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Beskrivning

LandSverige
ListaMid Cap Stockholm
SektorHälsovård
IndustriBioteknik
BioInvent International är verksamt inom bioteknikbranschen och fokuserar på utveckling av innovativa antikroppsterapier för cancerbehandling. Bolaget forskar på nya behandlingar som kan förbättra patientresultat och livskvalitet. Verksamheten är global med en närvaro på internationella marknader. BioInvent International grundades 1983 och har sitt huvudkontor i Lund.

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2026-03-31 11:45:00

Lund, Sweden – March 31, 2026 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immunomodulatory antibodies for cancer immunotherapy, today announced that the Annual Report for 2025 has been published. The Annual Report is attached to this press release in pdf format and is available on the company’s website www.bioinvent.com.

BioInvent’s key achievements in 2025 centered on advancing the lead programs BI-1808 and BI-1206 into mid-stage clinical development, presenting encouraging data at major scientific meetings, and strengthening the financial and strategic position.

“During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier stage programs to maximize the probability of success and near-term value creation. This portfolio optimization reflects a disciplined approach to development and partnering, aligning investment with the strongest clinical signals and upcoming milestones. In summary, 2025 was a year of clinical validation and strategic consolidation. We advanced our most promising programs into Phase 2a, delivered encouraging data, and controlled our financial position through disciplined portfolio management and royalty monetization.” – Martin Welschof, CEO of BioInvent.

KEY EVENTS IN 2025

• (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025
• (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025
• Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma
• Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL)
• (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab
and Calquence® for the treatment of NHL
• BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency
• (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025
• Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced
• (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million
• FDA Fast Track Designation received for BI-1808 for the treatment of CTCL
• BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL

(R)= Regulatory event

In line with the information in the Year-end report for 2025 issued end of February 2026, it is the Board of Directors’ and the CEO’s assessment that the company is, based on ongoing projects, financed into the latter part of Q1 2027. The Board of Directors and the CEO continuously evaluate various options to finance the company’s activities, but since no such financing has been secured at the time of signing of the annual report, this indicates an uncertainty. However, the Board of Directors and the CEO assess that there are good possibilities for future financing solutions. See page 35 and 69 of the annual report.

EXPECTED KEY CATALYSTS 2026

The priorities for 2026 are clear: complete the ovarian cancer cohort expansion with BI-1808 and report data in H2 2026; continue to optimize BI-1808 development for CTCL; and progress BI-1206 in NHL as datasets mature and partnering opportunities develop. By the second half of this year, we expect to have the first data from the BI-1206 Phase 2a study in first-line NSCLC.

Mid-2026:
• First combination data for BI-1808 and pembrolizumab for the treatment of cutaneous T-cell lymphoma (CTCL), as well as additional CTCL monotherapy data
• Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin’s lymphoma (NHL)
H2 2026:
• Additional Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors
• First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients.

About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities.

The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com.

For further information, please contact:
Cecilia Hofvander, VP Investor Relations
Phone: +46 (0)46 286 85 50
Email: cecilia.hofvander@bioinvent.com

BioInvent International AB (publ)
Co. Reg. No.: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com


The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.