Abivax S.A. SEC Filings

Abivax SA is conducting a public offering of 6,400,000 ADSs at $125.00 per ADS. The offering price implies gross proceeds of $800,000,000 before underwriting discounts; proceeds to the company before expenses are $762,000,000. The underwriters have a 30-day option to purchase up to 960,000 additional ADSs.

The company recently repurchased royalty certificates for aggregate consideration of $90.0 million, funded half in cash and half by issuing 403,347 ordinary shares (including ADSs). Abivax reported positive topline Phase 3 maintenance results for obefazimod in ulcerative colitis, with higher response and remission rates at the 50 mg dose in exploratory cohorts and safety findings summarized across treatment arms.

Abivax SA is offering up to $600,000,000 of American Depositary Shares (ADSs), each representing one ordinary share. The ADSs trade on Nasdaq under the symbol ABVX and the ordinary shares trade on Euronext Paris under ABVX. The prospectus supplement describes offering mechanics, underwriting arrangements and customary lock-ups, and registers resale of ADSs issued in a prior private placement in connection with a $90.0 million royalty certificate repurchase (403,347 ADSs issued).

The supplement also discloses positive topline results from Part 2 of the Phase 3 ABTECT 44‑week maintenance trial for obefazimod, including Week 44 clinical remission of 37.2% for the 50 mg arm (induction non-responders) and safety tables summarizing treatment-emergent adverse events and malignancy incidence metrics used for exposure‑adjusted comparisons.

Abivax SA filed a Post-Effective Amendment No. 1 to its Form F-3 to add debt securities under Rule 413(b) and replace its base prospectus. The amendment, dated June 30, 2026, becomes effective immediately upon filing and updates the prospectus to permit offerings of ordinary shares, ADSs, warrants and debt securities.

The prospectus states offerings may be made from time to time, either by the company or by selling security holders, in one or more transactions, and that specific terms will be provided in prospectus supplements. The document discloses recent market prices for ADSs and ordinary shares and summarizes governance, shareholder rights and distribution mechanics under French law.

Abivax reported positive topline results from ABTECT Maintenance Part 2, a Phase 3 trial of oral obefazimod in adults with moderately to severely active ulcerative colitis who were either induction non-responders or maintenance relapsers, a highly refractory population.

Among induction non-responders treated continuously with 50 mg obefazimod, Week 44 outcomes included clinical remission of 37.2%, clinical response of 61.5%, endoscopic improvement of 48.0%, Histologic-Endoscopic Mucosal Improvement of 44.6%, and endoscopic remission of 34.5%. In patients who relapsed during maintenance and were re-treated with 50 mg, clinical response rates reached 69.7% and 66.7%, with clinical remission around 45% in both retreatment groups.

Part 2 meaningfully expanded long-term safety exposure. Four non-melanoma skin cancer events and two other malignancies were observed, largely in patients with established risk factors, with malignancy and NMSC exposure-adjusted incidence rates across Phase 2 and 3 falling within published ulcerative colitis background ranges. Abivax states it remains on track to submit a U.S. New Drug Application for obefazimod in ulcerative colitis in the fourth quarter of 2026.

Abivax reported positive Phase 3 ABTECT 44-week maintenance results for obefazimod, its once-daily oral miR-124 enhancer, in moderately to severely active ulcerative colitis. Among 580 induction responders, clinical remission at Week 44 reached 50.8% on 25 mg and 51.3% on 50 mg, versus 10.4% on placebo, with placebo-adjusted differences of 39.3% and 40.3% (p<0.0001 for both doses).

Both doses met all key secondary endpoints, including endoscopic improvement, endoscopic remission, HEMI, corticosteroid-free clinical remission and sustained clinical remission. Safety was generally favorable, with no deaths and similar rates of serious treatment-emergent adverse events to placebo. Abivax intends to submit a New Drug Application for obefazimod in ulcerative colitis in late fourth quarter 2026, while the ENHANCE-CD Phase 2b Crohn’s induction trial continues with topline data expected mid-2027.

Abivax reported a net loss of €48.5 million for the three months ended March 31, 2026, narrower than the €52.4 million loss a year earlier. Operating loss widened to €56.2 million as research and development spending rose 26% to €49.5 million, mainly for obefazimod clinical programs.

Financial income swung to a €8.0 million gain driven by foreign exchange gains and returns on invested IPO proceeds. Cash, cash equivalents and other short-term investments totaled €491.6 million, which management expects to fund operations into the fourth quarter of 2027.

After quarter-end, Abivax agreed to repurchase all outstanding royalty certificates for $90 million (about €76.5 million), paid half in cash and half via 403,347 new ADSs at $111.57. The certificates were cancelled, and the transaction is expected to generate an expense of about €43.0 million in the second quarter of 2026, alongside derecognition of a €6.1 million deferred tax liability.

Abivax SA reported the detailed voting results of its May 11, 2026 annual general meeting, where shareholders approved all 33 resolutions proposed by the Board.

Ordinary items included approval of the 2025 parent and consolidated financial statements, income allocation, and renewals of three directors. Shareholders also backed executive and director compensation items and policies, as well as an authorization for the Board to repurchase the Company’s own shares.

At the extraordinary meeting, investors supported multiple delegations allowing the Board to conduct share capital increases with or without preferential subscription rights, including for public offers, qualified investors, and an At-The-Market equity financing program on the U.S. market. They also approved authorities for capital reductions via treasury share cancellations, capitalizations of reserves, non‑cash contribution deals, public exchange offers, and employee share plans.

Sofinnova-affiliated investors have updated their stake in Abivax S.A. following a royalty buyback deal. As of May 11, 2026, Sofinnova Crossover I SLP directly holds 3,377,494 Ordinary Shares, representing about 4.3% of Abivax’s outstanding Ordinary Shares and 5,499,478 voting rights, or about 6.7% of voting rights.

On May 4, 2026, Abivax repurchased royalty certificates from Sofinnova and other holders for an aggregate $90.0 million, split between $45.0 million in cash and $45.0 million in shares through the issuance of 403,347 Ordinary Shares in a private placement. Sofinnova Crossover I SLP received 42,755 ADSs in this transaction, and Abivax agreed to register these ADSs for resale. The filing also notes that Kinam Hong is no longer on Abivax’s Board of Directors.

Abivax SA agreed to repurchase all of its outstanding royalty certificates for a total of $90 million, paying $45 million in cash and $45 million through issuing 403,347 new American Depositary Shares at $111.57 per ADS.

The royalty certificates will be cancelled, simplifying Abivax’s capital structure. The share issuance represents about 0.5% dilution; a 1% holder would move to roughly 0.99%. Abivax reported cash, cash equivalents and short-term investments of €530.4 million as of December 31 2025, supporting a projected cash runway into Q4 2027, which remains unchanged after this transaction. Abivax also filed a prospectus supplement to register potential resales of up to 403,347 ADSs held by the former royalty certificate holders.