menlo therapeutics merger

SP is a naturally occurring peptide in the tachykinin neuropeptide family. 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. 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. All statements in this press release which are not historical facts are forward-looking statements. Security holders may obtain a free copy of the joint proxy statement/prospectus (when it is available) and other documents filed by Menlo and Foamix with the SEC at the SEC’s website at www.sec.gov. For more information, visit www.menlotherapeutics.com. © 2021 GlobeNewswire, Inc. All Rights Reserved. Foamix Pharmaceuticals, based in Rehovot, Israel and Bridgewater, New Jersey, is merging with Menlo Therapeutics, based in Redwood City, California.The two companies will join to become a biopharma company focusing on dermatology. Combination Creates a Differentiated Dermatology-Focused Company. 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. The combined company will look to continue developing products that will leverage the existing infrastructure. Guggenheim Securities, LLC acted as exclusive financial advisor to Menlo. The combined company will have a diversified portfolio including an approved product and three late-stage product candidates focused on dermatologic indications. “I am excited about the opportunities ahead for the combined company as we work towards improving the lives of patients with a differentiated and innovative product pipeline.”. Additional Information and Where to Find It. “We are encouraged by the initial performance and activities in support of the launch of AMZEEQ,” continued Mr. Domzalski. 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. The merger values Urovant at $16.25 per share, a 96% premium on the biotech’s closing price of $8.28 on Thursday. Foamix shareholders with questions about their shares can contact American Stock Transfer & Trust Company, LLC at (877) 248-6417. 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. The initial launch intends to focus on 6,000 high-prescribing dermatologists. REHOVOT, Israel and BRIDGEWATER, N.J. and REDWOOD CITY, Calif., Nov. 11, 2019 (GLOBE NEWSWIRE) — Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX ) (“Foamix”) and Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo”) today announced that they have signed a definitive merger agreement to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics … Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, the neurokinin-1 receptor, or NK1 receptor. Serlopitant is a small molecule, highly selective NK1 receptor antagonist. Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. 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. 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. Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. Ilan Hadar, CFO 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. 646-889-1200 Upon completion of the merger, pursuant to the terms of the Foamix Corporate Contact: See in particular Item 1A of Part II of Menlo’s Quarterly Report on Form 10-Q for the quarter ended September 30, 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 June 30, 2019 under the heading “Risk Factors.” The risks and uncertainties described above and in Menlo’s most recent Quarterly Report on Form 10-Q and Foamix’s most recent Quarterly Report on Form 10-Q 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. Effective upon the closing of the merger, Foamix’s management team will manage the Company, led by David Domzalski as Chief Executive Officer. Both companies create products in dermatology. Rooted in Innovation. 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™. We are excited about what these two companies can accomplish together.”. Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix”) and Menlo Therapeutics Inc. (MNLO) (“Menlo”) 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. March 09, 2020 08:00 ET. 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). We are excited about the momentum our company has now, and want to thank our employees and partners for their hard work and deep commitment as we enter this next phase.”, Steve Basta, Menlo Chief Executive Officer, said: “Our goal with this merger is to maximize value by developing and commercializing our assets in the context of a broader dermatology franchise. 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. All Rights Reserved. The merged company is called and trades under Menlo Therapeutics. 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. Certain significant shareholders of Foamix and Menlo, together with the CEOs of both companies, have entered into agreements, whereby they have agreed to vote the shares they hold at the time of the shareholder meeting in favor of the merger and/or share issuance (subject to limited exceptions). “This is an exciting day as we take a significant step toward becoming a broad dermatology franchise. VYNE Therapeutics™ is working to solve some of today’s most difficult therapeutic challenges. Menlo Therapeutics Inc. has announced the completion of its merger with Foamix Pharmaceuticals Ltd. following the satisfaction of all closing conditions required by the merger agreement.. 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. 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. Under the deal, Giants Merger Subsidiary Ltd., a subsidiary of Menlo, will merge with and into Foamix, with Foamix surviving as a wholly-owned subsidiary of Menlo. About Foamix Pharmaceuticals 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. Menlo Therapeutics Inc. recently announced the completion of its merger with Foamix Pharmaceuticals Ltd. following the satisfaction of all closing conditions required by the merger agreement. Guggenheim Securities, LLC acted as exclusive financial advisor to Menlo. 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. 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. +972-8-9316233 Menlo may use its website to comply with its disclosure obligations under Regulation FD. 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 quarterly report on Form 10-Q 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. Menlo Therapeutics and Foamix Pharmaceuticals Complete Merger, Creating a Combined Company Focused on the Development and Comme March 9, 2020, 8:18 AM EDT A replay of the call will be archived on the Company’s website at www.menlotherapeutics.com promptly after the conference call. Foamix is finalizing the implementation of the commercial infrastructure in preparation for a U.S. commercial launch anticipated in January 2020. 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. 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. 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. http://public.viavid.com/index.php?id=138439. Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. 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”). 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. 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. Skadden, Arps, Slate, Meagher & Flom, LLP and Meitar, Liquornik, Geva, Leeshem and Tal acted as Foamix’s legal counsel in connection with the transaction. Latham & Watkins LLP and Herzog, Fox & Neeman acted as Menlo’s legal counsel in connection with the transaction. 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. 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. 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. 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. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. Since announcing the transaction on November 11, 2019, the Company achieved a major milestone with the launch of its first product, AMZEEQ™ for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. 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. 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/). Menlo’s lead late stage product candidate, serlopitant, is being developed as a novel treatment for pruritus (itch). 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. 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. 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. 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. Foamix Pharmaceuticals, an Israeli pharmaceutical company with its U.S. headquarters in Bridgewater, announced on Thursday a merger agreement with Redwood City, California-based Menlo Therapeutics, a late-stage biopharmaceutical firm.. 312-396-9703 Webcast: http://public.viavid.com/index.php?id=137044. 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. 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. 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. Barclays acted as exclusive financial advisor to Foamix. Foamix Pharmaceuticals Ltd. 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. About Acne Menlo Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results. Cautionary Statement Regarding Forward-Looking Statements. By way of background MNLO merged with Foamix Inc. on March 7, 2020. 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. Under the terms of the merger, Foamix shareholders received 0.5924 of a share of Menlo common stock for each Foamix share owned, as well as a non-transferrable contingent stock right. Readers are urged to consider these factors carefully in evaluating these forward-looking statements. The Boards of Directors of both Foamix and Menlo have unanimously approved the transaction. Read More November 13, 2020 07:28 AM EST Updated 12:45 PM Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. Foamix Pharmaceuticals Ltd. and Menlo Therapeutics Inc. announced Monday 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.The Boards of Directors of both Foamix and Menlo have unanimously approved the … The FDA set a Prescription Drug User Fee Act action date of June 2nd, 2020. Foamix is currently developing the commercial infrastructure to support the upcoming U.S. commercial launch of AMZEEQTM anticipated in January 2020. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Foamix recently announced approval by the U.S. Food and Drug Administration (FDA) of Amzeeq (minocycline) topical foam, 4%, for … 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. 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. For more information, visit www.foamix.com. Menlo uses its website as a channel to distribute information about Menlo and its products and product candidates from time to time. Zeno Group 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. 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. Vusi Moyo Under the previously announced terms of the all-stock deal, each Foamix share will be exchanged for 0.5924 of a common share of Menlo and a contingent stock right, or CSR. Shareholders of Foamix Pharmaceuticals Ltd. and Redwood City, Calif.-based Menlo Therapeutics Inc. approved the companies' planned merger.. Skadden, Arps, Slate, Meagher & Flom, LLP and Meitar | Law Offices acted as Foamix’s legal counsel in connection with the transaction. --Menlo Therapeutics Inc. announced today the completion of its merger with Foamix Pharmaceuticals Ltd. following the satisfaction of all closing conditions required by the merger agreement.. 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. 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. vusi.moyo@zenogroup.com, U.S. Investor Relations: 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. Menlo Therapeutics is now VYNE Therapeutics Inc., according to a company announcement September 2, 2020. Menlo Therapeutics and Foamix Pharmaceuticals Complete Merger, Creating a Combined Company Focused on the Development and Commercialization of Therapeutics for Dermatologic Indications. 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. Menlo has designated two of its pre-closing directors, Steve Basta, Menlo’s Chief Executive Officer prior to the consummation of the merger, and Elisabeth Sandoval, to be directors of the Company following the merger. 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. AMZEEQTM is the first topical formulation of minocycline. 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 … 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%. 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