Abivax reports 2023 financial results and operational update

EQS-News: ABIVAX / Key word(s): Annual Results
Abivax reports 2023 financial results and operational update

02.04.2024 / 08:30 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Abivax reports 2023 financial results and operational update

  * Raised EUR 500M in 2023, including a EUR 130M capital increase, two
    structured debt financing transactions aggregating EUR 150M and EUR
    223.3M initial public offering on the Nasdaq Global Market

  * Sufficient funds to finance operations into Q4 2025, including through
    the announcement of top-line data from the Phase 3 ABTECT induction
    trials of obefazimod in ulcerative colitis (UC)

  * Implementation of U.S. and European operational infrastructure to
    progress the Company's ongoing clinical and preclinical programs

PARIS, France, April 2, 2024, 8:30 a.m. CEST - Abivax SA (Euronext Paris &
Nasdaq: ABVX) ("Abivax" or the "Company"), 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, today announced its 2023 annual financial
results, as of December 31, 2023, and provided an update on the progress of
its development programs. The financial statements for 2023 have been
audited and approved by the Company's Board of Directors on March 28, 2024,
and the financial reports are planned to be filed with the French and U.S.
securities regulatory authorities, respectively, on April 5, 2024. The audit
procedures on the consolidated financial statements have been performed and
the certification report is being prepared by the Company's external
auditors.

The Company will organize a webcast on the 2023 financial results on Monday,
April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST).

Marc de Garidel, Chief Executive Officer of Abivax, said: "In 2023, Abivax
accomplished several major milestones and made significant progress on its
ongoing clinical and preclinical projects. Beyond executing one of the top
worldwide financing raises in the biotech sector last year, the company
implemented a strategy designed to take advantage of obefazimod's unique and
differentiated profile for the treatment of IBD. We believe we built the
necessary U.S and European operational infrastructure to conduct the Phase 3
ABTECT program in UC and the planned Phase 2b Crohn's Disease trial,
potentially expanding the long-term use of obefazimod for a large patient
population in a field with high unmet medical needs. In 2024, the execution
of this strategy is underway by advancing our UC and CD clinical programs
and, in parallel, strengthening our pipeline by evaluating a potential
combination therapy with obefazimod in UC as well as advancing research on a
follow-on candidate. Abivax's scientific excellence has further been
highlighted by several abstracts presented by leading U.S. and European KOLs
at major scientific congresses. In addition, we continue to reinforce our
Board of Directors after notable changes in 2023 and I am glad to welcome
Camilla Soenderby as a new member of the Abivax Board. We are very much
looking forward to working with Camilla and to benefiting from her
expertise."

Didier Blondel, Chief Financial Officer of Abivax, added: "The past year was
also very successful looking at the trust that our existing and new U.S. and
European investors placed in us, reflected in the significant capital raises
in 2023. With the successful Nasdaq IPO last year, the largest Nasdaq IPO of
a French-listed biotech company, we continue to implement our multi-pronged
financial strategy to fund our projects in 2024 and beyond. Abivax has
secured more than EUR 500M financing in 2023 and we expect to have
sufficient funds to finance our operations into Q4 2025, including through
the anticipated release of top-line Phase 3 induction data from the ABTECT
program."


2023 financial highlights (IFRS figures)

    Income Statement                             FY 2023 FY 2022   Change
    in millions of euros
    Total operating income                         4.6     4.6      0.0
    Total operating expenses
      of which Research and Development costs    (103.2) (48.3)    (54.9)
    of which Sales and Marketing costs            (6.4)    0.0     (6.4)
    of which General and Administrative costs    (22.4)   (7.5)    (14.9)
    of which Goodwill impairment loss             (0.0)  (13.6)     13.6
    Operating loss                               (127.4) (64.8)   (62.6)
    Financial (loss) gain                        (20.4)    4.1     (22.3)
    Net loss for the period                      (147.4) (60.7)   (84.9)
  Balance Sheet                                      FY2023 FY2022  Change
  in millions of euros

  Net financial position                             203.2  (14.5)  217.7
  of which other financial assets and other           28.3   8.3      20.0
  receivables and assets*
  of which fixed-term deposits (maturing in > 1       0.0    0.0      0.0
  year)
  of which fixed-term deposits (maturing in < 1       9.0    0.0      9.0
  year)
  of which available cash and cash equivalents       251.9   26.9    225.0
  (of which financial liabilities)**                 (77.0) (49.8)   (27.2)
  Total Assets                                       327.1   75.5   251.5

  Total Shareholders' Equity                         196.0   7.2    191.0
  * Excluding items of the liquidity contract
  (liquidity and own shares) and prepaid expenses
  ** Financial liabilities include borrowings,
  convertible loan notes, derivative instruments,
  royalty certificates and other financial
  liabilities
  * Operating loss increased by EUR 62.6M to EUR -127.4M compared to EUR
    -64.8M as of December 31, 2022. Operating income, consisting
    predominantly of Research Tax Credit, was comparable between both
    financial periods. The increase in operating loss was driven by
    operating expenses as described further below.

  * Research and development (R&D) expenses increased by EUR 54.9M to EUR
    -103.2M in 2023 compared to EUR -48.3M in 2022. This increase was
    predominantly driven by a EUR 45.2M, or 117%, increase in expenses
    related to:

      * Our UC clinical program, driven by the progression of Phase 3
        clinical trials for obefazimod in UC (where Phase 3 clinical trial
        costs were significantly higher than in Phase 2);

      * A EUR 2.7M increase in expenses related to our Crohn's disease (CD)
        clinical program, driven by planning costs incurred for the Phase 2b
        CD trial; and

      * A EUR 4.5M, or 71%, increase 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.

  * Sales and marketing (S&M) expenses were EUR -6.4M for 2023. We did not
    incur any sales and marketing expenses in 2022. These expenses consist
    primarily of consulting costs associated with market research,
    re-branding of our company in preparation of our U.S. initial public
    offering and listing on Nasdaq, as well as an early team build out in
    preparation for our future sales and commercialization efforts in the
    U.S.

  * General and administrative (G&A) expenses increased to EUR -22.4M
    compared to EUR -7.5M for 2022 (excluding the one-time goodwill
    impairment charge taken in 2022 of EUR -13.6M to ABX196 for the
    treatment of hepatocellular cancer). This increase was primarily due to:

      * An increase in personnel costs of EUR 11.7M, resulting from the
        issuance of new equity awards to our officers and employees;

      * Management changes that occurred during the period and an increased
        G&A headcount to support the expansion of the company; and

      * Increased legal and professional fees and other costs associated
        with operating as a dual-listed public company.

  * Total number of employees at the end of December 2023 was 61 and
    significantly increased compared to 2022, due to the implementation of
    the U.S. and European operational infrastructure.

  * For the year ended December 31, 2023, our EUR -20.4M net financial loss
    was driven primarily by the following items:

* Interest expenses of EUR -4.7M relation to borrowings and loans;

      * Non-cash expense of EUR -8.9M in relation to the fair value of our
        royalty certificates;

      * Non-cash expense of EUR -3.4M related to the derecognition of
        certain financial liabilities;

      * Non-cash expense of EUR -3.0M in relation to an increase in the fair
        value of warrant derivatives issued in relation to the Kreos/Claret
        financing; and

      * Foreign exchange losses of EUR -5.6M (including the EUR -3.2M
        non-cash impact of the year-end revaluation of USD-denominated cash
        and cash equivalents);

      * Partially offset by interest income of EUR 2.4M in relation to the
        invested proceeds from our U.S. initial public offering and listing
        on Nasdaq and decrease in the fair value of the Heights convertible
        notes by EUR 3.2M.

  * Cash position (including other financial assets of EUR 9.0M) at the end
    of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022. The
    increase was due to a EUR 130M gross equity financing (EUR 123M net
    proceeds) concluded in February 2023, and two additional structured debt
    agreements (EUR 27M net proceeds from the first tranches) signed in
    August 2023. In addition, in October 2023 the Company completed its
    Nasdaq IPO with gross proceeds of EUR 223.3M.

  * As part of the structured debt financing transaction for a total amount
    of up to EUR 75M with Kreos Capital and Claret European Growth Capital
    entered into on August 21, 2023 (the "Kreos/Claret financing"), Abivax
    proceeded with the drawdown of the second tranche of the Kreos/Claret
    financing for EUR 25M.

      * This second tranche consists of 25,000,000 senior secured
        non-convertible bonds with a par value of EUR 1.00 each, which will
        not be listed on any market;

      * The issuance of the Kreos/Claret non-convertible bonds occurred on
        March 28, 2024;

      * A variable interest rate of 7.5% European Central Bank Base Rate
        (MRO) (with a floor at 2.5% and a cap at 4%) applies to such
        tranche. These non-convertible bonds will be repaid monthly through
        March 31, 2027, after a deferred repayment of the principal until
        February 1, 2025.

Based on the currently available funds, including the drawdown of the second
tranche Kreos/Claret financing described above, Abivax expects to be able to
finance its operating cash flow requirements into Q4 2025.


Operating highlights - Ongoing clinical trials

Obefazimod Phase 3 program in UC (ABTECT)

The obefazimod Phase 3 ABTECT program investigating efficacy and safety in
adults with moderately to severely active UC is progressing. Recruitment
into both induction trials, ABTECT-1 and ABTECT-2, is ongoing in all
designated regions.

The ABTECT program is designed for 1,200 UC patients across 36 countries
with more than 600 trial sites taking part in the pivotal Phase 3 program
that covers North America, Europe, Latin America, and Asia Pacific. Clinical
remission is the primary endpoint for the 8-week induction trials as well as
for the 52-week maintenance trial (which is week 44 of the maintenance
trial).

Anticipated milestones:

* Q4 2024: ABTECT planned enrollment of last patient into induction trials

  * Q1 2025: ABTECT planned top-line induction data read-out after eight
    weeks of treatment

  * Q1 2026: ABTECT planned top-line maintenance results after one year of
    treatment

Objectives:

  * Obtain robust Phase 3 data for obefazimod in moderately to severely
    active UC as a potentially differentiated oral treatment option

  * Establish obefazimod as a potential first-line advanced therapy for the
    treatment of UC

Obefazimod 25 mg long-term extension trial in UC

UC patients initially treated with 50 mg of oral, once-daily obefazimod and
who completed the Phase 2a or Phase 2b maintenance trials could roll over
into a follow-on, open-label long-term extension trial with a reduced dose
of 25 mg.

In an interim analysis as of July 31, 2023, of the 71 eligible patients, 63
completed their 48-week visit, with a demonstrated disease control rate
(stable or improved Modified Mayo Score) of 84% (53 of 63 patients) with the
25 mg once-daily dose of obefazimod. No new safety signals were detected in
UC patients treated up to five years with oral, once daily obefazimod.

Anticipated milestones:

  * Q3 2024: New obefazimod UC extension trial read-out after one and two
    years of continued treatment with reduced dose of 25 mg

Objectives:

  * Confirm safety and efficacy data of Phase 2 maintenance trials and
    long-term extension trial interim analysis

  * Confirm safety and efficacy results for reduced dose of 25 mg obefazimod
    for chronic long-term use

Operating highlights - Planned clinical trials

Obefazimod Phase 2b trial in Crohn's disease (ENHANCE-CD)

The obefazimod Phase 2b clinical trial in moderately to severely active CD
is a double-blind placebo-controlled trial, evaluating three obefazimod
doses. The CD investigational new drug (IND) application was filed with the
FDA and cleared to proceed in Q4 2023. The trial design consists of a
12-week induction period and a subsequent 40-week maintenance period.

In alignment with FDA feedback on the Company's initial Phase 2a IND
application submission, the CD trial design was adapted to be a dose ranging
Phase 2b clinical trial. These adjustments to the obefazimod CD clinical
program are not expected to have an impact on the overall program budget and
projected supplemental New Drug Application (sNDA) submission timeline.

Anticipated milestones:

* Q3 2024: ENHANCE-CD planned start of patient enrollment

* 2H 2026: ENHANCE-CD planned 12-week induction data read-out

Objectives:

  * Reproduce obefazimod UC Phase 2 safety and efficacy data for the
    treatment of CD

Operating highlights - Ongoing R&D work

  * Obefazimod in combination therapy: Based on its early clinical profile,
    the formal process evaluating combination therapy of oral and injectable
    candidates with obefazimod in UC is ongoing in preclinical models.
    Preclinical data to support decision-making on a combination agent is
    expected in 2H 2024.

  * Obefazimod follow-on candidate selection from miR-124 library: R&D work
    on potential follow-on drug candidates from Abivax's compound library is
    ongoing. Selection of the first follow-on drug candidate to further
    strengthen the Abivax pipeline is expected in Q3 2024.

Anticipated milestones:

  * 2H 2024: Disclosure of preclinical data of obefazimod combination
    therapy for the treatment of moderately to severely active UC

  * Q3 2024: Selection of first obefazimod follow-on drug candidate from
    Abivax's miR-124 library

Objectives:

  * Strengthen Abivax product pipeline with 1) additional opportunities to
    use obefazimod in a combination therapy; and 2) additional compounds in
    the field of chronic inflammatory diseases

Congress participation

Abivax participated at all major IBD conferences in 2023 and Q1 2024. The
submitted abstracts were accepted by the conference hosts and presented by
leading U.S. and European KOLs. The potential of obefazimod to become a safe
and long-term effective treatment option in IBD, as well as its novel
mechanism of action, gains increasing interest among the scientific
community and the industry.

Abivax plans to participate and present at all major upcoming congresses in
2024:

Digestive Disease Week (May 18-21, 2024, Washington, D.C., U.S.)

  * Four submitted Abivax abstracts were accepted for presentation at DDW
    2024

* Visit the Abivax booth at the DDW exhibitor hall (booth #529)

United European Gastroenterology Week (October 12-15, 2024, Vienna, Austria)

* Visit the Abivax booth at the UEGW exhibitor hall

American College of Gastroenterology Scientific Meeting (October 25-30,
2024, Philadelphia, U.S.)

* Visit the Abivax booth at the ACG exhibitor hall


Abivax appoints Camilla Soenderby as Independent Board Member

Abivax announces today the appointment of Camilla Soenderby as an
Independent Board Member, in replacement of Santé Holdings S.R.L. which has
resigned from its position as Board member.

Camilla Soenderby brings 25 years of international leadership experience
from executive roles in top ten biopharma companies in the EU, United States
and Asia. Ms. Soenderby was most recently a corporate officer at Takeda,
leading global portfolio commercialization and commercial excellence,
overseeing global brands and a large pipeline, working in close partnership
with R&D. Prior to that, she worked as SVP, Head of Global Product Strategy
for Shire, having previously held regional- and general management positions
at Roche Pharma, Abbott (now AbbVie) and Schering Plough. Ms. Soenderby has
a proven international P&L track record of developing and growing
businesses. She also has extensive experience in leading worldwide cross
functional teams to drive portfolio strategy and commercialization of
therapies to treat rare diseases, oncology and specialty conditions,
including inflammatory bowel diseases. In the IBD field, Ms Soenderby has
notably been involved in the strategic development and the commercialization
of Humira (adalimumab) and Entyvio (vedolizumab). She began her career as a
management consultant at McKinsey & Company focused on healthcare.

Currently, Ms. Soenderby is a member of the Board of Directors for the
investment company BB Biotech and two biotech companies, F2G and Affibody.
In addition, she is a member of Novo Holdings Advisory Group and industrial
advisor for the private equity group EQT.

Santé Holdings S.R.L., represented by Mr. Paolo Rampulla, an historical
investor in Abivax, will continue to contribute to the work of the Board of
Directors as an observer alongside Mr. Maurizio PetitBon from Kreos
Capital/Blackrock.

Ms. Soenderby has also been appointed as a member of the Nomination and
Compensation Committee, which now comprises four members: June Lee (Chair),
Sofinnova Partners (represented by Kinam Hong), Truffle Capital (represented
by Philippe Pouletty) and Camilla Soenderby.


Webcast on 2023 financial results

A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST
(8:30 a.m. EST) following the announcement of the 2023 yearly results. The
Abivax management will give an overview of the Company's 2023 highlights and
projects going forward, followed by a live Q&A session.

To participate and ask questions during the webcast, please register via the
Abivax website.


Financial calendar 2024

  * April 5, 2024: Planned Filing of the financial reports with the French
    (URD) and U.S. (20-F) securities regulatory agencies

* May 30, 2024: 10:00 a.m. CEST: Shareholders' Meeting

  * September 9, 2024: First Half Business and Financial Report 2024 (as of
    June 30, 2024)

  * November 7, 2024: Third Quarter 2024 Financial Information (as of
    September 30, 2024)

*****

About Abivax

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


Contacts:

   Abivax Communications                Abivax Investor Relations
   Regina Jehle                         Patrick Malloy
   (1)regina.jehle@abivax.com           (1)patrick.malloy@abivax.com
   +33 6 24 60 69 63                    +1 847 987 4878

1. mailto:regina.jehle@abivax.com 1. mailto:patrick.malloy@abivax.com
FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and
estimates, including those relating to the Company's business and financial
objectives. Words such as "design," "expect," "forward," "future,"
"potential," "plan," "project," "will" and variations of such words and
similar expressions are intended to identify forward-looking statements.
These forward-looking statements include statements concerning or implying
the therapeutic potential of Abivax's drug candidates, Abivax's expectations
regarding the availability of data and timing of reporting results from its
clinical trials, including its Phase 3 ABTECT-1 and ABTECT-2 induction
trials, obefazimod extension trials in UC, and obefazimod Phase 2b trial in
CD, the availability and timing of preclinical data to support
decision-making on therapy candidates for use in combination with obefazimod
in UC, as well as the availability and timing of disclosure of preclinical
data of any such combination therapy, the selection of an obefazimod
follow-on drug candidate from Abivax's miR-124 library, the impact of the
adjustments to the obefazimod CD clinical program on the overall program
budget and projected supplemental New Drug Application (sNDA) submission
timeline, obefazimod's potential to provide meaningful benefit to patients
suffering from UC, CD, IBD or other indications, and enrollment of patients
in clinical trials, Abivax's plans to strengthen its product pipeline with
additional opportunities to use obefazimod in a combination therapy and
additional compounds in the field of chronic inflammatory diseases, Abivax's
cash runway and strategy to extend its cash runway, and other statements
that are not historical fact. Although Abivax's management believes that the
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks, contingencies and uncertainties, many of which are
difficult to predict and generally beyond the control of Abivax, that could
cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information
and statements. A description of these risks, contingencies and
uncertainties can be found in the documents filed by the Company with the
French Autorité des Marchés Financiers pursuant to its legal obligations
including its universal registration document (Document d'Enregistrement
Universel). These risks, contingencies and uncertainties include among other
things, the uncertainties inherent in research and development, future
clinical data and analysis, decisions by regulatory authorities, such as the
FDA or the EMA, regarding whether and when to approve any drug candidate, as
well as their decisions regarding labelling and other matters that could
affect the availability or commercial potential of such product candidates.
Special consideration should be given to the potential hurdles of clinical
and pharmaceutical development including further assessment by the Company
and regulatory agencies and IRBs/ethics committees following the assessment
of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical
data. Furthermore, these forward-looking statements, forecasts and estimates
are made only as of the date of this press release. Readers are cautioned
not to place undue reliance on these forward-looking statements. Abivax
disclaims any obligation to update these forward-looking statements,
forecasts or estimates to reflect any subsequent changes that the Company
becomes aware of, except as required by law. Information about
pharmaceutical products (including products currently in development) that
is included in this press release is not intended to constitute an
advertisement. This press release is for information purposes only, and the
information contained herein does not constitute either an offer to sell, or
the solicitation of an offer to purchase or subscribe securities of the
Company in any jurisdiction. Similarly, it does not give and should not be
treated as giving investment advice. It has no connection with the
investment objectives, financial situation or specific needs of any
recipient. It should not be regarded by recipients as a substitute for
exercise of their own judgment. All opinions expressed herein are subject to
change without notice. The distribution of this document may be restricted
by law in certain jurisdictions. Persons into whose possession this document
comes are required to inform themselves about and to observe any such
restrictions.


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1870929 02.04.2024 CET/CEST