Interim / Quarterly Report • Aug 22, 2019
Interim / Quarterly Report
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Progress in hematological cancer and expanding into solid cancer

"We are executing according to plan. Our lead candidate BI-1206 has shown encouraging initial data in hematological cancers, and has now also entered clinical trials in solid cancer."
Martin Welschof, CEO BioInvent
BioInvent made significant progress in the second quarter and we executed our activities according to plan.
In particular, initial data from the two parallel Phase I/IIa trials of our lead product BI-1206 further supported its development as a potential first-inclass therapeutic with a unique mechanism of action. It was encouraging to see that the analysis at current doses showed depletion of peripheral B cells. The next step is now to define the optimal dose.

We are encouraged by the current data for our lead compound BI-1206 in hematological cancer, but it is important to emphasize that BioInvent is much more than just one program. We have put tremendous efforts into our pre-clinical portfolio and especially into our BI-1206 program in solid tumors. Therefore, it was very rewarding that the FDA approved our IND application for a Phase I/IIa study and I am pleased that this program now has advanced into clinical stage.
These efforts targeting solid tumor indications demonstrate the depth of our pipeline and the productivity of our proprietary F.I.R.S.T™ platform technology. Through our technology we can simultaneously identify targets and high-quality antibodies that bind to them, generating potentially promising new drug candidates.
In the quarter our n-CoDeR® antibody library and our F.I.R.S.T™ platform received further validation when Pfizer selected its first target under the agreement signed in December 2016. Furthermore, the acceptance by the FDA of an IND application for TAK-169 was another recognition for our technology.
Taken together, these milestones demonstrate the strength of our platform – producing novel antibody-based cancer therapies, broadening our own pipeline and opening up for more licensing and partnering.
Martin Welschof CEO
| Indication | Program | Discovery | Preclinical | Phasel | Phase II |
|---|---|---|---|---|---|
| Target: FcyRIIB | |||||
| NHL (MCL, MZL, iFL) | BI-1206/rituximab | ||||
| Solid canos | BI-1206/pembrolizumab | ||||
| Solid cancer | BI-1607 | ||||
| Target: Treg | |||||
| Solid canos | aCTLA-4-GM-CSF-W | Partner: Transgene |
|||
| Solid cancer | BI-1808 (αTNFR2) | ||||
| Solid cancer | F.I.R.S.TTM a Treg | ||||
| Target: Tumor-associated myeloid cells | |||||
| Solid canog | F.I.R.S.TTM a.TAMs | Partner: Pfizer |
BioInvent's current operational activities are focused on:
In June 2019 BioInvent announced the publication of the first data from the two parallel Phase l/lla clinical trials. Up to that point, in the UK trial, 10 patients had received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients had received up to 100 mg BI-1206 in combination with rituximab. The data are published in the Abstract Book from the 15-ICML International Conference on Malignant Lymphoma.
Receptor occupancy is dose proportionate and yields high levels of receptor blockade at clinically relevant doses of BI-1206. Target-mediated drug disposition has not yet been overcome, and thus, the optimal dose has not yet been reached. Notwithstanding, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy.
BI-1206 is a monoclonal antibody that recognizes with high affinity and selectivity FcγRIIB (CD32B), the only inhibitory member of the FcγR family. CD32B is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking FcγRIIB, BI-1206 is expected to recover and enhance the activity of rituximab or other anti-CD20 monoclonal antibodies in the treatment of these diseases. The combination of the two drugs could provide a new and important option for patients suffering from NHL, and represents a substantial commercial opportunity.
In September 2018 BioInvent started dosing of the first patient in a dose escalation, consecutivecohort, open-label phase I/IIa study of BI-1206. The study will recruit approximately 30 patients across sites in the EU and the U.S. The trial is evaluating BioInvent's proprietary antibody BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma. The targeted subindications are mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. The study will explore BI-1206's safety and tolerability, and seek to determine a recommended phase ll dose (RP2D) when given in combination with rituximab. Expression of biomarkers will be assessed to explore a potential correlation with clinical activity. Topline results from the study are expected in the first half of 2020.
This study is run in parallel with the ongoing Phase I/IIa study of BI-1206 in patients with CLL and NHL conducted in the UK by Cancer Research UK. The ongoing study is currently testing single agent activity and is open for enrollment.
In January 2019 the U.S. Food and Drug Administration granted orphan designation for BI-1206 for the treatment of mantle cell lymphoma.
In July 2019 BioInvent received authorization from the FDA to proceed with an IND application for a Phase I/IIa clinical trial of BI-1206 in combination with pembrolizumab for the treatment of solid tumors.
The program is based on BioInvent's preclinical data demonstrating the ability of BI-1206 to address an important mechanism of resistance to PD1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. The Phase I/IIa clinical trial will evaluate the drug combination in patients with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies, and is a multicenter, dose-finding, consecutive-cohort, open-label trial. The Phase I/IIa trial is planned to be carried out in the U.S. and the EU.
The study progresses according to plan, and the fourth dose level is ongoing. Initial data from this study are anticipated towards the end of 2019.
TB-403 is currently in a Phase I/II study for the treatment of patients with medulloblastoma in cooperation with a US based pediatric oncology network, Beat Childhood Cancer.
TB-403 has received Orphan Designation for medulloblastoma from the European Medicines Agency (EMA). TB-403 is developed in collaboration with Oncurious, a subsidiary of Oxurion. BioInvent's ownership in TB-403 is 50 percent and it contributes with 50 percent of the development costs.
In August 2019 Oxurion reported topline month 3 results of Phase lla Study Evaluating THR-317 in Combination with Ranibizumab, for Diabetic Macular Edema. The combination therapy did not show increase in best corrected visual acuity (BCVA) in the overall population at Month 3. Certain improvement in mean BCVA at Month 3 was observed with the combination therapy in two prespecified subgroups.Topline data confirmed that THR-317 in combination with ranibizumab is safe and well-tolerated.
Oxurion carries all costs for the development of THR-317 in non-oncology indications, and BioInvent is entitled to five percent of the project's economic value.
BioInvent's preclinical research is focused on developing novel immuno-modulatory antibodies for cancer therapy. Such antibodies may significantly improve efficacy of currently available checkpoint inhibitor therapies and/or activate anti-cancer immunity in currently non-responding patients and cancer types.
In partnership with Pfizer Inc. since December 2016, BioInvent works to identify novel oncology targets and therapeutic antibodies that may either reverse the immunosuppressive activity of tumorassociated myeloid cells or reduce the number of tumor-associated myeloid cells in the tumor.
BioInvent announced in July 2019 selection of the first target discovered by BioInvent's proprietary F.I.R.S.T™ technology platform under the collaboration with Pfizer Inc. The selection of a target triggered a payment from Pfizer to BioInvent of \$0.3 million. Under the terms of the 2016 agreement, potential selection and development of antibodies directed against this target, as well as potential selection of further targets and development of antibodies directed at them, would allow BioInvent to be eligible for further milestone payments.
BioInvent is eligible for potential future development milestones in excess of \$500 million (assuming five antibodies are developed through to commercialization). The Company could also receive up to double digit royalties related to product sales. In exchange, Pfizer will have the right to develop and commercialize any antibodies generated from this agreement.
BioInvent received an upfront payment of \$3 million when the agreement was signed in December 2016, and research funding has been received during 2017, 2018 and 2019. Pfizer also made a \$6 million equity investment in new shares of BioInvent when the agreement was signed.
Tregs can substantially inhibit various immune responses, enabling tumor cells to escape detection. BioInvent is utilizing its F.I.R.S.T™ platform to identify and characterize monoclonal antibodies to cancer-associated Treg targets in a function-first, target-agnostic, manner. The company is also pursuing differentiated antibodies to known targets through novel mechanisms and pathways.
BioInvent has identified TNFR2, a member of the so called TNFR superfamily (TNFRS) as a target within the Treg program. The company has antibody candidates with various mechanisms of action that show promising preclinical data. The most advanced candidate is BI-1808 and a first clinical study is scheduled for H1 2020.
BioInvent and Transgene collaborate to co-develop oncolytic virus (OV) candidates encoding a validated anti-CTLA-4 antibody sequence - potentially with additional transgenes - aimed at treating solid tumors.
Transgene is contributing both its OV design and engineering expertise, as well as its proprietary Vaccinia viruses, designed to directly and selectively destroy cancer cells by intracellular replication of the virus in the cancer cell (oncolysis). Oncolysis induces an immune response against tumors, while the "weaponized" virus allows the expression of genes carried by the oncolytic viral genome, such as an immune modulatory anti-CTLA-4 antibody, to further boost immune response against the tumor.
BioInvent is providing its cancer biology and antibody expertise to the collaboration, as well as anti-CTLA-4 antibody sequences generated through its proprietary n-CoDeR® /F.I.R.S.TTM platforms.
This novel OV product has the potential to be significantly more effective than the combination of single agents. Transgene has generated preclinical proof-of-concept data showing that an oncolytic vaccinia virus encoded with a checkpoint inhibitor resulted in better overall survival than the corresponding combination of separate single agents.
In March 2019 BioInvent and Transgene announced an extension of their collaboration to co-develop multi-functional oncolytic viruses encoding antibodies targeting an undisclosed target, which can be used in the treatment of a broad range of solid tumors.
The research and development costs, as well as revenue and royalties from candidates generated from the collaboration, will be shared 50:50
Figures in parentheses refer to the outcome for the corresponding period in the preceding year.
Net sales amounted to SEK 32.9 million (9.8). Revenues for the period are mainly derived from production of antibodies for clinical studies, revenues from research funding and also a €0.75 million milestone payment received under the collaboration with Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in a Phase II clinical trial and a \$0.5 million milestone payment from XOMA Corporation related to the acceptance by FDA of an IND application.
The Company's total costs amounted to SEK 66.1 million (53.3). Operating costs are divided between external costs of SEK 46.0 million (35.0), personnel costs of SEK 17.2 million (17.0) and depreciation of SEK 2.9 million (1.3). During the period, the transition to IFRS 16 affected the operating result by 1.5 SEK million in increased depreciation and SEK 1.5 million in reduced external costs, and thus had no material effect on the operating result.
Research and development costs amounted to SEK 58.4 million (45.7).
Loss after tax amounted to SEK -32.8 million (-43.2). The net financial items amounted to SEK -0.1 million (0.0). Loss per share before and after dilution amounted to SEK -0.07 (-0.12).
Net sales amounted to SEK 50.3 million (21.1). Revenues for the period are mainly derived from production of antibodies for clinical studies, revenues from research funding and also a €0.75 million milestone payment received under the collaboration with Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in a Phase II clinical trial and a \$0.5 million milestone payment from XOMA Corporation related to the acceptance by FDA of an IND application.
The Company's total costs amounted to SEK 114.5 million (90.0). The increased costs is mainly due to that additional projects are moving towards clinical phase. Operating costs are divided between external costs of SEK 76.5 million (56.6), personnel costs of SEK 32.3 million (31.0) and depreciation of SEK 5.7 million (2.4). During the period, the transition to IFRS 16 affected the operating result by 3.0 SEK million in increased depreciation and SEK 3.1 million in reduced external costs, and thus had no material effect on the operating result.
Research and development costs amounted to SEK 99.9 million (74.6).
Loss after tax amounted to SEK -60.6 million (-68.1). The net financial items amounted to SEK -0.2 million (0.1). Loss per share before and after dilution amounted to SEK -0.15 (-0.21).
The Board of Directors of BioInvent resolved in February 2019 on a fully underwritten rights issue of SEK 210.5 million (prior to issue costs) and a directed issue of SEK 30.0 million (prior to issue costs) with a Swedish pension fund and a Swedish life science fund. The rights issue and the directed issue have been completed and 46.9 percent of the rights issue was subscribed for with subscription rights. 0.7 percent was subscribed for without subscription rights and 52.4 percent was subscribed for by guarantors.
In June 2018, 669,936 shares were subscribed for to secure the fulfilment of the Company's obligations under the Board Share Program 2018. The subscription price per share amounted to the share's quota value (0.08).
After the share issues the share capital consists of 501,769,896 shares.
As of June 30, 2019, the Group's liquid funds amounted to SEK 210.3 million (144.7). The cash flow from operating activities and investment activities for the January-June period amounted to SEK -75.8 million (-69.4).
The shareholders' equity amounted to SEK 247.3 million (142.5) at the end of the period. The Company's share capital at the end of the period was SEK 40.1 million. The equity/assets ratio at the end of the period was 78 (77) percent. As an effect of the transition to IFRS 16, the Group's total assets have increased. As of June 30, 2019 lease assets amounted to 6 percent of total assets, which had a negative impact on the key financial ratio equity/assets ratio. Shareholders' equity per share amounted to SEK 0.49 (0.41).
Investments for the January - June period in tangible fixed assets amounted to SEK 1.9 million (2.6).
All operations of the Group are conducted by the Parent Company. Except for financial leases, the Group's and the Parent Company's financial statements coincide in every material way.
As of June 30, 2019, BioInvent had 67 (58) employees. 61 (51) of these work in research and development.
The 2016 Annual General Meeting resolved to adopt an incentive program for the Company's employees in the form of a subscription warrants program. Under the program 957,571 subscription warrants have been transferred with a maximum dilution effect of approximately 0.2 percent. The program includes all employees except the CEO and other senior executives comprised by the retention bonus program implemented in 2015. Subscription of shares by exercise of subscription warrants shall take place during the period from and including July 1, 2019 up to and including December 1, 2019. The subscription price per share shall be SEK 2.81.
The 2017 Annual General Meeting resolved to adopt a long-term incentive program in the form of an option program comprising management and other key persons, entailing a directed issue of maximum of 7,117,000 warrants (corresponding to approximately 1.4 percent of the total number of shares and votes in the Company) and approval of transfer of warrants to secure the fulfilment of the Company's obligations under the program and social security charges. The program means that the participants may be allotted a maximum of 5,650,000 warrants depending on performance and the Company's long-term value growth. Each option entitles the holder to subscribe for one new share in BioInvent during the period from the day of release of the Company's year-end report for the financial year 2019 up to and including December 15, 2020. The subscription price per share shall be SEK 3.00. The program has been implemented in the third quarter 2017 and includes currently 10 persons. Allotment of 591,759 options took place in January 2018 and 462,766 in January 2019.
The 2019 Annual General Meeting resolved to adopt a long-term incentive program in the form of an option program comprising the management group. The option program comprise a maximum of 3,971,000 stock options and the participants may be allotted options free of charge based on performance and continued employment. Each option entitles the holder to subscribe for one new share in BioInvent during the period from the day of release of the company's year-end report for the financial year 2022 up to and including 15 December 2025. The subscription price per share shall be SEK 3.16, corresponding to 140 percent of the volume-weighted average price paid for the company's share on the Nasdaq Stockholm during ten trading days before 25 February 2019. To enable the company's delivery of shares pursuant to the option program and to secure costs connected therewith, primarily social security charges, the AGM resolved on a directed issue of maximum of 5,040,000 warrants (corresponding to approximately 1.0 percent of the total number of shares and votes in the company) and approval of transfer of warrants.
More information is available at www.bioinvent.se (Investors / Corporate Governance / Incentive Program)
For description of benefits to senior executives, see page 45 in the Company's annual report 2018. Otherwise there are no transactions with related parties, in accordance with IAS 24, to report.
The Company's operations are associated with risks related to factors such as pharmaceutical development, clinical trials and product responsibility, commercialization and partners, competition and fast technological development, biotechnology and patent risk, compensation for pharmaceutical sales, qualified personnel and key individuals, additional financing requirements, currency risk and
interest risk. The risks summarize the factors of significance for BioInvent and thus an investment in the BioInvent share.
No significant changes to the risks and uncertainty factors occurred during the period. For a more detailed description of risk factors, see section "Risks and Risk Management", page 30, in the Company's annual report 2018.
This interim report in brief for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting and applicable parts of the Annual Accounts Act. The interim report of the Parent Company has been prepared in accordance with Chapter 9 of the Annual Accounts Act. For the Group and the Parent Company, the same accounting policies and accounting estimates and assumptions were applied to this interim report as were used in the preparation of the most recent annual report, except in respect of IFRS 16 as described below.
The Group applies IFRS 16 Leases with effect from 1 January 2019. IFRS 16 introduces a uniform lease recognition model for lessees. A lessee recognizes a right-of-use asset, representing a right to use the underlying asset, and a lease liability, representing an obligation to make future lease payments. Leases with a short term or where the underlying asset is of low value are exempted. The Group recognizes new assets and liabilities for operating leases relating to laboratory, production and office facilities. The cost of these leases changes, since the Group recognizes depreciation on lease assets and interest expense on lease liabilities. The Group applies the modified retrospective approach of 1 January 2019 without restating comparative information. In accordance with the transitional rules, the value of the asset has been set at the same amount as the liability as of January 1, 2019 (with adjustment for prepaid lease charges reported in the balance sheet as of December 31, 2018). A discount rate of 2.5 percent has been applied. Low-value leases (assets with a value of less than around SEK 50 thousand when new) are not included in the lease liability, but instead continued to be expensed on a straight line basis over the term of the lease. It is assessed that the Group does not have any significant volume of leases with a term of less than 12 months, known as short-term leases.
Other changes in IFRS standards entered into force in 2019 has had no material impact on the financial statements. The financial statements of the Parent Company coincide in every material way with the consolidated financial statements.
The definition of alternative performance measures not defined by IFRS is unchanged from those presented in the most recent annual report.
For more detailed information about the Group's accounting principles regarding revenues, see Note 1 Accounting principles, page 41, in the Company's annual report 2018.
BioInvent will present the following financial reports:
• Interim report October 24, 2019
| 3 MONTHS | 3 MONTHS | 6 MONTHS | 6 MONTHS | 12 MONTHS | |
|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
| Net sales | 32,898 | 9,793 | 50,300 | 21,125 | 38,548 |
| Operating costs | |||||
| Research and development costs | -58,416 | -45,662 | -99,863 | -74,585 | -140,182 |
| Sales and administrative costs | -7,666 | -7,648 | -14,653 | -15,380 | -27,955 |
| Other operating income and costs | 513 | 252 | 3,828 | 628 | 6,357 |
| -65,569 | -53,058 | -110,688 | -89,337 | -161,780 | |
| Operating loss | -32,671 | -43,265 | -60,388 | -68,212 | -123,232 |
| Loss from financial investments | -128 | 45 | -181 | 85 | 69 |
| Loss before tax | -32,799 | -43,220 | -60,569 | -68,127 | -123,163 |
| Tax | - | - | - | - | - |
| Loss | -32,799 | -43,220 | -60,569 | -68,127 | -123,163 |
| Other comprehensive income | |||||
| Items that have been or may be reclassified subsequently to profit or loss |
- | - | - | - | - |
| Comprehensive income | -32,799 | -43,220 | -60,569 | -68,127 | -123,163 |
| Other comprehensive income | |||||
| attributable to parent Company's shareholders | -32,799 | -43,220 | -60,569 | -68,127 | -123,163 |
| Loss per share, SEK | |||||
| Before dilution | -0.07 | -0.12 | -0.15 | -0.21 | -0.36 |
| After dilution | -0.07 | -0.12 | -0.15 | -0.21 | -0.36 |
| 2019 | 2018 | 2018 | |
|---|---|---|---|
| 30 June | 30 June | 31 Dec. | |
| Assets Fixed assets |
|||
| Intangible fixed assets | 0 | 0 | 0 |
| Tangible fixed assets - leases | 19,793 | ||
| Tangible fixed assets - other | 17,143 | 19,421 | 18,033 |
| Total fixed assets | 36,936 | 19,421 | 18,033 |
| Current assets Inventories |
5,832 | 2,703 | 2,950 |
| Current receivables | 63,521 | 17,745 | 30,566 |
| Liquid funds | 210,343 | 144,703 | 68,851 |
| Total current assets | 279,696 | 165,151 | 102,367 |
| Total assets | 316,632 | 184,572 | 120,400 |
| Shareholders' equity and liabilities | |||
| Shareholders' equity | 247,317 | 142,542 | 87,621 |
| Non-current liabilities - leases | 12,328 | ||
| Current liabilities - leases | 6,057 | ||
| Current liabilities - other | 50,930 | 42,030 | 32,779 |
| Shareholders' equity and liabilities | 316,632 | 184,572 | 120,400 |
| 2019 | 2018 | 2019 | 2018 | 2018 | |
|---|---|---|---|---|---|
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
| Shareholders' equity at beginning of period | 89,840 | 185,623 | 87,621 | 130,225 | 130,225 |
| Comprehensive income | |||||
| Loss | -32,799 | -43,220 | -60,569 | -68,127 | -123,163 |
| Comprehensive other income Total comprehensive income |
- -32,799 |
- -43,220 |
- -60,569 |
- -68,127 |
- -123,163 |
| Total, excluding transactions with equity | |||||
| holders of the Company | 57,041 | 142,403 | 27,052 | 62,098 | 7,062 |
| Transactions with equity holders of the Company | |||||
| Employee options program | 207 | 107 | 196 | 112 | 227 |
| Directed share issue | 80,300 | 80,300 | |||
| Directed share issue, Board Share Program 2017 | 32 | 32 | 32 | ||
| Directed share issue, Board Share Program 2018 | 54 | 54 | |||
| Rights issue and directed issue | 190,015 | 220,015 | |||
| Shareholders' equity at end of period | 247,317 | 142,542 | 247,317 | 142,542 | 87,621 |
The share capital as of June 30, 2019 consists of 501,769,896 shares and the share's ratio value is 0.08. The rights issue and directed issue completed in April 2019, amounted to in total SEK 220.0 million after issue expenses of SEK 20.5 million.
| 2019 | 2018 | 2019 | 2018 | 2018 | |
|---|---|---|---|---|---|
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
| Operating activities | |||||
| Operating loss | -32 671 | -43,265 | -60,388 | -68,212 | -123,232 |
| Depreciation | 2 898 | 1,275 | 5,730 | 2,424 | 5,061 |
| Adjustment for other non-cash items | 207 | 107 | 196 | 112 | 227 |
| Interest received and paid | -128 | 0 | -259 | 38 | 129 |
| Cash flow from operating activities | |||||
| before changes in working capital | -29 694 | -41,883 | -54,721 | -65,638 | -117,815 |
| Changes in working capital | -4 233 | 4,267 | -19,146 | -1,152 | -23,579 |
| Cash flow from operating activities | -33 927 | -37,616 | -73,867 | -66,790 | -141,394 |
| Investment activities | |||||
| Acquisition of tangible fixed assets | -1 342 | -2,509 | -1,888 | -2,599 | -3,847 |
| Cash flow from investment activities | -1 342 | -2,509 | -1,888 | -2,599 | -3,847 |
| Cash flow from operating activities and | |||||
| investment activities | -35 269 | -40,125 | -75,755 | -69,389 | -145,241 |
| Financing activities | |||||
| Directed issue | 76,644 | 80,300 | 80,300 | ||
| Directed issue, Board Share Program 2017 | 32 | 32 | 32 | ||
| Directed issue, Board Share Program 2018 | 54 | 54 | |||
| Rights issue and directed issue | 218 515 | 220,015 | |||
| Amortization of lease liability | -1 415 | -2,822 | |||
| Cash flow from financing activities | 217 154 | 76,676 | 217,247 | 80,332 | 80,332 |
| Change in liquid funds | 181 885 | 36,551 | 141,492 | 10,943 | -64,909 |
| Opening liquid funds | 28 458 | 108,152 | 68,851 | 133,760 | 133,760 |
| Liquid funds at end of period | 210 343 | 144,703 | 210,343 | 144,703 | 68,851 |
| Liquid funds, specification: | |||||
| Current investments | - | 30,098 | - | 30,098 | - |
| Cash and bank | 210 343 | 114,605 | 210,343 | 114,605 | 68,851 |
| 210 343 | 144,703 | 210,343 | 144,703 | 68,851 |
| 2019 | 2018 | 2018 | |
|---|---|---|---|
| 30 June | 30 June | 31 Dec. | |
| Shareholders' equity per share at end of period, SEK | 0.49 | 0.41 | 0.25 |
| Number of shares at end of period (thousand) | 501,770 | 350,800 | 350,800 |
| Equity/assets ratio, % | 78.1 | 77.2 | 72.8 |
| Number of employees at end of period | 67 | 58 | 62 |
| 3 MONTHS 2019 |
3 MONTHS 2018 |
6 MONTHS 2019 |
6 MONTHS 2018 |
12 MONTHS 2018 |
|
|---|---|---|---|---|---|
| April-June | April-June | Jan.-June | Jan.-June | Jan.-Dec. | |
| Net sales | 32,898 | 9,793 | 50,300 | 21,125 | 38,548 |
| Operating costs Research and development costs Sales and administrative costs Other operating income and costs |
-58,473 -7,671 513 -65,631 |
-45,662 -7,648 252 -53,058 |
-99,977 -14,663 3,828 -110,812 |
-74,585 -15,380 628 -89,337 |
-140,182 -27,955 6,357 -161,780 |
| Operating loss | -32,733 | -43,265 | -60,512 | -68,212 | -123,232 |
| Profit from financial investments | -5 | 45 | 73 | 85 | 69 |
| Loss after financial items | -32,738 | -43,220 | -60,439 | -68,127 | -123,163 |
| Tax | - | - | - | - | - |
| Loss | -32,738 | -43,220 | -60,439 | -68,127 | -123,163 |
| Other comprehensive income | - | - | - | - | - |
| Comprehensive income | -32,738 | -43,220 | -60,439 | -68,127 | -123,163 |
| (SEK thousand) | |
|---|---|
| ---------------- | -- |
| 2019 | 2018 | 2018 | |
|---|---|---|---|
| 30 June | 30 June | 31 Dec. | |
| Assets | |||
| Fixed assets | |||
| Intangible fixed assets Tangible fixed assets |
0 17,143 |
0 19,421 |
0 18,033 |
| Financial fixed assets | 687 | 687 | 687 |
| Total fixed assets | 17,830 | 20,108 | 18,720 |
| Current assets Inventories |
5,832 | 2,703 | 2,950 |
| Current receivables | 65,059 | 17,745 | 30,566 |
| Current investments | - | 30,098 | - |
| Cash and bank | 210,343 | 114,605 | 68,851 |
| Total current assets | 281,234 | 165,151 | 102,367 |
| Total assets | 299,064 | 185,259 | 121,087 |
| Shareholders' equity and liabilities | |||
| Shareholders' equity | |||
| Restricted equity | |||
| 67,835 | 55,757 | 55,757 | |
| Non-restricted equity | 179,650 247,485 |
86,823 142,580 |
31,902 87,659 |
| Total shareholders' equity | |||
| Liabilities | |||
| Current liabilities | 51,579 | 42,679 | 33,428 |
| Total shareholders' equity and liabilities | 299,064 | 185,259 | 121,087 |
The board of directors and the CEO hereby ensure that this interim report for the period 1 January 2019 – 30 June 2019 provides a fair overview of the operations, financial position and performance of the Company and the Group and describes the material risks and uncertainty factors faced by the Company and the companies included in the Group.
Lund, August 22, 2019
| Leonard Kruimer | Vessela Alexieva | Dharminder Chahal | Elin Jaensson Gyllenbäck |
|---|---|---|---|
| Chairman of the Board | Board member | Board member | Board member |
| An van Es Johansson | Vincent Ossipow | Bernd Seizinger | Martin Welschof |
| Board member | Board member | Board member | CEO |
We have reviewed the summarized interim financial information for BioInvent International AB (publ) on June 30, 2019 and for the six month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity". A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with the International Standards on Auditing, ISA, and other generally accepted auditing practices. The procedures performed in a review do not enable us to obtain a level of assurance that would make us aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion expressed based on an audit.
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the group's part according to IAS 34 and the Annual Accounts Act and for the parent Company's part according to the Annual Accounts Act.
Malmö, August 22, 2019 KPMG AB
Eva Melzig Authorised Public Accountant
BioInvent International AB (publ) (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Three preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. The Company's validated, proprietary F.I.R.S.TTM 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. More information is available at www.bioinvent.com.
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0)46 286 85 50, [email protected]. The report is also available at www.bioinvent.com.
Co. reg. no. 556537-7263 Address: Sölvegatan 41, 223 70 Lund Tel.: +46 (0)46 286 85 50 [email protected]
This interim report contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual out-come may deviate significantly from the scenarios described in this press release.
This information is information that BioInvent International AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 8.30 a.m. CET, on August 22, 2019.
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