Core Insights - Aclaris has entered into an exclusive license agreement with Biosion for worldwide rights to BSI-045B and BSI-502, targeting severe asthma and chronic rhinosinusitis [1][2] - BSI-045B is expected to generate significant sales in the U.S. and EU markets, with projections indicating potential peak annual sales of approximately $9.8 billion [3][9] - Analyst Raghuram Selvaraju upgraded Aclaris from Neutral to Buy, setting a price target of $20, reflecting positive market sentiment [6] Group 1: Product Development and Market Potential - BSI-045B is currently in multiple Phase 2 studies in China, which may accelerate proof-of-concept across additional indications [2] - The drug is projected to reach the U.S. market by 2029 for chronic asthma and by 2030 for atopic dermatitis [9] - Selvaraju's forecasts suggest pricing for BSI-045B in the U.S. could be around $30,000 and approximately $10,000 in Europe, aligning with the pricing of Dupixent [4] Group 2: Financial Projections - Selvaraju anticipates Aclaris will report fourth-quarter revenue of $2.9 million with an EPS of $(0.10) [5] - The potential for BSI-045B to generate billions in sales is underscored by the success of similar therapies, such as Xolair, which approached $4 billion in sales in 2023 [10] Group 3: Clinical Trials and Efficacy - A completed Phase 2a trial in the U.S. demonstrated that BSI-045B has a promising pharmacodynamic, safety, and efficacy profile, positioning it as a potential best-in-class therapy [7] - Aclaris is expected to initiate multiple mid-stage clinical studies in the U.S. next year, contingent on positive results from ongoing trials in China [8]

Core Points - Aclaris Therapeutics granted stock options and restricted stock units to new employees as part of its 2024 Inducement Plan [1][2] - The total granted includes 251,000 shares for 4 new employees and 375,000 shares for the new President and COO, Hugh Davis, Ph.D [1] - The exercise price for the options is set at $3.96 per share, equal to the closing price on the grant date [3] Summary by Sections Stock Options and Restricted Stock Units - Aclaris granted a total of 251,000 nonstatutory stock options and 73,000 restricted stock units to 4 new employees [1] - Hugh Davis, the new President and COO, received 375,000 stock options and 107,000 restricted stock units [1] 2024 Inducement Plan - The 2024 Inducement Plan is designed for granting equity awards to individuals who were not previously employees or directors of Aclaris [2] - This plan serves as an inducement for new employees to join the company [2] Vesting and Exercise Terms - The stock options and restricted stock units will vest at a rate of 25% on each of the first four anniversaries of the recipient's start date [3] - The options have an exercise price of $3.96 per share, which matches the closing stock price on the grant date [3]

Core Insights - Aclaris Therapeutics, Inc. is participating in the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024 [1] - The company focuses on developing novel drug candidates for immunoinflammatory diseases [3] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company with a pipeline aimed at addressing unmet needs in immuno-inflammatory diseases [3] - The company utilizes a robust R&D engine to explore protein kinase regulation [3] Event Details - The fireside chat will take place at 1:00 PM ET in New York, New York [1] - A webcast of the event will be available on the company's website and archived for at least 30 days [2]

Core Insights - Aclaris Therapeutics entered into an exclusive license agreement with Biosion Inc for worldwide rights (excluding Greater China) to BSI-045B and BSI-502, a novel bispecific antibody targeting TSLP and IL4R [1] - BSI-045B has shown a promising pharmacodynamic, safety, and efficacy profile in a Phase 2a trial for moderate to severe atopic dermatitis [1] - The agreement includes an upfront cash payment of over $40 million, reimbursement for development costs, and potential milestone payments exceeding $900 million [2][3] Financial Projections - The analyst estimates BSI-045B could generate approximately $1.3 billion in revenue by 2035, with a 35% probability of success [5] - Additional regulatory and sales milestone payments could significantly enhance the financial outlook for Aclaris [3] Market Reactions - Leerink Partners upgraded Aclaris from Market Perform to Outperform, raising the price target from $2 to $7, indicating a positive shift in investor focus towards Aclaris' immunology pipeline [4] - BTIG also upgraded Aclaris from Neutral to Buy, setting a price target of $8 [7] - Following these upgrades, ACRS stock experienced a significant increase of 55.60%, reaching $4.88 [8]

Core Viewpoint - Aclaris Therapeutics has entered into an exclusive licensing agreement with Biosion for global rights to two pipeline candidates, leading to a significant increase in its stock price [1][4]. Group 1: Licensing Agreement Details - Aclaris will pay $30 million upfront for the global rights to BSI-045B and BSI-502, with additional payments of up to $125 million for regulatory milestones and up to $795 million for sales milestones [7][8]. - BSI-045B is in clinical development for moderate-to-severe atopic dermatitis, showing promising results in a phase IIa study [2][3]. - BSI-502 is a bispecific antibody targeting TSLP and IL4R, currently in the preclinical stage [3]. Group 2: Financial Performance and Projections - Aclaris shares have increased by 199% year-to-date, contrasting with a 6% decline in the industry [4]. - The company announced a private offering expected to raise approximately $80 million, aimed at funding research and development and supporting strategic growth [9][10]. Group 3: Strategic Implications - The licensing deal concludes Aclaris' strategic review process and is expected to enhance its existing portfolio of ITK inhibitors, targeting high-value immunologic and respiratory indications [5][6].

Core Viewpoint - Aclaris Therapeutics, Inc. has announced a private placement of 35,555,555 shares of common stock at a price of $2.25 per share, aiming to raise approximately $80.0 million for research and development and general corporate purposes [1][2]. Group 1: Private Placement Details - The private placement is expected to close on or about November 19, 2024, pending customary closing conditions [1]. - Vivo Capital led the private placement, with participation from various investors including Forge Life Science Partners, Rock Springs Capital, RA Capital Management, Adage Capital Partners LP, Decheng Capital, Logos Capital, and Samsara BioCapital [2]. - The net proceeds will primarily fund the research and development of Aclaris' pipeline and support general corporate needs [2]. Group 2: Securities Information - The securities issued in the private placement have not been registered under the Securities Act of 1933, meaning they cannot be offered or sold in the U.S. without an effective registration statement or applicable exemption [3]. - A registration rights agreement has been established, obligating the company to file a registration statement with the SEC for the resale of the shares sold in the private placement [3]. Group 3: Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, addressing unmet treatment needs [5]. - The company has a multi-stage portfolio of drug candidates supported by a robust research and development engine that explores protein kinase regulation [5].

Financial Performance - The net loss for the nine months ended September 30, 2024, was $35.5 million, and for the year ended December 31, 2023, it was $88.5 million, with an accumulated deficit of $806.3 million as of September 30, 2024[104]. - In the three months ended September 30, 2024, total revenue decreased to $4.346 million from $9.282 million in the same period of 2023, a decline of approximately 53.1%[141]. - Licensing revenue recognized during the three months ended September 30, 2024, was $0.7 million, compared to $8.3 million for the same period in 2023[113]. - The net loss for the three months ended September 30, 2024, was $(7.586) million, an improvement from $(29.261) million in the same period of 2023, reflecting a decrease of approximately 74%[141]. - The company anticipates incurring net losses in the near term as it continues to discover and develop drug candidates[171]. Research and Development - In September 2023, positive results from a Phase 1 trial of ATI-2138 showed it was well tolerated at all doses tested, with near maximal inhibition of biomarkers achieved at a 30 mg total daily dose[91]. - The Phase 2a trial of ATI-2138 for moderate to severe atopic dermatitis began in September 2024, with top-line data expected in the first half of 2025[94]. - The Phase 2b trial of lepzacitinib demonstrated a statistically significant EASI score improvement of 69.7% for the 2% BID group compared to 58.7% for the vehicle group (p=0.035)[96]. - The company discontinued the development of zunsemetinib for immuno-inflammatory diseases in 2023 following Phase 2 trial results[103]. - Total research and development expenses for the nine months ended September 30, 2024, were $24.6 million, a significant decrease of $47.2 million compared to $71.7 million in the same period of 2023[149]. Revenue and Expenses - Contract research revenue for the three months ended September 30, 2024, was $645 thousand, down from $705 thousand in 2023, a decrease of about 8.5%[141]. - Licensing revenue fell to $3.701 million in the three months ended September 30, 2024, compared to $8.577 million in 2023, representing a decline of approximately 56.5%[141]. - General and administrative expenses decreased to $5.653 million in the three months ended September 30, 2024, from $7.091 million in 2023, a decline of approximately 20.2%[141]. - Personnel expenses for general and administrative purposes decreased to $1.2 million for the three months ended September 30, 2024, down from $1.9 million in 2023, a reduction of approximately 37.1%[155]. - Professional and legal fees increased to $1.9 million for the three months ended September 30, 2024, compared to $1.0 million in 2023, reflecting an increase of about 77.5%[156]. Cash Flow and Capital - Cash and cash equivalents as of September 30, 2024, were $47.7 million, an increase from $39.9 million as of December 31, 2023[167]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $11.1 million, a decrease from $71.6 million in the same period of 2023, indicating improved cash flow management[168]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $173.4 million[165]. - Net cash provided by investing activities for the nine months ended September 30, 2024, was $18.954 million, a decrease from $38.670 million for the same period in 2023[169]. - Net cash used in financing activities for the nine months ended September 30, 2024, was $44 thousand, a significant decrease from net cash provided of $26.657 million in the same period of 2023[170]. Strategic Partnerships and Agreements - A royalty purchase agreement with OCM IP Healthcare Portfolio LP resulted in an upfront payment of $26.5 million, with potential additional payments of up to $5.0 million based on sales milestones for OLUMIANT in 2024[107]. - An exclusive patent license agreement with Sun Pharmaceutical Industries, Inc. included an upfront payment of $15.0 million, with additional milestone payments and royalties based on net sales[110]. - The company is seeking a global development and commercialization partner for lepzacitinib, excluding Greater China, where Pediatrix Therapeutics, Inc. has exclusive rights[97]. Operational Changes - The company approved a workforce reduction of approximately 46% in December 2023 to streamline operations and reduce costs[117]. - The company recognized a severance expense of $26 thousand for the three months ended September 30, 2024, and $2.6 million for the nine months ended September 30, 2024[118]. - During the nine months ended September 30, 2024, the company recorded a charge to the contingent consideration liability of $3.8 million due to changes in estimated sales levels and probability of success for certain drug candidates[138]. Market and Economic Conditions - The company does not expect an immediate 10% change in market interest rates to materially affect the fair market value of its investment portfolio[182]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the nine months ended September 30, 2024[184].

Core Viewpoint - Aclaris Therapeutics reported a quarterly loss of $0.11 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.08, marking a 37.50% earnings surprise [1]. Financial Performance - The company posted revenues of $4.35 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 47.68%, compared to $9.28 million in the same quarter last year [2]. - Over the last four quarters, Aclaris has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2]. Stock Performance - Aclaris shares have increased by approximately 111.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 21.2% [3]. Future Outlook - The company's earnings outlook will be crucial for determining the stock's immediate price movement, with current consensus EPS estimates at -$0.15 for the coming quarter and -$0.65 for the current fiscal year [4][7]. - The estimate revisions trend for Aclaris is currently mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6]. Industry Context - The Medical - Drugs industry, to which Aclaris belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8].

Financial Performance - Aclaris reported a net loss of $7.6 million for Q3 2024, a significant decrease from a net loss of $29.3 million in Q3 2023, representing a 74% improvement[8]. - Total revenue for Q3 2024 was $4.3 million, down from $9.3 million in Q3 2023, primarily due to higher milestones earned in the prior year[8]. - Year-to-date net loss for 2024 was $35.5 million, significantly lower than the $87.0 million loss reported for the same period in 2023[12]. Expenses - Research and development (R&D) expenses decreased to $6.0 million in Q3 2024 from $23.9 million in Q3 2023, a reduction of 75%[9]. - General and administrative (G&A) expenses were $5.7 million for Q3 2024, down from $7.1 million in the prior year, reflecting a 20% decrease[10]. Cash and Liquidity - As of September 30, 2024, Aclaris had cash, cash equivalents, and marketable securities totaling $173.4 million, down from $181.9 million at the end of 2023[7]. - Aclaris expects its cash resources to be sufficient to fund operations into 2028 without considering potential business development transactions[7]. Development and Partnerships - The company anticipates top-line data from the Phase 2a trial of ATI-2138 for atopic dermatitis in the first half of 2025[2]. - Aclaris is seeking a global development and commercialization partner for lepzacitinib, excluding Greater China, where rights have been granted to Pediatrix Therapeutics[4]. Liabilities - Total liabilities increased to $52.2 million as of September 30, 2024, compared to $40.2 million at the end of 2023[20].

Table of Contents 7 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37581 Aclaris Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | |------ ...