VYNE VYNE Therapeutics Inc.

0.63
-0.01  -2%
Previous Close 0.64
Open 0.64
52 Week Low 0.623
52 Week High 13.2
Market Cap $33,716,285
Shares 53,517,912
Float 47,367,142
Enterprise Value $-17,537,716
Volume 1,333,076
Av. Daily Volume 3,351,516
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Upcoming Catalysts

Drug Stage Catalyst Date
FMX114
Atopic Dermatitis
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
AMZEEQ (FMX101)
Acne
Approved
Approved
FDA Approval announced October 18, 2019.
ZILXI (FMX103)
Papulopustular rosacea
Approved
Approved
FDA Approval announced May 29, 2020.
FCD105
Acne
Phase 2
Phase 2
Phase 2 data released June 2, 2020. Phase 3 trial planned,

Latest News

  1. Systemic bioavailability of JAK inhibitor (tofacitinib) and S1P receptor modulator (fingolimod) in topical formulation substantially lower compared to oral equivalents

    Mean Cmax of tofacitinib 50-fold and 1500-fold lower at Day 1 and 14 of study compared to the lowest commercially available oral alternative

    Findings from Phase 1b safety portion of study support trial continuation

    Topline Phase 2a results expected in Q1 2022

    BRIDGEWATER, N.J., Jan. 19, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that it has completed the Phase 1b portion of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) (Study VY2021-01). FMX114…

    Systemic bioavailability of JAK inhibitor (tofacitinib) and S1P receptor modulator (fingolimod) in topical formulation substantially lower compared to oral equivalents

    Mean Cmax of tofacitinib 50-fold and 1500-fold lower at Day 1 and 14 of study compared to the lowest commercially available oral alternative

    Findings from Phase 1b safety portion of study support trial continuation

    Topline Phase 2a results expected in Q1 2022

    BRIDGEWATER, N.J., Jan. 19, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that it has completed the Phase 1b portion of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) (Study VY2021-01). FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.

    The objective of the Phase 1b portion of the study was to evaluate the preliminary clinical safety, dermal tolerance and pharmacokinetics of FMX114 and vehicle gels when topically applied for up to 2 weeks to individual qualifying atopic dermatitis lesions. The study planned to enroll up to 6 subjects with mild to moderate atopic dermatitis in this Phase 1b safety portion. However, based on the data obtained from the first two completing subjects, the Human Research Ethics Committee (HREC) in Australia overseeing the study agreed to reduce the enrollment number to 4 subjects with mild to moderate atopic dermatitis.

    At the study baseline visit, each subject had two AD lesions of comparable severity and extent based on the Atopic Dermatitis Severity Index (ADSI) scoring assessment and qualifying lesions were randomized to either FMX114 or vehicle gel treatment. Adverse events, clinical laboratory results and local dermal tolerance data was collected throughout subject participation in the study. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate were evaluated based on blood/plasma concentration data obtained from highly sensitive and validated bioanalytical methods.

    Both FMX114 and vehicle gel treatments were generally well-tolerated, and no serious adverse events were recorded during study conduct. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate are summarized below:

    • The mean plasma Cmax of tofacitinib calculated on treatment day 1 and day 14 were approximately 50-fold and 1500-fold lower, respectively, when compared to the equivalent data for the lowest commercially available adult oral dose of tofacitinib (XELJANZ 5mg BD).1
      • The mean plasma Cmax of tofacitinib was determined to be 0.914 ng/ml and 0.0220 ng/ml on treatment day 1 and 14 respectively (assay Lower Limit of Quantification [LLOQ]: 0.01ng/ml).
      • Systemic drug accumulation of tofacitinib was negligible over the dosing period, with an accumulation ratio calculation based on Cmax of 0.03. In samples obtained one week after the end of treatment, tofacitinib was not quantifiable (<0.01ng/ml).
    • The pharmacokinetics of fingolimod and active metabolite, fingolimod 1-phosphate could not be determined as all whole blood concentrations were below the assay LLOQ (0.08ng/ml for both analytes). The mean whole blood Cmax for fingolimod and fingolimod 1-phosphate for the adult oral dose of fingolimod (GILENYA 0.5mg QD) is 3.7ng/ml and 1.8ng/ml respectively at steady state.2

    Dr. Iain Stuart, Chief Scientific Officer of VYNE, stated, "FMX114 was designed to deliver both active drugs efficiently to the skin while minimizing their respective systemic exposures. We are encouraged by the results from the Phase 1b portion of study VY2021-01 and look forward to announcing top-line Phase 2a results later this quarter."

    About Study VY2021-01 (ClinicalTrials.gov Identifier: NCT04927572)

    The Phase 1b/2a study is a randomized, double-blinded trial designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The study is expected to enroll up to 31 subjects, with each subject serving as their own control. The enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry. Participants will have FMX114 gel applied to one of these lesions and vehicle gel to the other. Up to six subjects will be initially treated twice daily with FMX114 and vehicle for up to two weeks to evaluate preliminary safety of FMX114 and the pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate. A further 25 subjects will receive FMX114, and vehicle treatment applied twice daily for four weeks in a double-blinded phase of the study to further evaluate safety, pharmacokinetics and efficacy. After completion of this phase, these subjects may continue into a two-week open-label treatment phase and will be able to apply the active drug to both lesions. The trial is being conducted in Australia in subjects with mild-to-moderate atopic dermatitis (clinicaltrials.gov link) in two segments:

    1. XELJANZ/XELJANZ XR/XELJANZ Oral Solution US Prescription Information, December 2021
    2. Clinical Pharmacokinetics of Fingolimod, Clin Pharmacokinet 2012;51(1):15-28]

    About FMX114

    FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by developing a distinct combination of tofacitinib (a Janus kinase inhibitor) aimed at reducing inflammation by inhibiting cytokine release from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) which approaches the reduction of inflammation by inhibiting migration of inflammatory cells, and in addition may also directly support skin barrier recovery. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the cheeks, arms, and legs. Flare ups often occur and symptoms can worsen leading to more-intense itching and worsening of disease. AD flares are triggered by stress, temperature changes, sweat, various skin irritants, and allergies. AD can have a wide-ranging impact on quality of life and there is a substantial monetary burden from direct and indirect costs to this patient population. While AD occurs most often in childhood, it can develop at any point in a person's lifetime and affects approximately 30 million people in the U.S. alone. Approximately 22 million of those diagnosed are on treatment, with 19 million registering mild to moderate disease.  According to Symphony Health data, there were over 7 million prescriptions written in 2019 alone for the treatment of AD.

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

    For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Investor Relations:

    John Fraunces

    LifeSci Advisors, LLC

    917-355-2395

    Tyler Zeronda

    VYNE Therapeutics Inc.

    908-458-9106

    Cautionary Statement Regarding Forward-Looking Statements

    This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE's product candidate, FMX114, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the outcome and cost of preclinical and clinical trials for current and future product candidates; determination by the FDA that results from VYNE's preclinical and clinical trials are not sufficient to support registration or marketing approval of product candidates; adverse events associated with the development and commercialization of FMX114 and VYNE's other product candidates; the COVID-19 pandemic and its impact on our business operations and liquidity, including our ability to progress a preclinical or clinical trial; the size of the atopic dermatitis market; the potential patient base and commercial potential of FMX114 or any of VYNE's other product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE's patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE's patent applications may not be granted and potential competitors may also seek to design around VYNE's granted patents or patent applications; additional competition in the markets in which we compete; inability to raise additional capital on favorable terms or at all; VYNE's ability to recruit and retain key employees; and VYNE's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in VYNE's Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE's subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE 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.



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  2. 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…

    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.

    Guggenheim Securities, LLC served as financial advisor to VYNE in connection with the transaction.

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions.

    VYNE is working to develop and commercialize a variety of therapies for major immuno-inflammatory conditions and rare skin diseases with high unmet medical need. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

    For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Investor Relations:

    John Fraunces

    LifeSci Advisors, LLC

    917-355-2395

    Tyler Zeronda

    VYNE Therapeutics Inc.

    908-458-9106

    Cautionary Statement Regarding Forward-Looking Statements

    This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the transaction between VYNE and Journey and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Journey's ability to achieve the levels of the net sales specified in the Agreement and lack of obligations to achieve any such net sales milestones and VYNE's ability to realize any related milestone payments; the risk that Journey may not license or sublicense any territory outside of the United States and therefore may not owe any additional related payments to VYNE; VYNE's ability to successfully develop its product candidates; the timing of commencement of future non-clinical studies and clinical trials; VYNE's ability to successfully progress, complete, and receive favorable results in, clinical trials for its product candidates; VYNE's ability to select a lead candidate and exercise its exclusive option with respect to an oral BETi candidate pursuant to the terms of the option agreement with In4Derm Limited in the anticipated timeframe or at all; VYNE's intentions and its ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; disruptions related to COVID-19 or another pandemic, epidemic or outbreak of a contagious disease on the ability of VYNE's suppliers to manufacture and provide materials for its product candidates; initiating and retaining patients in clinical trials, operating results, liquidity and financial condition; the regulatory approval process for VYNE's product candidates, including any delay or failure in obtaining requisite approvals; VYNE's ability to comply with various regulations applicable to its business; VYNE's ability to create intellectual property and the scope of protection it is able to establish and maintain for intellectual property rights covering its product candidates, including the projected terms of patent protection; risks that any of VYNE's patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE's patent applications may not be granted and potential competitors may also seek to design around VYNE's granted patents or patent applications; VYNE's ability to attract and retain key scientific or management personnel; VYNE's expectations regarding licensing, business transactions and strategic operations; VYNE's future financial performance and liquidity; and volatility in VYNE's stock price may result in rapid and substantial increases or decreases in the stock price that may or may not be related to the company's operating performance or prospects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in VYNE's Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE's subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE 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.

    AMZEEQ and ZILXI Important Safety Information Indications

    AMZEEQ® (minocycline) topical foam, 4% is for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 9 years age and older. It is not known if AMZEEQ is safe and effective in children under 9 years of age.

    ZILXI® (minocycline) topical foam, 1.5% is for the treatment of adults with pimples and bumps caused by a condition called rosacea. It is not known if ZILXI is safe and effective in children.

    AMZEEQ or ZILXI are both topical forms of the antibiotic minocycline and are available by prescription only. AMZEEQ and ZILXI are for use on skin only (topical use). AMZEEQ and ZILXI are not for use in the mouth, eyes or vagina.

    AMZEEQ and ZILXI should not be used for the treatment of infections.

    Important Safety Information

    • AMZEEQ or ZILXI should not be used in people who are allergic to AMZEEQ, ZILXI, or any tetracycline medicine. Use of AMZEEQ or ZILXI should be stopped right away if a rash or other allergic symptom occurs.
    • AMZEEQ or ZILXI should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ or ZILXI, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
    • AMZEEQ or ZILXI are flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ or ZILXI.
    • People should protect their skin from the sun while using AMZEEQ or ZILXI and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ or ZILXI should be stopped if skin is sunburned.
    • When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

    AMZEEQ or ZILXI are both topical foams that contain minocycline, a tetracycline medicine. They are not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.

    The most common side effect of AMZEEQ is headache. The most common side effect of ZILXI is diarrhea.

    These are not all of the possible side effects for AMZEEQ or ZILXI. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ or ZILXI.

    People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see full Prescribing Information for AMZEEQ and ZILXI.

    AMZEEQ and ZILXI are registered trademarks owned by Journey Medical Corporation.



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  3. BRIDGEWATER, N.J., Jan. 03, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that management will participate in one-on-one investor meetings at the LifeSci Partners 11th Annual Corporate Access Event, to be held virtually January 5-7, 2022.

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential…

    BRIDGEWATER, N.J., Jan. 03, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that management will participate in one-on-one investor meetings at the LifeSci Partners 11th Annual Corporate Access Event, to be held virtually January 5-7, 2022.

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

    For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Investor Relations:



    John Fraunces

    LifeSci Advisors, LLC

    917-355-2395

    Tyler Zeronda

    Chief Financial Officer

    VYNE Therapeutics

    908-458-9106

     



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  4. BRIDGEWATER, N.J., Nov. 18, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that David Domzalski, Chief Executive Officer, will present at the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference.

    The presentation will take the form of a pre-recorded fireside chat, which will be available on the Company's website beginning November 22nd. Management will also be available for 1-on-1 meetings with investors during the conference November 29th – December 2nd.

    Presentation details
      
    Date:Monday, November 22, 2021
      
    Time:Beginning at 10:00 a.m. Eastern Time
      
    Presentation Type:Pre-Recorded Fireside Chat

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives…

    BRIDGEWATER, N.J., Nov. 18, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that David Domzalski, Chief Executive Officer, will present at the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference.

    The presentation will take the form of a pre-recorded fireside chat, which will be available on the Company's website beginning November 22nd. Management will also be available for 1-on-1 meetings with investors during the conference November 29th – December 2nd.

    Presentation details
      
    Date:Monday, November 22, 2021
      
    Time:Beginning at 10:00 a.m. Eastern Time
      
    Presentation Type:Pre-Recorded Fireside Chat

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. VYNE is working to develop and commercialize a variety of therapies for major immuno-inflammatory conditions and rare skin diseases with high unmet medical need. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

    For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.



    Investor Relations:

    Joseph Ranieri

    LifeSci Advisors, LLC

    617-430-7582

    Tyler Zeronda

    Chief Financial Officer

    VYNE Therapeutics

    908-458-9106



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  5. Lead BET Inhibitor Candidate, VYN201, Demonstrates Potent Anti-Inflammatory Effect in Preclinical Studies

    VYN201 Expected to Enter Clinic in 2022

    Phase 2a Results for FMX114 in Mild-to-Moderate Atopic Dermatitis Expected Early Q1 2022

    Process for Sale of Topical Minocycline Franchise Continues to Advance

    Conference call and Live Webcast Today at 8:30 am Eastern Time

    BRIDGEWATER, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced financial results for the third quarter ended September 30, 2021 and provided a business update.

    "The third quarter marks an important turning point for VYNE, as our company is now fully engaged in the development of next-generation therapeutics…

    Lead BET Inhibitor Candidate, VYN201, Demonstrates Potent Anti-Inflammatory Effect in Preclinical Studies

    VYN201 Expected to Enter Clinic in 2022

    Phase 2a Results for FMX114 in Mild-to-Moderate Atopic Dermatitis Expected Early Q1 2022

    Process for Sale of Topical Minocycline Franchise Continues to Advance

    Conference call and Live Webcast Today at 8:30 am Eastern Time

    BRIDGEWATER, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced financial results for the third quarter ended September 30, 2021 and provided a business update.

    "The third quarter marks an important turning point for VYNE, as our company is now fully engaged in the development of next-generation therapeutics designed to address multiple immuno-inflammatory diseases," said David Domzalski, CEO of VYNE. "Based upon a growing body of preclinical data, we believe the evolving therapeutic profile for the BET inhibitor drug class represents a potential breakthrough in the treatment of immuno-inflammatory diseases. Our lead candidate, VYN201, is demonstrating a strong ability to effect multiple pro-inflammatory pathways while also appearing to be well tolerated in animal models. As we move toward 2022, creating shareholder value remains front and center for our company and we look forward to our Phase 2a data readout for FMX114 in Q1 2022 and advancing our lead BET inhibitor candidates."  

    Pipeline Update

    VYN201, Topical BET Inhibitor Program: On October 26, 2021 and November 4, 2021, VYNE announced data from preclinical studies showing that its pan-bromodomain BET inhibitor, VYN201, significantly reduced the expression of several key pro-inflammatory cytokines relevant to Th17-mediated autoimmune diseases and demonstrated improvement in reducing fibrotic tissue mass and overall skin repair outcomes. Key highlights from the preclinical studies include:

    • VYN201 exhibited anti-inflammatory effect similar to super-potent glucocorticosteroids.
    • VYN201 appeared well-tolerated in mice, as seen through animal body weight and skin condition.
    • VYN201 also demonstrated stronger inhibition of key Th17 cytokines in ex vivo data with human skin tissue when directly compared to JAK1/2 inhibitor, ruxolitinib.
    • VYN201, demonstrated improvements in reducing fibrotic tissue mass and overall skin repair outcomes with no negative impact on healing time, supporting the continued progression of the VYN201 development program.

    Following the completion of the prerequisite IND-enabling non-clinical safety assessments, the Company intends to communicate the initial indication it will be pursuing for VYN201 and expects to enter the program into the clinic in 2022.

    VYN202, Oral BET Inhibitor Program: VYN202 is an orally delivered, first-in-class BET inhibitor that is highly selective for Bromodomain 2 ("BD2"). By selectively inhibiting BD2, the Company believes VYN202 could have a more targeted anti-inflammatory effect with an improved benefit/risk profile. Upon the selection of a lead candidate, VYNE intends to exercise its exclusive option with In4Derm Limited and commence an IND-enabling non-clinical safety program.

    FMX114 for Atopic Dermatitis (AD): In October, VYNE announced the first patient had enrolled in its Phase 1b/2a study comparing the safety and efficacy of FMX114 gel with vehicle gel in patients with mild-to-moderate AD. Topline results from the Phase 2a portion of the study are anticipated early in the first quarter of 2022.

    Strategic Process to Sell Topical Minocycline Franchise

    The Company continues to execute its process to divest 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 (MST) platform specific to this portfolio.

    "We believe our minocycline franchise is a high-quality commercial platform that has significant value," said Mr. Domzalski. "We are encouraged by the level of interest we have received and will provide additional details as we continue to progress the sale process."

    Recent Highlights:

    • On October 5, 2021, we announced that the first patient was enrolled in Cutia's Phase 3 study in China evaluating AMZEEQ for the purposes of seeking regulatory approval in China.



    • On October 19, 2021, we announced that the first patient was enrolled in our Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis. We expect topline results from the study early in the first quarter of 2022.



    • On October 21, 2021, we announced the formation of a scientific advisory board ("SAB") composed of leading scientists and academics specializing in immunological and inflammatory diseases. The SAB will provide scientific expertise and guidance to the VYNE management team and Board, as the Company progresses its pipeline of innovative treatments for immuno-inflammatory conditions.



    • On October 26, 2021, we announced preclinical data showing that VYN201 significantly reduced the expression of several key pro-inflammatory cytokines relevant to Th17-mediated autoimmune diseases in an animal model and an ex vivo human tissue study.



    • On November 4, 2021, we announced preclinical data showing that VYN201 demonstrated improvements in reducing fibrotic tissue mass and overall skin repair outcomes with no negative impact on healing time, the results of which support the continued progression of VYN201 development program for autoimmune skin diseases.



    Financial Performance

    (in thousands, except per share amounts)
    Three Months Ended



    September 30,
     Nine Months Ended



    September 30,
     20212020 20212020
    Total Revenues$4,086   $3,269   $12,463   $16,707  
    Net Loss$(21,285) $(24,714) $(61,759) $(232,387)
    Diluted Net Loss per Share$(0.41) $(0.59) $(1.22) $(7.98)
    Adjusted Net Loss*$(18,880) $(22,094) $(55,011) $(78,169)
    Adjusted Diluted Net Loss per Share*$(0.36) $(0.53) $(1.09) $(2.68)
    Adjusted EBITDA*$(15,378) $(20,934) $(49,318) $(74,944)

    * See "Note Regarding the Use of Non-GAAP Financial Measures" elsewhere in this earnings release.

    Cash and Cash Equivalents

    As of September 30, 2021, VYNE had cash, cash equivalents and restricted cash of $52.9 million. On August 11, 2021, the Company paid its lenders approximately $36.5 million in respect of its outstanding indebtedness and the Credit Agreement was terminated. See Note 1 to our unaudited interim condensed consolidated financial statements included in VYNE's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 for additional discussion on liquidity.

    Financial Results for the Third Quarter Ended September 30, 2021

    Revenues

    Revenues totaled $4.1 million for the three months ended September 30, 2021 compared to $3.3 million for the three months ended September 30, 2020. For the three months ended September 30, 2021, our revenue consisted of $4.0 million of product sales and $0.1 million of royalty revenue. For the three months ended September 30, 2020, revenues consisted of $2.9 million of product sales, and $0.4 million of royalty revenue.

    Cost of Goods Sold

    Cost of goods sold was $1.0 million and $0.4 million for the three months ended September 30, 2021 and 2020, respectively. The increase in cost of goods sold was primarily due to an increase in sales volume.

    Our gross margin percentage was 73% for the three months ended September 30, 2021. Our gross margin percentage of 87% for the three months ended September 30, 2020 was favorably impacted by product sales with certain materials produced prior to FDA approval and therefore expensed in prior periods.

    Research and Development Expenses

    Our research and development expenses for the three months ended September 30, 2021 were $7.0 million, representing an increase of $0.4 million, or 5.4%, compared to $6.6 million for the three months ended September 30, 2020. Employee-related expenses, including stock-based compensation, increased by $1.0 million. Expenditures for FMX114 and our BET inhibitor programs increased by $1.8 million, including fees due to In4Derm upon the execution of the Option Agreement and in connection with the exercise of the Topical BETi Option. The increases were offset by a decrease in clinical trial and manufacturing expenses due to the completion of FCD105 and serlopitant clinical trials and the product launches of AMZEEQ and ZILXI during 2020.

    Selling, General and Administrative Expenses

    Our selling, general and administrative expenses for the three months ended September 30, 2021 were $13.8 million, representing a decrease of $5.9 million, or 30.0%, compared to $19.8 million for the three months ended September 30, 2020. Employee-related expenses decreased by $2.0 million primarily due to lower headcount in 2021. Commercial operations and marketing expenditures decreased by $2.5 million as a result of the strategic shift of the business announced in August 2021. The balance of the decrease was primarily due to corporate costs incurred during 2020 following the merger between Menlo Therapeutics Inc. and Foamix Pharmaceuticals Ltd. that were eliminated or reduced in 2021. See Note 1 to our unaudited interim condensed consolidated financial statements included in VYNE's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 for additional information regarding the merger.

    Conference Call and Live Webcast

    VYNE management will host a conference call and live webcast today, Wednesday, November 10, 2021, at 8:30 am Eastern Time to discuss the financial results and provide a business update.

    Toll Free:855-327-6837
    International:631-891-4304
    Conference ID:10017178
    Webcast:https://viavid.webcasts.com/starthere.jsp?ei=1512469&tp_key=ee68066700



    A replay of the call will be archived on the Company's website at www.vynetherapeutics.com promptly after the conference call.

    Note Regarding the Use of Non-GAAP Financial Measures

    The Company has provided certain non-GAAP financial information as additional information to measure operating performance, including, among others, Adjusted Total Operating Expenses, Adjusted Net Loss, Adjusted Diluted Net Loss per Share and Adjusted EBITDA. The Company believes that its presentation of such non-GAAP measures provides useful information to management and investors regarding its financial condition and operations. Specifically, these measures exclude, among other things, share-based compensation. The Company does not believe that such expenses accurately reflect the Company's ongoing operations, and the Company does not expect to incur similar expenses in future periods. These measures are not in accordance with, or an alternative for, generally accepted accounting principles in the United States ("GAAP") and may be different from similarly titled non-GAAP measures reported by other companies. The Company has provided required reconciliations to the most comparable GAAP measures elsewhere in the document.

    About Bromodomain and Extra-Terminal Domain (BET) Inhibitors

    BET proteins play a key role in regulating gene transcription via epigenetic interactions ("reading"), and recent research has determined a key role for these BET proteins in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. Inhibiting BET proteins blocks cytokine transcription and therefore may have significant therapeutic potential across a wide variety of immuno-inflammatory/fibrotic and myeloproliferative neoplastic disorders. A topically applied BET inhibitor product has the possibility to positively impact diseases involving multiple, diverse inflammatory cell signaling pathways that are active in rare neutrophilic dermatoses. Furthermore, bromodomain 2 selective oral BET inhibitors may present as more conveniently-administered non-biologic treatment options for both acute control and chronic management of immuno-inflammatory indications, where the damaging effects of unrestricted inflammatory signaling activity is common.

    About VYNE Therapeutics Inc.

    VYNE's mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. VYNE is working to develop and commercialize a variety of therapies for major immuno-inflammatory conditions and rare skin diseases with high unmet medical need. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory conditions and rare skin diseases.

    For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Investor Relations:

    Joseph Ranieri

    LifeSci Advisors, LLC

    617-430-7582

    Tyler Zeronda

    Chief Financial Officer

    VYNE Therapeutics

    908-458-9106

    Cautionary Statement Regarding Forward-Looking Statements

    This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the development of VYNE's product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this presentation which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, VYNE's ability to complete a sale or out-license of its minocycline franchise on terms acceptable to VYNE in a timely manner or at all; VYNE's ability to successfully develop its product candidates; the timing of commencement of future non-clinical studies and clinical trials; VYNE's ability to successfully progress, complete, and receive favorable results in, clinical trials for its product candidates; VYNE's ability to exercise its exclusive option with respect to an oral BETi candidate pursuant to the terms of the option agreement with In4Derm Limited; VYNE's intentions and its ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; disruptions related to COVID-19 or another pandemic, epidemic or outbreak of a contagious disease, on the ability of VYNE's suppliers to manufacture and provide materials for our product candidates, initiating and retaining patients in clinical trials, operating results, liquidity and financial condition; supply chain disruptions; the regulatory approval process for VYNE's product candidates, including any delay or failure in obtaining requisite approvals; the potential market size of treatments for any diseases and market adoption of products, if approved or cleared for commercial use, by physicians and patients; developments and projections relating to competitors and the pharmaceuticals industry, including competing drugs and therapies; the timing or likelihood of regulatory filings and approvals or clearances for product candidates; VYNE's ability to comply with various regulations applicable to its business; VYNE's ability to create intellectual property and the scope of protection it is able to establish and maintain for intellectual property rights covering its product candidates, including the projected terms of patent protection; risks that any of VYNE's patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE's patent applications may not be granted and potential competitors may also seek to design around VYNE's granted patents or patent applications; the timing, costs or results of litigation, including litigation to protect its intellectual property, including the matter with Padagis Israel Pharmaceuticals Ltd.; VYNE's ability to successfully challenge intellectual property claimed by others; estimates of VYNE's expenses, capital requirements, its needs for additional financing and its ability to obtain additional capital on acceptable terms or at all; VYNE's ability to attract and retain key scientific or management personnel; VYNE's defense of any litigation that may be initiated against it; VYNE's expectations regarding licensing, business transactions and strategic operations; VYNE's future financial performance and liquidity; and volatility in VYNE's stock price may result in rapid and substantial increases or decreases in the stock price that may or may not be related to the company's operating performance or prospects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in VYNE's Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE's subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE 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.



    VYNE THERAPEUTICS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. dollars in thousands, except per share data)

    (Unaudited)

     September 30 December 31
     2021 2020
    Assets   
    Current Assets:   
    Cash and cash equivalents$52,306  $57,563 
    Restricted cash605  855 
    Investment in marketable securities  1,027 
    Trade receivables, net of allowances10,084  15,819 
    Prepaid and other assets5,064  4,591 
    Inventory8,070  7,404 
    Total Current Assets76,129  87,259 
    Property and equipment, net472  555 
    Operating lease right-of-use assets1,036  1,583 
    Prepaid and other assets3,678  4,345 
    Total Assets$81,315  $93,742 
        
    Liabilities and shareholders' equity   
    Current Liabilities:   
    Trade payables$7,621  $4,780 
    Accrued expenses9,613  11,452 
    Debt   
    Employee related obligations3,382  4,360 
    Operating lease liabilities277  757 
    Other104  104 
    Total Current Liabilities20,997  21,453 
    Liability for employee severance benefits206  312 
    Operating lease liabilities775  853 
    Long-term debt  33,174 
    Other liabilities451  457 
    Total Liabilities22,429  56,249 
    Commitments and Contingencies   
    Shareholders' Equity:   
    Preferred stock: $0.0001 par value; 20,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; no shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively   
    Common stock: $0.0001 par value; 150,000,000 shares and 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; 53,510,599 and 43,205,221 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively5  4 
    Additional paid-in capital686,836  603,685 
    Accumulated deficit(627,955) (566,196)
    Total Shareholders' Equity58,886  37,493 
    Total Liabilities and Shareholders' Equity$81,315  $93,742 



    VYNE THERAPEUTICS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (U.S. dollars in thousands, except per share data)

    (Unaudited)

     Three months ended

    September 30
     Nine months ended

    September 30
     2021 2020 2021 2020
    Revenues       
    Product sales$3,953  $2,863  $11,805  $6,096 
    License revenues      10,000 
    Royalty revenues133  406  658  611 
    Total Revenues4,086  3,269  12,463  16,707 
            
    Cost of goods sold1,049  371  2,445  858 
            
    Operating Expenses:       
    Research and development6,981  6,623  19,723  35,695 
    Selling, general and administrative13,832  19,766  46,283  71,640 
    Goodwill and in-process research & development impairments      54,345 
    Contingent Stock Right Remeasurement      84,726 
    Total Operating Expenses20,813  26,389  66,006  246,406 
    Operating Loss17,776  23,491  55,988  230,557 
    Interest expense3,474  1,092  5,610  3,229 
    Other expense (income), net35  130  161  (1,141)
    Loss Before Income Tax21,285  24,713  61,759  232,645 
    Income tax expense (benefit)  1    (258)
    Net Loss$21,285  $24,714  $61,759  $232,387 
            
    Loss per share basic and diluted$0.41  $0.59  $1.22  $7.98 
            
    Weighted average shares outstanding - basic and diluted52,028  41,934  50,776  29,132 

    Non-GAAP Financial Measures

    The following tables reconcile non-GAAP financial measures presented in this press release or that may be presented on the Company's conference call with analysts and investors. The Company believes that these non-GAAP financial measures provide management, analysts, investors and other users of the Company's financial information with meaningful supplemental information regarding the performance of the Company's business. These non-GAAP financial measures should not be considered superior to, but rather in addition to, other financial measures prepared by the Company in accordance with GAAP, including the year-to-year results. The Company's method of determining these non-GAAP financial measures may be different from other companies' methods and, therefore, may not be comparable to those used by other companies, and the Company does not recommend the sole use of these non-GAAP measures to assess its financial and earnings performance. For reasons noted above, the Company is presenting certain non-GAAP financial measures for the three and nine months ended September 30, 2021 and September 30, 2020. In order for investors to be able to more easily compare the Company's performance across periods, the Company has included comparable reconciliations for the 2020 period in the reconciliation tables below.

    Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP)

    The following table provides a reconciliation of Net loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) for the three and nine months ended September 30, 2021 and 2020 (in thousands):

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     20212020 20212020
          
    Net loss (GAAP)(21,285)(24,714) (61,759)(232,387)
    Income tax expense (benefit) 1   (258)
    Interest expense, net3,474 1,092  5,610 3,229 
    Depreciation and amortization28 67  83 254 
    EBITDA (non-GAAP)(17,783)(23,554) (56,066)(229,162)
          
    Share based compensation expense2,405 2,620  6,748 15,147 
    Goodwill and in-process research & development impairments    54,345 
    Contingent Stock Right Remeasurement    84,726 
    Adjusted EBITDA (non-GAAP)(15,378)(20,934) (49,318)(74,944)

    Reconciliation of Adjusted Net Loss and other non-GAAP metrics

    The following table provides detailed reconciliations of various other income statement data between GAAP and non-GAAP amounts for the three and nine months ended September 30, 2021 and 2020 (in thousands, except per share data):

     Three months ended

    September 30
     Nine months ended

    September 30
     20212020 20212020
          
    Net Loss (GAAP)(21,285)(24,714) (61,759)(232,387)
    Share based compensation expense2,405 2,620  6,748 15,147 
    Goodwill and in-process research & development impairments    54,345 
    Contingent Stock Right Remeasurement    84,726 
    Adjusted Net Loss (non-GAAP)(18,880)(22,094) (55,011)(78,169)
          
    Research and development expense (GAAP)6,981 6,623  19,723 35,695 
    Share based compensation expense(435)(361) (1,335)(3,927)
    Adjusted Research and development expense (non-GAAP)6,546 6,262  18,388 31,768 
          
    Selling, general and administrative expense (GAAP)13,832 19,766  46,283 71,640 
    Share based compensation expense(1,970)(2,259) (5,413)(11,220)
    Adjusted Selling, general and administrative expense (non-GAAP)11,862 17,507  40,870 60,420 
          
    Total Operating Expenses (GAAP)20,813 26,389  66,006 246,406 
    Share based compensation expense(2,405)(2,620) (6,748)(15,147)
    Goodwill and in-process research & development impairments    (54,345)
    Contingent Stock Right Remeasurement    (84,726)
    Adjusted Total Operating Expenses18,408 23,769  59,258 92,188 
          
    Total Operating Loss (GAAP)(17,776)(23,491) (55,988)(230,557)
    Share based compensation expense2,405 2,620  6,748 15,147 
    Goodwill and in-process research & development impairments    54,345 
    Contingent Stock Right Remeasurement    84,726 
    Adjusted Total Operating Loss (non-GAAP)(15,371)(20,871) (49,240)(76,339)
          
    Net loss per common share - basic and diluted (GAAP)(0.41)(0.59) (1.22)(7.98)
    Share based compensation expense0.05 0.06  0.13 0.52 
    Goodwill and in-process research & development impairments    1.87 
    Contingent Stock Right Remeasurement    2.91 
    Adjusted Net loss per share - basic and diluted (non-GAAP)(0.36)(0.53) (1.09)(2.68)
    Weighted average number of common shares outstanding - basic and diluted52,028 41,934  50,776 29,132 


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