• Enrollment Completed
    • Data Expected Mid-Year 2021

    WAYNE, Pa., March 15, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that it has completed enrollment in its Phase 2a clinical trial of ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the potential treatment of moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201).

    ATI-1777-AD-201 is a Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe…

    • Enrollment Completed
    • Data Expected Mid-Year 2021

    WAYNE, Pa., March 15, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that it has completed enrollment in its Phase 2a clinical trial of ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the potential treatment of moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201).

    ATI-1777-AD-201 is a Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD. Subjects will apply ATI-1777 or vehicle twice daily for 4 weeks. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.

    "This is an important trial because it explores whether a topical JAK inhibitor can successfully treat moderate to severe AD rather than mild disease," said Dr. David Gordon, Chief Medical Officer of Aclaris. "We hope to establish that a topical JAK inhibitor can safely and effectively treat moderate to severe AD while limiting systemic exposure."

    Dr. Neal Walker, President and CEO of Aclaris, said, "This is another important milestone for the Company for its second development program generated by KINect®, our proprietary drug discovery platform. Earlier this year, we announced our positive preliminary topline results for our Phase 2a clinical trial of ATI-450, our investigational oral MK2 inhibitor, for moderate to severe rheumatoid arthritis. We are very pleased with the progress of our development programs."

    Aclaris expects data from this trial by mid-year 2021.

    About ATI-1777

    ATI-1777 is an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor. "Soft" JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in systemic circulation. Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. Aclaris is developing ATI-1777 as a potential treatment for moderate to severe atopic dermatitis.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-1777 as a potential treatment for moderate to severe atopic dermatitis and the clinical development of ATI-1777, including the timing of data for ATI-1777-AD-201. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC Filings" page of the "Investors" section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact



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    • Positive Preliminary Topline Data for ATI-450, an Investigational Oral MK2 Inhibitor, in Moderate to Severe Rheumatoid Arthritis Announced in January 2021
    • ATI-450 Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis
    • Public Offering of $103.5M in January 2021 Strengthens Balance Sheet 

    WAYNE, Pa., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year of 2020 and provided a corporate update.

    "As we reflect on 2020, we are proud of how we have progressed our immuno-inflammatory…

    • Positive Preliminary Topline Data for ATI-450, an Investigational Oral MK2 Inhibitor, in Moderate to Severe Rheumatoid Arthritis Announced in January 2021
    • ATI-450 Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis
    • Public Offering of $103.5M in January 2021 Strengthens Balance Sheet 

    WAYNE, Pa., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year of 2020 and provided a corporate update.

    "As we reflect on 2020, we are proud of how we have progressed our immuno-inflammatory development programs," said Dr. Neal Walker, President & CEO of Aclaris. "We are very excited about the platform potential of ATI-450, an oral MK2 inhibitor which we have shown to inhibit TNFα, IL1β, and IL6. Given its novel mechanism, there are several immuno-inflammatory indications that ATI-450 may potentially address. We are also excited about the potential of our pipeline which is internally generated from KINect®, our proprietary drug discovery platform, for various immuno-inflammatory indications. We look forward to building on this momentum in 2021."

    Research and Development Highlights:

    The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

    • ATI-450, an investigational oral small molecule MK2 inhibitor compound:



      • ATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
        • Positive preliminary topline data announced in January 2021. In this trial, ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks. This clinical activity was further supported by pharmacodynamic analyses showing a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 in ex vivo stimulated samples as well as an endogenous inflammation biomarker analysis which also demonstrated a marked and sustained inhibition of median concentrations of hsCRP, TNFα, IL6, IL8, and MIP1β in the treatment arm over the 12 week period.
        • ATI-450 was generally well tolerated. The most common adverse events (AE) (each reported in 2 subjects) were urinary tract infection (UTI), elevated lipids and ventricular extrasystoles, all of which were determined to be unrelated to treatment except for one UTI. There was one non-treatment-related serious adverse event (COVID-19) reported in the four-week safety follow-up phase of the trial in a subject who was no longer receiving treatment.
        • Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
        • Aclaris is currently evaluating additional potential indications driven by TNFα, IL1β and IL6 as part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs.



      • ATI-450-PKPD-102: A Phase 1, placebo-controlled, randomized, observer-blind clinical trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 at 80 mg and 120mg twice daily in health subjects.
        • Positive preliminary topline data announced in January 2021. Pharmacodynamic analysis demonstrated incremental cytokine suppression at these higher doses. ATI-450 was generally well tolerated. The most common AEs (reported by 2 or more subjects who received ATI-450) were headache, dizziness, nausea, parasthesia and, in the post-dosing safety follow-up phase of the trial, dry skin. These AEs were all mild in severity.
        • A final analysis of this trial is underway.



      • ATI-450-CAPS-201: A Phase 2a, multicenter, open-label, single-arm clinical trial to investigate the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome (CAPS) previously managed with anti-IL1 therapy. Due to the COVID-19 pandemic, subject enrollment in this trial was paused. As a result of the ongoing pandemic and given the positive preliminary topline data from the ATI-450-RA-201 trial, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.
    • ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:



      • ATI-1777-AD-201: An ongoing Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe atopic dermatitis. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4. Data from this trial are expected mid-year 2021.
    • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:



      • Aclaris is developing ATI-2138 as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug Application for ATI-2138 in the second half of 2021.

    Financial Highlights:

    Liquidity and Capital Resources

    As of December 31, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $54.1 million compared to $75.0 million as of December 31, 2019. The changes in cash and cash equivalents and marketable securities during the year included:

    • Net cash used in operating activities was $38.6 million resulting from net loss of $51.0 million and changes in operating assets and liabilities of $2.4 million, partially offset by non-cash adjustments of $14.7 million.



    • Net borrowings of $10.9 million pursuant to a Loan and Security Agreement.



    • Net proceeds of $7.7 million from the sale of 2.1 million shares of common stock under an equity line of credit agreement.

    In January 2021, Aclaris closed a public offering in which it sold approximately 6.3 million shares of common stock. Proceeds from the offering were $103.5 million, net of underwriting discounts, commissions and offering expenses. Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2020 in combination with the proceeds from the January 2021 public offering will be sufficient to fund its operations through the end of 2023, without giving effect to any potential business development transactions or financing activities.

    Financial Results

    Fourth Quarter 2020

    • Net loss was $13.2 million for the fourth quarter of 2020 compared to $18.6 million for the fourth quarter of 2019. Loss from continuing operations was $13.6 million for the quarter ended December 31, 2020 compared to $19.2 million for the prior year period.

    • Total revenue was $1.6 million for the fourth quarter of 2020 compared to $1.1 million for the fourth quarter of 2019.



    • Research and development (R&D) expenses were $9.0 million for the quarter ended December 31, 2020 compared to $11.5 million for the prior year period.



      • The quarter-over-quarter decrease of $2.6 million was primarily the result of expenses related to Aclaris' legacy JAK inhibitors ATI-501 and ATI-502, including the substantial completion of Aclaris' various Phase 2 clinical trials, and the substantial completion of two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019.
    • General and administrative (G&A) expenses were $4.9 million for the quarter ended December 31, 2020 compared to $5.8 million for the prior year period.



      • The quarter-over-quarter decrease of $0.9 million was primarily the result of lower non-cash stock-based compensation expense resulting from headcount reductions. Stock-based compensation expense was $1.6 million compared to $2.6 million in the prior year period.

    Full Year 2020

    • Net loss was $51.0 million for the year ended December 31, 2020 compared to $161.4 million for the year ended December 31, 2019. Loss from continuing operations was $51.2 million for the year ended December 31, 2020 compared to $113.5 million for the prior year period. Income from discontinued operations was $0.1 million for the year ended December 31, 2020 compared to a loss from discontinued operations of $47.8 million for the year ended December 31, 2019.



    • Total revenue was $6.5 million for the year ended December 31, 2020 compared to $4.2 million for the year ended December 31, 2019.



    • R&D expenses were $31.7 million for the year ended December 31, 2020 compared to $64.9 million for the prior year period.



      • The decrease of $33.2 million was primarily the result of expenses related to ATI-501 and ATI-502, including the substantial completion of Aclaris' various Phase 2 clinical trials, and the substantial completion of two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019.
      • R&D expenses in 2020 included non-cash stock-based compensation expense of $2.9 million compared to $5.1 million in the prior year period.

    • G&A expenses were $20.5 million for the year ended December 31, 2020 compared to $27.8 million for the prior year period.



      • The decrease of $7.3 million was primarily the result of lower personnel and non-cash stock-based compensation resulting from headcount reductions.
      • G&A expenses in 2020 included non-cash stock-based compensation expense of $7.3 million compared to $10.3 million in the prior year period.

    • For the year ended December 31, 2019, there was also a $18.5 million non-cash charge for the impairment of goodwill.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials and timing for regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC Filings" page of the "Investors" section of Aclaris' website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.



    Aclaris Therapeutics, Inc.

    Consolidated Statements of Operations

    (unaudited, in thousands, except share and per share data)

     Three Months Ended Year Ended
     December 31, December 31,
     2020  2019  2020  2019 
    Revenues:           
    Contract research$1,413  $1,095  $5,786  $4,227 
    Other revenue 167      696    
    Total revenue 1,580   1,095   6,482   4,227 
                
    Costs and expenses:           
    Cost of revenue (1) 1,286   1,028   5,133   4,055 
    Research and development (1) 8,956   11,540   31,731   64,899 
    General and administrative (1) 4,898   5,809   20,530   27,827 
    Goodwill impairment          18,504 
    Total costs and expenses 15,140   18,377   57,394   115,285 
    Loss from operations (13,560)  (17,282)  (50,912)  (111,058)
    Other expense, net (219)  (1,895)  (424)  (2,484)
    Loss from continuing operations before income taxes (13,779)  (19,177)  (51,336)  (113,542)
    Income tax benefit (182)     (182)   
    Loss from continuing operations (13,597)  (19,177)  (51,154)  (113,542)
    Income (loss) from discontinued operations, net of tax (1) 424   583   139   (47,812)
    Net loss$(13,173) $(18,594) $(51,015) $(161,354)
    Net loss per share, basic and diluted$(0.30) $(0.45) $(1.20) $(3.90)
    Weighted average common shares outstanding, basic and diluted 43,588,095   41,405,657   42,539,293   41,323,921 
                
    (1) Amounts include stock-based compensation expense as follows:           
                
    Cost of revenue$218  $249  $946  $703 
    Research and development 727   358   2,919   5,091 
    General and administrative 1,559   2,581   7,342   10,288 
    Income (loss) from discontinued operations, net of tax    (7)     95 
    Total stock-based compensation expense$2,504  $3,181  $11,207  $16,177 





    Aclaris Therapeutics, Inc.

    Selected Consolidated Balance Sheet Data

    (unaudited, in thousands)

            
      December 31, 2020 December 31, 2019 
    Cash, cash equivalents, restricted cash and marketable securities $54,131 $75,015 
    Total assets  70,784  98,297 
    Total current liabilities  14,874  22,432 
    Total liabilities  33,134  28,385 
    Total stockholders' equity  37,650  69,912 

    Aclaris Contact

     



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  1. WAYNE, Pa., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that Dr. Neal Walker, President and CEO of Aclaris, will present a company overview at the following upcoming virtual investor conferences:

    • H.C. Wainwright Global Life Sciences Conference. Tuesday, March 9, 2021 at 7:00 a.m. ET. Management will be available March 9th and 10th throughout the day for virtual one-on-one meetings.
    • Oppenheimer 31st Annual Healthcare Conference. Tuesday, March 16, 2021 at 10:00 a.m. ET. Management will be available March 16th throughout the day for virtual one-on-one meetings.

    A live audio webcast…

    WAYNE, Pa., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that Dr. Neal Walker, President and CEO of Aclaris, will present a company overview at the following upcoming virtual investor conferences:

    • H.C. Wainwright Global Life Sciences Conference. Tuesday, March 9, 2021 at 7:00 a.m. ET. Management will be available March 9th and 10th throughout the day for virtual one-on-one meetings.
    • Oppenheimer 31st Annual Healthcare Conference. Tuesday, March 16, 2021 at 10:00 a.m. ET. Management will be available March 16th throughout the day for virtual one-on-one meetings.

    A live audio webcast of each presentation may be accessed through the "Events" page of the "Investors" section of Aclaris' website, www.aclaristx.com. Each webcast will be archived for at least 30 days on the Aclaris website.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Aclaris Contact

     



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  2. WAYNE, Pa., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in a virtual fireside chat at the 10th Annual SVB Leerink Global Healthcare Conference on Thursday, February 25, 2021 at 8:00 a.m. ET. Management will be available February 25th throughout the day for virtual one-on-one meetings.

    A live audio webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris' website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

    About Aclaris Therapeutics, Inc.

    WAYNE, Pa., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in a virtual fireside chat at the 10th Annual SVB Leerink Global Healthcare Conference on Thursday, February 25, 2021 at 8:00 a.m. ET. Management will be available February 25th throughout the day for virtual one-on-one meetings.

    A live audio webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris' website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Aclaris Contact



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  3. Frazier Healthcare Partners announced the planned addition of Albert Cha, M.D., Ph.D. as Managing Partner on the Life Sciences team. He has over 20 years of experience investing in public and private biopharmaceutical and medical device companies.

    Dr. Cha was previously a Managing Partner at Vivo Capital. He currently serves on the boards of Ascendis Pharma A/S (NASDAQ:ASND) and KalVista Pharmaceuticals (NASDAQ:KALV), and has served on the boards of Aclaris Therapeutics (NASDAQ:ACRS), Biohaven Pharma (NYSE:BHVN), Menlo Therapeutics (NASDAQ:MNLO), Sierra Oncology (NASDAQ:SRRA), Ceptaris Therapeutics (acquired by Actelion), Neomend (acquired by Bard), Vicept Therapeutics (acquired by Allergan), Bioform Medical (NASDAQ:BFRM, acquired by Merz…

    Frazier Healthcare Partners announced the planned addition of Albert Cha, M.D., Ph.D. as Managing Partner on the Life Sciences team. He has over 20 years of experience investing in public and private biopharmaceutical and medical device companies.

    Dr. Cha was previously a Managing Partner at Vivo Capital. He currently serves on the boards of Ascendis Pharma A/S (NASDAQ:ASND) and KalVista Pharmaceuticals (NASDAQ:KALV), and has served on the boards of Aclaris Therapeutics (NASDAQ:ACRS), Biohaven Pharma (NYSE:BHVN), Menlo Therapeutics (NASDAQ:MNLO), Sierra Oncology (NASDAQ:SRRA), Ceptaris Therapeutics (acquired by Actelion), Neomend (acquired by Bard), Vicept Therapeutics (acquired by Allergan), Bioform Medical (NASDAQ:BFRM, acquired by Merz))), Biodel (NASDAQ:BIOD), and NextWave Pharmaceuticals (acquired by Pfizer).

    Dr. Cha is a co-founder of the annual Dermatology Summit and Dermatology Innovation Forum. He also worked at Oracle Corporation in pharmaceutical consulting and at the Palo Alto VA Hospital as a biomedical engineer.

    Dr. Cha received his B.S. and M.S. in Electrical Engineering from Stanford University. He subsequently completed the Medical Scientist Training Program at UCLA School of Medicine, where he received his M.D. and Ph.D. in Neuroscience.

    "We are excited to welcome Albert to the Life Sciences team," said Patrick Heron, Managing Partner at Frazier. "He is a highly experienced investor who will be critical in helping us continue to identify attractive public and private investments."

    About Frazier Healthcare Partners

    Founded in 1991, Frazier Healthcare Partners is a leading provider of growth and venture capital to healthcare companies. With nearly $4.8 billion total capital raised, Frazier has invested in over 200 companies, with investment types ranging from company creation and venture capital to buyouts of profitable lower-middle market companies. The firm's Growth Buyout team invests in healthcare and pharmaceutical services, medical products and related sectors. The Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, WA and Menlo Park, CA, and invests broadly across the US, Canada, and Europe.

    For more information about Frazier Healthcare Partners, visit the company's website at http://www.frazierhealthcare.com.

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  4. WAYNE, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the pricing of its underwritten public offering of 5,483,714 shares of its common stock at a price to the public of $17.50 per share.  In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 822,557 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $96.0 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise…

    WAYNE, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the pricing of its underwritten public offering of 5,483,714 shares of its common stock at a price to the public of $17.50 per share.  In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 822,557 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $96.0 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters' option. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions.  

    Cantor Fitzgerald & Co. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering. 

    A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on March 13, 2020 and declared effective by the SEC on April 29, 2020.  The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement.  A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.  A final prospectus supplement and accompanying prospectus will be filed with the SEC.  When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: ; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Aclaris Therapeutics, Inc., including statements about Aclaris' public offering related to expected gross proceeds and anticipated closing date, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all and such other factors as are set forth in the risk factors detailed in Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings Aclaris makes with the SEC from time to time.  In addition, the forward-looking statements included in this press release represent Aclaris' views as of the date hereof. Aclaris anticipates that subsequent events and developments will cause Aclaris' views to change. However, while Aclaris may elect to update these forward-looking statements at some point in the future, Aclaris specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Aclaris' views as of any date subsequent to the date hereof.

    Aclaris Contact



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  5. WAYNE, Pa., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering.  All of the shares of common stock to be sold in the offering will be offered by Aclaris. Aclaris also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions.  The offering is subject to market conditions, and there can be no assurance as to whether or when the offering…

    WAYNE, Pa., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering.  All of the shares of common stock to be sold in the offering will be offered by Aclaris. Aclaris also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions.  The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Cantor Fitzgerald & Co. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering.

    A shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on March 13, 2020 and declared effective by the SEC on April 29, 2020.  The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement.  A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.  Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: ; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Aclaris Therapeutics, Inc., including statements about Aclaris' anticipated public offering and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all and such other factors as are set forth in the risk factors detailed in Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and other filings Aclaris makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Aclaris' views as of the date hereof. Aclaris anticipates that subsequent events and developments will cause Aclaris' views to change. However, while Aclaris may elect to update these forward-looking statements at some point in the future, Aclaris specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Aclaris' views as of any date subsequent to the date hereof.

    Aclaris Contact



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    • Durable Clinical Activity over 12 Weeks was Demonstrated
    • Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis
    • ATI-450, an Investigational Oral MK2 Inhibitor, was Generally Well Tolerated
    • Data Support Progression to Phase 2b
    • Management to Host Conference Call at 8:00 AM ET Today

    WAYNE, Pa., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical…

    • Durable Clinical Activity over 12 Weeks was Demonstrated
    • Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis
    • ATI-450, an Investigational Oral MK2 Inhibitor, was Generally Well Tolerated
    • Data Support Progression to Phase 2b
    • Management to Host Conference Call at 8:00 AM ET Today

    WAYNE, Pa., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450, an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis (RA) (ATI-450-RA-201). ATI-450 was developed internally utilizing Aclaris' proprietary KINect™ drug discovery platform.

    In the trial, 19 subjects were randomized in a 3:1 ratio and received either ATI-450 at 50 mg twice daily or placebo, in combination with methotrexate, for 12 weeks. The primary endpoint was safety and tolerability. Key secondary and exploratory endpoints included the disease activity scores, DAS28-CRP and ACR20/50/70, and the change from baseline in high sensitivity C-reactive protein (hsCRP) and relevant endogenous cytokine levels. As this trial was designed to generate proof of concept, it was not powered to detect statistically significant outcomes on efficacy endpoints.

    The mean DAS28-CRP score at baseline was 5.71 for the 16 subjects in the treatment arm and 5.77 for the three subjects in the placebo arm. Seventeen subjects (15 in the treatment arm and two in the placebo arm) completed 12 weeks of treatment.

    In this trial, ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and evaluation of ACR20/50/70 responses over 12 weeks. The mean change from baseline in DAS28-CRP score at week 12 was a 2.0 reduction in the treatment arm compared to a 0.35 increase in the placebo arm. The proportion of subjects with a DAS28-CRP score at week 12 of ≤ 3.2 (low disease activity or remission) was 40% and 0% in the treatment and placebo arms, respectively, and the proportion of subjects with a DAS28-CRP score of < 2.6 (remission) was 20% and 0% in the treatment and placebo arms, respectively.

    ACR20/50/70 was observed at week 12 in 60%, 33% and 20%, respectively, of the 15 subjects in the treatment arm, and in 0% of the two subjects in the placebo arm. The median reduction from baseline in hsCRP was >40% throughout the 12 weeks of the trial in the treatment arm. A sustained median reduction from baseline in hsCRP was not observed in the placebo arm. An interim analysis (11 treatment, two placebo) of ex vivo stimulated cytokines from blood samples taken from the treatment arm showed a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 over the 12 week dosing period. Similarly, analysis of endogenous cytokines also demonstrated a marked and sustained inhibition of median concentrations of TNFα, IL6, IL8, and MIP1β in the treatment arm over the 12 week period.

    ATI-450 was generally well tolerated. No serious adverse events were reported and all adverse events were mild to moderate. The most common adverse events (each reported in 2 subjects) were urinary tract infection (UTI), elevated lipids and ventricular extrasystoles, all of which were determined to be unrelated to treatment except for one UTI. Two subjects withdrew from the trial, one in the treatment arm and one in the placebo arm.

    ATI-450 was also evaluated at higher doses in a separate Phase 1 clinical trial in healthy subjects (ATI-450-PKPD-102). In this placebo-controlled Phase 1 trial, one group of healthy subjects received 80 mg of ATI-450 twice daily and another group of healthy subjects received 120 mg of ATI-450 twice daily over 6.5 days. No dose-limiting toxicity was observed. Ex vivo analysis of blood samples from this Phase 1 trial showed that increased cytokine inhibition was achieved with these higher doses of ATI-450. A final analysis of this trial is underway.

    Dr. David Gordon, Chief Medical Officer of Aclaris, said, "We're very pleased with these data which demonstrate that ATI-450 was generally well tolerated and showed durable clinical activity in RA over 12 weeks. We believe these data support our hypothesis that MK2 inhibition is an important novel target for the treatment of immuno-inflammatory diseases, such as rheumatoid arthritis, and we look forward to progressing ATI-450 to Phase 2b. We want to thank everyone who participated in these informative trials."

    "Despite recent advances, rheumatoid arthritis continues to be a significant burden for large numbers of patients," said Stanley Cohen, MD, Clinical Professor in the Department of Internal Medicine and a Clinical Faculty Member in the Division of Rheumatology at UT Southwestern Medical School, and a Co-Director of the Division of Rheumatology at Presbyterian Hospital, Dallas. "These results are very encouraging and support further development of ATI-450 to treat rheumatoid arthritis with a new mechanism of action."

    Aclaris expects to submit a full analysis of the Phase 2a data for publication in a peer-reviewed scientific journal. The full analysis will include data from other secondary and exploratory endpoints evaluated in the trial, including the four-week safety follow-up data and a full analysis of MRI, pharmacodynamic and pharmacokinetic data.

    Conference Call and Webcast

    Management will host a conference call and webcast with an accompanying slide presentation at 8:00 AM ET today to review these preliminary topline Phase 2a data and related matters. To participate in the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international) and reference conference ID 7166952. To access the live webcast of the call and the accompanying slide presentation, please visit the "Events" page of the "Investors" section of Aclaris' website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

    About ATI-450

    ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor. This mechanism potentially leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this mechanism include tumor necrosis factor α (TNFα) and interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris is developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-450 as a potential treatment for RA, the clinical development of ATI-450, including the further development at higher doses, and the publication of the full analysis from the ATI-450-RA-201 trial. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, risks and uncertainties associated with preliminary trial results varying from final results, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC Filings" page of the "Investors" section of Aclaris' website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact



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    • New Scientific Advisory Board of Immuno-Inflammatory Experts
    • Preliminary Topline Data for the ATI-450-RA-201 Trial Expected in January 2021

    WAYNE, Pa., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the formation of a new Scientific Advisory Board consisting of Stanley Cohen, MD, Marco Colonna, MD, James Krueger, MD, PhD, and Michael Weinblatt, MD.

    "We are looking forward to working with each of these leading experts in rheumatology and other immuno-inflammatory diseases," said Dr. David Gordon, Chief Medical Officer of Aclaris. "Their collective wealth of knowledge and expertise…

    • New Scientific Advisory Board of Immuno-Inflammatory Experts
    • Preliminary Topline Data for the ATI-450-RA-201 Trial Expected in January 2021

    WAYNE, Pa., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the formation of a new Scientific Advisory Board consisting of Stanley Cohen, MD, Marco Colonna, MD, James Krueger, MD, PhD, and Michael Weinblatt, MD.

    "We are looking forward to working with each of these leading experts in rheumatology and other immuno-inflammatory diseases," said Dr. David Gordon, Chief Medical Officer of Aclaris. "Their collective wealth of knowledge and expertise will be extremely beneficial to us as we continue to advance our immuno-inflammatory programs."

    The members of the Scientific Advisory Board are:

    Stanley Cohen, MD

    Dr. Stanley Cohen is a physician at Rheumatology Associates, a Clinical Professor in the Department of Internal Medicine and a Clinical Faculty Member in the Division of Rheumatology at UT Southwestern Medical School, a Co-Director of the Division of Rheumatology at Presbyterian Hospital, Dallas, and a Co-Medical Director of Metroplex Clinical Research Center. He is a past president of the American College of Rheumatology and in 2016 was designated as a Master by the American College of Rheumatology. Dr. Cohen is board certified in internal medicine and rheumatology.

    Marco Colonna, MD

    Dr. Colonna is the Robert Rock Belliveau, M.D. Endowed Professor of Pathology, a Professor of Immunobiology, a Professor of Medicine and the Head of Colonna Lab at the Washington University School of Medicine in St. Louis. Dr. Colonna is a member of the National Academy of Sciences.

    James Krueger, MD, PhD

    Dr. Krueger is the D. Martin Carter Professor in Clinical Investigation and Head of the Laboratory of Investigative Dermatology at The Rockefeller University. He also serves as the Chief Executive Officer, a Co-Director for the Center for Clinical and Translational Science and Senior Attending Physician at The Rockefeller University Hospital. Dr. Krueger has received numerous awards, including the Eugene J. Van Scott Award for Innovative Therapy of the Skin by the American Academy of Dermatology in 2015, the Astellas Award by the American Academy of Dermatology in 2010 and the Farber Award by the Society of Investigative Dermatology in 2010. Dr. Krueger is board certified in dermatology.

    Michael Weinblatt, MD

    Dr. Weinblatt is the Co-Director of Clinical Rheumatology at the Brigham and Women's Hospital. He is also the John R. Riedman Professor of Medicine at Harvard Medical School. Dr. Weinblatt is a past president of the American College of Rheumatology. He was awarded the Presidential Gold Medal by the American College of Rheumatology in 2017 and is a Master of the American College of Rheumatology. Dr. Weinblatt is board certified in internal medicine and rheumatology.

    Aclaris also announced today that it now expects preliminary topline data for the ATI-450-RA-201 trial, its Phase 2a trial of ATI-450, an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis, in January 2021.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' drug candidates, including the timing of preliminary topline data from the ATI-450-RA-201 trial. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact



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  6. WAYNE, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 7:30 a.m. ET. Management will be available December 1st and 2nd throughout the day for virtual one-on-one meetings.

    A live audio webcast of the fireside chat may be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. An archived version of the webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics…

    WAYNE, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 7:30 a.m. ET. Management will be available December 1st and 2nd throughout the day for virtual one-on-one meetings.

    A live audio webcast of the fireside chat may be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. An archived version of the webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Aclaris Contact



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  7. Jonathan Piazza appointed Chief Financial Officer

    Andrew Powell, J.D. joins board as independent director

    Silverback Therapeutics Inc., a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer and other serious diseases, today announced the appointment of Jonathan Piazza as chief financial officer. He joins Silverback from Goldman Sachs & Co., where he served as a managing director of Healthcare Investment Banking, advising on and executing biopharma and life sciences financing and strategic transactions. Mr. Piazza will be a member of the executive leadership team and will be responsible for…

    Jonathan Piazza appointed Chief Financial Officer

    Andrew Powell, J.D. joins board as independent director

    Silverback Therapeutics Inc., a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer and other serious diseases, today announced the appointment of Jonathan Piazza as chief financial officer. He joins Silverback from Goldman Sachs & Co., where he served as a managing director of Healthcare Investment Banking, advising on and executing biopharma and life sciences financing and strategic transactions. Mr. Piazza will be a member of the executive leadership team and will be responsible for finance, corporate strategy, investor relations and corporate communications.

    "With his range of strategic finance experience, leadership and management capability, Jonathan is ideally suited to meet the needs of Silverback and all of our stakeholders as we continue to advance our pipeline that marries the curative potential of IO treatment with the precision of targeted drugs. We are thrilled to welcome Jonathan to our leadership team," said Laura Shawver, Ph.D., chief executive officer.

    Mr. Piazza has more than 20 years of experience in healthcare investment banking, finance and large pharma roles. Before joining Goldman Sachs & Co., Mr. Piazza spent 13 years at Barclays Capital and Lehman Brothers, most recently serving as a managing director in Healthcare Banking. Previously, he was a financial advisor at Smith Barney (now Morgan Stanley Smith Barney), and prior to that, he worked in engineering, development and international marketing disciplines at Abbott Laboratories across multiple divisions of the company. Mr. Piazza earned a Bachelor of Science degree in Chemical Engineering from The Ohio State University and an MBA from the Haas School of Business at the University of California at Berkeley.

    "I am passionate about working with companies that can change the lives of patients, and the Silverback team has turned innovative science into drug candidates that are on the cusp of demonstrating the power of the ImmunoTAC platform. I can't think of a better opportunity to rejoin the biopharma industry than the one presented by Silverback Therapeutics," said Mr. Piazza. "I look forward to partnering with Laura, the management team and the board to grow the company and deliver a new class of systemically delivered, tissue targeted therapies to patients in need."

    The Company also expanded its board of directors appointing Andrew Powell, J.D., effective October 2020. Mr. Powell is a highly accomplished executive with expertise in the areas of commercialization strategy, governance, compliance, licensing and mergers and acquisitions. He is a member of the board of directors of Landec Inc. (NASDAQ:LNDC) and Aclaris Therapeutics, Inc. (NASDAQ:ACRS), and served on the board of Synthorx Inc. Previously, he was senior vice president, general counsel and corporate secretary of Medivation, Inc. from May 2015 until November 2016, when the company was acquired by Pfizer, Inc., and executive vice president, general counsel, and corporate secretary of InterMune, Inc. from September 2013 to March 2015, when the company was acquired by Roche, Inc. Mr. Powell holds a Bachelor of Arts degree from the University of North Carolina at Chapel Hill and a Juris Doctorate from Stanford Law School.

    About Silverback Therapeutics

    Silverback Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer and other serious diseases. Silverback's platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback's lead product candidate, SBT6050, is a therapeutic comprised of a TLR8 agonist payload conjugated to a HER2-directed monoclonal antibody that targets tumors such as certain breast, gastric and non-small cell lung cancers. SBT6050 is currently in a Phase 1 clinical study in patients with advanced or metastatic HER2-expressing solid tumors (ClinicalTrials.gov Identifier: NCT04460456). Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.

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    • First Subject Dosed in Phase 2a Trial of ATI-1777, an Investigational Topical "Soft" JAK 1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis

    • Initiated Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, for the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)

    WAYNE, Pa., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2020 and provided a corporate update.

    "We have continued to meet our milestones and meaningfully advance our pipeline," said Dr. Neal Walker, President & CEO of Aclaris. "We…

    • First Subject Dosed in Phase 2a Trial of ATI-1777, an Investigational Topical "Soft" JAK 1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis



    • Initiated Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, for the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)

    WAYNE, Pa., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2020 and provided a corporate update.

    "We have continued to meet our milestones and meaningfully advance our pipeline," said Dr. Neal Walker, President & CEO of Aclaris. "We recently announced that we dosed our first subject in our Phase 2a trial of ATI-1777 for the treatment of moderate to severe atopic dermatitis. In addition, we initiated our Phase 2a trial of ATI-450 as a potential treatment for cryopyrin-associated periodic syndrome, an orphan immuno-inflammatory indication. We look forward to progressing these trials as well as our ongoing trial of ATI-450 for rheumatoid arthritis."

    Research and Development Highlights:

    The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

    • ATI-450, an investigational oral small molecule MK2 inhibitor compound:
      • ATI-450-RA-201: An ongoing Phase 2a clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis. Aclaris' planned enrollment for this trial is up to 25 subjects.
        • Aclaris anticipates reporting data from this trial in the first half of 2021.
      • ATI-450-CAPS-201: An ongoing Phase 2a open-label, single-arm clinical trial to investigate the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome (CAPS) previously managed with anti-IL1 therapy. Aclaris' planned enrollment for this trial is up to 10 subjects. The primary endpoint of the trial is an assessment of safety and tolerability. The key secondary efficacy endpoint of the trial is the proportion of subjects who maintain disease remission.
        • Aclaris initiated this trial and filed for orphan drug designation for the indication in November 2020.
      • IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in approximately 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
    • ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
      • ATI-1777-AD-201: An ongoing Phase 2a multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate or severe atopic dermatitis. Aclaris' planned enrollment for this trial is approximately 42 subjects. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.
        • The first subject was dosed in October 2020.



    • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
      • Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug (IND) Application for ATI-2138 in 2021.

    Business Development Highlights:

    • Aclaris continues to pursue strategic alternatives, including seeking partners for:
      • A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
      • ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
      • ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    Financial Highlights:

    Liquidity and Capital Resources

    As of September 30, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $55.2 million compared to $75.0 million as of December 31, 2019. For the three and nine months ended September 30, 2020, net cash used in operating activities was $12.2 million and $29.8 million, respectively. As of September 30, 2020, Aclaris had approximately 42.9 million shares of common stock outstanding.

    In August 2020, Aclaris entered into an equity purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park). The agreement allows Aclaris to sell, at its discretion, up to $15.0 million of its common stock to Lincoln Park.

    Aclaris anticipates that its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

    Third Quarter 2020 and Year-to-Date Financial Results

    • The accompanying condensed consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations.
    • Net loss was $10.7 million for the third quarter of 2020 compared to $55.3 million for the third quarter of 2019, and was $37.8 million for the nine months ended September 30, 2020 compared to $142.8 million for the nine months ended September 30, 2019.
    • Total revenue was $1.4 million for the third quarter of 2020 compared to $1.0 million for the third quarter of 2019, and was $4.9 million for the nine months ended September 30, 2020 compared to $3.1 million for the nine months ended September 30, 2019.
    • Research and development (R&D) expenses were $6.9 million for the quarter ended September 30, 2020 compared to $16.2 million for the prior year period, and were $22.8 million for the nine months ended September 30, 2020 compared to $53.3 million for the prior year period.



      • The quarter-over-quarter decrease of $9.3 million was primarily the result of the substantial completion of Aclaris' various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs. Additionally, Aclaris made a $4.0 million milestone payment for the achievement of a development milestone in the third quarter of 2019 which also contributed to the decrease quarter-over-quarter.
      • R&D expenses in the third quarter of 2020 included non-cash stock-based compensation expense of $0.4 million compared to $1.4 million in the prior year period.
    • General and administrative (G&A) expenses were $3.9 million for the quarter ended September 30, 2020 compared to $6.8 million for the prior year period, and were $15.6 million for the nine months ended September 30, 2020 compared to $21.8 million for the prior year period.



      • The quarter-over-quarter decrease of $3.0 million was primarily the result of lower personnel costs resulting from Aclaris' decision to discontinue commercial operations in September 2019.
      • G&A expenses in the third quarter of 2020 included non-cash stock-based compensation expense of $1.3 million compared to $2.6 million in the prior year period.
    • Loss from continuing operations was $10.7 million for the quarter ended September 30, 2020 compared to $23.1 million for the prior year period, and was $37.6 million for the nine months ended September 30, 2020 compared to $94.1 million for the prior year period. Loss from discontinued operations was $0 for the third quarter of 2020 compared to $32.2 million for the third quarter of 2019, and was $0.3 million for the nine months ended September 30, 2020 compared to $48.7 million for the nine months ended September 30, 2019.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund its operations through the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

     
     
    Aclaris Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited, in thousands, except share and per share data)
         
      Three Months Ended Nine Months Ended
      September 30, September 30,
      2020

        2019

        2020

        2019

    Revenues:            
    Contract research $1,331  $983  $4,373  $3,132 
    Other revenue  118      529    
    Total revenue  1,449   983   4,902   3,132 
                 
    Costs and expenses:            
    Cost of revenue (1)  1,189   826   3,847   3,028 
    Research and development (1)  6,866   16,183   22,775   53,334 
    General and administrative (1)  3,859   6,838   15,632   21,771 
    Goodwill impairment           18,504 
    Total costs and expenses  11,914   23,847   42,254   96,637 
    Loss from operations  (10,465)  (22,864)  (37,352)  (93,505)
    Other expense, net  (194)  (274)  (205)  (589)
    Loss from continuing operations  (10,659)  (23,138)  (37,557)  (94,094)
    Loss from discontinued operations (1)     (32,181)  (285)  (48,666)
    Net loss $(10,659) $(55,319) $(37,842) $(142,760)
    Net loss per share, basic and diluted $(0.25) $(1.34) $(0.90) $(3.46)
    Weighted average common shares outstanding, basic and diluted  42,802,582   41,364,387   42,187,140   41,296,377 
                 
    (1) Amounts include stock-based compensation expense as follows:            
                 
    Cost of revenue $216  $25  $728  $454 
    Research and development  437   1,418   2,192   4,733 
    General and administrative  1,288   2,581   5,783   7,707 
    Loss from discontinued operations     (704)     102 
    Total stock-based compensation expense $1,941  $3,320  $8,703  $12,996 
                     



    Aclaris Therapeutics, Inc.

    Selected Consolidated Balance Sheet Data

    (unaudited, in thousands)
     
      September 30, 2020 December 31, 2019
           
    Cash, cash equivalents, restricted cash and marketable securities $55,230 $75,015
    Total assets  71,902  98,297
    Total current liabilities  12,788  22,432
    Total liabilities  31,145  28,385
    Total stockholders' equity  40,757  69,912
           

    Aclaris Contact

     

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  8. WAYNE, Pa., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 was developed internally utilizing Aclaris' proprietary KINect™ drug discovery platform.

    "We are excited about progressing this drug candidate into the clinic," said Dr. David Gordon, Chief Medical Officer of Aclaris. "This trial is an important first step in the clinical development of ATI-1777…

    WAYNE, Pa., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 was developed internally utilizing Aclaris' proprietary KINect™ drug discovery platform.

    "We are excited about progressing this drug candidate into the clinic," said Dr. David Gordon, Chief Medical Officer of Aclaris. "This trial is an important first step in the clinical development of ATI-1777 and we hope to establish that a topical JAK inhibitor can safely and effectively treat AD while limiting systemic exposure."

    The Phase 2a trial is a multicenter, randomized, double-blind, vehicle-controlled, parallel-group trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate or severe AD. Subjects will apply ATI-1777 or vehicle twice daily for 28 days. Aclaris' planned enrollment for this trial is approximately 42 subjects and the trial will be conducted in the U.S. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4.

    About ATI-1777

    ATI-1777 is an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor. "Soft" JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in the systemic circulation. Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. Aclaris is developing ATI-1777 as a potential treatment for moderate to severe atopic dermatitis.



    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-1777 as a potential treatment for moderate to severe atopic dermatitis and the clinical development of ATI-1777. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact

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  9. WAYNE, Pa., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference. On Tuesday, September 15, 2020 at 12:30 p.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will present a company overview. Management will be available September 15th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.
       
    • Cantor Virtual Global Healthcare Conference. On Thursday, September 17, 2020 at 10:40…

    WAYNE, Pa., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that management will participate in the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference. On Tuesday, September 15, 2020 at 12:30 p.m. ET, Dr. Neal Walker, the President and CEO of Aclaris, will present a company overview. Management will be available September 15th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.

       
    • Cantor Virtual Global Healthcare Conference. On Thursday, September 17, 2020 at 10:40 a.m. ET., Dr. Walker will participate in a fireside chat. Management will be available September 17th throughout the day for virtual one-on-one meetings with investors who are registered to attend the conference.

    A live audio webcast of each presentation may be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. An archived version of each webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

    Aclaris Contact 

     

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  10.  First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
     First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
     Clinical Trial of ATI-1777, an Investigational "Soft" Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis

    WAYNE, Pa., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and…

     First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
     First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
     Clinical Trial of ATI-1777, an Investigational "Soft" Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis

    WAYNE, Pa., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and business highlights.

    "As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times," said Dr. Neal Walker, President and CEO of Aclaris. "In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans."

    R&D Highlights:

    The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

    • ATI-450, an investigational oral small molecule MK2 inhibitor compound:
      • ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
        • This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
      • ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
      • IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
        • The first subject was dosed in August 2020.
    • ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
      • Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
      • ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
    • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
      • Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.

    Business Development Highlights:

    • Aclaris continues to pursue strategic alternatives, including seeking partners for:
      • A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
      • ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
      • ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    Financial Highlights:

    Liquidity and Capital Resources

    As of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of $68.1 million compared to $75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was $10.8 million and $17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

    Second Quarter 2020 and Year-to-Date Financial Results

    • The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations.
    • Net loss was $11.6 million for the second quarter of 2020, compared to $49.9 million for the second quarter of 2019, and was $27.2 million for the six months ended June 30, 2020, compared to $87.4 million for the six months ended June 30, 2019.
    • Total costs and expenses from continuing operations for the second quarter of 2020 were $13.4 million, compared to $44.5 million for the second quarter of 2019, and were $30.3 million for the six months ended June 30, 2020, compared to $72.8 million for the six months ended June 30, 2019.
      • Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of $3.3 million, compared to $4.6 million in the prior year period. 
      • Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of $6.8 million, compared to $8.9 million in the prior year period.
      • Recorded a non-cash goodwill impairment charge of $18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020.
    • R&D expenses were $6.5 million and $15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $17.5 million and $37.2 million for the quarter and six months ended June 30, 2019, respectively.
      • The quarter-over-quarter decrease of $11.1 million was primarily the result of the substantial completion of Aclaris' various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
    • General and administrative expenses were $5.6 million and $11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to $7.5 million and $14.9 million for the quarter and six months ended June 30, 2019, respectively.
      • The quarter-over-quarter decrease of $1.9 million was primarily the result of lower personnel costs resulting from the Company's decision to discontinue commercial operations in September 2019.
    • Loss from continuing operations was $11.6 million and $26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $43.7 million and $71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was $27,000 and $0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to $6.2 million and $16.5 million for the quarter and six months ended June 30, 2019, respectively.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.



    Aclaris Therapeutics, Inc.

    Consolidated Statements of Operations

    (unaudited, in thousands, except share and per share data)

      Three Months Ended Six Months Ended
      June 30, June 30,
      2020 2019 2020 2019
    Revenues:            
    Contract research $1,853 $886 $3,042 $2,149
    Other revenue  193    411  
    Total revenues  2,046  886  3,453  2,149
                 
    Costs and expenses:            
    Cost of revenue (1)  1,389  994  2,658  2,201
    Research and development (1)  6,466  17,519  15,909  37,161
    General and administrative (1)  5,572  7,469  11,773  14,926
    Goodwill impairment    18,504    18,504
    Total costs and expenses  13,427  44,486  30,340  72,792
    Loss from operations  (11,381)  (43,600)  (26,887)  (70,643)
    Other expense, net  (189)  (85)  (11)  (315)
    Loss from continuing operations  (11,570)  (43,685)  (26,898)  (70,958)
    Loss from discontinued operations (1)  (27)  (6,191)  (285)  (16,483)
    Net loss $(11,597) $(49,876) $(27,183) $(87,441)
    Net loss per share, basic and diluted $(0.28) $(1.21) $(0.65) $(2.12)
    Weighted average common shares outstanding, basic and diluted  42,133,646  41,274,808  41,876,037  41,261,808
                 
    (1) Amounts include stock-based compensation expense as follows:            
                 
    Cost of revenue $252 $223 $512 $429
    Research and development  939  1,721  1,755  3,315
    General and administrative  2,118  2,654  4,495  5,126
    Loss from discontinued operations    216    806
    Total stock-based compensation expense $3,309 $4,814 $6,762 $9,676



    Aclaris Therapeutics, Inc.

    Selected Consolidated Balance Sheet Data

    (unaudited, in thousands)

      June 30, 2020 December 31, 2019
           
    Cash, cash equivalents, and marketable securities $68,115 $75,015
    Total assets  84,999  98,297
    Total current liabilities  17,745  22,432
    Total liabilities  35,633  28,385
    Total stockholders' equity  49,366  69,912



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  11. WAYNE, Pa., July 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical "soft" drug.

    "We are very pleased to have achieved another development milestone with the submission of this IND and look forward…

    WAYNE, Pa., July 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical "soft" drug.

    "We are very pleased to have achieved another development milestone with the submission of this IND and look forward to exploring the therapeutic potential of ATI-1777 in patients with moderate to severe AD," said Dr. David Gordon, Chief Medical Officer of Aclaris. "ATI-1777 is designed to be active in the skin but rapidly metabolized in the systemic circulation, with the goal of developing a medicine that is efficacious in the treatment of AD while limiting systemic exposure."

    If the IND is allowed, Aclaris plans to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at 4 weeks.

    About ATI-1777

    ATI-1777 is an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor.  "Soft" JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in the systemic circulation.  Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. If the IND is allowed, Aclaris plans to develop ATI-1777 as a potential treatment for moderate to severe atopic dermatitis.



    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-1777 as a potential treatment for patients with moderate to severe atopic dermatitis and the clinical development of ATI-1777. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact

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    • FDA Allows IND to Study ATI-450 in Hospitalized Patients with COVID-19
    • Aclaris Supports Investigator-Initiated Clinical Trial Sponsored by the University of Kansas Medical Center
    • ATI-450 Inhibits Multiple Key Inflammatory Cytokines

    WAYNE, Pa., June 17, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.  Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized…

    • FDA Allows IND to Study ATI-450 in Hospitalized Patients with COVID-19
    • Aclaris Supports Investigator-Initiated Clinical Trial Sponsored by the University of Kansas Medical Center
    • ATI-450 Inhibits Multiple Key Inflammatory Cytokines

    WAYNE, Pa., June 17, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.  Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The trial will be led by co-investigators Gregory Gan, M.D., Ph.D. and Deepika Polineni, M.D., M.P.H. The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy. The primary endpoint is the proportion of subjects who are free from respiratory failure by day 14.

    "CRS leads to the release of multiple inflammatory cytokines such as IL1β, IL6 and TNFα, which precedes acute respiratory distress syndrome, and is associated with significant morbidity and mortality in patients with COVID-19. ATI-450, a novel oral compound, has demonstrated that it targets the expression of inflammatory cytokines in a Phase 1 clinical trial in healthy volunteers. Therefore, we believe that ATI-450 may be an innovative approach to managing this disease," said Dr. Gan. As further noted by Dr. Polineni, "By mitigating CRS, important clinical outcomes such as oxygenation in patients with COVID-19 would be improved which could result in the reduced need for ventilation in patients in the intensive care setting." 

    ATI-450 has been observed to regulate pro-inflammatory cytokines associated with CRS.  Pharmacodynamic analysis from the first-in-human study using an ex vivo lipopolysaccharide (LPS) stimulation model demonstrated dose-dependent reduction of TNFα, IL1β, IL6 and IL8.   Further analysis using this LPS model showed marked inhibition of additional cytokines linked to CRS, including GM-CSF, IL2, IFNγ and MIP1α.  Furthermore, anti-inflammatory activity for ATI-450 was observed in a rat model of airway neutrophilia induced by inhaled LPS.  In addition, anti-viral1,2,3 and anti-fibrotic4,5 activity has been observed following blockade of the MK2 pathway in preclinical studies.

    "Many of the investigational drugs that are being evaluated to treat CRS target a single cytokine," said Dr. David Gordon, Chief Medical Officer of Aclaris. "We believe inhibiting multiple cytokines has the potential to achieve clinical benefits in patients with CRS, and this study will explore if ATI-450 is an effective approach in these patients. Thanks to KUMC, who are sponsoring this trial, we are able to evaluate ATI-450 as a potential treatment for COVID-19 at this critical time without impacting our ongoing clinical development programs. If successful, we hope to further explore the role that ATI-450 may have in helping patients with COVID-19 and addressing the healthcare challenges of the pandemic."

    Company to Host Conference Call

    Management will conduct a conference call at 8:30 AM ET today to discuss this trial and related matters.  The conference call will be webcast live over the Internet and can be accessed through the Events page under the Investors section of Aclaris' website, www.aclaristx.com. A replay of the webcast will be archived on the Aclaris website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1366937 prior to the start of the call.

    About COVID-19

    Coronavirus disease 2019 (COVID-19) is a new pandemic disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some patients require hospitalization, mostly due to pneumonia, and can progress quickly to severe acute lung injury and acute respiratory distress syndrome (ARDS), which is associated with high mortality.6,7 A viral-induced cytokine storm or "hyperimmune response" is hypothesized to be a major pathogenic mechanism of ARDS.8,9,10

    About ATI-450

    ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development. This mechanism leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this mechanism include tumor necrosis factor α (TNFα) and interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris is developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.



    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding ATI-450 as a potential treatment for patients with COVID-19 and the clinical development of ATI-450. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" page of the Investors section of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact

    References

    1. McCaskill JL, Ressel S, Alber A, et al. Broad-Spectrum Inhibition of Respiratory Virus Infection by MicroRNA Mimics Targeting p38 MAPK Signaling. Mol Therapy: Nuc Acids. 2017;7:256-266.
    2. Luig C, Köther K, Dudek SE, et al. MAP kinase-activated protein kinases 2 and 3 are required for influenza A virus propagation and act via inhibition of PKR. FASEB J. 2010;24:4068-4077.
    3. Jimenez-Guardeño JM, Nieto-Torres JL, DeDiego ML, et al. The PDZ-Binding Motif of Severe Acute Respiratory Syndrome Coronavirus Envelope Protein Is a Determinant of Viral Pathogenesis. PLoS Pathog. 2014;10(8):1-20.
    4. Liang J, Liu N, Liu X, et al. Mitogen-activated Protein Kinase–activated Protein Kinase 2 Inhibition Attenuates Fibroblast Invasion and Severe Lung Fibrosis. Am J Respir Cell Mol Biol. 2019;60(1):41–48.
    5. Vittal R, Fisher A, Gu H, et al. Peptide-Mediated Inhibition of Mitogen-Activated Protein Kinase–Activated Protein Kinase–2 Ameliorates Bleomycin-Induced Pulmonary Fibrosis. Am J Respir Cell Mol Biol. 2013;49(1):47–57.
    6. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506.
    7. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395:1054-1062.
    8. Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020;395:1033-1034.
    9. Moore, JB, June CH. Cytokine release syndrome in severe COVID-19. Science. 2020;368(6490):473-474.
    10. Zhang C, Wu Z, Li JW, et al. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int. J. Antimicrob. Agents. 2020;55(5):1-6.

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  12. WAYNE, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced the publication of an abstract at the 2020 European Congress of Rheumatology (EULAR 2020 E-Congress) being held June 3-6, 2020.  The abstract details are as follows:

    Abstract No: SAT0143
    Title: A Phase 1 Study in Healthy Volunteers Exploring the Safety, Pharmacokinetics and Pharmacodynamics of ATI-450: A Novel Oral MK2 Inhibitor
    Authors: J. Schnyder, J. Monahan, W. Smith, H. Hope, D. Kelly, D. Burt, E. Huff, A. Kaul, A. Hildebrand, B. Burnette, N. Klug, M. Bangs, D. Gordon

    The abstract is published in the electronic Abstract…

    WAYNE, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, today announced the publication of an abstract at the 2020 European Congress of Rheumatology (EULAR 2020 E-Congress) being held June 3-6, 2020.  The abstract details are as follows:

    Abstract No: SAT0143
    Title: A Phase 1 Study in Healthy Volunteers Exploring the Safety, Pharmacokinetics and Pharmacodynamics of ATI-450: A Novel Oral MK2 Inhibitor
    Authors: J. Schnyder, J. Monahan, W. Smith, H. Hope, D. Kelly, D. Burt, E. Huff, A. Kaul, A. Hildebrand, B. Burnette, N. Klug, M. Bangs, D. Gordon

    The abstract is published in the electronic Abstract Archive located here: "Abstract Archive."

    About ATI-450

    ATI-450 is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor in Phase 2 clinical development. This mechanism leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this mechanism include tumor necrosis factor α (TNFα) and interleukin-1α, -1β, -6 and -8 (IL1α, IL1β, IL6 and IL8). Aclaris is developing ATI-450 as a potential treatment for rheumatoid arthritis and other immuno-inflammatory diseases.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ATI-450. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact:
     

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  13. WAYNE, Pa., May 26, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 1:00 p.m. ET.

    A live audio webcast of the presentation may be accessed through the Events section of Aclaris' website, www.aclaristx.com. An archived version of the webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's

    WAYNE, Pa., May 26, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 1:00 p.m. ET.

    A live audio webcast of the presentation may be accessed through the Events section of Aclaris' website, www.aclaristx.com. An archived version of the webcast will be available for 30 days.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Aclaris Contact

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    • Projected Cash Runway into the First Quarter of 2022
    • Borrowed $11 Million from Term Loan Facility

    WAYNE, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the first quarter of 2020 and provided research and development (R&D) and business highlights.

    "In the first quarter, we borrowed $11 million from Silicon Valley Bank enabling us to extend our cash runway, and started enrolling subjects with moderate-to-severe rheumatoid arthritis in our Phase 2a trial of ATI-450.  As a result of the COVID-19 pandemic and as a precautionary measure, we temporarily paused subject enrollment in this trial…

    • Projected Cash Runway into the First Quarter of 2022
    • Borrowed $11 Million from Term Loan Facility

    WAYNE, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the first quarter of 2020 and provided research and development (R&D) and business highlights.

    "In the first quarter, we borrowed $11 million from Silicon Valley Bank enabling us to extend our cash runway, and started enrolling subjects with moderate-to-severe rheumatoid arthritis in our Phase 2a trial of ATI-450.  As a result of the COVID-19 pandemic and as a precautionary measure, we temporarily paused subject enrollment in this trial.  At this time, we have decided to resume enrollment at one clinical trial site. We will continue to monitor the COVID-19 pandemic and engage additional clinical trial sites, as appropriate, based on our assessment of the impact on our trial.  I'm proud of our team's focus, dedication and resilience while navigating through the unique challenges that the COVID-19 pandemic has created," said Dr. Neal Walker, President and CEO of Aclaris.

    R&D Highlights:
    The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

    • ATI-450:
      • ATI-450 is an investigational oral small molecule MK2 inhibitor.
      • ATI-450-RA-201:  A Phase 2a trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 in subjects with moderate-to-severe rheumatoid arthritis.
        • Aclaris started subject enrollment in the first quarter of 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment of subjects in the trial. At this time, Aclaris has decided to resume enrolling subjects at one clinical trial site. The initiation of additional clinical trial sites will be determined on an ongoing basis as the COVID-19 pandemic evolves.
        • Aclaris previously anticipated reporting data from this trial in the second half of 2020; however, Aclaris expects that the data may be delayed and will provide an update, at a later date, regarding the timing of reporting data from this trial.
      • ATI-450-PKPD-101: This Phase 1 single and multiple ascending dose (SAD/MAD) trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.
        • Final data from this trial demonstrated that ATI-450:
          • resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
          • was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;
          • had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and
          • had no meaningful food effect or drug-drug interaction with methotrexate.
      • Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 in an additional immuno-inflammatory indication.
         
    • ATI-1777:
      • ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound.
      • Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.
      • If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.
         
    • ATI-2138:
      • ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.
      • Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.

    Business Development Highlights:

    • Aclaris continues to pursue strategic alternatives, including seeking partners for:
      • A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
      • ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
      • ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    Financial Highlights:
    Liquidity and Capital Resources

    As of March 31, 2020, Aclaris had aggregate cash, cash equivalents and restricted cash and marketable securities of $79.0 million compared to $75.0 million as of December 31, 2019. For the quarter ended March 31, 2020, net cash used in operating activities was $6.8 million, which includes $5.2 million received from Allergan Sales, LLC on behalf of EPI Health, LLC for sales of RHOFADE (oxymetazoline hydrochloride) cream, 1%. On March 30, 2020, Aclaris entered into a loan and security agreement with Silicon Valley Bank pursuant to which Aclaris borrowed $11.0 million. As of March 31, 2020, Aclaris had approximately 41.8 million shares of common stock outstanding.

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2020, will be sufficient to fund its operations into the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

    First Quarter 2020 Financial Results

    • The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris' historical format.  Aclaris believes this format provides comparability with its previously filed financial statements.
    • Net loss was $15.6 million for the first quarter of 2020, compared to $37.6 million for the first quarter of 2019. Total costs and expenses from continuing operations for the first quarter of 2020 were $16.9 million, compared to $28.3 million for the first quarter of 2019.
      • Total costs and expenses in the first quarter of 2020 included non-cash stock-based compensation expense of $3.5 million, compared to $4.3 million in the prior year period. 
    • R&D expenses were $9.4 million for the quarter ended March 31, 2020, compared to $19.6 million for the prior year period.
      • The quarter-over-quarter decrease of $10.2 million was primarily the result of the substantial completion of Aclaris' various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
      • These reductions were offset by a $1.8 million non-cash charge for the change in the fair value of contingent consideration that was recorded in the first quarter of 2020.
    • General and administrative expenses were $6.2 million for the first quarter of 2020, compared to $7.5 million for the first quarter of 2019. The decrease was primarily the result of lower personnel and stock-based compensation related costs due to lower headcount.
    • Loss from continuing operations was $15.3 million for the first quarter of 2020 compared to $27.3 million for the first quarter of 2019, while our loss from discontinued operations was $0.3 million for the first quarter of 2020 compared to $10.3 million for the first quarter of 2019.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


    Aclaris Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands, except share and per share data)

        Three Months Ended
        March 31,
        2020     2019  
    Revenues:            
    Contract research   $ 1,189     $ 1,263  
    Other revenue     218        
    Total revenue     1,407       1,263  
                 
    Costs and expenses:            
    Cost of revenue (1)     1,269       1,207  
    Research and development (1)     9,444       19,643  
    General and administrative (1)     6,200       7,464  
    Total costs and expenses     16,913       28,314  
    Loss from operations     (15,506 )     (27,051 )
    Other income (expense), net     178       (230 )
    Loss from continuing operations     (15,328 )     (27,281 )
    Loss from discontinued operations (1)     (258 )     (10,284 )
    Net loss   $ (15,586 )   $ (37,565 )
    Net loss per share, basic and diluted   $ (0.37 )   $ (0.91 )
    Weighted average common shares outstanding, basic and diluted     41,618,429       41,248,663  
                 
    (1) Amounts include stock-based compensation expense as follows:            
                 
    Cost of revenue   $ 260     $ 206  
    Research and development     816       1,594  
    General and administrative     2,377       2,472  
    Loss from discontinued operations           590  
    Total stock-based compensation expense   $ 3,453     $ 4,862  
                     


    Aclaris Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)

                   
        March 31, 2020   December 31, 2019  
                   
    Cash, cash equivalents and restricted cash and marketable securities   $ 79,005   $ 75,015  
    Total assets     96,812     98,297  
    Total current liabilities     20,603      22,432  
    Total liabilities     38,637      28,385  
    Total stockholders' equity     58,175      69,912  
                   

    Aclaris Contact

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  14. WAYNE, Pa., March 31, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company, today announced that it has entered into a loan and security agreement with Silicon Valley Bank ("SVB") pursuant to which Aclaris has borrowed $11.0 million.

    "This financing allows us to strengthen our financial position by extending our cash runway and to continue to execute on our refocused business strategy as planned," said Dr. Neal Walker, President and CEO of Aclaris. Aclaris believes the proceeds from the loan, in combination with its existing cash, cash equivalents, and marketable securities, will be sufficient to fund its operations into the first quarter of 2022.

    Terms of Financing

    The term loan requires…

    WAYNE, Pa., March 31, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company, today announced that it has entered into a loan and security agreement with Silicon Valley Bank ("SVB") pursuant to which Aclaris has borrowed $11.0 million.

    "This financing allows us to strengthen our financial position by extending our cash runway and to continue to execute on our refocused business strategy as planned," said Dr. Neal Walker, President and CEO of Aclaris. Aclaris believes the proceeds from the loan, in combination with its existing cash, cash equivalents, and marketable securities, will be sufficient to fund its operations into the first quarter of 2022.

    Terms of Financing

    The term loan requires interest only payments beginning April 1, 2020 and continuing through March 1, 2022, followed by monthly installments of principal, plus monthly payments of accrued interest, starting on April 1, 2022 and continuing through March 1, 2024.  The loan is secured by substantially all of Aclaris' assets, other than intellectual property.  In connection with the term loan, Aclaris issued SVB a warrant to purchase up to 460,251 shares of Aclaris' common stock at an initial exercise price of $0.956 per share. The warrant became immediately exercisable in full upon the funding of the loan.  Other material terms related to the term loan and the warrant can be found in Aclaris' Current Report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include Aclaris' continued execution on its refocused business strategy and its belief that its existing cash, cash equivalents and marketable securities, together with the proceeds from the loan, will be sufficient to fund its operations into the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President
    Corporate Strategy/Investor Relations
    484-329-2140
     

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    • Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor
    • Projected Cash Runway into the Third Quarter of 2021
    • Management to Host Conference Call at 5:00 PM ET today

    WAYNE, Pa., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year 2019 and provided research and development (R&D) and business highlights.

    "In 2019, we repositioned the company to focus on our core competency in developing small molecule kinase inhibitors.  Thus far, we are very pleased with the progression of our immuno-inflammatory…

    • Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor
    • Projected Cash Runway into the Third Quarter of 2021
    • Management to Host Conference Call at 5:00 PM ET today

    WAYNE, Pa., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year 2019 and provided research and development (R&D) and business highlights.

    "In 2019, we repositioned the company to focus on our core competency in developing small molecule kinase inhibitors.  Thus far, we are very pleased with the progression of our immuno-inflammatory pipeline, as well as with the positive results from our Phase 1 clinical trial of ATI-450, an oral small molecule MK2 inhibitor," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "We look forward to initiating a Phase 2a trial of ATI-450 in subjects with rheumatoid arthritis in the first half of this year and executing on our new business plan."

    R&D Highlights:

    • ATI-450:
      • ATI-450 is an investigational oral small molecule MK2 inhibitor.
      • ATI-450-PKPD-101: A Phase 1 single and multiple ascending dose (SAD/MAD) trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in 77 healthy subjects.
        • Preliminary data from this trial demonstrated that ATI-450:
          • resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
          • was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea;
          • had dose-proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours in the MAD cohort; and
          • had no meaningful food effect or drug-drug interaction with methotrexate.
      • ATI-450-RA-201:  Aclaris intends to initiate a Phase 2a clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020.
      • Aclaris is also planning to initiate a Phase 2a clinical trial of ATI-450 for an additional immuno-inflammatory indication.
         
    • ATI-1777:
      • ATI-1777 is an investigational topical soft-Janus Kinase (JAK) inhibitor compound that Aclaris is developing as a potential treatment for moderate-to-severe atopic dermatitis.
      • Aclaris expects to submit an IND for ATI-1777 for the treatment of atopic dermatitis in mid-2020.
      • If the IND is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in both healthy subjects and subjects with atopic dermatitis in the second half of 2020 evaluating ATI-1777 as a potential topical treatment for moderate-to-severe atopic dermatitis.
         
    • ATI-2138:
      • ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound that Aclaris is developing as a potential treatment for psoriasis and/or inflammatory bowel disease.
      • Aclaris expects to submit an IND for ATI-2138 in the fourth quarter of 2020 or the first quarter of 2021.

    Corporate Highlights:

    • Divested RHOFADE (oxymetazoline hydrochloride) cream, 1% to EPI Health, LLC and repaid in full $30 million term loan with Oxford Finance LLC, in October 2019.
    • Appointed Vincent Milano to the Board in January 2020.

    Business Development Highlights:

    • Aclaris continues to pursue strategic alternatives, including seeking partners for:
      • A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
      • ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
      • ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    Financial Highlights:
    Liquidity and Capital Resources

    As of December 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $75.0 million compared to $168.0 million as of December 31, 2018. For the quarter and year ended December 31, 2019, net cash used in operating activities was $20.4 million and $96.4 million, respectively.  As of December 31, 2019, Aclaris had no long-term debt outstanding and had approximately 41.5 million shares of common stock outstanding.

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential business development transactions or financing activities.

    Fourth Quarter 2019 and Year-to-Date Financial Results

    • The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris' historical format.  Aclaris believes this format provides comparability with its previously filed financial statements. 
    • Total costs and expenses from continuing operations for the fourth quarter of 2019 were $18.4 million, compared to $26.9 million for the fourth quarter of 2018. For the year ended December 31, 2019, total costs and expenses were $115.3 million, compared to $90.9 million in 2018.
      • These amounts included non-cash stock-based compensation expenses of $3.2 million and $16.1 million for the quarter and year ended December 31, 2019, respectively, compared to $4.2 million and $16.6 million for the prior year periods, respectively.
      • For the year ended December 31, 2019, there was also a $18.5 million non-cash charge for the impairment of goodwill. There was no such charge in the prior year.
    • R&D expenses were $11.5 million and $64.9 million for the quarter and year ended December 31, 2019, respectively, compared to $19.0 million and $60.8 million for the quarter and year ended December 31, 2018, respectively.
      • The year-over-year fourth quarter decrease of $7.5 million was mainly the result of Aclaris' Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution, which were at or near completion in the third quarter of 2019, as well as a reduction in personnel-related costs.
      • These reductions were offset by increased expenses related to Aclaris' preclinical development programs and the Phase 1 clinical trial for ATI-450 which was initiated in 2019, and by a milestone expense related to one of Aclaris' licensing agreements.
    • General and administrative expenses were $5.8 million and $27.2 million for the quarter and year ended December 31, 2019, respectively, compared to $6.6 million and $25.6 million for the quarter and year ended December 31, 2018, respectively.
    • Loss from continuing operations was $19.2 million for the fourth quarter of 2019, compared to $24.7 million for the fourth quarter of 2018. Loss from continuing operations was $113.5 million for the year ended December 31, 2019, compared to $82.1 million for the year ended December 31, 2018.
    • The gain from discontinued operations was $0.6 million for the fourth quarter of 2019, compared to a loss of $13.9 million for the fourth quarter of 2018. The loss from discontinued operations was $47.8 million for the year ended December 31, 2019, compared to $50.6 million for the year ended December 31, 2018.
    • Net loss was $18.6 million for the fourth quarter of 2019, compared to net loss of $38.6 million for the fourth quarter of 2018, and was $161.4 million for the year ended December 31, 2019, compared to $132.7 million for the year ended December 31, 2018.

    Company to Host Conference Call

    Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris' financial results and provide a general business update.  The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9958112 prior to the start of the call.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and for ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the third quarter of 2021. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


    Aclaris Therapeutics, Inc.
    Consolidated Statements of Operations
    (unaudited, in thousands, except share and per share data)


        Three Months Ended   Year Ended
        December 31,   December 31,
        2019     2018     2019     2018  
    Revenues:                        
    Product sales, net   $     $     $     $  
    Contract research     1,095       1,272       4,227       4,651  
    Other revenue           500             1,500  
    Total revenue, net     1,095       1,772       4,227       6,151  
                             
    Costs and expenses:                        
    Cost of revenue (1)     1,028       1,266       4,055       4,329  
    Research and development (1)     11,540       19,022       64,899       60,841  
    Sales and marketing (1)     44       82       671       170  
    General and administrative (1)     5,765       6,561       27,156       25,591  
    Goodwill impairment                 18,504        
    Amortization of definite-lived intangible                        
    Total costs and expenses     18,377       26,931       115,285       90,931  
    Loss from operations     (17,282 )     (25,159 )     (111,058 )     (84,780 )
    Other (expense) income, net     (1,895 )     487       (2,484 )     2,676  
    Loss from continuing operations     (19,177 )     (24,672 )     (113,542 )     (82,104 )
    Gain / (loss) from discontinued operations (1)     583       (13,879 )     (47,812 )     (50,634 )
    Net loss   $ (18,594 )   $ (38,551 )   $ (161,354 )   $ (132,738 )
    Net loss per share, basic and diluted   $ (0.45 )   $ (0.99 )   $ (3.90 )   $ (4.03 )
    Weighted average common shares outstanding, basic and diluted     41,405,657       38,760,676       41,323,921       32,909,762  
                             
    (1) Amounts include stock-based compensation expense as follows:                        
                             
    Cost of revenue   $ 249     $ 206     $ 703     $ 766  
    Research and development     358       1,564       5,091       6,480  
    Sales and marketing                        
    General and administrative     2,581       2,381       10,288       9,317  
    Gain / (loss) from discontinued operations     (7 )     805       95       3,492  
    Total stock-based compensation expense   $ 3,181     $ 4,956     $ 16,177     $ 20,055  


    Aclaris Therapeutics, Inc.
    Selected Consolidated Balance Sheet Data
    (unaudited, in thousands)

                   
        December 31, 2019   December 31, 2018  
                   
    Cash, cash equivalents and marketable securities   $ 75,015   $ 167,972  
    Total assets     98,297      275,566  
    Total current liabilities      22,432      27,342  
    Total liabilities      28,385      60,442  
    Total stockholders' equity      69,912      215,124  


    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140
     

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  15. WAYNE, Pa., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will report financial results for the fourth quarter and full year 2019, Tuesday, February 25th, after U.S. financial markets close.

    Management will conduct a conference call at 5:00 PM ET on the same day to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days…

    WAYNE, Pa., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will report financial results for the fourth quarter and full year 2019, Tuesday, February 25th, after U.S. financial markets close.

    Management will conduct a conference call at 5:00 PM ET on the same day to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9958112 prior to the start of the call.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140

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  16. WAYNE, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present a company overview at the SVB Leerink 9th Annual Global Healthcare Conference on Thursday, February 27, 2020 at 10:00 AM ET in New York, New York.

    A live audio webcast of the presentation may be accessed through the Company's web site, www.aclaristx.com, on the 'Events' section. An archived version of the presentation will be available for 30 days.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases…

    WAYNE, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present a company overview at the SVB Leerink 9th Annual Global Healthcare Conference on Thursday, February 27, 2020 at 10:00 AM ET in New York, New York.

    A live audio webcast of the presentation may be accessed through the Company's web site, www.aclaristx.com, on the 'Events' section. An archived version of the presentation will be available for 30 days.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Contact:
    Aclaris Contact
    Michael Tung, M.D.
    Corporate Strategy/Investor Relations
    484-329-2140

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  17. •  Oral small molecule showed marked inhibition of TNFα, IL1β, IL8, and IL6
    •  Preliminary data support progression to Phase 2a Proof of Concept Trials in Immuno-Inflammatory Diseases

    WAYNE, Pa., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from ATI-450-PKPD-101, a Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Phase 1 clinical trial of the investigational compound ATI-450. Preliminary data demonstrated that ATI-450:

    • resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
    • was generally well-tolerated at all doses tested in the trial;
    • had dose proportional pharmacokinetics (PK) with…

    •  Oral small molecule showed marked inhibition of TNFα, IL1β, IL8, and IL6
    •  Preliminary data support progression to Phase 2a Proof of Concept Trials in Immuno-Inflammatory Diseases

    WAYNE, Pa., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from ATI-450-PKPD-101, a Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Phase 1 clinical trial of the investigational compound ATI-450. Preliminary data demonstrated that ATI-450:

    • resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
    • was generally well-tolerated at all doses tested in the trial;
    • had dose proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours; and
    • had no meaningful food effect or drug-drug interaction (DDI) with methotrexate.

    ATI-450-PKPD-101 was a first-in-human, randomized, observer-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in healthy subjects (n=77). The trial consisted of three parts:

    • Single Ascending Dose (SAD) plus food effect (n=32, 8 subjects per dose cohort - 2 placebo, 6 active). A single dose of 10mg, 30mg, 50mg and 100mg was tested.
    • Multiple Ascending Dose (MAD) (n=30, 10 subjects per dose cohort - 2 placebo, 8 active). 10mg BID, 30mg BID and 50mg BID doses were tested over 7 days of administration.
    • Methotrexate DDI (n=15). Single 7.5-mg oral doses of methotrexate given alone or after ATI-450 50mg BID.

    No serious adverse events or severe adverse events were reported, and no adverse events led to discontinuation of the study medication. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, nausea, and abdominal pain. All adverse events were mild. A trend of a decrease in absolute neutrophil count (ANC) was observed without correlated clinical sequelae. This effect is consistent with the pharmacodynamic profile of certain anti-TNF therapies1. Other laboratory findings were generally unremarkable.

    In this trial, ATI-450 had dose proportional pharmacokinetics with a terminal half-life of 9-12 hours in the MAD cohort on day 7. The PK profile was not meaningfully affected when taking ATI-450 with a high fat meal. Further, co-administration of ATI-450 with methotrexate had little impact on methotrexate pharmacokinetics.

    The pharmacodynamics of ATI-450 were evaluated by investigating the potential to inhibit production of key cytokines in ex vivo stimulated blood samples collected from subjects. At the 50mg BID dose (the dose with the highest degree of inhibition) at day 7 (12 hours post last dose): the mean trough drug levels were above the IC80 for TNFα, IL1β and IL8; IL6 plasma levels were inhibited by more than 50% for part of the dosing interval; and the mean trough drug level was above the IC80 for phosphorylation of Heat Shock Protein 27, a downstream substrate of MK2 (and marker of inhibition of the MK2 target).

    "We believe these data support the progression of ATI-450 into Phase 2 clinical development," said Dr. David Gordon, Chief Medical Officer of Aclaris. "The potential for an oral small molecule which suppresses multiple proinflammatory cytokines could be very meaningful for the treatment of a number of immuno-inflammatory diseases."

    Aclaris intends to initiate the first Phase 2 clinical trial in subjects with rheumatoid arthritis in the first half of 2020.

    About ATI-450

    ATI-450 is an investigational oral small molecule inhibitor of the p38α mitogen-activated protein kinase-activated protein kinase 2 (MK2) inflammatory signaling pathway. This pathway drives the expression of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this pathway include tumor necrosis factor α (TNFα), interleukin-1α and -1β (IL1α and IL1β), and interleukin-6 (IL6). On the basis of this mechanism, Aclaris is developing ATI-450 as a potential treatment for immuno-inflammatory diseases.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' drug candidates and the timing of the initiation of clinical trials. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President
    Corporate Strategy/Investor Relations
    484-329-2140

    1  Dillingh M, et al. Front. Immunol. 2016;7(508):1-9.

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  18. WAYNE, Pa., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced the appointment of Vincent Milano to its board of directors, effective January 7, 2020.

    Vincent Milano has served as the President and Chief Executive Officer, and as a member of the board of directors, of Idera Pharmaceuticals, Inc., a publicly held biopharmaceutical company, since December 2014. Prior to joining Idera, between 1996 and 2014, Mr. Milano served in increasingly senior roles at ViroPharma Inc., a pharmaceutical company that was acquired by Shire Plc in 2014, most recently as Chairman, President and Chief Executive Officer from 2008 to 2014…

    WAYNE, Pa., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced the appointment of Vincent Milano to its board of directors, effective January 7, 2020.

    Vincent Milano has served as the President and Chief Executive Officer, and as a member of the board of directors, of Idera Pharmaceuticals, Inc., a publicly held biopharmaceutical company, since December 2014. Prior to joining Idera, between 1996 and 2014, Mr. Milano served in increasingly senior roles at ViroPharma Inc., a pharmaceutical company that was acquired by Shire Plc in 2014, most recently as Chairman, President and Chief Executive Officer from 2008 to 2014. Prior to joining ViroPharma, Mr. Milano served in increasingly senior roles, most recently as a senior manager, at KPMG LLP, an independent registered public accounting firm, from 1985 to 1996. Mr. Milano also served on the board of directors of ViroPharma from 2008 to 2014, Spark Therapeutics, Inc. from 2014 to 2019 and Vanda Pharmaceuticals Inc. from 2010 to 2019. Mr. Milano currently serves on the board of directors of VenatoRx Pharmaceuticals, Inc., a private company, and Life Sciences Cares Philadelphia, a non-profit organization. Mr. Milano holds a Bachelor of Science degree in Accounting from Rider College.

    "We are pleased to welcome Vin to the Aclaris Board of Directors. His extensive operational and business development experience will be invaluable as we continue to progress our small molecule kinase inhibitor pipeline for immuno-inflammatory diseases," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. We look forward to leveraging Vin's deep experience and leadership to help guide Aclaris as we continue to execute on our new strategic direction."

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' pipeline. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, the Form 10-Q for the quarter ended September 30, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140

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  19. WAYNE, Pa., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present at the following conferences:

    • Dr. Neal Walker, President and Chief Executive Officer, together with members from the Company's R&D team, will present a company overview at SVB Leerink's 13th Annual POLARxPRESS Bus Tour in New York, New York on Thursday, November 21, 2019. The R&D team will include:
      • Joseph Monahan, Ph.D. - EVP R&D (Head of Discovery)
      • Walter Smith - SVP, R&D
      • Paul Changelian, Ph.D. - VP, Biology
      • Jon Jacobsen, Ph.D. - VP, Chemistry
      • Dr. David Gordon - Chief Medical Officer

    • Dr. Walker will also present a company overview…

    WAYNE, Pa., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced that management will present at the following conferences:

    • Dr. Neal Walker, President and Chief Executive Officer, together with members from the Company's R&D team, will present a company overview at SVB Leerink's 13th Annual POLARxPRESS Bus Tour in New York, New York on Thursday, November 21, 2019. The R&D team will include:
      • Joseph Monahan, Ph.D. - EVP R&D (Head of Discovery)
      • Walter Smith - SVP, R&D
      • Paul Changelian, Ph.D. - VP, Biology
      • Jon Jacobsen, Ph.D. - VP, Chemistry
      • Dr. David Gordon - Chief Medical Officer

    • Dr. Walker will also present a company overview at the Evercore ISI 2nd Annual HealthCONx Conference on Wednesday, December 4, 2019 at 3:05 PM ET at the Four Seasons Hotel in Boston, Massachusetts. A live audio webcast of the presentation may be accessed through the Company's web site, www.aclaristx.com, on the 'Events' section. An archived version of the presentation will be available for 30 days.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Aclaris Contact
    Michael Tung, M.D.
    Corporate Strategy/Investor Relations
    484-329-2140

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    • Completed Strategic Review and Announced Refocusing of Resources on Immuno-inflammatory Development Pipeline
    • Divested RHOFADE® (oxymetazoline hydrochloride) cream, 1%
    • Repaid $30 Million Term Loan 
    • Successful Pivotal Phase 3 Clinical Trials of A-101 45% Topical Solution as a Potential Treatment for Common Warts (THWART-1 and THWART-2)
    • Management to Host Conference Call at 5:00 PM ET today

    WAYNE, Pa., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the third quarter of 2019 and provided business highlights and an update on its research and development programs.

    Business Highlights:

    • Announced…
    • Completed Strategic Review and Announced Refocusing of Resources on Immuno-inflammatory Development Pipeline
    • Divested RHOFADE® (oxymetazoline hydrochloride) cream, 1%
    • Repaid $30 Million Term Loan 
    • Successful Pivotal Phase 3 Clinical Trials of A-101 45% Topical Solution as a Potential Treatment for Common Warts (THWART-1 and THWART-2)
    • Management to Host Conference Call at 5:00 PM ET today

    WAYNE, Pa., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the third quarter of 2019 and provided business highlights and an update on its research and development programs.

    Business Highlights:

    • Announced the completion of the strategic review of its business in September 2019, as a result of which Aclaris is refocusing its resources on its immuno-inflammatory development programs and is actively seeking partners for its commercial products and certain clinical development assets.
      • Divested RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE) to EPI Health, LLC in October 2019 for up to $55.0 million, consisting of:
        • Upfront payment of $35.0 million; and
        • Potential sales milestone payments of up to $20.0 million in the aggregate upon the achievement of specified levels of net sales of products covered by the agreement; as well as
        • A high single-digit royalty on net sales, on a product-by-product and country-by-country basis; and
        • 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the United States, subject to specified exceptions.
      • Seeking partners to:
        • Commercialize A-101 45% Topical Solution, an investigational compound being developed as a potential treatment for common warts (verruca vulgaris);
        • Further develop and commercialize ATI-501 (oral) and ATI-502 (topical), which are investigational Janus Kinase (JAK) 1/3 inhibitor compounds, as potential treatments for alopecia; and
        • Commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).

    R&D Program Updates:

    • Recently announced positive results from THWART-1 (WART-301) and THWART-2 (WART-302), Aclaris' two pivotal Phase 3 clinical trials of A-101 45% Topical Solution as a potential treatment for common warts.
    • Announced in August that the first subject in its Phase 1 clinical trial of ATI-450, an investigational oral MK2 inhibitor compound, has been dosed.  ATI-450 is Aclaris' first internally developed novel compound to enter the clinical phase of development.

    "We are excited with the progress we have made toward executing on our new business strategy, with our first step being the divestiture of RHOFADE," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "With the success of our two pivotal Phase 3 trials for A-101 45% Topical Solution, which has the potential to be the first FDA-approved prescription treatment for common warts, we believe this program will be of interest to potential commercial partners.  In September, we presented our new focus on immuno-inflammatory diseases at our R&D day.  We look forward to reporting the results of our Phase 1 trial for ATI-450 by the end of the first quarter of 2020 and providing further updates on the execution of our new strategy," said Dr. Walker.

    Clinical Pipeline Update:

    • A-101 45% Topical Solution:
      • A-101 45% Topical Solution met the primary and all secondary efficacy endpoints in both THWART-1 and THWART-2, Aclaris' pivotal Phase 3 clinical trials for the treatment of common warts.
      • The majority of adverse events (AEs) in THWART-1 and THWART-2 were application site reactions, which were predominantly mild or moderate.  No treatment-related serious adverse events were observed in the trials. Only one subject in the Phase 3 program had an AE that led to treatment discontinuation. The most common AEs occurring in more than 5% of subjects in the A-101 45% Topical Solution group were AEs at the application site such as pain, scabbing, erythema, pruritus, pallor and erosion.
      • An open-label safety extension Phase 3 clinical trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution as a potential treatment for common warts, has completed enrollment of 425 patients. Aclaris expects WART-303 to be completed in the first half of 2020.
    • ATI-450:
      • ATI-450-PKPD-101 - This is an ongoing Single Ascending Dose / Multiple Ascending Dose (SAD/MAD) safety, pharmacokinetic and pharmacodynamic Phase 1 clinical trial of approximately 60-80 subjects. If successfully completed, Aclaris expects to initiate a Phase 2 clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020. Aclaris is also considering developing ATI-450 for an additional inflammatory indication.
         
    • ATI-1777:
      • ATI-1777 is an investigational topical soft-JAK inhibitor compound that Aclaris is developing as a potential treatment for moderate-to-severe atopic dermatitis.
      • Aclaris expects to submit an IND/regulatory filing for ATI-1777 in mid-2020.
      • If the IND/regulatory filing is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in the second half of 2020.

    Financial Highlights:
    Liquidity and Capital Resources

    As of September 30, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $91.4 million compared to $168.0 million as of December 31, 2018. For the quarter and nine months ended September 30, 2019, net cash used in operating activities was $23.4 million and $76.1 million, respectively. As of September 30, 2019, Aclaris had approximately 41.4 million shares of common stock outstanding. 

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2019, after giving effect to both the upfront payment from the sale of RHOFADE and the full repayment of the loan facility with Oxford Finance LLC, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.

    Third Quarter 2019 and Year-to-Date Financial Results

    • As described above, on September 5, 2019, Aclaris announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products.  The accompanying condensed consolidated statements of operations and selected condensed consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris' commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris' historical format.  Aclaris believes this format provides comparability with its previously filed financial statements. 

    • Contract research revenues decreased to $1.0 million and $3.1 million for the quarter and nine months ended September 30, 2019, compared to $1.1 million and $3.4 million for the quarter and nine months ended September 30, 2018. Cost of revenue was $0.8 million and $3.0 million for the quarter and nine months ended September 30, 2019, compared to $1.1 million and $3.1 million for the quarter and nine months ended September 30, 2018. These amounts included non-cash stock-based compensation, and amortization and depreciation expenses, of $0.2 million and $0.8 million for the quarter and nine months ended September 30, 2019, respectively, and $0.3 million and $0.8 million for the quarter and nine months ended September 30, 2018, respectively.

    • Research and development expenses were $16.2 million and $53.3 million for the quarter and nine months ended September 30, 2019, respectively, compared to $15.2 million and $41.5 million for the quarter and nine months ended September 30, 2018, respectively. The increases were mainly the result of a $4.0 million milestone payment made by Aclaris to Rigel Pharmaceuticals, Inc. for the achievement of a specified development milestone, and activities associated with preclinical development and the recently initiated Phase 1 clinical trial for ATI-450.  These increases were offset in part by decreases in expenses for several Phase 2 clinical trials of ATI-501 and ATI-502 and two Phase 3 clinical trials of A-101 45% Topical Solution, which reached or neared completion in the third quarter of 2019.

    • General and administrative expenses were $6.7 million and $21.1 million for the quarter and nine months ended September 30, 2019, respectively, compared to $6.1 million and $20.5 million for the quarter and nine months ended September 30, 2018, respectively.

    • Total costs and expenses from continuing operations for the third quarter of 2019 were $23.8 million, compared to $22.5 million for the third quarter of 2018. For the nine months ended September 30, 2019, total costs and expenses were $96.6 million, compared to $65.1 million for the same period in 2018. These amounts included non-cash stock-based compensation expenses of $4.0 million and $12.9 million for the quarter and nine months ended September 30, 2019, respectively, compared to $4.0 million and $12.4 million for the prior year periods, respectively. For the nine months ended September 30, 2019, there was also an $18.5 million non-cash charge for the impairment of goodwill. There was no such charge in the prior year.

    • Loss from continuing operations was $23.1 million for the third quarter of 2019, compared to $20.6 million for the third quarter of 2018. Loss from continuing operations was $94.1 million for the nine months ended September 30, 2019, compared to $58.5 million for the nine months ended September 30, 2018.

    • Loss from discontinued operations was $32.2 million for the third quarter of 2019, compared to $12.1 million for the third quarter of 2018, and was $48.7 million for the nine months ended September 30, 2019, compared to $35.6 million for the nine months ended September 30, 2018.

    • Net loss, which combines loss from continuing and discontinued operations, was $55.3 million for the third quarter of 2019, compared to net loss of $32.7 million for the third quarter of 2018, and was $142.8 million for the nine months ended September 30, 2019, compared to $94.2 million for the nine months ended September 30, 2018.

    2019 Financial Outlook and Cash Runway

    • As a result of Aclaris' new strategic direction announced on September 5, 2019, which resulted in the reclassification of expenses related to its commercial products, Aclaris' prior full-year 2019 estimated operating expense guidance no longer represents an accurate estimate of its anticipated operating expenses, and Aclaris does not believe that updated full-year guidance for 2019 would be meaningful. 

    • Aclaris now anticipates that its cash, cash equivalents and marketable securities as of September 30, 2019, after giving effect to both the upfront payment from the sale of RHOFADE and the full repayment of the loan facility with Oxford Finance LLC, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.

    Company to Host Conference Call
    Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris' financial results and provide a general business update.  The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 2698128 prior to the start of the call.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx. 

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding seeking a third-party partner to commercialize A-101 45% Topical Solution, further develop and commercialize ATI-501 and ATI-502 and commercialize ESKATA, the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation or completion of clinical trials and timing for regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the third quarter of 2021. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and the commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, the Form 10-Q for the quarter ended September 30, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Therapeutics, Inc.
    Condensed Consolidated Statements of Operations
    (unaudited, in thousands, except share and per share data)

        Three Months Ended   Nine Months Ended
        September 30,   September 30,
         2019     2018     2019     2018 
    Revenues:                
      Product sales, net   $   —     $   —     $   —     $   —  
      Contract research     983       1,118       3,132       3,379  
      Other revenue                       1,000  
    Total revenues, net     983       1,118       3,132       4,379  
                     
    Costs and expenses:                
      Cost of revenue (1)     826       1,067        3,028       3,063  
      Research and development (1)     16,183       15,189        53,334       41,482  
      Sales and marketing (1)     112       63        629       89  
      General and administrative (1)     6,726       6,141        21,142       20,481  
      Goodwill impairment      —        —        18,504        —  
      Amortization of definite-lived intangible      —        —        —        —  
    Total costs and expenses     23,847       22,460        96,637       65,115  
    Loss from operations     (22,864 )       (21,342 )      (93,505 )     (60,736 )
      Other (expense) income, net     (274 )     710        (589 )     2,189  
    Loss from continuing operations     (23,138 )     (20,632 )      (94,094 )     (58,547 )
    Loss from discontinued operations (1)     (32,181 )     (12,108 )      (48,666 )     (35,640 )
    Net loss   $   (55,319 )   $   (32,740 )   $   (142,760 )   $   (94,187 )
    Net loss per share, basic and diluted $   (1.34 )   $   (1.06 )   $   (3.46 )   $   (3.04 )
    Weighted average common shares outstanding, basic and diluted   41,364,387       30,982,192       41,296,377       30,938,026  
                   
    (1) Amounts include stock-based compensation expense as follows:              
                   
    Cost of revenue $   25     $   194     $   454     $   560  
    Research and development   1,418       1,433       4,733       4,916  
    Sales and marketing    —        —        —        —  
    General and administrative    2,581       2,320       7,707       6,936  
    Loss from discontinued operations    (704 )     760       102       2,687  
    Total stock-based compensation expense $   3,320     $   4,707     $   12,996     $   15,099  
                   

    Aclaris Therapeutics, Inc.
    Selected Condensed Consolidated Balance Sheet Data
    (unaudited, in thousands)

                   
        September 30, 2019   December 31, 2018  
                   
    Cash, cash equivalents and marketable securities   $ 91,428   $ 167,972  
    Total assets      160,416      275,566  
    Total current liabilities      38,989      27,342  
    Total liabilities      75,141      60,442  
    Total stockholders' equity      85,275      215,124  

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140

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  20. WAYNE, Pa., Oct. 31, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will report financial results for the third quarter 2019, Thursday, November 7th, after U.S. financial markets close.

    Management will conduct a conference call at 5:00 PM ET to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

    To participate

    WAYNE, Pa., Oct. 31, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will report financial results for the third quarter 2019, Thursday, November 7th, after U.S. financial markets close.

    Management will conduct a conference call at 5:00 PM ET to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 2698128 prior to the start of the call.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Aclaris Contact
    Michael Tung, M.D.
    Corporate Strategy/Investor Relations
    484-329-2140

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  21. If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

    • Highly statistically significant results for the primary efficacy endpoint
    • Highly statistically significant results for all secondary efficacy endpoints
    • Management to host conference call at 4:30 PM ET today

    WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and…

    If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts

    • Highly statistically significant results for the primary efficacy endpoint
    • Highly statistically significant results for all secondary efficacy endpoints
    • Management to host conference call at 4:30 PM ET today

    WAYNE, Pa., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from its second Phase 3 clinical trial, THWART-1 (WART-301), of A-101 45% Topical Solution (A-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). A-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. A-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. 

    THWART-1 is the second of two Phase 3 pivotal trials: THWART-1 and THWART-2 (WART-301 and WART-302, respectively) conducted by Aclaris.  The two randomized, double-blind, vehicle-controlled trials were designed to evaluate the efficacy and safety of A-101 45% as compared to placebo (vehicle) for the treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).

    The THWART-1 trial randomized 503 subjects who self-administered either A-101 45% or vehicle twice a week over 8 weeks, for a total of 16 treatments. Each subject had one to six common warts at baseline. The trial achieved its primary endpoint with a high degree of statistical significance (p=0.0003), i.e. a higher proportion of subjects treated with A-101 45% versus vehicle had all their identified common warts reported as clear at day 60.  Warts were assessed using the Physician Wart Assessment™ scale which is a validated four-point scale of the investigators' assessment of the severity of all treated common warts (PWA=0 means clear).  All secondary efficacy endpoints also achieved statistical significance in favor of A-101 45% versus vehicle.

    Efficacy results from the THWART-1 and THWART-2 trials for the primary and first two secondary endpoints are summarized in the table below:

      PRIMARY
    Proportion of subjects
    whose identified common
    warts are determined to
    be clear at day 60
    (PWA=0)

    (%)
    SECONDARY
    Proportion of subjects
    whose identified common
    warts are determined to
    be clear at day 137
    (PWA=0) 

    (%)
    SECONDARY
    Mean per-subject percent
    of all common warts that
    are clear at day 137
    (PWA=0)


    (%)
    THWART-1      
    A-101 45% (n=254) 15.7% 22.4% 28.6%
    VEHICLE (n=249) 5.2% 11.6% 14.5%
    p-value 0.0003
    0.0024
    <0.0001
           
    THWART-2      
    A-101 45% (n=251) 13.1% 22.3% 27.7%
    VEHICLE (n=251) 3.2% 10% 12.2%
    p-value <0.0001 0.0001
    <0.0001

    In the THWART-1 trial, the two other secondary efficacy endpoints also achieved statistical significance in favor of A-101 45% Topical Solution versus vehicle and are described as follows:

    • Proportion of subjects with a single common wart whose wart is clear at day 60 (p=0.0009); and
    • Time for subjects to achieve clearance of all treated common warts (p<0.0001).

    In THWART-1, there were no treatment-related serious adverse events (SAEs) in subjects treated with A-101 45%; however, 2 non-related treatment emergent SAEs were reported (an animal bite in the A-101 45% group and a suicide attempt in the vehicle group).  The most common adverse events (AEs) occurring in more than 5% of subjects in the A-101 45% group were application site pain, scabbing, erythema, pruritus and erosion.  Treatment-related AEs were reported in 52.8% (34.6% mild, 17.3% moderate and 0.8% severe) and 6% of the subjects in the A-101 45% and vehicle groups, respectively.  No subjects withdrew because of AEs, but one subject in the A-101 45% group discontinued treatment due to application site erythema and vesicles.

    The safety data from THWART-1 trial was comparable to that of the THWART-2 trial, which were previously reported in Aclaris' September 16, 2019 press release.

    "These results provide robust clinical evidence for the efficacy and safety of A-101 45% and support its viability as a potential treatment for common warts," said Dr. David Gordon, Chief Medical Officer of Aclaris. "These data will serve as the basis for an NDA filing, and we believe A-101 45% will be of interest to partners seeking to commercialize this drug candidate, which has the potential to be the first FDA-approved prescription treatment for common warts."

    Company to Host Conference Call

    Management will conduct a conference call at 4:30 PM ET today to review these Phase 3 results and related matters.  The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call. A slide presentation will accompany the conference call.

    To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9299384 prior to the start of the call.

    About Common Warts

    Common warts, also called verruca vulgaris, are skin growths caused by a virus infecting the top layer of the skin. They affect an estimated 19 million Americans each year with a higher incidence in children than adults. Common warts are often skin-colored and feel rough but can be darker and smooth. Symptoms include pain, bleeding, itching, and burning. Common warts are contagious and may interfere with social activities, cause embarrassment, and carry a social stigma. Each year, over 2 million people in the U.S. are diagnosed with common warts during a visit to a health care professional.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' drug candidates, including A-101 45%, the potential NDA filing for A-101 45% and the potential for partnerships for commercializing A-101 45%. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Aclaris Contact
    Michael Tung, M.D.
    Corporate Strategy/Investor Relations
    484-329-2140
     

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  22. WAYNE, Pa., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it has divested RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE) and related intellectual property assets to EPI Health, LLC (EPI Health). The divestiture of RHOFADE is a key component of Aclaris' recently announced strategic plan to refocus resources on the development of its immuno-inflammatory development programs.

    "This transaction provides us with an opportunity to refocus our resources on the development of our immuno-inflammatory assets so that we may develop treatments for patients with immuno-inflammatory diseases who lack satisfactory treatment…

    WAYNE, Pa., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it has divested RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE) and related intellectual property assets to EPI Health, LLC (EPI Health). The divestiture of RHOFADE is a key component of Aclaris' recently announced strategic plan to refocus resources on the development of its immuno-inflammatory development programs.

    "This transaction provides us with an opportunity to refocus our resources on the development of our immuno-inflammatory assets so that we may develop treatments for patients with immuno-inflammatory diseases who lack satisfactory treatment options." said Dr. Neal Walker, Aclaris' President and Chief Executive Officer. "We also believe that EPI Health's extensive dermatology and commercial expertise will be instrumental in their commercialization of RHOFADE."

    Aclaris and EPI Health have entered into a purchase agreement whereby Aclaris sold the worldwide rights to RHOFADE, which includes the assignment of certain licenses for related intellectual property assets. Pursuant to the terms of the agreement, EPI Health has agreed to pay Aclaris total cash consideration of up to $55.0 million, consisting of (i) an upfront payment of $35.0 million and (ii)  potential sales milestone payments of up to $20.0 million in the aggregate upon the achievement of specified levels of net sales of products covered by the agreement. In addition, EPI Health has agreed to pay Aclaris, (i) a specified high single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, subject to specified reductions, limitations and adjustments and (ii) 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the United States, subject to specified exceptions. 

    SVB Leerink LLC acted as exclusive financial advisor and DLA Piper LLP (US) served as legal counsel to Aclaris.

    Concurrently with the closing of this transaction, Aclaris repaid in full its $30 million term loan (plus fees and expenses) with Oxford Finance LLC. EPI Health has agreed to assume the obligation to pay specified royalties and milestone payments under Aclaris' existing agreements with Allergan Sales, LLC, Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc.

    As a result of these changes, Aclaris anticipates that its current cash, cash equivalents and marketable securities on hand, including the upfront proceeds received from EPI Health, and the repayment of the outstanding term loan, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics' active development programs focus on areas where significant treatment gaps exist. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx. 

    About EPI Health, LLC
    Headquartered in Charleston, South Carolina, EPI Health is a specialty pharmaceutical company committed to delivering innovative prescription therapies to dermatologists while improving the quality of life of patients and providing outstanding medical services to dermatology community. EPI Health is a wholly owned subsidiary of EPI Group. For more information, visit the EPI Health website at www.epihealth.com.

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the third quarter of 2021 and the commercialization of RHOFADE by EPI Health. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140

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  23. WAYNE, Pa., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, announced today that the company, together with Allergan, Inc., has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Taro Pharmaceuticals, Inc. ("Taro"), related to an Abbreviated New Drug Application ("ANDA") that Taro filed with the U.S. Food and Drug Administration ("FDA") to market a generic version of RHOFADE® (oxymetazoline hydrochloride) cream, 1% ("RHOFADE").

    The lawsuit claims infringement of U.S. Patent Nos. 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA's Approved…

    WAYNE, Pa., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, announced today that the company, together with Allergan, Inc., has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Taro Pharmaceuticals, Inc. ("Taro"), related to an Abbreviated New Drug Application ("ANDA") that Taro filed with the U.S. Food and Drug Administration ("FDA") to market a generic version of RHOFADE® (oxymetazoline hydrochloride) cream, 1% ("RHOFADE").

    The lawsuit claims infringement of U.S. Patent Nos. 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for RHOFADE. Aclaris Therapeutics received a Paragraph IV Notice Letter from Taro dated August 28, 2019, advising that Taro had submitted an ANDA to the FDA seeking approval from the FDA to manufacture and market a generic version of RHOFADE prior to the expiration of the Orange Book-listed patents.

    Aclaris intends to vigorously enforce its intellectual property rights relating to RHOFADE.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris' intent to vigorously defend its intellectual property. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties related to the ability of the company to protect its intellectual property and defend its patents and the possible introduction of generic products, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse portfolio includes one late-stage investigational medicine and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics' active development programs focus on areas where significant treatment gaps exist. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Aclaris Contact:

    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140

    Source: Aclaris Therapeutics, Inc.

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  24. WAYNE, Pa., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will host an R&D day for analysts and investors focused on its pipeline of novel drug candidates for immuno-inflammatory diseases on Friday, September 27, 2019 from 8:00 AM to 11:00 AM in New York, New York.

    Topics to be covered include:

    • KINect Platform: Our Drug Discovery Engine
    • ATI-450 (MK2 Inhibitor): An Oral Alternative to Injectable Anti-Cytokine Biologics and JAK Inhibitors for Immuno-Inflammatory Diseases
    • ATI-1777: A "Soft" Topical JAK 1/3 Inhibitor
    • ATI-2138: An ITK/TXK/JAK3 Inhibitor for Autoimmune Disease
    • Gut Restricted Inhibitors of ITK and/or…

    WAYNE, Pa., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced it will host an R&D day for analysts and investors focused on its pipeline of novel drug candidates for immuno-inflammatory diseases on Friday, September 27, 2019 from 8:00 AM to 11:00 AM in New York, New York.

    Topics to be covered include:

    • KINect Platform: Our Drug Discovery Engine
    • ATI-450 (MK2 Inhibitor): An Oral Alternative to Injectable Anti-Cytokine Biologics and JAK Inhibitors for Immuno-Inflammatory Diseases
    • ATI-1777: A "Soft" Topical JAK 1/3 Inhibitor
    • ATI-2138: An ITK/TXK/JAK3 Inhibitor for Autoimmune Disease
    • Gut Restricted Inhibitors of ITK and/or JAK Kinases as Drugs for Inflammatory Bowel Disease

    The event will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event on the morning of September 27, 2019. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call. If you are a member of the investment community and would like to attend, please RSVP to .

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse portfolio includes one late-stage investigational medicine and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics' active development programs focus on areas where significant treatment gaps exist. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' drug candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris Quarterly report on Form 10-Q for the quarter ended June 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President
    Corporate Strategy/Investor Relations
    484-329-2140

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    • Highly statistically significant results at the primary endpoint - statistical significance seen as early as Day 29
    • Highly statistically significant results on all secondary efficacy endpoints
    • WART-302 is the first of two Phase 3 pivotal trials for the NDA
    • If approved, A-101 45% Topical Solution would be the first FDA approved prescription treatment for common warts

    WAYNE, Pa., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced positive results from its Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution (A-101 45% Topical Solution), an investigational new drug for the treatment…

    • Highly statistically significant results at the primary endpoint - statistical significance seen as early as Day 29
    • Highly statistically significant results on all secondary efficacy endpoints
    • WART-302 is the first of two Phase 3 pivotal trials for the NDA
    • If approved, A-101 45% Topical Solution would be the first FDA approved prescription treatment for common warts

    WAYNE, Pa., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced positive results from its Phase 3 clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution (A-101 45% Topical Solution), an investigational new drug for the treatment of common warts (verruca vulgaris). A-101 45% Topical Solution met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts. A-101 45% Topical Solution is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. 

    THWART-2 is one of two randomized double-blind vehicle-controlled Phase 3 pivotal trials conducted by Aclaris to evaluate A-101 45% Topical Solution as a potential treatment for common warts. Aclaris expects to report data from THWART-1 (WART-301), the second Phase 3 trial during the fourth quarter of 2019. Both trials evaluated the efficacy and safety of A-101 45% Topical Solution as compared to placebo (vehicle). The two randomized, double-blind, vehicle-controlled trials were designed to demonstrate the efficacy and safety of A-101 45% Topical Solution for the potential treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).

    In the THWART-2 trial, 502 subjects who had one to six warts at baseline were randomized and self-administered either A-101 45% Topical Solution or vehicle twice a week over 8 weeks, for a total of 16 treatments. The trial achieved its primary endpoint with a high degree of statistical significance (p<0.0001), i.e. a higher proportion of subjects treated in the A-101 45% Topical Solution arm versus vehicle had all their identified common warts reported as clear at Day 60. Warts were assessed using the Physician Wart Assessment scale (PWA=0) which is a validated four-point scale of the investigators' assessment of the severity of all treated warts. 

    In the trial, all secondary efficacy endpoints achieved statistical significance in favor of A-101 45% Topical Solution versus vehicle and are described as follows:

    • Complete clearance of all warts at Day 137 (12 weeks after last treatment) (p=0.0001)
    • Mean per subject percent of treated warts cleared at Day 137 (p<0.0001)
    • Clearance in subjects with a single baseline wart at Day 60 (p=0.0006)
    • Time to complete clearance of all warts (p<0.0001)

    There were no treatment-related serious adverse events (SAEs) in subjects treated with A-101 45% Topical Solution; however, SAEs of intestinal obstruction (in the A-101 45% Topical Solution group) and staghorn renal calculus (vehicle group) were assessed by the investigators as unrelated. Treatment-related application site adverse events (AEs) were reported in 53.4% and 8.4% of the A-101 45% Topical Solution and vehicle groups respectively. In the active arm 2% (5 subjects) of application site events were severe (1 pain, and 4 site pallor). The most common AEs (occurring in more than 5% of subjects) were application site pain, pallor, erythema, pruritus, scabbing and erosion. No subjects withdrew because of AEs. 

    "There are no FDA approved prescription treatments for common warts and we are excited by these data and look forward to the results of the second pivotal Phase 3 trial, THWART-1 (WART-301)," said Dr. Neal Walker, President and CEO of Aclaris. "This treatment is self-administered twice a week for 8 weeks (a total of 16 applications) and we believe these results will be of interest to partners seeking to commercialize A-101 45% Topical Solution."

    About Common Warts

    Common warts, also called verruca vulgaris, are skin growths caused by a virus infecting the top layer of the skin. They affect an estimated 22 million Americans each year with a higher incidence in children than adults. Common warts are often skin-colored and feel rough but can be darker and smooth. Symptoms include pain, bleeding, itching, and burning. Common warts are contagious and may interfere with social activities, cause embarrassment, and carry a social stigma. Each year, over 2 million people in the U.S. are diagnosed with common warts during a visit to a health care professional.

    About Aclaris Therapeutics, Inc.

    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory and dermatological diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes two FDA-approved medicines, one late-stage investigational medicine, and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx. 

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the development of Aclaris' drug candidates, including A-101 45% Topical Solution, and the potential for partnerships for commercializing A-101 45% Topical Solution. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris Quarterly report on Form 10-Q for the quarter ended June 30, 2019, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President 
    Corporate Strategy/Investor Relations
    484-329-2140
     

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  25. NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period") of the important September 30, 2019 lead plaintiff deadline in securities class action. The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    To join the Aclaris class action, go to http://www.rosenlegal.com/cases-register-1637.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU…

    NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period") of the important September 30, 2019 lead plaintiff deadline in securities class action. The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    To join the Aclaris class action, go to http://www.rosenlegal.com/cases-register-1637.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR'S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

    According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Aclaris's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) Aclaris was reasonably likely to face regulatory scrutiny; and (3) as a result of the foregoing, defendants' positive statements about Aclaris's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

    A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 30, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1637.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at or .

    Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

    Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013.   Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

    -------------------------------

    Contact Information:
    Laurence Rosen, Esq.
    Phillip Kim, Esq.
    The Rosen Law Firm, P.A.
    275 Madison Avenue, 34th Floor
    New York, NY 10016
    Tel: (212) 686-1060
    Toll Free: (866) 767-3653
    Fax: (212) 202-3827



    www.rosenlegal.com

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  26. NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26…

    NEW YORK, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26th Floor
    New York, NY 10017
    Attn:  Richard Gonnello, Esq.

    Telephone: (877) 247-4292 or (212) 983-9330

    The lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all those who purchased Aclaris securities between May 8, 2018 and June 20, 2019 (the "Class Period").  The case, Rosi v. Aclaris Therapeutics, Inc., No. 1:19-cv-07118 was filed on July 30, 2019.

    The lawsuit focuses on whether the Company and its executives violated federal securities laws by making materially false and/or misleading statements, as well as failing to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy.

    Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell from $5.11 to $4.54 over the next two trading sessions to $4.54 on June 21, 2019—a $0.57 or a 11.15% drop.

    The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. 

    Faruqi & Faruqi, LLP also encourages anyone with information regarding Aclaris's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

    Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.

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  27. Shareholder rights law firm Robbins Arroyo LLP reminds shareholders that a purchaser of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) filed a class action complaint against the company's officers and directors for alleged violations of the Securities Exchange Act of 1934 between May 8, 2018 and June 20, 2019. Aclaris, a pharmaceutical company, identifies, develops, and commercializes therapies for dermatological and immune-inflammatory diseases. Its lead product is ESKATA, a hydrogen peroxide topical solution that treats seborrheic keratosis.

    If you suffered a loss as a result of Aclaris' misconduct, click here.

    Aclaris Therapeutics Accused of Making Misleading Claims in Video Advertisement

    According to the complaint, in May 2018, Aclaris…

    Shareholder rights law firm Robbins Arroyo LLP reminds shareholders that a purchaser of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) filed a class action complaint against the company's officers and directors for alleged violations of the Securities Exchange Act of 1934 between May 8, 2018 and June 20, 2019. Aclaris, a pharmaceutical company, identifies, develops, and commercializes therapies for dermatological and immune-inflammatory diseases. Its lead product is ESKATA, a hydrogen peroxide topical solution that treats seborrheic keratosis.

    If you suffered a loss as a result of Aclaris' misconduct, click here.

    Aclaris Therapeutics Accused of Making Misleading Claims in Video Advertisement

    According to the complaint, in May 2018, Aclaris announced the launch of ESKATA, touting the product as the "first and only FDA-approved topical treatment for seborrheic keratosis." Despite positive expectations, Aclaris acknowledged in its 2017 10-K that ESKATA was subject to post-marketing restrictions and that failure to comply with regulations could lead to penalties. In its subsequent filings with the SEC, Aclaris touted its revenue from its sale of ESKATA and consistently assured that there were no material changes in its risk factors. However, in reality, Aclaris' advertising materials for ESKATA minimized its risks and overstated its efficacy, leaving the company vulnerable to regulatory scrutiny. This reality was realized on June 20, 2019, when the FDA issued a letter in response to a direct-to-consumer video interview with a paid Aclaris spokesperson, stating that Aclaris' advertisement for ESKATA "[made] false or misleading claims" about the product's risks and efficacy by failing to mention risk of serious eye disorders or severe skin reactions. Since this news, Aclaris' share price has fallen $3.99, almost 80%.

    If you purchased Aclaris Therapeutics, Inc. (ACRS) securities between May 8, 2018 and June 20, 2019, you have until September 30, 2019, to ask the court to be appointed lead plaintiff for the class.

    Contact us to learn more:

    Leo Kandinov

    (800) 350-6003



    Shareholder Information Form

    Robbins Arroyo LLP is a nationally recognized leader in shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested. Click here to receive free alerts from Stock Watch when companies engage in wrongdoing.

    Attorney Advertising. Past results do not guarantee a similar outcome.

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  28. NEW YORK, Sept. 05, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and indexed under 19-cv-08284, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise acquired publicly traded Aclaris securities between May 8, 2018, and June 20, 2019, inclusive (the "Class Period"), seeking to pursue remedies under the Securities Exchange Act of 1934 (the "Exchange Act").

    If you are a shareholder who purchased Aclaris securities during the class period, you…

    NEW YORK, Sept. 05, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and indexed under 19-cv-08284, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise acquired publicly traded Aclaris securities between May 8, 2018, and June 20, 2019, inclusive (the "Class Period"), seeking to pursue remedies under the Securities Exchange Act of 1934 (the "Exchange Act").

    If you are a shareholder who purchased Aclaris securities during the class period, you have until September 30, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

    [Click here for information about joining the class action]

    Aclaris is a biopharmaceutical company that identifies, develops, and commercializes therapies to address unmet needs in medical and aesthetic dermatology and immunology. The Company's lead product ESKATA is a hydrogen peroxide topical solution to treat raised seborrheic keratosis, a common non-malignant tumor.

    The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (i) the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (ii) as a result, the Company was reasonably likely to face regulatory scrutiny; and (iii) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for ESKATA "makes false or misleading claims" regarding the product's risk and efficacy. Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning . . . because it fails to include information regarding the serious risks associated with ESKATA, which bears warnings and precautions related to the risks of serious eye disorders . . . in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, the Company's share price fell $0.57 per share, or over 11%, over two consecutive trading sessions to close at $4.54 per share on June 21, 2019, on unusually heavy trading volume.

    The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

    CONTACT:
    Robert S. Willoughby
    Pomerantz LLP

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    • Completion of Strategic Review and Refocusing of Resources on Immuno-Inflammatory Development Pipeline
    • Actively Seeking a Commercialization Partner for RHOFADE® (oxymetazoline hydrochloride) cream, 1%
    • Actively Exploring Strategic Alternatives for Commercial Assets, Alopecia and Wart Development Assets

    WAYNE, Pa., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced the completion of a strategic review of its business, as a result of which the Company will refocus its resources on its immuno-inflammatory development programs and actively seek commercialization partners for its commercial products business…

    • Completion of Strategic Review and Refocusing of Resources on Immuno-Inflammatory Development Pipeline
    • Actively Seeking a Commercialization Partner for RHOFADE® (oxymetazoline hydrochloride) cream, 1%
    • Actively Exploring Strategic Alternatives for Commercial Assets, Alopecia and Wart Development Assets

    WAYNE, Pa., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced the completion of a strategic review of its business, as a result of which the Company will refocus its resources on its immuno-inflammatory development programs and actively seek commercialization partners for its commercial products business.

    This review of the Company's overall business strategy is intended to streamline operations and reduce costs, to position the Company for long-term growth and maximize shareholder value. "Our goal when we commenced this review was to find an effective way to refocus our resources on our novel drug candidates for immuno-inflammatory diseases," said Dr. Neal Walker, President and Chief Executive Officer.

    This new strategic direction includes the following actions:

      1)   Aclaris is actively seeking partners for its commercial products business. For its remaining marketed product, RHOFADE® (oxymetazoline hydrochloride) cream, 1%, Aclaris will no longer utilize a sales force to promote the product. In the interim, Aclaris will continue to sell and distribute RHOFADE in the United States. In addition, Aclaris will also seek strategic partners for ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).
      2)   Aclaris is actively seeking a strategic partner to commercialize its drug candidate A-101 45% Topical Solution, an investigational compound being developed as a potential treatment for verruca vulgaris (common warts). The Company's two ongoing Phase 3 pivotal clinical trials, THWART-1 and THWART-2, in which A-101 45% Topical Solution is being evaluated as a potential treatment for common warts, are progressing as planned. Aclaris has completed enrollment of more than 1,000 patients across these two trials, and data from both trials are expected in the second half of 2019.
      3)   Aclaris is actively seeking a development and commercialization partner for its drug candidates, ATI-501 (oral) and ATI-502 (topical), which are investigational Janus Kinase (JAK) 1/3 inhibitor compounds for the potential treatment of alopecia.

    In addition, Aclaris plans to focus on its portfolio of novel kinase inhibitors and its proprietary kinase discovery platform. To that end, Aclaris will continue the development of its drug candidate, ATI-450, an internally developed, investigational oral MK2 inhibitor, which is currently in a Phase 1 clinical trial for development as a potential treatment for rheumatoid arthritis. Aclaris also plans further investment in its drug candidate, ATI-1777 and other preclinical drug candidates, utilizing its robust drug discovery technology and scientific expertise, to develop treatments that may benefit patients suffering from immuno-inflammatory diseases.

    "We believe this change in strategy will benefit Aclaris in the near term by lowering expenses and eliminating the inherent risks and investment related to maintaining a commercial infrastructure. By actively seeking a commercialization partner for our commercial products business and refocusing our resources with a view to optimizing our immuno-inflammatory development portfolio, we believe we can significantly reduce our costs, strengthen the organization, and extend our cash runway," said Dr. Walker. "Our resources can now be dedicated to prudently advancing our pipeline of novel drug candidates for immuno-inflammatory diseases."

    "As part of our new business strategy, we have approved a plan to significantly reduce our workforce. We expect to complete this reduction over the course of the next six months. This decision was extremely difficult but necessary. I would like to personally thank all of the affected employees for their contributions over the past years," said Dr. Walker.

    Aclaris' restructuring plan includes the termination of 86 employees across the organization, actively seeking commercialization partners for its commercial products business, and the elimination of various development programs. During the time Aclaris is seeking a commercialization partner for RHOFADE, Aclaris will continue to incur certain expenses related to the sale and distribution of RHOFADE in the United States.

    This restructuring plan is estimated to cost between $3.0 million and $3.5 million in total over the next 6 months, excluding non-cash charges, with the related cash payments to be substantially complete by March 31, 2020. Aclaris anticipates that its current cash and cash equivalents will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities. The estimates of costs that Aclaris expects to incur and the timing thereof are subject to a number of assumptions and actual results may differ.

    Additional financial guidance will be provided when Aclaris announces its third quarter operating results.

    Aclaris also announced today that it will host an R&D Investor Event focused on our pipeline of novel drug candidates for immuno-inflammatory diseases on September 27, 2019 in New York, New York.

    About Aclaris Therapeutics, Inc.
    Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse portfolio includes one late-stage investigational medicine and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics' active development programs focus on areas where significant treatment gaps exist. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include statements about changes in Aclaris' future corporate focus and strategy, development plans with respect to its preclinical and clinical drug candidates, anticipated cost savings as a result of the restructuring actions, the duration of time that Aclaris' cash and cash equivalents will be able to fund its operations and anticipated costs of the restructuring. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, Aclaris' Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Aclaris Contact
    Michael Tung, M.D.
    Senior Vice President
    Corporate Strategy/Investor Relations
    484-329-2140

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  29. NEW YORK, Sept. 04, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26…

    NEW YORK, Sept. 04, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26th Floor
    New York, NY 10017
    Attn:  Richard Gonnello, Esq.

    Telephone: (877) 247-4292 or (212) 983-9330

    The lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all those who purchased Aclaris securities between May 8, 2018 and June 20, 2019  (the "Class Period").  The case, Rosi v. Aclaris Therapeutics, Inc., No. 1:19-cv-07118 was filed on July 30, 2019.

    The lawsuit focuses on whether the Company and its executives violated federal securities laws by making materially false and/or misleading statements, as well as failing to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy.

    Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell from $5.11 to $4.54 over the next two trading sessions to $4.54 on June 21, 2019—a $0.57 or a 11.15% drop.

    The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. 

    Faruqi & Faruqi, LLP also encourages anyone with information regarding Aclaris's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

    Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.

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  30. NEW YORK, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Mallinckrodt Plc (NYSE:MNK), Oasmia Pharmaceutical AB (NASDAQ:OASM), Aclaris Therapeutics, Inc. (NYSE:ACRS), and Carbonite, Inc. (NASDAQ:CARB). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Mallinckrodt Plc (NYSE:MNK)

    Lead Plaintiff Deadline: September 24, 2019

    Class Period: February 28, 2018 to July 16, 2019

    The complaint, filed on July 26, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding…

    NEW YORK, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Mallinckrodt Plc (NYSE:MNK), Oasmia Pharmaceutical AB (NASDAQ:OASM), Aclaris Therapeutics, Inc. (NYSE:ACRS), and Carbonite, Inc. (NASDAQ:CARB). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Mallinckrodt Plc (NYSE:MNK)

    Lead Plaintiff Deadline: September 24, 2019

    Class Period: February 28, 2018 to July 16, 2019

    The complaint, filed on July 26, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) Acthar posed significant safety concerns that rendered it a non-viable treatment for ALS; (ii) accordingly, Mallinckrodt overstated the viability of Acthar as an ALS treatment; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.

    On July 16, 2019, post-market, Mallinckrodt announced that the Company was permanently discontinuing the PENNANT Trial assessing Acthar's safety and efficacy as an ALS treatment. Mallinckrodt stated that it decided "to halt the trial after careful consideration of a recent recommendation by the study's independent Data and Safety Monitoring Board" ("DSMB"), which "was based on the specific concern for pneumonia, which occurred at a higher rate in the ALS patients receiving Acthar Gel compared to those on placebo" and that "the board also mentioned other adverse events specific to this patient population." On this news, Mallinckrodt's stock price fell $0.64 per share, or 7.8%, to close at $7.56 per share on July 17, 2019.

    For more information on the Mallinckrodt class action, go to: https://bespc.com/MNK-2.

    Oasmia Pharmaceutical AB (NASDAQ:OASM)

    Lead Plaintiff Deadline: September 27, 2019

    Class Period: October 23, 2015 to July 9, 2019

    According to the complaint, on June 28, 2019, Oasmia issued a press release that stated it was reporting suspicious transactions made between Oasmia and related partners Alceco and Ardenia to the Swedish Economic Crime Authority and appointing a special examiner to review them. On this news, shares of Oasmia fell $0.319 per share, or almost 24%, to close at $1.021 per share on June 28, 2019, damaging investors.

    On July 9, 2019, after the close of the market, Oasmia issued another press release that stated it had ended its relationship with former executive chairmen Julian Aleksov because of the transactions mentioned in the Company's June 28, 2019 press release. On this news, shares of Oasmia fell $0.34, or over 13%, to close at $2.26 per share on July 10, 2019, further damaging investors. As a result of defendants' wrongful acts and omissions, and the precipitous decline in the market value of the Company's common shares, Plaintiff and other Class members have suffered significant losses and damages.

    For more information on the Oasmia class action, go to: https://bespc.com/OASM.

    Aclaris Therapeutics, Inc. (NYSE:ACRS)

    Lead Plaintiff Deadline: September 30, 2019

    Class Period: May 8, 2018 to June 29, 2019

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy. Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders . . . in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell $0.57, or over 11%, over the next two trading sessions to close at $4.54 on June 21, 2019.

    The complaint, filed on July 30, 2019, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    For more information on the Aclaris class action, go to: https://bespc.com/ACRS.

    Carbonite, Inc. (NASDAQ:CARB)

    Class Period: February 7, 2019 to July 25, 2019

    Lead Plaintiff Deadline: September 30, 2019

    The complaint, filed on August 1, 2019, alleges that throughout the Class Period defendants issued materially false and misleading statements regarding the technological quality of the Server Backup VM Edition and its potential to add "meaningfully" to Carbonite's financial performance for fiscal 2019. Specifically, defendants failed to disclose that: (i) Carbonite's Server Backup VM Edition was of poor quality and technologically flawed; (ii) Carbonite was receiving poor reviews and complaints from customers about the Server Backup VM Edition; (iii) the poor quality and technological flaws of the Server Backup VM Edition was acting as a "disruptive" factor throughout the Carbonite salesforce and keeping that sales organization from closing opportunistically on several larger deals during fiscal 2019; and (iv) as a result of the foregoing, Carbonite lacked any reasonable basis for issuing its positive projections and financial forecasts.

    Finally, on July 25, 2019, Carbonite announced that it was withdrawing its Server Backup VM Edition product from the marketplace and consequently dramatically lowered its financial projections for fiscal 2019 and 2020. That same day, the strongest proponent and supporter of Server Backup VM Edition, Defendant Ali, announced he was leaving Carbonite. On this news, Carbonite stock declined more than 24%, from $23.90 per share when the market closed on July 25, 2019, to $18.01 per share when the market closed on July 26, 2019, on extremely heavy trading volume.

    For more information about the Carbonite class action, go to: https://bespc.com/CARB.

    Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising.  Prior results do not guarantee similar outcomes.

    Contacts
    Bragar Eagel & Squire, P.C.
    Brandon Walker, Esq.
    Melissa Fortunato, Esq.
    (212) 355-4648

    www.bespc.com

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  31. NEW YORK, Sept. 02, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period") of the important September 30, 2019 lead plaintiff deadline in securities class action. The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    To join the Aclaris class action, go to http://www.rosenlegal.com/cases-register-1637.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU…

    NEW YORK, Sept. 02, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period") of the important September 30, 2019 lead plaintiff deadline in securities class action. The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    To join the Aclaris class action, go to http://www.rosenlegal.com/cases-register-1637.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email or for information on the class action.

    NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR'S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

    According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Aclaris's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) Aclaris was reasonably likely to face regulatory scrutiny; and (3) as a result of the foregoing, defendants' positive statements about Aclaris's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

    A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 30, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1637.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at or .

    Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

    Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013.   Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

    -------------------------------

    Contact Information:
          Laurence Rosen, Esq.
          Phillip Kim, Esq.
          The Rosen Law Firm, P.A.
          275 Madison Avenue, 34th Floor
          New York, NY 10016
          Tel: (212) 686-1060
          Toll Free: (866) 767-3653
          Fax: (212) 202-3827
         
         
         
          www.rosenlegal.com

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  32. NEW YORK, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26…

    NEW YORK, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS) of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRSThere is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to  

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26th Floor
    New York, NY 10017
    Attn:  Richard Gonnello, Esq.

    Telephone: (877) 247-4292 or (212) 983-9330

    The lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all those who purchased Aclaris securities between May 8, 2018 and June 20, 2019  (the "Class Period").  The case, Rosi v. Aclaris Therapeutics, Inc., No. 1:19-cv-07118 was filed on July 30, 2019.

    The lawsuit focuses on whether the Company and its executives violated federal securities laws by making materially false and/or misleading statements, as well as failing to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy.

    Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell from $5.11 to $4.54 over the next two trading sessions to $4.54 on June 21, 2019—a $0.57 or a 11.15% drop.

    The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. 

    Faruqi & Faruqi, LLP also encourages anyone with information regarding Aclaris's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

    Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.

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  33. NEW YORK, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS). Such investors are advised to contact Robert S. Willoughby at or 888-476-6529, ext. 9980.

    The investigation concerns whether Aclaris and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

    [Click here for information about joining the class action]

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") asserted that an Aclaris advertisement for its Eskata hydrogen peroxide topical solution "makes false or misleading claims" regarding the product's risk and efficacy.  Specifically…

    NEW YORK, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Aclaris Therapeutics, Inc. ("Aclaris" or the "Company") (NASDAQ:ACRS). Such investors are advised to contact Robert S. Willoughby at or 888-476-6529, ext. 9980.

    The investigation concerns whether Aclaris and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

    [Click here for information about joining the class action]

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") asserted that an Aclaris advertisement for its Eskata hydrogen peroxide topical solution "makes false or misleading claims" regarding the product's risk and efficacy.  Specifically, the FDA stated that "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders . . . in the case of exposure to the eye and severe skin reactions including scarring." 

    On this news, Aclaris's stock price fell $0.57 per share, or over 11%, over two consecutive trading sessions to close at $4.54 per share on June 21, 2019.

    The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

    CONTACT:
    Robert S. Willoughby
    Pomerantz LLP
     

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  34. New York, New York--(Newsfile Corp. - August 28, 2019) - Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. (NASDAQ:ACRS) ("Aclaris" or the "Company") of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRS. There is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to .

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third…

    New York, New York--(Newsfile Corp. - August 28, 2019) - Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Aclaris Therapeutics, Inc. (NASDAQ:ACRS) ("Aclaris" or the "Company") of the September 30, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

    If you invested in Aclaris stock or options between May 8, 2018 and June 20, 2019 and would like to discuss your legal rights, click here: www.faruqilaw.com/ACRS. There is no cost or obligation to you.

    You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail to .

    CONTACT:
    FARUQI & FARUQI, LLP
    685 Third Avenue, 26th Floor
    New York, NY 10017
    Attn: Richard Gonnello, Esq.

    Telephone: (877) 247-4292 or (212) 983-9330

    The lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all those who purchased Aclaris securities between May 8, 2018 and June 20, 2019 (the "Class Period"). The case, Rosi v. Aclaris Therapeutics, Inc., No. 1:19-cv-07118 was filed on July 30, 2019.

    The lawsuit focuses on whether the Company and its executives violated federal securities laws by making materially false and/or misleading statements, as well as failing to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy.

    Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell from $5.11 to $4.54 over the next two trading sessions to $4.54 on June 21, 2019-a $0.57 or a 11.15% drop.

    The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.

    Faruqi & Faruqi, LLP also encourages anyone with information regarding Aclaris's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

    Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/47332

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  35. NEW YORK, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Oasmia Pharmaceutical AB (NASDAQ:OASM), Aclaris Therapeutics, Inc. (NYSE:ACRS), Evolent Health, Inc. (NYSE:EVH), and International Flavors & Fragrances, Inc. (NYSE:IFF). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Oasmia Pharmaceutical AB (NASDAQ:OASM)

    Lead Plaintiff Deadline: September 27, 2019

    Class Period: October 23, 2015 to July 9, 2019

    According to the complaint, on June 28, 2019, Oasmia issued a press release that stated it was reporting suspicious…

    NEW YORK, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C. reminds investors that class action lawsuits have been commenced on behalf of stockholders of Oasmia Pharmaceutical AB (NASDAQ:OASM), Aclaris Therapeutics, Inc. (NYSE:ACRS), Evolent Health, Inc. (NYSE:EVH), and International Flavors & Fragrances, Inc. (NYSE:IFF). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

    Oasmia Pharmaceutical AB (NASDAQ:OASM)

    Lead Plaintiff Deadline: September 27, 2019

    Class Period: October 23, 2015 to July 9, 2019

    According to the complaint, on June 28, 2019, Oasmia issued a press release that stated it was reporting suspicious transactions made between Oasmia and related partners Alceco and Ardenia to the Swedish Economic Crime Authority and appointing a special examiner to review them. On this news, shares of Oasmia fell $0.319 per share, or almost 24%, to close at $1.021 per share on June 28, 2019, damaging investors.

    On July 9, 2019, after the close of the market, Oasmia issued another press release that stated it had ended its relationship with former executive chairmen Julian Aleksov because of the transactions mentioned in the Company's June 28, 2019 press release. On this news, shares of Oasmia fell $0.34, or over 13%, to close at $2.26 per share on July 10, 2019, further damaging investors. As a result of defendants' wrongful acts and omissions, and the precipitous decline in the market value of the Company's common shares, Plaintiff and other Class members have suffered significant losses and damages.

    For more information on the Oasmia class action go to: https://bespc.com/OASM

    Aclaris Therapeutics, Inc. (NYSE:ACRS)

    Lead Plaintiff Deadline: September 30, 2019

    Class Period: May 8, 2018 to June 29, 2019

    On June 20, 2019, the U.S. Food & Drug Administration ("FDA") stated that an advertisement for Aclaris's hydrogen peroxide topical solution, Eskata, "makes false or misleading claims" regarding the product's risk and efficacy. Specifically, "a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson" was "especially concerning from a public health perspective because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders . . . in the case of exposure to the eye and severe skin reactions including scarring."

    On this news, Aclaris's stock price fell $0.57, or over 11%, over the next two trading sessions to close at $4.54 on June 21, 2019.

    The complaint, filed on July 30, 2019, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the Company's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) that, as a result, the Company was reasonably likely to face regulatory scrutiny; and (3) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    For more information on the Aclaris class action go to: https://bespc.com/ACRS

    Evolent Health, Inc. (NYSE:EVH)

    Lead plaintiff deadline: October 7, 2019

    Class Period: March 3, 2017 to May 28, 2019

    The complaint, filed on August 8, 2019, alleges that during the Class Period, defendants issued a series of false and/or misleading statements and failed to disclose material adverse facts about Evolent's business, operations, and prospects, including Evolent's "partnership" with Passport specifically. Among other things, defendants mispresented and failed to disclose that: (1) Evolent's partnership model did not align the company's interests with those of its partners, as the model was designed to inflate the Company's revenue by extracting enormous administrative and management fees at the expense of its operating partners such as Passport; (2) Passport was struggling financially, particularly after Kentucky cut its reimbursement rates, and the partnership between Evolent and Passport was becoming increasingly unsustainable; (3) Evolent was draining Passport of functions, employees and money, to such an extent that Passport was left on the verge of insolvency; (4) Passport was conducting a bidding process for several months to sell itself to prevent liquidation; and (5) as a result of the foregoing, defendants' public statements were materially false and/or misleading and/or lacked a reasonable basis.

    Ultimately, on May 29, 2019, Evolent shocked investors when it unexpectedly announced that it was buying a controlling interest in Passport, which was essentially a bailout of the financially distressed health plan. Evolent acquired Passport despite previously stating that it had no intention of buying Passport or any other health plans for the foreseeable future, and that acquiring health plans was not part of its strategic focus. In addition, Evolent admitted that Passport was performing poorly and was not being run or managed properly, despite paying massive management fees to Evolent for what was previously understood by investors to be an aligned relationship. In reaction to these disclosures, Evolent's stock price plummeted nearly 30%, to close at $10.10 on May 29, 2019.

    For more information on the Evolent Health class action go to: https://bespc.com/evh

    International Flavors and Fragrances (NYSE:IFF)

    Lead Plaintiff Deadline: October 11, 2019

    Class Period: May 7, 2018 to August 5, 2019

    The company acquired Frutarom Industries, Ltd. ("Frutarom") in October 2018. On August 5, 2019, after the market closed, the company disclosed that Frutarom had "made improper payments to representatives of a number of customers" in Russia and Ukraine and that "key members of Frutarom's senior management at the time were aware of such payments." The Company also lowered its 2019 financial guidance for sales to a range of $5.15 billion to $5.25 billion, from a range of $5.2 billion to $5.3 billion, and for adjusted earnings per share to a range of $4.85 to $5.05, from $4.90 to $5.10.

    On this news, the company's share price fell $22.56 per share, or nearly 16%, to close at $118.91 per share on August 6, 2019.

    The complaint, filed on August 12, 2019, alleges that throughout the Class Period, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Frutarom had bribed customers in Russia and Ukraine; (2) that senior management at Frutarom were aware of such improper payments; (3) that, as a result, Frutarom's financial results were materially overstated; (4) that, as a result of the improper payments, the Company was reasonably likely to face regulatory scrutiny; (5) that the Company had not completed adequate due diligence before acquiring Frutarom; (6) that, as a result of the foregoing, the Company was unlikely to achieve purported synergies from the acquisition; and (7) that, as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

    For more information on the Flavors and Fragrances class action go to: https://bespc.com/IFF

    Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising.  Prior results do not guarantee similar outcomes.

    Contacts
    Bragar Eagel & Squire, P.C.
    Brandon Walker, Esq.
    Melissa Fortunato, Esq.
    (212) 355-4648

    www.bespc.com 

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  36. NEW YORK, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Zhang Investor Law announces the filing of a class action lawsuit on behalf of shareholders who bought shares of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period"). The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    If you wish to serve as lead plaintiff, you must move the Court no later than September 30, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to obtain a recovery is not dependent upon being a lead plaintiff. If you wish to join the http://zhanginvestorlaw.com/join-action-form/?slug=aclaris-therapeutics-inc&id=1965

    NEW YORK, Aug. 26, 2019 (GLOBE NEWSWIRE) -- Zhang Investor Law announces the filing of a class action lawsuit on behalf of shareholders who bought shares of Aclaris Therapeutics, Inc. (NASDAQ:ACRS) from May 8, 2018 through June 20, 2019, inclusive (the "Class Period"). The lawsuit seeks to recover damages for Aclaris investors under the federal securities laws.

    If you wish to serve as lead plaintiff, you must move the Court no later than September 30, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to obtain a recovery is not dependent upon being a lead plaintiff. If you wish to join the http://zhanginvestorlaw.com/join-action-form/?slug=aclaris-therapeutics-inc&id=1965 or to discuss your rights or interests regarding this class action, please contact Sophie Zhang, Esq. or Spencer Lee toll-free at 800-991-3756 or email , for information on the class action.

    如果您想加入这个集体诉讼案,请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=aclaris-therapeutics-inc&id=1965.

    According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Aclaris's advertising materials minimized the risks and overstated the efficacy of ESKATA to generate sales; (2) Aclaris was reasonably likely to face regulatory scrutiny; and (3) as a result of the foregoing, defendants' positive statements about Aclaris's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

    A class has not been certified.  You may retain counsel of your choice.  You may take no action at this time and be an absent class member. Your ability to obtain a recovery is not dependent upon being a lead plaintiff.

    Zhang Investor Law represents investors worldwide.  Attorney Advertising.  Prior results do not guarantee similar outcomes.

    Zhang Investor Law P.C.
    99 Wall Street, Suite 232
    New York, New York 10005

    tel: (800) 991-3756

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