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VYNE Therapeutics (VYNE)

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Last Post: 11/10/2021 2:51:40 PM - Followers: 20 - Board type: Free - Posts Today: 0

Company Website
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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VYNE News: VYNE Therapeutics EPS misses by $0.04, misses on revenue 11/10/2021 02:36:34 AM
VYNE News: Current Report Filing (8-k) 11/10/2021 02:31:58 AM
VYNE News: VYNE Therapeutics Q3 2021 Earnings Preview 11/09/2021 06:53:01 AM
VYNE News: Current Report Filing (8-k) 11/04/2021 04:36:51 AM
VYNE News: Current Report Filing (8-k) 10/26/2021 04:16:43 AM
#734   https://investorshub.advfn.com/uimage/uploads/2021/11/10/FPCZSAQCCVGBGKGYZKG.png Tzr250rg 11/10/21 02:51:40 PM
#733   Premarket 1.45 Tzr250rg 11/09/21 08:55:08 AM
#732   premarket 1.66 Tzr250rg 11/04/21 08:57:46 AM
#731   HOD 1.48 Tzr250rg 11/03/21 11:40:36 AM
#730   HOD 1.42 Tzr250rg 11/02/21 02:58:47 PM
#729   HOD 1.41 Tzr250rg 11/01/21 10:51:51 AM
#728   HOD 1.39 Tzr250rg 10/29/21 12:06:40 PM
#727   https://vynetherapeutics.com/press-releases/vyne-therapeutics-to-report-third-qu Tzr250rg 10/28/21 09:17:24 AM
#726   up 9% today Green Tzr250rg 10/26/21 11:18:54 AM
#725   I thought it was safe to nibble my artfulife 10/05/21 04:21:01 PM
#724   the end has arrrived realfast95 08/12/21 07:50:56 AM
#723   Patent infringement Tzr250rg 08/10/21 08:42:23 AM
#722   In the last month or so mostly small hubwolf1 07/21/21 11:41:00 AM
#721   The form 4's I see say code "A" realfast95 07/21/21 10:38:37 AM
#720   Some insider buying...Form 4 Tzr250rg 07/21/21 09:33:01 AM
#719   well, the positive spin on this news, is realfast95 07/19/21 10:44:05 AM
#718   VYNE Therapeutics Announces Initiation of Investigator Initiated Trial realfast95 07/19/21 08:51:54 AM
#717   I'm not sticking around to find out. Sold artfulife 07/18/21 07:56:49 PM
#716   Can this bouce back? is this bottom? Tzr250rg 07/16/21 12:05:40 PM
#715   I had no idea. my deepest sympathy to Tzr250rg 07/15/21 11:09:09 AM
#714   Sadly, jugs passed away in January of this year. artfulife 07/15/21 11:06:43 AM
#713   I haven't seen Jugs. did he close his position? Tzr250rg 07/15/21 09:38:23 AM
#712   Sometimes, it's the little things... I remember a artfulife 07/09/21 09:42:23 AM
#711   another day... another beating? hope not Tzr250rg 07/09/21 09:32:08 AM
#710   i was going to average down as well. Tzr250rg 07/08/21 09:12:57 AM
#709   bought more below 3 today - i don't Billr05 07/07/21 11:57:38 AM
#708   this is insane 2.95 low today Tzr250rg 07/07/21 11:09:56 AM
#707   this is insane 2.95 low today Tzr250rg 07/07/21 11:09:48 AM
#706   On June 4, 2021, Andrew Saik tendered his realfast95 06/07/21 07:29:51 AM
#705   Director LePore bought 12,500 shares for $3.5966 realfast95 05/27/21 09:36:36 PM
#704   Can it get worse? yes realfast95 05/07/21 07:21:20 PM
#703   $VYNE HC Wainwright & Co. analyst Oren Livnat realfast95 05/07/21 06:58:21 AM
#702   as if kicking us with so-so earnings wasn't realfast95 05/07/21 06:54:09 AM
#701   Ive been a long holder of this, even DB1787 05/06/21 09:02:41 AM
#700   missed both revenue and earnings realfast95 05/06/21 07:15:47 AM
#699   VYNE Therapeutics Reports First Quarter 2021 Financial Results realfast95 05/06/21 07:13:15 AM
#698   $VYNE BRIDGEWATER, N.J., April 28, 2021 (GLOBE NEWSWIRE) realfast95 04/28/21 08:03:32 AM
#697   That's wrong information. realfast95 04/15/21 09:31:55 AM
#696   some positive news Tzr250rg 04/15/21 09:00:52 AM
#695   ugly realfast95 04/09/21 06:13:01 PM
#694   blood in the streets, scavengers are not even biting realfast95 04/09/21 03:18:08 PM
#693   FD Disclosure. realfast95 03/30/21 06:54:30 PM
#692   new slide added realfast95 03/30/21 06:48:39 PM
#691   $vyne $7.8 ^ 0.4 (5.41%) Taurus69 03/21/21 09:12:23 PM
#690   Good day realfast95 03/17/21 07:30:11 PM
#689   Yeah. Weird daleb2130 03/16/21 06:15:48 PM
#688   I don't know if that will make any realfast95 03/16/21 06:14:14 PM
#687   Ahhh. So do you think the patent news daleb2130 03/16/21 05:52:05 PM
#686   the after hours rise, is from the SEC realfast95 03/16/21 05:43:33 PM
#685   Is that why it's up .36 cents after hours? daleb2130 03/16/21 05:35:33 PM
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