ACRS Aclaris Therapeutics Inc.

21.65
+0.46  (+2%)
Previous Close 21.19
Open 21.13
52 Week Low 1.2
52 Week High 30.375
Market Cap $1,128,124,236
Shares 52,107,355
Float 43,022,617
Enterprise Value $987,176,852
Volume 341,246
Av. Daily Volume 618,093
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ATI-1777-AD-201
Atopic dermatitis
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
ATI-450
Psoriatic arthritis
Phase 2
Phase 2
Phase 2 trial planned.
ATI-450
Hidradenitis suppurativa
Phase 2
Phase 2
Phase 2 trial planned.
ATI-450
Rheumatoid arthritis (RA)
Phase 2b
Phase 2b
Phase 2b trial to be initiated 2H 2021.
ATI-450
COVID-19
Phase 2a
Phase 2a
Phase 2a dosing commenced August 2020.
A-101 THWART-1 and THWART-2
Common warts (verruca vulgaris)
Phase 3
Phase 3
Phase 3 data met all endpoints - September 16, 2019 and October 24, 2019.
ATI-502 (VITI-201 Topical)
Vitiligo
Phase 2
Phase 2
Development to be discontinued - noted August 8, 2019.
ATI-502 (ATI-50002-AA-201) - dose ranging
Alopecia areata
Phase 2
Phase 2
Phase 2 data did not meet primary endpoint - June 26, 2019.
ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
Approved
Approved
Approval announced December 15, 2017.

Latest News

  1. WAYNE, Pa., May 17, 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 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 1:00 p.m. ET. Management will be available June 1st throughout the day for virtual one-on-one meetings.

    A live video webcast of the presentation 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…

    WAYNE, Pa., May 17, 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 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 1:00 p.m. ET. Management will be available June 1st throughout the day for virtual one-on-one meetings.

    A live video webcast of the presentation 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



    Primary Logo

    View Full Article Hide Full Article
    •  Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis Expected in Second Quarter of 2021
    • Advancing ATI-450 with Planned Initiation of Phase 2b Trial for Moderate to Severe Rheumatoid Arthritis in Second Half of 2021
    • Advancing ATI-450 into Two Additional Indications: Hidradenitis Suppurativa and Psoriatic Arthritis
    • Expands Scientific Advisory Board

    WAYNE, Pa., May 07, 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 first quarter of 2021 and provided a corporate update.

    "We're very pleased with the progress of our novel immuno-inflammatory…

    •  Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis Expected in Second Quarter of 2021
    • Advancing ATI-450 with Planned Initiation of Phase 2b Trial for Moderate to Severe Rheumatoid Arthritis in Second Half of 2021
    • Advancing ATI-450 into Two Additional Indications: Hidradenitis Suppurativa and Psoriatic Arthritis
    • Expands Scientific Advisory Board

    WAYNE, Pa., May 07, 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 first quarter of 2021 and provided a corporate update.

    "We're very pleased with the progress of our novel immuno-inflammatory drug development pipeline and look forward to reporting data from our Phase 2a trial of ATI-1777 in the second quarter of 2021," said Dr. Neal Walker, President & CEO of Aclaris. "ATI-1777 is our second development program generated by KINect, our proprietary drug discovery platform. After generating proof of mechanism in inhibiting TNFα, IL1β and IL6 in our Phase 2a trial of ATI-450 in moderate to severe rheumatoid arthritis, we are planning to move ATI-450 forward with a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021 and planning to initiate two additional trials of ATI-450 in hidradenitis suppurativa and psoriatic arthritis."

    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 19 subjects with moderate to severe rheumatoid arthritis. The trial consisted of a 12-week treatment period and a 4-week follow-up period. Two subjects withdrew from the trial during the treatment period, one in the treatment arm and one in the placebo arm.
        • Final per-protocol analysis, which consisted of 17 subjects who completed the treatment period (15 in the treatment arm and two in the placebo arm), confirmed that 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.
        • Overall, ATI-450 was generally well tolerated. There were no treatment-related serious adverse events and all adverse events were mild to moderate. There was one non-treatment-related serious adverse event (COVID-19) reported in the 4-week follow-up period of the trial in a subject who was no longer receiving treatment. The subject withdrew during the 4-week follow-up period of the trial.
      • Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
      • As part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs, Aclaris also plans to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis.
    • 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 50 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.
        • Enrollment in this trial was completed in March 2021.
        • Data from this trial are now expected in the second quarter of 2021.
    • ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
      • Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
      • Submission of Investigational New Drug Application is expected in the second half of 2021.

    Aclaris is also expanding its Scientific Advisory Board with the addition of Dr. Philip Mease. Dr. Mease, a rheumatologist, currently serves as a Director of the Division of Rheumatology Clinical Research at the Swedish Medical Center/Providence St. Joseph Health and is a Clinical Professor at the University of Washington in Seattle. His major clinical and research focus is psoriatic arthritis and axial spondyloarthritis.

    Financial Highlights:

    Liquidity and Capital Resources

    As of March 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $142.7 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the three months ended March 31, 2021 included:

    • Net proceeds of $103.3 million from a public offering in January 2021 in which Aclaris sold 6.3 million shares of common stock.



    • Net cash used in operating activities of $12.2 million resulting from net loss of $28.8 million and changes in operating assets and liabilities of $2.9 million, partially offset by non-cash adjustments of $19.4 million which was primarily related to a $16.4 million charge for the revaluation of contingent consideration.

    Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021 will be sufficient to fund its operations through the end of 2023, including estimated costs for the Phase 2b trial of ATI-450 for moderate to severe rheumatoid arthritis and the planned expansion of its Phase 2 immuno-inflammatory clinical development programs for hidradenitis suppurativa and psoriatic arthritis, without giving effect to any potential business development transactions or financing activities.

    Financial Results

    First Quarter 2021

    • Net loss was $28.8 million for the first quarter of 2021 compared to $15.6 million for the first quarter of 2020.



    • Total revenue was $1.8 million for the first quarter of 2021 compared to $1.4 million for the first quarter of 2020.



    • Research and development (R&D) expenses were $7.8 million for the quarter ended March 31, 2021 compared to $7.7 million for the prior year period.

      • The quarter-over-quarter increase of $0.1 million was primarily the result of continued investment in the further development of Aclaris' immuno-inflammatory drug development pipeline, including ATI-450, ATI-1777 and ATI-2138, partially offset by a reduction in spend for legacy dermatology assets and personnel costs.
    • General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021 compared to $6.2 million for the prior year period.
      • The quarter-over-quarter decrease of $1.4 million was primarily the result of lower personnel and non-cash stock-based compensation expenses.
    • Revaluation of contingent consideration charges related to the Confluence acquisition was $16.4 million for the quarter ended March 31, 2021 compared to $1.8 million for the prior year period.
      • The quarter-over-quarter increase in contingent consideration of $14.7 million primarily resulted from updates to probability of success and estimated future sales level assumptions following the completion of a Phase 2a clinical trial of ATI-450 in subjects with moderate to severe rheumatoid arthritis.

    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.

    Condensed Consolidated Statements of Operations

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

      Three Months Ended
      March 31,
         2021     2020 
    Revenues:      
    Contract research $1,535  $1,189 
    Other revenue  242   218 
    Total revenue  1,777   1,407 
           
    Costs and expenses:      
    Cost of revenue (1)  1,202   1,269 
    Research and development (1)  7,838   7,677 
    General and administrative (1)  4,827   6,200 
    Revaluation of contingent consideration  16,439   1,767 
    Total costs and expenses  30,306   16,913 
    Loss from operations  (28,529)  (15,506)
    Other income (expense), net  (225)  178 
    Loss from continuing operations  (28,754)  (15,328)
    Loss from discontinued operations     (258)
    Net loss $(28,754) $(15,586)
    Net loss per share, basic and diluted $(0.57) $(0.37)
    Weighted average common shares outstanding, basic and diluted  50,337,807   41,618,429 
           
    (1) Amounts include stock-based compensation expense as follows:      
           
    Cost of revenue $247  $260 
    Research and development  876   816 
    General and administrative  1,552   2,377 
    Total stock-based compensation expense $2,675  $3,453 





    Aclaris Therapeutics, Inc.

    Selected Consolidated Balance Sheet Data

    (unaudited, in thousands, except share data)

           
         March 31, 2021    December 31, 2020
           
    Cash, cash equivalents and marketable securities $142,657 $54,131
    Total assets $161,399 $70,784
    Total current liabilities $14,505 $14,874
    Total liabilities $49,105 $33,134
    Total stockholders' equity $112,294 $37,650
    Common stock outstanding  52,081,729  45,109,314



    Aclaris Contact

    investors



    Primary Logo

    View Full Article Hide Full Article
    • 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



    Primary Logo

    View Full Article Hide Full Article
    • 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

     



    Primary Logo

    View Full Article Hide Full Article
  2. 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

     



    Primary Logo

    View Full Article Hide Full Article
View All Aclaris Therapeutics Inc. News