On August 3, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the second quarter of 2022 and provided a corporate update (Press release, Aclaris Therapeutics, AUG 3, 2022, View Source [SID1234617322]).

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"It has been a busy first half of the year as we continue in our pursuit of becoming a leading development-stage immunology company," said Dr. Neal Walker, Chief Executive Officer of Aclaris. "We have strengthened our senior leadership team this year with the addition of a number of accomplished leaders, including James Loerop, Chief Business Officer, Gail Cawkwell, MD, PhD, Chief Medical Officer, and most recently, Doug Manion, MD, President and Chief Operating Officer. During the second quarter we also were able to raise additional capital, which extended our expected cash runway to the end of 2025. We look forward to continuing to advance our clinical and pre-clinical programs as we move through the second half of the year."

Research and Development Highlights:

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases
Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Aclaris continues to expect topline data in 2023.
Hidradenitis Suppurativa (ATI-450-HS-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe hidradenitis suppurativa (HS) is ongoing. Aclaris continues to expect topline data in the first half of 2023.
Psoriatic Arthritis (ATI-450-PsA-201): Aclaris initiated study activities in the second quarter in this Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis (PsA). Aclaris continues to expect topline data in the first half of 2023.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)
Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD is ongoing. In this trial, Aclaris will explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older. Aclaris continues to expect topline data in the first half of 2023.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases
ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing. Aclaris continues to expect topline data in 2022.
If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a Phase 1 multiple ascending dose (MAD) trial of ATI-2138 in subjects with psoriasis in 2022. Aclaris is also currently exploring alternative indications that are relevant to the mechanism of action.
Preclinical Programs

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer
Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.
IND-enabling studies are underway, and Aclaris expects to submit an IND by the end of 2022.
Financial Highlights:

Liquidity and Capital Resources

As of June 30, 2022, Aclaris had aggregate cash, cash equivalents and marketable securities of $256 million compared to $226 million as of December 31, 2021. Aggregate cash, cash equivalents and marketable securities as of June 30, 2022 included $73 million of net proceeds from the sale of 4.8 million shares under its ATM facility in April 2022.

Aclaris continues to anticipate that its cash, cash equivalents and marketable securities as of June 30, 2022 will be sufficient to fund its operations through the end of 2025, without giving effect to any potential business development transactions or additional financing activities.

Financial Results

Second Quarter 2022

Net loss was $20.5 million for the second quarter of 2022 compared to $18.2 million for the second quarter of 2021.
Total revenue was $1.5 million for the second quarter of 2022 compared to $1.8 million for the second quarter of 2021.
Research and development (R&D) expenses were $18.8 million for the quarter ended June 30, 2022 compared to $7.9 million for the prior year period.
The $10.9 million increase was primarily the result of higher:
Zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA, a Phase 2a trial for HS and a Phase 2a trial for PsA.
ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial.
Preclinical development activities related to ATI-2231.
Compensation-related expenses due to an increase in headcount.
General and administrative (G&A) expenses were $6.1 million for the quarter ended June 30, 2022 compared to $5.9 million for the prior year period.
Revaluation of contingent consideration resulted in a $3.4 million reduction of expense for the quarter ended June 30, 2022 mainly due to higher discount rates, compared to a revaluation of contingent consideration expense of $4.8 million for the prior year period.
Year-to-date 2022

Net loss was $39.3 million for the six months ended June 30, 2022 compared to $46.9 million for the six months ended June 30, 2021.
Total revenue was $3.0 million for the six months ended June 30, 2022 compared to $3.6 million for the six months ended June 30, 2021.
R&D expenses were $33.1 million for the six months ended June 30, 2022 compared to $15.7 million for the prior year period.
The $17.4 million increase was primarily the result of higher:
Zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA, a Phase 2a trial for HS and a Phase 2a trial for PsA.
ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial.
Preclinical development activities related to ATI-2231.
Compensation-related expenses due to an increase in headcount.
G&A expenses were $12.2 million for the six months ended June 30, 2022 compared to $10.7 million for the prior year period.
The $1.5 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, due to increased headcount and the impact of new equity awards granted during the six months ended June 30, 2022.
Revaluation of contingent consideration resulted in a $4.6 million reduction of expense for the six months ended June 30, 2022 mainly due to higher discount rates, compared to a revaluation of contingent consideration expense of $21.2 million for the prior year period.