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Active Biotech — Interim / Quarterly Report 2011
Nov 3, 2011
3133_10-q_2011-11-03_c00e6b87-abae-4228-9eb7-2a638eb61bbb.pdf
Interim / Quarterly Report
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Interim Report January – September 2011
- Laquinimod ― Phase III BRAVO trial concluded. Teva plans an additional clinical study before filing a registration application in the US
- TASQ ― enrolment of patients for Phase III trial ongoing
- TASQ ― Phase II trial published in Journal of Clinical Oncology
- ANYARA ― Phase III trial proceeding according to plan
- 57-57 ― a clinical trial in being prepared in systemic sclerosis
- ISI ― project is proceeding as planned
- RhuDex®― preparations for continued clinical development ongoing
- Net sales SEK 231.3 M (8.5)
- Operating loss SEK 6.2 M (loss: 149.7)
- Loss after tax SEK 1.3 M (loss: 156,8)
- Loss per share for the period amounted to SEK 0,02 (loss: 2.40)
For further information, please contact:
Tomas Leanderson President and CEO Tel +46 (0)46-19 20 95
Hans Kolam Active Biotech AB
This report is also available at www.activebiotech.com Fax: +46 (0) 46-19 11 00
CFO (Corp. Reg. No. 556223-9227) Tel: +46 (0)46-19 20 44 PO Box 724, SE-220 07 Lund Tel: +46 (0)46-19 20 00
Laquinimod – a novel oral immunomodulatory compound for the treatment of autoimmune diseases
Laquinimod is a quinoline compound under development for the treatment of such diseases as multiple sclerosis (MS). Active Biotech has an agreement with the Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd (June 2004) covering the development and commercialization of laquinimod. New data was presented in September 2009 showing that laquinimod has both neuroprotective and anti-inflammatory properties. In December 2010, positive results from the Phase III ALLEGRO study were presented. Laquinimod met the primary endpoint of reducing annualized relapse rate and significantly slowed progression of disability.
– On August 1, 2011, the initial results were announced from the Phase III BRAVO study, which was designed to evaluate the efficacy, safety and tolerability of oral laquinimod compared to placebo and to provide a benefit-risk assessment comparing oral laquinimod and a reference arm of injectable Interferon β-1a (Avonex®). BRAVO is the second of two pivotal Phase III studies in the clinical development program for laquinimod, an investigational, oral, once-daily therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The BRAVO findings support the direct effect of laquinimod in the central nervous system (CNS) and are in line with the results of the first laquinimod Phase III trial, ALLEGRO. The BRAVO study demonstrated a trend of reducing the annualized relapse rate in laquinimod treated patients compared to placebo, the primary end point of the study, but did not reach statistical significance (p=0.075). The reduction of disability progression measured by EDSS also showed a trend in favor of laquinimod without reaching statistical significance. The reduction of brain atrophy observed in the laquinimod treated patients was significantly reduced compared to the placebo group.
The randomization process for BRAVO was adequately performed and according to the study protocol; however, placebo and treatment study groups showed dissimilarity in two baseline magnetic resonance imaging (MRI) characteristics. According to a standard and pre-specified sensitivity analysis included within the original statistical analysis plan, when this imbalance was corrected laquinimod demonstrated a significant reduction in the annualized relapse rate (21.3 percent, p=0.026), as well as a significant reduction in the risk of disability progression measured by EDSS (33.5 percent, p=0.044). In this analysis laquinimod also demonstrated a significant reduction of brain atrophy (27.5 percent, p<0.0001).
Additionally, as in ALLEGRO, the BRAVO study showed that laquinimod has a very favorable safety and tolerability profile.
– The clinical Phase II trials for the treatment of Crohn's disease and Lupus are continuing according to plan.
TASQ – an antiangiogenic compound for the treatment of prostate cancer
The development of TASQ is principally focused on the treatment of prostate cancer. TASQ is an antiangiogenic compound, meaning that it cuts off the supply of nutrients to the tumor. Studies concluded that TASQ exhibits anti-tumor activity via inhibition of tumor angiogenesis. The upregulation of the antiangiogenic protein thrombospondin-1 (TSP1) is a part of this mechanism. It was announced in December 2009 that the primary endpoint of the Phase II study, to show a higher fraction of patients with no disease progression during the six-month period of treatment using TASQ, had been attained. In April 2011, Active Biotech and Ipsen (Euronext: IPN; ADR: IPSEY) entered a broad partnership for the co-development and commercialization of the Active Biotech's compound, TASQ. Under the terms of the agreement, Active Biotech granted Ipsen exclusive rights to commercialize TASQ worldwide, except for North and South America and Japan where Active Biotech retains all commercial and marketing rights. Both companies will co-develop TASQ for the treatment of castrate-resistant prostate cancer (CRPC), with the possibility of developing TASQ in other cancer indications.
– Enrolment of patients to a clinical Phase III trial is under way. The study is a global, randomized, double-blind, placebo-controlled Phase III trial in patients with metastatic CRPC. The aim of the study is to confirm TASQ's effect on the disease, with radiological progression-free survival (PFS) as the primary endpoint and overall survival as the secondary endpoint. The study will include about 1,200 patients in more than 250 clinics. Ipsen will conduct and finance a supporting European study in prostate cancer patients. Preparations for the start of this study are in progress.
– In September 2011, the Journal of Clinical Oncology published the complete results from a controlled Phase II study of TASQ. It was concluded in the study that TASQ significantly slowed disease progression and improved Progression Free Survival (PFS) in patients with metastatic castrateresistant prostate cancer (CRPC), alongside an acceptable side effect profile. Of 201 evaluable patients, the six-month progression-free proportion for TASQ and placebo treatment groups were 69% and 37%, respectively (p<0.0001), with a median PFS of 7.6 vs. 3.3 months (p=0.0042).
– In August 2011, an article was published in the scientific journal The Prostate presenting TASQ's antiangiogenic properties "Tasquinimod prevents the angiogenic rebound induced by fractionated radiation resulting in an enhanced therapeutic response of prostate cancer xenografts," Dalrymple SL, Becker RE, Zhou H, Deweese TL, Isaacs JT.
ANYARA – fusion protein for immunological treatment of renal cancer
ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes the treatment of cancer tumor-specific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported in connection with the interim analysis in Phase II/III and from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. The median survival of 26.2 months observed for patients with advanced renal cell cancer and treated with ANYARA is twice the expected length. In July 2009, the results from two Phase I studies of ANYARA were published in the Journal of Clinical Oncology, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere®) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel. Pivotal Phase III trials in patients with advanced renal cell cancer are currently under way. The Phase III trials are fully enrolled since June 2009 and include a total of approximately 500 patients at about 50 clinics in Europe. ANYARA has been granted orphan-drug status by the EMA for the indication renal cell cancer. Information concerning the ongoing clinical trial is available at www.activebiotech.com and www.clinicaltrials.gov.
– The ongoing Phase III study is evaluating the effect of ANYARA in combination with interferonalpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary clinical efficacy parameter is survival and will be read after 384 registered events (deaths). It is expected that it will be possible to present the results in 2012.
57-57 – novel oral immunomodulatory compound for the treatment of systemic sclerosis/ scleroderma
57-57 is a quinoline compound primarily intended for the treatment of systemic sclerosis/ scleroderma. This rare disease is classified as an "orphan drug indication." In February 2011, the 57-57 project was granted orphan medicinal product status, for the indication Systemic Sclerosis (SSc). The EMA's "Orphan Medicinal Product Designation" is implemented to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or chronically debilitating. Under EMA guidelines, Orphan Medicinal Product Designation provides ten years of potential market exclusivity if the product candidate is approved for marketing in the European Union.
– Preparations are in progress for the launch of an explorative study in systemic sclerosis.
ISI (Inhibition of S100 interactions) – preclinical project based on the mechanism of action of quinoline compounds
Active Biotech is conducting a new research project aimed at utilizing the company's own preclinical results that were generated with respect to a target molecule for the quinoline (Q) compounds and their biological mechanism of action. The results of a target molecule for the Q compounds were published in PLoS Biology (Volume 7, Issue 4, pp. 800-812) in April 2009. The study shows that Q compounds bind to a molecule called S100A9, which is expressed in white blood cells involved in the regulation of immune responses. Furthermore, it is shown that S100A9 interacts with two known proinflammatory receptors (Toll like receptor 4 (TLR4) and receptor of advanced glycation end products (RAGE)) and that this interaction is inhibited by Q compounds. The project aims at producing new, patentable chemical substances that interact with the target molecule of the Q compounds and to select a candidate drug in 2012.
– The project is proceeding according to plan.
RhuDex® – a novel oral compound for the treatment of rheumatoid arthritis
In the project covering Active Biotech's patented CD80 antagonists, the RhuDex candidate drug is under development for the treatment of rheumatoid arthritis (RA). In April 2002, Active Biotech entered a licensing agreement with Avidex Ltd, now a wholly owned subsidiary of the German biotechnology company MediGene AG, according to which MediGene has the exclusive rights to develop CD80 antagonists and market products in which these compounds are included. Two Phase I trials have already been successfully concluded in which the RhuDex candidate drug was studied with respect to its safety, tolerability and pharmacokinetic properties in healthy volunteers. In June 2008, MediGene announced that a clinical Phase IIa trial had achieved its objective. For further information and the latest news concerning RhuDex, visit www.medigene.com.
– On August 2, 2011, Active Biotech's partner MediGene announced that it was preparing to resume clinical development of RhuDex. The aim is to initiate a Phase I clinical trial in 2011, in which a new formulation customized for treatment of chronic conditions will be tested and optimized.
Events after the end of the period
Laquinimod
During Teva's 3rd Quarter 2011 Results Conference Call today, Teva's CEO Shlomo Yanai commented "Last week we held a meeting with the FDA to discuss the NDA for laquinimod. Following the meeting we now believe that it would be premature to file NDA at this time. The FDA has offered to work with us to determine the best design for conducting an additional trial".
Phase III clinical and pre-clinical data was featured in more than 20 scientific posters and presentations at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, the Netherlands on October 19-22, 2011. The results collectively demonstrate that once-daily oral laquinimod modulates the pathological processes of multiple sclerosis to impact disease activity, disability progression and brain atrophy.
TASQ
On October 5, 2011, an article was published in The Prostate demonstrating that TASQ has an inhibiting effect on metastasis; "Inhibition of metastasis in a castration resistant prostate cancer model by the quinoline-3-carboxamide tasquinimod (ABR-215050)" Karin Jennbacken, Karin Welén, Anders Olsson, Bengt Axelsson, Marie Törngren, Jan-Erik Damber, Tomas Leanderson.
RhuDex®
On October 28, Active Biotech AB's collaboration partner MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted the authorization of the planned clinical formulation study of RhuDex. The
objective of the RapidFACTTM trial (Rapid Formulation Development and Clinical Testing) is to determine an optimized formulation for chronic treatment. To read the complete press release, please see www.medigene.com.
Financial information
Comments on the Group's results for the January – September 2011 period
The operating loss for the period amounted to SEK 6.2 M (loss: 149.7), an improvement of SEK 143.5 M compared with the year-earlier period.
Net sales for the period amounted to SEK 231.3 M (8.5) and included an upfront payment of SEK 223.2 M from Ipsen Pharma for the exclusive rights to commercialize TASQ worldwide, except for North and South America and Japan. Service and rental revenues amounted to SEK 8.1 M (8.5).
The operation's research and administration expenses amounted to SEK 237,6 M (158.2), of which research expenses amounted to SEK 224.6 M (142.4) M. The increase in expenses was entirely attributable to the cost for the ongoing Phase III trials of TASQ for the treatment of prostate cancer. At full enrolment, the clinical Phase III trial will comprise approximately 1,200 patients in more 250 clinics in 40 countries. The costs for the ongoing Phase III trial for the ANYARA renal cancer project, the explorative study for the 57-57 project and the preclinical research project ISI were lower than the cost level recorded a year earlier. Previously out-licensed projects, laquinimod and RhuDex, are fully financed by the relevant partners.
Administration expenses amounted to SEK 12.9 M (15.8). Net financial items for the period totaled income of SEK 3.1 M (expense: 7.1) and the net loss was SEK 1.3 M (loss: 156.8).
Comments on the Group's earnings for the July – September 2011 period
The third-quarter operating loss amounted to SEK 76.8 M (loss: 47.3). The earnings trend is attributable to costs for clinical studies related to TASQ.
Net sales amounted to SEK 2.6 M (2.3) and operating expenses to SEK 79.4 M (49.6). The increase in expenses is attributable in full to intensified activity in the TASQ clinical development program in prostate cancer. Net financial items for the period amounted to an expense of SEK 2.8 M (expense: 1.2) and the net loss was SEK 79.0 M (loss: 48.5).
Cash flow, liquidity and financial position
Cash and cash equivalents at the end of the period amounted to SEK 530.1 M, compared with SEK 131.1 M at the end of 2010.
Cash flow for the period amounted to SEK 398.9 M (19.9), of which cash flow from operating activities was SEK 15.8 M (neg: 151.8). Cash flow from financing activities amounted to SEK 383.6 M (171.6), as a result of the implementation during the period of the private placement to international institutional investors and qualified investors in Sweden and the exercise of employee stock options, which provided an injection of SEK 389.6 M in total after issue expenses.
Investments
Investments in tangible fixed assets amounted to SEK 0.4 M (0.0).
Comments on the Parent Company's earnings and financial position
The Parent Company's operating loss for the period was SEK 24.4 M (loss: 10.0), net sales for the period amounted to SEK 238.9 M (2.6) and operating expenses totaled SEK 263.4 M (12.6).
Net financial items amounted to income of SEK 14.8 M (0.9), the loss after financial items was SEK 9.7 M (loss: 9.0).
Cash and cash equivalents, including short-term investments, totaled SEK 525.7 M at the end of the period, compared with SEK 125.4 M on January 1, 2011.
Share capital
Consolidated shareholders' equity at the end of the period amounted to SEK 575.1 M, compared with SEK 181.8 M at year-end 2010. At September 30, 2011, the total number of shares outstanding amounted to 68 923 582.
At the end of the period, the equity/assets ratio for the Group was 63.8 percent, compared with 36.1 percent at year-end 2010. The corresponding figures for the Parent Company, Active Biotech AB, were 90.5 percent and 81.3 percent, respectively.
Organization
The average number of employees was 80 (88), with the average number of employees in the research and development operation accounting for 65 (72). At the end of the period, the Group had 80 employees (87).
Outlook, including significant risks and uncertainties
A vital factor for Active Biotech's long-term financial strength and stability is the company's ability to develop pharmaceutical projects to the point at which partnership agreements can be entered into and the partner can assume responsibility for future development and commercialization of the project. During this development phase, the value of projects is expected to increase. The development of partnership agreements already signed and the addition of new agreements are assumed to have a significant impact on future revenues and cash balances. The Board of Directors is of the opinion that existing cash and cash equivalents and income from already signed partnership agreements will safeguard financing under current plans.
A research company such as Active Biotech is characterized by a high operational and financial risk, since the projects in which the company is involved are at the clinical phase, where a number of factors have an impact on the likelihood of commercial success. In brief, the operation is associated with risks related to such factors as pharmaceutical development, competition, advances in technology, patents, regulatory requirements, capital requirements, currencies and interest rates. Since no significant changes took place with regard to risks and uncertainties during the period, refer to the detailed account of these factors presented in the Directors' Report in the 2010 Annual Report.
| Consolidated profit and loss | July -Sept. | Jan. - Sept | |||
|---|---|---|---|---|---|
| SEK M | 2011 | 2010 | 2011 | 2010 | 2010 |
| Net sales | 2.6 | 2.3 | 231.3 | 8.5 | 11.4 |
| Administrative expenses | -3.2 | -4.0 | -12.9 | -15.8 | -23.1 |
| Research and development costs | -76.2 | -45.6 | -224.6 | -142.4 | -217.3 |
| Operating profit/loss | -76.8 | -47.3 | -6.2 | -149.7 | -229.0 |
| Net financial items | -2.8 | -1.2 | 3.1 | -7.1 | -4.7 |
| Profit/loss before tax | -79.6 | -48.5 | -3.1 | -156.8 | -233.6 |
| Tax | 0.6 | – | 1.8 | – | 12.6 |
| Net profit/loss for the period | -79.0 | -48.5 | -1.3 | -156.8 | -221.1 |
| Comprehensive loss attributable to: | |||||
| Parent company shareholders | -79.0 | -48.5 | -1.3 | -156.8 | -221.1 |
| Non controlling interests | – | – | – | – | – |
| Net profit/loss for the period | -79.0 | -48.5 | -1.3 | -156.8 | -221.1 |
| Comprehensive profit/loss per share before dilution (SEK) | -1.15 | -0.74 | -0.02 | -2.40 | -3.38 |
| Comprehensive profit/loss per share after dilution (SEK) | -1.15 | -0.74 | -0.02 | -2.40 | -3.38 |
| Statement of consolidated comprehensive income | |||||
| Net profit/loss for the period | -79.0 | -48.5 | -1.3 | -156.8 | -221.1 |
| Other comprehensive income | |||||
| Change in revaluation reserve | 1.8 | -0.3 | 5.4 | -1.0 | 46.4 |
| Taxes attributable to other comprehensive income | -0.5 | 0.1 | -1.4 | 0.3 | -12.2 |
| Total comprehensive profit/loss for the period | -77.7 | -48.7 | 2.7 | -157.5 | -186.8 |
| Total other comprehensive profit/loss for the period attributable to: | |||||
| Parent company shareholders | -77.7 | -48.7 | 2.7 | -157.5 | -186.8 |
| Non controlling interests | – | – | – | – | – |
| Total comprehensive profit/loss for the period | -77.7 | -48.7 | 2.7 | -157.5 | -186.8 |
| Depreciation/amortization included in the amount of | 3.0 | 2.4 | 9.0 | 7.3 | 9.8 |
| Investments in tangible fixed assets | 0.1 | – | 0.4 | – | 0.1 |
| Weighted number of outstanding common shares before dilution (000s) | 68 924 | 65 964 | 68 487 | 65 288 | 65 465 |
| Weighted number of outstanding common shares after dilution (000s) | 68 924 | 65 964 | 68 487 | 65 288 | 65 465 |
| Number of shares at close of the period (000s) | 68 924 | 65 968 | 68 924 | 65 968 | 66 000 |
| Outstanding warrants (000s) | – | 374 | – | 374 | 348 |
| - entitlement to number of shares after full exercise (000s) | – | 460 | – | 460 | 428 |
| Consolidated statement of financial position | Sept. 30 | Dec 31 | |||
| SEK M | 2011 | 2010 | 2010 | ||
| Tangible fixed assets | 357.7 | 312.9 | 358.5 | ||
| Long term receivables | 0.0 | 0.0 | 0.0 | ||
| Total fixed assets | 357.7 | 312.9 | 358.5 | ||
| Current receivables | 13.3 | 19.5 | 13.4 | ||
| Cash and cash equivalents | 530.1 | 175.9 | 131.1 | ||
| Total current assets | 543.4 | 195.4 | 144.6 | ||
| Total assets | 901.1 | 508.3 | 503.1 | ||
| Shareholders equity | 575.1 | 209.0 | 181.8 | ||
| Long-term liabilities | 236.3 | 243.6 | 241.7 | ||
| Current liabilities | 89.6 | 55.7 | 79.7 | ||
| Total shareholders equity and liabilities | 901.1 | 508.3 | 503.1 | ||
| Consolidated statement of changes in shareholders equity | |||||
| Opening balance | 181.8 | 188.6 | 188.6 | ||
| Transfer from revaluation reserve | 1.1 | 0.7 | 1.0 | ||
| New share issue | 389.6 | 177.2 | 179.0 | ||
| Net loss for the period | 2.7 | -157.5 | -186.8 | ||
| Balance at close of period | 575.1 | 209.0 | 181.8 |
| Condensed consolidated cash-flow statement | Jan. - Sept. | Full Year | |
|---|---|---|---|
| SEK M | 2011 | 2010 | 2010 |
| Loss after financial items | -3.1 | -156.8 | -233.6 |
| Adjustment for non-cash items, etc. | 9.0 | 7.3 | 9.8 |
| Cash flow from operating activities | |||
| before changes in working capital | 5.8 | -149.5 | -223.9 |
| Changes in working capital | 9.9 | -2.3 | 27.5 |
| Cash flow from operating activities | 15.8 | -151.8 | -196.3 |
| Investments in tangible fixed assets | -0.4 | – | -0.1 |
| Cash flow from investing activities | -0.4 | – | -0.1 |
| New share issue | 389.6 | 177.2 | 179.0 |
| Loans raised/amortization of loan liabilities | -6.0 | -5.6 | -7.5 |
| Cash flow from financing activities | 383.6 | 171.6 | 171.5 |
| Cash flow for the period | 398.9 | 19.9 | -24.9 |
| Opening cash and cash equivalents | 131.1 | 156.0 | 156.0 |
| Closing cash and cash equivalents | 530.1 | 175.9 | 131.1 |
| Sept. 30 | |||
| Key figures | 2011 | 2010 | 2010 |
| Shareholders equity, SEK M | 575.1 | 209.0 | 181.8 |
| Equity per share, SEK | 8.34 | 3.17 | 2.75 |
| Equity/assets ratio in the Parent Company | 90.5% | 97.9% | 81.3% |
| Equity/assets ratio in the Group | 63.8% | 41.1% | 36.1% |
| Average number of annual employees | 80 | 88 | 87 |
Active Biotech - parent company
| Consolidated profit and loss | July - Sept. | Jan. - Sept. | Full Year | ||
|---|---|---|---|---|---|
| SEK M | 2011 | 2010 | 2011 | 2010 | 2010 |
| Net sales | 5.0 | 0.9 | 238.9 | 2.6 | 23.2 |
| Administration expenses | -7.8 | -5.3 | -17.3 | -12.6 | -24.2 |
| Research and development costs | -81.4 | – | -246.1 | – | -233.5 |
| Operating profit/loss | -84.2 | -4.4 | -24.4 | -10.0 | -234.4 |
| Profit/loss from financial items: | |||||
| Interest income and similar income-statement items | 6.4 | 0.4 | 17.1 | 0.9 | 1.7 |
| Interest expense and similar income-statement items | -1.0 | – | -2.3 | 0.0 | 0.0 |
| Profit/loss after financial items | -78.8 | -4.0 | -9.7 | -9.0 | -232.7 |
| Tax | – | – | – | – | – |
| Net profit/loss for the period | -78.8 | -4.0 | -9.7 | -9.0 | -232.7 |
| Statement of comprehensive income parent company | |||||
| Net profit/loss for the period | -78.8 | -4.0 | -9.7 | -9.0 | -232.7 |
| Other comprehensive income | – | – | – | – | – |
| Total comprehensive profit/loss for the period | -78.8 | -4.0 | -9.7 | -9.0 | -232.7 |
| Balance sheet, condensed | June 30 | Dec. 31 | |||
| SEK M | 2011 | 2010 | 2010 | ||
| Goodwill | 149.4 | – | 161.5 | ||
| Tangible fixed assets | 1.2 | 0.4 | 1.0 | ||
| Financial fixed assets | 40.6 | 202.5 | 40.6 | ||
| Total fixed assets | 191.2 | 202.8 | 203.1 | ||
| Current receivables | 21.3 | 160.0 | 25.9 | ||
| Short-term investments | 20.0 | – | – | ||
| Cash and bank balances | 505.7 | 157.8 | 125.4 | ||
| Total current assets | 547.0 | 317.8 | 151.3 | ||
| Total assets | 738.2 | 520.6 | 354.4 | ||
| Shareholders equity | 667.9 | 509.9 | 288.1 | ||
| Current liabilities | 70.2 | 10.7 | 66.3 | ||
| Total equity and liabilities | 738.2 | 520.6 | 354.4 |
Any errors in addition are attributable to rounding of figures
Accounting policies
This interim report 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 as well as accounting estimates and assumptions have been used in this interim report as were used to prepare the most recent annual report.
Legal disclaimer
This financial report includes statements that are forward-looking and actual results may differ materially from those anticipated. In addition to the factors discussed, other factors that can affect results are developments in research programs, including clinical trials, the impact of competing research programs, the effect of economic conditions, the effectiveness of the company's intellectual patent protection, obstacles due to technological development, exchange-rate and interest-rate fluctuations, and political risks
Financial calendar
Year-end report 2011: February 16, 2012 Interim Report, January – March 2012: April 26, 2012 Interim Report, January – June 2012: August 10, 2012 Interim Report, January – September 2012: November 9, 2012 Year-end Report 2012: February 14, 2013
The reports will be available from these dates at www.activebiotech.com.
Lund, November 3, 2011 Active Biotech AB (publ)
Tomas Leanderson President and CEO
Report on Review of Interim Financial Information
Introduction
We have reviewed the interim report of Active Biotech AB ( Corporate registration number 556223- 9227) as of 30 September, 2011 and for the nine month period then ended. The Board of Directors and the President are responsible for the preparation and fair presentation of this interim financial information in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim annual report based on our review. Scope of Review
We conducted our review in accordance with the Standard on Review Engagements (SÖG) 2410, Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review of interim financial information 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 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. Conclusion
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, in accordance with IAS 34 and the Annual Accounts Act for the Group and in accordance with the Annual Accounts Act for the Parent Company.
Malmö, November 3, 2011 KPMG AB David Olow Authorized Public Accountant Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, TASQ for prostate cancer and ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. Further projects in clinical development comprise the two orally administered compounds, 57- 57 for Systemic Sclerosis as well as RhuDex™ for RA. Please visit www.activebiotech.com for more information.
Active Biotech Active Biotech is obligated to publish the information contained in this interim report in accordance with the Swedish Securities Market Act. This information was provided to the media for publication on November 3, 2011 at 8:30 a.m.