- 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
“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.
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-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.
- 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.
- Enrollment in this trial was completed in
- 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.
- 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
Financial Highlights:
Liquidity and Capital Resources
As of
- Net proceeds of
$103.3 million from a public offering inJanuary 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
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 endedMarch 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.
- The quarter-over-quarter increase of
- General and administrative (G&A) expenses were
$4.8 million for the quarter endedMarch 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.
- The quarter-over-quarter decrease of
- Revaluation of contingent consideration charges related to the Confluence acquisition was
$16.4 million for the quarter endedMarch 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.
- The quarter-over-quarter increase in contingent consideration of
About
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
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
Three Months Ended | ||||||||
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 |
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
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
Source: Aclaris Therapeutics, Inc.