Interim report
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The information was submitted for publication, through the agency of the contact person set out on page 23 at 6:15 p.m. CET on October 28, 2026. BioInvent International AB (publ) Interim Report January 1 – September 30, 2026 Q3
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BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Highlights Highlights in the third quarter 2026 THIRD QUARTER JANUARY-SEPTEMBER All figures in SEK million unless otherwise stated 2026 2025 2026 2025 Net sales 10.8 3.3 37.0 223.5 Profit/loss after tax -118.9 -129.2 -361.0 -207.1 Profit/loss after tax per share before and after dilution, SEK -1.81 -1.96 -5.49 -3.15 Cash flow from operating activities -113.5 -104.0 -358.3 -157.2 Liquid funds and current investments at the end of the period 224.6 690.5 224.6 690.5 2 Note to the reader. This Interim Report is published in Swedish and English. In the event of any discrepancy between the English version and the Swedish original, the Swedish version shall prevail. EVENTS IN THE THIRD QUARTER • BI-1808 received FDA Fast Track Des- ignation for the treatment of ovarian cancer • BioInvent’s BI-1808 abstract from Mod- est to Meaningful in platinum-resistant ovarian cancer accepted for poster presentation at ESMO 2026 • BioInvent published two scientific pa- pers in peer-reviewed journals. One in Cancer Research: “Ligand-Blocking and Agonist Antibodies Targeting TNFR2 Em- ploy Distinct Modes of Action to Induce Antitumor Immunity” and one in JECCR: Tailored FcγR Blockade with BI-1206 and BI-1607 Enhances Cancer Antibody Therapies and Overcomes Resistance in Preclinical Models EVENTS AFTER THE END OF THE PERIOD • (R) The Board of Directors has decided to carry out a rights issue of approxi- mately SEK 430 million (gross, before issue costs), of which SEK 350 million is covered by subscription commitments and guarantee undertakings, subject to approval at an Extraordinary General Meeting • (R) Streamlining of the organization to support prioritized clinical programs • (R) BI-1808 and KEYTRUDA® induce du- rable responses in heavily pretreated platinum-resistant ovarian cancer. The poster was granted Best Poster Award, Investigational Immunotherapy at ESMO 2026 • (R) The company announced that its CFO will retire in 2027 • First-in-Human BI-1808 Data Published in Clinical Cancer Research (R) = Regulatory event
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BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 CEO comments BI-1808 Development Defines Next Steps Encouraging clinical progress in ovarian cancer and a planned financing to support the next phase of development Martin Welschof, CEO The rights issue announced today is in- tended to provide BioInvent with the finan- cial resources to advance its prioritized clinical programs, with a particular focus on BI-1808 in platinum-resistant ovarian cancer. Building on the encouraging and durable responses observed to date, we plan to initiate a randomized Phase 2a study in Q1 2027 to further evaluate BI-1808 in combination with Keytruda and pacli- taxel, with first data expected in the second half of 2027. In parallel, we are sharpening our strategic focus and adapting our organization to concentrate resources on our most prom- ising clinical opportunities. We have also engaged an experienced international business development adviser to support partnering discussions across our pipeline. Together, these initiatives are intended to strengthen BioInvent’s position as we advance towards important clinical mile- stones and seek to unlock the potential of our programs for patients and sharehold- ers. At ESMO 2026, we presented updated data showing that BI-1808 combined with pem- brolizumab continues to deliver durable re- sponses in heavily pretreated platinum-re- sistant ovarian cancer. With 34 evaluable patients, the 24% response rate presented at ASCO remains the same, and the com- bination is safe and well tolerated. Building on these results, we plan to start a ran- domized Part C in Q1 2027, adding BI-1808 to the newly established pembrolizumab and paclitaxel backbone. The poster was granted “Best poster award”, Investigation- al Immunotherapy. This award recognizes researchers, clinicians, and scientists who present standout poster abstracts demon- strating high scientific relevance, innova- tive research design, or impactful clinical data in oncology. Winning the award highlights the quality of both the underlying data and the clear, structured presentation of complex medi- cal research. In early August, the FDA granted Fast Track Designation to BI-1808 for the treatment of ovarian cancer. In October, Clinical Cancer Research published Phase 1 data showing that the mechanism we characterized in preclinical models translates to treated patients, with dose-dependent regulatory T-cell (Treg) depletion at every dose level. These steps build on the results we pre- sented earlier this year: a 24% objective re- sponse rate for BI-1808 plus pembrolizum- ab in recurrent ovarian cancer at ASCO, and an 83% objective response rate for the BI-1206 triplet in relapsed/refractory NHL at EHA. Both programs are moving beyond single read-outs toward the evidence base needed to support pivotal trial design. For BI-1206, our anti-FcγRIIB antibody, Phase 2a work continues toward first solid tumor data and a potential pivotal trial in non-Hodgkin’s lymphoma (NHL). BI-1808 (ANTI-TNFR2) Encouraging ESMO data in 34 patients The updated analysis (cutoff September 14, 2026) includes 34 evaluable patients, up from 25 at ASCO, with a median of four prior lines of therapy. Eight patients re- sponded (one complete and seven partial responses), for an objective response rate of 24%, including patients with high-grade serous and clear cell histology and pa- tients with active liver metastases. The dis- ease control rate was 53%, with several pa- tients in stable disease beyond 10 months, and six patients remained on treatment at cutoff. Duration of response was not met at cutoff (median follow-up 11.6 months), sug- gesting that responses are durable. Median progression-free survival was 4.1 months by RECIST and 10.3 months by iRE- CIST, a criterion designed to capture de- layed responses. For context, KEYNOTE-100 reported 2.1 months by RECIST for pembroli- zumab alone (an indirect comparison). Treatment-related discontinuations oc- curred in fewer than 5% of the 81 solid 3
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BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 CEO comments 4 tumor patients treated with the combi- nation to date, and biomarker data were consistent with the mechanism, including Treg reduction and induction of cytokines and chemokines linked to myeloid repro- gramming and tertiary lymphoid structure formation. Following the KEYNOTE-B96 results, which established pembrolizumab plus weekly paclitaxel, with or without bevacizumab, as a new standard of care in this setting, Part C will randomize 20 patients to each of three arms: BI-1808 at 1000 mg, BI-1808 at 500 mg, or control, each with pembroli- zumab and paclitaxel. Part C is expected to start in Q1 2027, with first data in H2 2027. Randomized triplet study to start in Q1 2027 Part C will evaluate a randomized triplet of BI-1808, pembrolizumab and weekly paclitaxel, with or without bevacizumab, in patients with platinum-resistant ovarian cancer. New preclinical studies show that BI-1808 combines with paclitaxel, alone and with anti-PD-1 therapy, and that add- ing BI-1808 increases intratumoral immune activation and improves survival in exper- imental models compared with paclitaxel with or without anti-PD-1 therapy. Enroll- ment to the BI-1808 plus pembrolizumab combination cohort is complete. Fast Track Designation now covers ovarian cancer and two CTCL subtypes The ovarian cancer designation reflects the significant unmet medical need in this difficult-to-treat disease. BI-1808 also holds Fast Track Designation for relapsed or refractory mycosis fungoides and Sézary syndrome, which are forms of cutaneous T-cell lymphoma (CTCL). Phase 1 monotherapy results published: no maximum tolerated dose In October, we announced publication of the first-in-human Phase 1 results for BI- 1808 in Clinical Cancer Research. The study treated 24 patients with advanced solid tumors across five dose cohorts. It did not identify a maximum tolerated dose, with no dose-limiting toxicities and no deaths, and all treatment-related adverse events were Grade 1 or 2. Tumor regression occurred in 2 of 21 evaluable patients, including a partial response lasting more than two years in a patient with GIST. Treg depletion was dose dependent at all dose levels and sustained at 1000 mg every three weeks, the recom- mended Phase 2 dose. A complementary paper in Cancer Research describes how ligand-blocking and agonist antibodies targeting TNFR2 use distinct modes of ac- tion to induce antitumor immunity. BI-1206 (ANTI-FCγRIIB) BI-1206 data in NHL Phase 2a triplet data are maturing, no clinical data in 1L NSCLC yet The most recent clinical data for BI-1206 come from the Phase 2a triplet with rit- uximab and acalabrutinib in relapsed/ refractory NHL. At the May 6, 2026 cutoff, the triplet achieved an 83% objective response rate among 23 evaluable patients, with 11 complete responses and 8 partial re- sponses. Phase 2a triplet data are matur- ing to be ready for a potential pivotal trial, pending partnering. In our recent publication in Journal of Ex- perimental & Clinical Cancer Research (JECCR), preclinical models showed that tailored FcγR blockade with BI-1206 and BI- 1607 (currently paused) enhances cancer antibody therapies and overcomes resis- tance. The Phase 2a study of BI-1206 plus pembrolizumab in first-line non-small cell lung cancer (NSCLC) and uveal melanoma continues, with first data expected in H1 2027 (previously H2 2026), due to ongoing patient follow-up. FINANCING AND ORGANIZATION To secure funding for our clinical programs, the Board has decided to carry out a rights issue of approximately SEK 430 million (gross, before issue costs), of which SEK 350 million is covered by subscription com- mitments and guarantee undertakings, subject to approval at an Extraordinary General Meeting on December 1. As part of adapting to our project needs and financial situation, we will reduce the organization with up to 20 positions. The reduction is designed to preserve our core capabilities and keep the focus on advancing primarily BI-1808 and secondly BI-1206. STEFAN ERICSSON TO RETIRE AS CFO IN JANUARY 2027 On October 12, we announced that Stefan Ericsson, our Chief Financial Officer, will retire when he turns 64 in January 2027. He has been with BioInvent since 1998 and will remain in his current role until his depar- ture in January 2027 and a successor has taken office. We thank Stefan for nearly 30 years of outstanding service. MILESTONES AHEAD We expect the following key events: H1 2027: • Start of the BI-1808 Phase 2a random- ized triplet study (60 patients) in ovarian cancer (Part C) • First read-out from the Phase 2a study of BI-1206 in combination with Keytruda® for treatment-naïve NSCLC patients and uveal melanoma patients H2 2027: • First Phase 2a data from BI-1808 triplet study (+Keytruda® + paclitaxel +/- beva- cizumab) in ovarian cancer • Potential start of Phase 2b BI-1206 in combination with Keytruda®, pending partnering OUR FOCUS Our clinical portfolio remains focused on two targets, TNFR2 and FcγRIIB, but with a current priority on BI-1808 in cancers where patients have few effective options. With the planned rights issue and a leaner or- ganization, we aim to secure the resources to advance BI-1808 into randomized and potentially pivotal studies, while continuing to develop BI-1206 together with a partner. Thank you to all the patients, investigators, employees and shareholders who support this work. Sincerely, Martin Welschof Chief Executive Officer
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5 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Clinical programs Sharp focus to maximize clinical and commercial success BioInvent is developing novel immu- no-modulatory antibodies for cancer therapy. These innovative antibodies may significantly improve the effica- cy of currently available checkpoint inhibitors and/or activate anti-cancer immunity in non-responding patients. Our clinical portfolio is currently fo- cused on the immunological targets TNFR2 and FcyRIIB, but with a current priority on BI-1808 in cancers where patients have few effective options. A supply agreement with MSD supports the combination study with pembrolizum- ab of our BI-1808 and BI-1206 solid tumor programs and the triplet study of BI-1206 in NHL is conducted under a supply agree- ment for acalabrutinib with AstraZeneca. BI-1808 BI-1808 is a first-in-class monoclonal an- tibody targeting TNFR2, a novel immuno- modulatory target with potential for thera- peutic efficacy across many tumor types. It selectively focuses on TNFR2, a target which is overexpressed on immune cells of the tumor microenvironment and is now known to promote cancer progression. BI-1808 is associated with several crucial activities such as depletion of Tregs, ex- pansion of effector T-cells, and reprogram- ming of myeloid cells, and potential direct killing of tumoral T-cells in the case of T-cell lymphomas. Its strong safety and tolera- bility features allow single agent admin- istration as well as combinations for high clinical impact. BI-1206 BI-1206 is a first-in-class, high-affinity monoclonal antibody targeting FcγRIIB (CD32B), the only inhibitory Fcγ receptor and a key resistance mechanism to sever- al antibody-based cancer therapies. FcγRIIB is overexpressed in multiple forms of non-Hodgkin’s lymphoma (NHL) and is associated with poor prognosis in dif- ficult-to-treat subtypes such as mantle cell lymphoma. By blocking FcγRIIB, BI-1206 is designed to restore and enhance the activity of rituximab and other anti-CD20 antibodies, overcoming a well-recognized barrier to effective treatment. BioInvent’s preclinical data has demon- strated the ability of BI-1206 to address an important mechanism of resistance to PD-1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. Phase 1Indication/ Combination agent Phase 2a Phase 2b Ongoing Planned Preparatory phase Preparatory phase Preparatory phase Ongoing Ongoing Ongoing Ongoing Ongoing Ovarian cancer Pembrolizumab l Ovarian cancer Pembrolizumab’ + Paclitaxel CTCL Single agent CTCL Pembrolizumab l NHL (FL, MCL, MZL) Rituximab + Acalabrutinib 2 NSCLC 1L Pembrolizumab l Uveal melanoma 1L Pembrolizumab l TNFR2 FcγRIIB BI-1808 BI-1206 CTCL: Cutaneous T-cell Lymphoma NHL: Non-Hodgkin’s Lymphoma FL: Follicular Lymphoma MCL: Mantle Cell Lymphoma MZL: Marginal Zone Lymphoma 1L: First-line treatment NSCLC: Non-small cell lung cancer Notes 1. Supply agreement with MSD 2. Supply agreement with AstraZeneca
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6 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Clinical programs BI-1808 for the treatment of ovarian cancer BI-1808 is a first-in-class antibody tar- geting TNFR2 and is part of BioInvent’s program against tumor-associated regulatory T cells (Tregs). The antibody blocks TNFR2 signaling and is designed to deplete immunosuppressive Tregs in the tumor and modulate the myeloid compartment, which is intended to promote activation and expansion of tumor-reactive CD8+ T cells. BI-1808 is being developed for solid tumors and T-cell lymphoma and is being evalu- ated in an ongoing Phase 1/2a study, in which the combination with pembroli- zumab has shown clinical efficacy and good tolerability in ovarian cancer. STATUS BI-1808: ovarian cancer data presented at ESMO 2026 Enrollment in the ovarian cancer cohort of Part B of the BI-1808 Phase 1/2a study (NCT04752826, KEYNOTE-D20) has been completed. The cohort evaluates BI-1808 in combination with pembrolizumab (KEY- TRUDA®) in heavily pretreated patients with platinum-resistant recurrent ovarian can- cer. Updated data vs ASCO 2026 were pre- sented in a poster at the ESMO Congress 2026 on October 24. At September 14, 2026 data cutoff, 8 of 34 evaluable patients had an objective response (1 complete and 7 partial re- sponses; objective response rate 24%). The disease control rate was 53%, with several patients in stable disease for more than 10 months, and 6 patients remained on treat- ment. Preliminary median progression-free survival was 4.1 months per RECIST 1.1, compared with 2.1 months reported for pembrolizumab alone in KEYNOTE-100 (an indirect comparison), and 10.3 months per iRECIST, which captures delayed responses. Responses were seen in both high-grade serous and clear cell histology, including in patients with liver metastases. The combination was well tolerated, with fewer than 5% treatment-related discon- tinuations among the 81 patients with solid tumors treated to date. Translational data showed Treg depletion and CD8+ T-cell activation, as well as signs of myeloid re- programming and tertiary lymphoid struc- ture formation. Based on these results, BioInvent plans to start Part C, a randomized evaluation of two BI-1808 dose levels (1000 mg and 500 mg) versus control, each combined with pembrolizumab and weekly paclitaxel with or without bevacizumab. STUDY DESIGN This Phase 1/2a trial (NCT04752826) is de- signed to assess the safety and tolerability of BI-1808 as a single agent (Part A), in combination with pembrolizumab (Part B) and in a triple combination with pembroli- zumab and paclitaxel (Part C). The study aims to characterize safety, pharmaco- kinetics and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and pro- gression-free survival (PFS), as measured by RECIST v1.1 and iRECIST. OUT-LICENSING AND PARTNERING Since August 2021, BioInvent has a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combina- tion of BI-1808 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). OUTLOOK Part C (BI-1808 + standard-of care) of the Phase 1/2a trial is expected to start in Q1 2027, with first data expected in the second half of 2027. Selection of drug candidate Proof-of-concept Toxicology study Pre-clinical data Study design Meeting with Regulatory Authorities IND/CTA application IND/CTA approval First patient dosed Signal seeking Data CMC Process development GMP production & Release Characterization Supply agreement with MSD PARTNERING Completed Ongoing Planned DISCOVERY PRECLINICAL DEVELOPMENT OUT-LICENCING CLINICAL DEVELOPMENT Phase 2a First patient dosed Dose Escalation All patient dosed Data (Go/No-go) Single agent Pembrolizumab Phase 1 study Pembrolizumab +paclitaxel
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7 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Clinical programs BI-1808 for the treatment of CTCL BioInvent’s anti-TNFR2 antibody BI- 1808 is a first-in-class drug candidate in clinical development for cutaneous T-cell lymphoma (CTCL) and solid tu- mors. In the ongoing CTCL cohort of the Phase 1/2a study, BI-1808 has shown single-agent activity, as well as prom- ising signs of efficacy and a favorable safety profile in combination with pem- brolizumab. BI-1808 has been granted FDA Fast Track Designation for relapsed or refractory mycosis fungoides and Sézary syndrome, FDA Orphan Drug Designation for T-cell lymphoma, and EMA Orphan Drug Designation for CTCL. STATUS Efficacy in clinical Phase 1/2a study in CTCL In June 2026, updated positive data from the ongoing Phase 2a dose expansion study of BI-1808 monotherapy in cutaneous T-cell lymphoma (CTCL) was announced. The data was presented at the European Hematology Association (EHA) 2026 Con- gress in Stockholm, Sweden in a poster titled “Targeting TNFR2 with BI-1808 with or without pembrolizumab: Immune activa- tion and promising responses in advanced cutaneous T-cell lymphomas (CTCLs)”. Low Rate of Severe Side Effects Allows Patients to Remain on Treatment Long- Term BI-1808 was very well tolerated as a single agent. Only one patient (4%) discontinued due to an adverse event. The combination with pembrolizumab was generally well tolerated in this heavily pretreated popu- lation. BI-1808 Single Agent Cohort Of 15 patients evaluable, BI-1808 achieved an ORR of 40%, with 5 confirmed partial re- sponses across both MF and SS subtypes, and one Sézary syndrome patient achiev- ing a complete response that remains ongoing at approximately two years. Eight additional patients achieved stable dis- ease as best response, corresponding to a disease control rate (DCR) of 93%. Two patients with peripheral T-cell lymphoma (PTCL), an aggressive type of lymphoma, were also evaluable, with one achieving a partial response and one stable disease. Combination with Pembrolizumab Of 8 evaluable patients in the combina- tion arm, 4 achieved a partial response at first assessment and 2 achieved stable disease, resulting in an ORR of 50% and a DCR of 75%. The lower DCR of 75% in the combination arm compared to 93% in the monotherapy arm is consistent with the smaller, more heavily pretreated patient population evaluated to date. Translational data from the study provides important mechanistic support for BI- 1808’s activity. STUDY DESIGN The aim of Phase 2a (NCT04752826) is to further assess the safety and tolerabil- ity of BI-1808 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its pharmacoki- netics and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS), the mod- ified Severity-Weighted Assessment Tool (mSWAT) for CTCL. OUT-LICENSING AND PARTNERING Since August 2021, BioInvent has a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combina- tion of BI-1808 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). OUTLOOK Complete Phase 2a dose optimization monotherapy data is expected H1 2027. Selection of drug candidate Proof-of-concept Toxicology study Pre-clinical data Study design Meeting with Regulatory Authorities IND/CTA application IND/CTA approval First patient dosed Signal seeking Data CMC Process development GMP production & Release Characterization Supply agreement with MSD PARTNERING Completed Ongoing Planned DISCOVERY PRECLINICAL DEVELOPMENT OUT-LICENCING CLINICAL DEVELOPMENT Phase 2a First patient dosed Dose Escalation All patient dosed Data (Go/No-go) Single agent Pembrolizumab Phase 1 study
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8 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Clinical programs BI-1206 for the treatment of NHL (FL, MCL, MZL) BI-1206 is a first-in-class antibody tar- geting FcγRIIB, which is overexpressed in several forms of non-Hodgkin lym- phoma (NHL) and has been associated with poor prognosis in difficult-to-treat forms, such as mantle cell lymphoma (MCL). By blocking FcγRIIB on tumor cells, BI-1206 is expected to restore and enhance the activity of rituximab in the treatment of several forms of NHL. BI-1206 has been granted Orphan Drug Designation by the FDA for the treatment of follicular lymphoma (FL), the most common form of indolent non-Hodgkin lymphoma, and for MCL. STATUS Triple combination arm of clinical Phase 1/2a study ongoing As of data cut-off May 6, 2026, the trip- let of BI-1206 + rituximab + acalabrutinib delivered an 83% objective response rate (ORR) in the total population (n=23 evalu- able), with 11 complete responses (CR) and 8 partial responses (PR). In the follicular lymphoma (FL) subset (n=16), ORR was 81% and complete response rate (CRR) was 44%. All remaining patients exhibited stable disease as best response, giving a disease control rate (DCR) of 100%. The regimen showed a very favorable tolerability profile, with treatment-related serious adverse events observed in only 4 (14%) patients and discontinuation due to a drug-related adverse event in 1 pa- tient. Grade 3+ treatment-related adverse events observed in only 31% of patients, versus 54–84% for comparator regimens. STUDY DESIGN The triple combination arm in the ongoing Phase 2a part of the study (NCT03571568) combines the sub- cutaneous formulation of BI-1206 with rit- uximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin’s lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approxi- mately 30 patients) has been completed in Spain, Germany, USA, and Brazil. BioInvent has a clinical supply agreement with As- traZeneca (LSE/STO/Nasdaq: AZN) providing Calquence® (acalabrutinib) for the combi- nation arm. CLINICAL DEVELOPMENT IN CHINA Since October 2020, BioInvent has a licens- ing agreement in place with CASI Pharma- ceuticals for China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, BioInvent and CASI develop BI-1206 in both hematological and solid cancers, with CASI responsible for development and com- mercialization in China and associated markets. BioInvent received USD 12 million upfront in combination of cash and equity investment and is eligible to receive up to USD 83 million in milestone payments, plus tiered royalties. OUT-LICENSING AND PARTNERING BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence® (acalabrutinib) for the triple combination arm. In January 2023, BioInvent was selected as partner of Blood Cancer United (formerly The Leukemia & Lymphoma Society)’s Ther- apy Acceleration Program® (TAP), aimed at advancing the company’s program to treat blood cancers. The partnership gives access to the unique scientific, clinical and drug development expertise of Blood Cancer United and entailed a strategic capital equity investment from them of USD 3 million. OUTLOOK Phase 2a triplet data for BI-1206 in com- bination with rituximab and acalabrutinib are maturing to be ready for initiation of a potential pivotal trial in H1 2027E, pending partnering. Selection of drug candidate Proof-of-concept Toxicology study Pre-clinical data Study design Meeting with Regulatory Authorities IND/CTA application IND/CTA approval First patient dosed Dose Escalation (Safety study) All patients dosed Phase 1 data (Go/No-go) First patient dosed Signal seeking Data CMC Process development GMP production & Release Characterization Supply agreement with AZ lanoigeR partnering with CASI Phase 1 study PARTNERING Completed Ongoing Planned DISCOVERY PRECLINICAL DEVELOPMENT OUT-LICENCING CLINICAL DEVELOPMENT Rituximab Rituximab + Calquence Rituximab Phase 2a
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9 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Clinical programs BI-1206 for the treatment of NSCLC and uveal melanoma BI-1206 is a first-in-class antibody tar- geting FcγRIIB. Based on clinical Phase 1 data in patients with solid tumors, in which BI-1206 enhanced the effect of anti-PD-1 therapy, MSD and BioInvent agreed to study the combination of BI-1206 and pembrolizumab (KEY- TRUDA®) at an earlier stage of disease. The ongoing Phase 2a study is being conducted in patients who have not previously received any treatment for their disease (treatment-naive), with non-small cell lung cancer (NSCLC) or uveal melanoma. STATUS Clinical Phase 1/2a study with BI-1206 in combination with pembrolizumab ongoing The ongoing Phase 2a clinical trial is eval- uating BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) an- ti-PD-1 therapy KEYTRUDA® (pembrolizum- ab) in patients with advanced or metastat- ic non-small cell lung cancer (NSCLC) and uveal melanoma in the first-line setting. As previously presented, in Phase 1, BI-1206 was deemed to be safe and well-tolerat- ed and demonstrated promising clinical activity in heavily pre-treated patients, with one complete response (CR), one long-lasting partial response (PR), and 11 patients with stable disease (SD) out of 36 evaluable patients. All patients had progressed after previous treatments with anti-PD-1/L1 agents. The subcutaneous formulation provided slower systemic entry and prolonged time on target while im- proving safety and tolerability. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all lung cancer cases. While checkpoint inhibitors are widely accepted and can produce durable responses in NSCLC, the overall response rate remains low, rarely exceeding 25 percent. A common resistance mechanism in cancer is the binding and degradation of therapeutic antibodies against PD-1 such as pembrolizumab by FcyRIIB expressing immune cells. Therefore, based on preclin- ical and early clinical data, the company believes that resistance or lack of response to anti-PD-1 treatment may be overcome by FcyRIIB blockade in particular in subjects who have never been exposed to anti PD-1 agents. STUDY DESIGN The ongoing Phase 2a trial (NCT04219254) will evaluate the safety and efficacy of BI- 1206 in combination with pembrolizumab in patients with advanced or metastatic NSCLC and uveal melanoma. Patients will be enrolled at sites in Georgia, Germany, Poland, Rumania, Spain, Sweden and the US, with first data expected in H2 2026. The trial is designed in two parts. In the first part, or signal-seeking phase, up to 30 NSCLC and 12 uveal melanoma patients will receive BI-1206 and pembrolizumab every 21 days for up to 2 years. The study may then proceed to a dose optimiza- tion phase, designed to refine the dosing strategy to maximize both efficacy and tolerability of the combination. During dose optimization, patients will be randomized to receive a higher or a lower dose of BI-1206. A third cohort will then receive pembroli- zumab alone. OUT-LICENSING AND PARTNERING In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Mer- ck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BioInvent’s BI-1206 and MSD’s anti-PD-1 therapy, KEYTRUDA (pem- brolizumab) in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, MSD supplies KEYTRUDA. OUTLOOK The first data from the Phase 2a study in first line NSCLC and uveal melanoma are expected in H1 2027. Selection of drug candidate Proof-of-concept Toxicology study Pre-clinical data Study design Meeting with Regulatory Authorities IND/CTA application IND/CTA approval First patient dosed First patient dosed Signal seeking Data Dose Escalation (Safety study) All patients dosed Phase 1 data (Go/No-go) CMC Process development GMP production & Re- lease Characterization Supply agreement with MSD Phase 1 study PARTNERING Completed Ongoing Planned DISCOVERY PRECLINICAL DEVELOPMENT OUT-LICENCING CLINICAL DEVELOPMENT Pembrolizumab Phase 2a
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10 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Collaborations Strategic collaborations BioInvent collaborates with a number of important players within the pharma- ceutical industry and within academia. The collaborations with other phar- maceutical companies focus on com- mercial partnerships for BioInvent’s clinical assets. The further the clinical programs have advanced, the greater is the chance of establishing partner- ships that bring real value to BioInvent. Academic partnerships, on the other hand, allow BioInvent to tap into world class scientific expertise to advance the company’s early programs, and potentially to acquire high quality early assets that could be of interest to BioIn- vent for further development. COLLABORATIONS WITH LEADING PHARMACEUTICAL COMPANIES For its clinical programs, BioInvent has dif- ferent kinds of collaborations with leading pharmaceutical companies such as CASI, MSD, AstraZeneca, and Transgene, see pages 6-10 and 12 for details. BioInvent has supply and collaboration agreements with MSD to support the de- velopment of the clinical trial programs for the anti-TNFR2 antibody BI-1808 and the anti-FcyRIIB antibody BI-1206, and also for the oncolytic virus BT-001. The agreements with MSD give BioInvent the opportunity to explore the potential synergistic activity of its proprietary drug candidates in combi- nation with pembrolizumab. The agreement with AstraZeneca is a supply agreement to clinically evaluate Calquence® in combination with BI-1206 and rituximab. As the external partners carefully review programs before establishing such agree- ments, these agreements provide further validation of the high quality of the pro- grams. STRATEGIC CLINICAL COLLABORATIONS Since 2023, BioInvent has been a selected partner of Blood Cancer United’s (for- mer The Leukemia & Lymphoma Society) Therapy Acceleration Program® (TAP). The company has received a strategic equity investment of USD 3 million to support clin- ical advancement of BI-1206 in non-Hod- gkin’s Lymphoma and BI-1808 in cutaneous T-cell lymphoma. TAP is a strategic funding initiative to accelerate innovative blood cancer therapeutics worldwide. ROYALTY TRANSACTION WITH XOMA In May 2025, XOMA Royalty purchased the future mezagitamab (TAK-079) royalty and milestone interests held by BioInvent for a total transaction value of up to USD 30 million. Under the terms of XOMA Royalty’s purchase of BioInvent’s economic interest in mezagitamab, XOMA Royalty paid to Bio- Invent USD 20 million at closing and will pay an additional USD 10 million upon mezagi- tamab achieving a specific pre-defined regulatory milestone associated with receiving marketing approval in the IgA nephropathy indication from the U.S. Food and Drug Administration. THREE CLINICAL PROJECTS OUTLICENSED BioInvent currently has three clinical proj- ects outlicensed to other companies. In the short term BioInvent may receive minor clinical milestone payments, but the up- side in these projects lies in commercial milestones and potential royalties five to ten years from now. It is impossible to know if any of BioInvent’s external projects will go all the way to market but statistically it is highly probable that at least one or two will be successful. TLB-33 Orticumab HMI-115 anti-IL33 anti-ApoB100 anti-PRLR Thymic preservation Cardiovascular Endometriosis Phase 1Program Phase 2 Phase 3 Market LicenseeTarget Primary indication Tolerance Bio Abcentra Hope Medicine/Bayer Completed Ongoing
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11 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Collaborations BT-001 co-developed with Transgene BT-001 is an oncolytic virus armed with BioInvent’s anti-CTLA-4 antibody. When the virus is infecting the tumor cells it releases the anti-CTLA-4 locally in the tumor to decrease the risk for systemic side-effects. BT-001 is a drug candidate being developed in collabo- ration with the French biotech compa- ny Transgene. STATUS Clinical phase 1/2a study (NCT04725331) concluded BioInvent and Transgene have jointly pre- sented clinical results and positive antitu- moral activity of BT-001 in patients with ad- vanced refractory tumors. The data show that intra-tumoral (IT) BT-001 injection in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) intravenous (IV) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), was well tolerated and showed positive local, abscopal, and sustained antitumoral ac- tivity in injected and non-injected lesions. Long lasting partial responses (PRs) were observed in a patient with melanoma re- sistant to anti-PD-1/anti-CTLA-4 combina- tion therapy and in a heavily pre-treated, PD-L1 negative leiomyosarcoma patient. These immune-mediated tumor shrink- ages are consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns “cold” tumors into immunologically active ones. The over- all data support further development of BT-001 across a range of solid tumors to improve responses to cancer immunother- apies. STUDY DESIGN The Phase 1/2a study was a multicenter, open label, dose escalation trial evaluating BT-001 as a single agent and in combina- tion with pembrolizumab (anti-PD-1 treat- ment). The Phase 1 study was divided into two parts. In part A, patients with metastatic/ advanced tumors received single agent, intra-tumoral administrations of BT-001. Part B explored intra-tumoral injections of BT-001 in combination with pembrolizum- ab. OUT-LICENSING AND PARTNERING In June 2022, BioInvent and Transgene an- nounced a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the oncolytic virus BT-001 in com- bination with MSD’s anti-PD-1 therapy KE- YTRUDA® (pembrolizumab) in a Phase 1/2a clinical trial for the treatment of patients with solid tumors. Since 2017, BioInvent and Transgene have been collaborating to develop the drug candidate BT-001, which encodes both a differentiated and proprietary CTLA-4 an- tibody and the cytokine GM-CSF. The re- search and development costs as well as revenue and royalties are shared 50:50. OUTLOOK BioInvent and its partner Transgene con- tinue the evaluation of BT-001 via an in- vestigator-initiated trial in an early-stage setting.
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12 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Financial information REVENUES AND RESULT Figures in parentheses refer to the out- come for the corresponding period in the preceding year. Third quarter Net sales amounted to SEK 10.8 million (3.3). Revenues for the period were mainly derived from production of antibodies for clinical studies. Revenues for the corresponding period 2025 were mainly derived from production of antibodies for clinical studies. See also note 2. The Company’s total costs amounted to SEK 131.0 million (137.2). These are divided between external costs of SEK 94.3 million (95.7), personnel costs of SEK 32.5 million (36.7) and depreciation of SEK 4.2 million (4.8). Research and development costs amount- ed to SEK 115.0 million (119.5). Sales and administrative costs amounted to SEK 16.0 million (17.7). Profit/loss after tax amounted to SEK -118.9 million (-129.2). The net financial items amounted to SEK 1.6 million (4.5). Profit/ loss per share before and after dilution amounted to SEK -1.81 (-1.96). January-September Net sales amounted to SEK 37.0 million (223.5). Revenues for the period were mainly derived from a EUR 1.0 million (SEK 11.3 million) milestone payment under the collaboration with Bayer/Hope Medicine related to the initiation of a Phase 3 clinical trial, and revenue from production of anti- bodies for clinical studies. Revenues for the corresponding period 2025 were mainly derived from USD 20 million (SEK 191.0 million) that BioInvent received when XOMA Royalty acquired the rights to future royalty and milestone in- terests for mezagitamab (TAK-079), prior to that a milestone payment of USD 1.0 million (SEK 9.9 million) was received in the col- laboration, and revenue from production of antibodies for clinical studies. See also note 2. The Company’s total costs amounted to SEK 403.8 million (445.5). These are divided between external costs of SEK 280.9 million (314.5), personnel costs of SEK 109.6 million (116.0) and depreciation of SEK 13.3 million (15.0). Research and development costs amount- ed to SEK 353.8 million (392.0). Sales and administrative costs amounted to SEK 50.0 million (53.5). Profit/loss after tax amounted to SEK -361.0 million (-207.1). The net financial items amounted to SEK 6.4 million (15.4). Profit/ loss per share before and after dilution amounted to SEK -5.49 (-3.15). FINANCIAL POSITION AND CASH FLOW On October 28, 2026, BioInvent announced that the Board of Directors had, subject to approval by an extraordinary general meeting, resolved to carry out a new issue of shares of approximately SEK 430 million with preferential rights for the Company’s existing shareholders. The rights issue is carried out to strengthen the Company’s financial position and fund the continued clinical development of the Company’s priority programs, principally its solid tumor opportunities for BI-1808 and BI-1206. The Company has received subscrip- tion commitments from the three largest shareholders, Redmile, Van Herk and For- bion, as well as other existing sharehold- ers, including HealthInvest, amounting to approximately SEK 80 million, and share- holding members of the Board of Directors and Management intend to enter into subscription commitments following the publication of the interim report January – September 2026 amounting to approxi- mately SEK 0.6 million in total, including pro rata subscription commitments from CEO Martin Welschof and Chairman Leonard Kruimer. Additionally, due to restrictions on participation of US persons in the Rights Issue, members Kate Hermans, Bernd Seizinger and Scott Zinober of the Board of Directors have declared their intention to purchase shares on the market during the subscription period in the rights issue corresponding to approximately SEK 0.7 million in total. The Company has also received guarantee undertakings up to approximately SEK 270 million. Accordingly, the rights issue is covered by subscription commitments and guarantee undertak- ings up to approximately SEK 350 million, corresponding to approximately 81 percent of the rights issue. Based on the Company’s cash position as of September 30, 2026, and the current business plan, successful completion of the part of the rights issue covered by subscription commitments and guarantee undertakings is expected to extend the Company’s cash runway to the end of 2027. Any additional net proceeds in addition to the amount covered by the subscription commitments and guarantee undertak- ings, up to full subscription in the rights issue, are intended primarily to strengthen the Company’s liquidity reserve and pro- vide additional financial flexibility in the implementation of the Company’s priority clinical programs. The share capital consists of 65,804,362 shares as of September 30, 2026.
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13 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information As of September 30, 2026, the Group’s liquid funds and current investments amounted to SEK 224.6 million (690.5). The cash flow from operating activities for the Janu- ary-September period amounted to SEK -358.3 million (-157.2). The shareholders’ eq- uity amounted to SEK 200.9 million (683.0) at the end of the period. The Company’s share capital was SEK 13.2 million. The equi- ty/assets ratio at the end of the period was 65 (87) percent. Shareholders’ equity per share amounted to SEK 3.05 (10.38). INVESTMENTS Investments for the January-September period in tangible fixed assets amounted to SEK 1.4 million (6.0). PARENT COMPANY The main operations of the Group are con- ducted by the Parent Company. Except for operations in BioInvent Support Inc. and financial leases, the Group’s and the Parent Company’s financial statements coincide in every material way. ORGANIZATION As of September 30, 2026, BioInvent had 107 (124) employees (full time equivalent). 92 (110) of these work in research and devel- opment. DISCLOSURE OF RELATED PARTY TRANSACTIONS For description of benefits to senior ex- ecutives, see page 56 in the Company’s annual report 2025. Otherwise, there are no transactions with related parties, in accor- dance with IAS 24, to report. RISK FACTORS The Company’s operations are associated with risks related to factors such as phar- maceutical development, clinical trials and product responsibility, commercialization and partners, competition, intellectual property protection, compensation for pharmaceutical sales, qualified personnel and key individuals, additional financing requirements, currency risk and interest risk. The risks summarize the factors of significance for BioInvent and thus an in- vestment in the BioInvent share. For a more detailed description of risk fac- tors, see section “Risks and Risk Manage- ment”, page 39, in the Company’s annual report 2025.
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14 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Consolidated statement of comprehensive income in brief for the Group (SEK thousand) 3 MONTHS 3 MONTHS 9 MONTHS 9 MONTHS 12 MONTHS 2026 2025 2026 2025 2025 JULY-SEP. JULY-SEP. JAN.-SEP. JAN.-SEP. JAN.-DEC. Net sales 10,793 3,321 36,966 223,479 226,495 Operating costs Research and development costs -115,031 -119,458 -353,765 -391,972 -504,218 Sales and administrative costs -15,936 -17,716 -50,056 -53,545 -73,668 Other operating income and costs -259 247 -382 -234 -293 -131,226 -136,927 -404,203 -445,751 -578,179 Operating profit/loss -120,433 -133,606 -367,237 -222,272 -351,684 Profit/loss from financial investments 1,596 4,457 6,425 15,429 19,223 Profit/loss before tax -118,837 -129,149 -360,812 -206,843 -332,461 Tax -75 -74 -231 -213 -397 Profit/loss after tax -118,912 -129,223 -361,043 -207,056 -332,858 Other comprehensive income Items that have been or may be reclassified subsequently to profit or loss Translation differences for the period 28 -5 82 -45 -65 Comprehensive income -118,884 -129,228 -360,961 -207,101 -332,923 Profit/loss attributable to parent Company’s shareholders -118,912 -129,223 -361,043 -207,056 -332,858 Comprehensive income attributable to parent Company’s shareholders -118,884 -129,228 -360,961 -207,101 -332,923 Profit/loss per share, SEK Before dilution -1.81 -1.96 -5.49 -3.15 -5.06 After dilution -1.81 -1.96 -5.49 -3.15 -5.06
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15 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Consolidated statement of financial position in brief for the Group (SEK thousand) 2026 2025 2025 SEP. 30 SEP. 30 DEC. 31 ASSETS Intangible fixed assets 0 0 0 Tangible fixed assets - leases 21,343 11,585 9,639 Tangible fixed assets - other 17,733 25,399 23,870 Financial fixed assets - long-term investments - - - Total fixed assets 39,076 36,984 33,509 Inventories 9,739 9,419 12,292 Current receivables 34,679 48,962 32,653 Current investments - 207,181 236,579 Liquid funds 224,562 483,274 356,169 Total current assets 268,980 748,836 637,693 Total assets 308,056 785,820 671,202 SHAREHOLDERS’ EQUITY Total shareholders’ equity 200,937 683,016 557,615 LIABILITIES Lease liabilities 10,908 1,593 1,157 Total long term liabilities 10,908 1,593 1,157 Lease liabilities 8,418 9,093 7,370 Other liabilities 87,793 92,118 105,060 Total short term liabilities 96,211 101,211 112,430 Total shareholders’ equity and liabilities 308,056 785,820 671,202
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16 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Statement of changes in equity for the Group (SEK thousand) 2026 2025 2026 2025 2025 JULY-SEP. JULY-SEP. JAN.-SEP. JAN.-SEP. JAN.-DEC. Shareholders’ equity at beginning of period 317,335 810,744 557,615 885,815 885,815 Comprehensive income Profit/loss -118,912 -129,223 -361,043 -207,056 -332,858 Other comprehensive income 28 -5 82 -45 -65 Total comprehensive income -118,884 -129,228 -360,961 -207,101 -332,923 Total, excluding transactions with equity holders of the Company 198,451 681,516 196,654 678,714 552,892 Transactions with equity holders of the Company Employee options program 2,486 1,500 4,283 4,302 4,723 Shareholders’ equity at end of period 200,937 683,016 200,937 683,016 557,615 The share capital as of September 30, 2026 consists of 65,804,362 shares and the share’s ratio value was 0.20.
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17 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Consolidated statement of cash flows in brief for the Group (SEK thousand) 2026 2025 2026 2025 2025 JULY-SEP. JULY-SEP. JAN.-SEP. JAN.-SEP. JAN.-DEC. Operating activities Operating profit/loss -120,433 -133,606 -367,237 -222,272 -351,684 Depreciation 4,152 4,812 13,266 15,019 19,871 Adjustment for other non-cash items 2,486 1,500 4,283 4,302 4,723 Interest received and paid 1,522 3,541 7,373 22,392 29,878 Income taxes paid -66 - -514 -164 -177 -112,339 -123,753 -342,829 -180,723 -297,389 Changes in working capital -1,210 19,770 -15,484 23,518 49,634 Cash flow from operating activities -113,549 -103,983 -358,313 -157,205 -247,755 Investment activities Acquisition of tangible fixed assets -153 -1,834 -1,434 -5,981 -7,260 Changes of financial investments 34,238 183,561 236,001 216,389 187,387 Cash flow from investment activities 34,085 181,727 234,567 210,408 180,127 Cash flow from operating activities and investment activities -79,464 77,744 -123,746 53,203 -67,628 Financing activities Amortization of lease liability -2,148 -2,258 -6,602 -6,728 -8,985 Cash flow from financing activities -2,148 -2,258 -6,602 -6,728 -8,985 Change in liquid funds -81,612 75,486 -130,348 46,475 -76,613 Opening liquid funds 306,480 404,053 356,169 434,826 434,826 Accrued interest on investments classified as liquid funds -306 3,735 -1,259 1,973 -2,044 Liquid funds at end of period 224,562 483,274 224,562 483,274 356,169 Liquid funds, specification: Cash and bank 99,757 86,633 99,757 86,633 97,106 Current investments, equivalent to liquid funds 124,805 396,641 124,805 396,641 259,063 224,562 483,274 224,562 483,274 356,169
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18 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Key financial ratios for the Group 2026 2025 2025 SEP. 30 SEP. 30 DEC. 31 Shareholders’ equity per share at end of period, SEK 3.05 10.38 8.47 Number of shares at end of period (thousand) 65,804 65,804 65,804 Equity/assets ratio, % 65.2 86.9 83.1 Number of employees at end of period 107 124 109
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19 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Consolidated income statement in brief for the Parent Company (SEK thousand) 3 MONTHS 3 MONTHS 9 MONTHS 9 MONTHS 12 MONTHS 2026 2025 2026 2025 2025 JULY-SEP. JULY-SEP. JAN.-SEP. JAN.-SEP. JAN.-DEC. Net sales 10,793 3,321 36,966 223,479 226,495 Operating costs Research and development costs -115,453 -118,793 -354,707 -392,551 -504,957 Sales and administrative costs -16,168 -17,879 -50,785 -53,928 -74,223 Other operating income and costs -211 247 -193 -234 -461 -131,832 -136,425 -405,685 -446,713 -579,641 Operating profit/loss -121,039 -133,104 -368,719 -223,234 -353,146 Profit/loss from financial investments 1,782 4,547 6,822 15,743 19,612 Profit/loss after financial items -119,257 -128,557 -361,897 -207,491 -333,534 Tax -33 -32 -97 -117 -205 Profit/loss -119,290 -128,589 -361,994 -207,608 -333,739 Other comprehensive income - - - - - Comprehensive income -119,290 -128,589 -361,994 -207,608 -333,739
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20 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Consolidated balance sheet in brief for the Parent Company (SEK thousand) 2026 2025 2025 SEP. 30 SEP. 30 DEC. 31 ASSETS Intangible fixed assets 0 0 0 Tangible fixed assets 17,733 25,399 23,870 Financial fixed assets - Shares in subsidiaries 1,008 1,008 1,008 Financial fixed assets - long-term investments - - - Total fixed assets 18,741 26,407 24,878 Current assets Inventories 9,739 9,419 12,292 Current receivables 38,648 50,610 34,426 Current investments - 207,181 236,579 Cash and bank 224,359 482,844 355,752 Total current assets 272,746 750,054 639,049 Total assets 291,487 776,461 663,927 SHAREHOLDERS’ EQUITY Restricted equity 40,854 40,854 40,854 Non-restricted equity 159,348 642,769 517,059 Total shareholders’ equity 200,202 683,623 557,913 LIABILITIES Short term liabilities 91,285 92,838 106,014 Total short term liabilities 91,285 92,838 106,014 Total shareholders’ equity and liabilities 291,487 776,461 663,927 Lund, October 28, 2026 Martin Welschof CEO
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21 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Review report Review report To the Board of Directors of BioInvent International AB (publ.) Corp. id. 556537-7263 INTRODUCTION We have reviewed the condensed interim financial information (interim report) of BioInvent International AB (publ.) as of 30 September 2026 and the nine-month peri- od then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this in- terim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review. SCOPE OF REVIEW We conducted our review in accordance with International Standard on Review Engagements ISRE 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing practices and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an au- dit. Accordingly, we do not express an audit opinion. CONCLUSION Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the Group in accor- dance with IAS 34 and the Annual Accounts Act, and for the Parent Company in accor- dance with the Annual Accounts Act. Malmö, October 28, 2026 KPMG AB Linda Bengtsson Authorized Public Accountant Auditor in charge
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22 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Financial information Information notes NOTE 1 ACCOUNTING PRINCIPLES This interim report in brief for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting and applicable parts of the Annual Accounts Act. The inter- im report of the Parent Company has been prepared in accordance with Chapter 9 of the Annual Accounts Act. For the Group and the Parent Company, the same accounting policies and accounting estimates and assumptions were applied to this interim report as were used in the preparation of the most recent annual report. Changes in IFRS standards entered into force in 2026 has had no material impact on the financial statements. Except for leases, the Group’s and the Par- ent Company’s financial statements coin- cide in every material way. Disclosures according to IAS 34.16A appear in addition to the financial statements and their associated notes, also in other parts of the interim report. The definition of alternative performance measures not defined by IFRS is un- changed from those presented in the most recent annual report. NOTE 2 NET REVENUE NOTE 3 EVENTS AFTER THE PERIOD • (R) The Board of Directors has decided to carry out a rights issue of approxi- mately SEK 430 million (gross, before issue costs), of which SEK 350 million is covered by subscription commitments and guarantee undertakings, subject to approval at an Extraordinary General Meeting • (R) Streamlining of the organization to support prioritized clinical programs • (R) BI-1808 and KEYTRUDA® induce du- rable responses in heavily pretreated platinum-resistant ovarian cancer. The poster was granted Best Poster Award, Investigational Immunotherapy at ESMO 2026 • (R) The company announced that its CFO will retire in 2027 • First-in-Human BI-1808 Data Published in Clinical Cancer Research (R) = Regulatory event 2026 2025 2026 2025 2025 SEK thousand JULY-SEP. JULY-SEP. JAN.-SEP. JAN.-SEP. JAN.-DEC. Revenue by geographical region: Sweden 56 2,036 673 12,241 13,723 Europe 167 134 12,299 968 1,238 USA 10,476 1,151 22,933 209,958 210,952 Other countries 94 - 1,061 312 582 10,793 3,321 36,966 223,479 226,495 Revenue consists of: Revenue from collaboration agree- ments associated with outlicensing of proprietary projects - - - - - Revenue from technology licenses 89 - 11,365 200,941 200,941 Revenue from external development projects 10,704 3,321 25,601 22,538 25,554 10,793 3,321 36,966 223,479 226,495 The net revenue of the Group and the Parent Company coincide. In January-September 2026, BioInvent had two customers where revenues exceeded ten percent of total revenues. Revenues for these customers amounted to SEK 21.9 million (59%) and SEK 11.3 million (31%) of total revenues of SEK 37.0 million. In January-September 2025, BioInvent had one customer where revenues exceeded ten percent of total revenues. Revenues for the customer amounted to SEK 200.9 million (90%) of total revenues of SEK 223.5 million. In the 2025 financial year, BioInvent had one customer where revenues exceeded ten percent of total revenues. Revenues for the customer amounted to SEK 200.9 million (89%) of total revenues of SEK 226.5 million.
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23 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Other information Other information EXTRA GENERAL MEETING The Extra General Meeting will be held on December 1, 2026, at 4 p.m. at the Alfa house (room Focus), Scheelevägen 15, Lund. Notice to attend will be announced in Post- och Inrikes Tidningar and on the Company website. FINANCIAL CALENDAR • Year-end report 2026: March 4, 2027 • Interim report January-March 2027: April 29 • Interim report January-June 2027: Au- gust 26 • Interim report January-September 2027: October 28 CONTACT Any questions regarding this report will be answered by: Cecilia Hofvander, VP Investor Relations +46 (0)46 286 85 50 cecilia.hofvander@bioinvent.com. The report is also available at www.bioinvent.com. BioInvent International AB (publ) Co. reg. no. 556537-7263 Address: Ideongatan 1, 223 70 Lund Phone: +46 (0)46 286 85 50 FORWARD LOOKING INFORMATION This interim report contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of 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 interim report. TRADEMARKS n-CoDeR® and F.I.R.S.T™ are trademarks be- longing to BioInvent International AB. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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24 BioInvent International AB (publ) Interim Report January 1 - September 30, 2026 Interview with Andres McAllister Q&A with CMO Andres McAllister on BI-1808 ESMO data The response rate came in at 24 percent, three times the 8 percent for pembrolizumab alone. What does a difference like that mean clinically? “Platinum-resistant ovarian cancer is a set- ting where patients have few options and where checkpoint inhibitors alone have mostly disappointed. At 8 percent, roughly one patient in twelve responds. At 24 per- cent it’s closer to one in four. For a patient, that is the difference between a drug that rarely shrinks the tumor and one that does so with some regularity. We also see this in a population that is heavily pretreated, so the bar is high.” “I’d add two cautions. This is a single-arm study compared against a historical benchmark, so we are careful about draw- ing hard conclusions. Response rate is also only one measure, and what matters in the end is duration of benefit. But a tripling of the response rate, achieved without che- motherapy and with very few treatment discontinuations due to side effects, is a signal worth taking seriously.” You have worked on this mechanism for years. With Part B now complete, what stands out most to you in the data? “What stands out is how well the clinical picture matches the biology we have been describing. TNFR2 is highly expressed on regulatory T cells in the tumor, and BI-1808 is designed to deplete them and to repro- gram myeloid cells, which should make a PD-1 inhibitor work better. When we see responses in a setting where PD-1 block- ade has historically done little, and we see the biomarker changes you would expect, such as a shift in the balance between CD8 T cells and Ttregs in tumor biopsies, that is a coherent story.” “The second thing is that the activity holds across both high-grade serous and clear cell subtypes, which are quite different diseases. And the safety profile has stayed clean across a large body of patients, which matters a great deal when you want to build on top of the combination.” One of the responders had already progressed on pembrolizumab in an earlier line. What does it tell you that the combination worked where the checkpoint inhibitor alone had not? “This is exactly the kind of case you hope to see if the mechanism is real. If a tumor has already shown it can escape PD-1 block- ade alone, and adding a Treg-depleting, myeloid-reprogramming antibody pro- duces a response, it suggests that BI-1808 is contributing something the checkpoint inhibitor was not providing, rather than simply riding along with it. It supports the idea that Treg-mediated suppression is one of the things holding these tumors back.” Why add chemotherapy in Part C after a chemotherapy-free Part B, and how did KEYNOTE-B96 shape that decision? “Part B was designed to answer a clean question: does BI-1808 add something to pembrolizumab on its own? It does appear to, and that was important to establish without the confounding effect of chemo- therapy.” “KEYNOTE-B96 changed the landscape, though. It showed that pembrolizumab with weekly paclitaxel is a meaningful step forward in platinum-resistant ovarian cancer, and it is becoming the reference regimen. So the relevant question for pa- tients and physicians is no longer only how we compare with pembrolizumab alone, but whether we can improve on the new standard. Chemotherapy can also help release tumor antigens and prime the immune system, which fits well with what BI-1808 does. Part C is therefore a random- ized comparison, with BI-1808 at two dose levels, against pembrolizumab plus weekly paclitaxel with or without bevacizumab, which is how the regimen is used in prac- tice.” “We think the chemotherapy-free combi- nation remains valuable for patients who cannot tolerate chemotherapy, and Part C addresses the larger group where the standard of care now sits.” Which upcoming readouts or decisions around BI-1808 do you see as the most important over the next 12 to 18 months? “First, the full Part B dataset, which we ex- pect before the end of this year. That will tell us whether the 24 percent holds as the numbers grow and give us more mature durability data, including by subtype.” “Second, the start of Part C, which we ex- pect to begin enrolling in the first quarter of 2027, with initial data in the second half of 2027. That is the most important readout, because it is randomized and it will also help us choose the dose.” – Third, the regulatory and partnering side. The FDA’s Fast Track designation for ovarian cancer gives us closer dialogue with the agency about what a registrational path could look like, and the data from Part C will shape those discussions. Alongside this, we continue to develop BI-1808 in T-cell lym- phoma, where it has orphan drug designa- tion, so there are several ways this program can move forward. The content of BioStock’s news and analyses is independent, but BioStock’s operations are to some extent financed by companies in the industry.