Adagene Reports Full Year 2024 Financial Results and Provides Corporate Update
Adagene (NASDAQ: ADAG) reported its full year 2024 financial results, highlighting significant progress in its clinical programs. The company's Muzastotug Phase 2 dose expansion study showed a 33% overall response rate in MSS CRC patients using a 20 mg/kg loading dose regimen.
Key financial metrics include a cash balance of $85.2 million providing runway into late 2026, net revenue of $0.1 million (down from $18.1 million in 2023), and reduced R&D expenses of $28.8 million (21% decrease from 2023). The company reported a net loss of $33.4 million for 2024.
Pipeline highlights include promising results for ADG126 in combination with pembrolizumab, showing good tolerability with only a 6% discontinuation rate. The company is advancing its SAFEbody technology platform, with two T cell engager programs: ADG138 (HER2-targeted) and ADG152 (CD20-targeted) in development.
Ongoing collaborations with Exelixis, Sanofi, and Roche continue to progress, with milestone payments received and potential future payments totaling up to $2.5 billion plus tiered royalties.
Adagene (NASDAQ: ADAG) ha riportato i risultati finanziari per l'intero anno 2024, evidenziando progressi significativi nei suoi programmi clinici. Lo studio di espansione della dose di fase 2 di Muzastotug ha mostrato un 33% di tasso di risposta complessivo nei pazienti con CRC MSS utilizzando un regime di carico di 20 mg/kg.
I principali indicatori finanziari includono un saldo di cassa di 85,2 milioni di dollari che fornisce un margine fino alla fine del 2026, ricavi netti di 0,1 milioni di dollari (in calo rispetto ai 18,1 milioni di dollari del 2023) e spese di R&S ridotte a 28,8 milioni di dollari (decremento del 21% rispetto al 2023). L'azienda ha riportato una perdita netta di 33,4 milioni di dollari per il 2024.
I punti salienti del pipeline includono risultati promettenti per ADG126 in combinazione con pembrolizumab, mostrando una buona tollerabilità con solo un tasso di interruzione del 6%. L'azienda sta avanzando la sua piattaforma tecnologica SAFEbody, con due programmi di attivazione delle cellule T: ADG138 (mirato a HER2) e ADG152 (mirato a CD20) in fase di sviluppo.
Le collaborazioni in corso con Exelixis, Sanofi e Roche continuano a progredire, con pagamenti per traguardi ricevuti e potenziali pagamenti futuri che ammontano a fino a 2,5 miliardi di dollari più royalties a livelli.
Adagene (NASDAQ: ADAG) informó sus resultados financieros del año completo 2024, destacando avances significativos en sus programas clínicos. El estudio de expansión de dosis de fase 2 de Muzastotug mostró una tasa de respuesta general del 33% en pacientes con CRC MSS utilizando un régimen de carga de 20 mg/kg.
Las métricas financieras clave incluyen un saldo de efectivo de 85.2 millones de dólares que proporciona un margen hasta finales de 2026, ingresos netos de 0.1 millones de dólares (una disminución desde los 18.1 millones de dólares en 2023) y gastos de I+D reducidos a 28.8 millones de dólares (una disminución del 21% desde 2023). La empresa reportó una pérdida neta de 33.4 millones de dólares para 2024.
Los aspectos destacados de la cartera incluyen resultados prometedores para ADG126 en combinación con pembrolizumab, mostrando buena tolerabilidad con solo un 6% de tasa de discontinuación. La empresa está avanzando en su plataforma tecnológica SAFEbody, con dos programas de activadores de células T: ADG138 (dirigido a HER2) y ADG152 (dirigido a CD20) en desarrollo.
Las colaboraciones en curso con Exelixis, Sanofi y Roche continúan avanzando, con pagos de hitos recibidos y pagos futuros potenciales que suman hasta 2.5 mil millones de dólares más regalías escalonadas.
Adagene (NASDAQ: ADAG)는 2024년 전체 연도 재무 결과를 발표하며 임상 프로그램에서의 중요한 진전을 강조했습니다. Muzastotug의 2상 용량 확장 연구는 20 mg/kg 로딩 용량을 사용한 MSS CRC 환자에서 33%의 전체 반응률을 보여주었습니다.
주요 재무 지표로는 2026년 말까지의 운영 자금을 제공하는 현금 잔고 8520만 달러, 2023년의 1810만 달러에서 감소한 10만 달러의 순수익, 2023년 대비 21% 감소한 2880만 달러의 R&D 비용이 포함됩니다. 회사는 2024년에 3340만 달러의 순손실을 보고했습니다.
파이프라인 하이라이트에는 pembrolizumab과의 조합으로 ADG126에 대한 유망한 결과가 포함되어 있으며, 6%의 중단율로 좋은 내약성을 보여주고 있습니다. 회사는 두 개의 T세포 결합제 프로그램인 ADG138 (HER2 표적) 및 ADG152 (CD20 표적)를 개발하며 SAFEbody 기술 플랫폼을 발전시키고 있습니다.
Exelixis, Sanofi, Roche와의 지속적인 협력도 진행 중이며, 이정표 지급금이 수령되었고 최대 25억 달러 및 단계별 로열티에 대한 잠재적 미래 지급금이 있습니다.
Adagene (NASDAQ: ADAG) a publié ses résultats financiers pour l'année complète 2024, mettant en évidence des progrès significatifs dans ses programmes cliniques. L'étude d'expansion de dose de phase 2 de Muzastotug a montré un taux de réponse global de 33% chez les patients atteints de CRC MSS utilisant un régime de charge de 20 mg/kg.
Les indicateurs financiers clés incluent un solde de trésorerie de 85,2 millions de dollars offrant une marge jusqu'à fin 2026, des revenus nets de 0,1 million de dollars (en baisse par rapport à 18,1 millions de dollars en 2023) et des dépenses de R&D réduites à 28,8 millions de dollars (une diminution de 21% par rapport à 2023). L'entreprise a enregistré une perte nette de 33,4 millions de dollars pour 2024.
Les points forts du pipeline comprennent des résultats prometteurs pour ADG126 en combinaison avec le pembrolizumab, montrant une bonne tolérance avec seulement un taux d'abandon de 6%. L'entreprise fait progresser sa plateforme technologique SAFEbody, avec deux programmes d'engagement des cellules T : ADG138 (ciblant HER2) et ADG152 (ciblant CD20) en développement.
Les collaborations en cours avec Exelixis, Sanofi et Roche continuent de progresser, avec des paiements d'étape reçus et des paiements futurs potentiels totalisant jusqu'à 2,5 milliards de dollars plus des redevances échelonnées.
Adagene (NASDAQ: ADAG) hat seine finanziellen Ergebnisse für das Gesamtjahr 2024 veröffentlicht und dabei bedeutende Fortschritte in seinen klinischen Programmen hervorgehoben. Die Phase-2-Dosiserweiterungsstudie von Muzastotug zeigte eine 33% Gesamtansprechrate bei MSS CRC-Patienten mit einem Lade-Dosierungsregime von 20 mg/kg.
Wichtige finanzielle Kennzahlen umfassen einen Cash-Bestand von 85,2 Millionen Dollar, der bis Ende 2026 reicht, einen Nettoumsatz von 0,1 Millionen Dollar (ein Rückgang von 18,1 Millionen Dollar im Jahr 2023) und reduzierte F&E-Ausgaben von 28,8 Millionen Dollar (21% Rückgang gegenüber 2023). Das Unternehmen berichtete von einem Nettoverlust von 33,4 Millionen Dollar für 2024.
Zu den Höhepunkten der Pipeline gehören vielversprechende Ergebnisse für ADG126 in Kombination mit Pembrolizumab, das eine gute Verträglichkeit mit nur einer Abbruchrate von 6% zeigt. Das Unternehmen entwickelt seine SAFEbody-Technologieplattform weiter, mit zwei T-Zell-Engager-Programmen: ADG138 (HER2-zielgerichtet) und ADG152 (CD20-zielgerichtet) in der Entwicklung.
Die laufenden Kooperationen mit Exelixis, Sanofi und Roche schreiten weiter voran, mit erhaltenen Meilensteinzahlungen und potenziellen zukünftigen Zahlungen von bis zu 2,5 Milliarden Dollar zuzüglich gestaffelter Lizenzgebühren.
- 33% overall response rate in Muzastotug Phase 2 trial for MSS CRC
- Strong cash position of $85.2M providing runway into late 2026
- 21% reduction in R&D expenses to $28.8M through focused development
- Low 6% discontinuation rate in ADG126 + pembrolizumab combination
- Multiple ongoing collaborations with major pharma companies including milestone payments
- Net revenue declined significantly to $0.1M from $18.1M in 2023
- Net loss increased to $33.4M from $18.9M in 2023
- Total borrowings from Chinese banks at $18.2M
- Non-GAAP net loss increased to $28.5M from $11.7M in 2023
Insights
Adagene's full-year 2024 results present a mixed picture with promising clinical data counterbalanced by concerning financials. The 33% overall response rate for ADG126 (anti-CTLA-4 SAFEbody) in microsatellite stable colorectal cancer (MSS CRC) represents a potentially significant advancement, as this population typically sees minimal benefit from checkpoint inhibitors. The tolerability profile appears manageable with low discontinuation rates (6%) and no Grade 4/5 safety events.
The company's financial position reveals substantial challenges. Revenue collapsed to just
Adagene's partnerships with Exelixis, Sanofi, and Roche validate its SAFEbody technology platform and provide potential milestone payments, but the company needs catalysts to reverse its financial trajectory. The planned expansion into earlier treatment lines and patients with liver metastases could expand ADG126's market potential if successful.
For a micro-cap biotech (
The clinical data for ADG126 in MSS colorectal cancer warrants attention. A
The mechanism targeting regulatory T cells (Tregs) in the tumor microenvironment addresses a key immunosuppressive mechanism in solid tumors. The company's SAFEbody masking approach for creating conditionally active antibodies theoretically allows higher dosing with reduced off-target toxicity, potentially overcoming the narrow therapeutic window that has broader CTLA-4 inhibitor deployment.
The company's expansion into neoadjuvant treatment at Singapore's National University Cancer Institute provides an opportunity to evaluate efficacy in earlier disease stages. Similarly, the planned inclusion of patients with liver metastases could address a significant unmet need, as these patients typically respond poorly to existing immunotherapies.
The development of masked T cell engagers (TCEs) represents a logical extension of the SAFEbody platform, potentially addressing the toxicity issues that have broader adoption of this powerful therapeutic class. The preclinical data suggesting reduced cytokine release syndrome for ADG152 (CD20-targeted) is particularly relevant given the safety concerns with existing TCEs.
Muzastotug Phase 2 dose expansion in MSS CRC with a 20 mg/kg loading dose regimen shows
SAFEbody technology utilized to create masked T cell engagers for potentially superior safety profile with enhanced therapeutic index
Cash balance of
SAN DIEGO and SUZHOU, China, March 24, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, today reported financial results for the full year 2024 and provided corporate updates.
“The clinical data we generated in 2024 with ADG126 gives us great confidence in our ability to provide patients with colorectal cancer a tolerable, efficacious treatment option. These data also provide the basis for us to expand our study in microsatellite stable colorectal cancer (MSS CRC) to include earlier lines of therapy and patients with liver metastases, a patient subpopulation that has historically seen little to no benefit from checkpoint inhibitors,” said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. “Regulatory T cells, a primary mechanism of resistance, can be overcome through higher and more frequent dosing of a conditionally active anti-CTLA-4 antibody. We continue to believe that anti-CTLA-4 therapy can transform immunotherapy in combination with anti-PD-1 and other therapies. Our SAFEbody masking capability enables the best therapeutic index among all CTLA-4 programs, showing the potential to unlock therapeutic value with a target previously limited by safety concerns.”
Dr. Luo continued, “In addition to ADG126, we have also utilized our SAFEbody masking technology to create T cell engagers (TCEs) that can link T cells to any number of antigens presented on tumor cells. These masked TCEs can recruit the immune system for conditional cytotoxicity, shrinking tumors and prolonging patient survival. The combination of TCEs with ADG126, which depletes CTLA-4 mediated regulatory T cells, is expected to enhance the response to TCE therapy. We look forward to sharing more on our TCE programs going forward.”
PIPELINE HIGHLIGHTS
ADG126 - Phase 1b/2 data:
- 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab, Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), cohort achieved an improved ORR of
33% .- All responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab
- All responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab
- Good tolerability with a manageable safety profile for ADG126 + pembrolizumab combo, with overall low discontinuation rate (
6% ) for the MSS CRC expansion cohort. No Grade 4/5 safety events were seen to date.
- Based on robust safety data of ADG126 at 20 mg/kg Q6W in combination with pembrolizumab, the efficacy of this dosing regimen is being evaluated in the cohort expansion stage of the Phase 1b/2 trial.
- Company also plans to evaluate a broader patient population, including patients with liver metastases, by combining with standard of care medicines, a combination that has been limited by safety concerns in the past.
- Investigator initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer to begin enrolling patients in April at the National University Cancer Institute in Singapore
ADG138, a SAFEbody engineered T cell engager targeting HER2, has shown a wide therapeutic window and extended half-life for prolonged circulation in the tumor micro-environment in preclinical models. ADG138 is currently IND-ready.
ADG152, a SAFEbody engineered T cell engager targeting CD20, is designed to conditionally bind to CD20 on tumor cells and show negligible interaction with healthy cells, yielding a 100-fold reduction in cytokine release syndrome in preclinical models. ADG152 is currently in the IND-enabling phase.
The Company is pursuing strategic partnerships to advance the SAFEbody T cell engager programs.
ONGOING COLLABORATIONS
Exelixis: In June 2023, Adagene received a US
Sanofi: Adagene and Sanofi are collaborating to develop both bispecific and monoclonal SAFEbody antibody candidates, preparing preclinical candidates using Adagene’s SAFEbody precision masking technology for future development and commercialization by Sanofi. The collaboration announced in March 2022 included an upfront payment of US
Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). To date, the combination has been well tolerated. Adagene retains global development and commercialization rights to ADG126.
2025 MILESTONES & CASH RUNWAY
Consistent with ongoing initiatives to prudently manage its cash balance, Adagene expects its current cash balance to fund activities into late 2026, with the following milestones expected in 2025:
- Provide longer-term time-to-event data from the existing Ph 1b/2 study of ADG126 + pembrolizumab in 3L+ MSS CRC
- Update 20 mg/kg loading dose cohort for durability of response (DOR and other time-to-event endpoints)
- Conduct EOP1 meeting with FDA by Q3 to obtain their endorsement on the proposed dose regimens, trial design and patient population
- Initiate evaluation of ADG126 + pembrolizumab in combination with standard of care in MSS CRC patients including those with liver metastases, beginning Q2
- Provide initial clinical data from investigator initiated Phase 2 trial for neoadjuvant ADG126 in colorectal cancer
- Establish additional collaboration/licensing agreements
CORPORATE UPDATES
JC Xu, M.D., Ph.D., Adagene’s Chief Strategy Officer and Head of Regulatory Affairs, has recently transitioned from a full-time employee of Adagene to a consulting role. JC will continue to support the Company’s development while serving as a consultant.
Ms. Yumeng Wang, a member of Adagene’s Board of Directors and a Vice President at General Atlantic, will step down from the Board upon filing of the Company’s 2024 Annual Report on form 20-F due to personal reason. Ms. Wang has served on Adagene’s Board since 2023 and provided invaluable guidance as Adagene has developed ADG126 through first-in-human clinical trials.
Mervyn Turner, Ph.D., Independent Director of Adagene’s Board of Directors, will complete his term as Independent Director concurrent with the filing of the Company’s 2024 Annual Report on form 20-F, and transition to an advisory role. Mr. Turner has served on Adagene’s Board of Directors since April of 2023 and will continue to provide strategic guidance to the Company in this advisory capacity.
FINANCIAL HIGHLIGHTS
Cash and Cash Equivalents:
Cash and cash equivalents were US
Net Revenue:
Net revenue was US
Research and Development (R&D) Expenses:
R&D expenses were US
Administrative Expenses:
Administrative expenses were US
Other Operating Income, Net:
Other operating income, net was nil for the year ended December 31, 2024 compared to US
Net Loss:
Net loss attributable to Adagene Inc.’s shareholders was US
Ordinary Shares Outstanding:
As of December 31, 2024, there were 58,886,944 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.
Non-GAAP Net Loss:
Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US
Non-GAAP Financial Measures:
The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year help identify underlying trends in the company’s business that could otherwise be distorted by the effect of certain expenses that the company includes in its loss for the year. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making.
Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year should not be considered in isolation or construed as an alternative to operating profit, loss for the year or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the company’s data. The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year represent net loss attributable to ordinary shareholders for the year excluding share-based compensation expenses. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The company believes that the exclusion of share-based compensation expenses from the net loss in the “Reconciliation of GAAP and Non-GAAP Results” assists management and investors in making meaningful period-to-period comparisons in the company's operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation. Please see the “Reconciliation of GAAP and Non-GAAP Results” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year to net loss attributable to ordinary shareholders for the year.
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science.
Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues.
Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers.
For more information, please visit: https://investor.adagene.com.
Follow Adagene on WeChat, LinkedIn and Twitter.
SAFEbody® is a registered trademark in the United tates, China, Australia, Japan, Singapore, and the European Union.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Investor Contacts:
Raymond Tam
Raymond_tam@adagene.com
Bruce Mackle
LifeSci Advisors
bmackle@lifesciadvisors.com
Unaudited Consolidated Balance Sheets
| December 31, 2023 | December 31, 2024 | |||||
| US$ | US$ | |||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | 109,934,257 | 85,194,502 | ||||
| Amounts due from related parties | 222,027 | 8,309 | ||||
| Prepayments and other current assets | 3,287,445 | 2,575,194 | ||||
| Total current assets | 113,443,729 | 87,778,005 | ||||
| Property, equipment and software, net | 1,835,121 | 1,125,389 | ||||
| Operating lease right-of-use assets | 365,103 | 283,645 | ||||
| Other non‑current assets | 84,885 | 81,386 | ||||
| TOTAL ASSETS | 115,728,838 | 89,268,425 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | 3,093,752 | 4,241,773 | ||||
| Amounts due to related parties | 16,714,326 | 13,187,966 | ||||
| Accruals and other current liabilities | 3,001,508 | 2,816,038 | ||||
| Income tax payable | 52,884 | 5,265 | ||||
| Short‑term borrowings | 4,235,673 | 4,868,956 | ||||
| Current portion of long-term borrowings | 4,161,549 | 12,923,599 | ||||
| Current portion of operating lease liabilities | 195,955 | 141,341 | ||||
| Total current liabilities | 31,455,647 | 38,184,938 | ||||
| Long‑term borrowings | 13,540,034 | 417,339 | ||||
| Operating lease liabilities | 173,660 | 142,304 | ||||
| TOTAL LIABILITIES | 45,169,341 | 38,744,581 | ||||
| Commitments and contingencies | ||||||
| Shareholders’ equity: | ||||||
| Ordinary shares (par value of US | 5,547 | 5,889 | ||||
| Treasury shares, at cost (1 share as of December 31, 2023 and nil as of December 31, 2024) | (4 | ) | — | |||
| Additional paid‑in capital | 350,105,518 | 362,220,445 | ||||
| Accumulated other comprehensive loss | (1,800,088 | ) | (526,903 | ) | ||
| Accumulated deficit | (277,751,476 | ) | (311,175,587 | ) | ||
| Total shareholders’ equity | 70,559,497 | 50,523,844 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 115,728,838 | 89,268,425 |
Unaudited Consolidated Statements of Comprehensive Loss
| For the Year Ended December 31, 2023 | For the Year Ended December 31, 2024 | |||||
| US$ | US$ | |||||
| Revenues | ||||||
| Licensing and collaboration revenue | 18,111,491 | 103,204 | ||||
| Operating expenses and income | ||||||
| Research and development expenses | (36,639,146 | ) | (28,781,412 | ) | ||
| Third parties | (33,978,642 | ) | (26,837,889 | ) | ||
| Related parties | (2,660,504 | ) | (1,943,523 | ) | ||
| Administrative expenses | (8,672,843 | ) | (7,273,335 | ) | ||
| Other operating income, net | 3,480,632 | — | ||||
| Loss from operations | (23,719,866 | ) | (35,951,543 | ) | ||
| Interest and investment income | 4,283,085 | 3,801,345 | ||||
| Interest expense | (1,107,820 | ) | (851,874 | ) | ||
| Other income, net | 1,843,437 | 466,620 | ||||
| Foreign exchange gain (loss), net | 1,446,202 | (906,212 | ) | |||
| Loss before income tax | (17,254,962 | ) | (33,441,664 | ) | ||
| Income tax benefit (expense) | (1,691,408 | ) | 17,553 | |||
| Net loss attributable to Adagene Inc.’s shareholders | (18,946,370 | ) | (33,424,111 | ) | ||
| Other comprehensive income (loss) | ||||||
| Foreign currency translation adjustments, net of nil tax | (950,783 | ) | 1,273,185 | |||
| Total comprehensive loss attributable to Adagene Inc.’s shareholders | (19,897,153 | ) | (32,150,926 | ) | ||
| Net loss attributable to Adagene Inc.’s shareholders | (18,946,370 | ) | (33,424,111 | ) | ||
| Net loss attributable to ordinary shareholders | (18,946,370 | ) | (33,424,111 | ) | ||
| Weighted average number of ordinary shares used in per share calculation: | ||||||
| —Basic | 54,737,530 | 56,287,903 | ||||
| —Diluted | 54,737,530 | 56,287,903 | ||||
| Net loss per ordinary share | ||||||
| —Basic | (0.35 | ) | (0.59 | ) | ||
| —Diluted | (0.35 | ) | (0.59 | ) | ||
Reconciliation of GAAP and Non-GAAP Results
| For the Year Ended December 31, 2023 | For the Year Ended December 31, 2024 | |||||
| US$ | US$ | |||||
| GAAP net loss attributable to ordinary shareholders | (18,946,370 | ) | (33,424,111 | ) | ||
| Add back: | ||||||
| Share-based compensation expenses | 7,271,700 | 4,909,573 | ||||
| Non-GAAP net loss | (11,674,670 | ) | (28,514,538 | ) | ||
| Weighted average number of ordinary shares used in per share calculation: | ||||||
| —Basic | 54,737,530 | 56,287,903 | ||||
| —Diluted | 54,737,530 | 56,287,903 | ||||
| Non-GAAP net loss per ordinary share | ||||||
| —Basic | (0.21 | ) | (0.51 | ) | ||
| —Diluted | (0.21 | ) | (0.51 | ) | ||
FAQ
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