Reported Earnings • May 02
First quarter 2026 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2026 results: kr1.81 loss per share (further deteriorated from kr1.77 loss in 1Q 2025). Revenue: kr13.4m (down 39% from 1Q 2025). Net loss: kr119.2m (loss widened 2.2% from 1Q 2025). Revenue missed analyst estimates by 9.8%. Earnings per share (EPS) exceeded analyst estimates by 4.9%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 9.9% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings. 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 Price Target Changed • Mar 18
Price target increased by 14% to kr96.67 Up from kr85.00, the current price target is an average from 3 analysts. New target price is 313% above last closing price of kr23.40. Stock is down 26% over the past year. The company is forecast to post a net loss per share of kr7.04 next year compared to a net loss per share of kr5.06 last year. New Risk • Mar 18
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr333m Forecast net loss in 2 years: kr284m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. 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 New Risk • Mar 02
New major risk - Revenue and earnings growth Earnings have declined by 26% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 26% per year over the past 5 years. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr46m net loss in 2 years). Reported Earnings • Feb 27
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: kr5.06 loss per share (improved from kr6.53 loss in FY 2024). Revenue: kr226.5m (up 407% from FY 2024). Net loss: kr332.9m (loss narrowed 23% from FY 2024). Revenue missed analyst estimates by 4.4%. Earnings per share (EPS) were also behind analyst expectations. Revenue is forecast to grow 26% p.a. on average during the next 2 years, compared to a 10% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 27% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings. 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. New Risk • Nov 22
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr324m Forecast net loss in 2 years: kr69m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr69m net loss in 2 years). Share price has been volatile over the past 3 months (8.6% average weekly change). Reported Earnings • Oct 30
Third quarter 2025 earnings released: kr1.96 loss per share (vs kr1.48 loss in 3Q 2024) Third quarter 2025 results: kr1.96 loss per share (further deteriorated from kr1.48 loss in 3Q 2024). Revenue: kr3.32m (down 74% from 3Q 2024). Net loss: kr129.2m (loss widened 33% from 3Q 2024). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 5% per year, which means it has not declined as severely as earnings. Price Target Changed • Aug 28
Price target decreased by 8.1% to kr85.00 Down from kr92.50, the current price target is an average from 2 analysts. New target price is 174% above last closing price of kr31.00. Stock is down 14% over the past year. The company is forecast to post earnings per share of kr9.74 next year compared to a net loss per share of kr6.53 last year. Breakeven Date Change • Aug 28
Forecast breakeven date moved forward to 2026 The 2 analysts covering BioInvent International previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of kr197.9m in 2026. Average annual earnings growth of 51% is required to achieve expected profit on schedule. Reported Earnings • Aug 26
Second quarter 2025 earnings released: EPS: kr0.59 (vs kr2.09 loss in 2Q 2024) Second quarter 2025 results: EPS: kr0.59 (up from kr2.09 loss in 2Q 2024). Revenue: kr198.1m (up kr193.5m from 2Q 2024). Net income: kr38.8m (up kr176.1m from 2Q 2024). Profit margin: 20% (up from net loss in 2Q 2024). The move to profitability was driven by higher revenue. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 53% 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. New Risk • Aug 25
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr468m Forecast net loss in 2 years: kr59m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. 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. New Risk • May 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr35m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). New Risk • May 02
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr468m Forecast net loss in 2 years: kr35m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. Price Target Changed • Apr 29
Price target decreased by 11% to kr80.00 Down from kr90.00, the current price target is provided by 1 analyst. New target price is 159% above last closing price of kr30.90. Stock is up 19% over the past year. The company is forecast to post earnings per share of kr9.74 next year compared to a net loss per share of kr6.53 last year. Reported Earnings • Apr 08
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2024 results: kr6.53 loss per share (further deteriorated from kr5.02 loss in FY 2023). Net loss: kr429.4m (loss widened 30% from FY 2023). Products in clinical trials Phase I: 6 Phase II: 5 Revenue exceeded analyst estimates by 49%. Earnings per share (EPS) missed analyst estimates by 66%. Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 17% per year, which means it has not declined as severely as earnings. 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 Breakeven Date Change • Mar 09
Forecast breakeven date pushed back to 2026 The analyst covering BioInvent International previously expected the company to break even in 2025. New forecast suggests the company will make a profit of kr161.5m in 2026. Average annual earnings growth of 75% is required to achieve expected profit on schedule. Reported Earnings • Mar 03
Full year 2024 earnings released: kr6.53 loss per share (vs kr5.02 loss in FY 2023) Full year 2024 results: kr6.53 loss per share (further deteriorated from kr5.02 loss in FY 2023). Net loss: kr429.4m (loss widened 30% from FY 2023). Revenue is forecast to grow 66% p.a. on average during the next 2 years, compared to a 19% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 4% per year, which means it has not declined as severely as earnings. 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. Reported Earnings • Nov 01
Third quarter 2024 earnings released: kr1.48 loss per share (vs kr1.08 loss in 3Q 2023) Third quarter 2024 results: kr1.48 loss per share (further deteriorated from kr1.08 loss in 3Q 2023). Net loss: kr97.2m (loss widened 37% from 3Q 2023). Revenue is forecast to grow 85% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has remained flat, which means it is well ahead of earnings. 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 (9.4% 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 17% growth forecast for the Biotechs industry in Sweden. 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 9% 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 24
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 15% growth forecast for the Biotechs industry in Sweden. 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 21% per year, which means it is performing significantly worse than earnings. Price Target Changed • Apr 10
Price target decreased by 23% to kr83.00 Down from kr108, the current price target is provided by 1 analyst. New target price is 361% above last closing price of kr18.00. Stock is down 39% over the past year. The company is forecast to post a net loss per share of kr3.93 next year compared to a net loss per share of kr5.02 last year. 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: Revenues exceed analysts expectations while EPS lags behind 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 exceeded analyst estimates by 36%. Earnings per share (EPS) missed analyst estimates by 1.5%. Revenue is forecast to grow 114% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Sweden. 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 33% 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 02
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr1.03b (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: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 13%. Revenue is forecast to grow 118% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in Sweden. 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 30% 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 kr603k worth of stock On the 30th of August, Bernd Seizinger bought around 36k shares on-market at roughly kr16.76 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 kr1.5m more in shares than they have sold in the last 12 months. Reported Earnings • Aug 31
Second quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind 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 exceeded analyst estimates by 46%. Earnings per share (EPS) missed analyst estimates by 5.6%. Revenue is forecast to grow 105% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in Sweden. 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 19% per year, which means it is significantly lagging earnings. New Risk • Aug 16
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: kr1.08b (US$99.0m) 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 (kr1.08b market cap, or US$99.0m). Recent Insider Transactions • Jul 16
Independent Director recently bought kr238k worth of stock On the 13th of July, Kristoffer Bissessar bought around 14k shares on-market at roughly kr17.00 per share. This transaction amounted to 93% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought kr762k more in shares than they have sold in the last 12 months. 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. Recent Insider Transactions • Jun 02
Independent Chairman of the Board recently bought kr127k worth of stock On the 25th of May, Leonard Kruimer bought around 5k shares on-market at roughly kr25.45 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Leonard has been a buyer over the last 12 months, purchasing a net total of kr172k worth in shares. Recent Insider Transactions • May 31
Independent Chairman of the Board recently bought kr127k worth of stock On the 25th of May, Leonard Kruimer bought around 5k shares on-market at roughly kr25.45 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Leonard has been a buyer over the last 12 months, purchasing a net total of kr172k worth in shares. 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 19
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: Revenues exceed analyst expectations Full year 2022 results: Revenue: kr326.1m (up kr306.7m from FY 2021). Net loss: kr42.5m (loss narrowed 85% from FY 2021). Revenue exceeded analyst estimates by 4.3%. Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Sweden. 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 2% per year, which means it is significantly lagging earnings. 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. 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 Sweden. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has fallen by 4% per year, which means it is significantly lagging earnings. Breakeven Date Change • Jan 01
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. Price Target Changed • Nov 16
Price target increased to kr113 Up from kr102, the current price target is an average from 2 analysts. New target price is 224% above last closing price of kr34.85. Stock is down 22% over the past year. The company is forecast to post a net loss per share of kr0.96 next year compared to a net loss per share of kr5.14 last year. Reported Earnings • Oct 28
Third quarter 2022 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 119%. Earnings per share (EPS) also surpassed analyst estimates by 15%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 27% growth forecast for the Biotechs industry in Sweden. 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. Major Estimate Revision • Sep 27
Consensus revenue estimates increase by 130% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from kr84.2m to kr193.6m. Forecast losses expected to reduce from -kr4.75 to -kr0.96 per share. Biotechs industry in Sweden expected to see average net income growth of 8.6% next year. Consensus price target up from kr102 to kr112. Share price rose 11% to kr45.90 over the past week. Price Target Changed • Sep 26
Price target increased to kr112 Up from kr99.50, the current price target is an average from 2 analysts. New target price is 157% above last closing price of kr43.40. Stock is up 20% over the past year. The company is forecast to post a net loss per share of kr4.75 next year compared to a net loss per share of kr5.14 last year. Announcement • Sep 07
BioInvent International AB (publ) to Report Q2, 2023 Results on Aug 30, 2023 BioInvent International AB (publ) announced that they will report Q2, 2023 results on Aug 30, 2023 