Aclaris Therapeutics, Inc.

Previous wording

The primary endpoint is percent change from baseline in EASI at week 24. Secondary endpoints at week 24 include EASI response (EASI-50, EASI-75, EASI-90), validated IGA response, body surface area (“BSA”) response, and Peak Pruritus Numerical Rating Scale (“PP-NRS”) score, relative to baseline. We expect to announce top-line data in the fourth quarter of 2026.

Current wording

In June 2025, we initiated a Phase 2 trial to evaluate the efficacy, safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of bosakitug compared to placebo in 109 patients with moderate to severe atopic dermatitis. The primary endpoint is percent change from baseline in EASI at week 24. Secondary endpoints at week 24 include EASI response (EASI-50, EASI-75, EASI-90), validated IGA response, body surface area (“BSA”) response, and Peak Pruritus Numerical Rating Scale (“PP-NRS”) score, relative to baseline. We expect to announce top-line data in the fourth quarter of 2026.

Previous wording

In April 2026, we announced positive full top-line results from our Phase 1a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) portion of our first-in-human study evaluating ATI-052 in healthy volunteers. The randomized, blinded, placebo-controlled study enrolled 48 participants across four SAD cohorts (receiving single doses of 30, 120, 360, or 720 mg or placebo) and two MAD cohorts (receiving five doses of 240 or 480 mg or placebo administered every seven days). ATI-052 was well tolerated and demonstrated a favorable safety and tolerability profile across all dose levels. The PK profile showed dose proportionality across the pharmacologic dose range with an estimated half-life of approximately 45 days (based on accumulation ratio at 240 mg weekly dosing). PD results demonstrated robust

Current wording

In April 2026, we announced positive full top-line results from our Phase 1a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) portion of our first-in-human study evaluating ATI-052 in healthy volunteers. The randomized, blinded, placebo-controlled study enrolled 48 participants across four SAD cohorts (receiving single doses of 30, 120, 360, or 720 mg or placebo) and two MAD cohorts (receiving five doses of 240 or 480 mg or placebo administered every seven days). ATI-052 was well tolerated and demonstrated a favorable safety and tolerability profile across all dose levels. The PK profile showed dose proportionality across the pharmacologic dose range with an estimated half-life of approximately 45 days (based on accumulation ratio at 240 mg weekly dosing). PD results demonstrated robust target engagement, including complete and sustained inhibition through at least week 20 (four months post last dose) of ex vivo TSLP stimulated CCL17 (TARC) and at least week 12 of ex vivo IL-4 stimulated CCL17 in the 480 mg MAD cohort. These combined PK and PD characteristics support the potential for dosing intervals of up to every three months. No impact of anti-drug antibodies on PK or PD was observed.

Previous wording

We initiated a Phase 1b proof-of-concept trial with ATI-052 in atopic dermatitis in January 2026 and a Phase 1b proof-of-concept trial in asthma in February 2026, with top-line data from both studies expected in the second half of 2026. We plan to initiate a Phase 2b program for ATI-052 initially targeting asthma in the fourth quarter of 2026, with atopic dermatitis as a potential second indication.

Current wording

We initiated a Phase 1b proof-of-concept trial with ATI-052 in atopic dermatitis in January 2026 and a Phase 1b proof-of-concept trial in asthma in February 2026, with top-line data from both studies expected in the second half of 2026. We plan to initiate a Phase 2b program for ATI-052, commencing with a Phase 2b trial in asthma in the fourth quarter of 2026. We also expect to commence startup activities for a Phase 2b trial in atopic dermatitis and for a proof-of-concept trial in eosinophilic esophagitis.

Previous wording

ATI-2138, an Investigational, Oral Covalent ITK/JAK3 Inhibitor

Current wording

Modzatinib, an Investigational, Oral Covalent ITK/JAK3 Inhibitor

Previous wording

ATI-2138 is a highly potent and selective novel investigational dual inhibitor of interleukin-2-inducible T cell kinase (“ITK”) and Janus kinase 3 (“JAK3”) for the potential treatment of T cell-mediated autoimmune diseases. The unique dual pharmacology of ATI-2138 regulates T cell development and function both upstream (ITK) and downstream (JAK3), inhibiting both TCR-mediated and cytokine-mediated activation of T cells, which may provide a more potent and complete anti-inflammatory response.

Current wording

Modzatinib (ATI-2138) is a highly potent and selective novel investigational dual inhibitor of interleukin-2-inducible T cell kinase (“ITK”) and Janus kinase 3 (“JAK3”) for the potential treatment of T cell-mediated autoimmune diseases. The unique dual pharmacology of modzatinib regulates T cell development and function both upstream (ITK) and downstream (JAK3), inhibiting both TCR-mediated and cytokine-mediated activation of T cells, which may provide a more potent and complete anti-inflammatory response.

Previous wording

In July 2025, we announced positive top-line results from our open-label, single-arm Phase 2a trial of ATI-2138 in patients with moderate to severe atopic dermatitis. The trial met the primary and key secondary safety, efficacy, and pharmacodynamic endpoints. ATI-2138 demonstrated near complete and sustained inhibition and occupancy of ITK. Proteome and transcriptome lesional skin tape strip analyses showed significant reductions of multiple inflammatory pathways associated with ITK, including strong downregulation of Th2, Th17, and TCR pathways, along with the Th1 pathway and fibrosis-related markers.

Current wording

In July 2025, we announced positive top-line results from our open-label, single-arm Phase 2a trial of modzatinib in patients with moderate to severe atopic dermatitis. The trial met the primary and key secondary safety, efficacy, and pharmacodynamic endpoints. Modzatinib demonstrated near complete and sustained inhibition and occupancy of ITK. Proteome and transcriptome lesional skin tape strip analyses showed significant reductions of multiple inflammatory

Previous wording

In April 2026, we announced plans to conduct a phased multi-part Phase 2b basket study of ATI-2138 in the three most common subtypes of lichen planus: erosive mucosal, cutaneous and lichen planopilaris. Lichen planus is an unaddressed chronic, inflammatory, CD8 cytotoxic T-cell-driven interface dermatitis. We expect to initiate Part A (erosive mucosal; cutaneous) of this trial in the second half of 2026 and intend to initiate Part B (lichen planopilaris) soon thereafter. We are also exploring the potential of ATI-2138 in additional indications that are relevant to the dual pharmacology and mechanism of action, including other inflammatory disorders.

Current wording

In April 2026, we announced plans to conduct a phased multi-part Phase 2b basket study of modzatinib in the three most common subtypes of lichen planus: erosive mucosal, cutaneous and lichen planopilaris. Lichen planus is an unaddressed chronic, inflammatory, CD8 cytotoxic T-cell-driven interface dermatitis. We expect to initiate Part A (erosive mucosal; cutaneous) of this trial in the fourth quarter of 2026 and intend to initiate Part B (lichen planopilaris) soon thereafter. We are also exploring the potential of modzatinib in additional indications that are relevant to the dual pharmacology and mechanism of action, including other inflammatory disorders.

Previous wording

We are developing ATI-9494, a highly potent, oral, covalent, investigational dual inhibitor of ITK and Resting Lymphocyte Kinase (TXK), and other covalent JAK-sparing ITK inhibitors with differentiated pharmacological properties and selectivity profiles. These inhibitors have the potential to differentially modulate T cell biology across a broad range of disease indications with extended half-lives and potential best-in-class potency, ITK occupancy, and ITK activation at low doses. We expect to file an IND application for ATI-9494 in the second half of 2026.

Current wording

We are developing ATI-9494, a highly potent, oral, covalent, investigational dual inhibitor of ITK and Resting Lymphocyte Kinase (TXK), and other covalent JAK-sparing ITK inhibitors with differentiated pharmacological properties and selectivity profiles. These inhibitors have the potential to differentially modulate T cell biology across a broad range of disease indications with extended half-lives and potential best-in-class potency, ITK occupancy, and ITK activation at low doses. We expect to file an IND application for ATI-9494 in the fourth quarter of 2026.

Previous wording

Since our inception, we have incurred significant net losses. Our net loss was $19.8 million for the three months ended March 31, 2026 and $64.9 million for the year ended December 31, 2025. As of March 31, 2026, we had an accumulated deficit of $987.6 million. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates from discovery through preclinical and clinical development. In addition, our product candidates, even if they are approved by regulatory agencies for marketing, may not achieve commercial success. We may also not be successful in identifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our product candidates. Furthermore, we have incurred and expect to continue to incur significant costs associated with operating as a public company, including legal, accounting, investor relations and other expenses. As a result, we will need substantial additional funding to support our continuing operations.

Current wording

Since our inception, we have incurred significant net losses. Our net loss was $41.3 million for the six months ended June 30, 2026 and $64.9 million for the year ended December 31, 2025. As of June 30, 2026, we had an accumulated deficit of $1.0 billion. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates from discovery through preclinical and clinical development. In addition, our product candidates, even if they are approved by regulatory agencies for marketing, may not achieve commercial success. We may also not be successful in identifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our product candidates. Furthermore, we have incurred and expect to continue to incur significant costs associated with operating as a public company, including legal, accounting, investor relations and other expenses. As a result, we will need substantial additional funding to support our continuing operations.

Previous wording

We recognized $0.9 million and $0.8 million of non-cash royalty income related to the OMERS agreement during the three months ended March 31, 2026 and 2025, respectively.

Current wording

We recognized $1.0 million of non-cash royalty income related to the OMERS agreement for each of the three months ended June 30, 2026 and 2025, and $1.8 million for each of the six months ended June 30, 2026 and 2025.

Previous wording

We recognized $0.2 million of licensing revenue related to the Sun Pharma agreement during the three months ended March 31, 2026, a portion of which was payable to third parties.

Current wording

We recognized $0.1 million and $0.3 million of licensing revenue related to the Sun Pharma agreement during the three and six months ended June 30, 2026, respectively, a portion of which was payable to third parties.

Previous wording

We recognized $1.3 million and $1.0 million of licensing revenue related to the Lilly agreement during the three months ended March 31, 2026 and 2025, respectively, all of which was payable to third parties.

Current wording

We recognized $1.1 million and $1.3 million of licensing revenue related to the Lilly agreement during the three months ended June 30, 2026 and 2025, respectively, and $2.4 million and $2.3 million during the six months ended June 30, 2026 and 2025, respectively, all of which was payable to third parties.

Previous wording

elect to discontinue, delay or modify the development, including clinical trials, of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

Current wording

Our expenditures are subject to additional uncertainties, including the preparation of regulatory filings for our product candidates. We may obtain unexpected results from our clinical trials or other development activities. We may elect to discontinue, delay or modify the development, including clinical trials, of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

Previous wording

The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in our estimates include the probability of achieving regulatory milestones and commencing commercialization (collectively referred to as “probability of success”), which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success assumptions ranged between 21% and 40% at March 31, 2026. Additionally, estimated future sales levels and the risk-adjusted discount rate applied to the potential payments are also significant assumptions used in calculating the fair value. As of March 31, 2026, the discount rate ranged between 7.5% and 9.3% depending on the year of each potential payment.

Current wording

The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in our estimates include the probability of achieving regulatory milestones and commencing commercialization (collectively referred to as “probability of success”), which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success assumptions ranged between 21% and 40% at June 30, 2026. Additionally, estimated future sales levels and the risk-adjusted discount rate applied to the potential payments are also significant assumptions used in calculating the fair value. As of June 30, 2026, the discount rate ranged between 7.5% and 9.5% depending on the year of each potential payment.

Previous wording

Comparison of Three Months Ended March 31, 2026 and 2025

Current wording

Comparison of Three and Six Months Ended June 30, 2026 and 2025

Previous wording

The increase in contract research revenue for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was driven by higher overall hours billed, which was partially offset by a lower average billing rate.

Current wording

The decrease in contract research revenue for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was driven by lower overall hours billed, which was partially offset by a higher average billing rate.

Previous wording

The increase in licensing revenue during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due to higher royalties earned under the Lilly and Sun Pharma license agreements.

Current wording

The increase in licensing revenue during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due to higher royalties earned under the Lilly and Sun Pharma license agreements.

Previous wording

The decrease in cost of revenue for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was driven by a decrease in personnel related costs.

Current wording

The decrease in cost of revenue for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was driven by a decrease in personnel-related costs.

Previous wording

The decrease in expenses for bosakitug for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to lower product candidate manufacturing costs, partially offset by an increase in clinical development expenses associated with a Phase 2 trial in atopic dermatitis.

Current wording

The increase in expenses for bosakitug for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to an increase in clinical development expenses associated with a Phase 2 trial in atopic dermatitis, partially offset by lower product candidate manufacturing costs.

Previous wording

The increase in expenses for ATI-052 for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to an increase in clinical development expenses associated with a Phase 1a program, as well as Phase 1b programs in atopic dermatitis and asthma.

Current wording

The increase in expenses for ATI-052 for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to an increase in product candidate manufacturing costs and clinical development expenses associated with a Phase 1a program, as well as Phase 1b programs in atopic dermatitis and asthma, partially offset by a decrease in preclinical development expenses associated with toxicity studies.

Previous wording

The decrease in expenses for ATI-2138 during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to a decrease in preclinical development expenses associated with toxicity

Current wording

The decrease in expenses for modzatinib during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to a decrease in preclinical development expenses associated

Previous wording

studies and clinical development expenses associated with a Phase 2a trial in atopic dermatitis, which was completed in July 2025.

Current wording

with toxicity studies and clinical development expenses associated with a Phase 2a trial in atopic dermatitis, which was completed in July 2025, partially offset by an increase in product candidate manufacturing costs.

Previous wording

The increase in expenses for ATI-9494 during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to an increase in product candidate manufacturing costs to support IND enabling studies.

Current wording

The increase in expenses for ATI-9494 during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to an increase in product candidate manufacturing costs and preclinical development expenses associated with toxicity studies to support IND enabling studies.

Previous wording

The increase in discovery expenses during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to increased investment in JAK-sparing ITK inhibitors as we progress toward candidate selection.

Current wording

The increase in discovery expenses during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to increased investment in JAK-sparing ITK inhibitors.

Previous wording

The increase in other research and development expenses during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to consulting costs associated with our clinical programs during the three months ended March 31, 2026.

Current wording

The increase in other research and development expenses during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to an increase in consulting costs associated with our clinical programs.

Previous wording

The increase in personnel expenses during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to higher headcount.

Current wording

The increase in personnel expenses during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to higher headcount. The decrease in stock-based compensation expense during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was due to the full amortization of awards granted in prior periods.

Previous wording

The increase in personnel expenses during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to higher headcount.

Current wording

The increase in personnel expenses during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to higher headcount.

Previous wording

The increase in professional and legal fees during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to higher compliance and business development-related expenses during the three months ended March 31, 2026.

Current wording

The increase in professional and legal fees during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to higher compliance and business development-related expenses during the three and six months ended June 30, 2026.

Previous wording

The increase in licensing expense during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due to higher royalties earned under the Lilly and Sun Pharma license agreements.

Current wording

The increase in licensing expense during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due to higher royalties earned under the Lilly and Sun Pharma license agreements.

Previous wording

The revaluation of contingent consideration loss decreased during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 mainly due to changes in estimated sales levels and market rates during the three months ended March 31, 2026, which offset an increase to the liability due to the passage of time. This resulted in no change to the contingent consideration liability during the three months ended March 31, 2026.

Current wording

The revaluation of contingent consideration loss decreased during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 mainly due to changes to the probability of success for certain product candidates and lower discount rates being applied to potential payments during the three and six months ended June 30, 2025.

Previous wording

Interest income decreased during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 due to a lower average investment balance and lower interest rates during the three months ended March 31, 2026.

Current wording

Interest income decreased during the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 due to a lower average investment balance and lower interest rates during the three and six months ended June 30, 2026.

Previous wording

Non-cash royalty income was consistent during the three months ended March 31, 2026 and March 31, 2025 and includes income related to the proceeds from the sale of a portion of our OLUMIANT® royalty payments to OMERS in July 2024.

Current wording

Non-cash royalty income was consistent during the three and six months ended June 30, 2026 and June 30, 2025 and includes income related to the proceeds from the sale of a portion of our OLUMIANT® royalty payments to OMERS in July 2024.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and marketable securities of $190.8 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view towards liquidity and capital preservation.

Current wording

As of June 30, 2026, we had cash, cash equivalents and marketable securities of $170.6 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view towards liquidity and capital preservation. Subsequent to June 30, 2026, we raised aggregate gross proceeds of $40.2 million through our at-the-market facility.

Previous wording

In March 2026, we sold an aggregate of 18.4 million shares of our common stock for gross proceeds of $59.8 million, pursuant to an amended and restated sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as sales agents, dated February 27, 2025. We paid selling commissions and other fees of $1.8 million in connection with the sales.

Current wording

In March 2026, we sold an aggregate of 18.4 million shares of our common stock for gross proceeds of $59.8 million, pursuant to an amended and restated sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as

Previous wording

Cash and cash equivalents were $28.7 million as of March 31, 2026 compared to $20.0 million as of December 31, 2025. We also had $162.1 million in short- and long-term marketable securities as of March 31, 2026 compared to $131.4 million as of December 31, 2025.

Current wording

Cash and cash equivalents were $19.2 million as of June 30, 2026 compared to $20.0 million as of December 31, 2025. We also had $151.5 million in short- and long-term marketable securities as of June 30, 2026 compared to $131.4 million as of December 31, 2025.

Previous wording

Net cash used in operating activities increased for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 primarily as a result of higher net losses after adjusting for non-cash items during the three months ended March 31, 2026. This increase was partially offset by a net decrease in cash used for accounts payable and accrued expenses, after adjusting for the receipt and corresponding payment of a third-party milestone during the three months ended March 31, 2025.

Current wording

Net cash used in operating activities increased for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 primarily as a result of higher net losses after adjusting for non-cash items during the six months ended June 30, 2026, as well as an increase in cash used for accounts payable and accrued expenses, after adjusting for the receipt and corresponding payment of a third-party milestone during the six months ended June 30, 2025.

Previous wording

The change in net cash used in investing activities for the three months ended March 31, 2026 compared to the net cash provided by investing activities for the three months ended March 31, 2025 resulted primarily from greater purchases of marketable securities and lower proceeds from sales and maturities of marketable securities during the three months ended March 31, 2026.

Current wording

The change in net cash used in investing activities for the six months ended June 30, 2026 compared to the net cash provided by investing activities for the six months ended June 30, 2025 resulted primarily from greater purchases of

Previous wording

The change in net cash provided by financing activities for the three months ended March 31, 2026 compared to net cash used in financing activities for the three months ended March 31, 2025 was primarily due to proceeds from sales under our at-the-market sales agreement in March 2026.

Current wording

The change in net cash provided by financing activities for the six months ended June 30, 2026 compared to net cash used in financing activities for the six months ended June 30, 2025 was primarily due to proceeds from sales under our at-the-market sales agreement in March 2026.

Previous wording

Our aggregate remaining lease payment obligation for these two spaces was $2.3 million as of March 31, 2026.

Current wording

Our aggregate remaining lease payment obligation for these two spaces was $2.1 million as of June 30, 2026.

Previous wording

We have agreed to certain payment obligations in accordance with and subject to the terms of the Confluence Agreement (see “Overview—Acquisition and License Agreements—Agreement and Plan of Merger with Confluence”). As of March 31, 2026, the balance of our contingent consideration liability was $11.0 million.

Current wording

We have agreed to certain payment obligations in accordance with and subject to the terms of the Confluence Agreement (see “Overview—Acquisition and License Agreements—Agreement and Plan of Merger with Confluence”). As of June 30, 2026, the balance of our contingent consideration liability was $11.3 million.