Aclaris Therapeutics Inc Stock Price, News & Analysis

Aclaris Therapeutics (NASDAQ: ACRS) reported Q1 2025 financial results and provided updates on its immuno-inflammatory drug pipeline. The company ended Q1 with $190.5 million in cash, extending runway through H1 2028. Net loss was $15.1 million, improved from $16.9 million in Q1 2024. Key pipeline updates include: - Plans to initiate Phase 2 trial of bosakitug (ATI-045) in atopic dermatitis in Q2 2025 - Seeking development partners for bosakitug in respiratory indications - Expecting Phase 2a trial results for ATI-2138 in June 2025 - Received FDA clearance for ATI-052 IND application - Appointed Dr. Jesse W. Hall as Chief Medical Officer R&D expenses increased to $11.6 million (vs $9.8M in Q1 2024), while G&A expenses decreased to $6.1 million (vs $6.8M). The company maintains focus on clinical execution and efficient capital utilization.

Aclaris Therapeutics has appointed Jesse Hall, M.D. as Chief Medical Officer, strengthening its leadership in immuno-inflammatory disease therapeutics. Dr. Hall brings extensive experience in clinical development, particularly in immunology and antibody development.

Dr. Hall's previous role was CMO at AltruBio, and he has held positions at notable companies including Sublimity Therapeutics, Ardea Biosciences (AstraZeneca), Amgen, and Abbott Labs. His track record includes work on successful monoclonal antibodies like HUMIRA and PROLIA.

As part of his employment package starting May 1, 2025, Dr. Hall will receive:

• 510,000 nonstatutory stock options
• 145,500 restricted stock units

These equity awards will vest over four years, with 25% vesting annually, subject to continued employment. The grants are part of Aclaris' 2024 Inducement Plan, designed for new employees under Nasdaq Rule 5635(c)(4).

Aclaris Therapeutics (NASDAQ: ACRS) has received FDA clearance for its Investigational New Drug (IND) application to conduct a Phase 1a/1b clinical trial of ATI-052, a bispecific anti-TSLP/IL-4R monoclonal antibody. The trial, expected to begin in Q2 2025, will evaluate single and multiple ascending doses followed by a proof-of-concept portion in an undisclosed indication.

ATI-052, acquired through a license agreement with Biosion, is designed to exhibit high binding affinity and dual blockade of both the TSLP ligand and IL-4 receptor, inhibiting key proinflammatory pathways. This bispecific antibody technology represents a potential advancement in immunotherapy, as these engineered antibodies can bind to two targets simultaneously, potentially offering enhanced efficacy over traditional monoclonal antibodies.

Aclaris Therapeutics (NASDAQ: ACRS), a clinical-stage biopharmaceutical company specializing in immuno-inflammatory diseases, has announced its participation in two major healthcare conferences this March.

The company's leadership team, led by CEO Dr. Neal Walker, will engage in:

• A fireside chat at the Leerink Partners Global Healthcare Conference in Miami, Florida on March 11, 2025, at 3:00 PM EDT
• A virtual fireside chat during the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, at 9:00 AM EDT

Both events will be webcast live and archived on the Events page of Aclaris' website, remaining accessible for at least 30 days following the presentations.

Aclaris Therapeutics (NASDAQ: ACRS) reported its Q4 and full-year 2024 financial results, highlighting multiple clinical catalysts expected in 2025. The company ended 2024 with $203.9 million in cash and equivalents, extending runway into 2028.

Key financial metrics include a Q4 net loss of $96.6 million compared to $1.5 million in Q4 2023, and total revenue of $9.2 million versus $17.6 million in the prior year period. R&D expenses decreased to $9.0 million from $26.6 million year-over-year.

Notable developments include:

• Acquisition of worldwide rights (excluding Greater China) to bosakitug (ATI-045) and ATI-052 from Biosion
• Expected Phase 2 data from CTTQ's studies in severe asthma and CRSwNP in H1 2025
• Planned initiation of Phase 2b trial for bosakitug in atopic dermatitis in H1 2025
• Completion of $80 million private placement in November 2024

Aclaris Therapeutics (NASDAQ: ACRS) announced a new publication highlighting the properties of ATI-2138, their novel investigational covalent inhibitor of ITK and JAK3 for treating autoimmune and inflammatory diseases. The drug demonstrates potent and selective blocking of both ITK and JAK3, effectively inhibiting key T cells involved in conditions like atopic dermatitis, alopecia areata, and vitiligo.

The publication details ATI-2138's performance in biochemical target inhibition, cellular systems, and animal models. Key findings show the drug's unique pharmacological profile with high potency in inhibiting both ITK and JAK3. In initial clinical trials, ATI-2138 was generally well-tolerated, with no serious adverse events reported. The drug showed dose- and time-dependent modulation of biomarkers linked to both ITK and JAK3 activity in healthy participants.

Aclaris Therapeutics (NASDAQ: ACRS) has announced the formation of a new Scientific Advisory Board (SAB) focused on pulmonology expertise. The initial board includes two distinguished members: Dr. Marianne Mann, a pulmonologist with over 30 years of experience in regulatory science and former FDA Deputy Director, and Dr. Zuzana Diamant, a renowned pulmonologist and clinical pharmacologist.

Dr. Mann brings extensive experience in clinical trial design and regulatory strategy from her roles at the FDA and NIH. Dr. Diamant, a guest professor at KU Leuven and past-chair of multiple respiratory medicine organizations, has co-authored over 200 peer-reviewed publications and brings expertise in drug development and clinical studies for respiratory diseases.

The SAB will guide Aclaris's development programs for immuno-inflammatory diseases, leveraging the members' combined expertise in respiratory medicine, clinical pharmacology, and immunology.

Aclaris Therapeutics (NASDAQ: ACRS) has announced inducement grants under NASDAQ Listing Rule 5635(c)(4). The company's Compensation Committee granted 215,000 nonstatutory stock options and 61,000 restricted stock units to one new employee under their 2024 Inducement Plan.

The stock options have an exercise price of $2.48 per share, matching Aclaris' common stock closing price on January 2, 2025. Both the options and restricted stock units will vest in four equal annual installments of 25% each, starting from the grant date, contingent on continued employment. These equity awards were granted as material inducements for the new employee joining Aclaris, in compliance with NASDAQ rules.

Aclaris Therapeutics (NASDAQ: ACRS) announced new employee equity grants under its 2024 Inducement Plan. The company granted nonstatutory stock options to purchase 251,000 shares and 73,000 restricted stock units to 4 new employees. Additionally, Hugh Davis, Ph.D, the new President and Chief Operating Officer, received options to purchase 375,000 shares and 107,000 restricted stock units.

The options have an exercise price of $3.96 per share, matching the closing price on December 2, 2024. Both options and restricted stock units will vest 25% annually over four years, contingent on continued employment. These grants were made as employment inducements in accordance with NASDAQ Listing Rule 5635(c)(4).