ACRS Aclaris Therapeutics Inc.

1.5
-0.15  -9%
Previous Close 1.65
Open 1.65
52 Week Low 0.7
52 Week High 2.49
Market Cap $62,799,518
Shares 41,866,345
Float 39,824,527
Enterprise Value $-9,925,531
Volume 396,553
Av. Daily Volume 558,883
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Drug Pipeline

Drug Stage Notes
ATI-450
COVID-19
Phase 2a
Phase 2a
Phase 2a trial to be initiated.
ATI-450
Rheumatoid arthritis (RA)
Phase 1/2
Phase 1/2
Phase 2 enrolment has paused due to COVID-19.
ATI-1777
Atopic dermatitis
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 2H 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
Androgenetic alopecia (AGA) - Hair loss
Phase 2
Phase 2
Partner required to further development.
ATI-501 (AUAT-201 Oral)
Alopecia areata
Phase 2
Phase 2
Phase 2 data met primary endpoint and some secondary endpoints - July 30, 2019. Partner required for further development.
ATI-502 (VITI-201 Topical)
Vitiligo
Phase 2
Phase 2
Development to be discontinued - noted August 8, 2019.
ATI-502 (AD-201 Topical)
Atopic dermatitis (AD)
Phase 2
Phase 2
Phase 2 trial completed.
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

    • 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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  1. 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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  2. 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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  3. 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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