Aclaris Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
Aclaris Therapeutics (NASDAQ: ACRS) reported Q3 2024 financial results with a net loss of $7.6 million, improved from $29.3 million in Q3 2023. Revenue decreased to $4.3 million from $9.3 million year-over-year. The company maintains a strong cash position of $173.4 million, expected to fund operations into 2028.
Key developments include the first patient dosed in the ATI-2138 Phase 2a trial for atopic dermatitis, with top-line data expected in H1 2025. R&D expenses decreased to $6.0 million from $23.9 million, while G&A expenses reduced to $5.7 million from $7.1 million in the prior year period.
Aclaris Therapeutics (NASDAQ: ACRS) ha riportato i risultati finanziari del terzo trimestre del 2024, registrando una perdita netta di 7,6 milioni di dollari, migliorata rispetto ai 29,3 milioni di dollari nel terzo trimestre del 2023. I ricavi sono diminuiti a 4,3 milioni di dollari rispetto ai 9,3 milioni di dollari dell'anno precedente. L'azienda mantiene una solida posizione di cassa di 173,4 milioni di dollari, prevista per finanziare le operazioni fino al 2028.
Sviluppi chiave includono il primo paziente trattato nel trial di Fase 2a ATI-2138 per la dermatite atopica, con dati preliminari attesi nella prima metà del 2025. Le spese per R&S sono diminuite a 6,0 milioni di dollari rispetto ai 23,9 milioni, mentre le spese generali e amministrative sono scese a 5,7 milioni di dollari rispetto ai 7,1 milioni dell'anno precedente.
Aclaris Therapeutics (NASDAQ: ACRS) reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 7,6 millones de dólares, mejorando respecto a los 29,3 millones de dólares del tercer trimestre de 2023. Los ingresos disminuyeron a 4,3 millones de dólares desde 9,3 millones de dólares en comparación interanual. La compañía mantiene una sólida posición de efectivo de 173,4 millones de dólares, que se espera financie las operaciones hasta 2028.
Los desarrollos clave incluyen el primer paciente dosificado en el ensayo de Fase 2a ATI-2138 para dermatitis atópica, con datos preliminares esperados en la primera mitad de 2025. Los gastos de I+D se redujeron a 6,0 millones de dólares desde 23,9 millones, mientras que los gastos generales y administrativos se redujeron a 5,7 millones de dólares desde 7,1 millones del mismo periodo del año anterior.
Aclaris Therapeutics (NASDAQ: ACRS)는 2024년 3분기 재무 결과를 보고하며 760만 달러의 순손실을 기록했으며 이는 2023년 3분기의 2930만 달러에서 개선된 수치입니다. 수익은 지난해 같은 기간의 930만 달러에서 430만 달러로 감소했습니다. 회사는 2028년까지 운영 자금을 지원할 것으로 예상되는 1억7340만 달러의 강력한 현금 포지션을 유지하고 있습니다.
주요 개발 사항으로는 아토피 피부염을 위한 ATI-2138 2a상 시험에 첫 번째 환자가 투여되었으며, 초기 데이터는 2025년 상반기에 예상됩니다. 연구 및 개발 비용은 2390만 달러에서 600만 달러로 줄어들었고, 일반 및 관리 비용은 지난해 같은 기간의 710만 달러에서 570만 달러로 감소했습니다.
Aclaris Therapeutics (NASDAQ: ACRS) a rapporté les résultats financiers du troisième trimestre 2024, avec une perte nette de 7,6 millions de dollars, en amélioration par rapport à 29,3 millions de dollars au troisième trimestre 2023. Les revenus ont diminué à 4,3 millions de dollars contre 9,3 millions de dollars d'une année sur l'autre. L'entreprise maintient une solide position de trésorerie de 173,4 millions de dollars, qui devrait financer les opérations jusque 2028.
Les développements clés incluent le premier patient traité dans l'
Aclaris Therapeutics (NASDAQ: ACRS) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und einen Nettoverlust von 7,6 Millionen Dollar gemeldet, eine Verbesserung gegenüber 29,3 Millionen Dollar im dritten Quartal 2023. Die Einnahmen gingen auf 4,3 Millionen Dollar von 9,3 Millionen Dollar im Vorjahresvergleich zurück. Das Unternehmen hat eine starke Liquiditätsposition von 173,4 Millionen Dollar, die voraussichtlich die Betriebsführung bis 2028 unterstützen wird.
Wichtige Entwicklungen umfassen den ersten Patienten, der in die ATI-2138 Phase 2a-Studie zur atopischen Dermatitis aufgenommen wurde, mit erwarteten Hauptdaten in der ersten Hälfte von 2025. Die F&E-Ausgaben sanken auf 6,0 Millionen Dollar von 23,9 Millionen Dollar, während die Verwaltungs- und Betriebskosten auf 5,7 Millionen Dollar von 7,1 Millionen Dollar im Vorjahreszeitraum gesenkt wurden.
- Net loss improved significantly from $29.3M to $7.6M year-over-year
- Strong cash position of $173.4M expected to fund operations into 2028
- R&D expenses decreased by $17.9M to $6.0M
- G&A expenses reduced by $1.4M to $5.7M
- Revenue declined 54% to $4.3M from $9.3M year-over-year
- Licensing revenue decreased due to lower milestone payments
- $0.8M loss from revaluation of contingent consideration
Insights
The Q3 2024 results show a significant improvement in operational efficiency, with net loss narrowing to
The reduction in revenue to
The advancement of ATI-2138, a novel ITK/JAK3 inhibitor, into Phase 2a trials for atopic dermatitis represents a strategic pivot in the company's pipeline. The earlier positive results from lepzacitinib's Phase 2b trial and the ongoing search for a global commercialization partner could potentially unlock significant value. The company's diversified approach, including the development of a second-generation ITK selective inhibitor and the repurposing of zunsemetinib for oncology applications, demonstrates a balanced risk management strategy in drug development.
– First Patient Dosed in ATI-2138 Phase 2a Trial in Atopic Dermatitis As Previously Announced;
Top-line Data Anticipated in First Half of 2025 –
WAYNE, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2024 and provided a corporate update.
"The third quarter of 2024 marked an important milestone for Aclaris with the dosing of our first patient in the Phase 2a trial of ATI-2138 for moderate to severe atopic dermatitis," said Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors of Aclaris. "This milestone, combined with our robust financial position, underscores our commitment to executing a capital-efficient development strategy."
Research and Development Highlights:
- ITK Inhibitor Programs
- ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor
- Atopic Dermatitis (ATI-2138-AD-201): This Phase 2a open-label trial to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate to severe atopic dermatitis (AD) is ongoing. Aclaris continues to expect top-line data in the first half of 2025.
- ITK Selective Compound
- Aclaris is progressing a second generation ITK selective inhibitor to development candidate selection for autoimmune indications.
- ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor
- Lepzacitinib (ATI-1777), an investigational topical “soft” JAK 1/3 inhibitor
- In January 2024, Aclaris reported positive top-line results from its Phase 2b trial of lepzacitinib in AD.
- Aclaris is currently seeking a global development and commercialization partner for this program (excluding Greater China). As previously announced, in 2022 Aclaris granted Pediatrix Therapeutics exclusive rights to develop and commercialize lepzacitinib in Greater China.
- Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor
- Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University.
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions, financing activities or the outcome of its strategic review.
Financial Results
Third Quarter 2024
- Net loss was
$7.6 million for the third quarter of 2024 compared to$29.3 million for the third quarter of 2023. - Total revenue was
$4.3 million for the third quarter of 2024 compared to$9.3 million for the third quarter of 2023. The decrease was primarily driven by higher milestones earned during the prior year period compared to the current year period. - Research and development (R&D) expenses were
$6.0 million for the quarter ended September 30, 2024 compared to$23.9 million for the prior year period.- The
$17.9 million decrease was primarily the result of:- Zunsemetinib development expenses associated with clinical trials in 2023, and drug candidate manufacturing costs;
- Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD which was completed in January 2024;
- ATI-2138 development expenses, including costs associated with a Phase 1 multiple ascending dose (MAD) trial which was completed in September 2023 and other preclinical activities, which were partially offset by clinical development expenses associated with a Phase 2a clinical trial which commenced in August 2024; and
- Lower compensation-related expenses due to a decrease in headcount and higher forfeiture credits.
- The
- General and administrative (G&A) expenses were
$5.7 million for the quarter ended September 30, 2024 compared to$7.1 million for the corresponding prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits. - Licensing expenses were
$1.8 million for the quarter ended September 30, 2024 compared to$7.3 million for the corresponding prior year period. The decrease was primarily due to higher milestones earned during the prior year period compared to the current year period. - Revaluation of contingent consideration resulted in a
$0.8 million loss for the quarter ended September 30, 2024 compared to a loss of$1.7 million for the prior year period.
Year-to-date 2024
- Net loss was
$35.5 million for the nine months ended September 30, 2024 compared to$87.0 million for the nine months ended September 30, 2023. - Total revenue was
$9.5 million for the nine months ended September 30, 2024 compared to$13.7 million for the nine months ended September 30, 2023. The decrease was primarily driven by higher milestones earned during the prior year period compared to the current year period. - R&D expenses were
$24.6 million for the nine months ended September 30, 2024 compared to$71.7 million for the corresponding prior year period.- The
$47.1 million decrease was primarily the result of:- Zunsemetinib development expenses associated with clinical trials in 2023, and drug candidate manufacturing costs;
- Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD which was completed in January 2024;
- ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial which was completed in September 2023 and other preclinical activities, which were partially offset by clinical development expenses associated with a Phase 2a clinical trial which commenced in August 2024; and
- Lower compensation-related expenses due to a decrease in headcount and higher forfeiture credits.
- The
- G&A expenses were
$17.2 million for the nine months ended September 30, 2024 compared to$24.2 million for the prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits and the recognition of bad debt expense recorded in the prior year period from Aclaris’ determination that collection of amounts due from EPI Health are uncertain as a result of their filing for Chapter 11 bankruptcy protection. - Licensing expenses were
$4.1 million for the nine months ended September 30, 2024 compared to$9.0 million for the prior year period. The decrease was primarily due to higher milestones earned during the prior year period compared to the current year period. - Revaluation of contingent consideration resulted in a
$3.8 million loss for the nine months ended September 30, 2024 compared to a gain of$0.6 million for the corresponding prior year period.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.
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 “anticipate,” “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 its plans for its development programs, including its plans to seek a development and commercialization partner for lepzacitinib, the clinical development of ATI-2138, including the timing of top-line data, its plan to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib, the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into 2028, as well as its strategic review. 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 macroeconomic environment 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 December 31, 2023, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
| Aclaris Therapeutics, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (unaudited, in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Contract research | $ | 645 | $ | 705 | $ | 1,926 | $ | 2,469 | ||||||||
| Licensing | 3,701 | 8,577 | 7,583 | 11,210 | ||||||||||||
| Total revenue | 4,346 | 9,282 | 9,509 | 13,679 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of revenue (1) | 654 | 848 | 2,087 | 2,698 | ||||||||||||
| Research and development (1) | 5,956 | 23,876 | 24,560 | 71,738 | ||||||||||||
| General and administrative (1) | 5,653 | 7,091 | 17,249 | 24,198 | ||||||||||||
| Licensing | 1,754 | 7,344 | 4,070 | 8,955 | ||||||||||||
| Revaluation of contingent consideration | 800 | 1,700 | 3,800 | (600 | ) | |||||||||||
| Total costs and expenses | 14,817 | 40,859 | 51,766 | 106,989 | ||||||||||||
| Loss from operations | (10,471 | ) | (31,577 | ) | (42,257 | ) | (93,310 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 1,991 | 2,316 | 5,850 | 6,320 | ||||||||||||
| Non-cash royalty income | 894 | — | 894 | — | ||||||||||||
| Total other income | 2,885 | 2,316 | 6,744 | 6,320 | ||||||||||||
| Net loss | $ | (7,586 | ) | $ | (29,261 | ) | $ | (35,513 | ) | $ | (86,990 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.41 | ) | $ | (0.50 | ) | $ | (1.25 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 71,381,731 | 70,807,934 | 71,249,813 | 69,452,495 | ||||||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||||||
| Cost of revenue | $ | 232 | $ | 347 | $ | 707 | $ | 1,119 | ||||||||
| Research and development | 1,124 | 3,072 | 2,192 | 9,168 | ||||||||||||
| General and administrative | 1,648 | 2,529 | 5,097 | 8,989 | ||||||||||||
| Total stock-based compensation expense | $ | 3,004 | $ | 5,948 | $ | 7,996 | $ | 19,276 | ||||||||
| Aclaris Therapeutics, Inc. | ||||||||
| Selected Consolidated Balance Sheet Data | ||||||||
| (unaudited, in thousands, except share data) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 173,436 | $ | 181,877 | ||||
| Total assets | $ | 182,394 | $ | 197,405 | ||||
| Total current liabilities | $ | 18,816 | $ | 30,952 | ||||
| Total liabilities | $ | 52,243 | $ | 40,226 | ||||
| Total stockholders’ equity | $ | 130,151 | $ | 157,179 | ||||
| Common stock outstanding | 71,417,513 | 70,894,889 | ||||||
| Aclaris Therapeutics, Inc. | ||||||||
| Selected Consolidated Cash Flow Data | ||||||||
| (unaudited, in thousands) | ||||||||
| Nine Months Ended | Nine Months Ended | |||||||
| September 30, 2024 | September 30, 2023 | |||||||
| Net loss | $ | (35,513 | ) | $ | (86,990 | ) | ||
| Depreciation and amortization | 664 | 635 | ||||||
| Stock-based compensation expense | 7,996 | 19,276 | ||||||
| Revaluation of contingent consideration | 3,800 | (600 | ) | |||||
| Changes in operating assets and liabilities | 11,916 | (3,885 | ) | |||||
| Net cash used in operating activities | $ | (11,137 | ) | $ | (71,564 | ) | ||
Aclaris Therapeutics Contact:
investors@aclaristx.com
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