[6-K] Abivax SA American Current Report (Foreign Issuer)
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Abivax SA reported interim results and updates through June 30, 2025 and subsequent events through August 2025. The company completed enrollment in its Phase 3 ABTECT program for ulcerative colitis on April 29, 2025 and announced positive July 22, 2025 induction results: the 50 mg once-daily dose met the FDA primary endpoint of clinical remission at Week 8 with placebo-adjusted rates of 19.3% (ABTECT-1, p<0.0001) and 13.4% (ABTECT-2, p=0.0001). For the six months ended June 30, 2025, R&D expenses rose to €77.9 million (up 21% vs prior year) driven by clinical progression; net financial loss was impacted by €6.9 million interest, €2.3 million FX losses and other non-cash items. Cash and cash equivalents were €60.9 million at June 30, 2025. A July 28, 2025 offering generated gross proceeds of €637.5 million (≈$747.5M) with estimated net proceeds ≈€597.2 million, which management expects, together with existing cash and note conversions, to fund operations into Q4 2027 and provide 12 months of runway after a planned NDA submission, assuming positive maintenance results. The statements were prepared on a going concern basis; shareholders' equity was negative at €48.3 million as of June 30, 2025. The company disclosed conversions of convertible instruments and potential material fair-value impacts in subsequent periods.
Abivax SA ha comunicato risultati e aggiornamenti al 30 giugno 2025 e eventi successivi fino ad agosto 2025. La società ha completato il reclutamento del programma di Fase 3 ABTECT per la colite ulcerosa il 29 aprile 2025 e il 22 luglio 2025 ha reso noti risultati positivi per l’induzione: la dose da 50 mg una volta al giorno ha raggiunto l’endpoint primario FDA di remissione clinica a 8 settimane con tassi aggiustati rispetto a placebo di 19,3% (ABTECT-1, p<0,0001) e 13,4% (ABTECT-2, p=0,0001). Nei sei mesi chiusi il 30 giugno 2025 le spese R&S sono salite a €77,9 milioni (in aumento del 21% rispetto all’anno precedente) a causa dell’avanzamento clinico; la perdita finanziaria netta è stata influenzata da €6,9 milioni di interessi, €2,3 milioni di perdite FX e altri elementi non monetari. La liquidità era di €60,9 milioni al 30 giugno 2025. Un collocamento del 28 luglio 2025 ha raccolto proventi lordi per €637,5 milioni (≈$747,5M) con proventi netti stimati ≈€597,2 milioni, che la direzione ritiene, unitamente alla cassa disponibile e alle conversioni di note, sufficienti a finanziare le operazioni fino al quarto trimestre 2027 e a fornire 12 mesi di runway dopo una prevista presentazione NDA, assumendo risultati di mantenimento positivi. Le comunicazioni sono redatte sulla base della continuità aziendale; il patrimonio netto era negativo per €48,3 milioni al 30 giugno 2025. La società ha altresì segnalato conversioni di strumenti convertibili e possibili impatti significativi di fair value nei periodi successivi.
Abivax SA informó resultados interinos y actualizaciones hasta el 30 de junio de 2025 y eventos posteriores hasta agosto de 2025. La compañía completó la inscripción en su programa de Fase 3 ABTECT para colitis ulcerosa el 29 de abril de 2025 y anunció resultados de inducción positivos el 22 de julio de 2025: la dosis de 50 mg una vez al día cumplió el endpoint primario de la FDA de remisión clínica en la semana 8 con tasas ajustadas frente a placebo de 19,3% (ABTECT-1, p<0,0001) y 13,4% (ABTECT-2, p=0,0001). En los seis meses cerrados al 30 de junio de 2025, los gastos de I+D aumentaron a €77,9 millones (subida del 21% respecto al año anterior) impulsados por el avance clínico; la pérdida financiera neta se vio afectada por €6,9 millones en intereses, €2,3 millones en pérdidas por FX y otros elementos no monetarios. El efectivo y equivalentes ascendían a €60,9 millones al 30 de junio de 2025. Una emisión el 28 de julio de 2025 generó ingresos brutos de €637,5 millones (≈$747,5M) con ingresos netos estimados ≈€597,2 millones, que la dirección espera que, junto con la caja existente y las conversiones de notas, financien las operaciones hasta el cuarto trimestre de 2027 y proporcionen 12 meses de runway tras una prevista presentación de NDA, asumiendo resultados de mantenimiento positivos. Los estados se prepararon sobre la base de empresa en funcionamiento; el patrimonio neto era negativo en €48,3 millones al 30 de junio de 2025. La compañía divulgó conversiones de instrumentos convertibles y posibles impactos materiales de valor razonable en periodos posteriores.
Abivax SA는 2025년 6월 30일 기준 중간 결과와 2025년 8월까지의 이후 사건을 공시했습니다. 이 회사는 2025년 4월 29일 궤양성 대장염 대상 3상 ABTECT 프로그램의 등록을 완료했으며, 2025년 7월 22일 유도요법 결과가 긍정적임을 발표했습니다. 50mg 1일 1회 용량은 FDA의 8주차 임상 관해 주요 지표를 충족했으며 플라시보 보정 치유율은 19.3% (ABTECT-1, p<0.0001) 및 13.4% (ABTECT-2, p=0.0001)였습니다. 2025년 6월 30일로 끝난 6개월 동안 연구개발비는 임상 진전에 따라 €77.9백만(전년 대비 21% 증가)으로 증가했고, 순재무손실에는 €6.9백만의 이자, €2.3백만의 외환손실 및 기타 비현금항목이 영향을 미쳤습니다. 2025년 6월 30일 현금및현금성자산은 €60.9백만이었습니다. 2025년 7월 28일 진행된 유상증자에서 총 €637.5백만(≈$747.5M)을 조달했으며 순수입은 추정치로 ≈€597.2백만입니다. 경영진은 이를 기존 현금 및 어음 전환과 합쳐 2027년 4분기까지 운영자금을 조달하고, (유지요법 결과가 긍정적일 경우) 예정된 NDA 제출 후 12개월의 운영여력을 제공할 것으로 기대합니다. 재무제표는 계속기업 가정으로 작성되었으며, 2025년 6월 30일 기준 자본은 €48.3백만의 마이너스였습니다. 회사는 전환사채 등의 전환과 향후 기간에 발생할 수 있는 공정가치상의 중대한 영향 가능성도 공시했습니다.
Abivax SA a publié des résultats intermédiaires et des mises à jour au 30 juin 2025 ainsi que des événements ultérieurs jusqu’à août 2025. La société a achevé l’enrôlement de son programme de phase 3 ABTECT pour la rectocolite hémorragique le 29 avril 2025 et a annoncé le 22 juillet 2025 des résultats d’induction positifs : la dose de 50 mg une fois par jour a atteint le critère primaire de la FDA de rémission clinique à la semaine 8 avec des taux ajustés par rapport au placebo de 19,3% (ABTECT‑1, p<0,0001) et 13,4% (ABTECT‑2, p=0,0001). Pour les six mois clos le 30 juin 2025, les dépenses R&D ont augmenté à €77,9 M (soit +21% vs l’année précédente) en raison de la progression clinique ; la perte financière nette a été affectée par €6,9 M d’intérêts, €2,3 M de pertes de change et d’autres éléments non monétaires. La trésorerie et équivalents s’élevaient à €60,9 M au 30 juin 2025. Une émission du 28 juillet 2025 a généré des produits bruts de €637,5 M (≈$747,5M) avec des produits nets estimés à ≈€597,2 M, que la direction prévoit, avec la trésorerie existante et les conversions de billets, d’utiliser pour financer les opérations jusqu’au T4 2027 et fournir 12 mois de visibilité après un dépôt prévu de NDA, sous réserve de résultats de maintenance positifs. Les états ont été établis sur la base de la continuité d’exploitation ; les capitaux propres étaient négatifs à €48,3 M au 30 juin 2025. La société a également divulgué des conversions d’instruments convertibles et des impacts potentiellement significatifs de la juste valeur dans les périodes ultérieures.
Abivax SA berichtete über Zwischenergebnisse und Aktualisierungen zum 30. Juni 2025 sowie über nachfolgende Ereignisse bis August 2025. Das Unternehmen schloss die Rekrutierung für das Phase‑3‑Programm ABTECT bei Colitis ulcerosa am 29. April 2025 ab und meldete am 22. Juli 2025 positive Induktionsresultate: Die einmal täglich verabreichte 50‑mg‑Dosis erfüllte den primären FDA‑Endpunkt der klinischen Remission in Woche 8 mit placebokorrigierten Raten von 19,3% (ABTECT‑1, p<0,0001) bzw. 13,4% (ABTECT‑2, p=0,0001). Für die sechs Monate zum 30. Juni 2025 stiegen die F&E‑Aufwendungen auf €77,9 Mio. (plus 21% gegenüber dem Vorjahr) bedingt durch den klinischen Fortschritt; der Nettofinanzverlust wurde durch €6,9 Mio. Zinsen, €2,3 Mio. FX‑Verluste und weitere nicht zahlungswirksame Posten beeinflusst. Zahlungsmittel und Zahlungsmitteläquivalente beliefen sich zum 30. Juni 2025 auf €60,9 Mio. Eine Platzierung am 28. Juli 2025 brachte Bruttoerlöse von €637,5 Mio. (≈$747,5M) mit geschätzten Nettoerlösen von ≈€597,2 Mio., die das Management zusammen mit vorhandenen Barmitteln und Notenkonversionen voraussichtlich zur Finanzierung der Geschäftstätigkeit bis Q4 2027 und für 12 Monate Laufzeit nach einer geplanten NDA‑Einreichung, bei positiven Maintenance‑Ergebnissen, nutzen wird. Die Angaben wurden unter Fortführungsannahme erstellt; das Eigenkapital war zum 30. Juni 2025 negativ mit €48,3 Mio.. Das Unternehmen gab zudem Umwandlungen von wandelbaren Instrumenten und mögliche wesentliche Fair‑Value‑Auswirkungen in nachfolgenden Perioden an.
Positive
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Negative
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Insights
TL;DR: Positive Phase 3 outcomes and a large July 2025 equity raise materially improve funding and de-risk near-term development for obefazimod.
Abivax reported statistically significant induction efficacy at 50 mg in two large global Phase 3 trials, a high-impact clinical milestone that reduces regulatory uncertainty and increases probability of approval for UC. The July 2025 ADS offering raised gross €637.5M (net ≈€597.2M), materially strengthening liquidity and extending runway into late 2027 under management assumptions. This combination of clinical validation and substantial capital addresses two of the biggest value drivers for a clinical-stage biotech: clinical proof-of-concept and financing. Key metrics: R&D spend €77.9M H1 2025, cash €60.9M at June 30, 2025, and negative equity €48.3M offset by the offering proceeds and note conversions.
TL;DR: While financing and Phase 3 success reduce short-term funding risk, the company remains exposed to execution, regulatory and market risks.
Abivax faces continuing operational and financial risks despite the July offering. H1 2025 net financial losses were driven by sizable interest costs (≈€6.9M), FX volatility (≈€2.3M loss) and non-cash items; shareholders' equity remained negative as of June 30, 2025. Management expects runway into Q4 2027 assuming positive maintenance data and planned NDA timing; those assumptions are critical. The company also highlighted potential material fair-value adjustments from debt/royalty valuations and the dependency on successful commercialization and further financing if timelines or outcomes change.
Abivax SA ha comunicato risultati e aggiornamenti al 30 giugno 2025 e eventi successivi fino ad agosto 2025. La società ha completato il reclutamento del programma di Fase 3 ABTECT per la colite ulcerosa il 29 aprile 2025 e il 22 luglio 2025 ha reso noti risultati positivi per l’induzione: la dose da 50 mg una volta al giorno ha raggiunto l’endpoint primario FDA di remissione clinica a 8 settimane con tassi aggiustati rispetto a placebo di 19,3% (ABTECT-1, p<0,0001) e 13,4% (ABTECT-2, p=0,0001). Nei sei mesi chiusi il 30 giugno 2025 le spese R&S sono salite a €77,9 milioni (in aumento del 21% rispetto all’anno precedente) a causa dell’avanzamento clinico; la perdita finanziaria netta è stata influenzata da €6,9 milioni di interessi, €2,3 milioni di perdite FX e altri elementi non monetari. La liquidità era di €60,9 milioni al 30 giugno 2025. Un collocamento del 28 luglio 2025 ha raccolto proventi lordi per €637,5 milioni (≈$747,5M) con proventi netti stimati ≈€597,2 milioni, che la direzione ritiene, unitamente alla cassa disponibile e alle conversioni di note, sufficienti a finanziare le operazioni fino al quarto trimestre 2027 e a fornire 12 mesi di runway dopo una prevista presentazione NDA, assumendo risultati di mantenimento positivi. Le comunicazioni sono redatte sulla base della continuità aziendale; il patrimonio netto era negativo per €48,3 milioni al 30 giugno 2025. La società ha altresì segnalato conversioni di strumenti convertibili e possibili impatti significativi di fair value nei periodi successivi.
Abivax SA informó resultados interinos y actualizaciones hasta el 30 de junio de 2025 y eventos posteriores hasta agosto de 2025. La compañía completó la inscripción en su programa de Fase 3 ABTECT para colitis ulcerosa el 29 de abril de 2025 y anunció resultados de inducción positivos el 22 de julio de 2025: la dosis de 50 mg una vez al día cumplió el endpoint primario de la FDA de remisión clínica en la semana 8 con tasas ajustadas frente a placebo de 19,3% (ABTECT-1, p<0,0001) y 13,4% (ABTECT-2, p=0,0001). En los seis meses cerrados al 30 de junio de 2025, los gastos de I+D aumentaron a €77,9 millones (subida del 21% respecto al año anterior) impulsados por el avance clínico; la pérdida financiera neta se vio afectada por €6,9 millones en intereses, €2,3 millones en pérdidas por FX y otros elementos no monetarios. El efectivo y equivalentes ascendían a €60,9 millones al 30 de junio de 2025. Una emisión el 28 de julio de 2025 generó ingresos brutos de €637,5 millones (≈$747,5M) con ingresos netos estimados ≈€597,2 millones, que la dirección espera que, junto con la caja existente y las conversiones de notas, financien las operaciones hasta el cuarto trimestre de 2027 y proporcionen 12 meses de runway tras una prevista presentación de NDA, asumiendo resultados de mantenimiento positivos. Los estados se prepararon sobre la base de empresa en funcionamiento; el patrimonio neto era negativo en €48,3 millones al 30 de junio de 2025. La compañía divulgó conversiones de instrumentos convertibles y posibles impactos materiales de valor razonable en periodos posteriores.
Abivax SA는 2025년 6월 30일 기준 중간 결과와 2025년 8월까지의 이후 사건을 공시했습니다. 이 회사는 2025년 4월 29일 궤양성 대장염 대상 3상 ABTECT 프로그램의 등록을 완료했으며, 2025년 7월 22일 유도요법 결과가 긍정적임을 발표했습니다. 50mg 1일 1회 용량은 FDA의 8주차 임상 관해 주요 지표를 충족했으며 플라시보 보정 치유율은 19.3% (ABTECT-1, p<0.0001) 및 13.4% (ABTECT-2, p=0.0001)였습니다. 2025년 6월 30일로 끝난 6개월 동안 연구개발비는 임상 진전에 따라 €77.9백만(전년 대비 21% 증가)으로 증가했고, 순재무손실에는 €6.9백만의 이자, €2.3백만의 외환손실 및 기타 비현금항목이 영향을 미쳤습니다. 2025년 6월 30일 현금및현금성자산은 €60.9백만이었습니다. 2025년 7월 28일 진행된 유상증자에서 총 €637.5백만(≈$747.5M)을 조달했으며 순수입은 추정치로 ≈€597.2백만입니다. 경영진은 이를 기존 현금 및 어음 전환과 합쳐 2027년 4분기까지 운영자금을 조달하고, (유지요법 결과가 긍정적일 경우) 예정된 NDA 제출 후 12개월의 운영여력을 제공할 것으로 기대합니다. 재무제표는 계속기업 가정으로 작성되었으며, 2025년 6월 30일 기준 자본은 €48.3백만의 마이너스였습니다. 회사는 전환사채 등의 전환과 향후 기간에 발생할 수 있는 공정가치상의 중대한 영향 가능성도 공시했습니다.
Abivax SA a publié des résultats intermédiaires et des mises à jour au 30 juin 2025 ainsi que des événements ultérieurs jusqu’à août 2025. La société a achevé l’enrôlement de son programme de phase 3 ABTECT pour la rectocolite hémorragique le 29 avril 2025 et a annoncé le 22 juillet 2025 des résultats d’induction positifs : la dose de 50 mg une fois par jour a atteint le critère primaire de la FDA de rémission clinique à la semaine 8 avec des taux ajustés par rapport au placebo de 19,3% (ABTECT‑1, p<0,0001) et 13,4% (ABTECT‑2, p=0,0001). Pour les six mois clos le 30 juin 2025, les dépenses R&D ont augmenté à €77,9 M (soit +21% vs l’année précédente) en raison de la progression clinique ; la perte financière nette a été affectée par €6,9 M d’intérêts, €2,3 M de pertes de change et d’autres éléments non monétaires. La trésorerie et équivalents s’élevaient à €60,9 M au 30 juin 2025. Une émission du 28 juillet 2025 a généré des produits bruts de €637,5 M (≈$747,5M) avec des produits nets estimés à ≈€597,2 M, que la direction prévoit, avec la trésorerie existante et les conversions de billets, d’utiliser pour financer les opérations jusqu’au T4 2027 et fournir 12 mois de visibilité après un dépôt prévu de NDA, sous réserve de résultats de maintenance positifs. Les états ont été établis sur la base de la continuité d’exploitation ; les capitaux propres étaient négatifs à €48,3 M au 30 juin 2025. La société a également divulgué des conversions d’instruments convertibles et des impacts potentiellement significatifs de la juste valeur dans les périodes ultérieures.
Abivax SA berichtete über Zwischenergebnisse und Aktualisierungen zum 30. Juni 2025 sowie über nachfolgende Ereignisse bis August 2025. Das Unternehmen schloss die Rekrutierung für das Phase‑3‑Programm ABTECT bei Colitis ulcerosa am 29. April 2025 ab und meldete am 22. Juli 2025 positive Induktionsresultate: Die einmal täglich verabreichte 50‑mg‑Dosis erfüllte den primären FDA‑Endpunkt der klinischen Remission in Woche 8 mit placebokorrigierten Raten von 19,3% (ABTECT‑1, p<0,0001) bzw. 13,4% (ABTECT‑2, p=0,0001). Für die sechs Monate zum 30. Juni 2025 stiegen die F&E‑Aufwendungen auf €77,9 Mio. (plus 21% gegenüber dem Vorjahr) bedingt durch den klinischen Fortschritt; der Nettofinanzverlust wurde durch €6,9 Mio. Zinsen, €2,3 Mio. FX‑Verluste und weitere nicht zahlungswirksame Posten beeinflusst. Zahlungsmittel und Zahlungsmitteläquivalente beliefen sich zum 30. Juni 2025 auf €60,9 Mio. Eine Platzierung am 28. Juli 2025 brachte Bruttoerlöse von €637,5 Mio. (≈$747,5M) mit geschätzten Nettoerlösen von ≈€597,2 Mio., die das Management zusammen mit vorhandenen Barmitteln und Notenkonversionen voraussichtlich zur Finanzierung der Geschäftstätigkeit bis Q4 2027 und für 12 Monate Laufzeit nach einer geplanten NDA‑Einreichung, bei positiven Maintenance‑Ergebnissen, nutzen wird. Die Angaben wurden unter Fortführungsannahme erstellt; das Eigenkapital war zum 30. Juni 2025 negativ mit €48,3 Mio.. Das Unternehmen gab zudem Umwandlungen von wandelbaren Instrumenten und mögliche wesentliche Fair‑Value‑Auswirkungen in nachfolgenden Perioden an.
1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of September 2025
Commission file number: 001-41842
(Exact name of Registrant as specified in its charter and translation of Registrant’s name into English)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-
F.
Form 20-F ☒ Form 40-F ☐
2
On September 8, 2025, Abivax SA (the "Registrant") announced its financial results as of and for the three and six
months ended June 30, 2025 and issued a press release and its unaudited interim condensed consolidated financial
statements, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and incorporated herein by
reference.
Incorporation by Reference
This Report on Form 6-K, including Exhibits 99.1 and 99.2, except for the quotes contained therein, shall be deemed
to be incorporated by reference into the Registrant’s registration statements on Form F-3 (File No. 333-283336),
Form F-3 (File No. 288884) and Form S-8 (File No. 333-286069) and to be part thereof from the date on which this
Report is filed, to the extent not superseded by documents or reports subsequently filed.
Exhibit Index | |
Exhibit 99.1 | Press release, dated September 8, 2025 |
Exhibit 99.2 | Unaudited Interim Condensed Consolidated Financial Statements |
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly.
Abivax SA (Registrant) | ||
Date: September 8, 2025 | /s/ Marc de Garidel | |
Chief Executive Officer |
4
Exhibit 99.2
Unaudited Interim Condensed Consolidated Financial Statements
TABLE OF CONTENTS
Page | |
INTRODUCTION................................................................................................................. | 1 |
RISK FACTORS................................................................................................................... | 3 |
OPERATING RESULTS........................................................................................................ | 4 |
INDEX TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS......................................................... | F-1 |
5
INTRODUCTION
Unless otherwise indicated or the context otherwise requires, “Abivax,” “the Company,” “the Group,” “we,” “us”
and “our” refer to Abivax SA and its consolidated subsidiary, taken as a whole.
“Abivax” and the Abivax logo and other trademarks or service marks of Abivax SA appearing in this half-year
report are the property of Abivax SA. Solely for convenience, the trademarks, service marks and trade names
referred to in this half-year report are listed without the ® and ™ symbols, but such references should not be construed
as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their right
thereto. All other trademarks, trade names and service marks appearing in this half-year report are the property of
their respective owners. We do not intend to use or display other companies’ trademarks and trade names to imply
any relationship with, or endorsement or sponsorship of us by, any other companies.
This half-year report includes our unaudited interim condensed consolidated financial statements of financial
position as of June 30, 2025 and December 31, 2024 and the related unaudited condensed consolidated statements of
loss and comprehensive loss for each of the three- and six-month periods ended June 30, 2025 and June 30, 2024
and the unaudited condensed consolidated statements of cash flows and changes in shareholder's equity for the six-
month periods ended June 30, 2025 and June 30, 2024, prepared in accordance with International Financial
Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and adopted by
the European Union ("EU") regulation n°1606/2022 of July 19, 2022. None of our financial statements were
prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Our financial statements
are presented in euros and, unless otherwise stated, all monetary amounts are in euros. All references in this half-
year report to “$”, “U.S. dollars” and “dollars” mean U.S. dollars, and all references to “€”, “EUR” and “euros”
mean European Monetary Union euros, unless otherwise noted. Throughout this half-year report, references to
"ADSs" mean American Depositary Shares (“ADSs”) or ordinary shares represented by such ADSs, as the case may
be.
Special Note Regarding Forward-Looking Statements
This half-year report contains forward-looking statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"), that
are based on our management’s beliefs and assumptions and on information currently available to our management.
All statements other than present and historical facts and conditions contained in this half-year report, including
statements regarding our future results of operations and financial positions, business strategy, plans and our
objectives for future operations, are forward-looking statements. When used in this half-year report, the words
“anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,”
“will,” “would,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions
identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
•the prospects of attaining, maintaining and expanding marketing authorization for our drug candidates;
•the potential attributes and clinical advantages of our drug candidates;
•the initiation, timing, progress and results of our preclinical and clinical trials (and those conducted by third
parties) and other research and development programs;
•the timing of the availability of data from our clinical trials;
•the timing of and our ability to advance drug candidates through clinical development;
•the timing or likelihood of regulatory meetings and filings;
•the timing of and our ability to obtain and maintain regulatory approvals for any of our drug candidates;
•our ability to identify and develop new drug candidates from our preclinical studies;
•our ability to develop sales and marketing capabilities and transition into a commercial-stage company;
•the effects of increased competition as well as innovations by new and existing competitors in our industry;
•our ability to enter into strategic relationships or partnerships;
•our ability to obtain, maintain, protect and enforce our intellectual property rights and propriety
technologies and to operate our business without infringing the intellectual property rights and proprietary
technology of third parties;
•our expectations regarding our cash requirements;
6
•our estimates regarding expenses, future revenues, capital requirements and the need for additional
financing;
•the impact of government laws and regulations;
•our competitive position; and
•unfavorable conditions in our industry, the global economy or global supply chain, including financial and
credit market fluctuations, international trade relations, political turmoil, natural catastrophes, warfare (such
as the Russia-Ukraine war and the Israel-Hamas war), and terrorist attacks.
We encourage you to read and carefully consider all of the risk factors disclosed in our annual report on Form 20-F
for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 24,
2025 (the “Annual Report”) under the caption “Item 3.D—Risk Factors” for a more complete understanding of the
risks and uncertainties material to our business, including important factors that may cause our actual results to
differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we
cannot assure you that the forward-looking statements in this document will prove to be accurate. Furthermore, if
our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant
uncertainties in these forward-looking statements, you should not regard these statements as a representation or
warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at
all. These forward-looking statements represent our plans, objectives, estimates, expectations and intentions only as
of the date of this filing. We undertake no obligation to publicly update any forward-looking statements, whether as
a result of new information, future events or otherwise, except as required by law.
You should read this document and the documents that we reference herein completely and with the understanding
that our actual future results may be materially different from what we expect. We qualify all of our forward-looking
statements by these cautionary statements.
This half-year report contains market data and industry forecasts that were obtained from industry publications.
These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such
estimates. We have not independently verified any third-party information. While we believe the market position,
market opportunity and market size information included in this half-year report is generally reliable, such
information is inherently imprecise.
Rounding of Figures
Certain figures (including data expressed in thousands or millions of euros or dollars) and the percentages presented
in this half-year report have been rounded up or down. Accordingly, totals given may vary slightly from those
obtained by adding the exact (unrounded) values of those same figures.
7
RISK FACTORS
The Company’s business faces significant risks. You should carefully consider all of the information set forth in this
document and in the Company’s other filings with the SEC, including the risk factors which the Company faces and
which are faced by the Company’s industry described in “Item 3.D—Risk Factors” of the Company’s Annual
Report on Form 20-F for the fiscal year ended December 31, 2024. Our risk factors have not changed materially
from those described in our Annual Report on Form 20-F. Our business, financial condition or results of operations
could be materially adversely affected by any of these risks.
8
OPERATING RESULTS
Overview
We are 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. Our
lead drug candidate, obefazimod, is currently being evaluated in the following indications:
•Ulcerative colitis (“UC”): Phase 3 clinical trials for the treatment of adults with moderately to severely
active UC are ongoing (“ABTECT”). On July 22, 2025, we announced the positive Phase 3 results of our
ABTECT 8-week induction trials. Top-line results from the 44-week maintenance data read-out expected
during the second quarter of 2026.
•Crohn’s disease (“CD”): On October 3, 2024, we announced the first patient enrolled in our ENHANCE-
CD Phase 2b clinical trial of obefazimod in patients with CD with the 12-week induction data read-out
expected in second half of 2026.
•Combination therapy: In September 2024, we announced initial preclinical combination data of obefazimod
combined with etrasimod in a mouse model of inflammatory bowel diseases (“IBD"). The results showed
that treatment with the combination improved the response on body weight protection and Disease Activity
Index and a synergistic and statistically significant reduction of several cytokines (TNFa, IL-17, IL-6,
IFNg) in the blood compared to each drug alone. Additional preclinical data to support our decision-making
on a combination agent is expected in 2025.
In addition, we have launched a research and development program to generate new potential drug candidates
to strengthen our intellectual property portfolio on the miR-124 platform and to identify additional drug candidates
from our proprietary small molecule library that includes additional miR-124 enhancers. We expect to announce a
follow-on candidate selection in a new indication in the second half of 2025.
Results of Operations
The following table sets forth our results of operations for the six months ended June 30, 2024 and 2025.
The following discussion covers these periods. It also covers all the material changes in financials conditions
and results of operations, if any, for the three months ended June 30, 2024 and June 30, 2025, for which unaudited
consolidated statements of loss are presented in the accompanying financial statements, in addition to the six months
ended June 30, 2024 and June 30, 2025.
(In thousands of euros) | Six-Month Ended June 30, 2024 | Six-Month Ended June 30, 2025 | % 2024 Change |
Other operating income ......................................................... | 6,815 | 2,087 | (69)% |
Total operating income .................................................................. | 6,815 | 2,087 | (69)% |
Sales and marketing expenses ................................................. | (4,229) | (1,534) | (64)% |
Research and development expenses ...................................... | (64,650) | (77,946) | 21% |
General and administrative expenses .................................... | (17,932) | (16,303) | (9)% |
Total operating expenses ............................................................... | (86,811) | (95,783) | 10% |
Operating loss ................................................................................. | (79,997) | (93,696) | 17% |
Financial expenses ................................................................. | (9,514) | (10,857) | 14% |
Financial income .................................................................... | 7,873 | 3,769 | (52)% |
Financial income (loss) .................................................................. | (1,641) | (7,088) | 332% |
Net loss before tax .......................................................................... | (81,638) | (100,784) | 23% |
Income Tax ............................................................................. | — | — | —% |
Net loss for the period .................................................................... | (81,638) | (100,784) | 23% |
Total Operating Income
For the six months ended June 30, 2025, our total operating income was €2.1 million, as compared to
€6.8 million for the six months ended June 30, 2024, a decrease of (69)% as detailed below.
Other Operating Income
The following table sets forth our other operating income for the six months ended June 30, 2024 and 2025.
(In thousands of euros) | Six-Month Ended June 30, 2024 | Six-Month Ended June 30, 2025 | % 2024 Change |
CIR (Research Tax Credits) .............................................................. | 2,665 | 2,017 | (24)% |
Subsidies ........................................................................................... | 4,121 | — | (100)% |
Other ................................................................................................. | 29 | 70 | 139% |
Total other operating income ........................................................ | 6,815 | 2,087 | (69)% |
For the six months ended June 30, 2025, our other operating income was €2.1 million, as compared to
€6.8 million for the six months ended June 30, 2024.
10
Research Tax Credits
For the six months ended June 30, 2025, we recognized research tax credits for our research and development
projects of €2.0 million, as compared to €2.7 million for the six months ended June 30, 2024. Although research and
development expenses for the six months ended June 30, 2025 increased by 21% as compared to the six months
ended June 30, 2024, the €0.7 million decrease is mainly driven by (i) the maximum amount of eligible outsourced
research and development expenses being capped and internal research and development costs being stable, (ii) the
reimbursement of the CARENA and RNP-VIR conditional advances, deducted from the CIR calculation (for €0.4
million) and (iii) a change in the CIR regulation related to eligible expenses (for €0.2 million).
Subsidies
For the six months ended June 30, 2025, our subsidy income was nil, as compared to €4.1 million for the six
months ended June 30, 2024. The decrease is related to the RNP-VIR and CARENA conditional advances granted
by Bpifrance between 2013 and 2019. Following the termination of both projects, in June 2024, Bpifrance agreed to
waive 60% of the remaining conditional advances and accrued interests, resulting in a non-cash subsidy income of
€4.1 million (see Bpifrance - Conditional Advances and Subsidies within the "Liquidity and Capital Resources"
section).
Total Operating Expenses
For the six months ended June 30, 2025, our total operating expenses were €95.8 million, as compared to
€86.8 million for the six months ended June 30, 2024, an increase of €9.0 million, or 10%. This increase was
primarily due to an increase in research and development expenses of €13.3 million partially offset by a decrease in
sales and marketing expenses of €2.7 million, and a decrease in general and administrative expenses of €1.63
million, each as described below.
Sales and Marketing Expenses
For the six months ended June 30, 2025, our total sales and marketing expenses were €1.5 million, as
compared to €4.2 million for the six months ended June 30, 2024, a decrease of €2.7 million. The decrease was
predominantly driven by a reduction in headcount as well as one-time costs that were incurred in 2024 for the
Group's corporate re-branding, including its new website.
Research and Development Expenses
The following table sets forth our research and development expenses by drug candidate and therapeutic
indication for the six months ended June 30, 2024 and 2025.
(In thousands of euros) | Six-Month Ended June 30, 2024 | Six-Month Ended June 30, 2025 | % 2024 Change |
Obefazimod ............................................................................................ | €62,015 | €75,345 | 21% |
Ulcerative Colitis ........................................................................... | 51,752 | 51,929 | —% |
Crohn’s Disease ............................................................................. | 917 | 7,416 | 709% |
Obefazimod Other Indication ........................................................ | 257 | 1,171 | 356% |
Transversal activities ..................................................................... | 9,089 | 14,829 | 63% |
Others ..................................................................................................... | 2,636 | 2,601 | (1)% |
Research and development expenses ................................................... | €64,650 | €77,946 | 21% |
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For the six months ended June 30, 2025, our research and development expenses were €77.9 million, as
compared to €64.7 million for the six months ended June 30, 2024, an increase of €13.3 million, or 21%. This
increase was primarily due to a €6.5 million increase in expenses related to our CD program, resulting from the
progression of our Phase 2b trials in CD, and a €5.7 million increase in transversal activities related to the overall
expansion of the research and development headcount to support our organizational growth and the issuance of new
equity awards to officers and employees in research and development. Expenses related our UC clinical program
remained stable, increasing by €0.2 million, or 0.3%.
General and Administrative Expenses
(In thousands of euros) | Six-Month Ended June 30, 2024 | Six-Month Ended June 30, 2025 | % 2024 Change |
Personnel costs ..................................................................................... | 11,172 | 9,932 | (11)% |
Consulting and professional fees .......................................................... | 3,848 | 3,703 | (4)% |
Other general and administrative expenses .......................................... | 2,912 | 2,668 | (8)% |
General and administrative expenses ............................................... | 17,932 | 16,303 | (9)% |
For the six months ended June 30, 2025, our general and administrative expenses were €16.3 million, as
compared to €17.9 million for the six months ended June 30, 2024, a decrease of €1.6 million, or 9%. This decrease
was primarily due to a decrease in personnel costs of €1.2 million, or 11%, mainly 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, as well as strict adherence to
the approved budget, which includes savings through reducing non-essential spend. These were partially offset by
increased legal and professional fees and other costs associated with operating as a dual-listed public company.
Operating Loss
For the six months ended June 30, 2025, our net operating loss was €93.7 million, as compared to a net
operating loss of €80.0 million for the six months ended June 30, 2024, an increase of €13.7 million, or 17%. This
increase was primarily due to an increase of €13.3 million in research and development expenses, partially offset by
a decrease of €2.7 million in sales and marketing expenses.
Financial Income (Loss)
For the six months ended June 30, 2025, our net financial loss was €7.1 million, as compared to a net
financial loss of €1.6 million for the six months ended June 30, 2024.
For the six months ended June 30, 2025, our net financial loss was mainly driven by interest expenses of €6.9
million in relation to the first tranche of senior secured convertible bonds with warrants attached in the Kreos /
Claret Financing (the “Kreos / Claret OCABSA”), the second and third tranches of the senior secured bonds in the
Kreos / Claret Financing (drawn on March 28, 2024 and June 21, 2024 respectively) and the senior convertible notes
in the Heights Financing (the "Heights Convertible Notes"), non-cash expense of €1.1 million in relation to our
royalty certificates and foreign exchange losses of €2.3 million (including the €0.4 million non-cash impact of the
revaluation of U.S. dollar-denominated cash and cash equivalents as of June 30, 2025). These costs were partially
offset mainly by interest income of €1.1 million in relation to the invested proceeds from our U.S. initial public
offering and listing on Nasdaq, a non-cash income of €1.3 million related to the decrease in the fair value of the
Heights convertible notes and a €0.5 million income related to the fair value changes of certain of our cash
equivalents.
For the six months ended June 30, 2024, our net financial loss was mainly driven by interest expenses of €4.2
million in relation to the first tranche of the Kreos / Claret OCABSA, the second and third tranches of senior secured
bonds in the Kreos / Claret Financing (drawn on March 28, 2024 and June 21, 2024, respectively) and the Heights
Convertible Notes and €1.9 million in relation to our royalty certificates, a €1.5 million increase in the fair value of
12
derivatives and transaction costs amounting to €1.6 million. These costs were partially offset mainly by an interest
income of €4.8 million in relation to the invested proceeds from our U.S. initial public offering and listing on
Nasdaq and foreign exchange gains of €2.3 million (including the €1.8 million non-cash impact of the revaluation of
U.S. dollar-denominated cash and cash equivalents as of June 30, 2024).
Income Taxes
For each of the six months ended June 30, 2024 and 2025, our income tax charge was zero.
Net Loss
For the six months ended June 30, 2025, our net loss for the period was €100.8 million, as compared to
€81.6 million for the six months ended June 30, 2024, an increase of €19.1 million, or 23%.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred substantial operating losses since inception and expect to continue to incur significant
operating losses for the foreseeable future and may never become profitable. For the six-month periods ended June
30, 2024 and 2025, we reported net losses of €81.6 million and €100.8 million, respectively. As of December 31,
2024, we carried forward accumulated tax losses of €609.4 million.
Since inception, we have financed our operations through the issuance of ordinary shares with gross aggregate
proceeds of €1,194.7 million,of which €130.0 million of gross proceeds were from offerings of our ordinary shares
on Euronext Paris in February 2023, €223.3 million of gross proceeds were from offering of our ordinary shares in
the form of ADS on the Nasdaq Global Market in our U.S. initial public offering as well as ordinary shares in
Europe (including France) and countries outside of the United States in a private placement in October 2023, €637.5
million of gross proceeds were from the offering of our ordinary shares in the form of ADS on the Nasdaq Global
Market in July 2025 ("the Offering"), bank borrowings and structured loans for €175.0 million, reimbursements of
CIR in an amount of €41.3 million, subsidies received from Bpifrance (including €21.3 million of subsidies and €1.8
million of conditional advances) and royalty certificates in an amount of €2.9 million.
In addition, on November 19, 2024, we entered into an equity distribution agreement with Piper Sandler & Co.
(“Piper Sandler”) allowing us to issue and sell from time to time, in one or more "at the market" offerings through
Piper Sandler acting as sales agent, ordinary shares in the form of ADSs, each ADS representing one ordinary share,
nominal value of €0.01 per share, with aggregate gross sales proceeds of up to $150.0 million (the "ATM Program").
To date, we have not sold any ADSs pursuant to the ATM Program.
Based on (a) our existing cash and cash equivalents of €60.9 million as of June 30, 2025, (b) the gross
proceeds from the July 2025 Offering of €637.5 million and (c) the conversion of all 350 Heights convertible notes
in July and August 2025, we expect, as of the date of issuance of the unaudited interim condensed consolidated
financial statements included in this half-year report, to be able to fund our forecasted cash flow requirements into
the fourth quarter of 2027, allowing us to reach 12 months of expected cash runway post the planned NDA
submission for UC, assuming positive results from its Phase 3 maintenance trial. Our forecasted cash flow
requirements take into account our assumption of continued R&D expenditure related to the continuation of the
Phase 3 clinical trials of obefazimod in UC, progression of the Phase 2b clinical trials for CD and the initial stages of
the scale up of the commercial organization as we prepare for a potential launch of obefazimod in UC.
Based on the above, management has concluded that the substantial doubt about our ability to continue as a
going concern has been alleviated beyond 12 months from the date of issuance of the financial statements
accompanying this half-year report, and the accompanying financial statements have been prepared on a going
concern basis.
13
Capital Increases
During the six-month period ending June 30, 2025, there has been one capital increase relating to the vesting
of 124,096 AGAs, resulting in the issuance of 124,096 ordinary shares with a par value of €0.01 per share.
On July 28, 2025, we received gross proceeds of €637.5 million from the issuance of 11,679,400 ordinary
shares in the form of ADSs, at a price of $64.00 per share (corresponding to €54.58 per ordinary share). We intend
to use the net proceeds from the Offering as follows:
•approximately $140.0 (€119.4) million to $185.0 (€157.8) million to fund the clinical development of
obefazimod for UC;
•approximately $30.0 (€25.6) million to $65.0 (€55.4) million to fund the clinical development of
obefazimod for CD; and
•the remainder for working capital and for other general corporate purposes, including preparation of
commercialization, additional research and development and financing expenses.
Research Tax Credits
From our inception to June 30, 2025, we have benefited from refunds of CIRs in a total amount of €41.3
million. In November 2024, we received CIRs of €4.5 million with respect to the year ended December 31, 2023. In
June 2025, we received CIRs of €5.7 million with respect to the year ended December 31, 2024.
Bpifrance—Conditional Advances and Subsidies
We have received several conditional advances and subsidies from Bpifrance since our inception. Funds
received from Bpifrance in the form of conditional advances are recognized as financial liabilities, as we have a
contractual obligation to reimburse Bpifrance for such conditional advances in cash based on a repayment schedule.
Each award of an advance is made to help fund a specific development milestone. Subsidies are non-repayable
grants, which are recognized in the financial statements when there exists reasonable assurance that we will comply
with the conditions attached to the subsidies and the subsidies will be received.
Bpifrance—CARENA Contract
As part of the development of therapeutic and diagnostic solutions targeting alternative splicing and RNA
interference in the fields of virology (HIV-AIDS, HTLV-1) and metabolism (obesity), SPLICOS, which we acquired
in October 2014, entered into a Master Support Agreement and a conditional advance contract in December 2013 for
the “CARENA” Strategic Industrial Innovation Project (“CARENA project”), with Bpifrance. Under this contract,
we were eligible to receive up to €3.8 million in conditional advances to develop a therapeutic HIV treatment
program with obefazimod. As of December 31, 2024 (year during which the program was terminated), we had
received €3.4 million of conditional advances and subsidies in total.
In June 2024, the Company and Bpifrance agreed to terminate the project due to technical failure.
Bpifrance granted an additional amount of €1.1 million payable to the Company to reimburse additional expenses
incurred as part of the project, and agreed to waive 60% of the remaining conditional advance of €3.3 million and
accrued interests, for which we recognized a subsidy income of €2.3 million in the aggregate. We repaid the
outstanding amounts during the second half of 2024.
Bpifrance—RNP-VIR Contract
As part of the CARENA project, focused on the clinical development of a drug molecule and demonstrating
the validity of an innovative therapeutic approach targeting viral RNPs, we entered into a Master Support
Agreement with Bpifrance, as well as a beneficiary agreement dated March 21, 2017, with conditional advances for
the “RNP-VIR” structuring research and development project for competitiveness. Under the RNP-VIR contract, we
were eligible to receive up to €6.3 million in conditional advances to develop methods for the discovery of new
molecules for the treatment of viral infectious diseases through the development of the “Modulation of RNA
biogenesis” platform. As of December 31, 2024 (year during which the program was terminated), we had received
€3.9 million of conditional advances and subsidies in total.
In June 2024, the Company and Bpifrance agreed to terminate the project due to technical failure.
Bpifrance claimed the reimbursement of €1.2 million corresponding to overpayments of conditional advances and
subsidies (for which the Group had not incurred the corresponding R&D expenses) and agreed to waive 60% of the
14
remaining advances of €3.0 million and accrued interests, for which the Group recognized a subsidy income of €1.9
million in the aggregate. We repaid the outstanding amounts during the second half of 2024.
Bpifrance—Ebola
The Bpifrance and Occitanie Region joint support agreement was entered into on June 2, 2017 and provides
for conditional advances for a total amount of €0.4 million (€0.1 million from the Languedoc Roussillon Midi
Pyrénées Region and €0.3 million from Bpifrance) for the Ebola program. All funds under this contract were
received. In September 2019, we terminated this program due to the imminent licensing of a competing vaccine for
this indication, as well as changes in the macroeconomic climate for public funding. The reimbursement of the
conditional advance was spread over the period from September 2019 to June 2024.
Indebtedness
For a description of material financing agreements, see "Item 10.C. Material Contracts" of the Company’s
2024 Annual Report on Form 20-F.
During the six-month period ended June 30, 2025, we did not enter into any new financing agreements.
On July 23 and July 30, 2025, we received notices from entities affiliated with Heights Capital Management,
which hold amortizing senior convertible notes issued in August 2023 (the “Height Convertible Notes”), for the
conversion of 150 and 200 convertible notes (corresponding to the entirety of the outstanding principal amount of
€21.9 million) into an aggregate of 920 377 new ordinary shares of the Group at a conversion price of €23.7674 per
ordinary share in accordance with the terms and conditions of the convertible notes. Following these share issuances,
we no longer hold any debt with Heights Capital Management.
On August 6, 2025, Kreos Capital VII(UK) Limited converted its Tranche A portion (OCABSA) of the
Kreos / Claret Financing Agreement, resulting in the issuance of 785,389 ordinary shares if the Group. In addition,
on the same date, Kreos Capital VII Aggregator SCSp exercised all of its share warrants (the tranche A-B BSA and
tranche C BSA) resulting in the issuance of 319,251 ordinary shares of the Group.
On August 28, 2025, Claret European Growth Capital Fund III SCSp, exercised its share warrants (the
tranche A-B BSA and tranche C BSA) resulting in the issuance of respectively 319,251 shares 206,662 shares of the
Group.
Historical Changes in Cash Flows
The following table sets forth our cash inflows and outflows for the six-month periods ended June 30, 2024
and 2025.
(In thousands of euros) | Six-Month Ended June 30, 2024 | Six-Month Ended June 30, 2025 | % 2024 Change |
Net cash flows used in operating activities ............................................ | (85,175) | (66,618) | (22)% |
Net cash flows provided by investing activities ................................... | 13,458 | 1,269 | (91)% |
Net cash flows provided by (used in) financing activities ..................... | 40,322 | (16,604) | (141)% |
Effect of movements in exchange rates on cash held ............................ | 1,770 | (1,785) | (201)% |
Revaluation of cash equivalents measured at fair value ........................ | — | 462 | —% |
Net increase (decrease) in cash and cash equivalents ..................... | (29,625) | (83,275) | 181% |
— | |||
Cash and cash equivalents at the beginning of the period ............... | 251,942 | 144,221 | (43)% |
Cash and cash equivalents at the end of the period .......................... | 222,317 | 60,946 | (73)% |
15
Operating Activities
For the six months ended June 30, 2025, cash used in operating activities was €66.6 million, as compared to
€85.2 millionfor the six months ended June 30, 2024, a decrease of €18.6 million, or (22)%. Net cash used in both
periods was predominantly related to payments for the progression of our UC and CD trials, personnel, legal,
professional and infrastructure costs associated with operating as a dual-listed public company. The decrease was
mostly driven by changes in working capital requirements, from €(13.0) million for the six months ended June 30,
2024 to €15.5 million in 2025.
Investing Activities
For the six months ended June 30, 2025, cash provided by investing activities was €1.3 million and was
mainly due to interest received of €1.2 million.
For six months ended June 30, 2024, cash provided by investing activities was €13.5 million and was mainly
due to a decrease in short-term investments of €9.1 million from the payment of the Group's 6-month term deposit
and interest received of €4.8 million.
Financing Activities
For the six months ended June 30, 2025, cash used in financing activities was €16.6 million, which consisted
of repayments of €12.6 million (of which €9.1 million under the tranches A, B and C of the Kreos / Claret
Financing, €2.2 million under the Heights convertible notes and €1.2 million under the PGE) and interest payments
of €3.9 million.
For the six months ended June 30, 2024, cash provided by financing activities was €40.3 million, which
consisted of drawdowns on tranche B (in an amount of €25 million) and tranche C (in an amount of €25 million) of
the senior secured non-convertible bonds from the Kreos / Claret Financing, net of disbursed transaction costs and
deposits (in an amount of €2.6 million in the aggregate), partially offset by repayments of €6.0 million (of which
€4.4 million under the Heights convertible notes) and interest payments of €2.95 million.
Material Cash Requirements
Contractual Obligations and Loans
The following table sets forth aggregate information about material contractual obligations as of June 30,
2025.
The commitment amounts in the table below are associated with contracts that are enforceable and legally
binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or
variable price provisions, and the approximate timing of the actions under the contracts. Future events could cause
actual payments to differ from these estimates. All amounts except the retirement benefits in the table below are
presented gross and are undiscounted.
As of June 30, 2025 | As of June 30, 2025 | As of June 30, 2025 | |
Less than | More than | ||
(In thousands of euros) | 1 year | 1 year | Total |
Financial debt obligations .......................... | 36,278 | 65,017 | 101,294 |
Lease obligations ....................................... | 979 | 1,012 | 1,991 |
Retirements benefits .................................. | 0 | 756 | 756 |
Off-balance sheet obligations .................... | 215,046 | 0 | 215,046 |
Total .......................................................... | 252,303 | 66,785 | 319,087 |
In the ordinary course of our business, we regularly use the services of subcontractors and enter into research
and partnership arrangements with various CROs and with public-sector partners or subcontractors who conduct
clinical trials and studies in relation to the drug candidates. Off-balance sheet obligations in the table above are
16
commitments related to these research and partnership agreements. They are classified at less than one year maturity
in the absence of a fixed schedule in contracts, in case of multiple-year contracts, such as CRO contracts. CRO
contracts include payments that are conditional to the completion of future development milestones. The majority of
the commitments with our CROs are cancellable under certain circumstances such as insolvency, study put on hold
by competent authorities, breach in regulations or negligence in the provision of the services.
Our material cash requirements in the above table do not include potential future royalty payments related to
the royalty certificates, amounting to 2% of the future net sales of obefazimod (worldwide and for all indications).
The amount of royalties that may be paid under the royalty certificates is capped at €172.0 million in the aggregate.
Royalty payments are expected to take place before the expiry date of the certificates, which is 15 years after their
issuance date (September 2, 2037).
As of June 30, 2025, our contractual obligations and loans were €319.1 million, comprising financial debt
obligations of €101.3 million (in turn, comprising €45.7 million with respect to the second and third tranches of
senior secured non-convertible bonds in the Kreos / Claret Financing, €24.8 million with respect to Heights
Convertible Notes, €29.5 million with respect of the Kreos / Claret OCABSA and €1.3 million with respect to the
PGE) and off-balance sheet obligations of €215.0 million with respect to purchase obligations.
Following the conversion of all the Heights Convertible Notes and the Kreos / Claret OCABSA in July
2025 and August 2025, financial debt obligations amounting to €54.3 million as of June 30, 2025 were extinct.
F-1
INDEX TO UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Condensed Consolidated Statements of Financial Position ............................................................... | F-2 |
Condensed Consolidated Statements of Loss .................................................................................... | F-3 |
Condensed Consolidated Statements of Comprehensive Loss .......................................................... | F-4 |
Condensed Consolidated Statements of Changes in Shareholders’ Equity ....................................... | F-5 |
Condensed Consolidated Statements of Cash Flows ......................................................................... | F-6 |
Notes to the Condensed Consolidated Financial Statements ............................................................. | F-7 |
F-2
ABIVAX SA UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
(Amounts in thousands of euros) | Notes | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | ||
ASSETS | |||||
Non-current assets | |||||
Goodwill | 6 | ||||
Intangible assets | 7 | ||||
Property, plant and equipment | 8 | ||||
Other financial assets | 9 | ||||
Other receivables and assets | 10 | ||||
Total non-current assets | |||||
Current assets | |||||
Other financial assets | 9 | ||||
Other receivables and assets | 10 | ||||
Cash and cash equivalents | 11 | ||||
Total current assets | |||||
TOTAL ASSETS | |||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||
Shareholders’ equity | |||||
Share capital | |||||
Premiums related to share capital | |||||
Translation reserve | ( | ||||
Retained earnings | ( | ( | |||
Net loss for the period | ( | ( | |||
Total shareholders’ equity | 13 | ( | |||
Non-current liabilities | |||||
Retirement benefit obligations | 16 | ||||
Provisions | 14 | ||||
Borrowings | 15 | ||||
Convertible loan notes | 15 | ||||
Derivative instruments | 15 | ||||
Royalty certificates | 15 | ||||
Total non-current liabilities | |||||
Current liabilities | |||||
Borrowings | 15 | ||||
Convertible loan notes | 15 | ||||
Derivative instruments | 15 | ||||
Provisions | 14 | ||||
Trade payables and other current liabilities | 17.1 | ||||
Tax and employee-related payables | 17.2 | ||||
Total current liabilities | |||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
F-3
ABIVAX SA UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(Amounts in thousands of euros, except per share amounts) | Notes | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Other operating income | 18 | ||||||||
Total operating income | |||||||||
Sales and marketing | 19.1 | ( | ( | ( | ( | ||||
Research and development | 19.2 | ( | ( | ( | ( | ||||
General and administrative | 19.3 | ( | ( | ( | ( | ||||
Total operating expenses | ( | ( | ( | ( | |||||
Operating loss | ( | ( | ( | ( | |||||
Financial expenses | ( | ( | ( | ( | |||||
Financial income | |||||||||
Financial gain (loss) | 21 | ( | ( | ( | ( | ||||
Net loss before tax | ( | ( | ( | ( | |||||
Income tax | 22 | ||||||||
Net loss for the period | ( | ( | ( | ( | |||||
Weighted average number of outstanding shares used for computing basic/diluted loss per share | |||||||||
Basic / diluted loss per share (€/share) | 23 | ( | ( | ( | ( |
F-4
ABIVAX SA UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(Amounts in thousands of euros) | Notes | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Net loss for the period | ( | ( | ( | ( | |||||
Items that will not be reclassified to profit or loss | ( | ||||||||
Actuarial gains and losses on retirement benefit obligations | 16 | ( | |||||||
Items that are or may be reclassified subsequently to profit or loss | ( | ( | |||||||
Foreign currency translation differences | ( | ( | |||||||
Other comprehensive income (loss) | ( | ||||||||
Total comprehensive income (loss) for the period | ( | ( | ( | ( |
F-5
ABIVAX SA UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(In thousands of euros, except number of shares) | NUMBER OF SHARES ISSUED | SHARE CAPITAL | PREMIUMS RELATED TO SHARE CAPITAL | TRANSLATION RESERVE | RETAINED EARNINGS | NET LOSS FOR THE YEAR | TOTAL SHAREHOLDER 'S EQUITY | |||||||
AS OF JANUARY 1, 2024 | ( | ( | ||||||||||||
Net loss for the period | — | — | — | — | — | ( | ( | |||||||
Other comprehensive income (loss) | 16 | — | — | — | ( | — | ( | |||||||
Total comprehensive loss for the period | — | — | — | ( | ( | ( | ||||||||
Appropriation of prior period net loss | — | — | — | — | ( | |||||||||
Transaction costs related to capital increase | 13.3 | — | — | — | — | — | ||||||||
Issue of share warrants | — | — | — | — | — | |||||||||
Exercises of other share warrants | — | — | — | — | ||||||||||
Shares based compensation expense | — | — | — | — | — | |||||||||
AS OF JUNE 30, 2024 | 13.1 | ( | ( | |||||||||||
AS OF JANUARY 1, 2025 | ( | ( | ( | |||||||||||
Net loss for the period | — | — | — | — | — | ( | ( | |||||||
Other comprehensive income (loss) | 16 | — | — | — | — | |||||||||
Total comprehensive loss for the period | — | — | — | ( | ( | |||||||||
Appropriation of prior period net loss | — | — | — | — | ( | |||||||||
Issue of share warrants | 14 | — | — | — | — | — | ||||||||
Issue of free shares | 14 | ( | — | — | — | |||||||||
Shares based compensation expense | 14 | — | — | — | — | — | ||||||||
Other | — | — | — | — | — | |||||||||
AS OF JUNE 30, 2025 | 13.1 | ( | ( | ( |
F-6
ABIVAX SA UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of euros) | Notes | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||
Cash flows used in operating activities | |||||
Net loss for the period | ( | ( | |||
Ajustments for: | |||||
Elimination of amortization of intangibles and depreciation of property, plant and equipment | |||||
Elimination of retirement benefit obligations | 16 | ||||
Elimination of share-based compensation expenses | 14 | ||||
(-) Net gain on sale of treasury shares | ( | ||||
Interest expenses and other financial expenses | 21 | $— | |||
Financial income | 21 | $— | ( | ( | |
Effect of unwinding the discount related to advances | ( | ( | |||
Increase/(decrease) in derivatives and liabilities fair value | 15 | ( | |||
Forgiveness of conditional advances | 17 | ( | |||
Other | ( | ||||
Cash flows used in operating activities before change in working capital requirements | ( | ( | |||
Decrease / (increase) in other receivables and related accounts | |||||
Increase / (decrease) in trade payables | ( | ||||
Increase / (decrease) in tax and social security liabilities | ( | ( | |||
Increase / (decrease) in deferred income and other liabilities | |||||
Changes in working capital requirements | ( | ||||
Cash flows used in operating activities | ( | ( | |||
Cash flows provided by (used in) in investing activities | |||||
Acquisitions of intangible assets | ( | ||||
Acquisitions of property, plant and equipment | ( | ( | |||
Advances reimbursed by (made to) CROs | 10 | ||||
Increase in deposits | 9 | ( | ( | ||
Decrease in deposits | 9 | ||||
Interest received | |||||
Cash flows provided by (used in) in investing activities | |||||
Cash flows provided by (used in) financing activities | |||||
Transaction costs related to capital increase | 13 | ||||
Net proceeds from Kreos and Claret (2) 2 bond loans | 15.2 & 15.7 | ||||
Repayments of Kreos and Claret (2) 2 bond loans | 15 | ( | |||
Repayments of convertible loan notes (3) | 15 | ( | ( | ||
Repayment of PGE | 15 | ( | ( | ||
Repayments of conditional advances | 15 | ( | |||
Payments of the lease liabilities | 15 | ( | ( | ||
Interest paid | 15 | ( | ( | ||
Other | |||||
Cash flows provided by (used in) financing activities | ( | ||||
Effect of movements in exchange rates on cash held | 11 | ( | |||
Revaluation of cash equivalents measured at fair value | 11 & 21 | ||||
Increase (decrease) in cash and cash equivalents | ( | ( | |||
Cash and cash equivalents at the beginning of the year | 11 | ||||
Cash and cash equivalents at the end of the year | 11 | ||||
Increase (decrease) in cash and cash equivalents | ( | ( |
F-7
ABIVAX SA NOTES TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1. The Group
ABIVAX SA (the “Company”) is a société anonyme incorporated under the laws of France on December 4, 2013. Its registered office
is located at 7-11 Boulevard Haussmann—75009 Paris, France. The Company is developing therapeutics designed to harness the
body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases.
These unaudited interim condensed consolidated financial statements as of and for the three- and six-month periods ended June 30,
2025 comprise the Company and ABIVAX LLC (the “Subsidiary”), the United States subsidiary of ABIVAX SA, created on March
20, 2023 under the laws of the State of Delaware (together referred to as the “Group”).
The Group has incurred losses since its inception and had shareholders’ equity of €(48,280 ) thousand as of June 30, 2025. The Group
anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its drug candidates which
are currently under development. Substantial additional financing will be needed by the Group to fund its operations and to
commercially develop its drug candidates, if approved. See note 3.3. Subsequent event.
The Group's future operations are highly dependent on a combination of factors, including: (i) the success of its research and
development activities; (ii) regulatory approval and market acceptance of its proposed future products; (iii) the timely and successful
completion of additional financing and (iv) the development of competitive therapies by other biotechnology and pharmaceutical
companies. As a result, the Group is, and expects to continue to be, in the short to mid-term, financed through the issuance of new
equity or debt instruments.
The Group is focusing its efforts on the following points:
•Continuation of the Phase 3 clinical trial program (ABTECT) for obefazimod in moderately to severely active ulcerative
colitis (“UC”).
•Continuation of the Phase 2b clinical trial (ENHANCE-CD) of obefazimod in Crohn’s disease (“CD”).
•Evaluating oral or injectable combination therapy candidates with obefazimod in UC.
•Selecting a follow-on candidate for obefazimod.
The unaudited interim condensed consolidated financial statements and related notes have been prepared under the responsibility of
Note 2. Basis of preparation
Except for share data and per share amounts, the unaudited interim condensed consolidated financial statements are presented in
thousands of euros. Amounts are rounded up or down the nearest whole number for the calculation of certain financial data and other
information contained in these accounts. Accordingly, the total amounts presented in certain tables may not be the exact sum of the
preceding figures.
F-8
These unaudited interim condensed consolidated financial statements as of June 30, 2025 and for the three- and six-month periods
ended June 30, 2025 and 2024 have been prepared in accordance with IAS 34 “Interim Financial Reporting” as issued by the
International Accounting Standards Board ("IASB") and as adopted by the European Union (EU) and should be read in conjunction
with the latest Group’s annual financial statements for the years ended December 31, 2022, 2023 and 2024, prepared in accordance
with the International Financial Reporting Standards ("IFRS") as issued by IASB and as adopted by the EU.
They do not include all the information required for a complete set of financial statements prepared under IFRS. They do, however,
include selected notes explaining significant events and transactions in order to understand the changes in the Group’s financial
position and performance since the last annual financial statements.
The accounting policies used to prepare these unaudited interim condensed financial statements are identical to those applied by the
Group as of December 31, 2024, except for:
•the texts whose application is compulsory as from January 1, 2025;
•the specific provisions of IAS 34 used in the preparation of the unaudited interim condensed consolidated financial
statements.
The application of the new Amendments to IAS 21 "The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability" is
mandatory for annual reporting periods beginning on or after January 1, 2025. The Group concluded that these issued accounting
pronouncements are not applicable for the periods presented.
The standards and interpretations not yet mandatory as of June 30, 2025 are the following:
•Amendments to IFRS 9 Financial Instruments and IFRS 7 Financial Instruments: Disclosures – Amendments to the
Classification and Measurement of Financial Instruments, whose application is for annual reporting periods beginning on or
after January 1, 2026, as approved by the EU on May 28, 2025;
•Amendments to IFRS 9 Financial Instruments and IFRS 7 Financial Instruments: Disclosures – Contracts Referencing
Nature-dependent Electricity, whose application is for annual reporting periods beginning on or after January 1, 2026, as
approved by the EU on June 30, 2025;
•IFRS 18 Presentation and Disclosure in Financial Statements, whose application is for annual reporting periods beginning on
or after January 1, 2027 (not yet approved by the EU);
•IFRS 19 Subsidiaries without Public Accountability: Disclosures, whose application is for annual reporting periods beginning
on or after January 1, 2027 (not yet approved by the EU), and
•Annual Improvements Volume 11, whose application is for annual reporting periods beginning on or after January 1, 2026, as
approved by the EU on July 9, 2025.
These texts have not been early adopted. The expected impacts are not considered significant, except for IFRS 18, for which the Group
has not completed its assessment to date.
Preparation of the financial statements
The unaudited interim condensed consolidated financial statements of the Group were prepared on a historical cost basis, with the
exception of certain asset and liability categories and in accordance with the provisions set out in IFRS such as employee benefits
measured using the projected unit credit method, the Heights notes (classified under "Convertible loan notes") measured at fair value
and derivative financial instruments measured at fair value.
F-9
The Group has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the
foreseeable future and may never become profitable. For the six-month period ended June 30, 2025, the Group had a net loss of
€100.8 million. In addition, the Group had negative shareholder's equity of €48.3 million as at June 30, 2025 driven by the losses
incurred.
Since inception, the Group has financed its operations through the issuance of ordinary shares with gross aggregate proceeds of
€1,194.7 million, of which €130 million of gross proceeds were from offerings of its ordinary shares on Euronext Paris in February
2023, €223.3 million of gross proceeds were from its offering of ordinary shares in the form of American Depository Shares ("ADS")
on the Nasdaq Global Market as well as ordinary shares in Europe (including France) and countries outside of the United States in a
private placement in October 2023 and €637.5 million of gross proceeds were from the offering of our ordinary shares in the form of
ADS on the Nasdaq Global Market in July 2025 ("the Offering"), bank borrowings and structured loans for €175.0 million,
reimbursements of CIR in an amount of €41.3 million, subsidies received from Bpifrance (including €21.3 million of subsidies and
€1.8 million of conditional advances) and royalty certificates in an amount of €2.9 million.
Based on (a) the Group’s existing cash and cash equivalents of €60.9 million as of June 30, 2025, (b) the gross proceeds from the July
2025 Offering of €637.5 million and (c) the conversion of all 350 Heights convertible notes in July and August 2025 (see Note 3.3.
below), the Group expects, as of the date of issuance of these financial statements, to be able to fund its forecasted cash flow
requirements into the fourth quarter of 2027, allowing it to reach 12 months of expected cash runway following the planned NDA
submission for UC, assuming positive results from its Phase 3 maintenance trial. This takes into account management's assumptions
of continued R&D expenditure related to the continuation of the Phase 3 clinical trials of obefazimod in UC, progression of the Phase
2b clinical trials for CD and the initial stages of the scale up of the commercial organization as the Group prepares for a potential
launch of obefazimod in UC.
Based on the above, these financial statements have been prepared on a going concern basis.
In February 2022, Russia invaded Ukraine. The conflict has already had major implications for the global economy and the rate of
inflation, particularly in relation to the supply of energy, raw materials and food products. It has also caused intense volatility on the
financial markets, something that is still ongoing at the reporting date and has pushed down stock market prices around the world.
Given these developments, the Group has decided not to include Russia and Belarus in its global Phase 3 program for obefazimod in
UC. However, the global scale of this conflict cannot be predicted at this stage. The Group, therefore, cannot rule out an adverse
impact of this conflict on its business, including in terms of access to raw materials, logistics, the performance of clinical studies and
in relation to any future financing the Group may seek.
The long-term safety and efficacy extension of the Phase 2b maintenance trial of obefazimod in moderately to severely active UC is
the Group’s only clinical trial with patients currently enrolled in Ukraine. The Phase 2b 12-month assessment was carried out in all the
Ukrainian patients before the war broke out and these patients are therefore included in the one-year maintenance results that were
reported on April 6, 2022. Ukrainian patients who completed the two-year Phase 2b maintenance trial have been transitioned to the
long-term safety and efficacy trial that is still on-going. The Group also has a few Ukrainian sites active in the western part of Ukraine
in the ABTECT Phase 3 clinical trials. None of these sites are located in the Crimea Region of Ukraine, the so-called Donetsk
People’s Republic, or the so-called Luhansk People’s Republic. The Group continues to monitor developments in the region, but any
instability as a result of the war may have material adverse impacts on these clinical sites, which could negatively impact our Phase 3
clinical trials.
Together with its CROs, the Group is making considerable efforts to ensure the follow-up of patients who are unable to come to the
study centers. Monitoring takes place through a remote monitoring system that was established and used successfully during the
F-10
Note 3. Significant events for the year ended December 31, 2024 and the six-month period ended June 30, 2025 and subsequent
events
Changes in management – February-December 2024
On February 7, 2024, the Group announced the appointment of Ana Sharma as Vice President, Global Head of Quality. Ms. Sharma
left the Group in November 2024.
On April 2, 2024, the Group announced the appointment of Camilla Soenderby as Independent Board Member and also a member of
the Appointments and Compensation Committee. Ms. Soenderby replaces Santé Holdings S.R.L., represented by Mr. Paolo Rampulla,
who will continue to contribute to the work of the Board of Directors as an observer alongside Mr. Maurizio PetitBon from Kreos
Capital/Blackrock.
In July 2024, the Group announced the appointment of Sylvie Grégoire as Independent Board Member, Chairman of the Board and
also a member of the Audit Committee. Ms. Grégoire replaces Ms. Brosgart as Director, Mr. de Garidel as Chairman, and Mr. Hong as
member of the Audit Committee. As the Group entered into the final stages of the ABTECT program and prepared to commence the
Phase 2b ENHANCE-CD trial, Dr. Fabio Cataldi was appointed as Chief Medical Officer, taking over from Dr. Sheldon Sloan, MD,
M Bioethics. Additionally, David Zhang, Ph.D joined the Group as Chief Strategy Officer. Dr. Zhang has internal responsibility for
Biometrics, Quality, HEOR and Regulatory. Finally, the Group also announced that Chief Commercial Officer Michael Ferguson has
left the organization to pursue other opportunities.
On November 13, 2024, the Group announced the appointment of Mark Stenhouse as Board Observer & Advisor to the Group.
On December 23, 2024, the Group announced the resignation of Dr. Philippe Pouletty, representative of Truffle Capital, as director of
the Group, effective on December 31, 2024.
Share-based compensation plans – February-September 2024
In February, March, May, July and September 2024, the Group issued seven free-share compensation plans to certain of its officers
and employees, representing a maximum of 1,946,125 shares in the aggregate, the vesting of which is subject to the following service
condition: 50 % of the AGAs vest at the end of a two-year period from the allocation date, 25 % at the end of a three-year period from
the allocation date and 25 % at the end of a four-year period from the allocation date (with the exception of the 20,000 2024-6 AGAs,
whose vesting conditions are set forth in Note 14).
In March 2024, the Group granted its independent Board members the right to subscribe up to 77,820 share warrants (BSA) in the
aggregate, the vesting of which is subject to a service condition of four years , by tranches of 25 % each, vested on each anniversary
date. All the BSAs have been subscribed.
The detailed terms and conditions and the accounting treatment of these plans are presented in Note 14 to the annual consolidated
financial statements of the Group as of December 31, 2024 accompanying the Group’s annual report on Form 20-F for the year ended
December 31, 2024 filed with the Securities and Exchange Commission on March 24, 2025 (the “Annual Report”).
Drawdown of Tranches B and C of the Kreos / Claret Financing – March-June 2024
On March 28, 2024 and June 21, 2024, the Group drew down €25 million related to tranche B and €25 million related to tranche C of
senior secured non-convertible bonds from the Kreos / Claret Financing. These second and third tranches each consist of 25,000,000
senior secured non-convertible bonds with a par value of €1.00 each, that will not be listed on any market.
The detailed characteristics of these bond loans and their accounting treatments are set forth in Note 15.1 to the annual consolidated
financial statements of the Group as of December 31, 2024 accompanying the Group’s Annual Report.
F-11
Bpifrance RNP-VIR and Carena conditional advances – June 2024
In June 2024, the Group and Bpifrance renegotiated the RNP-VIR and CARENA conditional advances:
•Under the RNP-VIR contract, the Group was eligible to receive up to €6.3 million in conditional advances to further develop
methods for the discovery of new molecules for the treatment of viral infectious diseases through the development of the
“Modulation of RNA biogenesis” platform. Between September 2017 and November 2019, the Group had received repayable
conditional advances amounting €4,032 thousands and subsidies amounting to €1,123 thousand in relation to the RNP-VIR
project.
In June 2024, the Group and Bpifrance agreed to terminate the project due to technical failure. Bpifrance claimed the
reimbursement of €1,241 thousand corresponding to overpayments of conditional advances and subsidies (for which the
Group had not incurred the corresponding R&D expenses) and agreed to waive 60 % of the remaining advances of
€2,945 thousand and accrued interests, which resulted in a subsidy income of €1,872 thousand in the aggregate (see Note 18).
The outstanding amount was fully repaid by the Group during the last quarter of 2024.
•Under the CARENA agreement, the Group was eligible to receive up to €3,840 thousand to develop a therapeutic HIV
treatment program with ABX464. Between December 2013 and June 2016, the Group had received repayable conditional
advances amounting €2,187 .
In June 2024, the Group and Bpifrance agreed to terminate the project due to technical failure. Bpifrance granted an
additional amount of €1,068 thousand payable to the Group to reimburse additional expenses incurred as part of the project,
and agreed to waive 60 % of the remaining conditional advance of €3,255 thousand and accrued interests, which resulted in a
subsidy income of €2,251 thousand in the aggregate (see Note 18). The outstanding amount was fully repaid by the Group
during the last quarter of 2024.
Establishment of an At-the-Market ("ATM") Program on Nasdaq - November 2024
On November 19, 2024, the Group announced the implementation of an At-The-Market program (“ATM Program”) allowing the
Group to issue and sell, including with unsolicited investors who have expressed an interest, ordinary shares in the form of ADSs,
each ADS representing one ordinary share, nominal value €0.01 per share, of the Group, with aggregate gross sales proceeds of up to
$150,000 thousand (subject to French regulatory limits and within the limits of the investors’ requests expressed in the context of the
program), from time to time, pursuant to the terms of an equity distribution agreement with Piper Sandler & Co. (“Piper Sandler”),
acting as sales agent. The timing of any issuances in the form of ADSs will depend on a variety of factors. The ATM Program will be
effective until terminated in accordance with the equity distribution agreement or if ADSs representing the maximum gross sales
proceeds have been sold thereunder. To the extent that ADSs are sold pursuant to the ATM Program, the Group currently intends to
use the net proceeds (after deduction of fees and expenses), if any, of sales of ADSs issued under the ATM Program primarily to fund
the research and development of the Group's product candidates, for working capital and general corporate purposes, at its discretion.
A shelf registration statement on Form F-3, including a base prospectus relating to the Group's securities and an equity distribution
agreement prospectus relating to the ATM Program, was filed with the SEC and went into effect during 2024. The base prospectus
provides for the potential sale of ADSs of the Group with aggregate gross sales proceeds of up to $350,000 thousand (including the
$150,000 thousand covered by the equity distribution agreement prospectus) to grant additional flexibility to the Group in connection
with its financing strategy. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in one or
more prospectus supplements to the base prospectus. As of the date of issuance of our Annual Report, the Group has not utilized the
ATM Program.
F-12
Note 3.2. For the six-month period ended June 30, 2025
Share-based compensation plans – January-May 2025
In January 2025, the Group granted its independent Board members, as well as one of its Board Observers and Advisor, the right to
subscribe up to 125,000 share warrants (BSA) in the aggregate, the vesting of which (if subscribed) is subject to a service condition of
In February, March and May 2025, the Group issued six free-share compensation plans to certain of its officers and employees,
representing a maximum of 4,565,727 shares in the aggregate, the vesting of which is subject to the following service condition: 50 %
of the AGAs vest at the end of a two-year period from the allocation date, 25 % at the end of a three-year period from the allocation
date and 25 % at the end of a four-year period from the allocation date (with the exception of the 123,102 2025-2 AGAs, which vest at
the end of a two-year period from the allocation date, and the 50,000 2025-5 AGAs , which vest only upon the the achievement of
milestones related to clinical studies). Moreover, the vesting of almost half of the 4,319,500 2025-1 AGAs is subject to the occurrence
of a tender offer on the securities issued by the Group and resulting in a change of control of the Group before a certain date.
In April 2025, the Group granted to one of its Board members the right to subscribe up to 39,370 share warrants (BSA), the vesting of
which is subject to a service condition of four years , by tranches of 25 % each, vested on May 1 of each year. The BSAs were
subscribed in May 2025.
The detailed terms and conditions of these plans are set forth in Note 14.
Change in management – April 2025
On April 22, 2025, the Group announced the appointment of Dominik Höchli, MD to the Board of Directors of Abivax, effective
immediately.
Completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active UC - April 2025
On April 29, 2025, the Group announced the completion of enrollment for the Phase 3 ABTECT trials in patients with moderately to
severely active UC.
Note 3.3. Subsequent events
Publication of positive Phase 3 results from both ABTECT 8-week induction trials investigating obefazimod, in moderate to severely
active UC – July 2025
On July 22, 2025, the Group announced the results of the ABTECT-1 and ABTECT-2 induction trials in patients with moderately to
severely active UC. ABTECT-1 and 2 are global, multicenter, randomized, double-blind, placebo-controlled trials assessing once-
daily oral administration of obefazimod at 25 mg or 50 mg doses in adult patients with moderately to severely active UC. Eligible
participants had inadequate response, loss of response, or intolerance to conventional and/or advanced therapies. ABTECT-1 and
ABTECT-2 were conducted simultaneously and have enrolled 1,275 patients from over 600 participating clinical trial sites in 36
countries with the intent to satisfy regulatory requirements globally. The ABTECT Program is one of the largest Phase 3 ulcerative
colitis trials ever conducted and includes the largest population of patients with inadequate response to JAK inhibitor therapy.
Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission
at Week 8 in the 50 mg once-daily dose regimens for both trials. Individually, ABTECT-1 showed a placebo-adjusted clinical
remission rate of 19.3 % (p<0.0001) and ABTECT-2 demonstrated 13.4 % (p=0.0001), each at the 50 mg once-daily dose, with all key
secondary efficacy endpoints being met.
F-13
The 25 mg once-daily dose of obefazimod achieved the FDA primary endpoint of clinical remission at Week 8 in ABTECT-1
demonstrating a placebo-adjusted remission rate of 21.4 %. While the 25 mg dose did not achieve statistical significance for this
endpoint in ABTECT-2, it achieved a pooled placebo-adjusted clinical response rate of 28.6 %, indicating a strong signal for these
patients to achieve clinical remission with extended treatment in the maintenance trial.
The safety profile of obefazimod remained consistent with prior clinical experience. No new safety signals were observed in either
trial and the treatment was generally well tolerated across both dose groups.
The ABTECT Maintenance Trial (ABX464-107) is ongoing with top-line results expected to report out during the second quarter of
2026. Among the 1,275 patients randomized in the induction trials, 678 achieved clinical response and enrolled into part 1 of the
maintenance trial. The ABTECT program is one of the largest Phase 3 ulcerative colitis trials ever conducted.
Following this announcement and that of its Offering completed on July 28, 2025 (see Completion of a public offering – July 2025
within this section), the Group’s share price increased significantly, from €6.64 as of June 30, 2025, to €57.00 as of July 28, 2025.
At the same time, the Group reassessed the probability of success (“POS”) of obtaining a future market authorization for obefazimod
in UC, to reflect a reduced level of uncertainty following positive Phase 3 results.
The Group determined that these changes were non-adjusting subsequent events, which as such do not have any impact on the
financial position and the net loss of the Group as of June 30, 2025. These changes, however, are expected to have material effects on
the financial statements to be issued by the Group in future periods.
The estimated financial effects of this event on the Group’s financial statements are the following:
•A significant increase in the carrying value of the royalty certificates, measured at amortized cost, reflecting an increase in the
projected probability-weighted cash flows of the instrument, following the reassessment of the POS,
•Significant changes in the carrying value of the Group’s financial liabilities measured at fair value through profit or loss, i.e.
the Kreos / Claret BSA, the Kreos / Claret MRI and the Heights convertible notes (the latter as well as the Kreos / Claret BSA
being converted into ordinary shares at the request of the noteholders in July and August 2025, see Conversion of the Heights
convertible notes, Kreos / Claret OCABSA and Kreos / Claret BSA – July-August 2025 below),
•Significant changes in the disclosure of the fair values of other financial instruments measured at amortized cost (i.e. the
royalty certificates, the debt components of (i) the Kreos / Claret OCABSA (Tranche A, converted into shares in August
2025) and (ii) Tranche B and C bond loans, as well as the CRO advances; these fair value changes are not expected directly
to impact the future financial position and net loss of the Group).
Conversion of the Heights convertible notes, Kreos / Claret OCABSA and Kreos / Claret BSA – July-August 2025
On July 23 and July 30, 2025, the Group received notices from entities affiliated with Heights Capital Management, which hold
amortizing senior convertible notes of the Group issued in August 2023 (the “Height convertible notes”), for the immediate conversion
of respectively 150 and 200 convertible notes (corresponding to the entirety of the oustanding principal amount of €21.9 million) into
conditions of the convertible notes.
On August 6, 2025, Kreos Capital VII(UK) Limited converted the Tranche A portion of the Kreos / Claret Financing (the Kreos /
Claret OCABSA), resulting in the issuance of 785,389 ordinary shares. In addition, on the same date Kreos Capital VII Aggregator
SCSp exercised its share warrants (the tranche A-B BSA and tranche C BSA) resulting in the issuance of 319,251 ordinary shares of
the Group.
On August 28, 2025, Claret European Growth Capital Fund III SCSp, exercised its share warrants (the tranche A-B BSA and tranche
C BSA) resulting in the issuance of respectively 319,251 and 206,662 ordinary shares of the Group.
F-14
Completion of a public offering – July 2025
On July 28, 2025, the Group announced the completion of an underwritten public offering of 11,679,400 ADSs (the “Offering”), at a
price of $64.00 per ADS (corresponding to €54.58 per ordinary share, based on the exchange rate of €1.00 = $1.1726 as published by
the European Central Bank on July 23, 2025). The aggregate gross proceeds amount to approximately $747.5 million, equivalent to
approximately €637.5 million , before deduction of underwriting commissions and estimated expenses, and the estimated net proceeds,
after deducting underwriting commissions and estimated offering expenses, are approximately $700.3 million, equivalent to
approximately €597.2 million.
The Group believes that the net proceeds from the Offering, together with its current cash and cash equivalents, will allow it to finance
its operations into the fourth quarter of 2027, allowing it to reach 12 months of expected cash runway following the planned NDA
submission for UC, assuming positive results from its Phase 3 maintenance trial (see Note 2 above "Going concern").
F-15
Note 4. Accounting principles
The Group's accounting policies are the same as those described in the annual consolidated financial statements of the Group as of
December 31, 2024 accompanying the Annual Report.
In preparing these unaudited condensed consolidated financial statements, management has made judgments and estimates that affect
the application of the Group’s accounting policies and the reported amounts of assets and liabilities, income and expenses. Actual
values may differ from estimated values.
The significant judgments made by management in the application of the Group’s accounting policies and the key sources of
estimation uncertainty are the same as those described in the annual consolidated financial statements of the Group as of December 31,
2024 accompanying the Annual Report.
Measurement of fair values
A number of the Group’s accounting policies require the measurement of fair values, for both financial and non-financial assets and
liabilities.
When measuring the fair value of an asset or a liability, the Group uses market observable data as far as possible. Fair values are
categorized into different levels in a fair value hierarchy based on the inputs used in the valuation techniques as follows.
•Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
•Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly
(i.e., prices) or indirectly (i.e., derived from prices).
•Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs).
Seasonality of operations
The Group’s operations are not subject to significant seasonality.
Note 5. Segment information
The assessment of the Group’s performance and the decisions about resources to be allocated are made by the chief operating decision
maker, based on the management reporting system of the Group. The Group identified the Chief Executive Officer of the Group as
“Chief operating decision maker”. The Chief operating decision maker reviews on an aggregated basis the incurred expenses for
allocating and evaluating performance of the Group.
The Group operates in a single operating segment: R&D of pharmaceutical products in order to market them in the future.
Substantially all operations, assets, liabilities, and losses of the Group are located in France. As of June 30, 2025, the Subsidiary’s
contributions to the Group’s assets, liabilities and net losses were less than 10
F-16
Note 6. Goodwill and impairment test
Goodwill relates to the acquisition of Splicos SAS that occurred in 2014 (i.e., prior to the transition date to IFRS) which was merged
into the Group the same year.
Goodwill from the Splicos SAS acquisition corresponds to the “Modulation of RNA biogenesis / splicing” technological platform,
from which derived the lead drug candidate of the Group: ABX464.
In accordance with IAS 36, goodwill is allocated to groups of cash generating units (CGUs) at a level corresponding to the lead drug
candidates. Thus, goodwill from Splicos SAS is allocated to the ABX464 CGU.
The net carrying amount of Splicos SAS goodwill is €18,419
The ABX464 product candidate being currently in development, a clinical trial failure or a failure to obtain a marketing approval
could result in an impairment. As of June 30, 2025, the Group has not identified any indication of impairment loss related to goodwill,
Note 7. Intangible assets
Intangible assets are mainly comprised of the intellectual property underlying:
(i)The collaboration and license agreement with the CNRS, Montpellier 2 University and the Curie for which the Group
paid a milestone of €40 thousand in September 2019 as a result of the entry in phase 2 of ABX464.
(ii)Patents acquired through the acquisition of Prosynergia of €6,529 thousand. The patents are not yet amortized, similarly
to licenses, and are included in the ABX464 CGU for impairment test purposes.
Licenses and patents recognized as Intangible assets are not amortized since they are not operating in a manner intended by the
management. As a consequence, and in accordance with IAS 36, those assets were subject to an annual impairment test as of
December 31, 2024, which did not result in any impairment loss. As of June 30, 2025, no indicator of impairment has been identified.
F-17
(amounts in thousands of euros) | LICENCES | SOFTWARES | PATENTS | OTHER INTANGIBLE ASSETS | TOTAL | ||||
GROSS VALUES | |||||||||
AS OF JANUARY 1, 2024 | |||||||||
Acquisition | |||||||||
Disposal | |||||||||
AS OF JUNE 30, 2024 | |||||||||
GROSS VALUES | |||||||||
AS OF DECEMBER 31, 2024 | |||||||||
Acquisition | |||||||||
Disposal | |||||||||
AS OF JUNE 30, 2025 |
(amounts in thousands of euros) | LICENCES | SOFTWARES | PATENTS | OTHER INTANGIBLE ASSETS | TOTAL | ||||
AMORTIZATION | |||||||||
AS OF JANUARY 1, 2024 | ( | ( | ( | ||||||
Increase | |||||||||
Disposal | |||||||||
AS OF JUNE 30, 2024 | ( | ( | ( | ||||||
AS OF DECEMBER 31, 2024 | ( | ( | ( | ||||||
Increase | ( | ( | |||||||
Disposal | |||||||||
AS OF JUNE 30, 2025 | ( | ( | ( |
(amounts in thousands of euros) | LICENCES | SOFTWARES | PATENTS | OTHER INTANGIBLE ASSETS | TOTAL | ||||
NET BOOK VALUES | |||||||||
AS OF JUNE 30, 2024 | |||||||||
AS OF DECEMBER 31, 2024 | |||||||||
AS OF JUNE 30, 2025 |
F-18
Note 8. Property, plant and equipment
2024 and 2025:
(amounts in thousands of euros) | BUILDINGS | EQUIPMENT | FURNITURE AND COMPUTER EQUIPMENT | TOTAL | OF WHICH ROU | ||||
GROSS VALUES | |||||||||
AS OF JANUARY 1, 2024 | — | ||||||||
Acquisition | |||||||||
Disposal | ( | ( | ( | ( | |||||
Effect of the change in foreign currency exchange rates | |||||||||
AS OF JUNE 30, 2024 | — | — | 0 | 0 | |||||
AS OF DECEMBER 31, 2024 | — | ||||||||
Acquisition | |||||||||
Disposal | ( | ( | ( | ( | |||||
Effect of the change in foreign currency exchange rates | ( | ( | ( | ( | |||||
AS OF JUNE 30, 2025 | — | — | 0 | 0 |
(amounts in thousands of euros) | BUILDINGS | EQUIPMENT | FURNITURE AND COMPUTER EQUIPMENT | TOTAL | OF WHICH ROU | ||||
DEPRECIATION | |||||||||
AS OF JANUARY 1, 2024 | ( | ( | ( | ( | ( | ||||
Increase | ( | ( | ( | ( | ( | ||||
Disposal | |||||||||
AS OF JUNE 30, 2024 | ( | ( | ( | ( | ( | ||||
AS OF DECEMBER 31, 2024 | ( | ( | ( | ( | ( | ||||
Increase | ( | ( | ( | ( | ( | ||||
Disposal | |||||||||
Effect of the change in foreign currency exchange rates | |||||||||
AS OF JUNE 30, 2025 | ( | — | ( | — | ( | 0 | ( | ( |
F-19
(amounts in thousands of euros) | BUILDINGS | EQUIPMENT | FURNITURE AND COMPUTER EQUIPMENT | TOTAL | OF WHICH ROU | ||||
NET BOOK VALUES | |||||||||
AS OF JUNE 30, 2024 | — | — | 0 | — | |||||
AS OF DECEMBER 31, 2024 | |||||||||
AS OF JUNE 30, 2025 | — | — | 0 | — |
Right of use assets relate to buildings, vehicles and furniture. The net book value of right of use assets related to buildings amounted to
€2,081 thousand as of June 30, 2024 and €1,489 thousand as of June 30, 2025.
As of June 30, 2025, no indicator of impairment has been identified.
Note 9. Other financial assets
(amounts in thousands of euros) | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | ||
OTHER FINANCIAL ASSETS | ||||
Advances related to CRO contracts | ||||
Deposits | ||||
Other | ||||
Total other non-current financial assets | ||||
Advances related to CRO contracts | ||||
Deposits | ||||
Total other current financial assets | ||||
Other financial assets |
Advances related to CRO contracts
These advances granted in 2022 for clinical studies are to be recovered at the end of the studies after final reconciliation with pass-
through costs, which are being invoiced and paid as studies are carried out. These long-term advances were measured at fair value on
initial recognition, using discount rates ranging from 0.19 % to 7.16 %, and are subsequently measured at amortized cost. The recovery
dates of the first two advances are scheduled in the second half of 2025.
During the first half of 2023, additional advances related to CRO contracts amounting to €1,620 thousand were made (undiscounted
amount). These long-term advances were measured at fair value on initial recognition, using discount rates ranging from 7.09 % to
At inception, a prepaid expenses asset was recognized for the difference between the advances’ nominal value and fair value, and
spread over the term of the advances, at the rate of recognition of the related R&D expenses (see Note 10).
In March 2024, a change order was signed with the CRO, extending the scope (addition of maintenance studies) and end date of one of
the studies to 2029, thus postponing the recovery date of the corresponding advance of €5,538 thousand from June 2026 to June 2029.
The Group considered that this asset modification met the criteria for derecognition, and recognized a new financial asset at fair value
on that date, using a discount rate of 6.83 %. Since the Group considers that these advances are made in exchange for a discount on
future services to be received from the CROs, a prepaid expense asset was also recognized for the difference between the
derecognized asset carrying value and new asset fair value, and spread over the term of the advance in a similar manner.
F-20
The credit risk related to these advances is deemed insignificant due to the CROs' credit ratings.
Deposits
Deposits include the Paris and Boston offices lease contracts, the ATM Program, as well as other security deposits.
Note 10. Other receivables and assets
(amounts in thousands of euros) | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | ||
OTHER RECEIVABLES AND ASSETS | ||||
Prepaid expenses - non current | ||||
Total non-current other receivables and assets | ||||
Research tax credit ("CIR") | ||||
VAT receivables | ||||
Prepaid expenses | ||||
Credit notes | ||||
Other | ||||
Total current other receivables and assets | ||||
Other receivables and assets |
Research tax credit (“CIR”)
The CIR is recognized as Other Operating Income in the year to which the eligible research expense relates. The Group received the
payment for the CIR for the 2024 tax year of €5,640 thousand in June 2025. The additional CIR of €2,152 thousand recorded over the
six-month period ended June 30, 2025 relates to research expenses incurred during the period.
Prepaid expenses
Prepaid expenses as of June 30, 2025 include prepaid expenses related to CRO contracts for an amount of €1,332 thousand (see Note
9) and other expenses from various suppliers amounting to €1,803 thousand.
F-21
Note 11. Cash and cash equivalents
(amounts in thousands of euros) | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | ||
CASH AND CASH EQUIVALENTS | ||||
Cash equivalents | ||||
Cash | ||||
Cash and cash equivalents |
Cash equivalents mainly include term deposits with short-term maturities and highly liquid investments in mutual funds as of
December 31, 2024 and June 30, 2025.
As of December 31, 2024 and June 30, 2025, in addition to the Group’s bank accounts, cash includes notice accounts amounting to
€44,239 thousand and €12,707 thousand respectively. These funds are available on demand within 24 hours and without penalty.
As of December 31, 2024 and June 30, 2025, the impact of the revaluation of cash and cash equivalents held in U.S. dollars into the
F-22
Note 12. Financial assets and liabilities
levels in the fair value hierarchy.
Tax and employee-related payables are non-financial liabilities and are therefore excluded from the tables below. They are
presented in Note 17.2.
AS OF DECEMBER 31, 2024 | |||||||||
(amounts in thousands of euros) | AMOUNT RECOGNIZED IN THE STATEMENT OF FINANCIAL POSITION | FAIR VALUE | ASSETS/ LIABILITIES AT FAIR VALUE THROUGH PROFIT AND LOSS | ASSETS AT AMORTIZED COST | LIABILITIES AT AMORTIZED COST | ||||
Other financial assets (2) | — | ||||||||
Other receivables and assets (2) | — | ||||||||
Cash and cash equivalents (1) | — | ||||||||
Total financial assets | — | ||||||||
Financial liabilities—non-current portion (4, Note 15) | — | ||||||||
Financial liabilities—current portion (3, Note 15) | — | ||||||||
Trade payables and other current liabilities (3) | — | ||||||||
Total financial liabilities | — |
AS OF JUNE 30, 2025 | |||||||||
(amounts in thousands of euros) | AMOUNT RECOGNIZED IN THE STATEMENT OF FINANCIAL POSITION | FAIR VALUE | ASSETS/ LIABILITIES AT FAIR VALUE THROUGH PROFIT AND LOSS | ASSETS AT AMORTIZED COST | LIABILITIES AT AMORTIZED COST | ||||
Other financial assets (2) | — | ||||||||
Other receivables and assets (2) | — | ||||||||
Cash and cash equivalents (1) | — | ||||||||
Total financial assets | — | ||||||||
Financial liabilities—non-current portion (4, Note 15) | (50,401) | — | |||||||
Financial liabilities—current portion (3, Note 15) | — | ||||||||
Trade payables and other current liabilities (3) | — | ||||||||
Total financial liabilities | — |
(1) The fair value of cash and cash equivalents is determined based on Level 1 fair value measurement and corresponds to the
market value of the assets.
(2) The carrying amount of financial assets measured at amortized cost is deemed to be a reasonable estimate of fair value, except
for the long-term advances made to CROs, whose fair value is determined based on Level 3 fair value measurement and is estimated
based on future cash-flows discounted at market rates, using credit spreads ranging from 104 bp to 218 bp as of December 31, 2024
and 79 bp to 314 bp as of June 30, 2025. As of December 31, 2024 and June 30, 2025, an increase in the credit spread by +100
would result in a decrease in the advances fair value by €236 thousand and €186 thousand respectively.
(3) The carrying amount of short-term financial liabilities measured at amortized cost was deemed to be a reasonable estimate of
fair value.
F-23
(4) The fair value of the royalty certificates, Heights convertible notes, Kreos / Claret BSA and Minimum Return Indemnifications
is based on Level 3 fair value measurement and is estimated based on models and assumptions detailed in Note 15. The fair value of
other long-term financial liabilities is determined based on Level 3 fair value measurement and is estimated based on future cash-flows
discounted at market rates, using the following assumptions:
•For the debt components of the Kreos / Claret OCABSA (tranche A) and the tranches B and C of the Kreos / Claret straight
bond loans, a credit spread of 750 bp as of December 31, 2024 and 1,000 bp as of June 30, 2025.
As of December 31, 2024 and June 30, 2025, an increase in the credit spread by +100
Kreos / Claret tranche A (OCABSA), tranches B and C debt components fair value by respectively €538 thousand and
€1,580 thousand respectively.
•For the PGE loan, a credit spread of 900 bp as of December 31, 2024. As of December 31, 2024 an increase in the credit
spread by +100 bp would result in a decrease in the PGE loan fair value by €39 thousand. The PGE being a short-term
liability as of June 30, 2025, its carrying amount measured at amortized cost is deemed to be a reasonable estimate of its fair
value on that date.
Note 13. Shareholders’ equity
The Group manages its capital to ensure that it will be able to continue as a going concern while maximizing the return to
shareholders through the optimization of the debt and equity balance.
As of June 30, 2025, the Group’s share capital amounted to €635 thousand divided into 63,471,933 ordinary shares issued with a
par value of €0.01 each, fully paid up, after taking into account the various capital increases that took place since inception.
Share capital does not include founders’ share subscription warrants (“bons de souscription de parts de créateur d’entreprise” or
“BCE”), share subscription warrants (“Bons de souscription d’actions,” or “BSA”) and free shares (“Attributions gratuites d’actions,”
or “AGA”) that have been granted to certain investors or natural persons, both employees and non-employees of the Group, but not yet
exercised.
The Group held none
The increase in the share capital for the period ended June 30, 2025 relates to the vesting of 124,096 AGAs, resulting in the issuance
of 124,096 ordinary shares with a par value of €0.01 per share (see Note 14).
Distribution of dividends
The Group did not distribute any dividends for any of the periods presented, does not have any present plan to pay any cash dividends
on its equity securities in the foreseeable future and currently intends to retain all available funds and any future earnings to operate
F-24
Note 14. Share-based payments
The Group has granted BCEs, BSAs and free shares (attributions gratuites d’actions, or “AGAs”). These plans qualify as “equity
settled” under IFRS 2. The Group does not have any obligation to purchase these instruments in the event of departure or if a specific
event does not occur.
BCEs
TYPE | NUMBER OF BCEs ISSUED | NUMBER OF BCE OUTSTAND ING AS OF JANUARY 1, 2025 | NUMBER OF ISSUED BCEs | NUMBER OF LAPSED BCEs | NUMBER OF EXERCISE D BCEs | NUMBER OF BCEs OUTSTAND ING | NUMBER OF BCEs EXERCISA BLE | MAXIMUM NUMBER OF SHARES TO BE ISSUED IF ALL CONDITIONS ARE MET | ||||||||
FOR THE PERIOD ENDED JUNE 30, 2025 | AS OF JUNE 30, 2025 | |||||||||||||||
Total BCEs | ||||||||||||||||
BSAs
TYPE | Total NUMBER OF BSAs ISSUED | NUMBER OF BCAs OUTSTAND ING AS OF JANUARY 1, 2025 | NUMBER OF ISSUED BSAs | NUMBER OF LAPSED BSAs | NUMBER OF EXERCISE D BSAs | NUMBER OF BSAs OUTSTAND ING | NUMBER OF BSAs EXERCISA BLE | MAXIMUM NUMBER OF SHARES TO BE ISSUED IF ALL CONDITIONS ARE MET | |||||||
FOR THE PERIOD ENDED JUNE 30, 2025 | AS OF JUNE 30, 2025 | ||||||||||||||
Total BSAs | — | ||||||||||||||
BSAs granted in January and April 2025
In January 2025, the Group granted its independent Board members, as well as one of its Board Observers and Advisor, the right to
subscribe up to 125,000 BSAs in the aggregate, the vesting of which (if subscribed) is subject to a service condition of four years , by
tranches of 25 % each, vested on January, 1 of each year. Additionally, the BSAs are subject to a vesting acceleration condition in case
F-25
of a tender offer on the securities issued by the Group and resulting in a change of control of the Group. All of the granted BSAs were
subscribed by the beneficiaries in February 2025.
In April 2025, the Group granted to one of its Board members the right to subscribe up to 39,370 BSAs, the vesting of which is subject
to a service condition of four years , by tranches of 25 % each, vested on May, 1 of each year. The BSAs were subscribed in May 2025.
TYPE | FAIR VALUE OF THE UNDERLYING SHARE | FAIR VALUE OF THE BSA | NUMBER OF BSAs | SUBSCRIPTI ON PRICE | STRIKE PRICE PER SHARE | RISK FREE RATE | EXPECTED MATURITY | VOLATILITY | ||||||||
BSA-2025-1 | € | [€ | € | € | [ | |||||||||||
BSA-2025-2 | € | [€ | € | € | [ | |||||||||||
BSA-2025-3 | € | [€ | € | € | [ |
AGAs
accordance with IFRS 2—Share-based Payment:
TYPE | Total NUMBER OF AGAs ISSUED | NUMBER OF AGAs OUTSTANDING AS OF JANUARY 1, 2025 | NUMBER OF ISSUED AGAs | NUMBER OF LAPSED AGAs | NUMBER OF VESTED AGAs | NUMBER OF AGAs OUTSTANDING | ||||||
FOR THE PERIOD ENDED JUNE 30, 2025 | AS OF JUNE 30, 2025 | |||||||||||
Total AGAs | 0 | — | ( | — | ( | — | ||||||
TYPE | FAIR VALUE OF THE UNDERLYING SHARE | FAIR VALUE OF THE AGA | MATURITY | VOLATILITY | RISK FREE RATE | ||||
AGA-2025-1 | € | € | N/A | N/A | N/A | ||||
AGA-2025-2 | € | € | N/A | N/A | N/A | ||||
AGA-2025-3 | € | € | N/A | N/A | N/A | ||||
AGA-2025-4 | € | € | N/A | N/A | N/A | ||||
AGA-2025-5 | € | € | N/A | N/A | N/A | ||||
AGA-2025-6 | € | € | N/A | N/A | N/A |
AGAs granted in February, March and May 2025
In February and May 2025, certain of the Group’s officers and employees were allocated respectively 4,319,500 AGAs (AGA plan
2025-1), 123,102 AGAs (AGA plan 2025-2), 17,625 AGAs (AGA plans 2025-3), 30,500 AGAs (AGA plan 2025-4) and 25,000
AGAs (AGA plan 2025-6) in the aggregate, the vesting of which is subject to certain conditions:
•Subject to remaining employed with the Group, each such officer or employee’s AGAs will be vested as follows: (i) 50 % at
the end of a two-year period from the allocation date, (ii) 25 % at the end of a three-year period from the allocation date and
(iii) 25 % at the end of a four-year period from the allocation date (service condition).
•By exception to the above, the vesting of almost half of the 4,319,500 2025-1 AGAs is subject to the occurrence of a tender
offer on the securities issued by the Group and resulting in a change of control of the Group before a certain date, and the
F-26
•Additionally, all the remaining 2025-1 AGAs as well as the 2025-2, 2025-3 and 2025-4 AGAs are subject to a vesting
acceleration condition in case of a tender offer on the securities issued by the Group and resulting in a change of control of
the Group.
In March 2025, a Group employee was allocated 50,000 AGAs (AGA plan 2025-5), the vesting of which is subject to the achievement
of certain milestones related to clinical studies and market authorization of ABX464 in UC and CD. These AGAs are also subject to a
vesting acceleration condition in case of a tender offer on the securities issued by the Group and resulting in a change of control of the
Group.
2025:
TYPE (in thousands of euros) | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE PERIOD ENDED JUNE 30, 2024 | FOR THE PERIOD ENDED JUNE 30, 2025 | ||||
BCEs | ( | ( | — | |||||
BSAs | ( | ( | ( | — | ( | |||
AGAs | ( | ( | ( | — | ( | |||
Social taxes related to AGAs | ( | ( | ( | — | ( | |||
Total | ( | ( | ( | — | ( |
Provisions for social taxes related to AGAs are classified within the Current and Non-current Provisions line items in the balance
sheet.
F-27
Note 15. Financial liabilities
(amounts in thousands of euros) | ||||
FINANCIAL LIABILITIES | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | ||
Kreos & Claret bond loans | ||||
Lease liabilities | ||||
PGE | ||||
Borrowings | ||||
Kreos & Claret convertible notes (OCABSA) | ||||
Convertible loan notes | ||||
Kreos & Claret minimum return indemnifications | ||||
Derivative instruments | ||||
Royalty certificates | ||||
Other financial liabilities | ||||
Total non-current financial liabilities | ||||
Kreos & Claret bond loans | ||||
Lease liabilities | ||||
PGE | ||||
Borrowings | ||||
Heights convertible notes | ||||
Kreos & Claret convertible notes (OCABSA) | ||||
Convertible loan notes | ||||
Kreos & Claret BSA | ||||
Derivative instruments | ||||
Total current financial liabilities | ||||
Total financial liabilities |
The Kreos / Claret Financing consists of three tranches of €25,000 thousand each in aggregate principal amount (the convertible
OCABSA and the second and third tranches of non-convertible bonds, respectively the "tranches A, B and C") as well as a Minimal
Return Indemnification ("MRI") to the benefit of the bondholders.
In addition to the Kreos / Claret OCABSA, the Group has issued share warrants (the “tranche A-B BSA” and “tranche C BSA”),
giving Kreos and Claret the right to subscribe to up to 214,198 and 405,832 ordinary shares respectively.
The OCABSA are compound instruments, split between (i) a debt component (then measured at amortized cost) and (ii) an equity
component corresponding to the conversion option and the attached OCABSA warrants.
The OCABSA warrants are considered as an embedded component of the bonds rather than a separate stand-alone financial
instrument.
The Kreos / Claret second and third tranches are hybrid instruments, split between (i) debt host contracts accounted for at amortized
cost and (ii) bifurcated embedded derivatives accounted for at fair value through profit and loss, corresponding to the Minimal Return
Indemnifications and the prepayment options (the fair value of the prepayment options being deemed insignificant at issuance and as
of December 31, 2024 and June 30, 2025).
F-28
As the A-B and C warrants (the "Kreos / Claret BSA") are contractually transferable separately from the bonds and are redeemable in
a variable number of ordinary shares of the Group, they are classified as standalone derivative financial liabilities.
The detailed terms and conditions and the accounting treatment of these instruments are presented in Note 15.1 to the annual
consolidated financial statements of the Group as of December 31, 2024 accompanying the Group’s Annual Report.
On August 6, 2025, Kreos Capital VII(UK) Limited converted the Tranche A portion of the Kreos / Claret Financing (the Kreos /
Claret OCABSA), resulting in the issuance of 785,389 ordinary shares. In addition, on the same date Kreos Capital VII Aggregator
SCSp exercised its share warrants (the tranche A-B BSA and tranche C BSA) resulting in the issuance of 319,251 ordinary shares of
the Group.
On August 28, 2025, Claret European Growth Capital Fund III SCSp, exercised its share warrants (the tranche A-B BSA and tranche
C BSA) 206,662 shares of the Group.
F-29
Measurement of the Kreos / Claret second and third tranches hybrid instruments
At inception, the net cash proceeds reflect the tranches' initial fair values. The fair values of the Minimal Return Indemnifications were
deducted from the initial carrying values of the debt components of each tranche, which were subsequently measured at amortized cost
using the EIR method.
Tranche B Minimum Return Indemnification - Mars 2024 | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Final redemption scenario probability | |||
Minimal return | |||
Discount rate | |||
Probability-weighted present value of shortfall payment (in thousands of €) | |||
Probability-weighted fair value of tranche A-B warrants with MRI (in thousands of €) | |||
Probability-weighted fair value of tranche A-B warrants without MRI (in thousands of €) | |||
Total fair value of MRI (in thousands of €) | |||
Fair value of Tranche B MRI (in thousands of €) |
Tranche C Minimum Return Indemnification - June 2024 | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Final redemption scenario probability | |||
Minimal return | |||
Discount rate | |||
(a) Probability-weighted present value of shortfall payment (in thousands of €) | |||
(b) Probability-weighted fair value of tranche A-B warrants with MRI (in thousands of €) | |||
(c) Probability-weighted fair value of tranche A-B warrants without MRI (in thousands of €) | |||
Total fair value of MRI (in thousands of €) | |||
Fair value of Tranche C MRI (in thousands of €) |
For the purpose of measuring the fair value of the MRI (shortfall payment), the fair value of the tranche A-B and C BSA was
measured with a Black Scholes model under the Final redemption scenario and with a Monte Carlo model under the Tender offer
scenario.
The increase in the discount rate assumption for the Tranches B and C MRI between December 31, 2024 and June 30, 2025 primarily
reflects changes in market conditions and a higher credit risk.
As of December 31, 2024, using the same assumption with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate, +10 % in
the probability of achieving the Final redemption scenario and +1 % discount rate would result in changes of the MRI B and C fair
value by respectively €-1 thousand, €-3 thousand, €-3 thousand, €+3 thousand and €-82 thousand.
As of June 30, 2025, using the same assumption with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate, +10 % in the
probability of achieving the Final redemption scenario and +1 % discount rate would result in changes of the MRI B and C fair value
by respectively €1 thousand, €-82 thousand, €-6 thousand, €-6 thousand and €-60 thousand.
F-30
Measurement of the Kreos / Claret tranche A-B-C BSA
The Kreos / Claret tranche A-B and tranche C BSA are measured at fair value using a Black-Scholes valuation model. The model
considers two probability-weighted scenarios, i.e. (i) the 7-year expiry of the BSA and (ii) an earlier exercise upon a tender offer. The
main data and assumptions are the following:
Kreos/Claret Tranche A-B BSA - August 2023 | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Number of outstanding BSA | |||
Exercise price per share | |||
Ordinary share price | |||
Exercise date | 19/8/2030 (expiry) 18/2/2027 (tender offer) | 19/8/2030 (expiry) 18/2/2027 (tender offer) | |
7-year expiry scenario probability | |||
Volatility | |||
Dividend | |||
Risk-free rate | |||
Fair value of issued Kreos/Claret Tranche A-B BSA |
Kreos/Claret Tranche C BSA - November 2023 | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Number of outstanding BSA | |||
of which, number of conditional BSA | |||
Exercise price per share | |||
Ordinary share price | |||
Exercise date | 1/11/2030 (expiry) 18/2/2027 (tender offer) | 1/11/2030 (expiry) 18/2/2027 (tender offer) | |
7-year expiry scenario probability | |||
Probability of Drawdown of Tranche C credit facility | Drawn on June 21, 2024 | Drawn on June 21, 2024 | |
Volatility | |||
Dividend | |||
Risk-free rate | |||
Fair value of issued Kreos/Claret Tranche A-B BSA |
As of December 31, 2024, using the same assumption with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate and
+10 % in the probability of achieving the 7 years expiry scenario would result in an increase of Kreos / Claret A-B and C BSA fair
value by respectively €37 thousand, €350 thousand, €61 thousand and €75 thousand.
As of June 30, 2025, using the same assumption with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate and +10 % in
the probability of achieving the 7 -year expiry scenario would result in an increase of Kreos / Claret A-B and C BSA fair value by
respectively €34 thousand, €391 thousand, €50 thousand and €103 thousand.
F-31
The Heights convertible notes consists of (i) a host debt instrument and (ii) conversion and settlement options representing embedded
derivatives. The whole instrument is measured at fair value through profit or loss ("FVTPL") at each reporting date.
In application of the Amendments to IAS 1 Presentation of Financial Statements – Classification of Liabilities as Current or Non-
current, and Non-current Liabilities with Covenants, the Heights convertible notes are classified as current financial liabilities.
The fair value of the Heights convertible notes (including the embedded features) has been measured with a Monte Carlo model,
considering two probability-weighted scenarios: (i) a Put Event or Default/Dissolution scenario and (ii) a voluntary conversion at
maturity scenario. The main data and assumptions are the following:
Heights convertible notes - August 2023 | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 |
Number of outstanding notes | ||
Original principal amount (in thousands of €) | ||
Interest rate | ||
Conversion price per share | € | € |
Ordinary share price | € | € |
Maturity date | 24/08/2025 (put event) 24/08/2027 (HTM/voluntary conversion) | 24/08/2026 (put event) 24/08/2027 (HTM/voluntary conversion) |
Held to maturity scenario probability | ||
Initial price limit | € | € |
Early redemption amount (put event) | ||
Volatility | ||
Credit spread | ||
Risk-free rate | ||
Fair value of Heights convertible notes (in thousands of €) |
As of December 31, 2024, using the same assumptions with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate and
+10 % probability of achieving the held to maturity scenario would result in a change in the Heights convertible notes fair value by
respectively €+2 thousand, €+39 thousand, €-219 thousand and €-631 thousand.
As of June 30, 2025, using the same assumptions with an increase of +1 % volatility, €+1 share price, +1 % risk-free rate and +10 %
probability of achieving the held to maturity scenario would result in a change in the Heights convertible notes fair value by
respectively €+6 thousand, €+42 thousand, €-152 thousand and €-237 thousand.
On the limit date for the drawdown of the second tranche of the Heights Financing (i.e. August 4, 2024), the Group had not drawn
down this tranche and has therefore forgone its right to do so in the future.
On July 23 and July 30, 2025, the noteholders requested the conversion of respectively 150 and 200 convertible notes (corresponding
to the entirety of the outstanding principal amount of approximately €21.9 million) into 920,377 new ordinary shares of the Group at a
conversion price of €23.7674 per ordinary share (see Note 3.3 "Conversion of the Heights convertible notes – July-August 2025").
F-32
The payment of the last installment of the PGE is scheduled in June 2026.
(amounts in thousands of euros) | LEASE LIABILITY |
AS OF DECEMBER 31, 2023 | |
(+) Increase | |
(-) Decrease | ( |
AS OF JUNE 30, 2024 | |
AS OF DECEMBER 31, 2024 | |
(+) Increase | |
(-) Decrease | ( |
AS OF JUNE 30, 2025 |
Lease liabilities mainly relate the Group’s former headquarters in Paris, the Boston office entered into in November 2023, the
Montpellier offices entered into in April 2024, the new Paris headquarters entered into in May 2024 and to a lesser extent to vehicles,
parking lots and printers (Note 8).
As of December 31, 2024 and June 30, 2025, the lease liabilities of the Paris headquarters and Boston offices represented 93 % and
Lease expenses related to contracts for which a lease liability and right of use asset is recognized under IFRS 16 were €309 thousand
and €428 thousand for the six-month periods ended June 30, 2024 and 2025, respectively. They were recognized for (i) €405 thousand
and €362 thousand as Depreciation expenses and (ii) €25 thousand and €36 thousand as Interest expenses, for the six-month periods
ended June 30, 2024 and 2025, respectively.
Lease expenses related to short-term lease contracts and low value assets that are not included in the valuation of the lease liability
amount to €77 thousand, and €175 thousand for the six-month periods ended June 30, 2024 and 2025, respectively.
The royalty certificates are measured at amortized cost using the EIR method.
The fair value of the royalty certificates, calculated using the same model as their initial measurement, amounts to €7,313 thousand as
of December 31, 2024 and €9,417 thousand as of June 30, 2025.
F-33
The fair value of the royalty certificates is based on the net present value of royalties, which depends on assumptions made by the
Group with regards to the probability of success of its studies (“POS”), the commercialization budget of obefazimod (“peak
penetration”) and the Group's WACC. In addition, royalty projections have been adjusted to reflect any difference between the
Group’s value derived from management projections and the Group’s market capitalization.
As of December 31, 2024, using the same assumptions with an increase of +5 points of POS, +5 % of peak penetration (best case
scenario), +1 % WACC and €+1 share price would result in a change in the royalty certificates fair value by respectively €
+572 thousand, €+1,735 thousand, €-314 thousand and €+1,160 thousand. Using the same assumptions with a decrease of -5 % points
of POS, -5 % of peak penetration (worst case scenario) and -1 % WACC and €-1 share price would result in a change in the royalty
certificates fair value by respectively €-572 thousand, €-2,527 thousand, €+332 thousand and €-1,160 thousand.
As of June 30, 2025, using the same assumptions with an increase of +5 points of POS, +5 % of peak penetration (best case scenario),
+1 % WACC and €+1 share price would result in a change in the royalty certificates fair value by respectively €+740 thousand, €
+2,201 thousand, €-395 thousand and €+1,326 thousand. Using the same assumptions with a decrease of -5 % points of POS, -5 % of
peak penetration (worst case scenario) and -1 % WACC and €-1 share price would result in a change in the royalty certificates fair
value by respectively €-740 thousand, €-3,182 thousand, €+416 thousand and €-1,326 thousand.
F-34
(Amounts in thousands of euros) | Kreos/ Claret convertible notes (OCABSA) | Kreos & Claret bond loans | Heights convertibl e notes | PGE | Conditional advances BPI | Lease liabilities | Royalty certificates | Total | ||||||||
FINANCIAL LIABILITIES (excluding derivatives instruments) | ||||||||||||||||
AS OF JANUARY 1, 2024 | ||||||||||||||||
Proceeds | ||||||||||||||||
Repayments | ( | ( | ( | ( | ( | |||||||||||
Interest paid | ( | ( | ( | ( | ( | ( | ||||||||||
Non-cash changes: classification of embedded derivatives as separate derivative financial instruments | ( | ( | ||||||||||||||
Non-cash changes: (gain)/loss on recognition or derecognition | ( | ( | ||||||||||||||
Non-cash changes: interest expense and other | ||||||||||||||||
Non-cash changes: other fair value remeasurement | ( | ( | ||||||||||||||
Non-cash changes : subsidies | ( | ( | ||||||||||||||
Non-cash changes : other reclassifications | ( | ( | ||||||||||||||
Non cash changes: additional leases | ||||||||||||||||
AS OF JUNE 30, 2024 | ||||||||||||||||
(Amounts in thousands of euros) | Kreos/ Claret convertible notes (OCABSA) | Kreos & Claret bond loans | Heights convertibl e notes | PGE | Conditional advances BPI | Lease liabilities | Royalty certificates | Total | ||||||||
FINANCIAL LIABILITIES (excluding derivatives instruments) | ||||||||||||||||
AS OF DECEMBER 31, 2024 | ||||||||||||||||
Repayments | ( | ( | ( | ( | ( | |||||||||||
Interest paid | ( | ( | ( | ( | ( | ( | ||||||||||
Non-cash changes: (gain)/loss on recognition or derecognition | ( | ( | ||||||||||||||
Non-cash changes: interest expense and other | ||||||||||||||||
Non-cash changes: other fair value remeasurement | ( | ( | ||||||||||||||
Non cash changes : Effect of the change in foreign currency exchange rates | ( | ( | ||||||||||||||
AS OF JUNE 30, 2025 |
For the six-month period ended June 30, 2024, proceeds from the issuance of the Kreos / Claret tranches B and C bond loans are
presented net of transaction costs and deposits (corresponding to the prepayments of half of the last debt installments on issuance date)
included in the debt discount using the EIR method, and amounting to €1,475 thousand and €1,081 thousand respectively. Net
proceeds from non-convertible bond loans of €48,544 thousand disclosed in the Unaudited Condensed Consolidated Statements of
Cash Flows for the six-month period ended June 30, 2024 do not include transaction fees of (i) €500 thousand related to the Kreos /
Claret tranche A-B warrants classified as prepaid expenses as of December 31, 2023 and €600 thousand related to tranche C and not
yet disbursed as of June 30, 2024.
F-35
(amounts in thousands of euros) | Kreos/Claret BSA | Kreos/Claret Minimum Return Indemnifications | Total | |||
DERIVATIVE FINANCIAL INSTRUMENTS | ||||||
AS OF JANUARY 1, 2024 | ||||||
(+) Issuance | ||||||
(+) Increase in fair value | ||||||
(-) Decrease in fair value | ( | ( | ||||
AS OF JUNE 30, 2024 | ||||||
AS OF JANUARY 1, 2025 | ||||||
(+) Increase in fair value | ||||||
(-) Decrease in fair value | ( | ( | ||||
AS OF JUNE 30, 2025 |
Details related to these instruments' accounting treatments and terms and conditions are set forth in Notes 15.1 and 15.2 of these
financial statements, as well as in Notes 15.1 and 15.2 to the annual consolidated financial statements of the Group as of December 31,
2024 accompanying the Group’s Annual Report.
amounts are gross and undiscounted, and include contractual interest payments.
AS OF DECEMBER 31, 2024 | |||||||||||
CURRENT AND NON-CURRENT FINANCIAL LIABILITIES | GROSS AMOUNT | CONTRACTUAL CASH FLOWS | LESS THAN 1 YEAR | FROM 1 TO 2 YEARS | FROM 2 TO 5 YEARS | LONGER THAN 5 YEARS | |||||
(amounts in thousands of euros) | |||||||||||
Heights convertible notes | |||||||||||
Kreos/Claret convertible notes (OCABSA) | |||||||||||
Kreos/Claret bond loans | |||||||||||
PGE | |||||||||||
Royalty certificates | |||||||||||
Lease liabilities | |||||||||||
Derivative instruments | |||||||||||
Total financial liabilities | |||||||||||
F-36
AS OF JUNE 30, 2025 | |||||||||||
CURRENT AND NON-CURRENT FINANCIAL LIABILITIES | GROSS AMOUNT | CONTRACTUAL CASH FLOWS | LESS THAN 1 YEAR | FROM 1 TO 2 YEARS | FROM 2 TO 5 YEARS | LONGER THAN 5 YEARS | |||||
(amounts in thousands of euros) | |||||||||||
Heights convertible notes | |||||||||||
Kreos/Claret convertible notes (OCABSA) | |||||||||||
Kreos/Claret bond loans | |||||||||||
PGE | |||||||||||
Royalty certificates | |||||||||||
Lease liabilities | |||||||||||
Derivative instruments | |||||||||||
Total financial liabilities | $— | 0 | $— | 0 | |||||||
(1) The contractual cash flows above do not include potential future royalty payments related to the royalty certificates, amounting to
royalty certificates is capped at €172.0 million in the aggregate. Royalty payments are expected to take place before the expiry date of
the certificates, which is 15 years after their issuance date (September 2, 2037), and would be included in the "from 2 to 5 years" and
"longer than 5 years" maturity categories according to management's projections.
Note 16. Retirement benefit obligations
Retirement benefit obligations include the liability for the defined benefit plan, measured based on the provisions stipulated
under the applicable collective agreements, i.e. the French pharmaceutical industry’s collective agreement. This commitment
only applies to employees subject to French law. Employees in the U.S. benefit from defined contribution plans (401(k)).
Note 17. Payables and other current liabilities
(amounts in thousands of euros) | |||
TRADE PAYABLES AND OTHER CURRENT LIABILITIES | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Trade payables | |||
Accrued invoices | |||
Other | |||
Trade payables and other current liabilities | — |
The increase in accrued invoices as of June 30, 2025 compared to December 31, 2024 is mainly explained by upcoming
milestones and increased activity on ABTECT reflecting the progress on phase 3 clinical trials.
F-37
(amounts in thousands of euros) | |||
TAX AND EMPLOYEE-RELATED PAYABLES | AS OF DECEMBER 31, 2024 | AS OF JUNE 30, 2025 | |
Employee-related payables | |||
Social security and other | |||
Other tax and related payments | |||
Tax and employee-related payables |
Note 18. Operating income
(amounts in thousands of euros) | ||||||||
OPERATING INCOME | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Research tax credit ("CIR") | ||||||||
Subsidies | ||||||||
Other | ||||||||
Total operating income |
Research tax credit (“CIR”)
The Group carries out research and development projects. As such, it has benefited from a research tax credit for the six-month
periods ended June 30, 2024 and 2025 for an amount of €2,665 thousand and €2,017 thousand, respectively.
Subsidies
Subsidies primarily relate to the Bpifrance RNP-VIR and CARENA conditional advances, the repayments of which were partly
waived by Bpifrance in June 2024, for €1,872 thousand and €2,251 thousand respectively (see Note 3.1).
Note 19. Operating expenses
F-38
(amounts in thousands of euros) | ||||||||
SALES AND MARKETING | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Personnel costs | ||||||||
Consulting and professional fees | ||||||||
Other sales and marketing expenses | ||||||||
Sales & Marketing | ||||||||
The sales and marketing expenses as of June 30, 2025 consist primarily in consulting costs associated with market research in
preparation for the Group's future sales and commercialization efforts in the U.S. The decrease for the three- and six-month periods
ended June 30, 2025 compared to June 30, 2024 was predominantly driven by a reduction in headcount as well as one-time costs that
were incurred in 2024 for our corporate re-branding, including our new website.
(amounts in thousands of euros) | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Sub-contracting, studies and research | ||||||||
Personnel costs | ||||||||
Consulting and professional fees | ||||||||
Intellectual property fees | ||||||||
Other research and development expenses | ||||||||
Research and development expenses | ||||||||
For the six-month period ended June 30, 2025, research and development expenses were €77,946 thousand, as compared to
€64,650 thousand for the six-month period ended June 30, 2024, and consisted primarily of expenses related to the UC clinical
program for €51,929 thousand, the CD clinical program for €7,416 thousand, as well as transversal activities for €14,829 thousand.
This increase was primarily due to a €6,499 thousand increase in expenses related to the CD program, resulting from the progression
of the Phase 2b trials in CD and an increase in transversal activities related to the overall expansion of the research and development
headcount to support the Group's organizational growth and the issuance of new equity awards to officers and employees in research
and development. Similar factors have driven the increase for the three-month period ended June 30, 2025 compared to 2024.
F-39
(amounts in thousands of euros) | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Personnel costs | ||||||||
Consulting and professional fees | ||||||||
Other general and administrative expenses | ||||||||
General and administrative expenses | ||||||||
For the six-month period ended June 30, 2025, general and administrative expenses were €16,303 thousand, as compared to €17,932
thousand for the six-month period ended June 30, 2024. This decrease was primarily due to a decrease in personnel costs of
€1,240 thousand, or 11 %, mainly resulting from the expense recognition pattern of equity awards granted to certain of the Group's
officers and employees, many of which were issued in connection with the Group's U.S. initial public offering and listing on Nasdaq in
October 2023, as well as strict adherence to the approved budget, which includes savings through the gating of non essential spend.
These were partially offset by increased legal and professional fees and other costs associated with operating as a dual-listed public
company. Similar factors have driven the decrease for the three-month periods ended June 30, 2025 compared to 2024.
Note 20. Employees
HEADCOUNT | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||
France | ||||
United States | ||||
Total |
F-40
Note 21. Financial gain (loss)
(amounts in thousands of euros) | ||||||||
FINANCIAL GAIN (LOSS) | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Interest on bond loans | ( | ( | ( | ( | ||||
Interest on convertible loan notes | ( | ( | ( | ( | ||||
Interest on conditional advances and PGE | ( | ( | ( | ( | ||||
Interest on royalty certificates | ( | ( | ( | ( | ||||
Interest on lease liabilities | ( | ( | ( | ( | ||||
Increase in derivatives fair value | ( | ( | ( | ( | ||||
Increase (decrease) in other liabilities (assets) at fair value through profit and loss | ( | |||||||
Transaction costs | ( | ( | ||||||
Foreign exchange losses | ( | ( | ( | ( | ||||
Other financial expense | ( | ( | ( | ( | ||||
Financial expenses | ( | ( | ( | ( | ||||
Interest income | ||||||||
Decrease in derivatives fair value | ||||||||
Decrease (increase) in other liabilities (assets) at fair value through profit and loss | ||||||||
Effect of unwinding the discount related to advances made to CROs | ||||||||
Day-one gain on recognition of financial liabilities | ||||||||
Foreign exchange gains | ||||||||
Financial income | ||||||||
Financial gain (loss) | ( | ( | ( | ( |
Interest on bond loans consists of interests from the Kreos / Claret B and C tranches, drawn down in respectively March and June
2024, thus explaining the increase for the three- and six-month periods ended June 30, 2025 compared to 2024 (see Note 15.1).
Interests on convertible loan notes corresponds to interests from the Kreos / Claret OCABSA (tranche A) and from the Height notes
(see Notes 15.1 and 15.2).
Transaction costs for the three- and six-month periods ended June 30, 2024 mainly relate to the amortization of the prepaid expenses
related to the transaction costs of the Kreos / Claret tranche C bond loans (see Note 15.1).
Increases and decreases in the fair value of derivatives for the six-month period ended June 30, 2025 are detailed in Notes 15.1, 15.2
and 15.7.
The decrease and increase in other liabilities at fair value through profit or loss ("FVTPL") mainly relate to the Heights notes for the
three- and six-month periods ended June 30, 2024 and June 30, 2025 respectively (see Note 15.2). For the three- and six-month
periods ended June 30, 2025, this line item also includes an income of respectively €375 thousand the €462 thousand resulting from
the revaluation of cash equivalents measured at FVTPL.Interest income mainly relates to the invested proceeds from (i) the Group's
initial public offering on the Nasdaq Global Market and the concurrent European Private Placement from October 2023, and (ii) the
F-41
Kreos / Claret and Heights Financings. The decrease in interest income is mainly driven by the decrease in the cash & cash equivalents
position (see Note 11).
Foreign exchange losses for the three- and six-month periods ended June 30, 2025 relate to the translation of cash and cash equivalents
held in U.S. dollars into the Group's presentation currency as of June 30, 2025 , resulting in a loss of €1,083 thousand, and to other
realized and unrealized losses on foreign exchange transactions (see Note 11).
Note 22. Income tax
The Group incurred tax losses in the current period and prior years. As the recoverability of these tax losses is not considered probable
in subsequent periods due to the uncertainties inherent in the Group’s business, the Group has not recognized deferred tax assets
beyond deferred tax liabilities arising within the same taxable entity under the same taxable regime and with consistent timing of
reversal, after considering, if applicable, limitations in the use of deductible tax losses carried forward from prior periods applicable
under tax laws in France and in the U.S.
Note 23. Income (loss) per share
Basic losses per share is calculated by dividing income (loss) attributable to equity holders of the Group by the weighted-
average number of outstanding ordinary shares for the period.
Diluted losses per share are calculated by adjusting the weighted average number of ordinary outstanding shares to assume
conversion of all dilutive potential ordinary shares.
(amounts in thousands of euros, except share data) | ||||||||
BASIC AND DILUTED LOSS PER SHARE | FOR THE THREE MONTHS ENDED JUNE 30, 2024 | FOR THE THREE MONTHS ENDED JUNE 30, 2025 | FOR THE SIX MONTHS ENDED JUNE 30, 2024 | FOR THE SIX MONTHS ENDED JUNE 30, 2025 | ||||
Weighted average number of outstanding shares | — | |||||||
Net loss for the period | ( | ( | ( | — | ( | |||
Basic and diluted loss per share (€/share) | ( | ( | ( | ( |
Since net results for the three- and six-month periods ended June 30, 2024 and 2025 are losses, potentially dilutive instruments (BCEs,
BSAs, AGAs, the OCABSA, the Kreos / Claret BSAs and the Heights notes) have been excluded from the computation of diluted
weighted-average shares outstanding, because such instruments had an antidilutive impact. Consequently, the diluted losses per share
Note 24. Related parties
Except for share-based compensation plans (see Note 14), the Group has not engaged in any new transaction with its related parties
over the six-month period ended June 30, 2025.
Note 25. Off-balance sheet commitments given
On December 12, 2024, the Group was notified of a claim from the seller of Prosynergia requesting the payment of an earn-out in
connection with the transaction. Legal proceedings are ongoing in French court. The Group has not recorded any provision in its
financial statements in connection with this claim due to uncertainty in the outcome of this proceeding.
Over the period ended June 30, 2025, the Group has not given any significant additional off-balance sheet commitment or amended
already existing commitments. The off-balance sheet commitments given by the Group as of June 30, 2025 are identical to December
31, 2024, with the exception of the following changes in the commitments related to CRO contracts:
F-42
arrangements with various contract research organizations, or CROs, and with public- sector partners or subcontractors, who conduct
clinical trials and studies in relation to the drug candidates. As of December 31, 2024 and June 30, 2025, the Group’s commitments
amounted to respectively €234,908 thousand and €215,046 thousand. The cost of services performed by CROs is recognized as an
Note 26. Off-balance sheet commitments received and contingent assets
Over the six-month period ended June 30, 2025, the Group has not received any significant additional commitment and has not
identified any contingent assets susceptible to being recognized in the future.
Note 27. Management and assessment of financial risks
The Group is exposed to interest rate risk, credit risk, foreign currency risk and liquidity risk. The Group has not identified any
significant changes in the identified credit and interest rate risks as of June 30, 2025 compared to December 31, 2024.
Liquidity risk
The remaining contractual maturities of financial liabilities as of December 31, 2024 and June 30, 2025 are presented in Note 15.8.
The Group's estimate of its cash runway as of the date of approval of these financial statements is set forth in Note 2 - Going concern.
Foreign currency risk
The Group is exposed to a risk of exchange rates fluctuations on commercial transactions performed in currencies different from the
functional currency of the Group entity recording the transactions.
For six-month period ended June 30, 2025, expenses in U.S. dollars totaled €7,408 thousand based on the average annual exchange
rate on that date. As a result, an adverse 10 % change in the exchange rate for the U.S. dollar against the euro would have resulted in a
foreign exchange rate loss of approximately €823 thousand for the six-month period ended June 30, 2025.
At this stage, the Group has not adopted any other recurring mechanism of hedging to protect its activity against currency fluctuations.
From time to time, the Group may nevertheless subscribe currency term accounts in order to cover a commitment in currency as
described above. The Group may consider in the future using a suitable policy to hedge exchange risks in a more significant manner if
needed.
FAQ
What did Abivax (ABVX) report for its Phase 3 ABTECT induction trials?
Abivax announced on July 22, 2025 that obefazimod 50 mg once daily met the FDA primary endpoint of clinical remission at Week 8 with placebo-adjusted rates of 19.3% (ABTECT-1, p<0.0001) and 13.4% (ABTECT-2, p=0.0001).
How much cash did ABVX have at June 30, 2025 and what is its expected runway?
Cash and cash equivalents were €60.9 million at June 30, 2025. Management expects that, together with the July 2025 offering proceeds and note conversions, the company can fund operations into the fourth quarter of 2027 under current assumptions.
How much did Abivax raise in the July 2025 offering?
The company raised gross proceeds of approximately €637.5 million from 11,679,400 ADSs at $64.00 per ADS, with estimated net proceeds of about €597.2 million after fees and expenses.
What were the main financial drivers of ABVX's net loss in H1 2025?
Net financial loss in H1 2025 was mainly driven by €6.9M of interest expense (related to Kreos/Claret and Heights financings), foreign exchange losses of €2.3M, and non-cash expenses including royalty certificate effects.
Has Abivax completed enrollment for its Phase 3 UC trials?
Yes. The Group announced completion of enrollment for the Phase 3 ABTECT trials in moderately to severely active ulcerative colitis on April 29, 2025.
Abivax S.A.
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Aug 14, 2025
[SCHEDULE 13G/A] Abivax SA American SEC Filing
Jul 31, 2025
[SCHEDULE 13D/A] Abivax SA American SEC Filing