PART I [Key Information](index=9&type=section&id=Item%203.%20Key%20Information) The company faces significant financial, operational, and regulatory risks as a clinical-stage entity [Risk Factors](index=8&type=section&id=D.%20Risk%20Factors) Key risks include a history of losses, reliance on its lead drug candidate, and material weaknesses in internal controls - The company is a clinical-stage biopharmaceutical firm with a **limited operating history, no approved products, and no revenue**, making future prospects difficult to assess[19](index=19&type=chunk) Historical Net Losses | Year Ended December 31 | Net Loss (in millions of €) | | :--- | :--- | | 2023 | €147.7 | | 2022 | €60.7 | | 2021 | €42.5 | - The company anticipates needing **substantial additional funding** to complete clinical development, with existing cash expected to fund operations into the fourth quarter of 2025[27](index=27&type=chunk)[29](index=29&type=chunk) - **Material weaknesses in internal controls** over financial reporting have been identified, related to a lack of formal processes and sufficient experienced professionals[36](index=36&type=chunk)[38](index=38&type=chunk) - The company is **heavily dependent on the success of its lead drug candidate, obefazimod**, as other candidates are in much earlier stages of development[58](index=58&type=chunk)[80](index=80&type=chunk) - The company relies on a small number of **third-party suppliers and manufacturers**, including single-source suppliers, creating potential dependencies and risks[115](index=115&type=chunk) - The company may be classified as a **Passive Foreign Investment Company (PFIC)**, which could result in adverse U.S. federal income tax consequences for U.S. investors[247](index=247&type=chunk)[248](index=248&type=chunk) [Information on the Company](index=60&type=section&id=Item%204.%20Information%20on%20the%20Company) The company is a clinical-stage biotech developing obefazimod for chronic inflammatory diseases like UC and CD [History and Development of the Company](index=60&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) The company was founded in 2013, listed on Euronext in 2015, and completed its Nasdaq IPO in October 2023 - The company was incorporated in France in 2013 and is listed on both **Euronext Paris (since 2015) and the Nasdaq Global Market (since October 2023)**[290](index=290&type=chunk) - In October 2023, the company raised approximately **$235.8 million in gross proceeds** from its initial public offering of ADSs on Nasdaq[290](index=290&type=chunk) [Business Overview](index=60&type=section&id=B.%20Business%20Overview) The business centers on advancing obefazimod through Phase 3 trials for UC, leveraging its novel mechanism of action - The company's lead drug candidate, obefazimod, is being evaluated in **Phase 3 trials for ulcerative colitis (UC)** and a Phase 2b trial is planned for Crohn's disease (CD)[292](index=292&type=chunk) - Obefazimod has a **novel mechanism of action**, enhancing the expression of a single micro-RNA, miR-124, a natural regulator of inflammation[295](index=295&type=chunk)[329](index=329&type=chunk) Obefazimod Development Pipeline | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | | :--- | :--- | :--- | :--- | :--- | | **Obefazimod** | | | | | | Ulcerative Colitis | ✓ | ✓ | ✓ | **Ongoing** | | Crohn's Disease | ✓ | ✓ | **Planned** | | - Top-line data from the two Phase 3 induction trials in UC are expected in the **first quarter of 2025**, with maintenance trial data expected in the first quarter of 2026[301](index=301&type=chunk)[327](index=327&type=chunk) - In the Phase 2b maintenance trial for UC, **53% of patients achieved clinical remission** and 73% achieved clinical response after two years of treatment[298](index=298&type=chunk)[322](index=322&type=chunk) - The company **outsources all manufacturing operations** to third-party CMOs and is scaling up its supply chain for potential commercial supply[413](index=413&type=chunk)[414](index=414&type=chunk) - Key competitors in the chronic inflammatory disease field include major pharmaceutical companies such as **AbbVie, Eli Lilly, Johnson & Johnson, Pfizer, and Takeda**[416](index=416&type=chunk) [Operating and Financial Review and Prospects](index=102&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) The company's net loss widened significantly due to increased R&D spending on Phase 3 trials for obefazimod [Operating Results](index=105&type=section&id=A.%20Operating%20Results) Net loss grew to €147.7 million in 2023, driven by a 114% rise in R&D and a 199% rise in G&A expenses Consolidated Results of Operations (in thousands of €) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Total operating income | 4,621 | 4,583 | 11,961 | | Research and development expenses | (103,176) | (48,295) | (47,781) | | General and administrative expenses | (22,390) | (7,492) | (5,580) | | Goodwill impairment loss | — | (13,632) | — | | **Operating loss** | **(127,376)** | **(64,836)** | **(41,400)** | | Financial income (loss) | (20,364) | 4,096 | (1,052) | | **Net loss for the period** | **(147,740)** | **(60,740)** | **(42,452)** | - Research and development expenses **increased by 114% in 2023 to €103.2 million**, primarily due to the progression of the Phase 3 clinical trials for obefazimod in UC[548](index=548&type=chunk) - General and administrative expenses **increased by 199% in 2023 to €22.4 million**, driven by higher personnel costs and costs of being a dual-listed public company[550](index=550&type=chunk) - In 2022, the company recorded a **goodwill impairment loss of €13.6 million** related to the ABX196 cash-generating unit after freezing its development[553](index=553&type=chunk) [Liquidity and Capital Resources](index=110&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) Operations are funded by equity and debt, with cash expected to last into Q4 2025 following a 2023 IPO - As of December 31, 2023, the company had **cash and cash equivalents of €251.9 million** and other short-term investments of €9.0 million[560](index=560&type=chunk) - The company expects its current cash position to fund its forecasted cash flow requirements **into the fourth quarter of 2025**[561](index=561&type=chunk) Major Capital Increases (2021-2023) | Date | Type | Gross Proceeds (in thousands of €) | | :--- | :--- | :--- | | July 30, 2021 | Issuance of ordinary shares | 60,001 | | September 2, 2022 | Issuance of ordinary shares | 46,231 | | February 23, 2023 | Issuance of ordinary shares | 130,000 | | October 24, 2023 | Initial Public Offering (Nasdaq) | 223,300 | Historical Cash Flows (in thousands of €) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Net cash flows (used in) operating activities | (97,130) | (53,936) | (45,048) | | Net cash flows from (used in) investing activities | (8,095) | (12,026) | (6,232) | | Net cash flows provided by (used in) financing activities | 335,290 | 32,211 | 82,679 | [Directors, Senior Management and Employees](index=117&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) The section details company leadership, board structure, compensation, and employee demographics - The company is led by CEO and Chairman **Marc de Garidel**, who has over 40 years of experience in the pharmaceutical and biotechnology sector[601](index=601&type=chunk) - The aggregate compensation paid to all current executive officers and directors for the year ended December 31, 2023, was **€9.8 million**[622](index=622&type=chunk) - The Board of Directors consists of **eight members** and has established an audit committee and an appointments and compensation committee[670](index=670&type=chunk) - As of December 31, 2023, the company had **61 full-time employees**, with 40 in research and development[694](index=694&type=chunk) - The company uses various equity incentive instruments, including **founder's share warrants (BCE), share warrants (BSA), and free shares (AGA)**, as compensation tools[644](index=644&type=chunk) [Major Shareholders and Related Party Transactions](index=137&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) The company's ownership is concentrated among several investment funds, with related party transactions disclosed Major Shareholders (as of February 29, 2024) | Shareholder | Percentage of Ordinary Shares Beneficially Owned | | :--- | :--- | | TCG Crossover | 9.63% | | Invus | 8.85% | | Sofinnova Crossover | 8.37% | | Entities managed by Truffle Capital | 7.73% | | Deep Track Capital | 6.83% | | Entities affiliated with Venrock | 5.74% | | All directors and officers as a group | 18.18% | - As of December 31, 2023, an estimated **10,589,234 outstanding ordinary shares** (including ADSs) were held by eight shareholders of record in the United States[704](index=704&type=chunk) - Related party transactions in 2023 included **significant participation from major shareholders** in the company's private placement and U.S. Initial Public Offering[706](index=706&type=chunk)[708](index=708&type=chunk) [Financial Information](index=143&type=section&id=Item%208.%20Financial%20Information) The company has no history of paying dividends and reports no material legal proceedings - The company has **never declared or paid cash dividends** and does not intend to in the foreseeable future, planning to retain all available funds for business operations[718](index=718&type=chunk) - The company is **not currently a party to any material legal proceedings** that are expected to have a material adverse effect on its business[717](index=717&type=chunk) [Additional Information](index=144&type=section&id=Item%2010.%20Additional%20Information) Material contracts include significant debt facilities, with key tax risks related to its PFIC status - In August 2023, the company secured up to **€150 million in structured debt financing** through two separate agreements with Kreos/Claret and Heights Capital Management[724](index=724&type=chunk)[726](index=726&type=chunk) - The company has a Royalty Agreement with CNRS, the University of Montpellier, and the Institut Curie, entitling them to **milestone payments and low single-digit royalties**[737](index=737&type=chunk) - For U.S. Holders, dividends are generally subject to a French withholding tax, typically **reduced to 15% under the U.S.-France tax treaty**[757](index=757&type=chunk)[758](index=758&type=chunk) - The company does not believe it was a **Passive Foreign Investment Company (PFIC)** for the 2023 tax year, but notes there is no assurance it will not be treated as a PFIC in the future[780](index=780&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=160&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks include liquidity, foreign currency, and credit risk, with liquidity being most significant - The company's principal financial risks are identified as **liquidity risk, interest rate risk, foreign currency exchange risk, and credit risk**[794](index=794&type=chunk) - **Liquidity risk is a key concern**, as operations have required substantial cash and will continue to require significant additional capital for clinical development[795](index=795&type=chunk)[796](index=796&type=chunk) - The company is exposed to foreign currency risk, with operating expenses in U.S. dollars totaling €10.1 million in 2023; an adverse 10% change in the USD/EUR exchange rate would have resulted in a **loss of approximately €0.4 million** for 2023[800](index=800&type=chunk) PART II [Material Modifications to the Rights of Security Holders and Use of Proceeds](index=165&type=section&id=Item%2014.%20Material%20Modifications%20to%20the%20Rights%20of%20Security%20Holders%20and%20Use%20of%20Proceeds) The company raised net proceeds of $212.2 million from its 2023 global offering with no change in planned use - The company raised approximately **$212.2 million in net proceeds** from its Global Offering, which closed on October 24, 2023[814](index=814&type=chunk)[815](index=815&type=chunk) - There has been **no material change in the planned use of proceeds** from the offering as described in the final prospectus[816](index=816&type=chunk) [Controls and Procedures](index=167&type=section&id=Item%2015.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective as of year-end 2023 due to identified material weaknesses - Management concluded that as of December 31, 2023, the company's **disclosure controls and procedures were not effective**[817](index=817&type=chunk) - The ineffectiveness is due to **material weaknesses** related to a lack of risk assessment, formal processes, and a sufficient number of experienced professionals[818](index=818&type=chunk) - **Remediation efforts are underway**, including hiring an SVP of Finance and initiating a SOX documentation project, but were not complete as of year-end[818](index=818&type=chunk)[819](index=819&type=chunk) [Other Information](index=168&type=section&id=Item%2016.%20Other%20Information) This section covers governance topics, including the audit committee, accountant fees, and cybersecurity - The Board has determined that **Troy Ignelzi is an "audit committee financial expert"**[823](index=823&type=chunk) Principal Accountant Fees (in thousands of €) | Fee Category | 2023 | 2022 | | :--- | :--- | :--- | | Audit fees | 1,714 | 100 | | All other fees | 492 | 740 | | **Total** | **2,206** | **840** | - As a foreign private issuer, the company **relies on exemptions from certain Nasdaq corporate governance standards**, following home country practices[829](index=829&type=chunk) - The company has a **cybersecurity risk management program** overseen by the Board of Directors and managed by the CFO, an external IT Director, and a Data Protection Officer[833](index=833&type=chunk)[837](index=837&type=chunk)[838](index=838&type=chunk) PART III [Financial Statements](index=173&type=section&id=Item%2018.%20Financial%20Statements) The report includes audited IFRS financial statements with an unqualified opinion from the independent auditor - The independent auditor, PricewaterhouseCoopers Audit, issued an **unqualified opinion** on the consolidated financial statements, stating they present fairly in conformity with IFRS[851](index=851&type=chunk) Consolidated Statement of Financial Position (in thousands of €) | | As of Dec 31, 2023 | As of Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **327,062** | **75,544** | | Cash and cash equivalents | 251,942 | 26,950 | | **Total Liabilities** | **131,050** | **68,355** | | **Total Shareholders' Equity** | **196,010** | **7,189** | - The financial statements have been prepared on a **going concern basis**, with management concluding that existing cash is sufficient to fund operations into Q4 2025[871](index=871&type=chunk)[874](index=874&type=chunk)

Abivax publishes financial reports with the French and U.S. securities regulatory agencies PARIS, France, April 5, 2024, 10:00 p.m. CEST – Abivax SA ((Euronext Paris &amp, 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, announces the filing of its Universal Registration Document (Document d'Enregistrement Un ...

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 MarketSufficient 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 progr ...

MENLO PARK, Calif.--(BUSINESS WIRE)--Sofinnova Investments, a healthcare investment firm, announced today the appointment of Troy Ignelzi to the investment team as an Executive Advisor. In this role, he will be advising Sofinnova’s portfolio companies on corporate and financial strategy. Mr. Ignelzi brings to Sofinnova over two decades of financial leadership experience in the biotech and pharmaceuticals sectors. He is currently Chief Financial Officer at Rapport Therapeutics, a clinical-stage biotechnol ...

Abivax appoints Ana Sharma as Vice President, Global Head of Quality PARIS, France, February 7, 2024, 8:30 a.m. CET – Abivax SA (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 the appointment of Ana Sharma as Vice President, Global Head of Quality. Ms. Sharma brings over 20 years of experien ...

Abivax announces update to obefazimod Phase 2b clinical development program in moderately to severely active Crohn's disease Obefazimod Crohn's Disease (CD) IND filed with the FDA in December 2023 and cleared to proceedIn alignment with FDA feedback, Abivax to modify CD trial design and conduct dose ranging Phase 2b clinical trialStart of patient enrollment planned for Q3 202412-week induction data read-out expected in 2H 2026 PARIS, France, February 2, 2024, 8:30 a.m. CET – Abivax SA ((Euronext Paris &amp, ...

Abivax to host KOL Investor Event to review phase 2b clinical data and phase 3 trial design for obefazimod in patients with moderately to severely active ulcerative colitis on February 6, 2024 PARIS, France, January 24, 2024, 8:30 a.m. CET – Abivax SA ((Euronext Paris &amp, NASDAQ:ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammato ...

Abivax provides 2024 strategic outlook and lays out key milestones over next 12 months Induction data read-out expected Q1 2025 from the pivotal Phase 3 ABTECT program evaluating obefazimod in moderately to severely active ulcerative colitis (UC) Formal process evaluating oral and injectable combination therapy candidates with obefazimod in UC has commenced; preclinical data to support decision-making on combination agent expected in 2H 2024Top-line data from long-term extension trial with 25mg obefazimod o ...

Abivax 2024 Financial Communication Calendar PARIS, France, January 4, 2024, 8:30 a.m. CET – Abivax SA ((Euronext Paris &amp, NASDAQ:ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today publishes its 2024 financial communication calendar. Tuesday, April 2, 20242023 Annual Business and Financial Report (as of Decemb ...