Aclaris Therapeutics(ACRS) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash, cash equivalents, and marketable securities of $204 million, down from $230 million at year-end 2022 [36] - The net loss for Q1 2023 was $28.2 million, compared to $18.8 million in Q1 2022, primarily due to advancements in ongoing clinical programs [37] - Total revenue for the quarter was $2.5 million, an increase from $1.5 million in the prior year's quarter, driven by higher licensing revenue [37] Business Line Data and Key Metrics Changes - The Phase 2a trial of ATI-450 in hidradenitis suppurativa (HS) did not meet primary or secondary efficacy endpoints, but provided valuable safety and pharmacodynamic data [10][18] - The Phase 2b study of ATI-1777 in atopic dermatitis is ongoing, with an expanded protocol to include mild patients, and top-line results are now expected in the second half of 2023 [14][35] - The company is advancing its Phase 1 clinical asset ATI-2138 and plans to initiate a Phase 2a proof-of-concept study in ulcerative colitis [12][34] Market Data and Key Metrics Changes - The company is positioned in the immune-inflammatory disease space, which has seen significant transactions, indicating a competitive landscape with opportunities for shareholder value creation [7] - The competitive landscape in atopic dermatitis is evolving, with the company focusing on differentiators for ATI-1777 [76] Company Strategy and Development Direction - The company aims to complete and report results from ongoing trials in rheumatoid arthritis and psoriatic arthritis, while exploring the MK2 mechanism in other indications [39] - The leadership team emphasizes a fiscally prudent approach to executing clinical programs, with a focus on advancing key assets [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of ATI-450, noting that the drug's performance in HS does not raise red flags for the upcoming rheumatoid arthritis study [43] - The team remains optimistic about the potential of ATI-450 and is focused on timely reporting of ongoing trials [39] Other Important Information - The company completed chronic toxicology studies for ATI-450, with no issues of concern identified [25] - The data safety monitoring committee for the rheumatoid arthritis trial has not raised any safety concerns to date [34] Q&A Session Summary Question: Read-through from HS to RA study and CK levels - Management expressed confidence in the safety profile of ATI-450, indicating no red flags and a positive outlook for the RA study [43][44] Question: Atopic dermatitis enrollment challenges - Management acknowledged enrollment challenges due to a mild winter and noted that expanding criteria to include mild patients should enhance recruitment [45] Question: Choice of ulcerative colitis as first indication - Management highlighted the attractiveness of ATI-238 in ulcerative colitis and the competitive landscape in inflammatory bowel disease [46] Question: CK elevations compared to other therapies - Management noted that asymptomatic CK elevations are common and not a concern among clinicians, with no evidence of significant pathology [49][50] Question: CNS adverse events in HS study - Management indicated that the etiology of CNS events like dizziness and headache remains unclear, but they are generally transient [55][56] Question: Discontinuation rates in RA study - Management stated that discontinuation rates in the RA study are tracking at or below those seen in competitive studies [59][60]