Breakeven Date Change • May 21
Forecast breakeven date pushed back to 2027 The 3 analysts covering BioInvent International previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 18% to 2026. The company is expected to make a profit of kr153.2m in 2027. Average annual earnings growth of 42% is required to achieve expected profit on schedule. Announcement • Mar 25
BioInvent International AB (publ), Annual General Meeting, Apr 29, 2026 BioInvent International AB (publ), Annual General Meeting, Apr 29, 2026, at 16:00 W. Europe Standard Time. Location: elite hotel, ideon on scheelevagen 27 in lund, Sweden Announcement • Mar 17
BioInvent International AB (publ) to Report Fiscal Year 2025 Final Results on Mar 31, 2026 BioInvent International AB (publ) announced that they will report fiscal year 2025 final results on Mar 31, 2026 Announcement • Jan 05
Bioinvent Reports Promising Data from Ongoing Phase 2A Study for Bi-1808 with Keytruda®(Pembrolizumab) in Recurrent Ovarian Cancer BioInvent International AB announced encouraging interim results from its ongoing Phase 2a signal-seeking study evaluating BI-1808, a novel immuno-oncology candidate, in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with recurrent ovarian cancer who have progressed following platinum-based therapy. The interim data from the signal-seeking cohort of patients with recurrent ovarian cancer demonstrates an overall response rate (ORR) of 24%, which represents a meaningful improvement over pembrolizumab monotherapy. Some responses have been observed after several months of treatment, suggesting that additional responses with potentially important impact on PFS (Progression Free Survival) may be observed. The combination was generally safe and well-tolerated, and all adverse events were manageable with standard medical treatments. Exploratory analyses indicate strong activity in both high-grade serous and clear cell ovarian cancer subtypes. The Phase 2a expansion will enroll an additional 20 patients focusing on these subtypes to validate and quantify the signal with an expected readout in H2 2026. Clinical trial collaboration and supply agreement. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, NJ., USA, to evaluate the combination of BI-1808 and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizum AB). This Phase 2a trial (NCT04752826) is designed to assess BI-1808 administered as a single agent (Part A) and in combination with pembrolizumab (Part B) at the respective recommended Phase 2 dose (RP2D) determined in Phase 1. Phase 2a expansion is being conducted in indication specific cohorts of subjects. The aim of the Phase 2a is to further assess the safety and tolerability of BI-1808 as a single agent (PartA) and in combination with p Embrolizumab (PartB), characterize its PK and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST. BI-1808 is a ligand-blocking FcgR-engaging antibody that depletes immunosuppressive Treg cells and reprograms myeloid cells. BI-1910 is a pure agonist antibody that directly co-stimulates T and NK cells through partially FcgR-independent mechanisms. Announcement • Jun 05
BioInvent International AB Presents Model-Informed Early Clinical Development at PAGE 2025 BioInvent International AB announced the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1910 at the Population Approach Group in Europe (PAGE) 2025 meeting, being held in Thessaloniki, Greece from June 4 to 6, 2025. BI-1910 data and progress. BI-1910 is being investigated as both a single agent and in combination with KEYTRUDA (pembrolizumab). The first part of the BI-1910 Phase 1/2a study was a dose escalation Phase 1 study to evaluate the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent (Part A) in patients with advanced solid tumors. In another part of the study, BI-1910 in combination (Part B) with MSD's anti-PD-1 therapy, KEYTRUDA ("pembrolizumab) were evaluated. Both Phase 1 parts have been successfully concluded. In January 2025 BioInvent reported stable disease for six out of 12 evaluable patients in the single agent dose escalation Phase 1 study. The Phase 2a study of BI-1910 as an single agent (Part A) In January 2025 BioInvent reports stable disease for six out of12 evaluable patients in the single agents dose escalation Phase 1 study. the Phase 2a study of BI -1910 as a single agent in several tumor types including HCC (hepatocellular cancer) patients is planned to start in H2 2025. Furthermore, BioInvent will also initiate Phase 2a part of the study evaluating BI-1910 with pembrolizumab (Part B) in the same indications during second half of 2025. Announcement • Mar 26
BioInvent International AB (publ), Annual General Meeting, Apr 29, 2025 BioInvent International AB (publ), Annual General Meeting, Apr 29, 2025, at 16:00 W. Europe Standard Time. Location: elite hotel ideon, scheelevagen 27 in lund, Sweden Announcement • Mar 22
BioInvent International AB (publ) to Report Fiscal Year 2024 Final Results on Apr 04, 2025 BioInvent International AB (publ) announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Apr 04, 2025 Announcement • Dec 03
Bioinvent International AB Appoints Ashley Robinson as SVP Strategy & Finance to Lead U.S. Expansion Bioinvent International AB announced the appointment of Ashley Robinson as SVP Strategy & Finance, effective as of December 3, 2024. In this role, Mr. Robinson will spearhead efforts to strengthen BioInvent’s presence and strategy in the US. Ashley Robinson is an accomplished biotechnology business leader and joins BioInvent with 25 years in capital markets and corporate strategy experience. Most recently, he served as Managing Director at LifeSci Advisors, where he established a Life Sci office in Boston, advising key clients in the healthcare sector. Prior roles have been healthcare product specialist, sector head at Guggenheim Securities, Managing Director and Senior Partner at Leerink Partners, Vice President at Lehman Brothers in the ECM division. Board Change • Nov 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Lex Eggermont was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Oct 17
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: kr53m (US$5.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (8.4% average weekly change). Revenue is less than US$5m (kr53m revenue, or US$5.0m). Announcement • Sep 16
Bioinvent and Transgene’S Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase 1/2A Trial in Solid Tumors That Failed Previous Treatments BioInvent International AB and Transgene announced new initial data from their ongoing Phase 2/2a study on the multifunctional oncolytic virus BT-001, demonstrating antitumor activity in patients with refractory solid tumors. The data presented at the2024European Society for Medical Oncology (ESMO) Annual Meeting, showed that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as a monotherapy and in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab).
Preliminary translational data suggest that BT-001 replicates in the tumor where the payloads are expressed with undetectable systemic exposure. BT-001 alone or in combination with pembrolizumab was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 refractory patients when given in combination with pembrolizumab. BT-001 treatment turned "cold" tumors to "hot" inducing T cell infiltration, a higher M1/M2 ratio, and a shift toPD(L)-1 positivity in the tumor microenvironment. Announcement • Sep 12
Bioinvent International AB Announces the Enrollment of the First Patient in Triple Combination Arm of Phase 1/2A Study, Bi-1206, Rituximab and Calquence(R) for the Treatment of Non-Hodgkin's Lymphoma BioInvent International AB announced it has enrolled the first patient in the triple combination arm of the Phase 1/2a study of its anti-FcgRIIB antibody, BI-1206 in non-Hodgkin's lymphoma (NHL). The Phase 2a study arm will combine the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib), a selective inhibitor of Bruton's tyrosine kinase (BTK). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. Preliminary data are expected by the end of 2024. In February 2024BioInvent signed a clinical supply agreement with AstraZeneca to provide Calquence® for the combination arm. Reported Earnings • Aug 30
Second quarter 2024 earnings released: kr2.09 loss per share (vs kr1.34 loss in 2Q 2023) Second quarter 2024 results: kr2.09 loss per share (further deteriorated from kr1.34 loss in 2Q 2023). Net loss: kr137.3m (loss widened 55% from 2Q 2023). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has only fallen by 10% per year, which means it has not declined as severely as earnings. Announcement • Jul 30
BioInvent Receives Notice of Allowance from USPTO for BI-1910 Patent Application BioInvent International AB announced that the US Patent and Trademark office (USPTO) has issued a Notice of Allowance for a patent application relevant to the anti-TNFR2 antibody BI-1910 by the - The patent, once granted, provides a composition-of-matter protection for BI-1910 and the use of the antibody for the treatment of cancer. Announcement • Jun 26
Bioinvent International AB Presents Poster Highlighting Model-Informed Early Clinical Development of Anti-TNFR2 Agent BI-1808 At PAGE 2024 BioInvent International AB announced the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1808 at the Population Approach Group in Europe (PAGE) 2024 meeting, being held in Rome, Italy from June 26 to 28, 2024. BI-1808 could represent a new class of immunomodulatory agent with the potential to improve efficacy of cancer therapy. As earlier communicated, initial efficacy and safety data from the ongoing Phase 1/2a study show so far: One complete response (CR), one partial response (PR) that is still improving, and nine patients with stable disease (SD) of 26 evaluable patients in the single agent arm of BI-1808; Promising signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab). Poster summary: The objective was to characterize the population pharmacokinetics (PK), receptor occupancy (RO), and concentrations of the target engagement biomarker soluble tumor necrosis factor receptor 2 (sTNFR2) at different BI-1808 doses, to support the dose selection for the dose expansion trial. Data and methods: Data was available from patients in the ongoing Phase 1/2a dose escalation trial. Model building and application proceeded in a sequential manner: Development of a joint PK-RO model to simultaneously characterize BI-1808 concentrations and TNFR2 receptor occupancy. Extension of the PK-RO model with a sTNFR2 PD model. Typical value simulations for RO as well as PK and sTNFR2 (not shown) considering different doses and dosing frequencies. Conclusions: A simultaneous model of the BI-1808 PK, RO, and sTNFR2 successfully explained the observed profiles across a wide dose range. Simulations provided insights into the expected PK, RO, and sTNFR2 levels across potential dose levels and dosing frequencies and will support the selection of doses for further exploration. Poster Title: Model-informed early clinical development of BI-1808, a novel monoclonal antibody to tumor necrosis factor receptor 2; Abstract Number: 10786; Session: Drug/Disease Modelling - Oncology; Date: June 27, 2024; Time: 9:50 - 11:20 AM CEST. Announcement • Jun 25
BioInvent International Gains Patent for BI-1808 in China BioInvent International AB announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-TNFR2 antibody BI-1808 will be granted. The patent provides composition-of matter protection for BI-1808 and the use of the antibody for the treatment of cancer. Announcement • May 16
Bioinvent to Present Additional Promising Phase 1/2A Data At EHA 2024 for BI-1206 with rituximab in NHL BioInvent International AB (publ) announced that promising clinical data for BI-1206 in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), dosed in combination with rituximab, will be presented in a poster at the European Hematology Association congress held in Madrid, Spain from June 13-16, 2024. Overview: While anti-CD20 antibodies such as rituximab are a cornerstone of NHL care, approximately 15% of patients are refractory to treatment and 25% relapse within 3 years after treatment. The inhibitory Fc receptor CD32b (Fc?RIIB) promotes resistance by triggering tumor cells to internalize and destroy rituximab. BI-1206 has been designed as an anti-Fc?RIIB mAb to block rituximab internalization. Methods: BioInvent conducted a Phase 1/2a trial in several R/R B-cell NHL subtypes to evaluate safety and tolerability of BI-1206 in combination with rituximab. Dose expansion is ongoing for the IV formulation since the recommended Phase 2 dose (RP2D) of IV BI-1206 has been established. Phase 1 dose escalation is still ongoing for the SC formulation. Reported Earnings • Apr 25
First quarter 2024 earnings released: kr1.18 loss per share (vs kr1.12 loss in 1Q 2023) First quarter 2024 results: kr1.18 loss per share (further deteriorated from kr1.12 loss in 1Q 2023). Net loss: kr77.9m (loss widened 5.7% from 1Q 2023). Revenue is forecast to grow 71% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 24% per year, which means it is performing significantly worse than earnings. Announcement • Mar 28
BioInvent International AB (publ), Annual General Meeting, May 03, 2024 BioInvent International AB (publ), Annual General Meeting, May 03, 2024, at 16:00 Central European Standard Time. Location: Elite Hotel Ideon on Scheelevägen 27 Lund Sweden Agenda: To consider opening of the meeting; to consider election of Chairperson of the meeting; to consider preparation and approval of the voting list; to consider election of persons to approve the minutes; to consider determination of compliance with the rules of convocation; to consider approval of the agenda; and to consider other matters. Reported Earnings • Feb 23
Full year 2023 earnings released: kr5.02 loss per share (vs kr0.69 loss in FY 2022) Full year 2023 results: kr5.02 loss per share (further deteriorated from kr0.69 loss in FY 2022). Net loss: kr330.3m (loss widened kr287.8m from FY 2022). Revenue is forecast to grow 114% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Announcement • Feb 21
BioInvent International AB (publ) to Report Fiscal Year 2023 Results on Feb 22, 2024 BioInvent International AB (publ) announced that they will report fiscal year 2023 results at 8:00 AM, Central European Standard Time on Feb 22, 2024 New Risk • Feb 03
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €90.6m (US$97.8m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. This is currently the only risk that has been identified for the company. Announcement • Dec 06
BioInvent International AB (publ) Presents Positive First Clinical Data on Anti-FcyRIIB Antibody BI-1607 BioInvent International AB presented the first clinical data from a Phase 1/2a trial of its second FcyRIIB-blocking antibody BI-1607. BioInvent pipeline currently includes five drug candidates progressing through six clinical trials. The Phase 1 data, presented in a poster 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 in the poster was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients. 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 this will provide the basis for further investigation in a Phase 2a trial, which planned to start 2024. BI-1607 is developed to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. The reported trial is a first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. Announcement • Dec 05
Bioinvent Enrolls First Patient in Phase 1/2A Clinical Trial with TNFR2 Antibody BI-1910 BioInvent International AB announced it has enrolled the first patient in its Phase 1/2a trial of the monoclonal antibody BI-1910, the company's second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development. The Phase 1/2a clinical trial will be conducted in the US and Europe and is using an innovative, adaptive design for dose escalation. The first phase of the trial will enroll all solid cancer entities initially as single agent, followed by a dose escalation phase with BI-1910 in combination with pembrolizumab. Subsequently, Exploratory expansion cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody which is 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 simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline or for additional licensing and partnering. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. Announcement • Nov 04
BioInvent Presents Positive Data at SITC from Clinical Phase 1/2a Trial of BI-1808 as Single Agent BioInvent International AB presents the latest data from a Phase 1/2a trial of its first-in-class anti-tumor necrosis factor receptor 2 (TNFR2) antibody BI-1808 as a single agent, at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting in San Diego, California. The poster presentation, entitled "Phase 1/2a Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2) as Single Agent and in Combination with Pembrolizumab" include data from the BI-1808 monotherapy arm of the Phase 1 study and display encouraging results in the form of early efficacy signals. Furthermore, BI-1808 exhibited a favorable safety profile with no dose-limiting toxicity observed in the monotherapy arm and no maximum tolerated dose could be found. BI-1808 was well tolerated across all dose levels studied. The data strengthens the outlook for the ongoing Phase 2 part of the clinical trial and positions BI-1808 as the best-in-class. BI-1808 administered as single agent induced a robust partial response (PR) in a patient with a gastrointestinal tumor (GIST) who had received 12 previous lines of treatment. Immune checkpoint inhibitors have previously shown very limited activity in this tumor type. The patient is still receiving BI-1808 treatment, and the most recent scan showed a tumor burden reduced to 48% compared to baseline, with 2/4 target lesions no longer detectable. There are a further 7 cases of stable disease out of 21 evaluable patients and pharmacokinetic/pharmacodynamic data has enabled identification of a wide dose range where complete target coverage can be achieved with a remarkable safety profile. The title and number of the SITC poster presentation is as follows: Title: Phase 1/2a Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2) as Single Agent and in Combination with Pembrolizumab Number: 757. BI-1808 and the second anti-TNFR2 antibody BI-1910, are part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be determinant for tumor growth and survival, representing a new and promising target for cancer immunotherapy. The dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label trial of BI-1808 is investigating it as a single agent and in combination with MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in subjects with advanced malignancies, whose disease has progressed after standard therapy. It consists of Phase 1 Parts A and B (dose escalation as single agent and in combination with pembrolizumab, respectively), and Phase 2a Parts A and B (dose expansion cohorts with treatment as single agent and in combination, respectively). The efficacy of BI-1808 as single agent is currently further explored in an ongoing Phase 2a trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), BioInvent plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far. Phase 1 data on the combination of BI-1808 with pembrolizumab is due in H1 2024. Announcement • Nov 01
BioInvent Presents Preclinical Data at SITC Providing Clear Evidence of the Potential of Anti-TNFR2 Antibody BI-1910 BioInvent will present preclinical data on its anti-tumor necrosis factor receptor 2 (TNFR2) agonistic antibody BI-1910 at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting in San Diego, California. The presentation, scheduled for November 4, 2023, entitled "Preclinical development of an agonistic anti-TNFR2 antibody (BI-1910) for cancer immunotherapy," demonstrates 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. BI-1910 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor growth and survival, representing a new and promising target for cancer immunotherapy. BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, and both monoclonal antibodies were chosen as potential best-in-class from a large collection of fully characterized binders generated through BioInvent's proprietary F.I.R.S.T™ technology platform. The latest data from the other Treg program, i.e. the BI-1808 single agent Phase 1 study, will be presented at SITC on November 3, 2023. Reported Earnings • Oct 27
Third quarter 2023 earnings released: kr1.08 loss per share (vs kr1.00 loss in 3Q 2022) Third quarter 2023 results: kr1.08 loss per share (further deteriorated from kr1.00 loss in 3Q 2022). Net loss: kr71.1m (loss widened 11% from 3Q 2022). Revenue is forecast to grow 118% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Announcement • Sep 22
Bioinvent International AB Recruits First Patient in Single Agent Phase 2a Part of its Phase 1/2a Trial of its First-in-Class Anti-TNFR2 Antibody BI-1808 in Advanced Malignancies BioInvent International AB announced recruitment of the first patient in the single agent Phase 2a part of its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. In June 2023, the company reported strong interim safety data on BI-1808 as a single agent, from the dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study. The trial is investigating the use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. Stable disease as best response was observed in six subjects during the single agent dose escalation part. The efficacy of BI-1808 as single agent will now be further explored in the Phase 2a part of the trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), the company plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far. Announcement • Sep 08
BioInvent International AB Initiates Subcutaneous Arm of Phase 1/2 Trial with BI-1206 in Solid Tumors BioInvent International AB announced the enrollment of the first patient in a Phase 1/2 trial (NCT04219254; KEYNOTE-A04) in combination with KEYTRUDA® (pembrolizumab), MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy, investigating a subcutaneous (SC) formulation of its lead drug candidate, the novel anti-FcyRIIB antibody BI-1206, in solid tumors. SC administration provides a significant improvement in terms of convenience and flexibility to both patients and healthcare professionals when compared to intravenous (IV) administration. In the ongoing Phase 1/2 trial of BI-1206, in combination with rituximab in non-Hodgkin's lymphoma (NHL), pharmacokinetically equivalent doses to IV have already been administered improving exposure and receptor engagement as had been predicted. Furthermore, there have been no safety or tolerability concerns. The trial is recruiting patients with advanced solid tumors who had progressed after prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients will receive three-week cycles of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. As reported on June 7, 2023, the IV part of the study has already generated early signs of efficacy, e.g., two partial responses and two patients displaying stable disease, out of a total of 18 evaluable patients having received BI-1206+pembrolizumab. Recent Insider Transactions • Sep 03
Independent Director recently bought €51k worth of stock On the 30th of August, Bernd Seizinger bought around 36k shares on-market at roughly €1.42 per share. This transaction increased Bernd's direct individual holding by 1x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €135k more in shares than they have sold in the last 12 months. Reported Earnings • Aug 31
Second quarter 2023 earnings released: kr1.34 loss per share (vs kr2.86 profit in 2Q 2022) Second quarter 2023 results: kr1.34 loss per share (down from kr2.86 profit in 2Q 2022). Net loss: kr88.3m (down 153% from profit in 2Q 2022). Revenue is forecast to grow 105% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings. New Risk • Aug 17
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €89.7m (US$97.8m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr23m net loss in 2 years). Market cap is less than US$100m (€89.7m market cap, or US$97.8m). Recent Insider Transactions • Jul 26
Independent Chairman of the Board recently bought €16k worth of stock On the 17th of July, Leonard Kruimer bought around 10k shares on-market at roughly €1.56 per share. This transaction amounted to 44% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth €21k. Leonard has been a buyer over the last 12 months, purchasing a net total of €31k worth in shares. Announcement • Jun 21
BioInvent International AB (publ) Reports Strong Interim Safety Data and Early Signs of Efficacy in Phase 1/2a Trial with Anti-TNFR2 Antibody BI-1808 in Advanced Malignancies BioInvent International AB announced strong interim safety data from its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. The dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study is investigating use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. No significant safety concerns were observed in relation to the administration of BI-1808 as single agent in Phase 1, Part A of the trial. A total 24 subjects were dosed with a range of 25-1000 mg with 22 patients evaluable for efficacy. The BI-1808 infusions were well tolerated and no dose limiting toxicity or serious adverse events related to BI-1808 were observed, at any dose level. Stable disease was observed in six patients subjects so far - 1 in the 25 mg cohort, 3 subjects at 75 mg, 1 at 225 mg and 1 at 1000 mg. The efficacy of BI-1808 As single agent and in combination with Pembrolizumab will be further explored in the subsequent Phase 2a part of the trial, which is intended to enroll pre-defined malignancies and a larger sample size. Phase 2a Part A (single agent) is planned to start during H2 2023. Announcement • Jun 13
BioInvent International AB Announces Abstract Presentation of BI-1206 At the 17th International Conference of Malignant Lymphoma 2023 BioInvent International AB announced that an abstract reporting the clinical profile of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, has been accepted at the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023. In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin's lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified. A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023. The SC formulation should allow a great deal of flexibility in dosing and regimen to assure the best development of BI-1206. All patients in the ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 12th, 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose expansion cohort is currently enrolling patients. Announcement • Jun 08
BioInvent International AB Announces Additional Efficacy Data from Intravenous Part of Phase 1/2 Trial with BI-1206 in Solid Tumors BioInvent International AB announced six additional patients have been treated in the intravenous (IV) arm of its Phase 1/2 trial (NCT04219254; KEYNOTE-A04) of the novel anti-FcyRIIB antibody BI-1206 in combination with KEYTRUDA®? (pembrolizumab), MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy, in solid tumors. The additional patients have been treated at a dose of 1 mg/kg. Previous observations had revealed that BI-1206 may enhance the activity of pembrolizumab in patients who have previously progressed on PD-1/PDL-1 targeting therapies. In addition to the patients previously reported, (1 case of pseudo progression and 1 partial response (PR), new data now show one patient experiencing a long-lasting stable disease, with more than 80 weeks of treatment in the study, and another patient experiencing a PR. Both patients have melanoma, and both had previously been treated with immune checkpoint inhibitors. The latter had progressed after previous lines of those agents. The first PR observed is still responding and has been on treatment for more than 90 weeks. BioInvent will share additional updates from the IV arm of the trial during the second half of 2023. The 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 rituximab in non-Hodgkin's lymphoma (NHL), is also continuing. Announcement • Jun 07
BioInvent Ready for Combination Studies with BT-001 BioInvent and its partner Transgene have reported positive results in the phase I/IIa study with the oncolytic virus BT-001. In 11 of the 18 included patients, the lesions were stabilised. In two patients, objective antitumour activity was also seen. This means that both partners can continue the evaluation as planned with the part of the study where BT-001 will be studied in combination with pembrolizumab. Announcement • May 24
BioInvent International AB (Publ) Appoints of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs BioInvent International AB ("BioInvent") announced the appointment of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs. Lindvig, an experienced regulatory affairs leader who has worked across all stages of product development and has hands-on experience of the US and EU regulatory systems, will join on June 12, 2023, be part of the BioInvent management team and report to CEO Martin Welschof. Lindvig joins from Norwegian biotech company Circio, where she was Vice President and Head of Regulatory Affairs since 2019. She was previously Head of Regulatory Affairs at Nordic Nanovector and also held senior regulatory positions at Photocure and Nycomed/GE Healthcare. She holds a PhD in biology from the University of Oslo. Board Change • May 18
High number of new directors Director Erik Esveld was the last director to join the board, commencing their role in 2023. Breakeven Date Change • Apr 27
Forecast to breakeven in 2025 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr713.7m in 2025. Average annual earnings growth of 94% is required to achieve expected profit on schedule. Reported Earnings • Apr 08
Full year 2022 earnings released Full year 2022 results: Revenue: kr326.1m (up kr306.7m from FY 2021). Net loss: kr42.5m (loss narrowed 85% from FY 2021). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings. Reported Earnings • Feb 28
Full year 2022 earnings released: kr0.69 loss per share (vs kr5.14 loss in FY 2021) Full year 2022 results: kr0.69 loss per share (improved from kr5.14 loss in FY 2021). Revenue: kr326.1m (up kr306.7m from FY 2021). Net loss: kr42.5m (loss narrowed 85% from FY 2021). Products in clinical trials Phase I: 7 Phase II: 4 Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Feb 28
Forecast to breakeven in 2025 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr713.7m in 2025. Average annual earnings growth of 67% is required to achieve expected profit on schedule. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr713.7m in 2025. Average annual earnings growth of 74% is required to achieve expected profit on schedule. Reported Earnings • Oct 28
Third quarter 2022 earnings released: kr1.00 loss per share (vs kr1.07 loss in 3Q 2021) Third quarter 2022 results: kr1.00 loss per share. Revenue: kr17.9m (up 499% from 3Q 2021). Net loss: kr63.9m (loss widened 2.0% from 3Q 2021). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Germany. Breakeven Date Change • Oct 09
Forecast to breakeven in 2024 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr144.0m in 2024. Average annual earnings growth of 23% is required to achieve expected profit on schedule. Breakeven Date Change • Aug 27
Forecast to breakeven in 2024 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr144.0m in 2024. Average annual earnings growth of 36% is required to achieve expected profit on schedule. Reported Earnings • Aug 26
Second quarter 2022 earnings released: EPS: kr2.86 (vs kr0.98 loss in 2Q 2021) Second quarter 2022 results: EPS: kr2.86 (up from kr0.98 loss in 2Q 2021). Revenue: kr270.9m (up kr265.6m from 2Q 2021). Net income: kr167.4m (up kr224.7m from 2Q 2021). Profit margin: 62% (up from net loss in 2Q 2021). The move to profitability was driven by higher revenue. Over the next year, revenue is forecast to stay flat compared to a 10% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 43% per year but the company’s share price has only increased by 27% per year, which means it is significantly lagging earnings growth. Announcement • Jul 13
Bioinvent International Resolves to Elect Natalie Berner and Nanna Lüneborg as New Board Members BioInvent International AB (publ)'s resolved to elect Natalie Berner and Nanna Lüneborg as new Board members. The EGM resolved, in accordance with the Nomination Committee's proposal, to increase the Board of Directors with two members through new election of Natalie Berner and Nanna Lüneborg as Board members. The annual fees per Board member, as resolved by the Annual General Meeting, shall continue to apply. Fees are to be paid to incoming Board members pro rata in relation to the Board member's actual duty period. Announcement • Jun 28
Transgene SA and BioInvent International AB (publ) Announce Positive Progress for BT-001 Transgene SA and BioInvent International AB (BioInvent) jointly announced positive progress and safety data of the ongoing Phase I/IIa trial evaluating BT-001 in patients with solid tumors, including melanoma. The initial data generated in Phase I part A demonstrated that BT-001 alone is well tolerated, with first signs of anti-tumor activity in a hard-to-treat population and confirmed the mechanism of action of BT-001 as a single agent. The initial findings are as follows: After administration, the virus was found in the tumors after several days. This suggests that BT-001 is able to persist and replicates within tumors; This finding is consistent with the expression of the anti-CTLA-4 observed in the tumor with no detectable systemic exposure; No spreading in blood or biological fluids has been detected, suggesting high tumor specificity; Tumor shrinkage was observed in one patient in the first cohort. The part A of the Phase I trial aims to establish the tolerability of BT-001 and to determine the dose and administration schedule for further development. Repeated (every 3 weeks) and ascending doses of intratumoral administration of BT-001, as a single agent, will be administered to up to 18 patients with metastatic/advanced tumors. The first two dose levels have been successfully completed, with 12 patients dosed to date. The Safety Review Committee (SRC) has stated that the safety profile supports escalation to the highest dose level of Phase I part A. The Phase I part B is planned to start in H2 2022. This part will assess the combination of intratumoral injections of BT-001 with intravenous administrations of the anti-PD1 antibody pembrolizumab. BT-001 is based on Transgene’s patented oncolytic vector and is encoding BioInvent’s proprietary anti-CTLA-4 antibody; it is codeveloped by the two biotechnology companies. About the trial: The ongoing Phase I/IIa (NCT04725331) 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 I is divided into two parts. In part A, patients with metastatic/advanced tumors receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab. The Phase IIa will evaluate the combination regimen in several patient cohorts with different 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. About BT-001: BT-001 is an oncolytic virus generated using Transgene’s Invir.IO™ platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody may be greatly improved. Announcement • Jun 10
Bioinvent International AB (Publ) Appoints Sylvie Ryckebusch as Chief Business Officer BioInvent International AB announced the appointment of Sylvie Ryckebusch as Chief Business Officer (CBO). Sylvie Ryckebusch is a pharmaceutical executive with over 20 years of experience in business development, alliance management, and corporate strategy. She has held senior leadership roles in both large multi-national corporations and biotech companies and has closed numerous biotech deals at all stages of a product life cycle. She has supported BioInvent on a part time basis since 2019 and with the new position as CBO, she will join the company's executive management team. Prior to joining BioInvent, Sylvie has served in key positions at Serono, Merck KGaA, and Index Ventures as well as McKinsey and Company and the Harvard Business School. Sylvie holds a PhD in neurobiology from the California Institute of Technology and BSc degrees in physics and mathematics from the University of Maryland. Breakeven Date Change • May 21
Forecast to breakeven in 2023 The 2 analysts covering BioInvent International expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr325.0m in 2023. Average annual earnings growth of 109% is required to achieve expected profit on schedule. Reported Earnings • Apr 28
First quarter 2022 earnings released: kr1.16 loss per share (vs kr1.94 loss in 1Q 2021) First quarter 2022 results: kr1.16 loss per share (up from kr1.94 loss in 1Q 2021). Net loss: kr67.7m (loss narrowed 15% from 1Q 2021). Over the next year, revenue is forecast to grow 556%, compared to a 43% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has only increased by 25% per year, which means it is significantly lagging earnings growth. Reported Earnings • Apr 11
Full year 2021 earnings released: kr5.14 loss per share (vs kr2.66 loss in FY 2020) Full year 2021 results: kr5.14 loss per share (down from kr2.66 loss in FY 2020). Net loss: kr278.4m (loss widened 265% from FY 2020). Products in clinical trials Phase I: 4 Over the next year, revenue is forecast to grow 457%, compared to a 44% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has only increased by 19% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions • Mar 15
President & CEO recently bought €23k worth of stock On the 9th of March, Martin Welschof bought around 7k shares on-market at roughly €3.15 per share. In the last 3 months, there was an even bigger purchase from another insider worth €74k. Martin has been a buyer over the last 12 months, purchasing a net total of €42k worth in shares. Reported Earnings • Feb 24
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: kr5.14 loss per share (down from kr2.66 loss in FY 2020). Net loss: kr278.4m (loss widened 265% from FY 2020). Revenue missed analyst estimates by 89%. Over the next year, revenue is forecast to grow 457%, compared to a 59% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has only increased by 3% per year, which means it is significantly lagging earnings growth. Announcement • Jan 22
Bioinvent International AB & Transgene Joint JITC Publication Demonstrates the Potential of BT-001 Oncolytic Virus to Provide Therapeutic Benefit Beyond Current Anti-PD-1/ Anti-CTLA-4 Immune Checkpoint Blockade BioInvent International AB and Transgene jointly announced the publication of extensive preclinical proof-of-concept data for BT-001 in the Journal for ImmunoTherapy of Cancer (JITC). This peer-reviewed article demonstrates that their co-developed clinical stage product, based on Transgene's patented oncolytic vector and encoding BioInvent's proprietary anti-CTLA-4 antibody, has the potential to provide greater therapeutic benefit than systemically administered anti-CTLA-4 antibodies. Systemically administered anti-CTLA-4 antibodies, such as the approved ipilimumab, have demonstrated substantial efficacy but also clinically limiting toxicity. The JITC paper provides in vivo evidence that vectorized anti-CTLA-4 antibodies delivered intratumorally (i.t.) can improve safety by reducing their systemic exposure. Efficacy may also be improved, with evidence from the immunocompetent murine model showing that vectorized anti-CTLA-4 antibodies have anti-tumoral activity even against `cold tumors' that are resistant to systemically-delivered checkpoint inhibitors. Furthermore, the precise targeting of the antibody to a unique functional epitope of CTLA-4 provides a higher level of regulatory T cells (Treg) depletion than ipilimumab. The safety-relevant data, published in JITC, show that a murine vector version of BT-001 delivered sustained levels of CTLA-4-receptor-saturating antibodies within tumors but low, sub-saturating exposure in blood and non-tumor tissue. These antibody levels were associated with high depletion of Tregs in the tumor but the absence of systemic Treg depletion, notably in the spleen. The study also provides several key insights into likely mechanisms underlying the efficacy of BT-001. Vectorized anti-CTLA-4: triggered both Fcy-receptor-dependent Treg depletion and antigen cross-presentation, mechanisms known to trigger and promote long-lasting, systemic, CD8+ T cell antitumor immunity. showed broad antitumor activity, including activity against murine `cold tumor' models which are resistant to systemic checkpoint inhibitors. Showed additive or synergistic anti-tumor activity when combined with anti-PD-1. The JITC paper is titled `Vectorized Treg-depleting anti-CTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject "cold" tumors' and can be accessed here. Recruitment in the ongoing Phase 1/2a clinical study of BT-001 (NCT04725331) in Europe is progressing steadily. The trial assesses BT-001 as a single agent and in combination with the PD-1 checkpoint inhibitor pembrolizumab against solid tumors. Initial Phase I data are expected in the first half of 2022. Announcement • Jan 06
BioInvent International AB (publ)(OM:BINV) dropped from OMX Nordic Small Cap Index "BioInvent International AB (publ) has been removed from OMX Nordic Small Cap Index Recent Insider Transactions • Dec 25
Independent Director recently bought €74k worth of stock On the 20th of December, Bernd Seizinger bought around 16k shares on-market at roughly €4.70 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €263k more in shares than they have sold in the last 12 months. Announcement • Dec 19
BioInvent International AB (publ) Announces Positive Early Data from Ongoing Solid Cancer Trial of BI-1206 in Combination with Pembrolizumab BioInvent International AB ("BioInvent") announced positive early data from the ongoing clinical study of its novel anti-FcyRIIB antibody BI-1206 in combination with anti-PD-1 therapy pembrolizumab (Keytruda®) for the treatment of patients with solid tumors. Early observations are that BI-1206 may stem and reverse metastatic disease progression in patients who have previously progressed on PD-1/PDL-1 therapies and other prior treatments. No major safety concerns have been noted. The study and the observed responses will be discussed as part of BioInvent's Key Opinion Leader Webinar on BI-1206 on December 17, 2021. The 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. As of November 29, 2021, eleven patients in three dose cohorts have been treated with BI-1206 in combination with pembrolizumab and four patients are still on treatment. During the study period, a patient with stage IV sarcoma was able to stop all pain medication, the coughing disappeared, and the shortness of breath markedly improved. From the time of ending participation in the BI-1206 study, the patient did not receive any other anti-cancer treatment and showed on a scan performed in September 2021 that some metastatic lesions have disappeared, some are smaller, and others have not changed. No lesions have grown, and no new lesions are evident. Another patient, with uveal melanoma, demonstrated a partial response and is still on treatment with the combination of BI-1206 and pembrolizumab. Metastatic uveal melanoma is a difficult-to-treat disease, with median overall survival of approximately 13.4 months, with only 8% of patients surviving after 2 years). Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA, with whom BioInvent has a clinical trial collaboration and supply agreement for this study. Announcement • Dec 13
Bioinvent International Announces Updated Positive Interim Top-Line Data from Its Novel Anti-FcyRIIB Antibody Bi-1206 BioInvent International AB ("BioInvent") announced updated positive interim top-line data from its novel anti-FcyRIIB antibody BI-1206 that show increased response levels and sustained complete responses. The data represent the status to early November 2021 - of the company's Phase 1/2a clinical trial of BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) treating patients with indolent relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). They are published in a poster at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021). The ASH 2021 poster shows that BI-1206 in combination with rituximab provided an objective response rate (ORR) of 54%, with three complete responses and four partial responses in 13 patients evaluated for therapeutic benefit for the three indications (Mantle cell lymphoma, Marginal zone lymphoma and Follicular lymphoma) enrolled in the clinical study. The treatment stabilized disease in one additional patient, giving a disease control rate of 62% (8 out of 13 patients). When considered alone, the response rate for Follicular lymphoma is particularly impressive: of nine evaluable patients, three developed a CR, three developed a PR and one patient had SD at the cut-off date, giving a 67% ORR and 78% DCR. Previous rituximab treatments without BI-1206 had failed in these patients, prior to participation in the trial all patients had relapsed on earlier lines of rituximab-containing treatments. Announcement • Dec 11
Bioinvent and CASI Pharmaceuticals Announce CTA Approval for Clinical Studies of BI-1206 in NHL in China BioInvent International AB announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), China's medical product regulator, has approved a Clinical Trial Application (CTA) submitted by BioInvent's licensee in China, CASI Pharmaceuticals (CASI). The CTA is for the initiation of two clinical trials of BioInvent's novel anti-FcyRIIB antibody, BI-1206, in patients with non-Hodgkin's Lymphoma (NHL) in China. BI-1206 is BioInvent's lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors, and the other in combination with rituximab for the treatment of non-Hodgkin's lymphoma. CASI is planning Phase 1 trials of BI-1206 as a single agent with the aim to evaluate the PK profile and in combination with rituximab in NHL (mantle cell lymphoma, marginal zone lymphoma and follicular lymphoma) to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in China and associated markets. The studies are expected to start in H1 2022. BioInvent and CASI have an exclusive licensing agreement for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau in both liquid and solid cancers, with CASI responsible for commercialization in China and associated markets. BioInvent is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206. Announcement • Dec 09
BioInvent International AB Submits Clinical Trial Application for a Phase 1/2a trial of BI-1607 BioInvent International AB announced it has submitted a Clinical Trial Application (CTA) for the novel, fully human FcyRIIB-blocking antibody, BI-1607. BI-1607 targets FcyRIIB but is modified in its Fc region to alter its affinity for Fc receptors. Byselectively blocking FcyRIIB, BI-1607 enhances the activity of other therapeutic monoclonalantibodies, whose mechanism-of-action involves depletion of tumors or immune suppressivecells. Understanding the biology of FcR/Fc interactions was essential for generating BI-1607,which has a clearly differentiated profile from BioInvent's lead drug candidate BI-1206.BioInvent intends to explore the activity of BI-1607 in advanced solid tumors and antibodycombinations supported by strong preclinical data. Reported Earnings • Oct 29
Third quarter 2021 earnings released: kr1.07 loss per share (vs kr1.00 loss in 3Q 2020) The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: kr2.99m (down 82% from 3Q 2020). Net loss: kr62.6m (loss widened 90% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 27
Second quarter 2021 earnings released: kr0.98 loss per share (vs kr2.00 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: kr5.29m (down 66% from 2Q 2020). Net loss: kr57.3m (loss widened 46% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. Announcement • Jun 25
BioInvent International AB (publ) Receives Notice of Allowance in China for BI-1206 Patent BioInvent International AB announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-Fc?RllB antibody BI-1206 is granted contingent on payment of the issue fee. This patent allowance is a strategic milestone in BioInvent's exclusive licensing agreement with CASI Pharmaceuticals Inc., a U.S. biopharmaceutical company with an established clinical development and commercial infrastructure in China. In 2020, CASI gained the rights for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau. Other patents in the same patent family have already been granted by the European Patent Office and in several other countries, including the US and Japan. The company also has related patent applications pending in some countries. Announcement • May 27
Bioinvent International AB and Transgene Receive IND Approval from the U.S. FDA for BT-001 BioInvent International AB and Transgene announced that their Investigational New Drug (IND) application for BT-001 has been granted by the U.S. Food and Drug Administration (FDA). This IND will allow patients in the U.S. to be enrolled into the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001. BT-001 is armed with both a differentiated Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF. The ongoing Phase 1/2a study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab. The Phase 1 part of the trial has already been initiated in Europe, where it is enrolling patients in several countries. BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity. As a consequence, the safety and tolerability profile of the anti-CTLA4 antibody is expected to be greatly improved due to reduced systemic exposure. BT-001 is being codeveloped through a 50/50 collaboration between BioInvent and Transgene. The Phase 1 trial is divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Patients will receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with the standard treatment regimen of pembrolizumab in 12 patients. The Phase 2a part of the trial will evaluate BT-001-based combination regimen in several patient cohorts with different 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. Reported Earnings • Apr 30
First quarter 2021 earnings released: kr1.94 loss per share (vs kr1.75 loss in 1Q 2020) The company reported a poor first quarter result with increased losses, weaker revenues and weaker control over costs. First quarter 2021 results: Revenue: kr6.20m (down 63% from 1Q 2020). Net loss: kr79.8m (loss widened 144% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has only increased by 10% per year, which means it is significantly lagging earnings growth. Reported Earnings • Apr 11
Full year 2020 earnings released: kr2.66 loss per share (vs kr7.64 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: kr147.4m (up 57% from FY 2019). Net loss: kr76.3m (loss narrowed 45% from FY 2019). Products in clinical trials Phase I: 4 Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth. 
