to the terms of the Barclays acted as exclusive financial advisor to Foamix. The Foamix management team also brings extensive R&D and commercial expertise, having developed two novel topical therapies for acne and rosacea at Foamix, and also in leading the successful commercial launches of several dermatology products prior to Foamix. Menlo Therapeutics Inc. is a different type of biopharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. Barclays acted as exclusive financial advisor to Foamix. Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. There are multiple near-term milestones: The rationale for this transaction is to create value for the combined shareholders of Foamix and Menlo that can be more advantageous together than separately through several synergies: The transaction is structured as a stock-for-stock exchange, enabling the Foamix and Menlo shareholders to share in the upside advantages of combining the companies. Menlo, Foamix and their respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Menlo and Foamix in connection with the proposed merger. Joyce Allaire Guggenheim Securities, LLC acted as exclusive financial advisor to Menlo. All Rights Reserved. The combination of the two companies is expected to capitalize on the collective skills sets, internal expertise and combined assets to create a comprehensive and more scaled biopharmaceutical company focused on dermatology. Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) and Menlo Therapeutics Inc. (Nasdaq: MNLO) today announced that they have signed a definitive merger agreement to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics to serve patients in the dermatology space. Read More November 13, 2020 07:28 AM EST Updated 12:45 PM All statements in this press release which are not historical facts are forward-looking statements. Foamix is also conducting a Phase II trial for FCD105, a topical combination foam of minocycline and adapalene, currently being evaluated for the treatment of moderate-to-severe acne vulgaris. Foamix Pharmaceuticals and Menlo Therapeutics announced that they have signed a definitive merger agreement to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics to serve patients in the dermatology space. On March 9, 2020, newly issued Menlo shares will commence trading under the ticker “MNLO” on Nasdaq. vusi.moyo@zenogroup.com, U.S. Investor Relations: Foamix shareholders with questions about their shares can contact American Stock Transfer & Trust Company, LLC at (877) 248-6417. Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. Recognizing the near term data coming from Menlo’s Phase III trials in PN, the transaction accounts for the data outcomes by providing a premium to Menlo in the event that both trials are successful, while creating a mechanism to provide more shares to Foamix shareholders to provide downside adjustment if one or both PN trials do not hit their primary endpoint. 312-396-9703 Foamix Pharmaceuticals Ltd. 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™. If approved, FMX103 would be the first minocycline product available for rosacea patients. BRIDGEWATER, N.J., March 09, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc (Nasdaq: MNLO) (“Menlo” or the “Company”) announced today the completion of its merger with Foamix Pharmaceuticals, Ltd. (Nasdaq: FOMX) (“Foamix”) following the satisfaction of all closing conditions required by the merger agreement. The combined company will look to continue developing products that will leverage the existing infrastructure. Additionally, the Company expects to announce the results of its Phase 2 clinical trial for FCD105 (minocycline 3% and adapalene 0.3% foam) for the treatment of acne in the second quarter of 2020. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. There will be a conference call and webcast with slides, at 8:30 a.m. Eastern Time today Monday, November 11th, with Foamix and Menlo to discuss the merger and respond to questions. Menlo Therapeutics is now VYNE Therapeutics Inc., according to a company announcement September 2, 2020. Foamix Corporate Contact: Webcast: http://public.viavid.com/index.php?id=137044. Readers are urged to consider these factors carefully in evaluating these forward-looking statements. We are excited about what these two companies can accomplish together.”. Investors and stockholders will be able to obtain a free copy of the joint proxy statement/prospectus and other documents containing important information about Menlo and Foamix, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Latham & Watkins LLP and Herzog, Fox & Neeman acted as Menlo’s legal counsel in connection with the transaction. 646-889-1200 The combined company is expected to have sufficient cash to support its operational plans through the first half of 2021. The exchange ratio (prior to any adjustment through the CSR) implies a 18% premium to Menlo shareholders based upon the 10-day average volume weighted trading price for each company. For more information, visit www.foamix.com. The webcast and slides will also be archived for a period of 90 days on the Investor Relations web pages  of Foamix (http://www.foamix.com/investors/events-and-presentations/events) and Menlo (http://ir.menlotherapeutics.com/). The forward-looking statements in this press release speak only as of the date of this press release. A combination with Foamix will help de-risk and accelerate serlopitant’s commercial launch, assuming approval. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, the neurokinin-1 receptor, or NK1 receptor. The combined company will be led by David Domzalski, CEO of Foamix and headquartered in New Jersey. * MENLO THERAPEUTICS INC - CO AND FOAMIX PHARMACEUTICALS COMPLETE MERGER Source text for Eikon: Further company coverage: Foamix ordinary shares ceased trading as of the close of trading on March 6, 2020. Latham & Watkins LLP and Herzog, Fox & Neeman acted as Menlo’s legal counsel in connection with the transaction. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate to severe acne. Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”) announced today the completion of its merger with Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix”) following the satisfaction of all closing conditions required by the merger agreement. There will be a conference call at 8:30 a.m. Eastern Time on Thursday, March 12th during which management of Menlo will provide a corporate update. Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. Foamix is currently developing the commercial infrastructure to support the upcoming U.S. commercial launch of AMZEEQTM anticipated in January 2020. 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