H1 (Interim) · Fiscal year 2026 · Published by Pham Hop
Abivax’s H1 2026 net loss widened to €165.9M, driven mostly by a non-cash €43.2M royalty-buyback charge and €39.4M of share-based pay, while ~€1.17bn of pro forma cash funds it into Q4 2029 ahead of a Q4 2026 US filing for obefazimod in ulcerative colitis.
Net income
-EUR 166M
-64.6% YoY
Diluted EPS
EUR -2.09
-31.4% YoY
Overview
Abivax, the Paris-based biotech developing obefazimod as a once-daily pill for ulcerative colitis (UC, a chronic inflammatory bowel disease), reported a first-half 2026 net loss of €165.9 million, up from €100.8 million a year earlier. Two things drove most of the wider loss, and neither is extra spending on clinical trials: a €43.2 million non-cash accounting loss from buying back its royalty certificates in May, and a jump in share-based compensation (pay in shares rather than cash, which is an expense but costs no cash) to €39.4 million from €11.0 million. The company still has no product sales. What matters more for a clinical-stage company is cash: €402.4 million at June 30, plus €767.1 million raised in a July share sale, which management says funds the business into Q4 2029. Over the half, positive Phase 3 maintenance results and a positive pre-submission meeting with the FDA kept the planned US approval filing (NDA) on track for the fourth quarter of 2026.
At a glance
€165.9M net loss (+65%): roughly €43M of the increase over last year is the one-off royalty buyback charge; the rest comes mainly from share-based pay and a bigger pre-launch organisation.
€102.5M of cash used by operations (+54%): this is the real cost of running the company for six months, still far below the cash it holds.
~€1.17bn of pro forma cash (€402.4M at June 30 plus €767.1M net from the July offering): management's stated runway is into Q4 2029, past the planned UC launch and the mid-2027 Crohn's disease readout.
The numbers
All figures are in euros under IFRS (the international accounting standard Abivax reports in), for the six months to June 30.
Metric
H1 2026
H1 2025
YoY Change
Revenue
none (pre-commercial)
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none
n/a
Other operating income (research tax credits + ADS depositary fees)
€2.5M
€2.1M
+22%
Research & development expenses
€107.9M
€77.9M
+38%
General & administrative expenses
€30.4M
€16.3M
+86%
Sales & marketing expenses
€4.6M
€1.5M
+202%
Operating loss
€140.3M
€93.7M
+50% wider
Net financial loss
€31.4M
€7.1M
+343% wider
Net loss
€165.9M
€100.8M
−64.6% (loss 64.6% wider)
Basic and diluted loss per share
€2.09
€1.59
−31.4% (loss per share 31.4% wider)
Share-based compensation (non-cash)
€39.4M
€11.0M
+258%
Cash used in operating activities
€102.5M
€66.6M
+54%
Cash and cash equivalents, June 30
€388.0M
€60.9M
+537%
The second quarter on its own was heavier than the first: Q2 net loss was €117.4 million (vs €48.4 million in Q2 2025), because the royalty buyback charge and most of the G&A jump (€24.1 million in Q2 vs €8.3 million a year earlier) landed in that quarter.
Where the money went
Research and development (€107.9M, +€29.9M). Spending on obefazimod rose to €103.3 million from €77.2 million. By program, the filing's breakdown is:
Ulcerative colitis: €60.4M (+16%). The increase came from share-based pay allocated to the program, partly offset by lower ABTECT trial costs because the big Phase 3 induction milestone payments fell in 2025 and did not recur.
Crohn's disease: €13.7M (+85%), driven by the ongoing Phase 2b ENHANCE-CD trial.
Other obefazimod indications, including combination therapy: €9.8M (+227%).
"Transversal" activities (manufacturing, quality and supply chain): €19.4M (+31%), which the company ties to trial progress and "anticipation of potential future commercial launch."
The key detail: the filing says share-based compensation, including the accelerated vesting of shares held by the former Chief Scientific Officer in March 2026, added €23.7 million to R&D, and related employer social charges (French payroll taxes on those awards) added another €8.4 million across all cost lines. In other words, most of the R&D increase is pay in shares and the tax on it, not more trial work.
General and administrative (€30.4M, +€14.1M). Personnel costs rose €8.6 million, "primarily attributable to" share-based awards granted in 2025 and their related taxes (€6.1 million); consulting and professional fees rose €4.5 million for "building our infrastructure to support future growth."
Sales and marketing (€4.6M, +€3.1M). Still small, but the company says these costs, which cover US launch preparation including hiring a commercial leadership team, "are expected to continue to accelerate."
The royalty certificate buyback
Abivax had earlier sold "royalty certificates" (raising €2.9 million, per the filing): instruments that would have paid their holders a slice of obefazimod's future sales. On May 7, 2026 it bought all of them back for $90 million (about €76.5 million): $45 million in cash and $45 million in new shares (403,347 ADSs at $111.57 each). The certificates were carried on the balance sheet at €33.5 million, so paying €76.7 million (the cash and share values at the exchange rates on settlement) created the €43.2 million loss. A related €5.8 million deferred tax liability was released, which shows up as a tax gain.
Economically, this swaps a royalty on future sales for about €38 million of cash and some dilution today, a bet that obefazimod's sales will be large enough to make the royalty expensive. The balance sheet now shows no royalty certificates (from €30.2 million at year-end) and borrowings of only €1.2 million, mostly leases.
What the headline numbers hide
Strip out the one-offs and the loss grew far less. Removing the €43.2 million buyback charge and the €5.8 million tax gain (our calculation from the filing's figures) gives a first-half net loss of about €128.5 million, about 27% more than last year rather than 65%.
Cash burn and accounting loss line up once non-cash pay is removed. Operating expenses of €142.9 million minus €39.4 million of share-based pay is about €103.5 million (our calculation), close to the €102.5 million of cash actually used in operations. Working capital (changes in payables and receivables) consumed €3.7 million this half; a year ago it helped by €15.5 million because trial bills were piling up unpaid. Part of the 54% rise in cash burn is that timing effect reversing, not faster spending.
Currency moves helped the financial line. Foreign exchange gains of €10.0 million (mostly non-cash revaluations of US-dollar balances: €6.7 million on an intercompany account and €2.7 million on dollar cash) plus €5.4 million of fair-value gains on invested cash offset part of the buyback charge. Without them, the net financial loss would have been larger.
Loss per share rose less than the loss because the share count grew 25%. The weighted average share count rose to 79.3 million from 63.4 million after the July 2025 offering, so the loss per share rose 31% while the total loss rose 65%. The July 2026 offering adds another 7.36 million shares, so per-share figures will be diluted further from H2.
Commitments not on the balance sheet. Abivax lists €186.4 million of obligations to contract research organisations (the outside firms that run its trials). Many are cancellable and some depend on trial milestones, but they are future cash calls.
Takeaway: The 65% wider loss looks alarming, but most of it is non-cash: a one-time €43.2M charge for buying out future royalties and €39.4M of stock-based pay. The number that matters, €102.5M of operating cash burn against roughly €1.17bn of pro forma cash, means Abivax can reach its FDA filing, a potential UC launch and the Crohn's readout without needing to raise money again.
Pipeline: what happened in the half
ABTECT Phase 3 maintenance (UC). On June 1 Abivax reported positive results from Part 1 of the 44-week maintenance trial, which the filing describes as showing "strong efficacy, including robust endoscopic remission" (healing seen on a camera exam of the colon). On June 29 it reported positive topline results from Part 2, which enrolled harder-to-treat patients who did not respond to induction or relapsed during Part 1, adding efficacy and safety data in that group. The half-year filing does not repeat the trial's detailed percentages.
Long-term data (Study 108). Among 130 patients who continued obefazimod at a halved 25 mg dose, 89% were in clinical remission at the start of the study, and 73%, 69% and 68% were in remission at weeks 48, 96 and 144. 80% were still enrolled at the three-year cutoff, and no new safety signals were reported.
Regulatory. After a positive pre-NDA meeting (a pre-submission discussion) with the FDA, Abivax says it agreed with the agency on the content and format of the application and remains on track to submit it in Q4 2026.
Management. Chief Medical Officer Fabio Cataldi leaves in Q4 2026, succeeded by Chris Rabbat (head of global medical affairs since 2023). Tim Kelly joins as Chief Technical Officer to run manufacturing, quality and IT ahead of a potential launch.
Outlook
Management's dated milestones: presentations at UEG Week (October 2026), NDA submission for obefazimod in UC by the end of 2026, a follow-on compound selection and additional combination-therapy preclinical data in 2026, and topline 12-week induction results from the Phase 2b ENHANCE-CD trial in Crohn's disease in mid-2027. The company expects about €3.2 million of research tax credit refunds in H2 2026.
Our read: financing is no longer the risk. At the first-half burn rate (about €205 million a year), €1.17 billion would last well beyond 2029, so the stated runway into Q4 2029 implies management expects spending to rise sharply, which fits a US commercial build-out and the sales and marketing guidance above. The risks now are regulatory and commercial: whether the FDA accepts and approves the application on the expected timeline (a standard US review typically runs about a year from submission, so an approval decision would most likely fall in late 2027 at the earliest), and whether a once-daily pill can win share in a UC market with established injectable and oral treatments. For the next report, watch whether the NDA is actually submitted by year-end, how fast sales and marketing costs climb, and whether share-based pay stays near H1's elevated level or falls back once the 2025 awards and one-time accelerated vesting work through.