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Abivax Presents First Quarter 2025 Financial Results

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Abivax (ABVX) reported Q1 2025 financial results, showing increased operating losses of EUR 47.2M compared to EUR 44.7M in Q1 2024. R&D expenses rose by EUR 3.6M to EUR 39.3M, primarily due to Crohn's Disease clinical program progression and expanded R&D headcount. The company recorded a net loss of EUR 52.4M, up from EUR 42.9M in Q1 2024. Cash position decreased to EUR 103.6M from EUR 144.2M at year-end 2024, with current funding expected to sustain operations into Q4 2025. Notable operational progress includes completion of Phase 3 ABTECT trial enrollment for ulcerative colitis treatment and advancement of Crohn's Disease clinical programs.
Abivax (ABVX) ha riportato i risultati finanziari del primo trimestre 2025, evidenziando un aumento delle perdite operative a 47,2 milioni di euro rispetto ai 44,7 milioni di euro del primo trimestre 2024. Le spese di R&S sono salite di 3,6 milioni di euro, raggiungendo 39,3 milioni, principalmente a causa dell'avanzamento del programma clinico per la Malattia di Crohn e dell'espansione del personale di ricerca e sviluppo. L'azienda ha registrato una perdita netta di 52,4 milioni di euro, in aumento rispetto ai 42,9 milioni del primo trimestre 2024. La posizione di cassa è diminuita a 103,6 milioni di euro dai 144,2 milioni di fine 2024, con i fondi attuali che dovrebbero garantire le operazioni fino al quarto trimestre 2025. Tra i progressi operativi significativi vi è il completamento dell'arruolamento nella fase 3 dello studio ABTECT per il trattamento della colite ulcerosa e l'avanzamento dei programmi clinici sulla Malattia di Crohn.
Abivax (ABVX) informó los resultados financieros del primer trimestre de 2025, mostrando un aumento en las pérdidas operativas a 47,2 millones de euros en comparación con 44,7 millones en el primer trimestre de 2024. Los gastos en I+D aumentaron 3,6 millones de euros, alcanzando 39,3 millones, principalmente debido al progreso del programa clínico para la enfermedad de Crohn y a la ampliación del equipo de I+D. La compañía registró una pérdida neta de 52,4 millones de euros, frente a los 42,9 millones del primer trimestre de 2024. La posición de caja disminuyó a 103,6 millones desde 144,2 millones a finales de 2024, con la financiación actual que se espera sostenga las operaciones hasta el cuarto trimestre de 2025. Entre los avances operativos destacados se incluye la finalización del reclutamiento en el ensayo de fase 3 ABTECT para el tratamiento de la colitis ulcerosa y el avance de los programas clínicos para la enfermedad de Crohn.
Abivax(ABVX)는 2025년 1분기 재무 실적을 발표하며, 2024년 1분기 4470만 유로에 비해 운영 손실이 4720만 유로로 증가했다고 밝혔습니다. 연구개발(R&D) 비용은 크론병 임상 프로그램 진행과 R&D 인력 확장으로 인해 360만 유로 증가하여 3930만 유로에 달했습니다. 순손실은 2024년 1분기 4290만 유로에서 5240만 유로로 확대되었습니다. 현금 보유액은 2024년 말 1억4420만 유로에서 1억360만 유로로 감소했으며, 현재 자금으로 2025년 4분기까지 운영을 지속할 것으로 예상됩니다. 주요 운영 진전 사항으로는 궤양성 대장염 치료를 위한 3상 ABTECT 임상시험 등록 완료와 크론병 임상 프로그램의 진전이 포함됩니다.
Abivax (ABVX) a publié ses résultats financiers du premier trimestre 2025, montrant une augmentation des pertes d'exploitation à 47,2 millions d'euros contre 44,7 millions au premier trimestre 2024. Les dépenses de R&D ont augmenté de 3,6 millions d'euros pour atteindre 39,3 millions, principalement en raison de la progression du programme clinique sur la maladie de Crohn et de l'expansion des effectifs en R&D. La société a enregistré une perte nette de 52,4 millions d'euros, en hausse par rapport à 42,9 millions au premier trimestre 2024. La trésorerie a diminué à 103,6 millions d'euros contre 144,2 millions à la fin 2024, les financements actuels devant permettre de soutenir les opérations jusqu'au quatrième trimestre 2025. Parmi les avancées opérationnelles notables figurent l'achèvement du recrutement de l'essai de phase 3 ABTECT pour le traitement de la colite ulcéreuse et le progrès des programmes cliniques sur la maladie de Crohn.
Abivax (ABVX) meldete die Finanzergebnisse für das erste Quartal 2025 und verzeichnete einen Anstieg der operativen Verluste auf 47,2 Mio. EUR gegenüber 44,7 Mio. EUR im ersten Quartal 2024. Die F&E-Ausgaben stiegen um 3,6 Mio. EUR auf 39,3 Mio. EUR, hauptsächlich aufgrund des Fortschritts im klinischen Programm zur Crohn-Krankheit und der Erweiterung des F&E-Teams. Das Unternehmen verzeichnete einen Nettoverlust von 52,4 Mio. EUR, verglichen mit 42,9 Mio. EUR im ersten Quartal 2024. Die Cash-Position sank von 144,2 Mio. EUR Ende 2024 auf 103,6 Mio. EUR, wobei die derzeitige Finanzierung voraussichtlich den Betrieb bis ins vierte Quartal 2025 sichert. Bedeutende operative Fortschritte umfassen den Abschluss der Einschreibung der Phase-3-Studie ABTECT zur Behandlung der Colitis ulcerosa und die Weiterentwicklung der klinischen Programme zur Crohn-Krankheit.
Positive
  • Completion of enrollment for Phase 3 ABTECT trials in Ulcerative Colitis
  • 736% increase in Crohn's Disease clinical program investment shows strong pipeline advancement
  • Reduction in Sales and Marketing expenses from EUR 2.0M to EUR 0.9M demonstrates cost management
  • EUR 103.6M cash position provides runway into Q4 2025
Negative
  • Operating loss increased by EUR 2.5M to EUR 47.2M
  • Net loss widened by EUR 9.5M to EUR 52.4M
  • Cash position decreased significantly from EUR 144.2M to EUR 103.6M
  • Negative shareholders' equity of EUR -6.6M compared to positive EUR 40.6M in previous quarter

Insights

Abivax reports widening losses as R&D spending increases for its inflammatory disease pipeline while cash runway extends to Q4 2025.

Abivax's Q1 2025 results reveal an increasing burn rate with operating losses widening to €47.2 million from €44.7 million in Q1 2024. This 5.6% deterioration stems primarily from heightened R&D investment, particularly in their Crohn's disease program which saw an extraordinary 736% increase in spending.

The cash position of €103.6 million represents a concerning 28.2% reduction from €144.2 million at year-end 2024, just three months prior. This accelerated cash utilization of approximately €40 million per quarter suggests significant financial pressure ahead, with management projecting runway only into Q4 2025 - effectively 5-6 months of operational capacity remaining.

While R&D increases align with the company's clinical advancement, including completed enrollment for Phase 3 ABTECT trials in ulcerative colitis and progression of Phase 2b trials in Crohn's disease, the deteriorating financial position is concerning. The company now reports negative shareholders' equity of €6.6 million, compared to positive €40.6 million at year-end 2024.

Most troubling is the €7.0 million negative swing in financial income/loss, shifting from a €1.8 million gain to a €5.2 million loss year-over-year. With €111.4 million in financial liabilities and a burn rate exceeding €33 million quarterly for operations alone, Abivax will likely require significant additional financing well before their stated Q4 2025 timeline to maintain operations and advance their clinical programs.


Abivax Presents First Quarter 2025 Financial Results

PARIS, France, June 2, 2025, 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, announces today its key financial results for the quarter ended March 31, 2025.

Abivax provided the following updates on its business and operational goals in press releases published:

  • On January 9, 2025 in a press release titled “Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment”
  • On January 23, 2025 in a press release titled “Abivax Announces Presentation of Seven Abstracts for Obefazimod in Ulcerative Colitis at 2025 European Crohn’s and Colitis Organization 20th Annual Congress”
  • On January 28, 2025 in a press release titled “Abivax Publishes 2025 Financial Calendar”
  • On February 21, 2025 in a press release titled “Abivax to Host Key Opinion Leader (KOL) Webcast on March 17, 2025”
  • On March 24, 2025 in a press release titled “Abivax Announces Full Year 2024 Financial Results”
  • On March 26, 2025 in a press release titled “Abivax Publishes Financial Reports with the French and U.S. Securities Regulatory Agencies”
  • On April 22, 2025 in a press release titled “Abivax Announces Appointment of Dominik Höchli, MD to Board of Directors”
  • On April 22, 2025 in a press release titled “Abivax Announces Annual General Meeting Details as Company Advances Toward Key 2025 Value-Driving Milestones”
  • On April 29, 2025 in a press release titled “Abivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis”

First Quarter 2025 Financial Highlights (IFRS figures)
(Consolidated, unaudited results)

Income Statement Three months ended
March 31,
 Change
in millions of euros 20252024  
Total operating income 1.01.2 -0.2
Total operating expenses     
of which Research and Development costs (39.3)(35.7) (3.6)
of which Sales and Marketing costs (0.9)(2.0) 1.1
of which General and Administrative costs (8.0)(8.1) 0.1
Operating loss (47.2)(44.7) (2.5)
Financial (loss) income (5.2)1.8 (7.0)
Net loss for the period (52.4)(42.9) (9.5)


Balance Sheet March 31, 2025December 31, 2024 Change
in millions of euros     
      
Net financial position 18.553.4 (34.9)
of which other current financial assets and other current receivables and assets* 26.323.2 2.6
of which available cash and cash equivalents 103.6144.2 (40.6)
(of which financial liabilities)** (111.4)(114.0) 2.6
      
Total Assets 166.9205.2 (38.3)
      
Total Shareholders’ Equity (6.6)40.6 (47.2)
* Excluding items of the liquidity contract (liquidity and own shares) and prepaid expenses

** Financial liabilities include borrowings, convertible loan notes, derivative instruments, royalty certificates and other financial liabilities


  • Operating loss increased by EUR 2.5M to EUR -47.2M for the three months ended March 31, 2025 compared to EUR -44.7M for the three months ended March 31, 2024. Operating income, consisting predominantly of Research Tax Credits and Subsidies, decreased by EUR 0.2M to EUR 1.0M for the three months ended March 31, 2025 compared to EUR 1.2M for the three months ended March 31, 2024. The increase in operating loss was driven by operating expenses as described further below.
  • Research and development (R&D) expenses increased by EUR 3.6M to EUR -39.3M in the first quarter of 2025 compared to EUR -35.7M in the same period in 2024. This increase was predominantly driven by expenses related to:
    • A EUR 3.0M, or 736% increase related to our Crohn’s Disease (CD) clinical program, driven by the progression of Phase 2b clinical trials for obefazimod in CD;
    • A EUR 2.7M, or 78%, increase in transversal activities related to the overall expansion of the R&D headcount to support our organizational growth and the issuance of new equity awards to officers and employees in R&D; and
    • Partially offset by a decrease of EUR 1.3M, or -4%, related to our Ulcerative Colitis (UC) clinical program as our Phase 3 clinical trials reached full enrollment.
  • Sales and marketing (S&M) expenses decreased to EUR -0.9M for the three-month period ended March 31, 2025 compared to EUR -2.0M for the same period in 2024. The decrease was predominantly driven by a reduction in non-critical expenses to manage our cash expense.
  • General and administrative (G&A) expenses decreased to EUR -8.0M for the first quarter of 2025 compared to EUR -8.1M for the first quarter of 2024. This decrease was primarily due to:
    • A decrease in personnel costs of EUR 0.6M, resulting from the expense recognition pattern of equity awards granted to certain of our officers and employees, many of which were issued in connection with our U.S. initial public offering and listing on Nasdaq in October 2023;
    • Offset by EUR 0.4M increase related to legal and professional fees and other costs associated with operating as a dual-listed public company.
  • For the three-months ended March 31, 2025, our EUR -5.2M net financial loss was driven primarily by the following items:
    • Interest expenses of EUR -3.5M in relation to borrowings and loans;
    • Non-cash expense of EUR -1.0M in relation in relation to our royalty certificates; and
    • Foreign Exchange losses of EUR -1.0M;
    • Mostly offset by interest income of EUR 0.9M in relation to the invested proceeds from our U.S. initial public offering and listing on Nasdaq.
  • Cash position as of March 31, 2025 was EUR 103.6M compared to EUR 144.2M as of December 31, 2024. The decrease was due to EUR -33.3M used in operating activities and EUR -7.8M related to principal and interest paid on our debt facilities. This decrease was partially offset by EUR 1.0M of interest received on cash.

Based on the currently available funds and operating assumptions, Abivax expects to be able to finance its operating cash flow requirements into the fourth quarter of 2025.

*****

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @ABIVAX.


Contacts:

Abivax Investor Relations
Patrick Malloy
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “design,” “expect,” “forward,” “future,” “potential,” “plan,” “project,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax's drug candidates, Abivax’s cash runway, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.


FAQ

What were Abivax's (ABVX) key financial results for Q1 2025?

Abivax reported a net loss of EUR 52.4M, operating loss of EUR 47.2M, and ended Q1 2025 with a cash position of EUR 103.6M.

How much did Abivax's R&D expenses increase in Q1 2025?

R&D expenses increased by EUR 3.6M to EUR 39.3M compared to EUR 35.7M in Q1 2024, mainly due to Crohn's Disease clinical program progression.

What is Abivax's cash runway as of Q1 2025?

Based on current funds and operating assumptions, Abivax expects to finance operations into the fourth quarter of 2025.

What progress did Abivax make in its clinical trials during Q1 2025?

Abivax completed enrollment for the Phase 3 ABTECT trials in ulcerative colitis patients and advanced its Phase 2b clinical trials for obefazimod in Crohn's Disease.

How did Abivax's financial position change from December 2024 to March 2025?

Cash position decreased from EUR 144.2M to EUR 103.6M, and shareholders' equity declined from EUR 40.6M to negative EUR -6.6M.
Abivax S.A.

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