Abivax SA Files Q2 2024 Financial Results

Ticker: AAVXF · Form: 6-K · Filed: Sep 9, 2024 · CIK: 1956827

Abivax S.A. 6-K Filing Summary
FieldDetail
CompanyAbivax S.A. (AAVXF)
Form Type6-K
Filed DateSep 9, 2024
Risk Levellow
Pages14
Reading Time17 min
Sentimentneutral

Sentiment: neutral

Topics: financial-results, sec-filing, 6-K

TL;DR

Abivax dropped its Q2 2024 financials on Sept 9th. Check the filings for details.

AI Summary

On September 9, 2024, Abivax SA filed a Form 6-K to report its financial results for the six months ended June 30, 2024. This filing includes a press release and its half-year financial report, which are incorporated by reference.

Why It Matters

This filing provides investors with an update on Abivax's financial performance and operational status for the first half of 2024.

Risk Assessment

Risk Level: low — This is a routine financial results filing for a public company, not indicating new or unusual risks.

Key Players & Entities

  • Abivax SA (company) — Registrant
  • September 9, 2024 (date) — Filing and announcement date
  • June 30, 2024 (date) — Reporting period end date
  • 001-41842 (other) — Commission file number

FAQ

What is the purpose of this Form 6-K filing?

The Form 6-K is filed by Abivax SA to report its financial results as of and for the six months ended June 30, 2024, and to attach its press release and half-year financial report.

When was the financial information reported in this filing announced?

The financial information was announced on September 9, 2024.

What period do the financial results cover?

The financial results cover the six months ended June 30, 2024.

What exhibits are included with this Form 6-K?

This Form 6-K includes Exhibit 99.1 (Press release, dated September 9, 2024) and Exhibit 99.2 (2024 half-year financial report).

Does Abivax SA file annual reports under Form 20-F or Form 40-F?

Abivax SA indicates that it files annual reports under Form 20-F.

Filing Stats: 4,317 words · 17 min read · ~14 pages · Grade level 11.1 · Accepted 2024-09-09 16:05:29

Filing Documents

SIGNATURES

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 9, 2024 s Marc de Garidel Chief Executive Officer 4 Exhibit 99.2 2024 Half-Year Financial Repor t TABLE OF CONTENTS Page INTRODUCTION ................................................................................................................. 1 RISK FACTORS ................................................................................................................... 3 OPERATING RESULTS ........................................................................................................ 4 INDEX TO THE 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 financial statements as of and for the six months ended June 30, 2024 and 2023 prepared in accor

RISK FACTORS

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, 2023. 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 Ulcerative colitis ("UC") Phase 3 clinical trials for the treatment of adults with moderately to severely active UC are ongoing ( " ABTECT " ). On August 6, 2024, we announced that our ABTECT trial surpassed the 600-patient enrollment milestone, therefore confirming that the trial is currently on pace to reach full enrollment in early first quarter of 2025. Top-line results from the ABTECT 8-week induction trial are expected in the early second quarter of 2025, with the 44-week maintenance data read-out expected during the first quarter of 2026. To date, participants' baseline characteristics and trial trends are in line with observations from the Phase 2b trial. Crohn's disease ("CD") We have cleared the Investigational New Drug application for Phase 2 trial of obefazimod in CD and expect to initiate a Phase 2b clinical trial of obefazimod in patients with CD in September of 2024 with the 12-week induction data read-out expected in second half of 2026. Combination therapy Formal process evaluatin

financial statements, and the accompanying financial statements have been prepared on a going concern basis

financial statements, and the accompanying financial statements have been prepared on a going concern basis. Capital Increases There have been no additional capital increases since December 31, 2023. Research Tax Credits From our inception to June 30, 2024 , we have benefited from refunds of CIRs in a total amount of 31.1 million. In November 2023, we received CIRs of 4.5 million with respect to the year ended December 31, 2022. We anticipate to receive CIRs of 4.5 million with respect to the year ended December 31, 2023 by 2024 year end. Bpifran ce—Conditional Advan ces 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 13 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 on 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 June 30, 2024, we had received 2.2 million of conditional advances, of which 1.2 million was received in December 2013, 1.0 million in S

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