VYNE Therapeutics Inc (VYNE)

[Big bucks]

1/2 billllllllllion dollars wow..... with 70 million cash on hand...

Pursuant to the terms of the definitive asset purchase agreement (the "Agreement"), which closed simultaneously with signing, Journey will pay VYNE an upfront payment of $20.0 million and will pay an additional $5.0 million on the one (1)-year anniversary of the closing. VYNE is also eligible to receive sales milestone payments of up to $450.0 million in the aggregate upon the achievement of specified levels of net sales of the products covered by the Agreement. In addition, VYNE is entitled to receive certain payments from any licensing or sublicensing of the assets by Journey outside of the United States.

[realfast95]

the day traders on discord have noticed it. So if it gets life, it could then run.
watching closely

[realfast95]

Even though the deal came in Q1/22 they probably have to account for it in Q4/21 with a massive write off and employee transfer exit.

[HolesInMyPockitz]

Its amazing to see all this volume. Why is dilution needed though if they roughly have $60 million in cash?

[realfast95]

Underwhelming. Never underestimate this CEO from
F-ing it up.

20 million is about 37 cents a share. 100 million in sales incentive, you should live so long.

You would be a fool to buy it. Maybe an analyst will dress up the pig

[Big bucks]

Sea of red selling all morning premarket.. must be warrants or dilution. This should have doubled on this news

[HolesInMyPockitz]

Fantastic news and added more.

Need to do some more DD on what else they have in their pipeline.

[realfast95]

VYNE Therapeutics Divests Topical Minocycline Assets; Transaction Includes Cash Payments Of $25M And Potential Milestones Of Up To $450M
7:12 am ET January 13, 2022 (Benzinga) Print

Transaction includes cash payments of $25 million and potential milestones of up to $450 million

Sale aligns with VYNE's strategic plan; proceeds will be used to fund development of Company's immuno-inflammatory pipeline

BRIDGEWATER, N.J., Jan. 13, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that it has sold its Molecule Stabilizing Technology (MST™) franchise, including AMZEEQ® (minocycline) topical foam, 4%, and ZILXI® (minocycline) topical foam, 1.5%, to Journey Medical Corporation (NASDAQ:DERM) ("Journey"). The sale, which also includes VYNE's pipeline combination product FCD105, aligns with VYNE's strategic plan to focus its resources on the development of its pipeline of proprietary, differentiated medicines for immuno-inflammatory conditions, including FMX114, in Phase 1b/2a, and the novel InhiBET™ platform of Bromodomain and Extra-terminal Domain (BET) inhibitors.

Pursuant to the terms of the definitive asset purchase agreement (the "Agreement"), which closed simultaneously with signing, Journey will pay VYNE an upfront payment of $20.0 million and will pay an additional $5.0 million on the one (1)-year anniversary of the closing. VYNE is also eligible to receive sales milestone payments of up to $450.0 million in the aggregate upon the achievement of specified levels of net sales of the products covered by the Agreement. In addition, VYNE is entitled to receive certain payments from any licensing or sublicensing of the assets by Journey outside of the United States.

"This transaction is a key component of our strategy to focus our future efforts and resources on the development of our immuno-inflammatory pipeline assets," said David Domzalski, CEO of VYNE. "We believe that Journey's growing dermatology portfolio and extensive commercial expertise provide significant opportunity for the topical minocycline franchise moving forward."

Mr. Domzalski continued, "2022 is poised to be a very important year for VYNE, driven by a pipeline of near-term inflection catalysts from FMX114 and the InhiBET™ platform. We expect to report Phase 1b/2a data from the FMX114 study in atopic dermatitis in the first quarter of 2022. In addition, we expect to file the first IND from the InhiBET™ platform, for VYN201, a topical pan-BD BET inhibitor, and enter the clinic in mid-2022. Further, we intend to select the first clinical candidate from the VYN202, oral BD2-selective BET inhibitor, program for major immuno-inflammatory conditions, in 2022. Cash proceeds from the Journey Agreement will help support VYNE's operations through the end of this year."

Further details related to the Agreement, the transaction and related matters will be contained in a Current Report on Form 8-K to be filed by the Company.

[adamski]

VYNE investor presentation Jan 2022

https://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=15462069-6894-38137&type=sect&TabIndex=2&dcn=0001104659-22-001257&nav=1&src=Yahoo

[Amrsto1000]

I came in today with 10,000 shares. The Q is is a pain with all the financing and agreements associated with the reverse merger.

They should have done eight to one or 10 to one with the reverse split I believe.


I wouldn't touch you if they didn't have decent revenues for the size of the company. Supposedly supposed to go down to 30 or 40 employees instead of over 100.

Obviously a few people like it with the volume we're trading.

Good luck to all!

[Tzr250rg]

yup

[MatrixMoney]

Blackrock owns 2% of the OS banks buy bottoms

[crudeoil24]

Multiple SEC form 4's. Employees loading VYNE fast & furious last several weeks.

[crudeoil24]

VYNE > Vyne Therapeutics Inc. is a specialty pharmaceutical company. The Company is focused on the developing proprietary therapies in dermatology. The Company's products include AMZEEQ minocycline, is used for the treatment of inflammatory lesions of moderate-to-severe acne vulgaris in adults and patients nine years of age and older, and ZILXI minocycline, is used for the treatment of inflammatory lesions of rosacea in adults. Its product pipeline includes FCD105, is a proprietary topical combination foam formulation of minocycline and adapalene for the treatment of moderate-to-severe acne vulgaris. In addition, it is also developing program for FMX114, which is a combination topical gel for the potential treatment of mild-to-moderate atopic dermatitis. The Company uses its proprietary Molecule Stabilizing Technology (MST) platform to develop FCD105.

[realfast95]

running in pre-market 3.9m shares traded so far at 6am
they took it above $2 but are selling it off now. We will see.

[hedge_fun]

Premarket hit at $2.34. What the......

[realfast95]

Still waiting for the Sale of the ointment business as a catalyst.
AMZEEQ, Zilxi and FCD105 (what ever happened to that?)

[Tzr250rg]

Nice climb this week ... hopefully it continues. GLTU

[realfast95]

VYNE Therapeutics assumed with a Buy at H.C. Wainwright 06:09 VYNE H.C. Wainwright analyst Joseph Pantginis assumed coverage of VYNE Therapeutics with a Buy rating and $7 price target. The company's "reinvigorated" pipeline of assets is focused on developing novel therapies for inflammatory indications, Pantginis tells investors in a research note.

Read more at:
https://thefly.com/n.php?id=3421371

[Tzr250rg]

30mil in volume Something is up. not sure what.

maybe shorts are covering, tutes are buying , ...etc..

GLTU

[EuroFund]

Looks like some funds are buying this. ;)

[Tzr250rg]

up +32%

[Tzr250rg]

up 24%

[Tzr250rg]

https://www.streetinsider.com/Analyst+Comments/Cantor+Fitzgerald+Reiterates+Overweight+Rating+on+VYNE+Therapeutics+%28VYNE%29/19193739.html

[Tzr250rg]

Premarket 1.45

[Tzr250rg]

premarket 1.66

[Tzr250rg]

HOD 1.48

[Tzr250rg]

HOD 1.42

[Tzr250rg]

HOD 1.41

[Tzr250rg]

HOD 1.39

[Tzr250rg]

https://vynetherapeutics.com/press-releases/vyne-therapeutics-to-report-third-quarter-2021-financial-results-on-november-10-2021/





VYNE Therapeutics to Report Third Quarter 2021 Financial Results on November 10, 2021
BRIDGEWATER, N.J., Oct. 28, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it will report its financial results for the third quarter ended September 30, 2021, on Wednesday, November 10, 2021, before the market opens. VYNE will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss the financial results and provide a corporate update. Conference Call Details: Wednesday, November 10th @ 8:30am Eastern Time Toll Free: 855-327-6837 International: 631-891-4304 Conference ID: 10017178 Webcast: https://themediaframe.com/mediaframe/webcast.html?webcastid=44cKOFEX A replay of the call will be archived on the Company’s website at www.vynetherapeutics.com...
Continue Reading

[Tzr250rg]

up 9% today Green
I hope they stop selling

GLTUA

[artfulife]

I thought it was safe to nibble my way back in at under $1.50. Maybe not.

[realfast95]

the end has arrrived

Strategic Process to Sell or License Topical Minocycline Franchise

VYNE conducted a review of its commercial and research and development portfolio of assets to determine how to optimally deploy capital and maximize shareholder value. Following this review, the Company has determined to initiate a process to explore a sale or license of its topical minocycline franchise, including AMZEEQ, ZILXI and FCD105 (the Company's Phase 3 proprietary novel topical combination foam formulation of minocycline and adapalene for the treatment of moderate-to-severe acne vulgaris), as well as the underlying Molecule Stabilizing Technology platform specific to this portfolio. As VYNE transitions its focus and spend toward developing its pipeline, the Company expects to immediately reduce certain of its operating expenses currently supporting its commercial operations, but intends to maintain its sales force into the fourth quarter of 2021 while it seeks a commercial partner.

"We continue to face headwinds commercializing our products in this environment," said David Domzalski, CEO of VYNE. "We have been evaluating our portfolio of assets for some time in order to determine how to optimally deploy capital and drive shareholder value. After careful consideration, we have made the strategic decision to initiate a process to sell or license our topical minocycline franchise. We continue to believe that these products have significant commercial value, but their full potential is more likely to be realized in the hands of a partner with additional scale and resources. Going forward, we will focus our efforts on our pipeline of novel drug candidates."

[Tzr250rg]

Patent infringement

8k out

https://www.sec.gov/ix?doc=/Archives/edgar/data/1566044/000110465921102172/tm2124117d1_8k.htm

[hubwolf1]

In the last month or so mostly small sells and options buys. Nothing to see here good or bad.

[realfast95]

The form 4's I see say code "A" with is option awards. We would want to see code "P"
I didn't look at all of them to see what they all are.

[Tzr250rg]

Some insider buying...Form 4

https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001566044&owner=include&count=40&hidefilings=0

[realfast95]

well, the positive spin on this news, is that they have the funds to start another trial.

[realfast95]

VYNE Therapeutics Announces Initiation of Investigator Initiated Trial Evaluating AMZEEQ® (Minocycline) with Oral Isotretinoin in Patients with Moderate to Severe Acne

VYNE Therapeutics Inc.
Mon, July 19, 2021, 8:00 AM
In this article:

View my watchlists

BRIDGEWATER, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced the initiation of an investigator initiated trial (“IIT” or “study”) evaluating the safety and efficacy of AMZEEQ® (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne. The study is supported by VYNE and is being conducted by the Austin Institute for Clinical Research in Texas.

“Isotretinoin has been widely used for the management of severe or scarring acne since its introduction as Accutane® in the 1980s. However, its teratogenic properties means that patients must be monitored very carefully and its use as a chronic treatment is limited,” said Dr. Edward Lain, MD MBA FAAD, practicing dermatologist at Sanova Dermatology in Austin, Texas, and Principal Investigator for the study. “The combination of an oral isotretinoin and a topical minocycline presents a combined proposition of achieving control of severe disease coupled with long-term disease management possibilities,” he said. Dr. Lain also served as an investigator in the clinical trials for AMZEEQ and is a consultant to VYNE.

“AMZEEQ is a valuable topical treatment option for moderate to severe acne. As a single agent, it has demonstrated strong efficacy as well as a very favorable side effect profile. We are pleased that AMZEEQ is also receiving interest from the dermatology community to study AMZEEQ as part of a combination regimen with oral isotretinoin for both acute and chronic management of the disease,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE.

IIT Study Description

The study is designed to assess the impact of AMZEEQ and oral isotretinoin concomitant use on the cutaneous adverse reactions often seen in the first few weeks of treatment with oral isotretinoin alone. These cutaneous adverse reactions are a leading contributory factor in premature treatment abandonment. Additionally, the study will evaluate the efficacy and safety of adding AMZEEQ to the indicated 20-week oral isotretinoin treatment course with a focus on whether AMZEEQ can impact the time to onset of efficacy and overall efficacy rates when compared to oral isotretinoin monotherapy. Finally, because prescribers often seek alternative treatments for patients once a course of oral isotretinoin has been completed, the study will evaluate the safety and efficacy of AMZEEQ subsequent to a course of oral isotretinoin for an additional 24 weeks of treatment.

The IIT is a randomized, multicenter, evaluator-blinded, study to evaluate the safety, tolerability, and efficacy over a 20-week treatment period of oral isotretinoin and AMZEEQ concomitant use compared to oral isotretinoin only in the treatment of patients with moderate to severe acne vulgaris. In addition, maintenance of clinical response by AMZEEQ only treatment will also be evaluated for a further 24 weeks after withdrawal of oral isotretinoin treatment. Patients with qualifying lesion counts (inflammatory and comedonal acne lesions) and Investigator’s Global Assessment (IGA) of acne severity scores will be randomized in a 1:1 ratio to one of two treatment groups:
Group A patients will receive 20 weeks of both oral isotretinoin and topical AMZEEQ® treatment concomitantly, followed by a further 24 weeks of AMZEEQ only treatment, Group B patients will receive 20 weeks of oral isotretinoin treatment only, followed by a further 24 weeks of topical AMZEEQ only treatment.

The efficacy endpoints are percent change from baseline in inflammatory and comedonal lesion counts at each visit, and IGA Treatment Success at each visit, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline. The safety assessments will include treatment emergent adverse events (TEAEs) (volunteered, observed, and elicited by general questioning in a non-suggestive manner), physical examinations, urinary pregnancy tests, clinical laboratory tests, vital signs, and local skin tolerability assessments (including itching, stinging/burning, dryness, edema, scaling, erythema, and hyperpigmentation). The planned enrollment is approximately 30 patients to be enrolled from two sites in the USA. For more information, refer to ClinicalTrials.gov Identifier: NCT04940767.

[artfulife]

I'm not sticking around to find out. Sold my last 200 shares on Friday. At one point, I had over 5,000 sh post r/s and, although I traded small amounts, overall, I lost a small bundle. Sold most of my shares at just under $4.

I can't see inside the company to know why things really have gone south. Maybe its covid. Maybe teens with acne don't like yellow skin. Poor leadership, or maybe market forces I don't understand. I believed we had a couple of great drugs and a decent pipeline.

The universe has a twisted sense of humor though so, it wouldn't surprise me a bit if tomorrow we get an announcement of a buyout. And, I would have to laugh.

So, on to greener pastures. Good luck to all you hangers-on. I'll be checking in from time to time so, behave yourselves!

[Tzr250rg]

Can this bouce back? is this bottom?

[Tzr250rg]

I had no idea. my deepest sympathy to his friends and family.
He always gave honest and great feedback on Ihub.

[artfulife]

Sadly, jugs passed away in January of this year.

[Tzr250rg]

I haven't seen Jugs. did he close his position?

[artfulife]

Sometimes, it's the little things... I remember a few months back reading a young person's blog about how she was using AMZEEQ for her acne. She said that it worked well but that it made her skin yellow. She described how she was able to apply smaller and smaller amounts than prescribed and still have it be effective, and how she was able to cover up her skin with make up to hide most of the yellowing.

If I had been paying closer attention, I should have asked myself whether or not teenagers with acne (and possibly low self-esteem) would feel worried or insecure about having a yellow face. Perhaps they would rather take an oral antibiotic, side effects be damned.

Is this the real reason why sales are flat? If the product is effective but, the consumer doesn't want to look jaundiced, then don't we have a problem?

I used to have a very large position in VYNE and sold almost all of it at under $4 for a sizeable loss. Lesson learned: Pay attention to consumer feedback.

[Tzr250rg]

another day... another beating? hope not
GLTUA

[Tzr250rg]

i was going to average down as well. but at this point I may just wait until it starts to climb out of this hole.

GLTU

[Billr05]

bought more below 3 today - i don't know why. maybe the tax loss will have some value for me by year end ;)

[Tzr250rg]

this is insane 2.95 low today