• | First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis | ||
• | First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19 | ||
• | Clinical Trial of ATI-1777, an Investigational “Soft” Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis |
“As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times,” said Dr.
R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.
- ATI-450, an investigational oral small molecule MK2 inhibitor compound:
- ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
- This trial was initiated in
March 2020 . Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, inMay 2020 . At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
- This trial was initiated in
- ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
- IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
- The first subject was dosed in
August 2020 .
- The first subject was dosed in
- ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
- ATI-1777, an investigational topical “soft” Janus Kinase (JAK) 1/3 inhibitor compound:
- Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in
June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD. - ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
- Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in
- ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
- Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.
Business Development Highlights:
- Aclaris continues to pursue strategic alternatives, including seeking partners for:
- A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
- ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
- ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources
As of
Aclaris anticipates that its cash, cash equivalents and marketable securities as of
Second Quarter 2020 and Year-to-Date Financial Results
- The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations.
- Net loss was
$11.6 million for the second quarter of 2020, compared to$49.9 million for the second quarter of 2019, and was$27.2 million for the six months endedJune 30, 2020 , compared to$87.4 million for the six months endedJune 30, 2019 .
- Total costs and expenses from continuing operations for the second quarter of 2020 were
$13.4 million , compared to$44.5 million for the second quarter of 2019, and were$30.3 million for the six months endedJune 30, 2020 , compared to$72.8 million for the six months endedJune 30, 2019 .- Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of
$3.3 million , compared to$4.6 million in the prior year period. - Total costs and expenses for the six months ended
June 30, 2020 included non-cash stock-based compensation expense of$6.8 million , compared to$8.9 million in the prior year period. - Recorded a non-cash goodwill impairment charge of
$18.5 million for the quarter and six months endedJune 30, 2019 . There were no impairment charges in either period in 2020.
- Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of
- R&D expenses were
$6.5 million and$15.9 million for the quarter and six months endedJune 30, 2020 , respectively, compared to$17.5 million and$37.2 million for the quarter and six months endedJune 30, 2019 , respectively.- The quarter-over-quarter decrease of
$11.1 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
- The quarter-over-quarter decrease of
- General and administrative expenses were
$5.6 million and$11.8 million for the quarter and six months endedJune 30, 2020 , respectively, compared to$7.5 million and$14.9 million for the quarter and six months endedJune 30, 2019 , respectively.- The quarter-over-quarter decrease of
$1.9 million was primarily the result of lower personnel costs resulting from the Company’s decision to discontinue commercial operations inSeptember 2019 .
- The quarter-over-quarter decrease of
- Loss from continuing operations was
$11.6 million and$26.9 million for the quarter and six months endedJune 30, 2020 , respectively, compared to$43.7 million and$71.0 million for the quarter and six months endedJune 30, 2019 , respectively. Loss from discontinued operations was$27,000 and$0.3 million for the quarter and six months endedJune 30, 2020 , respectively, compared to$6.2 million and$16.5 million for the quarter and six months endedJune 30, 2019 , respectively.
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, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
Revenues: | ||||||||||||
Contract research | $ | 1,853 | $ | 886 | $ | 3,042 | $ | 2,149 | ||||
Other revenue | 193 | — | 411 | — | ||||||||
Total revenues | 2,046 | 886 | 3,453 | 2,149 | ||||||||
Costs and expenses: | ||||||||||||
Cost of revenue (1) | 1,389 | 994 | 2,658 | 2,201 | ||||||||
Research and development (1) | 6,466 | 17,519 | 15,909 | 37,161 | ||||||||
General and administrative (1) | 5,572 | 7,469 | 11,773 | 14,926 | ||||||||
— | 18,504 | — | 18,504 | |||||||||
Total costs and expenses | 13,427 | 44,486 | 30,340 | 72,792 | ||||||||
Loss from operations | (11,381) | (43,600) | (26,887) | (70,643) | ||||||||
Other expense, net | (189) | (85) | (11) | (315) | ||||||||
Loss from continuing operations | (11,570) | (43,685) | (26,898) | (70,958) | ||||||||
Loss from discontinued operations (1) | (27) | (6,191) | (285) | (16,483) | ||||||||
Net loss | $ | (11,597) | $ | (49,876) | $ | (27,183) | $ | (87,441) | ||||
Net loss per share, basic and diluted | $ | (0.28) | $ | (1.21) | $ | (0.65) | $ | (2.12) | ||||
Weighted average common shares outstanding, basic and diluted | 42,133,646 | 41,274,808 | 41,876,037 | 41,261,808 | ||||||||
(1) Amounts include stock-based compensation expense as follows: | ||||||||||||
Cost of revenue | $ | 252 | $ | 223 | $ | 512 | $ | 429 | ||||
Research and development | 939 | 1,721 | 1,755 | 3,315 | ||||||||
General and administrative | 2,118 | 2,654 | 4,495 | 5,126 | ||||||||
Loss from discontinued operations | — | 216 | — | 806 | ||||||||
Total stock-based compensation expense | $ | 3,309 | $ | 4,814 | $ | 6,762 | $ | 9,676 |
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
Cash, cash equivalents, and marketable securities | $ | 68,115 | $ | 75,015 | ||
Total assets | 84,999 | 98,297 | ||||
Total current liabilities | 17,745 | 22,432 | ||||
Total liabilities | 35,633 | 28,385 | ||||
Total stockholders' equity | 49,366 | 69,912 |
Aclaris Contact
investors@aclaristx.com
Source: Aclaris Therapeutics, Inc.