Foamix Pharmaceuticals Ltd (FOMX)

Menlo Therapeutics and Foamix Pharmaceuticals Complete Merger, Creating a Combined Company Focused on the Development and Commercialization of Therapeutics for Dermatologic Indications
March 9, 2020 at 8:18 AM EDT
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BRIDGEWATER, N.J., March 9, 2020 /PRNewswire/ -- 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.

Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. 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. 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. Foamix ordinary shares ceased trading as of the close of trading on March 6, 2020. On March 9, 2020, newly issued Menlo shares will commence trading under the ticker "MNLO" on Nasdaq.

"This is an exciting day as we take a significant step toward becoming a broad dermatology franchise. 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. "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."

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. "We are encouraged by the initial performance and activities in support of the launch of AMZEEQ," continued Mr. Domzalski. In the coming weeks, the Company anticipates announcing the results of its Phase 3 clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis. 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. The Company has also taken meaningful steps towards facilitating a successful integration and capitalizing on expected cost synergies.

FOMX closed at 4pm at 3.14 on 3/6
MNLO closed at 4PM at 4.15 on 3/6

merger could close as soon as Monday 3/9

Strike one against the merger being a successful one

UGH!

MNLO failed phase 2


Menlo Therapeutics Announces Results from Phase 2 Trial of Serlopitant in Patients with Chronic Pruritus of Unknown Origin
February 26, 2020 at 7:30 AM EST
Menlo to Host Conference Call Today at 8:30 AM Eastern Time; Foamix’s CEO David Domzalski will be Available for Q&A

REDWOOD CITY, Calif., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage biopharmaceutical company, today announced results from its Phase 2 clinical trial evaluating the safety and efficacy of once daily oral serlopitant for the treatment of chronic pruritus (itch) of unknown origin (CPUO). The trial, which included 233 patients, did not meet its primary endpoint to show a statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. In the trial, 37.9% of patients in the serlopitant group (N=116) 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) versus 39.3% of patients treated with placebo (N=117). There were no meaningful differences observed between the serlopitant and placebo groups in the prospectively-defined secondary endpoints.

“We conducted this trial in CPUO in the hope of offering the first-ever approved therapy for patients suffering from severe pruritus associated with this condition,” said Steve Basta, chief executive officer of Menlo Therapeutics. “We were surprised to see a placebo response significantly larger than observed in our prior studies. The higher placebo response rate may be due to characteristics of the CPUO population, which is not well understood clinically.”

The Phase 2 multicenter, placebo-controlled double-blind clinical trial enrolled 233 patients with self-reported CPUO, who experienced pruritus for at least six months prior to enrollment with no identified underlying cause for the pruritus. This trial compared treatment with serlopitant versus placebo for 10 weeks.

Serlopitant was well-tolerated. The frequency of treatment-emergent adverse events assessed as likely related to treatment were 10.3% in the serlopitant group versus 2.6% in the placebo group. The most frequently reported adverse events in the serlopitant group were diarrhea (6.9%), somnolence (5.2%), fatigue and headache (2.6% each). The most frequently reported adverse events in the placebo group were gastroesophageal reflux disease and arthralgia (2.6% each). Two serlopitant-treated subjects reported a total of three serious adverse events which were deemed to not be related to study drug. To date, serlopitant has been administered to over 2,000 individuals, including patients who have received treatment for up to one year.

Results from the company’s Phase 3 trials for the treatment of pruritus associated with prurigo nodularis (PN) are expected in March or April of this year.

Menlo Therapeutics to Host Conference Call Tomorrow to Discuss Results from Phase 2 Trial of Serlopitant in Patients with Chronic Pruritus of Unknown Origin

Foamix Pharmaceuticals to Present at the Cowen and Company’s 40th Annual Health Care Conference
February 25, 2020 at 8:00 AM EST
PDF Version

REHOVOT, Israel and BRIDGEWATER, N.J., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, announced today that David Domzalski, Chief Executive Officer, will provide a corporate update at the Cowen 40th Annual Health Care Conference, taking place March 2-4, 2020 in Boston, Massachusetts.

Foamix Announces Integrated Efficacy Results from the FMX103 1.5% Topical Minocycline Foam Phase 3 Program for Rosacea
February 18, 2020 at 8:00 AM EST
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REHOVOT, Israel and BRIDGEWATER, N.J., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced results from an integrated efficacy analysis on the two pivotal Phase 3 clinical trials for FMX103 (minocycline, 1.5% foam) currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe papulopustular rosacea in adults. The new data have been presented at the 17th Annual South Beach Symposium in Dermatology held on February 6-9, 2020 in Miami, Florida.

Foamix previously announced that the FDA has accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for June 2nd, 2020 under the Prescription Drug User Fee Act (PDUFA).

Integrated Summary of Efficacy Highlights:

The integrated efficacy analysis compared FMX103 to vehicle from 2 identical Phase 3 studies (FX2016-11 and FX2016-12) with 1,522 subjects (1,009 subjects received FMX103 and 513 subjects received vehicle) after 12 weeks of once daily application.

In the combined analysis of both pivotal Phase 3 studies, FMX103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints
Significantly greater reduction of inflammatory lesion counts from Baseline to Week 12 for FMX103 compared to vehicle (-18.0 vs. -14.9; p<0.001), respectively.
Significantly greater number of subjects receiving FMX103 achieved IGA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12, (50.6% vs. 41.0%; p<0.001), respectively.
Statistical superiority of FMX103 when compared to vehicle was observed for both co-primary endpoints for all supporting sensitivity analyses.

In a subgroup analysis of disease severity, FMX103 demonstrated statistically significant efficacy over vehicle in both Baseline severity groups: IGA 3 (“moderate”) and IGA 4 (“severe”).

For subjects assessed as having severe papulopustular rosacea (IGA 4) at Baseline in each study:
The FMX103 integrated treatment group demonstrated a significantly higher reduction of inflammatory lesions compared to the vehicle integrated treatment group from Baseline to Week 12, (-26.0 vs. -15.1; p<0.001), respectively.
The FMX103 integrated treatment group demonstrated a significantly higher proportion of subjects achieving IGA treatment success compared to the vehicle integrated treatment group at Week 12, (36.8% vs. 14.9%; p=0.003), respectively.

The integrated efficacy analysis further demonstrated the effect of FMX103 treatment on disease improvement as early as week 4.

Approved


Foamix and Menlo Announce Shareholder Approval of Proposed Merger
February 6, 2020 at 1:00 PM EST
PDF Version
Transaction on Track to Close in early March 2020

REHOVOT, Israel and BRIDGEWATER, N.J. and REDWOOD CITY, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX ) and Menlo Therapeutics Inc. (Nasdaq: MNLO) today announced that the shareholders of Foamix and stockholders of Menlo voted to approve all shareholder and stockholder proposals necessary to complete the previously announced merger at their respective shareholder / stockholder meetings held earlier today. Pending the expiration of a 30-day waiting period required by Israeli law and satisfaction of closing conditions set forth in the merger agreement between Foamix, Menlo and Giants Merger Subsidiary Ltd., a wholly-owned subsidiary of Menlo, Menlo’s merger subsidiary will merge with and into Foamix, with Foamix surviving as a wholly-owned subsidiary of Menlo.

“We are pleased with the outcome of today’s extraordinary general meeting and thank our shareholders for their support for this combination,” said David Domzalski, Chief Executive Officer of Foamix. “The combination of Menlo with Foamix will accelerate our progression in becoming a leading dermatology-focused company with several late-stage assets that can leverage the commercialization infrastructure we have created to support the launch of AMZEEQTM.”

“I would like to thank our stockholders for their overwhelming support of this transaction,” said Steve Basta, Menlo’s Chief Executive Officer. “The combined company will be well positioned to develop and commercialize therapies to address the needs of patients with dermatologic conditions. We believe that together we have the potential to generate long-term, sustainable value for stockholders and superior solutions and choices for patients.”

The parties expect to complete the merger in early March 2020. If the merger closes before May 31, 2020, as planned, at closing Menlo will issue 0.5924 shares of its common stock for each outstanding ordinary share of Foamix, with those issued shares collectively representing approximately 59% of the combined company, as well as a non-transferable contingent stock right to potentially receive additional shares in Menlo based on the results of Menlo’s Phase III 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.

Each of Foamix and Menlo will file the final voting results from its extraordinary general meeting and special meeting, respectively, on Form 8-K with the U.S. Securities and Exchange Commission after certification by each company’s inspector of elections.

Foamix Announces Publication of Phase 3 Studies Evaluating FMX103 for the Treatment of Papulopustular Rosacea in Journal of the American Academy of Dermatology
February 6, 2020 at 8:00 AM EST
PDF Version

REHOVOT, Israel, and BRIDGEWATER, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced today the publication of the Company’s Phase 3 studies FX2016-11 and FX2016-12 (Studies 11 & 12) in the Journal of the American Academy of Dermatology (JAAD). Studies 11 and 12 were conducted by Foamix to support the New Drug Application (NDA) submission of FMX103 (minocycline, 1.5% foam), which is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe papulopustular rosacea in adults.

“The publication of these data represents another step forward in our efforts to bring an innovative, topical medication to market for moderate to severe papulopustular rosacea, which can be challenging to treat and represents an unmet need in dermatology with few new treatment developments in recent years,” said Dr. Iain Stuart, Chief Scientific Officer of Foamix. “We are proud that JAAD has accepted studies FX2016-11 and FX2016-12 (Studies 11 & 12) for publication, ensuring that a broad range of dermatology healthcare professionals globally will have access to these important data.”

Highlights from the Phase 3 Program:

Both studies demonstrated high statistically significant superiority of FMX103 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and Investigator’s Global Assessment (IGA) treatment success at Week 12 where approximately half of subjects achieved treatment success as defined by the latter endpoint.
There was a statistically significant reduction in inflammatory lesions versus vehicle as early as Week 4 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study.
Subjects were no more likely to experience treatment-emergent adverse events (TEAEs) from FMX103 than from vehicle treatment. The majority of TEAEs were mild to moderate.
More than 95% of subjects using FMX103 had skin tolerability scores of none or mild at the treatment application site at Week 12.
Specifically for erythema as part of skin tolerability assessments, 5.5% and 6.6% of subjects who received FMX103 in Studies 11 and 12 respectively, were assessed as being clear or almost clear at Baseline. At Week 12, 40.9% and 48.3% of subjects who received FMX103 respectively were assessed as clear or almost clear of erythema.

Yeah. I didn't see this happening...again... Sold this a.m. and hoping I can reload again below $3

Back under 4 bucks, just cant hold onto any gains at all

Clinical Focus | January 2020
An Update on the Use of Minocycline for the Treatment of Acne
Advances in formulation technology have led to the development of a stable topical minocycline that recently received FDA approval. Here’s what you should know.
Joshua Zeichner, MD
View PDF

Antibiotics are a mainstay of treatment for acne vulgaris for their direct anti-inflammatory effects and indirect anti-inflammatory effects by lowering C. acnes levels in the skin. Oral tetracyclines, such as minocycline and doxycycline, are considered first line for moderate to severe acne. Best practice is to limit the duration of use of antibiotics and combine with benzoyl peroxide-containing agents to minimize the risk of bacterial resistance.1 Topical antibiotics, like clindamycin and erythromycin, are an attractive option because of limited systemic exposure. They are commonly used in regimens along with other actives or as part of fixed-dose combination drugs. With the emergence of bacterial resistance, the utility of these topical antibiotics has decreased.2 For this reason, effective topical antibiotic options to treat acne remain an unmet need.
Up to Date: An Overview of Tetracyclines for Acne

Tetracycline antibiotics exert a variety of anti-inflammatory effects in the skin, which is why they are beneficial in treating acne. They downregulate production of proinflammatory cytokines (eg. TNF-a, IL-1?) and C. acnes lipase enzymes.3 Tetracyclines suppress neutrophil chemotaxis and subsequent production of reactive oxygen species.3 Finally, they decease matrix metalloproteinase and nitric oxide activity4 and reduce arachidonic acid metabolites by inhibition of phospholipase A2.3,5

The structure of minocycline offers specific advantages over other tetracyclines. It is highly lipophilic, enhancing high penetration into sebum and resulting in high follicular concentrations. Systemic absorption is virtually unaffected by stomach contents, including dairy. Of the tetracyclines, minocycline has been shown to have the lowest level of C. acnes resistance based on mean inhibitory concentrations (MICs).6 It has also been shown to have the largest log reductions in C. acnes counts, as compared to doxycycline, tetracycline, trimethoprim-sulfamethoxazole, and erythromycin.7

Minocycline has been available in the United States since 1971. Minocycline, particularly in immediate-release systemic formulas, has been associated with several potential adverse events.

Extended-release formulations were subsequently brought to the market in an attempt to limit potential adverse events. The extended-release formula allows for maintained efficacy despite lower doses. Lower maximum plasma concentration resulted in reductions in acute vestibular side effects. In 2006, extended-release minocycline became the first minocycline formula that was FDA approved for the treatment of inflammatory and non-nodular moderate to severe acne.8

Vestibular side effects, such as dizziness, may occur with immediate-release systemic formulas, but are less likely with longer-acting formulations. Idiosyncratic hypersensitivity reactions, DRESS syndrome, pneumonitis, and minocycline-induced lupus-like reactions are rare.9 Finally, minocycline-related hyperpigmenation may occur. This is most common with long-term exposure. All of the reported cases of pigmentation occurred after a minimum treatment of eight months and a cumulative dose of at least 70g of the drug.10

Topical application of minocycline has the advantage of limiting both systemic exposure and potential serious adverse events. Despite its introduction to the market more than 40 years ago, the structure of minocycline made it difficult to stabilize in a topical preparation. However, advances in formulation technology have led to the development of a stable topical minocycline that recently received FDA approval. Amzeeq (FMX-101), a novel lipohilic topical minocycline 4% foam from Foamix, is now approved for the treatment inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients down to the age of 9.11

In Phase 2 and 3 clinical trials, the drug was found to be safe and effective. A pharmacokinetic study evaluating once-daily topical application of Amzeeq foam 4% for up to 21 days did not demonstrate any significant systemic exposure.12 In its Phase 3 clinical trials, the drug met both of its co-primary endpoints, with statistically significant reductions in inflammatory lesion counts at week 12 compared to baseline, as well as week 12 treatment success, defined as clear or almost-clear with a 2-point reduction in global assessment score.13

The drug was safe and well tolerated, with no serious treatment-related adverse events. The most common treatment emergent adverse events (occurring in at least one percent of patients) were upper respiratory tract infections, worsening acne, headache, elevated CK, and influenza. The majority of these events were mild to moderate in severity. Notably, hyperpigmentation was only observed in one patient out of 1,488 and deemed to be post-inflammatory. The drug was found to be non-irritating and not associated with photosensitivity.13,14

Despite high levels of bacterial resistance to both topical and systemic antibiotics, in vitro data evaluating Amzeeq shows that it maintains its potency with a low rate of promoting bacterial resistance. In vitro studies comparing the Amzeeq formulation to several other antibiotics showed that Amzeeq had the lowest mean inhibitory concentration against C. acnes. Amzeeq was found to be four times more potent than tetracycline, eight times more potent than clindamycin, and more than 32 times more potent than erythromycin against C. acnes. Moreover, after 15 repeated exposures, Amzeeq maintained its antibacterial activity against C. acnes, while high levels of resistance developed with exposure to clindamycin.15
Minimizing Resistance

While effective in treating acne, the major concern with use of antibiotics is the development of resistant organisms. Topical application is beneficial in that it limits systemic exposure and disruption of the gut microbiome. However, the potential for local resistance of both C. acnes and commensal organisms may occur. One strategy to minimize the development of bacterial resistance is to deliver high enough drug concentrations to kill all susceptible organisms and prevent growth of mutants.

The term “mutant selection window” refers to the concentration of antibiotics that kills bacteria, but may still allow for growth of mutant organisms and can thus result in bacterial resistance. Antibiotic doses high above the mean inhibitory concentration may be needed to keep drug levels outside this window and prevent bacterial resistance. However, it may be impractical or impossible to dose many systemic antibiotics this way because of potential side effects. Notably, as these adverse events do not exist with the use of topical antibiotics, it is possible to deliver concentrations of topical antibiotics outside of the mutant selection window.16,17 This alone may prevent the development of bacterial resistance and circumvent the need for concurrent use of benzoyl peroxide alongside the topical antibiotic.

More data are needed to fully evaluate this concept with respect to this novel topical formulation of minocycline.

https://practicaldermatology.com/articles/2020-jan/an-update-on-the-use-of-minocycline-for-the-treatment-of-acne?c4src=topic:acne:feed

OT - $MNLO 13G filed

Steve Cohen’s family office.


Names of reporting persons Point72 Asset Management, L.P.

1,404,265

Percent of class represented by amount in Row (9) 5.8%

Foamix Announces OrbiMed’s Support of Merger with Menlo Therapeutics
January 17, 2020 at 8:00 AM EST
PDF Version

REHOVOT, Israel, and BRIDGEWATER, N.J., Jan. 17, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced today that OrbiMed Advisors LLC (“OrbiMed”), a significant shareholder of the Company, intends to vote in favor of the proposed merger with Menlo Therapeutics at the Company’s upcoming extraordinary general meeting of shareholders. OrbiMed expressed its support for the transaction in a press release issued on January 16, 2020. Perceptive Advisors LLC, the Company’s largest shareholder, previously signed a voting agreement on November 10, 2019 to vote its Foamix shares in favor of the merger at the meeting.

“We are delighted to have the support of both OrbiMed and Perceptive Advisors for our transformative transaction with Menlo Therapeutics,” said David Domzalski, Chief Executive Officer of Foamix. “Having the support of two of our largest shareholders is a significant step toward completing the transaction.”

About Foamix Pharmaceuticals

Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.

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. 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.

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.

Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. 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. For more information, visit www.foamix.com.

Looking forward to the future, the merger and beyond tdeck !!!

John ... ;)

$FOMX we are heading back to 7-7.50 to consolidate before we crank back to 11+ by June.



Peace out.

It's a beautiful day in the neighborhood.

Peace out.

Important Notice Regarding the Availability of Proxy Materials
for the Shareholder Meeting

2020 FOAMIX PHARMACEUTICALS LTD Special Meeting of Stockholders

MEETING DATE: February 6, 2020
For Holders as of: January 6, 2020
CUSIP NUMBER: M46135105

DSC Advisors goes from 5% to 5.5%
was 3,062,593
now 3,365,000

sounds like alot of bs

Foamix Announces AMZEEQ™ (minocycline) Achievement of Preferred Status on Express Scripts National Preferred Formulary, One of the Largest Commercial Formularies in the U.S.
January 14, 2020 at 8:00 AM EST
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Preferred Coverage Effective Immediately on Express Scripts National Preferred, Flex, and Basic Formularies

AMZEEQ is the First FDA Approved Topical Form of Minocycline for the Treatment of Moderate to Severe Acne

REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, today announced a coverage update for its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ is indicated 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. AMZEEQ is the first topical minocycline to be approved by the U.S. Food and Drug Administration (FDA) for any condition.

The Company announced that AMZEEQ has achieved preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. As a preferred medication, AMZEEQ will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to acne medications which are non-preferred or excluded.

The Company recently announced that the annual list price of AMZEEQ is $485 per 30-gram canister, a lower per unit cost than that of current brand leaders within the acne prescription market.

“As one of the largest pharmacy benefit managers in the U.S., Express Scripts’ decision to include AMZEEQ as a preferred agent on its national formularies is a significant step toward ensuring access to AMZEEQ for millions of moderate to severe acne patients,” said David Domzalski, Chief Executive Officer of Foamix. “We believe our pricing and overall access strategy prioritizes patients and their healthcare providers by providing a novel, first-of-its-kind acne treatment at pricing designed to help reduce barriers to treatment with AMZEEQ.”

Minocycline, a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, has not previously been available as a topical treatment due to its instability in traditional topical formulations. In AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.

AMZEEQ was approved by the U.S. Food and Drug Administration in October 2019. The Company has previously announced that the product is available in pharmacies nationwide as of January 13th.

About AMZEEQ™

INDICATIONS AND USAGE

AMZEEQ™ (minocycline) topical foam, 4% is indicated 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.

Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.

IMPORTANT SAFETY INFORMATION

Contraindications

Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.

Warnings and Precautions

Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

Teratogenic effects, inhibition of bone growth, & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent
discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
Central nervous system effects: Patients experiencing light-headedness, dizziness, or vertigo should be cautioned about driving vehicles or operating heavy machinery.
Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
Tissue Hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae, and heart valves.
Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.

Adverse Reactions

The most common adverse reaction reported during clinical trials of AMZEEQ was headache.

To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at

1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

Please see full Prescribing Information.

About Acne
Acne is a chronic, inflammatory skin condition that affects the skin’s sebaceous glands and hair follicles. 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. 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. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.

About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.

With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in Amzeeq, the world's first topical minocycline, and in the Company's 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.

Foamix is a different type of specialty pharmaceutical company by design, driven to see solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs.

Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. 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. For more information, visit www.foamix.com.

Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release which are not historical facts are forward-looking statements, including, but not limited to, statements regarding the future expectations, plans and prospects for Foamix and the commercialization plans of AMZEEQ, including the pricing, availability and healthcare and patient adoption of AMZEEQ to treat moderate to severe acne vulgaris in adults and pediatric patients. Forward-looking statements are based on Foamix’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, adverse events associated with AMZEEQ; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ or any other products or product candidates that Foamix 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 Foamix’s other product or product candidates; additional competition in the acne and dermatology markets; inability to raise additional capital; Foamix’s ability to recruit and retain key employees and its ability to stay in compliance with applicable laws, rules and regulations. Foamix discusses many of these risks in greater detail in its periodic filings with the SEC, including under the heading “Risk Factors” in its most recent annual report and subsequent quarterly reports. Although Foamix believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix 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.

Corporate Contact:
Ilan Hadar, CFO
Foamix Pharmaceuticals Ltd.
+972-8-9316233
ilan.hadar@foamixpharma.com

Media Relations:
Rebecca Schechner
Zeno Group
312-586-3429, x5632
rebecca.schechner@zenogroup.com

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

OT: $DERM to be bought out by $LLY for $1.1B

Foamix Announces AMZEEQ™ (minocycline) Topical Foam Available in Pharmacies Nationwide on January 13th for the Treatment of Moderate to Severe Acne
Stocks mentioned: FOMX

REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 9, 2020 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) ("Foamix" or the "Company"), a specialty pharmaceutical company, today announced that its novel AMZEEQ™ (minocycline) topical foam, 4% will be available on January 13, 2020 by prescription 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. Approved by the U.S. Food and Drug Administration (FDA) in October 2019, AMZEEQ is the first topical minocycline to be FDA approved for any condition and represents the company's first commercial product launch. This new once-daily therapy will be available in retail, community and specialty pharmacies nationwide.

The Company also announced that the annual list price of AMZEEQ will be $485 per 30-gram canister. This is a lower price per unit than that of current brand leaders in the acne prescription market, setting AMZEEQ apart in terms of its pricing approach.

Foamix employed a team of experts to develop the Company's approach for engaging commercial insurers to offer the broadest possible access to AMZEEQ for patients and healthcare professionals. The Company will provide copay card assistance for eligible commercially insured patients. An electronic benefit verification tool is also available through the product website, AMZEEQ.com, to assist healthcare professionals and patients to understand their likely insurance coverage and out-of-pocket costs.

Foamix has also developed a multi-channel tactical marketing plan to reach customers, including a sales force deployment to more than 6,000 acne-treating providers with product samples. Foamix will broadcast a promotional speaker program for relevant health care professionals ("HCPs") nationally on February 13, 2020 to share AMZEEQ product and prescribing information. In addition, Foamix is deploying a broad range of digital consumer outreach tactics, including product information and a unique unboxing-style "how to use" video designed to be easily understood by an adolescent patient population and based on AMZEEQ's instructions for use.

"Moderate to severe acne is a challenging and burdensome condition of many sufferers. AMZEEQ is now positioned to become an important tool in managing this condition," said David Domzalski, Chief Executive Officer of Foamix. "We recognize that providers and acne sufferers have been seeking alternatives in acne treatment, and I'm very proud of the program we've designed to provide broad awareness and availability of AMZEEQ for physicians and patients."

Minocycline, a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, has not previously been available as a topical treatment due to its instability in traditional topical formulations. With the development of AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to conveniently and effectively deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.

https://newsfilter.io/a/6433f9616910334b89551e6cd7f1f2a4

a twitter message on 1/8/2020

Britt
@test39519469
·
14h

We are delighted to announce that Foamix Pharmaceuticals has launch their first website for their recent FDA approval. Can’t wait to continue working together on future projects!

https://www.amzeeq.com/

https://publish.twitter.com/?query=https%3A%2F%2Ftwitter.com%2Ftest39519469%2Fstatus%2F1215012200450015232&widget=Tweet

can't find this So-Gel tretinoin mentioned in FOMX 10K. Anyone know?

I am assuming your posting on the wrong board.

Updates? We know that POS CEO here walks the line of SEC investigations with his bullshit....Thats why it's always better to just move onto the next BULLSHIT news and hope shareholders just forget about the past BULLSHIT....Just look at the list...I have it in oldest news first so everyone can see all ,the BULLSHIT that never happened!

looking good eom

looks like a new presentation of the combined company filed an an SEC document 425

not sure if anything is new

I think you guys are overthinking this thing.

Total combined shares prior to the merger 85.3M
Total shares after the merger 48.0M

Looks like a 1.78:1 reverse split to me.

Of course where the post-merger stock price goes is for the market to decide. Given the synergies of the merger, this looks like easy money and I'm long both MNLO and FOMX.

On December 17, 2019, Foamix Pharmaceuticals Inc. (the “Borrower”), a direct wholly owned subsidiary of Foamix Pharmaceuticals Ltd. (the “Company”), drew down the second tranche of $20.0 million (the “Tranche 2 Loan”) under the previously disclosed Credit Agreement and Guaranty (the “Credit Agreement”), dated as of July 29, 2019, among the Company, the Borrower, the subsidiary guarantors from time to time party thereto, the lenders from time to time party thereto and Perceptive Credit Holdings II, LP, as Administrative Agent. As previously disclosed, the Credit Agreement provides for up to a $50.0 million term loan facility, $15.0 million of which was borrowed at closing on July 29, 2019 (the “Tranche 1 Loan”). The Tranche 1 Loan and the Tranche 2 Loan each have a maturity date of July 29, 2024, unless earlier prepaid. Pursuant to the Credit Agreement and subject to the achievement of certain revenue milestones prior to September 30, 2020, the Borrower would have the right to draw down a third tranche of up to $15.0 million.



The Company expects to use the proceeds of the Tranche 2 Loan for the commercial launch of AMZEEQ™, certain pipeline development activities and other general corporate purposes.

You exposed the lie of the stock market. That the price of a stock means something. You want to say book value. But when you look up $FOMX book value, it's $.96 a share. Well that's not right you say. But it is. When you look the bank $BAC, you see book value of $26.31 but the stock price is $35.04

The myth of hundreds of millions of Americans who think that the monthly statement of their 401K is real money.

You can not look at the market cap of $FOMC and then look at the market cap of $MNLO and just add them together. Like magic.

Your investment is hope. You hope that the investors who bought $FOMC at $4.45 the day before the merger, have not jumped off a ledge.

The good news, is that the ratio is in line. One or two days doesn't make a trend, so it could change by Friday. Both stocks are much lower now than the day before the merger. But the hope is that investors will return now.

The other myth is that FOMX shareholders will have a larger share of the pie if MNLO's products fail. Yeah they will. But don't you think the price of both stocks will tank, if the products fail?

Yes, owners of FOMX recv. MNLO shares, BUT IMO the valuation you are setting is NOT correct.

You are implying the FOMX value is not going to be added to the total value of the "NEW" merged value of the 2 combined companies ...
How do you come up with a valuation that does not include the value of FOMX at the time of the merger as well as the MNLO value ???

yes you have me correct.


You are implying that the only value of the combined companies is MNLO ... MNLO alone

Shares will be created and sent to FOMX shareholders and what they have are cancelled. The amount of shares sent is dependent on the those events. The MNLO shareholders today get no more shares.

realfast, if your calculation were correct, why in the world would Foamix or Menlo shareholders approve to have LESS than they both have now???
It is the value of the COMBINED two companies not just the value of MNLO ... think about what you are saying. You are implying that the only value of the combined companies is MNLO ... MNLO alone ??? No, that is not the case at all. Shorts may want you to believe this, but you need to contact investor relations for your own clarification, if you truly believe this to be true.

Here is what is stated by the companies : "After closing the deal, Foamix shareholders will own approximately 59% of the combined company and Menlo shareholders will own approximately 41% on a pro forma, fully diluted basis.

Further, Foamix shareholders will increase pro forma ownership of the combined company to upto 82% based on the results of the Phase III prurigo nodularis trials before May 31, 2020.

The combined company will be led by David Domzalski, CEO of Foamix and headquartered in New Jersey. The board of the combined company will consist of five members designated by Foamix and two members designated by Menlo, including Steve Basta, its CEO. Foamix Pharm and Menlo Therapeutics to merge - Quick Facts

Foamix Pharmaceuticals Ltd. (FOMX) and Menlo Therapeutics Inc. (MNLO) 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 transaction.

The transaction is expected to be completed in late first quarter or early second quarter of fiscal 2020. This will be 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"

within range of the ratio to MNLO
FOMX closed at 3.11 range 2.87 to 3.15
MNLO closed at 4.86 (better volume today) range 4.5 to 4.99
.59x4.86=2.8674

In compliance with the Companies Law, 5759-1999 of the State of Israel and the regulations promulgated thereunder (the “Companies Law”), Foamix Pharmaceuticals Ltd. (“Foamix” or the “Company”) hereby notifies its shareholders that it will hold an extraordinary general meeting of shareholders (the “Meeting”) on Thursday, February 6, 2020 at 11:00 a.m. Eastern Standard Time (“EST”) at the Company’s U.S. offices, located at 520 U.S. Highway 22, Suite 204, Bridgewater, New Jersey 08807. The record date for the determination of the holders of Foamix ordinary shares, par value New Israeli Shekels 0.16 per share (“Foamix ordinary shares”), entitled to vote at the Meeting is Monday, January 6, 2020.



At the Meeting, Foamix shareholders will be asked to vote on the following two proposals:


· Approval and adoption of (i) the Agreement and Plan of Merger dated November 10, 2019 (as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 4, 2019, and as may be further amended from time to time, the “Merger Agreement”), by and among Menlo Therapeutics Inc., a Delaware corporation (“Menlo”), Giants Merger Subsidiary Ltd., a company organized under the laws of the State of Israel and a wholly-owned subsidiary of Menlo (“Merger Sub”), and Foamix, a copy of which was attached as Exhibit 2.1 to Foamix’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 12, 2019; (ii) the merger of Merger Sub with and into Foamix (the “Merger”) on the terms and subject to the conditions set forth in the Merger Agreement and in accordance with the provisions of Sections 314-327 of the Companies Law, following which Merger Sub will cease to exist, and Foamix will become a wholly-owned subsidiary of Menlo; (iii) (a) the Merger consideration for Foamix’s shareholders, consisting of 0.5924 of a share of Menlo common stock (subject to upwards adjustment to 1.2739 or 1.8006 shares of Menlo common stock if one or both of Menlo’s Phase III PN Trials (as defined in the Merger Agreement), respectively, fail to demonstrate Serlopitant Significance (as defined in the Merger Agreement)) for each Foamix share that is issued and outstanding (other than any dormant share under the Companies Law and any Foamix share that, immediately prior to the Effective Time (as defined in the Merger Agreement), is owned by Foamix, Menlo or Merger Sub, or by any direct or indirect wholly-owned subsidiary of Foamix, Menlo or Merger Sub) and that will be deemed transferred to Menlo upon the Merger and (b) if the closing of the Merger occurs on or before May 31, 2020 and the Efficacy Determination (as defined in the Merger Agreement) has not yet been received, one contingent stock right, subject to the terms and conditions of the contingent stock rights agreement, the form of which was attached as Exhibit 10.3 to Foamix’s Current Report on Form 8-K, filed with the SEC on November 12, 2019; and (iv) all other transactions contemplated by the Merger Agreement, all upon the terms and subject to the conditions set forth in the Merger Agreement (the “Merger Proposal”).

·

Approval, on a non-binding, advisory basis, in accordance with the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of certain compensation that may be paid or become payable to the named executive officers of Foamix in connection with the Merger and contemplated by the Merger Agreement (the “Executive Compensation Proposal”).



The Executive Compensation Proposal will be presented in accordance with the rules of the Exchange Act, and it is not anticipated that any compensatory payments or benefits will in fact be paid to Foamix’s named executive officers in connection with the Merger.









The Board of Directors of Foamix unanimously recommends that Foamix shareholders vote in favor of each of the above proposals.



As required under the Nasdaq Listing Rules, which supersede Foamix’s articles of association with respect to this issue, the presence, in person or by proxy, at the Meeting of one or more Foamix shareholders who hold, in the aggregate, at least 331/3% of the voting rights in Foamix, is necessary to constitute a quorum at the Meeting. Abstentions and broker non-votes will also be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Meeting.



If within half an hour from the time appointed for the Meeting a quorum is not present, the Meeting will be adjourned for one week, to Thursday, February 13, 2020, at the same time and place. At that adjourned meeting, the same 331/3% quorum requirement will apply.



The vote of all Foamix shareholders is important regardless of whether they attend the Meeting. Accordingly, Foamix asks all shareholders to participate and vote regardless of the number of Foamix ordinary shares they own.



The approval of the Merger Proposal requires the affirmative vote of a majority of the voting rights of Foamix ordinary shares represented, in person or by proxy, and voting thereon at the Meeting, provided that such majority includes at least a majority of the votes cast by Foamix shareholders that are not Menlo, Merger Sub or certain Menlo affiliates, who are present, in person or represented by proxy, and voting (abstentions and broker non-votes are disregarded).



The approval of the Executive Compensation Proposal, which will be presented on a non-binding, advisory basis, requires the affirmative vote of a majority of the voting rights of Foamix ordinary shares represented, in person or by proxy, and voting thereon at the Meeting, pursuant to the rules under the Exchange Act.



The approval of the Merger Proposal, in addition to being required under the Companies Law, is a condition to the completion of the Merger under the terms of the Merger Agreement. Therefore, the Merger cannot be consummated without the approval of the Merger Proposal. None of the steps contemplated in connection with the Merger, including the issuance of Menlo common stock to the Foamix shareholders in exchange for their Foamix ordinary shares, will take place unless the Merger Proposal is approved by Foamix’s shareholders. The Merger and all related steps can, however, be consummated even if the Executive Compensation Proposal is not approved by Foamix’s shareholders at the Meeting.



In addition to the requirement of obtaining Foamix shareholder approval for the Merger Proposal, each of the other closing conditions set forth in the Merger Agreement (including the approval by Menlo’s stockholders of certain of the transactions contemplated under the Merger Agreement) must be satisfied or waived for the Merger to be completed.



Foamix intends, promptly following the record date, to send to its shareholders a proxy statement for the Meeting that also will serve as a prospectus in respect of the shares of Menlo common stock to be issued to Foamix shareholders in the Merger. That proxy statement/prospectus will describe, in detail, the Merger, the Merger Agreement, the proposals to be voted upon at, and additional logistical information related to, the Meeting, the procedure for voting in person or by proxy at the Meeting and various other information related to the Meeting. The Company will also file copies of the proxy statement and a related proxy card with the SEC, which may also be obtained for free from Foamix’s proxy solicitor for the Meeting, Morrow Sodali, LLC, at FOMX@investor.morrowsodali.com. The full text of the proposed resolutions for each proposal, together with the form of proxy for the Meeting, may also be viewed beginning on Monday, January 6, 2020, at the registered office of the Company, 2 Holzman Street (Entrance 2B), Weizmann Science Park, Rehovot, Israel, from Sunday to Thursday, 10:00 a.m. to 5:00 p.m. (Israel time). The telephone number at the Company’s registered office is +972-8-931-6233.









Shareholders of record who are unable to attend the Meeting in person will be requested to complete, date and sign a proxy card and return it promptly in the pre-addressed envelope that will be provided. Shareholders who attend the Meeting in person may revoke their proxies and vote their Foamix ordinary shares at the Meeting. In order to be counted towards the tally of votes at the Meeting, a proxy card must be received at the Company’s Israeli registered office not later than four hours prior to the start of the Meeting (i.e., by 2:00 p.m., Israel time/ 7:00 a.m. Eastern time, on the Meeting date).



If your Foamix ordinary shares are held in “street name” (meaning held through a bank, broker or other nominee), you will be able to direct the record holder of your shares on how to vote your shares by completing and submitting a voting instruction form (including online at www.proxyvote.com). Your voting instructions, if submitted electronically, must be received by 11:59 p.m. EST on Tuesday, February 4, 2020, and if submitted via a physical voting instruction form, must be received by noon, EST, on Wednesday, February 5, 2020, to be counted. If you hold your shares in “street name” and wish to attend the Meeting, you must obtain a legal proxy from the record holder (together with a brokerage or bank statement showing that you owned the shares beneficially as of the record date) to enable you to participate in and to vote your shares at the Meeting (or to appoint a proxy to do so).



In accordance with the requirements of the Companies Law, any shareholder of the Company holding at least 1% of the outstanding voting rights of the Company may submit to the Company a proposed additional agenda item for the Meeting, to our principal executive offices located at 2 Holzman Street, Weizmann Science Park, Rehovot, Israel, Attention: Chief Financial Officer, no later than Monday, December 23, 2019. To the extent that there are any additional agenda items that Foamix’s Board of Directors deems appropriate to add as a result of any such submission, Foamix will publish in a Current Report on Form 8-K an updated notice with respect to the Meeting, which will be available at the SEC’s website, www.sec.gov.



Important Additional Information and Where to Find It


In connection with the proposed strategic combination involving Foamix and Menlo, Foamix and Menlo have been filing relevant materials with the SEC, including a preliminary registration statement on Form S-4 filed by Menlo on December 4, 2019 that includes a joint proxy statement/prospectus to be distributed to Foamix shareholders. Foamix will mail the joint proxy statement/prospectus and a proxy card to each shareholder entitled to vote at the Foamix extraordinary general meeting relating to the proposed merger. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS WHEN IT IS FILED IN FINAL FORM BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. FOAMIX’S EXISTING PUBLIC FILINGS WITH THE SEC SHOULD ALSO BE READ, INCLUDING THE RISK FACTORS CONTAINED THEREIN.



Investors and security holders may obtain copies of the Form S-4, including the joint proxy statement/prospectus, as well as other filings containing information about Foamix, free of charge, from the SEC’s website (www.sec.gov). Investors and security holders may also obtain Foamix’s SEC filings in connection with the transaction, free of charge, from Foamix’s website (www.Foamix.com) under the link “Investors & Media” and then under the tab “Filings & Financials,” or by directing a request to Foamix, Attention: Ilan Hadar, Chief Financial Officer. Copies of documents filed with the SEC by Menlo will be made available, free of charge, on Menlo’s website (www.Menlotherapeutics.com).









Participants in Solicitation



Foamix, Menlo and their respective directors, executive officers and employees and other persons may be deemed to be participants in the solicitation of proxies from the holders of Foamix ordinary shares in respect of the proposed transaction. Information regarding Foamix’s directors and executive officers is available in its definitive proxy statement for Foamix’s 2019 annual meeting of shareholders filed with the SEC on March 11, 2019, as modified or supplemented by any Form 3 or Form 4 filed with the SEC since the date of such definitive proxy statement. Information about the directors and executive officers of Menlo is set forth in the Form S-4. Other information regarding the interests of the participants in the proxy solicitation will be included in the joint proxy statement/prospectus when it becomes available in final form. These documents can be obtained free of charge from the sources indicated above. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

This will be just like RCEL was last year, the timing is exact except FOMX has far more catalysts after March than RCEL did especially the PDUFA in June and RCEL did not have an international partnership to be announced either where they would be getting up front money as they were already marketing overseas.

With MNLO they do add 4 other significant catalysts in the first half of 2020 where there will literally be one almost every 2 weeks. That's what keeps any biotech going catalysts which start with commercial launch in January. When there is a chance of no catalyst for a bit these things get flipped out of and shorted it is just fact, has zero to do with anything else.

Like RCEL this will start trending up after January commercial launch and will just steadily rise look at the chart for RCEL last year from January and you will see the future with this only difference this will be starting higher that the 1'1 but it sill exactly the same period. But, lets just see.

Peace out.

That was a title of an article on seeking alpha.

Until the stock prices gets into alignment, there is risk to the downside on $FOMX. The volume on $MNLO and lack of options, is a problem.

The Foamix And Menlo Merger Makes Sense
Dec. 5, 2019 12:44 AM ET

https://seekingalpha.com/article/4310676-foamix-and-menlo-merger-makes-sense

I agree with the previous post from realfast95 and I am a born sceptic. I had doubts too but digging deeper and adding rational thinking, I like my good sized position and will hold, may even add this month with tax loss sellers in play... I know others in this camp as well. Common sense points to a cost saving future which helps investor value.

Good Luck
-pete

No it doesn't. That's why this is tanking.

The Foamix And Menlo Merger Makes Sense
Dec. 5, 2019 12:44 AM ET

https://seekingalpha.com/article/4310676-foamix-and-menlo-merger-makes-sense

replays

MNLO


http://ir.menlotherapeutics.com/events/event-details/piper-jaffray-31st-annual-healthcare-conference

FOMX

http://www.foamix.com/events/event-details/piper-jaffray-31st-annual-healthcare-conference

Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced today that David Domzalski, Chief Executive Officer, will provide a corporate update via a fireside chat at the Piper Jaffray 31st Annual Healthcare Conference, taking place December 2-5, 2019 at the Lotte New York Palace Hotel in New York City.

Piper Jaffray 31st Annual Healthcare Conference
Date: Tuesday, December 3
Time: 4:30pm Eastern Time
Webcast: https://event.webcasts.com/starthere.jsp?ei=1274069&tp_key=17f3110ba2

https://finance.yahoo.com/news/foamix-pharmaceuticals-present-piper-jaffray-130010176.html

As always, I view 'bites' as perceptions. Our individual views have no effect on the corporate plans or realities.

This late year's turmoil is a buying opportunity that will mean I hope to add at lower prices in December tax selling season. The first 6 months of 2020 will be 'nothing but killer' to steal a phrase.

I have a lot, but will be adding at the right prices and we are close to that now.

the latest 425 is a reality bite to MNLO employees. Promise of bonus unspecified to stick around. I would have preferred some mention of retaining some Scientists and an office in California.
Maybe a West Coast sales office and clinic.

Reza Ganjavi DD video on FOMX/MNLO merger.....

If you read my post I am not blaming you or other Foamix investors. If you know anything about Hirsch, then you will also conclude that he is indeed a liar and a Fraud. A lot of Fraud gets committed on a daily basis and it happens with all stocks, not just penny stocks. Just wondering why anyone would not take his documented track record and question it?

You people who invested in a stock that was and always will be a penny and to get over your mistakes. The stock was a penny before will be a penny in the future and no director in the world will ever change that. Any who got sucked into that internet sham pump and dump needs to blame themselves or whoever ran it.

Blows my mind, people always look for someone to blame when it is themselves they should be blaming.