26.07.2016 08:49:00
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BioInvent Interim Report 1 January – 30 June 2016
Regulatory News:
BioInvent (STO:BINV)
Second quarter 2016, April - June
· Net sales for April-June 2016 amounted to SEK 10 (3.7) million.
· Earnings after tax for April-June 2016: SEK -27 (-25) million.
· Earnings after tax per share for April-June 2016 before and after dilution: -0.10 (-0.19) SEK.
· Cash flow from current operations and investment activities for April-June 2016: SEK -27 (-31) million.
Half year report 2016, January – June
· Net sales for January-June 2016 amounted to SEK 40 (4.3) million.
· Earnings after tax for January-June 2016: SEK -27 (-47) million.
· Earnings after tax per share for January-June 2016 before and after dilution: SEK -0.13 (-0.39).
· Liquid funds as of 30 June 2016: SEK 224 (63) million. Cash flow from current operations and investment activities for January-June 2016: SEK -26 (-51) million.
Important events in the second quarter and after the reporting period
· BioInvent’s rights issue of SEK 191 million was completed in April 2016. 85.4 percent of the new share issue, was subscribed for with subscription rights and 7.8 percent of the share issue, was subscribed for without subscription rights. The remaining part of the new share issue, 6.8 percent of the total proceeds, was subscribed for by guarantors. In parallel with the rights issue BioInvent carried out a directed share issue (private placement) to US specialist investor Omega Funds for SEK 43 million.
· BioInvent announced in April 2016 that the BI-505 Phase II trial received regulatory approval to initiate recruitment of patients with multiple myeloma. The first patient was included in May.
· BioInvent announced in May 2016 the initiation of a Phase I/IIa study that will evaluate the safety and tolerability, and explore the preliminary efficacy, of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumour mainly affecting children.
· BioInvent’s Board Director Mr. Dharminder Chahal increased his shareholding in BioInvent by the acquisition of 13,980,000 shares in May 2016. Following the transaction, Mr. Chahal held 5.02 percent of the outstanding shares and votes in BioInvent. Mr. Chahal has declined re-election and after the Annual General Meeting 12 May, 2016 he is no longer a Board Director.
· BioInvent announced in July 2016 it had signed an agreement with Alligator Bioscience AB to provide process development and manufacturing services for Alligator’s new bispecific antibody, ADC-1015. The agreement is expected to generate revenues of more than SEK 20 million, with the majority in 2017.
Comments from the CEO "In the second quarter, BioInvent has further strengthened the foundation that we believe is necessary for the company’s long term value creation.
Our clinical portfolio now contains of three programs aiming to treat different severe forms of cancer with our unique immuno-oncology antibodies. During the quarter, the last regulatory approvals were obtained for three clinical trials, which have been initiated or are scheduled to recruit during the year. In May, the first patient was included in the Phase II study with BI-505 – a potential new treatment for multiple myeloma, which is an incurable form of blood cancer. Furthermore a Phase I/II study was initiated in which the TB-403 antibody is investigated in children and adolescents with relapse in medulloblastoma. Regulatory approval was also obtained for study of BI-1206 for the treatment of chronic lymphatic leukemia and non-Hodgkin lymphoma, where patient enrollment is scheduled during the autumn.
BioInvent’s portfolio of clinical projects is derived from the company’s groundbreaking preclinical research. Interest in BioInvent’s scientific advances in the field of immuno-oncology has increased over the past few years. Articles published in some of the highest ranked scientific journals have drawn attention and the company has formed prestigious research partnerships with leading academic groups in both the UK and the US. In parallel with BioInvent’s extensive efforts preparing for and conducting clinical studies with BI-1206, BI-505 and TB-403, activity related to the company’s preclinical drug projects remained high during the quarter. These projects are described further below in this report.
In addition, during the spring we have strengthened BioInvent’s ability to independently produce antibodies, especially following the decision to invest in a "Single Use Bioreactor”. This investment will benefit the development of our internal projects, but could also generate revenue when we take advantage of our expertise and manufacturing capacity to provide external companies with antibodies. The manufacturing agreement signed with Alligator Bioscience earlier in July is an example of the latter, and is expected to generate revenues totaling more than SEK 20 million.
Through the progress BioInvent has made in the preclinical, clinical and technical manufacturing areas, we have created a strong foundation for long-term value creation. The company’s ability to produce results which clearly show it is executing on its strategy has enabled us to achieve two successful new share issues this spring, resulting in a solid financial position and a strengthened shareholder base. Consequently, we have excellent prospects for continuing our work to develop tomorrow's immuno-oncology drugs,” says Michael Oredsson, CEO of BioInvent.
The report is also available at www.bioinvent.com
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 8.40 a.m. CET, on 26 July, 2016.
BioInvent International AB, listed on Nasdaq Stockholm, develops immuno-oncology drugs. With one of the world’s largest antibody libraries, and a unique, proprietary discovery method, BioInvent can identify the optimal cellular targets and antibodies for the treatment of various tumour types. BioInvent currently has three proprietary projects in or close to clinical stage, two manufacturing agreements, and research and/or licensing agreements with seven global pharmaceutical and biotech companies. BioInvent is implementing an upgrade to its manufacturing facility for the manufacturing of antibodies and is installing a Single Use Bioreactor (SUB). This will provide BioInvent with the manufacturing capability to support its own expanding development programs while offering manufacturing support to selected partners.
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