DGAP-News: ABIVAX / Key word(s): Half Year Results Abivax presents first-half 2021 financial results and operations update 2021-09-23 / 18:00 The issuer is solely responsible for the content of this announcement.

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Abivax presents first-half 2021 financial results and operations update . In May and September, Abivax reported excellent efficacy and safety results of once daily oral ABX464 ina phase 2b induction study in ulcerative colitis (UC) after 8 and 16 weeks of treatment, primary and key secondaryendpoints were met . Abivax also communicated additional maintenance data of ABX464 phase 2a and 2b trials that confirmedlong-term efficacy and safety of 50mg once daily oral ABX464 in UC patients . In June, Abivax announced that ABX464 met the primary endpoint in a phase 2a study in rheumatoidarthritis (RA) patients and demonstrated a good safety and tolerability profile with 50mg once daily oraladministration . Abivax is currently evaluating the future clinical development prioritization for ABX464, focusing on theglobal phase 3 development in UC, to extend the Company's cash runway from Q2 2022 until the end of Q3 2022 . Cash for operations strengthened in July with a financing of EUR 85M secured by the pricing of anoversubscribed capital increase of EUR 60M and convertible bonds of EUR 25M . On October 4, at UEG Week Virtual 2021, a late-breaking abstract on ABX464 phase 2b data in UC will bepresented and Abivax will also be hosting a Live Industry Symposium at the conference

PARIS, France, September 23, 2021 - 6:00 pm (CEST) - Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today announces its 2021 half-year financial results, as of June 30, 2021, and provides an update on its clinical development progress. The financial statements for the first half of 2021, approved by the Company's Board of Directors on September 21, 2021, have been audited and the certification report is being prepared by the Company's external auditors.

"2021 has been a particularly positive and eventful year for Abivax. We announced excellent phase 2b clinical top-line and subsequent full results for the treatment of ulcerative colitis patients as well as very promising data of the phase 2a study in rheumatoid arthritis, both conducted with our lead compound ABX464. It is particularly encouraging to see, that our one-year and three-year long-term data of the ongoing phase 2a and phase 2b open-label maintenance studies confirm the sustained efficacy as well as the continued good safety profile of ABX464 in UC patients. We are also pleased that our late breaking abstract on the UC phase 2b data has been selected for an oral presentation at this year's United European Gastroenterology conference. This is another external validation of the potential of ABX464 to become an efficient durable treatment for patients suffering from UC.", said Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax.

He continued: "Additional laboratory analyses now also reinforce the novelty and differentiation factors of the mechanism of action of ABX464 with a statistically significant upregulation of miR-124, a specific, physiologic, anti-inflammatory microRNA, observed in rectal tissues of patients across all dose groups. With these very positive clinical results and laboratory data, Abivax engaged in advanced interactions with the relevant regulatory authorities to launch its priority phase 3 clinical program with ABX464 in ulcerative colitis as quickly as possible. There is an urgent need for long-term efficacious and safe new drugs in the field of inflammatory bowel diseases. The entire Abivax team and its scientific advisory board are committed to take ABX464 to the finish line and provide the many patients suffering from these very debilitating chronic diseases with a new, potent and well-tolerated therapeutic management option."

Didier Blondel, CFO of Abivax, added: "Abivax successfully secured EUR 85M major financing in July under attractive terms, with the pricing of an oversubscribed capital increase of EUR 60M and convertible bonds of EUR 25M. With our current and available cash resources, together with the planned outcome of the prioritization of our clinical development activities for ABX464, our operations are expected to be funded until the end of Q3 2022. We are now carefully evaluating the strategic possibilities for the Company. Our strategic priority remains a potential partnering with a large pharma or biotech company, under the premises that the full potential of ABX464 in inflammatory bowel diseases as well as in the entire chronic inflammatory field is taken into account. As an alternative strategic option, we are also looking into additional financing opportunities, notably in the US and in Europe, that would maximize shareholder value." FIRST HALF 2021 FINANCIAL HIGHLIGHTS 


Items in the Income Statement                  H1 2021 H1 2020   Change 
In millions of euros                             MEUR      MEUR        MEUR 
Total operating income                           9.6     1.6      8.0 
Total operating expenses                       (26.5)  (16.3)    (10.3) 
     of which Research and Development costs   (24.0)  (13.5)    (10.5) 
 of which administrative costs and overheads    (2.6)   (2.8)     0.2 
Operating result                               (16.9)  (14.6)    (2.3) 
Financial result                                (1.3)   (1.0)    (0.4) 
Ordinary result                                (18.2)  (15.6)    (2.7) 
Extraordinary result                             0.1     0.2     (0.1) 
Tax on income                                    1.6     0.0      1.6 
Result for the period                          (16.5)  (15.4)    (1.1) 
Financial Items from the Balance Sheet                30/06/2021 31/12/2020   Change 
in millions of euros                                      MEUR         MEUR         MEUR 
 
Net financial position                                  (27.5)     (4.7)      (22.8) 
of which financial fixed assets*                         0.0        0.0        0.0 
of which fixed-term deposits (maturing in > 1 year)      0.0        0.0        0.0 
of which fixed-term deposits (maturing in < 1 year)      0.0        0.0        0.0 
of which available cash flow                             4.3        29.3      (25.0) 
(of which financial debts)                              (31.8)     (34.0)      2.2 
Total Assets                                             55.1       71.3      (16.2) 
 
Total Equity                                             2.4        17.9      (15.5) 
of which equity capital                                 (4.5)       4.7       (9.1) 
of which conditional advances                            6.8        13.2      (6.4)

* Excluding items of the liquidity contract (liquidity and own shares) and deposits & guarantees . Operating loss EUR -16.9M (EUR -2.3M compared to EUR -14.6M as of June 30, 2020) due to increasedinvestments in R&D (EUR 10.5M), partly balanced by grants received from Bpifrance (EUR 9.6M). . Revenues of EUR 9.6M are relating to ABX464 Covid-19 funding by Bpifrance which have entirely becomegrants after the announcement of the failure of miR-AGE clinical study in March 2021. . R&D expenses increased to EUR 24M (an increase of EUR 10.5M compared to EUR 13.5M as of June 30, 2020),mainly due to overall strong progress of ABX464 development costs in inflammatory indications (94% of the total R&Dexpenses). . G&A expenses were at EUR 2.6M as of June 30, 2021 (10% of total operating costs) compared to EUR 2.8M(17%) as of June 30, 2020. . Total number of employees at the end of June 2021 is 29. . 2021 Research Tax Credit revenue amounts to EUR 1.6M as of June 30, 2021. . Cash at the end of June 2021 was EUR 4.3M, compared to EUR 29.3M at the end of 2020, before taking intoaccount the EUR 85M financing realized in July 2021. . The Company is currently funded until Q2 2022 and is expecting to extend the funding until the end of Q32022, taking into account the existing cash resources and the planned clinical development prioritization forABX464, focusing on the UC indication as a top priority. OPERATING HIGHLIGHTS: PORTFOLIO UPDATE

ABX464 phase 2b clinical induction study in ulcerative colitis In May and September 2021, Abivax announced the top-line and subsequent full results of its ABX464 randomized, placebo-controlled phase 2b trial in moderate to severe ulcerative colitis following 8 weeks and 16 weeks of induction treatment. The data confirm the potency of once daily oral ABX464 to maintain and to further improve clinical remission ^[1] rates over time, across all tested dose levels (25mg, 50mg and 100mg). The sustained and improved effects after 16 weeks of treatment could also be observed for the reduction of the modified Mayo Score^[2], the endoscopic improvement^ [3], the presence of clinical response^[4] as well as for the reduction in fecal calprotectin in patients treated with ABX464. This is true for both, the entire population as well as in the subset of patients who were previously refractory to biologic treatments and/or JAK inhibitors.

Consistent with the other clinical studies, ABX464 was found to be safe and well tolerated at all dose levels during the 8-week and 16-week induction period. Within the ABX464 phase 2b induction study, the most frequently reported adverse events were mild and transient (i.e. headache, nausea, gastrointestinal pain) and manageable with or without over-the-counter medication.

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