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BioInvent International

Earnings Release Feb 27, 2025

3011_10-k_2025-02-27_3d0538b5-4798-46d9-9e4f-ede0dbf7c605.pdf

Earnings Release

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Martin Welschof, CEO:

"2024 was a year with several exciting developments reported from across our broad portfolio of clinical programs. We now have two Phase 2 and four Phase 1 trials running in our six clinical programs leveraging the TNFR2 and FcyRIIB targets. Throughout the year, we pursued building our business by expanding our management team and signing important clinical collaboration and supply agreements with key partners."

FOURTH QUARTER JANUARY-DECEMBER
All figures in SEK million unless otherwise stated 2024 2023 2024 2023
Net sales 21.4 15.3 44.7 71.5
Profit/loss after tax -116.9 -97.2 -429.4 -330.3
Profit/loss after tax per share before and after dilution, SEK -1.78 -1.48 -6.53 -5.02
Cash flow from operating activities -98.3 -72.4 -380.5 -341.7
Liquid funds, current and long-term investments at the end of the period 867.2 1,283.0 867.2 1,283.0

BioInvent in numbers, December 31, 2024

6 projects in clinical development

10+ development agreements

114 employees (FTE)

SEK 867.2 m in liquid funds & investments

SEK 2,533 m in market cap

The information was submitted for publication, through the agency of the contact person set out on page 25, at 8:00 a.m. CET on February 27, 2025.

Swedish version prevails. 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.

Highlights 2024

EVENTS IN THE FOURTH QUARTER

  • First patient enrolled in Phase 1b/2a study of the company's second anti-FcyRIIB antibody, BI-1607, in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma
  • Expanded management team with appointment of Ashley Robinson as SVP of Strategy and Finance

EVENTS AFTER THE END OF THE PERIOD

  • (R) Positive initial efficacy data from Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of Non-Hodgkin's Lymphoma (NHL)
  • (R) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 as monotherapy for the treatment of solid tumors
  • BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency
  • Composition of matter patent for the BI-1808 antibody granted in Japan. It also covers the use of the antibody in the treatment of cancer.

EARLIER DURING 2024, IN BRIEF

  • (R) Additional positive efficacy data with single agent BI-1808 from the Phase 2a anti-TNFR2 program
  • (R) Phase 1 data for BI-1206 in combination with KEYTRUDA in patients with solid tumors presented at ASCO 2024
  • (R) Clinical efficacy and excellent safety for anti-TNFR2 agent BI-1808 presented at ASCO 2024
  • (R) Phase 1/2a data presented at EHA 2024 for BI-1206 with rituximab in NHL
  • (R) CASI Pharmaceuticals reported positive interim Phase 1 data for BI-1206 in the treatment of relapsed/refractory indolent NHL in China
  • ESMO presentations highlighting progress from the Phase 1 trial of BI-1910 monotherapy in solid tumors and Phase 1 trial of the oncoloytic virus BT-001 (anti-

CTLA-4) as a single agent and in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumors

  • Two clinical trial collaboration and supply agreements signed with MSD to evaluate BI-1607 in combination with KEYTRUDA and ipilimumab, and to evaluate BI-1910 in combination with KEYTRUDA
  • PAGE 2024 presentation showcased model-informed development of BI-1808
  • Clinical supply agreement signed with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate BioInvent's anti-FcyRIIB antibody, BI-1206, in combination with rituximab and Calquence® (acalabrutinib), in a Phase 1/2a study in NHL

ANTICIPATED 2025 MILESTONES

  • Additional Phase 2a monotherapy data of BI-1808 in solid tumors and T-cell lymphoma to be shared in mid-2025
  • Data from the ongoing Phase 2a trial of BI-1206 in combination with rituximab and Calquence (acalabrutinib) in NHL expected in mid-2025
  • Phase 1 data of BI-1206 as a subcutaneous formulation in combination with KEYTRUDA in solid tumors anticipated in mid-2025
  • First BI-1910 Phase 2a single agent data expected H2 2025
  • Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025
  • Data from Phase 2a dose-expansion study of BI-1808 in combination with KEYTRUDA in patients with advanced solid tumors and T-cell lymphoma anticipated in H2 2025
  • Initial data from the Phase 1b trial evaluating BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma expected in H2 2025

(R)= Regulatory event

Significant clinical progress across our broad portfolio

2024 was a year with several exciting developments reported from across our broad portfolio of clinical programs. We now have two Phase 2 and four Phase 1 trials running in our six clinical programs leveraging the TNFR2 and FcyRIIB targets. Throughout the year, we pursued building our business by expanding our management team, signing important clinical collaboration and supply agreements with key partners and strengthening our IP portfolio to protect our scientific innovation and our novel products. We look forward to another data rich period to come with multiple potential value inflection points in 2025.

TNFR2 PLATFORM

BI-1808 early data similar to best-selling immune checkpoint During the year we were very pleased to see the progress in our Phase 2a trial with BI-1808 as single agent, both in solid tumors and CTCL. BI-1808 is our lead program in our anti-TNFR2 platform, and we were pleased to be able to build on the solid tumor data presented at ASCO in June and reporting the additional efficacy data from the cohort with hematological malignancies, i.e. CTCL, in the second half of 2024. These data strengthen our belief in the importance of BI-1808 as a potential new treatment option for CTCL, opening the possibility for the company to achieve the major value inflexion points on its own.

The progress we've seen is particularly impressive given the heavily pre-treated CTCL patients, a group with significant unmet medical needs. Emerging data suggest that BI-1808 induces CD8+ tumor infiltration, which is associated with tumor regression, all while maintaining exceptional safety and tolerability profile. We are hopeful that single agent BI-1808 could become the treatment of choice in the front-line settings. Additional data are expected in mid-2025.

As a reminder, BI-1808 has demonstrated single-agent activity and induction of antitumor immunity in patients with various solid tumor malignancies including ovarian cancer (OC), non-small cell lung cancer (NSCLC), and gastrointestinal stromal tumors (GIST). Looking at early clinical data for KEYTRUDA ® (pembrolizumab), BI-1808 single agent response levels are very similar. In 2024, the global KEYTRUDA sales amounted to USD 29.5 billion1 . Furthermore, our hypothesis is that BI-1808 may also be a useful addition to other regimens and standard treatments of several cancer types.

BI-1910 progress both as single agent and in combination

Our second anti-TNFR2 program, BI-1910, continues to show encouraging progress. We recently announced the completion of Part A in the Phase 1 trial as single agent for the treatment of solid tumors and reached a biologically active dose level. Several cases of stable disease were observed with no notable adverse events even at the highest doses tested. This allowed us to move BI-1910 forward and we are pleased to have initiated Phase 1 Part B, which evaluates BI-1910 in combination with MSD's (a tradename of Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, KEYTRUDA. We look forward to reporting first Phase 2a single agent data and the first data from the combination study in second half of 2025.

FcyRIIB PLATFORM

BI-1206 + rituximab & Calquence® show promising early clinical responses

Moving onto our FcyRIIB platform, we were very pleased to report promising clinical responses from our Phase 2a triplet study combination with BI-1206, rituximab and Calquence® when we announced initial data in January 2025. BI-1206 is our lead candidate developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab and is currently being evaluated as a potential treatment in non-Hodgkin's lymphoma (NHL) and in solid tumors. This early data from the first two patients enrolled in the study showed one complete response (CR) and one partial response (PR). The treatment has been well-tolerated with no safety or tolerability concerns, and we anticipate additional data in mid-2025.

1 Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results - Merck.com

Martin Welschof, CEO

BI-1206 + pembrolizumab: subcutaneous administration well tolerated

Additionally, the Phase 1/2a study of BI-1206 in combination with MSD's KEYTRUDA in heavily pre-treated patients with solid tumors is progressing well. Subcutaneous administration of BI-1206 has been well tolerated with no significant injection reactions. Given the beneficial safety and tolerability profile, we've added an additional dose cohort with increased dose frequency to further characterize the dose relationship and enhance our chances of success in the subsequent Phase 2a part of the study. Importantly, the complete response observed in a patient with metastatic melanoma, previously reported at ASCO 2024, has passed the two-year milestone with the response maintained.

With BI-1206, we are generating compelling clinical data in both NHL and solid tumors highlighting the potential of targeting FcyRIIB to restore the activity of existing cancer treatments and offer potentially life-transforming therapies for patients. We look forward to additional data in 2025 and continue with a strong belief that BI-1206 could play an important role in future cancer treatment paradigms.

STRATEGIC COLLABORATIONS AND SUPPLY AGREEMENTS

During 2024 we also signed several important collaborations and supply agreements to support our clinical programs:

  • AstraZeneca: Clinical supply agreement to evaluate BI-1206, in combination with rituximab and Calquence® (acalabrutinib), in a Phase 1/2a study in non-Hodgkin's lymphoma (NHL)
  • MSD: Clinical collaboration and supply agreement to evaluate BI-1910 in combination with KEYTRUDA
  • MSD: Clinical trial collaboration and supply agreement to evaluate BI-1607 in combination with KEYTRUDA (pembrolizumab) and ipilimumab

WE CONTINUE OUR MISSION WITH GREAT PRIDE

I am incredibly proud of the progress made by the team in 2024, as we continue our mission to improve outcomes for patients with difficultto-treat cancers. The growing body of clinical evidence from our programs reinforces our confidence in the potential of our platforms to transform cancer care. We thank you for the continued trust, partnership, and support as we work to bring innovative therapies to patients in need.

Martin Welschof, CEO February 2025

EXPECTED KEY CLINICAL MILESTONES 2024-2025

Five drug candidates in six clinical studies

BioInvent is developing novel immuno-modulatory antibodies for cancer therapy. These innovative antibodies may significantly improve the efficacy of currently available checkpoint inhibitors and/or activate anti-cancer immunity in non-responding patients. Our clinical portfolio is currently focused on the immunological targets TNFR2, FcyRIIB, and CTLA-4.

TNFR2

BioInvent maximizes the chances of success and the patient populations we can treat, by choosing two drug candidates with different mechanisms of action against a novel target. Understanding the biology of the target is of the essence, and an area where the company excels.

BI-1808

BioInvent's anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate in clinical development for the treatment of solid tumors and for a type of blood cancer. BI-1808 has shown single agent activity and excellent tolerability in an ongoing Phase 2a study and signs of efficacy and favorable safety profile in combination with pembrolizumab in the ongoing Phase 1/2a study.

STATUS

Single agent efficacy in clinical Phase 1/2a study (NCT04752826) in solid tumors and CTCL

In September 2024, promising early signals were announced on the efficacy of BI-1808 as monotherapy for the treatment of CTCL (cutaneous T-cell lymphoma). Data showed three patients with partial response (PR) and one with stable disease (SD) out of four evaluable patients with CTCL in the monotherapy part of the Phase 2a study. All these patients had previously deteriorated after standard treatment. The three patients who responded had undergone nine, three and three previous lines of therapy respectively, and one of them had previously received anti-PD1 treatment.

These data support single agent data disclosed earlier in the year, showing one complete response (CR), one PR and nine patients with SD, presented at the American Society of Clinical Oncology conference (ASCO) in June 2024. The patient with PR continues to improve after more than 88 weeks (as of January 2025).

Early signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab) were also presented at ASCO. The Phase 2a combination arm of the study evaluating BI-1808 with pembrolizumab is ongoing.

In February 2025, the Japanese patent office decided to grant a patent that will provide composition of matter protection for the BI-1808 antibody and additional, similar antibodies. It also covers the use of these antibodies in the treatment of cancer and another type of disease. Corresponding patents have previously been granted in China and Russia. The patents will expire in 2039 or potentially later if patent term extensions are obtained.

STUDY DESIGN

During the first part of the Phase 1/2a study the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent (part A) and in combination with the anti-PD-1 therapy pembrolizumab (part B) are evaluated in patients with advanced solid tumors and T-cell lymphoma.

The efficacy of BI-1808 as single agent is currently explored in the Phase 2a part of the trial in a larger sample of patients. Expansion cohorts include ovarian cancer, all tumor types and T-cell lymphomas (including CTCL).

The dose escalation in Phase 1 Part B has been completed and the Phase 2a dose expansion study for the combination is ongoing. The expansion cohorts are planned to include ovarian cancer, all tumor types and T-cell lymphoma (including 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 combination of BI-1808 and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2a clinical trial in patients with advanced solid tumors. Under the agreement, MSD supplies KEYTRUDA which supports the evaluation of BI-1808 in combination with a very successful immuno-oncology drug on the market.

OUTLOOK

Additional data from Phase 2a study of single agent BI-1808 are expected by mid-2025. Data from the Phase 2a combination study with BI-1808 and pembrolizumab are expected to be presented in H2 2025.

BI-1910

BI-1910 offers a differentiated, agonistic approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody currently in a Phase 1/2a trial. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent's proprietary F.I.R.S.T™ technology platform.

STATUS

Clinical Phase 1/2a study (NCT06205706) ongoing Single agent dose escalation of BI-1910 in the ongoing Phase 1 study has successfully been completed without any notable adverse events. As reported in January 2025, 6 patients had stable disease out of the 12 evaluable patients. Early results indicate favorable pharmacokinetic data and a robust target engagement, with patients in the target dose range showing evidence of induction of T-cell proliferation.

In the Phase 1 Part B of the study, BI-1910 in combination with pembrolizumab, the first dose escalation cohort of patients treated at a biologically active dose has successfully been completed without any notable adverse events and dose escalation has progressed to the last dose level to be tested.

The Phase 1/2a study aims to establish the safety/tolerability profile, pharmacokinetics, pharmacodynamics and preliminary signs of efficacy of BI-1910 as single agent and in combination with pembrolizumab. Phase 2a will be performed in several tumor types including HCC (Hepatocellular carcinoma) patients in several expansion cohorts. Safety and efficacy of BI-1910 as single agent and in combination will be evaluated at two different dose levels for dose optimization.

The ongoing Phase 1 single agent study was presented as a trialin-progress poster at ESMO 2024 (European Society for Medical Oncology), entitled "A Phase 1/2a First-in-Human Phase 1 Study of BI-1910, a Monoclonal Antibody Agonistic to TNFR2, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors".

In November 2024, the US Patent and Trademark office (USPTO) issued a patent relevant to the anti-TNFR2 antibody BI-1910. The patent provides a composition-of-matter protection for BI-1910 and the use of the antibody for the treatment of cancer.

STUDY DESIGN

The first part of the BI-1910 Phase 1/2a study is a dose escalation Phase 1 study to evaluate the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent in patients with advanced solid tumors. In a subsequent part of the Phase 1 study, BI-1910 as single-agent (Part A) and in combination (Part B) with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) will be evaluated.

OUT-LICENSING AND PARTNERING

In April 2024, BioInvent announced a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate BI-1910 in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 1/2a clinical trial for the treatment of patients with solid tumors. Under the terms of the supply agreement, MSD will provide pembrolizumab to be used in combination with BI-1910 in the ongoing Phase 1/2a clinical trial.

OUTLOOK

First Phase 2a single agent data expected H2 2025. Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab is expected H2 2025.

BI-1206 in non-Hodgkin's lymphoma

FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab in the treatment of several forms of NHL. In February 2024, a clinical supply agreement was signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and Calquence® (acalabrutinib). The combination of drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity.

STATUS

Clinical Phase 1/2a study (NCT03571568) ongoing

In the ongoing Phase 1/2a study, BI-1206 in combination with rituximab and AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), is evaluated in patients with non-Hodgkin's lymphoma (NHL).

In January 2025, initial data showed that the triple combination treatment is well tolerated, with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR).

Up to 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil.

Positive data have previously been reported from the study with BI-1206 as subcutaneous (SC) formulation for the treatment of relapsed/ refractory (R/R) NHL. For BI-1206 as a subcutaneous formulation in combination with rituximab, a total of two CR, three PR and three SD out of nine evaluable patients have now been observed.

All patients in the ongoing study have received at least one previous line of rituximab-containing treatments. For the subgroup of patients with follicular lymphoma (FL), BI-1206 (IV and SC) dosing in combination with rituximab have so far yielded response rates of 55% ORR (overall response rate), 35% CRR (complete response rate) and 85% DCR (disease control rate). In the responding patients, the responses

have been long-lasting, some of them have lasted several years after the end of treatment. The results show how BI-1206 can restore the efficacy of rituximab in the treatment of advanced NHL.

The USPTO has recently issued a Notice of Allowance for a patent application covering the use of BI-1206 in combination with either rituximab or obinutuzumab in the treatment of relapsed NHL or CLL (Chronic lymphocytic leukemia).

STUDY DESIGN

The Phase 1/2a study (NCT03571568) is divided into two parts:

Phase 1: dose escalation with the aim of selecting the dose of BI-1206 to be further studied in Phase 2a; and

Phase 2a: signal seeking with a safety run-in, and a dose optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.

CLINICAL DEVELOPMENT IN CHINA

Since October 2020, BioInvent has a licensing agreement in place with CASI Pharmaceuticals 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 commercialization 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.

CASI is performing trials of BI-1206 in combination with rituximab in patients with NHL, to assess safety and tolerability, to further evaluate the pharmacokinetic profile, select the dose for Phase 2 and assess early signs of clinical efficacy as part of its development program for BI-1206 in China and associated markets.

In March 2024, CASI reported interim data from its ongoing Phase 1 dose-escalation study, reinforcing previously reported positive efficacy data from BioInvent. The presented results include one complete response (CR), one partial response (PR) out of 8 evaluable patients. A manageable safety profile was observed across all patients.

ODD FOR THE TREATMENT OF FL AND MCL

BI-1206 has been granted Orphan Drug Designation (ODD) by FDA for the treatment of follicular lymphoma (FL), the most common form of

slow-growing NHL as well as for the more difficult-to-treat form mantle cell lymphoma (MCL).

OUT-LICENSING AND PARTNERING

In February 2024, a clinical supply agreement was signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and Calquence (acalabrutinib). The ongoing trial of BI-1206 in combination with rituximab in NHL has been expanded to include acalabrutinib.

In January 2023, BioInvent was selected as partner of The Leukemia & Lymphoma Society's Therapy Acceleration Program® (LLS 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 LLS and also entails a strategic capital equity investment from LLS TAP of USD 3 million.

OUTLOOK

Further Phase 2a triplet data for BI-1206 in combination with rituximab and acalabrutinib are expected by mid-2025.

BI-1206 in solid tumors

The ongoing clinical program addresses the ability of BI-1206 to target an important mechanism of resistance to PD-1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. BI-1206 in combination with pembrolizumab has led to responses in melanoma patients who previously failed on anti-PD1 therapy.

STATUS

Clinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing

In January 2025, it was reported that the Phase 1/2a study of BI-1206 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress.

In May 2024, the company announced data from the Phase 1 part that showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients.

In an update in October 2024, the best clinical responses include one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) out of 28 evaluable patients, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained stable disease throughout the two-year study duration. The complete response in metastatic melanoma reported at ASCO 2024 has passed the two-year milestone, with the response maintained.

The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study.

STUDY DESIGN

The Phase 1/2a study is a multicenter, dose-finding, open-label study of BI-1206 in combination with pembrolizumab (KEYTRUDA®) in patients with advanced solid tumors. Patients in the study will previously have received treatment with PD-1/PD-L1 immune checkpoint inhibitors. It is conducted at several sites across the US and Europe and will assess potential signs of antitumoral activity, as well as exploring the expression of potential immunological markers that might be associated with and eventually predict clinical responses.

The overall objective of the Phase 1/2a study is to evaluate the safety and tolerability of BI-1206 in combination with pembrolizumab. The Phase 1 part is a dose escalation study with the aim to determine the recommended Phase 2 dose (RP2D) of BI-1206 in combination with pembrolizumab. The Phase 2a part will study the BI-1206/ pembrolizumab combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies.

OUT-LICENSING AND PARTNERING

In December 2019 BioInvent entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the combination of BioInvent's BI-1206 and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 1/2a clinical trial for patients with solid tumors. Under the agreement, MSD supplies KEYTRUDA.

OUTLOOK

Results from Phase 1 dose escalation part of subcutaneous (SC) BI-1206 and pembrolizumab are expected mid-2025.

BI-1607

BI-1607 is an FcγRIIB-blocking antibody that differs from BI-1206 in that it has been engineered for reduced Fcbinding to FcγRs. BI-1607 can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors.

STATUS

In December 2024, the first patient was enrolled in the Phase 1b/2a triple combination study evaluating the safety and anti-tumoral activity of BI-1607 in combination with YERVOY® (ipilimumab) and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma.

The study will incorporate four cohorts in which two different dose levels of BI-1607 will be tested along with two different dose levels of ipilimumab (anti-CTLA-4) in combination with a flat dose of pembrolizumab in patients with unresectable or metastatic melanoma previously treated with anti-PD-1/L1.

A first -in-human clinical Phase 1/ trial evaluating BI-1607 in combination with trastuzumab in HER2+ advanced or metastatic tumors has been concluded, demonstrating that BI-1607 is safe and well tolerated and achieves full receptor occupancy during the treatment interval at several dose levels. No serious adverse events related to BI-1607 were observed in combination with trastuzumab. The best clinical response reported was stable disease (SD) in seven patients, with disease control lasting up to nine cycles (27 weeks).

STUDY DESIGN

The study will incorporate four cohorts in which two dose levels of BI-1607 will be tested with two dose levels of the CTLA-4 antibody ipilimumab (3 mg/kg, approved for the treatment of melanoma, and also a lower dose 1 mg/kg), in combination with a 200 mg flat dose of pembrolizumab in patients with unresectable or metastatic melanoma previously treated with anti-PD-1/L1. Approximately 35 patients will be enrolled at 10 to 12 sites located in the UK, Germany and Spain.

OUT-LICENSING AND PARTNERING

In July 2024, a clinical trial and supply agreement with Merck was announced to support the expansion of the BI-1607 program with a new Phase 1b/2a triplet combination study in unresectable or metastatic melanoma. The study will evaluate the safety and antitumoral activity of BI-1607 in combination with ipilimumab (anti-CTLA-4), plus KEYTRUDA® (pembrolizumab).

OUTLOOK

The first data from the triplet Phase 1b/2a study are expected H2 2025.

BT-001

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. It is currently evaluated in a clinical Phase 1/2a study. BT-001 is a drug candidate being developed in collaboration with the French biotech company Transgene.

STATUS

Clinical phase 1/2a study (NCT04725331) ongoing In September 2024, at ESMO 2024, a poster was presented (Initial clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered as single agent and in combination with pembrolizumab in patients with advanced solid tumors) with data showing that BT-001 induced tumor reduction in patients who did not respond to prior anti-PD(L)-1 therapy, both as monotherapy and in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 treatment pembrolizumab.

Preliminary translational data indicate that BT-001 replicates in the tumor without being detectable in blood. BT-001 was shown as monotherapy, or in combination with pembrolizumab, to be well tolerated and showed first signs of efficacy with clinical response in 2/6 refractory patients, when given in combination with pembrolizumab. Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, a higher M1/M2 ratio, as well as PD(L)-1 expression in the tumor microenvironment.

STUDY DESIGN

The Phase 1/2a (NCT: 04725331) study is a multicenter, open label, dose escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment).

The Phase 1 is divided into two parts. In part A, patients with metastatic/advanced tumors received single agent, intra-tumoral administrations of BT-001. Part B is exploring intra-tumoral injections of BT-001 in combination with pembrolizumab.

Phase 2a will evaluate the combination regimen in several patient cohorts with selected tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

OUT-LICENSING AND PARTNERING

In June 2022, BioInvent and Transgene announced 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 combination with MSD's anti-PD-1 therapy KEYTRUDA® (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 antibody and the cytokine GM-CSF. The research and development costs as well as revenue and royalties are shared 50:50.

OUTLOOK

Finalizing the second cohort in Phase 1/2a Part B to define the strategy for further development.

Discovery and preclinical development

BioInvent's discovery and preclinical research is focused on developing novel immuno-modulatory antibodies for cancer therapy. Such antibodies may significantly improve efficacy of currently available checkpoint inhibitor therapies and/or activate anti-cancer immunity in currently non-responding patients and cancer types.

Traditionally, drug discovery work is carried out according to a hypothesis in which first a receptor is found that is believed to be suitable for antibody drugs. The search then begins for antibodies that bind to this receptor. However, by combining new techniques looking simultaneously for both antibodies and the receptors they bind to, it is possible to find many more functioning antibodies than previously.

What BioInvent does is find antibodies against large amounts of different receptors on the cell and look at these antibodies' function directly. The strategy is to test how the antibodies work without any prior assumptions; for example, whether it can kill a tumor cell. Once we have identified which antibodies work, various tests are carried out to determine which receptor they bind to. By doing this, we have found antibodies that bind to cancer cells but not to normal cells in healthy individuals.

The process of looking for antibodies and targets simultaneously, rather than first finding a target and then looking for a suitable antibody is central in BioInvent's F.I.R.S.T™ platform. It is this strategy, combined with new techniques, that enables many more antibodies to be found than before. This method is important for the development of future antibody drugs that can be used to treat many different diseases.

The Preclinical team at BioInvent is highly involved in all steps in a project – from idea to pulling out desired antibodies from our n-CoDeR library, functionally testing these in predictive cancer models, as well as in developing biomarkers for the clinic.

The flexibility of the team and the close communication between the Preclinical, Translational and Core Research Teams and Clinical Development ensures rapid adjustments to answer the most critical questions to advance our pipeline.

The strength of the company's technology platform with its development tool F.I.R.S.T™ and the n-CoDeR® antibody library is a strong driver in the discovery phase where the company currently is working on a number of promising candidates.

FUNCTION F.I.R.S.T DISCOVERY OF NEW ONCOLOGY TARGETS AND ANTIBODIES

Unique proprietary platform and deep immunology expertise yield both unique targets and high-quality antibodies.

Banor

Our approach contrasts with the more commonly used target-focused approach, where a target is picked on beforehand and consequently, functionality is restricted to this specified target. BioInvent applies a function-first approach, meaning it discovers the most functional

antibodies to unknown targets, which can then be identified in a subsequent step. As such, BioInvent's approach discovers highly efficacious antibodies to targets that have not previously been pursued in cancer immunotherapy, as well as uniquely functional antibodies

to validated targets. This is exemplified in, e.g., the company's BI-1808 first-in-class anti-TNFR2 antibody and the strongly Treg-depleting anti-CTLA-4 antibody that has been vectorized in the BT-001 program.

Strategic collaborations

BioInvent collaborates with a number of important players within the pharmaceutical industry and within academia. The collaborations with other pharmaceutical companies focus on commercial partnerships for BioInvent's clinical assets. The further the clinical programs have advanced, the greater is the chance of establishing partnerships 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 BioInvent for further development.

FIVE OUTLICENSED PROJECTS IN CLINICAL STUDIES

Program Target Primary indication Phase 1 Phase 2 Phase 3 Market Licensee
MT-2990 anti-IL33 Endometriosis Mitsubishi Tanabe
Mezagitamab (TAK-079) anti-CD38 ITP* Takeda
Orticumab anti-ApoB100 Cardiovascular Abcentra
DS-1055 anti-GARP Solid tumor Daiichi-Sankyo
HMI-115 anti-PRLR Alopecia Hope Medicine/Bayer

funding initiative to accelerate innovative blood cancer therapeutics worldwide.

FIVE CLINICAL PROJECTS OUTLICENSED

BioInvent currently has five clinical projects outlicensed to other companies. In the short term BioInvent may receive minor clinical milestone payments, but the upside 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.

*ITP=Primary Immune Thrombocytopenia

COLLABORATIONS WITH LEADING PHARMACEUTICAL COMPANIES

For its clinical programs, BioInvent has different kinds of collaborations with leading pharmaceutical companies such as CASI, MSD, AstraZeneca, and Transgene, see pages 6 to 10 for details.

BioInvent has five supply and collaboration agreements with MSD to support the expansion of the clinical trial programs for the anti-FcγRIIB antibodies BI-1206 and BI-1607, the anti-TNFR2 antibodies BI-1808 and BI-1910, and 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 combination 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 agreements, these agreements provide further validation of the high quality of the programs.

STRATEGIC CLINICAL COLLABORATIONS

Since 2023, BioInvent is a selected partner of The Leukemia & Lymphoma Society's Therapy Acceleration Program® (LLS TAP). The company has received a strategic equity investment of USD 3 million to support clinical advancement of BI-1206 in non-Hodgkin's Lymphoma and BI-1808 in cutaneous T-cell lymphoma. LLS TAP is a strategic

Financial information

REVENUES AND RESULT

Figures in parentheses refer to the outcome for the corresponding period in the preceding year.

Fourth quarter

Net sales amounted to SEK 21.4 million (15.3). Revenues for the period were mainly derived from production of antibodies for clinical studies.

Revenues for the corresponding period 2023 were mainly derived from production of antibodies for clinical studies and revenues from research services. See also note 2.

The Company's total costs amounted to SEK 147.0 million (126.7). These are divided between external costs of SEK 101.7 million (82.7), personnel costs of SEK 40.4 million (39.4) and depreciation of SEK 4.9 million (4.6).

Research and development costs amounted to SEK 129.3 million (111.6). Sales and administrative costs amounted to SEK 17.7 million (15.1).

Profit/loss after tax amounted to SEK -116.9 million (-97.2). The net financial items amounted to SEK 9.0 million (14.0). Profit/loss per share before and after dilution amounted to SEK -1.78 (-1.48).

January – December

Net sales amounted to SEK 44.7 million (71.5). Revenues for the period were mainly derived from production of antibodies for clinical trials, and revenues from research services.

Revenues for the corresponding period 2023 were mainly derived from a USD 1 million (SEK 11.1 million) milestone payment from Exelixis, when a research milestone had been achieved in the development of an antibody, as well as revenues from production of antibodies for clinical studies and revenues from research services. See also note 2.

The Company's total costs amounted to SEK 516.0 million (442.0). These are divided between external costs of SEK 356.8 million (299.7), personnel costs of SEK 139.9 million (125.5) and depreciation of SEK 19.3 million (16.8).

Research and development costs amounted to SEK 457.7 million (390.4). Sales and administrative costs amounted to SEK 58.3 million (51.6).

Profit/loss after tax amounted to SEK -429.4 million (-330.3). The net financial items amounted to SEK 41.8 million (39.8). Profit/loss per share before and after dilution amounted to SEK -6.53 (-5.02).

FINANCIAL POSITION AND CASH FLOW

The share capital consists of 65,804,362 shares as of December 31, 2024.

As of December 31, 2024, the Group's liquid funds, current and long-term investments amounted to SEK 867.2 million (1,283.0). The cash flow from operating activities for the January-December period amounted to SEK -380.5 million (-341.7).

The shareholders' equity amounted to SEK 885.8 million (1,309.7) at the end of the period. The Company's share capital was SEK 13.2 million. The equity/assets ratio at the end of the period was 90 (94) percent. Shareholders' equity per share amounted to SEK 13.46 (19.90).

INVESTMENTS

Investments for the January-December period in tangible fixed assets amounted to SEK 10.0 million (13.3).

PARENT COMPANY

All operations of the Group are conducted by the Parent Company. Except for financial leases, the Group's and the Parent Company's financial statements coincide in every material way.

ORGANIZATION

As of December 31, 2024, BioInvent had 114 (111) employees (full time equivalent). 100 (99) of these work in research and development.

DISCLOSURE OF RELATED PARTY TRANSACTIONS

For description of benefits to senior executives, see page 59 in the Company's annual report 2023. Otherwise, there are no transactions with related parties, in accordance with IAS 24, to report.

RISK FACTORS

The Company's operations are associated with risks related to factors such as pharmaceutical 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 investment in the BioInvent share.

For a more detailed description of risk factors, see section "Risks and Risk Management", page 42, in the Company's annual report 2023.

Consolidated statement of comprehensive income in brief for the Group (SEK thousand)

3 MONTHS 3 MONTHS 12 MONTHS 12 MONTHS
2024 2023 2024 2023
OCT.-DEC. OCT.-DEC. JAN.-DEC. JAN.-DEC.
Net sales 21,369 15,319 44,686 71,461
Operating costs
Research and development costs -129,291 -111,597 -457,733 -390,434
Sales and administrative costs -17,700 -15,136 -58,302 -51,606
Other operating income and costs -251 486 290 637
-147,242 -126,247 -515,745 -441,403
Operating profit/loss -125,873 -110,928 -471,059 -369,942
Profit/loss from financial investments 9,041 13,973 41,819 39,842
Profit/loss before tax -116,832 -96,955 -429,240 -330,100
Tax -48 -204 -135 -204
Profit/loss -116,880 -97,159 -429,375 -330,304
Other comprehensive income
Items that have been or may be reclassified subsequently to profit or loss - - - -
Comprehensive income -116,880 -97,159 -429,375 -330,304
Other comprehensive income attributable to parent Company's shareholders -116,880 -97,159 -429,375 -330,304
Profit/loss per share, SEK
Before dilution -1.78 -1.48 -6.53 -5.02
After dilution -1.78 -1.48 -6.53 -5.02

Consolidated statement of financial position in brief for the Group (SEK thousand)

2024 2023
DEC. 31 DEC. 31
ASSETS
Intangible fixed assets 0 0
Tangible fixed assets - leases 17,720 23,153
Tangible fixed assets - other 28,302 29,510
Financial fixed assets - long-term investments - 214,252
Total fixed assets 46,022 266,915
Inventories 10,967 11,844
Current receivables 65,088 52,722
Current investments 432,333 809,151
Liquid funds 434,826 259,548
Total current assets 943,214 1,133,265
Total assets 989,236 1,400,180
SHAREHOLDERS' EQUITY
Total shareholders' equity 885,815 1,309,727
LIABILITIES
Lease liabilities 8,215 14,535
Total long term liabilities 8,215 14,535
Lease liabilities 9,198 8,709
Other liabilities 86,008 67,209
Total short term liabilities 95,206 75,918
Total shareholders' equity and liabilities 989,236 1,400,180

Statement of changes in equity for the Group (SEK thousand)

2024 2023 2024 2023
OCT.-DEC. OCT.-DEC. JAN.-DEC. JAN.-DEC.
Shareholders' equity at beginning of period 1,003,093 1,406,269 1,309,727 1,606,122
Comprehensive income
Profit/loss -116,880 -97,159 -429,375 -330,304
Comprehensive other income - - - -
Total comprehensive income -116,880 -97,159 -429,375 -330,304
Total, excluding transactions with equity holders of the Company 886,213 1,309,110 880,352 1,275,818
Transactions with equity holders of the Company
Employee options program -398 617 5,463 2,950
Directed share issue 30,959
Shareholders' equity at end of period 885,815 1,309,727 885,815 1,309,727

The share capital as of December 31, 2024 consists of 65,804,362 shares and the share's ratio value was 0.20. The directed new share issue carried out in January 2023 raised SEK 31.3 million before issue expenses and SEK 31.0 million after issue expenses.

Consolidated statement of cash flows in brief for the Group (SEK thousand)

2024 2023 2024 2023
OCT.-DEC. OCT.-DEC. JAN.-DEC. JAN.-DEC.
Operating activities
Operating profit/loss -125,873 -110,928 -471,059 -369,942
Depreciation 4,876 4,560 19,300 16,755
Adjustment for other non-cash items -398 617 5,463 2,950
Interest received and paid 19,482 11,099 58,369 18,781
Income taxes paid - -90 -114 -90
Cash flow from operating activities before changes in working capital -101,913 -94,742 -388,041 -331,546
Changes in working capital 3,603 22,351 7,572 -10,145
Cash flow from operating activities -98,310 -72,391 -380,469 -341,691
Investment activities
Acquisition of tangible fixed assets -849 -2,754 -10,034 -13,304
Changes of financial investments -170,455 -250,891 574,380 72,985
Cash flow from investment activities -171,304 -253,645 564,346 59,681
Cash flow from operating activities and investment activities -269,614 -326,036 183,877 -282,010
Financing activities
Directed share issue 30,959
Amortization of lease liability -2,235 -2,056 -8,455 -7,820
Cash flow from financing activities -2,235 -2,056 -8,455 23,139
Change in liquid funds -271,849 -328,092 175,422 -258,871
Opening liquid funds 717,362 589,795 259,548 515,047
Accrued interest on investments classified as liquid funds -10,687 -2,155 -144 3,372
Liquid funds at end of period 434,826 259,548 434,826 259,548
Liquid funds, specification:
Cash and bank 75,564 48,237 75,564 48,237
Current investments, equivalent to liquid funds 359,262 211,311 359,262 211,311
434,826 259,548 434,826 259,548

Key financial ratios for the Group

2024 2023
DEC. 31 DEC. 31
Shareholders' equity per share at end of period, SEK 13.46 19.90
Number of shares at end of period (thousand) 65,804 65,804
Equity/assets ratio, % 89.5 93.5
Number of employees at end of period 114 111

Consolidated income statement in brief for the Parent Company (SEK thousand)

3 MONTHS 3 MONTHS 12 MONTHS 12 MONTHS
2024 2023 2024 2023
OCT.-DEC. OCT.-DEC. JAN.-DEC. JAN.-DEC.
Net sales 21,369 15,319 44,686 71,461
Operating costs
Research and development costs -129,474 -111,574 -458,125 -390,857
Sales and administrative costs -17,716 -15,134 -58,336 -51,643
Other operating income and costs -251 486 290 637
-147,441 -126,222 -516,171 -441,863
Operating profit/loss -126,072 -110,903 -471,485 -370,402
Profit/loss from financial investments 9,154 14,131 42,352 40,476
Profit/loss after financial items -116,918 -96,772 -429,133 -329,926
Tax -48 -204 -135 -204
Profit/loss -116,966 -96,976 -429,268 -330,130
Other comprehensive income - - - -
Comprehensive income -116,966 -96,976 -429,268 -330,130

Consolidated balance sheet in brief for the Parent Company (SEK thousand)

2024 2023
DEC. 31 DEC. 31
ASSETS
Intangible fixed assets 0 0
Tangible fixed assets 28,302 29,510
Financial fixed assets - Shares in subsidiaries 687 687
Financial fixed assets - long-term investments - 214,252
Total fixed assets 28,989 244,449
Current assets
Inventories 10,967 11,844
Current receivables 66,470 53,600
Current investments 432,333 809,151
Cash and bank 434,826 259,548
Total current assets 944,596 1,134,143
Total assets 973,585 1,378,592
SHAREHOLDERS' EQUITY
Restricted equity 40,854 40,854
Non-restricted equity 846,075 1,269,880
Total shareholders' equity 886,929 1,310,734
LIABILITIES
Short term liabilities 86,656 67,858
Total short term liabilities 86,656 67,858
Total shareholders' equity and liabilities 973,585 1,378,592

Declaration by the Board

The board of directors and the CEO hereby ensure that this interim report for the period January 1, 2024 – December 31, 2024 provides a fair overview of the operations, financial position and performance of the Company and the Group and describes the material risks and uncertainty factors faced by the Company and the companies included in the Group.

This report has not been reviewed by the company's auditors.

Lund, February 27, 2025

Leonard Kruimer Natalie Berner Elin Birgersson Kristoffer Bissessar
Chairman of the Board Board member Board member Board member
Thomas Hecht Laura Lassouw-Polman Nanna Lüneborg Vincent Ossipow
Board member Board member Board member Board member
Martin Pålsson Bernd Seizinger Martin Welschof
Board member Board member CEO

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 interim 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 2024 has had no material impact on the financial statements. Except for financial leases, the Group's and the Parent Company's financial statements coincide in every material way.

The definition of alternative performance measures not defined by IFRS is unchanged from those presented in the most recent annual report.

NOTE 3 EVENTS AFTER THE REPORTING PERIOD

  • (R) Positive initial efficacy data from Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of Non-Hodgkin's Lymphoma (NHL)
  • (R) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 as monotherapy for the treatment of solid tumors
  • BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency
  • Composition of matter patent for the BI-1808 antibody granted in Japan. It also covers the use of the antibody in the treatment of cancer.

NOTE 2 NET REVENUE

2024 2023 2024 2023
SEK THOUSAND OCT.-DEC. OCT.-DEC. JAN.-DEC. JAN.-DEC.
Revenue by geographical region:
Sweden 498 5,132 3,887 18,263
Europe 511 1,350 2,926 2,951
USA 19,978 8,702 36,822 47,393
Other countries 382 135 1,051 2,854
21,369 15,319 44,686 71,461
Revenue consists of:
Revenue from collaboration agreements associated with outlicensing of proprietary
projects - 6,995 572 44,303
Revenue from technology licenses - - - -
Revenue from external development projects 21,369 8,324 44,114 27,158
21,369 15,319 44,686 71,461

The net revenue of the Group and the Parent Company coincide.

(R)= Regulatory event

Other information

ANNUAL GENERAL MEETING

The Annual General Meeting will be held on April 29, 2025, at 4 p.m. Elite Hotel Ideon, Scheelevägen 27, Lund. Notice to attend will be announced in Post- och Inrikes Tidningar and on the Company website.

FINANCIAL CALENDAR

  • Interim report Q1: April 29, 2025
  • Interim report Q2: August 26, 2025
  • Interim report Q3: October 29, 2025

CONTACT

Any questions regarding this report will be answered by Cecilia Hofvander, VP Investor Relations, +46 (0)46 286 85 50, [email protected].

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 out-come may deviate significantly from the scenarios described in this interim report.

TRADEMARKS

n-CoDeR® and F.I.R.S.T™ are trademarks belonging to BioInvent International AB.

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