Welcome to our dedicated page for Valneva Se SEC filings (Ticker: VALN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Valneva SE filings document a foreign private issuer focused on prophylactic vaccines for infectious diseases. Its Form 6-K reports and Form 20-F disclosures cover consolidated financial results, product sales, research collaboration revenue, and business updates for marketed vaccines and clinical-stage programs, including Lyme disease, Shigella and chikungunya vaccine activities.
The filing record also includes material-event disclosures incorporated by reference into Form F-3 registration statements. These documents address material agreements, licensing and collaboration arrangements, capital-structure actions, shareholder voting and governance matters, risk factors, and clinical or regulatory updates for Valneva's vaccine candidates and commercial portfolio.
Valneva SE entered a private placement to raise approximately €37 million by issuing 15,893,817 new ordinary shares, each bundled with a warrant, at €2.33 per unit. If all attached warrants are exercised at €2.96 per share, the company could issue another 15,893,817 shares for about €47 million.
The warrants are exercisable for cash from shortly after issuance until the earlier of 30 days after FDA approval of Valneva’s investigational Lyme disease vaccine LB6V or just before March 31, 2028, with a possible extension to September 30, 2028 if approval is not obtained. Exercise is restricted by a “Beneficial Ownership Limitation” generally capped at 9.99%, adjustable up to 19.99% under conditions. Valneva granted investors registration rights for U.S. resale of the new and warrant shares, with deadlines to file and make effective a registration statement and cash liquidated damages of 1% of the invested amount per 30‑day delay period, subject to caps.
Valneva SE, a specialty vaccine company, reported that its leadership team will participate in multiple events at the 26th World Vaccine Congress in Washington, D.C., held from March 31 to April 2, 2026. Executives will present clinical updates and join a chikungunya-focused panel.
On April 1, 2026, Valneva’s Vice President Clinical Development, Susanne Eder-Lingelbach, will present on chikungunya vaccine development, including Phase IV and real-world evidence studies for its single-shot chikungunya vaccine IXCHIQ®. A pilot vaccination campaign in Brazil with partner Instituto Butantan has already vaccinated over 12,000 people.
Chief Medical Officer Dr. Juan Carlos Jaramillo will join a panel on chikungunya and mosquito-borne vaccines, while the company also meets partners and showcases at booth #538. Valneva highlights its broader pipeline, including a Lyme disease vaccine candidate with Pfizer and a Shigella vaccine candidate, alongside its marketed travel vaccines.
Valneva SE reported that PF-07307405 (LB6V), its Lyme disease vaccine candidate co-developed with Pfizer, showed more than 70% efficacy in the Phase 3 VALOR trial for people aged five and older. Pre-specified analyses found 73.2% efficacy from 28 days after the fourth dose and 74.8% efficacy from one day after the fourth dose, with no safety concerns identified at the time of analysis.
Because fewer Lyme disease cases occurred than expected, the first pre-specified analysis did not meet its statistical criterion. However, the second analysis did, giving Pfizer confidence to plan regulatory submissions for this investigational vaccine.
Valneva reported 2025 total revenues of €174.7 million, slightly above 2024, driven by higher IXIARO®/JESPECT® and IXCHIQ® sales and €16.8 million of collaboration and licensing revenue. Product sales were €157.9 million, with a planned 42.3% drop in third‑party sales but 9% proprietary growth at constant exchange rates.
The company posted a €115.2 million net loss, largely reflecting the absence of a €90.8 million one‑off gain from a 2024 Priority Review Voucher sale, and an adjusted EBITDA loss of €59.4 million. Cash stood at €109.7 million at year‑end, with operating cash burn reduced to €52.9 million.
For 2026, Valneva expects total revenues between €155 million and €170 million, including product sales of €145‑160 million, and plans further cash‑burn reduction while funding R&D. A potentially transformational Phase 3 readout for Lyme vaccine candidate VLA15 is expected in the first half of 2026, and first Phase 2 data for Shigella candidate S4V2 are expected mid‑2026.
Valneva SE’s major French public investors updated their ownership and voting positions. Bpifrance Participations sold 1,125,048 Ordinary Shares in open‑market and block trades between February 19 and March 5, 2026, at prices generally around EUR4.85–5.14 per share.
After these sales, Bpifrance Participations holds 7,514,838 Ordinary Shares with 15,029,676 voting rights, representing 8.0% of 188,750,888 voting rights as of January 31, 2026. CDC acquired 364,705 Ordinary Shares in open‑market purchases between February 16 and March 3, 2026. CDC Croissance holds 4,915,517 Ordinary Shares and voting rights, while Caisse des dépôts et consignations reports 19,946,304 voting rights, or 10.5% of voting rights, reflecting French double voting right mechanics.
Valneva SE, a specialty vaccine company, plans to report its full year 2025 consolidated financial results on March 18, 2026. The company will host a live webcast at 3 p.m. CET / 10 a.m. EDT to discuss the results and provide a business update.
The webcast will be available on Valneva’s website and archived after the event. The filing also reiterates Valneva’s focus on developing and commercializing vaccines for infectious diseases, including advanced candidates for Lyme disease and Shigella.
Valneva SE reported that its senior management will participate in several upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach and CFO Peter Buhler plan to present the company’s key value drivers and upcoming milestones, including the topline Phase 3 data readout for VLA15, Valneva’s Lyme disease vaccine candidate partnered with Pfizer, which Pfizer expects to report in the first half of 2026.
Events include a webcasted presentation and investor meetings at the TD Cowen 46th Annual Health Care Conference in Boston, and investor meetings at conferences hosted by Jefferies in Miami and Van Lanschot Kempen in Amsterdam.
Valneva reported preliminary unaudited 2025 revenue of €174.7 million, slightly above 2024’s €169.6 million, including €157.9 million in product sales. While reported product sales declined from €163.3 million, they rose 9% at constant exchange rates excluding third‑party sales. Cash and cash equivalents were €109.7 million as of December 31, 2025, down from €168.3 million a year earlier.
For 2026, Valneva expects total revenues of €155‑170 million, with product sales of €145‑160 million, reflecting growth in core brands but a wind‑down of third‑party sales. A potentially transformational Phase 3 data readout for Lyme disease vaccine candidate VLA15 is anticipated in the first half of 2026, and first Phase 2 data for its tetravalent Shigella vaccine S4V2 are expected, with a development decision in the second half of 2026. The Board renewed co‑founder Thomas Lingelbach’s Chief Executive Officer mandate for a further three‑year term, supporting leadership continuity.
Valneva SE reported that the United Kingdom’s Commission on Human Medicines has updated its recommendations for use of its single-dose chikungunya vaccine IXCHIQ®. The revised prescribing information adds restrictions for people over 60 years of age, for individuals with specified health conditions, and on timing of vaccination before travel.
The UK regulator confirmed that IXCHIQ’s benefit–risk profile remains favorable for people aged 18 to 59 years who are at risk of chikungunya infection and do not have the contraindicated underlying conditions. The update follows a temporary suspension of use in older individuals after serious adverse events were reported mainly in elderly people with significant underlying medical issues during an outbreak vaccination campaign on La Reunion. Valneva states it will continue monitoring post‑marketing safety data and work with authorities on any further adjustments.