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Menlo Therapeutics Inc. (MNLO) (MNLO)

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Last Post: 11/9/2020 11:29:50 PM - Followers: 18 - Board type: Free - Posts Today: 0

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Menlo's Nasdaq Page

Menlo's Edgar Filings



$MNLO; LICENSING ;;;;; 04-23-2020

-- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to
address unmet needs in dermatology, today announced that its wholly-owned subsidiary,

Foamix Pharmaceuticals Ltd. (“Foamix”), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics
(HK) Limited, an affiliate of Cutia Therapeutics
(“Cutia”) for AMZEEQ™ (minocycline) topical foam, 4% as well as
its other topical minocycline product candidates, once approved,
on an exclusive basis in Greater China.

Under the terms of the agreement, Cutia will have an exclusive
license to obtain regulatory approval of and commercialize AMZEEQ™ and,

if approved in the U.S., FMX103 and FCD105 in the Greater China territory.

Foamix will supply the finished licensed products to Cutia for
clinical and commercial use.

Foamix will receive an upfront cash payment of $10 million and will
be eligible to receive an additional $1 million payment upon the
receipt of marketing approval in China of the first licensed product.

Foamix will also receive royalties on net sales of any licensed products.

“We believe that this agreement with Cutia speaks to the importance
of our topical minocycline technology and the strong demand for
AMZEEQ worldwide,” said David Domzalski, CEO of Menlo.

“We intend to partner with other companies outside the U.S. to
extend our commercial reach in order to bring AMZEEQ and our
topical minocycline product candidates to the hundreds of millions
of patients suffering from acne and rosacea.”

“We recognized the value of Foamix’s unique foam technology for dermatology and looked to license its minocycline products as
anchor assets as we aim to build China’s leading dermatology platform,” said Lele Zhang, CEO of Cutia.

Cutia is a portfolio company of 6 Dimensions Capital, a leading global investment firm with a focus on life sciences and
healthcare with over 10B RMB ($1.5B USD) currently under management.

In October 2019,
Foamix received U.S. Food and Drug Administration (FDA) approval for AMZEEQ,
a minocycline topical foam, 4%,
for the treatment of non-nodular inflammatory moderate-to-severe
acne vulgaris in adults
and pediatric patients 9 years of age and older.

In addition to AMZEEQ, the Company is working to develop and commercialize in the U.S. a topical minocycline foam,
1.5% (FMX103) for the potential treatment of inflammatory
lesions (papules and pustules) of rosacea in adults,
which is currently being reviewed by the FDA with a PDUFA action
date of June 2, 2020, and FCD105, a topical foam combination of minocycline and adapalene therapy for the potential treatment
of acne vulgaris, which is currently in Phase 2 clinical development with top line results expected in the second quarter of 2020.

With over 200 granted patents worldwide Menlo is a leader in innovative topical technologies and
has out-licensed novel delivery platforms to pharmaceutical companies for the development of
proprietary topical products containing various active pharmaceutical ingredients.



Stock analysts at Piper Sandler decreased their Q2 2020 earnings estimates for
Menlo Therapeutics in a research report issued to clients and investors on

Monday, May 11th. Piper Sandler analyst D. Amsellem now forecasts
the company will post earnings of ($0.18) per share for the quarter,

down from their previous estimate of ($0.11).

Piper Sandler also issued estimates for Menlo Therapeutics’ Q3 2020 earnings at ($0.18) EPS,

Q4 2020 earnings at ($0.14) EPS,
FY2020 earnings at ($0.79) EPS,
Q1 2021 earnings at ($0.12) EPS,
Q2 2021 earnings at ($0.08) EPS,
Q3 2021 earnings at ($0.08) EPS,
Q4 2021 earnings at ($0.05) EPS,
FY2021 earnings at ($0.33) EPS and
FY2022 earnings at $0.03 EPS.







Menlo Announces Settlement to Conclude Finacea Foam Litigation and Announces that Partner,
LEO Pharma A/S, Remedies Finacea Foam Supply Issues

BRIDGEWATER, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology,
today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”) has entered into a settlement and license agreement
to resolve the remaining pending patent litigation involving Finacea® Foam.
Details of the settlement agreement are confidential, and the settlement agreement is subject to the review of the Federal Trade Commission and the U.S. Department of Justice.

Foamix is the owner of patents that have been licensed to LEO Pharma A/S (“LEO Pharma”) to market Finacea® Foam,
a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea.
This settlement concludes the litigation relating to Finacea® Foam and comes after the settlements in October 2019 with an
affiliate of Teva Pharmaceutical Industries Ltd. and in April 2019 with affiliates of Perrigo Company plc.

Expected Resupply of Finacea Foam

Menlo further announces that LEO Pharma has remedied the supply chain issues related to Finacea Foam that Foamix previously disclosed in April 2019.
Pursuant to the license agreement between Foamix and LEO Pharma, Foamix is entitled to the payment of royalties based on the net sales of Finacea Foam.
This week, LEO Pharma informed Menlo that it has remedied its supply issues and expects to resupply
batches of Finacea Foam for commercial sales in the U.S. in the coming weeks. Following the resupply, we anticipate that our royalty payments for Finacea Foam will increase. 

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MNLO News: Quarterly Report (10-q) 11/05/2020 07:27:12 AM
MNLO News: Current Report Filing (8-k) 11/05/2020 07:13:36 AM
MNLO News: Statement of Changes in Beneficial Ownership (4) 10/02/2020 04:32:40 PM
MNLO News: Current Report Filing (8-k) 10/01/2020 08:20:15 AM
MNLO News: Statement of Changes in Beneficial Ownership (4) 09/14/2020 04:40:13 PM
#545   $mnlo $1.35 ? 0.0 (0.00%) Taurus69 11/09/20 11:29:50 PM
#544   $mnlo $1.35 ? 0.0 (0.00%) Taurus69 10/30/20 06:14:25 PM
#543   Menlo Therapeutics I (MNLO) mick 10/25/20 04:47:11 PM
#542   $mnlo $1.35 ? 0.0 (0.00%) Taurus69 10/03/20 01:43:47 PM
#541   $mnlo $1.35 ? 0.0 (0.00%) Taurus69 09/29/20 09:13:56 PM
#540   Menlo Therapeutics I (MNLO) mick 09/24/20 08:57:39 PM
#539   ihub said can't change til finra does business mick 09/09/20 09:52:41 AM
#538   some insider buying yesterday Tzr250rg 09/09/20 08:03:25 AM
#537   VYNE Bid: 1.46 Ask: 1.47 Last: 1.47 Chg mick 09/08/20 01:39:44 PM
#536   I ASKED FOR NAME CHANGE MNLO to VYNE mick 09/08/20 01:37:54 PM
#535   Rooted in Innovation realfast95 09/08/20 08:33:55 AM
#534   Greetings, fellow clingers! jugs 09/08/20 07:43:31 AM
#533   Menlo Therapeutics I (MNLO) mick 09/05/20 04:38:14 PM
#532   If that works for you, so be it. jugs 09/04/20 07:40:49 PM
#531   Still buying at these high prices? I've said trunovice 09/04/20 07:15:49 PM
#530   Absolutely likely. I've seen it firsthand when jugs 09/04/20 02:01:58 PM
#529   Thanks, jugs, for cutting and pasting the original artfulife 09/04/20 01:51:28 PM
#528   artfulife 09/04/20 01:51:25 PM
#527   Just now find I got fills on two jugs 09/04/20 10:27:26 AM
#526   Recently fellow poster "artfulife" pasted an exhaustive interview jugs 09/04/20 08:48:56 AM
#525   I'm just glad to get away from the pick 09/02/20 09:29:54 PM
#524   Cute. Any idea as to what the name means/comes from? jugs 09/02/20 08:55:51 AM
#523   That would be deVYNE! artfulife 09/02/20 08:36:34 AM
#522   My hope is that with this name change jugs 09/02/20 08:18:38 AM
#521   VYNE artfulife 09/02/20 08:06:33 AM
#520   Excellent read! jugs 08/31/20 10:04:09 PM
#519   Interesting read: artfulife 08/31/20 09:38:05 PM
#518   $mnlo $1.4 v -0.06 (-4.11%) Taurus69 08/27/20 12:19:30 PM
#517   Sorry to hear... It's all a learning lesson trunovice 08/24/20 05:34:51 PM
#515   Menlo Therapeutics I (MNLO) mick 08/16/20 01:01:35 PM
#514   Looks sensible to me. There's a plan in jugs 08/07/20 04:59:34 PM
#513   Well, I guess we should expect them to artfulife 08/07/20 04:31:38 PM
#512   The lackluster earnings result from Covid 19, not jugs 08/07/20 03:54:02 PM
#511   In light of the lackluster earnings and the artfulife 08/07/20 03:42:58 PM
#508   My posts have no power or control over others. trunovice 08/06/20 10:18:05 PM
#507  Restored Share ALWAYS rise following a reverse split as trunovice 08/06/20 09:55:18 PM
#505   Disclosing numbers of shares held can be useful jugs 08/06/20 09:45:43 PM
#504   https://investorshub.advfn.com/boards/read_msg.aspx?message_id=156540740 trunovice 08/06/20 09:43:21 PM
#503   To clarify something I'd assumed all would understand: When jugs 08/06/20 09:36:49 PM
#502   I have no reason to crow about how trunovice 08/06/20 09:32:49 PM
#501   https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157303643 trunovice 08/06/20 09:21:26 PM
#500  Restored I have no reason to crow about how trunovice 08/06/20 09:17:09 PM
#498   My posts have no power or control jugs 08/06/20 08:54:02 PM
#497   Your right. Keep holding and see what happens trunovice 08/06/20 08:33:16 PM
#496   Interesting stuff here... jugs 08/06/20 04:20:09 PM
#495   20k loss for me on ANSA, MNLO was pickspicks1 08/06/20 04:05:41 PM
#494   How do you know? jugs 08/06/20 04:01:55 PM
#493   OK, here's my update: jugs 08/06/20 04:00:02 PM
#492   This is a no buy till it drops trunovice 08/06/20 03:59:07 PM
#491   Thinking about things I addressed a little while jugs 08/06/20 10:55:47 AM
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