Copenhagen and Oslo, 30th August, 2012, 2012-08-30 17:41 CEST (GLOBE NEWSWIRE) --
- Clinical trials sites initiated in Russia in late June 2012 by Affitech’s collaboration partner IBC Generium for anti-VEGF antibody AT001/r84
- Share capital reduction adopted at the AGM on 27th April 2012 completed
- Cash reserves of DKK 6.6 million as per 30th June 2012
- Net loss for the first half year DKK 29.5 million
- Maintain estimated net loss for 2012 of DKK 45-50 million
Additional key events following the end of the second quarter of 2012:
- First patients dosed in phase I clinical trial with AT001/r84 in Russia
- On 6th July, 2012 NASDAQ OMX Copenhagen accepted Affitech’s application for delisting of the Company provided that Trans Nova Investment Ltd., Affitech’s major shareholder, made a new offer to Affitech’s other shareholders. Such an offer was announced on 17th July, 2012 and it expired on 28th August, 2012. The delisting of the Company is expected to happen in October 2012
- An agreement for transfer of the MBASTM technology from Affitech to IBC Generium
- 1.5 million Euro short term loan provided by Trans Nova Investment Ltd.
- First development milestone payment from Roche re. LC06 antibody
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today reported a loss for the first half year 2012 of DKK 29.5 million and a cash position of DKK 6.6 million as of 30th June 2012.
Highlights of the second quarter of 2012
- Clinical trials with anti-VEGF antibody AT001/r84 were initiated in Russia in late June 2012 by Affitech’s collaboration partner IBC Generium
- On 10th May, 2012 Affitech announced the reduction of the Company's share capital by nominally DKK 156,070,892.48 from nominally DKK 243,860,769.50 to nominally DKK 87,789,877.02 for the purpose of covering losses, adopted at Affitech A/S' ordinary general meeting on 27th April, 2012. The capital reduction was carried out by a reduction of the denomination of all the shares of the company from nominally DKK 0.50 to nominally DKK 0.18.
- On 31th May, 2012, Affitech A/S issued an application to NASDAQ OMX Copenhagen for delisting of the Company according to the resolution at the Annual General Meeting on 27th April, 2012.
- On 8th June, 2012 Affitech announced that the Company had completed the reduction of the Company’s share capital by DKK 82,912,661.63, nominal value, from DKK 87,789,877.02, nominal value, to DKK 4,877,215.39, nominal value. The capital reduction was carried out by a reduction of the denomination of all the shares of the company from nominally DKK 0.18 to nominally DKK 0.01.
Progress with AT001/r84
AT001/r84 is a fully human antibody that binds to vascular endothelial growth factor A (VEGF-A), a drug target validated clinically and commercially by bevacizumab (Avastin®). Affitech’s product is a fully human antibody with highly selective binding properties: it inhibits binding to VEGF receptor 2, but not receptor 1, and in addition has very different binding kinetics to bevacizumab. Higher selectivity and altered affinity offer potential for an increased safety/efficacy profile when compared to other anti-angiogenesis compounds in the treatment of human cancer.
Manufacturing
AT001/r84 is a recombinant human antibody, and sufficient quantities of drug substance have been produced to support multiple clinical trials under Good Manufacturing Practice (GMP) standards. Drug product has been manufactured under ICH guidelines and released ready for human administration. A new production cell line has been developed that is expected to result in improved production yields at larger scales and discussions with contract manufacturing companies to scale up manufacturing are ongoing.
Clinical
Affitech’s Russian collaboration partner, IBC Generium, initiated the first clinical trial sites with AT001/r84 in late June and the first patients were dosed by August 2012. The clinical strategy for AT001/r84 is to develop the product for improved treatment of patients with various cancer sub-types which could be amenable to anti angiogenesis therapy, such as metastatic colorectal cancer, including co-administration with chemotherapy and other anticancer treatments. The first human clinical study will involve administration of single doses of the antibody to cancer patients to assess human safety and dosage level. A three month exploratory toxicology animal study has been successfully completed to help understand effects of longer term treatment. Currently a 26 week GLP animal study to support multiple dosing is ongoing.
Commercial
The pharmaceutical anti-angiogenesis market is large with world wide sales approaching $15 billion and Roche is predicting peak annual sales of bevacizumab (Avastin®) reaching USD 7.6 billion. AT001/r84 has the potential to have similar efficacy to bevacizumab with an improved safety profile. However, the properties and potential of AT001/r84 have yet to be confirmed through human clinical studies and until such data is available, it is not possible to make meaningful estimates for the probability of achieving marketing approval in different territories nor potential market size or share. Several new anti-angiogenic drugs have recently been approved for human use, while others are in late stage clinical development by a variety of pharmaceutical and biopharmaceutical companies.
AT008/CCR4 makes good progress
Affitech’s first anti-GPCR antibody program AT008, designed to block the binding of chemokine ligands to its cell surface receptor CCR4, continues to make good progress. A primary development candidate has been selected; in-vitro proof-of-concept has been achieved as well as in-vivo proof of concept in hematological tumor and solid tumor disease models; and the development of a manufacturing cell line has been initiated. The program includes several different antibodies with multiple potential mechanisms of action targeting both hematological cancers and solid tumors, and also has potential utility in some immunological diseases such as severe asthma.
Subsequent events after the end of the reporting period 30th June, 2012
- On 1st July, 2012 Affitech announced that International Biotech Center Generium (IBC Generium) and Affitech Research AS (Affitech A/S’ Norwegian subsidiary), had entered into an agreement for the transfer of Molecular Based Antibody Screening (MBASTM) technology to IBC Generium. This new agreement provides to IBC Generium access to parts of Affitech’s antibody technology platform and includes the transfer of MBASTM technology as well as access to Affitech’s phage antibody libraries. Affitech expects to obtain revenues of 0.5 million Euro in 2012 under this agreement.
- On 6th July, 2012 Affitech announced NASDAQ OMX Copenhagen’s response to the application as of May 31st for delisting of the Company. NASDAQ OMX accepted the request from Affitech provided that Trans Nova Investment Limited (Trans Nova) prepared a new offer to Affitech’s other shareholders.
- On 17th July, 2012 Trans Nova announced its new offer to all other shareholders with expiry date 28th August 2012. Trans Nova plans the announcement of the results of the new offer 31st August 2012.
- On 19th July, 2012 Affitech announced that Trans Nova had provided Affitech a short term loan of 1.5 million Euro paid out in three tranches of 0.5 million Euro in July, August and September 2012. This loan will in the short term finance Affitech’s current operations including the operations of Affitech’s subsidiary in Norway, Affitech Research AS, until Affitech’s total financing has been determined and resolved in the longer term which is expected to happen before the loan’s due date on 16th October, 2012.
- On 9th August, 2012 Affitech A/S announced that Roche has selected a development candidate and reached the first development milestone in a Research and License agreement between Hoffmann-La Roche and Affitech Research AS, Affitech A/S Norwegian subsidiary. Under the agreement Roche has licensed LC06, a human anti–angiopoietin 2 antibody, which has been generated by Affitech Research AS and which Roche has combined with its anti-VEGF antibody bevacizumab (Avastin®) to generate a bi-specific antibody, as described in Proceedings of the National Academy of Sciences, USA (PNAS July 5, 2011 vol. 108 no. 27 11187-11192).
- On 20th August, 2012 Affitech A/S announced that IBC Generium, the Company’s Russian collaboration partner has enrolled the first patients and thus initiated a First-in-Man clinical trial with Affitech’s anti-VEGF antibody AT001 in patients with various metastatic cancers.
Outlook for 2012
Affitech’s financial performance for 2012 is mainly dependent on the progress and expenses of its ongoing R&D projects. Affitech will focus on the further development of its novel anti-VEGF antibody AT001/r84, in particular on supporting the Company’s Russian strategic partner, IBC Generium, in its drive to conduct clinical trials of the drug in cancer patients.
A delisting of Affitech A/S from NASDAQ OMX Copenhagen is estimated to happen in October, 2012
Trans Nova agreed in line with its commitment to financially support Affitech’s operations until end of first quarter 2013, to provide Affitech a loan of 1.5 million Euro paid in three tranches to finance Affitech’s current operations until Affitech’s total financing needs have been determined and resolved in the longer term which is expected to happen before the loan’s due date on 16th October, 2012.
At current staffing levels and project commitments, expected net loss is estimated to be in the range of DKK 45-50 million as announced in the Annual Report 2011.
About Affitech
Affitech A/S is a publicly traded (NASDAQ OMX Copenhagen) human therapeutic antibody company based in Copenhagen, Denmark with R&D facilities in Oslo, Norway. The company utilizes a range of proprietary antibody technologies for the discovery of fully human antibodies for application in oncology, inflammation and other disease areas. CBAS™ (Cell Based Antibody Selection) is Affitech’s premier discovery engine for the isolation of lead antibodies to cell surface molecules. Affitech co-develops its two lead antibody drug programs AT001/r84 and AT008/CCR4 with Russian partner IBC Generium. The Company’s initial focus is on rapid and cost effective development by partnering clinical trials in emerging markets. Further information is available at www.affitech.com.
Disclaimer
This announcement may contain forward-looking statements including statements about Affitech’s expectations of the progression of its pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Affitech cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to transact viable and profitable commercial deals, the risk of non-approval of patents not yet granted, and difficulties of obtaining relevant governmental approvals for new products.
No expressed or implied representations or warranties are given concerning Affitech A/S or the accuracy or completeness of the information provided herein, and no claims shall be made by the recipient of this news release by virtue of the information contained herein.
Contact:
Randi Krogsgaard, Director IR & Corporate Communications
Tel # +45 2320 1001, e-Mail: ir@affitech.com
