Quarterly Report • Aug 29, 2024
Quarterly Report
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"The presentation of promising results from our two lead drug candidates at the ASCO Annual Meeting showcased their potential as first-in-class immunomodulatory agents and kicked off a data-rich period for BioInvent where we expect to report results from all six of our clinical programs."
| SECOND QUARTER | JANUARY-JUNE | |||
|---|---|---|---|---|
| All figures in SEK million unless otherwise stated | 2024 | 2023 | 2024 | 2023 |
| Net sales | 4.6 | 13.1 | 10.6 | 29.3 |
| Profit/loss after tax | -137.3 | -88.3 | -215.3 | -162.1 |
| Profit/loss after tax per share before and after dilution, SEK | -2.09 | -1.34 | -3.27 | -2.47 |
| Cash flow from operating activities | -119.2 | -84.1 | -185.1 | -163.1 |
| Liquid funds, current and long-term investments at the end of the period | 1,090.3 | 1,461.7 | 1,090.3 | 1,461.7 |
6 projects in clinical development
10+ development agreements
SEK 1,090 m in liquid funds & investments
The information was submitted for publication, through the agency of the contact person set out on page 26, at 8:00 a.m. CEST on August 29, 2024. Note to reader: figures in parentheses refer to the outcome for the corresponding period in the preceding year.
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.
(R)= Regulatory event
The presentation of promising results from our two lead drug candidates at the ASCO Annual Meeting showcased their potential as first-in-class immunomodulatory agents and kicked off a data-rich period for BioInvent where we expect to report results from all six of our clinical programs.
In June, we presented initial efficacy and safety data from the ongoing Phase 1/2a study evaluating BI-1808 as both a single agent and in combination pembrolizumab in patients with solid tumors at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The data demonstrated strong signs of antitumoral activity, especially in heavily pre-treated patients, along with a robust safety profile. These results strengthen our belief that BI-1808 could represent a new class of immunomodulatory agent with the potential to improve the efficacy of cancer therapy, which is highly encouraging.
Our second presentation at ASCO featured positive Phase 1 data for BI-1206 in combination with KEYTUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors, which demonstrated clinical efficacy signals and was well tolerated. The data showed promising and durable responses in patients who previously failed on anti-PD-1/ L1 therapy, an encouraging result which suggests blocking FcyRIIB enhances the activity of immune checkpoint inhibitors.
Also in June, we presented promising Phase 1/2a data for BI-1026 in combination with rituximab in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) in a poster at the European Hematology Association Congress (EHA) held in Madrid, Spain. Promising early efficacy data from the subcutaneous dosing was presented, with 1 complete response (CR), 2 partial response (PR), 1 stable disease (SD) out of 4

evaluable patients. The overall (IV+SC) response rates presented in the data suggest BI-1206 has the potential to overcome resistance to rituximab, an essential part of NHL treatment. Importantly, based on the strong combination data we have seen to date, and a belief that a triplet combination could further increase response rates, we will soon initiate a Phase 2a study arm with the subcutaneous formulation where the BTK inhibitor acalabrutinib (Calquence®) will be added to the BI-1206 and rituximab combination. Study sites across a number of countries will soon be ready to enrol patients in this arm and we expect to have the first data from this triplet combination by the end of 2024.
Following on from the data presentations at ASCO and EHA, we hosted a Key Opinion Leader event featuring Alexander Eggermont, MD, PhD, from the University Medical Center Utrecht, an internationally recognized expert in surgical oncology, immunotherapy, melanoma, sarcoma and cancer drug development. Dr. Eggermont joined me and representatives from the BioInvent management team to discuss the ASCO and EHA data and the role BI-1808 and BI-1206 could play as potential solutions treating both solid tumors and blood cancer. The event was well attended and included an in-depth look at the promise
of FcyRIIB and TNFR2 as important targets in immunotherapy, as well as an overview of BioInvent's broader development strategy.
In a presentation at the Population Approach Group Europe (PAGE) conference 2024 held in Rome, Italy at the end of June, we demonstrated our ability to leverage a model-informed approach to support dose selection and optimization in the clinical development of BI-1808. The data presented confirmed the wide potential dose range of BI-1808 and will be beneficial in the selection of doses as the Phase 1/2a study progresses.
Finally, this quarter, we were granted a patent covering BI-1808's composition of matter in China and the use of the antibody for the treatment of cancer. Ensuring that our intellectual property has robust protection is an essential part of our drug development program and our overall business strategy.
In July 2024, we announced a new clinical trial collaboration and supply agreement with MSD to evaluate our second FcγRIIB-blocking antibody BI-1607 in combination with KEYTRUDA (pembrolizumab) and ipilimumab. While anti-PD-1 therapy and/or anti-CTLA-4 therapy is the standard of care in metastatic melanoma, many patients cannot tolerate the treatment due to ipilimumab's toxicity. Our preclinical studies indicate that a triple combination regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy. We look forward to broadening the clinical evaluation of this promising antibody in a combination that has the potential to make a major impact on cancer care.
The second quarter was very busy and highly productive, and we will continue this momentum into the second half of the year.We look forward to several more data releases from clinical programs in our unique immunotherapy pipeline, including the first Phase 2 data for BI-1808 and BI-1206 expected by the end of this year. As always, I would like to thank our patients, employees and investors for your support and belief in our mission and I look forward to updating you further in our next report.
Martin Welschof, CEO August 2024

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.

| Program | Study arm | Discovery | Preclinical | Phase 1 | Phase 2 | Partner |
|---|---|---|---|---|---|---|
| BT-001 in solid tumors | + pembrolizumab1) | 4) | ||||
| 1) Supply agreement with MSD 2) Supply agreement with AZ 3) Licensed to CASI for China, Hong Kong, Macau and Taiwan 4) 50/50 co-development collaboration with Transgene |
Completed | Ongoing | Upcoming |
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.
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 blood cancer under the Leukemia & Lymphoma Society's Therapy Acceleration Program® (LLS TAP). LLS TAP is aimed at supporting and accelerating the advancement of the most promising and innovative blood cancer therapies worldwide. BI-1808 has shown single agent activity and excellent tolerability in an ongoing Phase 2 study and promising signs of efficacy and safety in combination with pembrolizumab in Phase 1.
Single agent efficacy in clinical Phase 1/2a study (NCT04752826) In May 2023, further promising early signs of BI-1808 single agent efficacy and a robust safety profile were announced. The data was presented in a poster at the 2024 ASCO Annual Meeting (ASCO 2024) in the US. Data showed one complete response (CR), one partial response (PR) and nine patients with stable disease (SD) out of 26 evaluable patients.
The CR was observed in the ongoing Phase 2a part of the study, in an ovarian cancer patient with disease progression after three previous lines of treatments. As previously reported, the PR was observed in a heavily pre-treated patient with metastatic GIST (12 prior lines of treatment). This PR represents a robust response and is still ongoing.
Promising signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab) was also presented at ASCO.
In June 2024, a poster was presented at PAGE (Population Approach Group) annual meeting, describing a model-informed approach to early clinical development, supporting dose selection and optimization. The data confirm a wide potential dose-range of BI-1808 in the continued clinical evaluation.
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 and in combination with the anti-PD-1 therapy pembrolizumab 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, melanoma, all tumor types (including GIST) and T cell lymphomas (including CTCL).
Dose-escalation in the combination Phase 1 part of the study is near completion.
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 the most successful immuno-oncology drug in the market.
Additional data from Phase 2a study of single agent BI-1808 are expected by year-end 2024. The Phase 2a combination part of the trial is expected to start H2 2024.

BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-inclass 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.
The ongoing Phase 1/2a clinical trial, conducted in the US and Europe, is using an innovative, adaptive design for dose escalation. The first phase of the trial will enroll all solid cancer entities as single agent, followed by a dose escalation phase with BI-1910 in combination with pembrolizumab (KEYTRUDA). Subsequently, exploratory expansion cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). The first patient was enrolled in December 2023.
During the first part of Phase 1/2a study the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent are evaluated in patients with advanced solid tumors. In the subsequent part of the Phase 1/2a study, BI-1910 as single-agent (Part A) and in combination (Part B) with the anti-PD-1 therapy pembrolizumab will be evaluated. The study is expected to enroll a total of approximately 180 patients.
In July, 2024, the US Patent and Trademark office (USPTO) issued a Notice of Allowance for a patent application relevant to the anti-TNFR2 antibody BI-1910. The patent, once granted, provides a compositionof-matter protection for BI-1910 and the use of the antibody for the treatment of cancer.
The presentation at SITC in November 2023, entitled "Preclinical development of an agonistic anti-TNFR2 antibody (BI-1910) for cancer immunotherapy," demonstrated that BI-1910 has broad anti-tumor activity, activating T cells and natural killer (NK) cells and showing antitumor activity independent of Fc gamma receptor (FcyR) expression.
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.
Progress in the Phase 1 part of the trial studying BI-1910 as single agent in solid tumors will be presented at ESMO in Barcelona on September 14, 2024. First clinical data is expected H2 2024.

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 and acalabrutinib 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 ongoing rituximab combination trial in NHL will be expanded to include the triplet arm. The combination of drugs could provide a new and important option for patients suffering from NHL and represents a substantial commercial opportunity.
In May 2024, promising clinical data for BI-1206 in relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL), dosed in combination with rituximab, were announced. First data for the subcutaneous (SC) arm was presented and the results include one complete response (CR), two partial responses (PR) and one stable disease (SD) out of four evaluable patients. Based on the strong data at hand, the subcutaneous formulation has been selected for the upcoming triplet study arm in which BI-1206 will be given in combination with the BTK inhibitor acalabrutinib (Calquence®) and rituximab.
Further updates were given from the intravenous (IV) arm where a fifth CR has been observed, adding to a total of five CR, one PR and six SD out of 17 evaluable patients in the IV arm. Data was presented at the European Hematology Association (EHA) annual meeting, June 13-16, 2024.
All patients in BioInvent's ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. IV dosing so far has produced response rates of a 35% ORR (overall response rate), 29% CRR (cumulative response rate) and 71% DCR (disease control rate), and promising early efficacy data from the SC dosing. In addition, an ORR of 56% in the subset of patients with follicular lymphoma (FL)
was reported. Among the CR population, responses have been long-lasting, several of them lasting years after end of treatment. The presented data are highly encouraging and show the benefit of BI-1206 in rescuing rituximab treatment in advanced NHL.
The Phase 1/2a study (NCT03571568) is divided into two parts, each with a subcutaneous (SC) and intravenous infusion (IV) arm:
1) Phase 1, with dose escalation cohorts using a 3+3 (IV) or Bayesian logistic regression model, BLRM (SC) dose-escalation design and selection of the dose to be studied further in the expansion phase; and
2) Phase 2a, an expansion cohort at the dose selected from Phase 1. Patients in each phase receive 1 cycle of induction therapy with 3 doses of BI-1206 in combination with 4 doses of rituximab.
Those who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.
CASI is performing the trials with the aim to further evaluate the pharmacokinetic profile of BI-1206 in combination with rituximab in NHL, to assess safety and tolerability, 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. The CR (in Marginal Zone Lymphoma (MZL) has been long-lasting, 20+ weeks. A manageable safety profile was observed across all patients.
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 Non-Hodgkin's lymphoma, as well as for the more difficult-to-treat form mantle cell lymphoma (MCL).
In February 2024, a clinical supply agreement was signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and Calquence (acalabrutinib). The ongoing rituximab combination trial in NHL will be expanded to include the triplet arm.
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 eligible to receive up to USD 83 million in milestone payments, plus tiered royalties.
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 entailed a strategic capital equity investment from LLS TAP of USD 3 million.
First Phase 2a triplet data for BI-1206 in combination with rituximab and acalabrutinib are expected by year-end 2024.
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.
In May 2024, the company announced promising Phase 1 data for 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. The data 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. The results included one complete response (CR), one partial response (PR) and seven patients with stable disease (SD) whereof one long-lasting, out of 24 evaluable patients.
BI-1206 is being evaluated as both an intravenous (IV) and subcutaneous (SC) administration and has the potential to overcome resistance to immune checkpoint inhibition (CPI).
The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. In September 2023, the first patient was recruited to a subcutaneous (SC) arm of the Phase 1/2a study.
As reported on June 7, 2023, the Phase 1, IV arm of the study has already generated early signs of efficacy, e.g., two long-lasting partial responses and two patients displaying stable disease, out of a total of 18 evaluable patients having received BI-1206 in combination with pembrolizumab. Both responding patients have melanoma, and both had previously been treated with immune checkpoint inhibitors.
These long-lasting responses in hard-to-treat metastatic diseases, in patients who had previously progressed after treatment with anti-PD1/PDL1 agents, strongly suggest that BI-1206 is enhancing and recovering the activity of pembrolizumab (an anti-PD1 agent).
The Phase 1/2a 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, 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.
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 which supports the evaluation of BI-1206 for the treatment of solid tumors in combination with one of the most successful immuno-oncology drugs.
Next milestone is to determine the recommended SC dose for the subsequent Phase 2a dose expansion part of the study. The Phase 2a part will include three expansion cohorts at the RP2D, each comprising a specific subset of subjects with advanced solid tumors (e.g., NSCLC, melanoma, and other tumors responsive to PD-1/PD-L1 inhibition).

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.
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 2 triplet combination study in metastatic melanoma. The study will evaluate BI-1607 with a low-dose anti-CTLA-4, ipilimumab, plus KEYTRUDA®(pembrolizumab). Preclinical studies indicate that a triple combination regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy.
A clinical Phase 1/2a study evaluating BI-1607 in combination with trastuzumab 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.
The Phase 1 data, presented in December 2023 in a poster with the title "Phase 1/2a Open-label Clinical Trial of BI-1607, an Fc Engineered Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors – CONTRAST" at the San Antonio Breast Cancer Symposium, covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. Treatment was well tolerated, and no serious adverse events related to BI-1607 were observed. The best clinical response reported was stable disease (SD) in 6/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks).
The concluded first-in-human Phase 1 trial was a dose escalation study of BI-1607 in combination with trastuzumab in HER2+ advanced or metastatic tumors. Pharmacokinetic and pharmacodynamic data allowed identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved and showed a good tolerability of BI-1607 in combination with trastuzumab.
The planned Phase 1b/2a triplet study will incorporate four cohorts; two different dose levels of BI-1607 will be tested with two different dose levels of ipilimumab in combination with 200 mg flat dose of pembrolizumab in patients with unresectable or metastatic melanoma, previously treated with anti-PD-1/L1.
Preparations ongoing to initiate patient recruitment for the triplet Phase 1b/2a study.

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.
Clinical phase 1/2a study (NCT04725331) ongoing Data generated in Phase 1 part A, demonstrated that BT-001 as single agent is well tolerated with first signs of anti-tumor activity in a hardto-treat population and confirmed the mechanism of action of BT-001.
The ongoing Phase 1 part B clinical trial is evaluating the combination of BT-001 and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). Part B of the trial explores repeated intratumoral injections of BT-001 in combination with intravenous infusions of KEYTRUDA. At least 12 patients with metastatic or advanced solid tumors, including melanoma, are planned to be enrolled. In accordance with our clinical trial and supply agreement, KEYTRUDA is being supplied by MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA). Trial endpoints include safety, evaluation of efficacy, and assessment of immune changes in the tumor microenvironment.
In May 2023, the company announced positive data from the ongoing Phase 1/2a study. Treatment with single agent BT-001 (Part A) in 18 patients has been completed with no safety concerns reported. Patients had at least one accessible superficial lesion and were studied in three dose-escalating cohorts. BT-001 stabilized the injected lesions in eleven patients in total: two at the 10^6 pfu dose (n=6), five at 10^7 pfu (n=6) and four at 10^8 pfu (n=6). Furthermore, objective antitumor activity, defined as decrease of injected lesion size of 50% or more, was observed in one patient in the 10^6 pfu cohort (n=6) and one patient in the 10^7 pfu cohort (n=6).
The ongoing 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). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.
This 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.
The 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.
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.
First results from Part B of the Phase 1 study, evaluating the combination of BT-001 and pembrolizumab will be presented at ESMO in September 2024.

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 is enabling 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 assures 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.
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.
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.
| Project | Target | Primary indication | Phase 1 Phase 2 |
Phase 3 Market |
Licensee |
|---|---|---|---|---|---|
| MT-2990 | anti-IL33 | Endometriosis | Mitsubishi Tanabe | ||
| 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 |
BioInvent currently has five clinical projects outlicensed to other companies. Long-term, these projects hold real financial potential. In the short term, say five years, 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.
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.
In January 2023, BioInvent was selected as partner of The Leukemia & Lymphoma Society's Therapy Acceleration Program® (LLS TAP) and 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 funding initiative to accelerate innovative blood cancer therapeutics worldwide.
Figures in parentheses refer to the outcome for the corresponding period in the preceding year.
Net sales amounted to SEK 4.6 million (13.1). 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 153.1 million (110.4). These are divided between external costs of SEK 110.1 million (74.0), personnel costs of SEK 38.1 million (32.3) and depreciation of SEK 4.9 million (4.1).
Research and development costs amounted to SEK 138.6 million (97.6). Sales and administrative costs amounted to SEK 14.5 million (12.8).
Profit/loss after tax amounted to SEK -137.3 million (-88.3). The net financial items amounted to SEK 11.0 million (8.4). Profit/loss per share before and after dilution amounted to SEK -2.09 (-1.34).
Net sales amounted to SEK 10.6 million (29.3). 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 production of antibodies for clinical studies and revenues from research services. See also note 2.
The Company's total costs amounted to SEK 248.8 million (207.3). These are divided between external costs of SEK 169.5 million (140.7), personnel costs of SEK 69.7 million (58.7) and depreciation of SEK 9.6 million (7.9).
Research and development costs amounted to SEK 221.0 million (182.1). Sales and administrative costs amounted to SEK 27.8 million (25.2).
Profit/loss after tax amounted to SEK -215.3 million (-162.1). The net financial items amounted to SEK 22.8 million (15.6). Profit/loss per share before and after dilution amounted to SEK -3.27 (-2.47).
The share capital consists of 65,804,362 shares as of June 30, 2024.
As of June 30, 2024, the Group's liquid funds, current and long-term investments amounted to SEK 1,090.3 million (1,461.7). The cash flow from operating activities for the January-June period amounted to SEK -185.1 million (-163.1).
The shareholders' equity amounted to SEK 1,097.5 million (1,476.3) 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 92 (92) percent. Shareholders' equity per share amounted to SEK 16.68 (22.44).
Investments for the January-June period in tangible fixed assets amounted to SEK 7.2 million (7.8).
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.
As of June 30, 2024, BioInvent had 112 (103) employees (full time equivalent). 99 (92) of these work in research and development.
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.
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.
| 3 MONTHS | 3 MONTHS | 6 MONTHS | 6 MONTHS | 12 MONTHS | |
|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | 2023 | |
| APR.-JUN. | APR.-JUN. | JAN.-JUN. | JAN.-JUN. | JAN.-DEC. | |
| Net sales | 4,611 | 13,095 | 10,553 | 29,345 | 71,461 |
| Operating costs | |||||
| Research and development costs | -138,594 | -97,646 | -220,976 | -182,108 | -390,434 |
| Sales and administrative costs | -14,479 | -12,778 | -27,783 | -25,200 | -51,606 |
| Other operating income and costs | 141 | 577 | 166 | 267 | 637 |
| -152,932 | -109,847 | -248,593 | -207,041 | -441,403 | |
| Operating profit/loss | -148,321 | -96,752 | -238,040 | -177,696 | -369,942 |
| Profit/loss from financial investments | 11,042 | 8,405 | 22,846 | 15,617 | 39,842 |
| Profit/loss before tax | -137,279 | -88,347 | -215,194 | -162,079 | -330,100 |
| Tax | -28 | - | -59 | - | -204 |
| Profit/loss | -137,307 | -88,347 | -215,253 | -162,079 | -330,304 |
| Other comprehensive income | |||||
| Items that have been or may be reclassified subsequently to profit or loss | - | - | - | - | - |
| Comprehensive income | -137,307 | -88,347 | -215,253 | -162,079 | -330,304 |
| Other comprehensive income attributable to parent Company's shareholders | -137,307 | -88,347 | -215,253 | -162,079 | -330,304 |
| Profit/loss per share, SEK | |||||
| Before dilution | -2.09 | -1.34 | -3.27 | -2.47 | -5.02 |
| After dilution | -2.09 | -1.34 | -3.27 | -2.47 | -5.02 |
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| JUN. 30 | JUN. 30 | DEC. 31 | |
| ASSETS | |||
| Intangible fixed assets | 0 | 0 | 0 |
| Tangible fixed assets - leases | 18,939 | 22,891 | 23,153 |
| Tangible fixed assets - other | 31,339 | 28,962 | 29,510 |
| Financial fixed assets - long-term investments | 28,746 | 360,485 | 214,252 |
| Total fixed assets | 79,024 | 412,338 | 266,915 |
| Inventories | 10,515 | 10,754 | 11,844 |
| Current receivables | 47,951 | 74,476 | 52,722 |
| Current investments | 591,249 | 530,599 | 809,151 |
| Liquid funds | 470,255 | 570,567 | 259,548 |
| Total current assets | 1,119,970 | 1,186,396 | 1,133,265 |
| Total assets | 1,198,994 | 1,598,734 | 1,400,180 |
| SHAREHOLDERS' EQUITY | |||
| Total shareholders' equity | 1,097,516 | 1,476,329 | 1,309,727 |
| LIABILITIES | |||
| Lease liabilities | 10,402 | 15,166 | 14,535 |
| Total long term liabilities | 10,402 | 15,166 | 14,535 |
| 8,709 | 7,966 | 8,709 | |
| Lease liabilities | 82,367 | 99,273 | 67,209 |
| Other liabilities | |||
| Total short term liabilities | 91,076 | 107,239 | 75,918 |
| Total shareholders' equity and liabilities | 1,198,994 | 1,598,734 | 1,400,180 |
| 2024 | 2023 | 2024 | 2023 | 2023 | |
|---|---|---|---|---|---|
| APR.-JUN. | APR.-JUN. | JAN.-JUN. | JAN.-JUN. | JAN.-DEC. | |
| Shareholders' equity at beginning of period | 1,232,637 | 1,563,845 | 1,309,727 | 1,606,122 | 1,606,122 |
| Comprehensive income | |||||
| Profit/loss | -137,307 | -88,347 | -215,253 | -162,079 | -330,304 |
| Comprehensive other income | - | - | - | - | - |
| Total comprehensive income | -137,307 | -88,347 | -215,253 | -162,079 | -330,304 |
| Total, excluding transactions with equity holders of the Company | 1,095,330 | 1,475,498 | 1,094,474 | 1,444,043 | 1,275,818 |
| Transactions with equity holders of the Company | |||||
| Employee options program | 2,186 | 831 | 3,042 | 1,327 | 2,950 |
| Directed share issue | 30,959 | 30,959 | |||
| Shareholders' equity at end of period | 1,097,516 | 1,476,329 | 1,097,516 | 1,476,329 | 1,309,727 |
The share capital as of June 30, 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.
| 2024 | 2023 | 2024 | 2023 | 2023 | |
|---|---|---|---|---|---|
| APR.-JUN. | APR.-JUN. | JAN.-JUN. | JAN.-JUN. | JAN.-DEC. | |
| Operating activities | |||||
| Operating profit/loss | -148,321 | -96,752 | -238,040 | -177,696 | -369,942 |
| Depreciation | 4,881 | 4,097 | 9,592 | 7,960 | 16,755 |
| Adjustment for other non-cash items | 2,186 | 831 | 3,042 | 1,327 | 2,950 |
| Interest received and paid | 13,719 | 2,674 | 18,930 | 4,100 | 18,781 |
| Income taxes paid | -57 | - | -114 | - | -90 |
| Cash flow from operating activities before changes in working capital | -127,592 | -89,150 | -206,590 | -164,309 | -331,546 |
| Changes in working capital | 8,383 | 5,017 | 21,480 | 1,252 | -10,145 |
| Cash flow from operating activities | -119,209 | -84,133 | -185,110 | -163,057 | -341,691 |
| Investment activities | |||||
| Acquisition of tangible fixed assets | -4,923 | -4,676 | -7,207 | -7,801 | -13,304 |
| Changes of financial investments | 121,339 | 118,963 | 393,861 | 197,270 | 72,985 |
| Cash flow from investment activities | 116,416 | 114,287 | 386,654 | 189,469 | 59,681 |
| Cash flow from operating activities and investment activities | -2,793 | 30,154 | 201,544 | 26,412 | -282,010 |
| Financing activities | |||||
| Directed share issue | 30,959 | 30,959 | |||
| Amortization of lease liability | -2,073 | -1,921 | -4,133 | -3,830 | -7,820 |
| Cash flow from financing activities | -2,073 | -1,921 | -4,133 | 27,129 | 23,139 |
| Change in liquid funds | -4,866 | 28,233 | 197,411 | 53,541 | -258,871 |
| Opening liquid funds | 469,142 | 542,516 | 259,548 | 515,047 | 515,047 |
| Accrued interest on investments classified as liquid funds | 5,979 | -182 | 13,296 | 1,979 | 3,372 |
| Liquid funds at end of period | 470,255 | 570,567 | 470,255 | 570,567 | 259,548 |
| Liquid funds, specification: | |||||
| Cash and bank | 85,577 | 348,301 | 85,577 | 348,301 | 48,237 |
| Current investments, equivalent to liquid funds | 384,678 | 222,266 | 384,678 | 222,266 | 211,311 |
| 470,255 | 570,567 | 470,255 | 570,567 | 259,548 |
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| JUN. 30 | JUN. 30 | DEC. 31 | |
| Shareholders' equity per share at end of period, SEK | 16.68 | 22.44 | 19.90 |
| Number of shares at end of period (thousand) | 65,804 | 65,804 | 65,804 |
| Equity/assets ratio, % | 91.5 | 92.3 | 93.5 |
| Number of employees at end of period | 112 | 103 | 111 |
| 3 MONTHS | 3 MONTHS | 6 MONTHS | 6 MONTHS | 12 MONTHS | |
|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | 2023 | |
| APR.-JUN. | APR.-JUN. | JAN.-JUN. | JAN.-JUN. | JAN.-DEC. | |
| Net sales | 4,611 | 13,095 | 10,553 | 29,345 | 71,461 |
| Operating costs | |||||
| Research and development costs | -138,641 | -97,794 | -221,001 | -182,405 | -390,857 |
| Sales and administrative costs | -14,484 | -12,791 | -27,786 | -25,226 | -51,643 |
| Other operating income and costs | 141 | 577 | 166 | 267 | 637 |
| -152,984 | -110,008 | -248,621 | -207,364 | -441,863 | |
| Operating profit/loss | -148,373 | -96,913 | -238,068 | -178,019 | -370,402 |
| Profit/loss from financial investments | 11,182 | 8,564 | 23,139 | 15,947 | 40,476 |
| Profit/loss after financial items | -137,191 | -88,349 | -214,929 | -162,072 | -329,926 |
| Tax | -28 | - | -59 | - | -204 |
| Profit/loss | -137,219 | -88,349 | -214,988 | -162,072 | -330,130 |
| Other comprehensive income | - | - | - | - | - |
| Comprehensive income | -137,219 | -88,349 | -214,988 | -162,072 | -330,130 |
| 2024 | 2023 | 2023 | |
|---|---|---|---|
| JUN. 30 | JUN. 30 | DEC. 31 | |
| ASSETS | |||
| Intangible fixed assets | 0 | 0 | 0 |
| Tangible fixed assets | 31,339 | 28,962 | 29,510 |
| Financial fixed assets - Shares in subsidiaries | 687 | 687 | 687 |
| Financial fixed assets - long-term investments | 28,746 | 360,485 | 214,252 |
| Total fixed assets | 60,772 | 390,134 | 244,449 |
| Current assets | |||
| Inventories | 10,515 | 10,754 | 11,844 |
| Current receivables | 49,013 | 75,036 | 53,600 |
| Current investments | 591,249 | 530,599 | 809,151 |
| Cash and bank | 470,255 | 570,567 | 259,548 |
| Total current assets | 1,121,032 | 1,186,956 | 1,134,143 |
| Total assets | 1,181,804 | 1,577,090 | 1,378,592 |
| SHAREHOLDERS' EQUITY | |||
| Restricted equity | 40,854 | 40,854 | 40,854 |
| Non-restricted equity | 1,057,934 | 1,436,315 | 1,269,880 |
| Total shareholders' equity | 1,098,788 | 1,477,169 | 1,310,734 |
| LIABILITIES | |||
| Short term liabilities | 83,016 | 99,921 | 67,858 |
| Total short term liabilities | 83,016 | 99,921 | 67,858 |
| Total shareholders' equity and liabilities | 1,181,804 | 1,577,090 | 1,378,592 |
The board of directors and the CEO hereby ensure that this interim report for the period January 1, 2024 – June 30, 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.
Lund, August 29, 2024
| Leonard Kruimer | Vessela Alexieva | Natalie Berner | Kristoffer Bissessar |
|---|---|---|---|
| Chairman of the Board | Deputy 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 |
We have reviewed the summarized interim financial information for BioInvent International AB (publ) on June 30, 2024 and for the sixmonth period then ended. The board of directors and the CEO are responsible for the preparation and presentation of this interim 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.
We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity". A review 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 ISA and other generally accepted auditing practices. The procedures performed in a review do not enable us to obtain a level of assurance that would make us aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion expressed based on an audit.
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's part according to IAS 34 and the Annual Accounts Act and for the parent Company's part according to the Annual Accounts Act.
Malmö, August 29, 2024
KPMG AB
Linda Bengtsson Authorized Public Accountant
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.
| 2024 | 2023 | 2024 | 2023 | 2023 | |
|---|---|---|---|---|---|
| SEK THOUSAND | APR.-JUN. | APR.-JUN. | JAN.-JUN. | JAN.-JUN. | JAN.-DEC. |
| Revenue by geographical region: | |||||
| Sweden | 613 | 2,360 | 2,706 | 7,529 | 18,263 |
| Europe | 394 | 1,713 | 704 | 3,023 | 2,951 |
| USA | 2,855 | 9,022 | 5,545 | 18,793 | 47,393 |
| Other countries | 749 | - | 1,598 | - | 2,854 |
| 4,611 | 13,095 | 10,553 | 29,345 | 71,461 | |
| Revenue consists of: | |||||
| Revenue from collaboration agreements associated with | |||||
| outlicensing of proprietary projects | - | 8,846 | 572 | 18,319 | 44,303 |
| Revenue from technology licenses | - | - | - | - | - |
| Revenue from external development projects | 4,611 | 4,249 | 9,981 | 11,026 | 27,158 |
| 4,611 | 13,095 | 10,553 | 29,345 | 71,461 |
The net revenue of the Group and the Parent Company coincide.
(R)= Regulatory event
FINANCIAL CALENDAR • Interim report Q3: October 31, 2024
Any questions regarding this report will be answered by Cecilia Hofvander, Senior Director Investor Relations, +46 (0)46 286 85 50, [email protected].
The report is also available at www.bioinvent.com.
Co. reg. no. 556537-7263 Address: Ideongatan 1, 223 70 Lund Phone.: +46 (0)46 286 85 50
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.
n-CoDeR ® and F.I.R.S.T™ are trademarks belonging to BioInvent International AB.

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