Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Active Biotech Interim / Quarterly Report 2009

Nov 5, 2009

3133_10-q_2009-11-05_23ccd18a-3b14-44c8-b342-90a62facd9b9.pdf

Interim / Quarterly Report

Open in viewer

Opens in your device viewer

{# SEO P0-1: filing HTML is rendered server-side so Googlebot sees the full text without executing JS or following an iframe to a Disallow'd CDN path. The content has already been sanitized through filings.seo.sanitize_filing_html. #}

Active Biotech AB Interim Report January – September 2009

  • Laquinimod ― new data presented at ECTRIMS
  • 57-57 ― exploratory clinical trial in progress
  • RhuDex™ ― clinical development to continue following feedback from UK MHRA
  • ANYARA ― complete Phase I data published
  • TASQ ― complete Phase I data published
  • ISI ― project proceeding according to plan
  • Net sales of SEK 7.7 M (8.8)
  • Operating loss of SEK 164.6 M (loss: 167.0)
  • Loss after tax of SEK 165.1 M (loss: 162.0)
  • Loss per share for the period amounted to SEK 2.90 (loss: 3.30)
  • Number of shares at the end of the period, thousands (incl. warrants): 64,943

For further information, please contact:

Tomas Leanderson President and CEO Tel: +46 (0)46-19 20 95

Göran Forsberg VP Investor Relations & Business Development Tel: +46 (0)46-19 11 54

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 Sweden Tel: +46 (0)46-19 20 00

Laquinimod – a novel oral immunomodulatory compound for the treatment of autoimmune diseases

Laquinimod is a quinoline compound in Phase III development for the treatment of multiple sclerosis (MS). Active Biotech has entered into an agreement with the Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd (June 2004) covering the development and commercialization of laquinimod. Positive data from a Phase IIb trial of relapsing-remitting multiple sclerosis (RRMS) has been published in the scientific journal The Lancet (2008; 371:2085-92). In September 2008, data from the post-Phase IIb extension study showed a significant decrease in the mean number of gadolinium-enhancing (GdE) lesions in the brains of both the patients who had switched from placebo to laquinimod and the patients who had continued with their initial laquinimod dose. At present, laquinimod is undergoing two global clinical Phase III trials, which will encompass a total of 2,200 MS patients in 175 clinics worldwide. Teva completed patent enrolment for the first of two Phase III studies (Allegro) in November 2008 and the second (Bravo) in June 2009. In February 2009, laquinimod received a "Fast Track" designation from the US Food and Drug Administration, FDA. Information regarding the ongoing clinical trials is available at www.tevaclinicaltrials.com and www.clinicaltrials.gov.

– New data further illuminating the biological effects of laquinimod was presented in September at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Laquinimod displays both neuroprotective and anti-inflammatory properties. Results from several preclinical studies suggest that laquinimod reduces demyelination and induces axonal protection. These studies expand upon a growing body of clinical data suggesting the mechanism of laquinimod in RRMS patients is targeted immunomodulation, and may help contribute to the favorable benefit-to-risk profile associated with this compound.

57-57 – novel oral immunomodulatory compound for the treatment of Systemic Lupus Erythematosus

57-57 is a quinoline compound primarily intended for the treatment of Systemic Lupus Erythematosus (SLE), a disease that causes inflammation and damage to connective tissue throughout the body, with serious secondary symptoms, such as kidney failure. Earlier documentation from preclinical trials indicates that 57-57 can prevent relapses and reduce steroid use in SLE patients. Updated data from the completed clinical Phase Ib trial of 57-57 was presented in June 2009 at the 10th Annual Congress of the European League against Rheumatism (EULAR) – an international event for specialists in the field of rheumatology. The overall safety profile throughout the study was favorable. The new results strengthen previous data which indicated that treatment with 57-57 could normalize pathways known to be important in SLE pathogenesis. Read the entire poster A Phase I, Dose-Escalation Study to Evaluate the Tolerability of ABR-215757 in patients with Systemic Lupus Erythematosus (SLE) here.

– A small-scale exploratory clinical study in SLE patients is being conducted in Sweden and Denmark. This study will include a maximum of 20 patients who are treated with 3 mg of 57-57 daily. Several parameters that correlate with the disease activity will be studied in detail. The study is expected to be concluded during 2010. For further information about the study, visit www.clinicaltrials.gov.

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 implemented in which the RhuDex candidate drug's safety, tolerability and pharmacokinetic properties in healthy volunteers were studied. 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.

– Please see "Events after the end of the period."

ANYARA – a fusion protein for immunological treatment of renal cancer

ANYARA is a TTS (Tumor Targeting Superantigens) 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. Pivotal Phase III trials in patients with advanced renal cell cancer are currently under way. The Phase III trials were fully enrolled in June 2009. The primary clinical efficacy parameter from this trial is overall survival and it will include a total of approximately 500 patients at about 50 clinics in Europe. ANYARA has been granted orphan-drug status by the EMEA for the indication renal cell cancer. Information concerning the ongoing clinical trial is available at www.activebiotech.com and www.clinicaltrials.gov.

– In July, 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.

– The ongoing Phase III study is progressing according to plan. The study is evaluating the effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell cancer. The primary clinical efficacy parameter from this trial is overall survival and the current assessment is that the results will be presented in early 2011.

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 but it does not belong to the most frequently occurring group of tyrosine kinase inhibitors. Positive results for the concluded Phase I trial show that TASQ is well-tolerated and has a favorable safety profile. In September 2008, the follow-up efficacy data from the Phase Ib trial of TASQ was presented, which showed that patients treated with TASQ developed few new bone metastases and displayed a reduced rate of increase of the disease marker PSA (Prostate-Specific Antigen). The project is currently in a placebo-controlled clinical Phase II trial in progress in the US, Canada and Sweden. The trial became fully enrolled in June 2009. Information about the ongoing clinical trial is available at www.activebiotech.com and www.clinicaltrials.gov.

– In September, the results from the Phase I trial of TASQ were published in the British Journal of Cancer, where TASQ was studied in patients with hormone-resistant prostate cancer. The results showed that long-term continuous oral administration of TASQ seems to be safe and that TASQ might delay disease progression.

– The ongoing clinical Phase II trial is progressing according to plan. The trial is a 2:1 random, placebo-controlled, double-blind study of 1 mg/day TASQ, compared with placebo. The study includes symptom-free patients with metastasized, hormone-resistant prostate cancer. The primary objective of the study is to measure the proportion of disease progression among the patients after six months of treatment with TASQ, compared with placebo. The results from this study are expected in late 2009/early 2010.

ISI (Inhibition of S100 Interactions) – preclinical project based on the mode 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 around a target molecule for the quinoline (Q) compounds and their biological mode of action. The results of the target molecule for the Q compounds were published in PLoS Biology (Volume 7, Issue 4, s. 800-812) in April. The study shows that Q compounds bind to a molecule called S100A9, which is expressed in some white blood cells involved in the regulation of immune responses. Furthermore, it is shown that S100A9 interacts with two known pro-inflammatory 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. The aim is to select a candidate drug during 2010.

– The project is progressing according to plan.

Events after the end of the period

RhuDex clinical development to continue following feedback from UK MHRA

At the beginning of October, Active Biotech's collaboration partner MediGene AG (Frankfurt: MDG, Prime Standard, TecDAX) received feedback from the UK MHRA (Medicines and Healthcare products Regulatory Agency) regarding the in-vitro studies conducted with the candidate drug RhuDex for the treatment of rheumatoid arthritis. Since these tests did not suggest any negative effects of RhuDex, the MHRA agreed to a continuation of the candidate drug's clinical development.

Read the entire press release at www.medigene.com.

Financial information

Comments on the Group's results for the period January – September, 2009

Net sales for the period amounted to SEK 7.7 M (8.8) and derived from service and rental revenues. The figure for the year-earlier period also included research grants of SEK 1.7 M from Vinnova.

The operation's research and administration expenses totaled SEK 172.4 M (175.8). The decrease in costs was due to lower administration expenses. Research costs amounted to SEK 158.9 M (151.7). The increase in costs was due to the ongoing Phase III trial for the ANYARA renal cancer project, the ongoing Phase II trial for the TASQ prostate cancer project and the 57-57 project for the treatment of SLE. In addition, Active Biotech conducted a new research project, ISI, aimed at utilizing the company's own preclinical results that were generated around a target molecule for the Q compounds and their biological mode of action. Costs for the period were also negatively impacted by the weakening of the SEK against the EUR and USD, since approximately 50% of research costs consist of purchased research services that are primarily invoiced in foreign currency.

The clinical development of RhuDex for the treatment of RA and the ongoing clinical Phase III studies with laquinimod are fully financed by the relevant partners.

An operating loss of SEK 164.6 M (loss: 167.0) was reported. Net financial expense for the period totaled SEK 0.5 M (income: 5.0), with net financial income for the year-earlier period including a capital gain of SEK 7.4 M from the divestment of the minority holding in Isogenica Ltd. A loss of SEK 165.1 M (loss: 162.0) was reported after tax.

Cash flow, liquidity and financial position

Cash and cash equivalents and short-term investments amounted to SEK 202.1 M at the end of the period, compared with SEK 138.7 M at the end of 2008.

Accordingly, cash flow for the period amounted to SEK 13.4 M (21.9), of which cash flow from operating activities was a negative SEK 180.4 M (neg: 139.0). During the period, SEK 50.0 M was invested in interest-bearing securities with maturities of more than 90 days, which explains the negative SEK 50.1 M (pos: 7.2) from investing activities. Cash flow from financing activities was a positive SEK 243.9 M (153.8).

Comments on the Parent Company's earnings and financial position

The operations of the Parent Company, Active Biotech AB, comprise Group-wide administrative functions. The Parent Company's net sales for the period amounted to SEK 2.6 M (4.3).

Operating expenses during the period totaled SEK 12.6 M (26.5) and net financial items amounted to income of SEK 1.6 M (11.5). Loss after financial items amounted to SEK 8.4 M (loss: 10.7). No investments in fixed assets were made during the period.

Cash and cash equivalents, including short-term investments, totaled SEK 195.8 M at the end of the period, compared with SEK 131.6 M on January 1, 2009.

Share capital

Consolidated shareholders' equity at the end of the period amounted to SEK 247.5 M, compared with SEK 163.6 M at year-end 2008.

A total of 64,052,238 shares were outstanding at the end of the period. In the event of redemption of share warrants outstanding, the number of shares in Active Biotech would increase to a maximum of about 64.9 million.

At the end of the period, the equity/assets ratio for the Group was 45.7%, compared with 34.6% at year-end 2008. The corresponding figures for the Parent Company, Active Biotech AB, were 96.4% and 91.1%, respectively.

Organization

The average number of employees was 90 (89), with the average number of employees in the research and development operation accounting for 73 (73). At the end of the period, the Group had 89 employees (89).

Implemented rights issue

On May 7, 2009, the Annual General Meeting resolved to implement a guaranteed rights issue to strengthen the company's financial position and drive the development of the company's clinical project portfolio. The issue entitled existing shareholders with preferential rights to subscribe for one new share for each four shares held at an issue price of SEK 20 per share. The principal owners, MGA Holding AB (30.0%) and Nordstjernan AB (15.3%), had undertaken to subscribe for the full amount of shares corresponding to their preferential rights. In addition, MGA Holding AB and Nordstjernan AB had undertaken, in the event the issue was not fully subscribed, to subscribe for any additional shares not subscribed with the support of preferential rights.

The issue was oversubscribed by 71% and contributed approximately SEK 249 M to the company after issue expenses.

Election Committee

In accordance with a decision made by the Annual General Meeting held on May 7, 2009, the Election Committee shall comprise the representatives for the three largest shareholders on September 30 and the Board Chairman. For the 2010 Annual General Meeting, the Election Committee shall propose Board members and a Board Chairman, and fees to Board members and auditors. The following individuals were appointed representatives for the largest shareholders and, accordingly, are members of the Election Committee:

Johnny Sommarlund, MGA Holding Tomas Billing, Nordstjernan Peter Thelin, Brummer & Partners

Under the leadership of the Board Chairman Mats Arnhög, the Election Committee shall prepare proposals for the Board of Directors that are to be presented to and decided upon at the Annual General Meeting on May 6, 2010.

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 the present level of available liquidity, the implemented rights issue and other available financial alternatives will provide sufficient financial resources to finance the company's operations in line with 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 2008 Annual Report.

Condensed consolidated statement of comprehensive income July - Sept January - Sept. Full Year
SEK M 2009 2008 2009 2008 2008
Net sales 2.5 3.0 7.7 8.8 53.5
Administrative expenses -3.9 -11.9 -13.5 -24.1 -30.7
Research and development costs -44.8 -53.3 -158.9 -151.7 -207.4
Operating loss -46.1 -62.3 -164.6 -167.0 -184.6
Net financial items -0.4 -0.5 -0.5 5.0 4.0
Loss after financial items -46.5 -62.7 -165.1 -162.0 -180.6
Tax -1.0
Net loss for the period -46.5 -62.7 -165.1 -162.0 -181.6
Comprehensive loss attributable to:
Parent company shareholders -46.5 -62.7 -165.1 -162.0 -181.6
Minority interest
Net loss for the period -46.5 -62.7 -165.1 -162.0 -181.6
Other comprehensive income during the period
Change in revaluation reserve -0.3 -0.3 -1.0 -1.0 -1.3
Change in translation reserve -0.6 -0.6
Taxes attributable to other comprehensive income 0.1 0.1 0.3 0.3 1.3
Comprehensive loss for the period -46.8 -63.0 -165.9 -163.4 -182.2
Comprehensive loss attributable to:
Parent company shareholders -46.8 -63.0 -165.9 -163.4 -182.2
Minority interest
Comprehensive loss for the period -46.8 -63.0 -165.9 -163.4 -182.2
Depreciation/amortization included in the amount of 2.4 2.3 7.2 9.1 11.5
Investments in tangible fixed assets 0.1 1.0 0.1 2.6 2.9
Earnings per share before dilution (SEK) -0.73 -1.22 -2.90 -3.30 -3.66
Earnings per share after dilution (SEK) -0.73 -1.22 -2.90 -3.30 -3.66
Comprehensive loss per share before dilution (SEK) -0.73 -1.23 -2.91 -3.33 -3.67
Comprehensive loss per share after dilution (SEK) -0.73 -1.23 -2.91 -3.33 -3.67
Weighted number of outstanding common shares before dilution (000s) 64 052 51 242 56 967 49 055 49 605
Weighted number of outstanding common shares after dilution (000s) 64 052 51 242 56 967 49 055 49 605
Number of shares at close of the period (000s) 64 052 51 242 64 052 51 242 51 242
Number of shares at close of the period, including warrants (000s) 64 943 52 572 64 943 52 572 52 572
Consolidated balance sheet, condensed Sept. 30 Dec. 31
SEK M 2009 2008 2008
Tangible fixed assets 321.1 324.7 324.6
Financial fixed assets 0.0 0.0 0.0
Total fixed assets 321.1 324.7 324.6
Current receivables 18.7 13.1 9.7
Short-term investments 50.0
Cash and cash equivalents 152.1 160.6 138.7
Total current assets 220.8 173.7 148.4
Total assets 541.9 498.3 472.9
Shareholders equity 247.5 182.0 163.6
Long-term liabilities 250.2 251.4 251.7
Current liabilities 44.2 64.9 57.6
Total shareholders equity and liabilities 541.9 498.3 472.9
Consolidated statement of changes in shareholders equity
Opening balance 163.6 189.6 189.6
Personnel options program 1.5 1.5
Transfer from revaluation reserve 0.7 0.7 0.9
New share issue 249.0 153.7 153.9
Net loss for the period -165.9 -163.4 -182.2
Balance at close of period 247.5 182.0 163.6
Condensed consolidated cash-flow statement January - Sept. Full Year
SEK M 2009 2008 2008
Loss after financial items -165.1 -162.0 -180.6
Adjustment for non-cash items, etc. 7.2 2.6 5.4
Cash flow from operating activities
before changes in working capital -158.0 -159.4 -175.3
Changes in working capital -22.5 20.4 15.8
Cash flow from operating activities -180.4 -139.0 -159.5
Investments in tangible fixed assets -0.1 -2.6 -2.9
Investments in financial fixed assets -50.0
Decrease in financial fixed assets 9.8 9.8
Cash flow from investing activities -50.1 7.2 7.0
New share issue 249.0 153.7 153.9
Loans raised/amortization of loan liabilities -5.1 0.1 -1.2
Cash flow from financing activities 243.9 153.8 152.6
Cash flow for the period 13.4 21.9 0.1
Opening cash and cash equivalents 138.7 138.6 138.6
Closing cash and cash equivalents 152.1 160.6 138.7
Sept. 30 Dec. 31
Key figures 2009 2008 2008
Shareholders equity, SEK M 247.5 182.0 163.6
Equity per share, SEK 3.86 3.55 3.19
Equity/assets ratio in the Parent Company 96.4% 66.6% 91.1%
Equity/assets ratio in the Group 45.7% 36.5% 34.6%
Average number of annual employees 90 89 89
Parent Company, income statement, condensed July - Sept. January - Sept. Full Year
SEK M 2009 2008 2009 2008 2008
Net sales 0.9 0.9 2.6 4.3 46.4
Administration expenses -2.5 -12.2 -12.6 -26.5 -33.2
Operating profit/loss -1.7 -11.3 -10.0 -22.2 13.1
Profit/loss from financial items:
Profit/loss from participations in Group companies 37.6
Profit/loss from other securities and receivables
classed as fixed assets 7.4 7.4
Interest income and similar income-statement items 1.2 2.1 1.6 4.1 5.5
Interest expense and similar income-statement items 0.0 0.0 0.0 0.0
Profit/loss after financial items -0.5 -9.2 -8.4 -10.7 63.6
Tax
Net profit/loss for the period -0.5 -9.2 -8.4 -10.7 63.6
Parent Company, balance sheet, condensed Sept. 30 Dec 31
SEK M 2009 2008 2008
Tangible fixed assets 0.4 0.4 0.4
Financial fixed assets 202.5 229.4 202.5
Total fixed assets 202.8 229.8 202.8
Current receivables 11.0 69.2 10.3
Short-term investments 50.0 75.0
Cash and bank balances 145.8 67.1 131.6
Total current assets 206.8 211.3 141.9
Total assets 409.7 441.0 344.7
Shareholders equity 394.7 293.6 314.1
Long-term liabilities
Current liabilities 14.9 147.5 30.6
Total equity and liabilities 409.7 441.0 344.7

Any errors in additions are attributable to rounding of figures.

Accounting and valuation principles

The interim report for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting. In addition, relevant regulations from the Swedish Annual Accounts Act and the Securities Market Act have been applied. The same accounting policies and bases for calculations were applied in this interim report as in the most recent Annual Report.

Revised IAS 1 Presentation of Financial Statements is applied as of January 1, 2009. This amendment affected Active Biotech's accounting retroactively as of December 31, 2007. Among other consequences, this amendment results in revenues and costs that were previously recognized directly in equity now being recognized in a separate statement immediately after the income statement. Another change is that new designations for the financial statements have been used.

The Parent Company interim report has been prepared in accordance with the Swedish Annual Accounts Act and the Securities Market Act, which complies with the stipulations in the Swedish Financial Reporting Board's recommendation RFR 2.2 Accounting for Legal Entities. The same accounting policies and bases for calculations were applied in this interim report as in 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.

2010 Annual General Meeting

The 2010 Annual General Meeting will be held on May 6, 2010 at the company's premises on Scheelevägen 22 in Lund. A more detailed invitation to attend the Annual General Meeting will be issued closer to the time.

Financial calendar

Year-end Report 2009: February 11, 2010 Interim Report January – March 2010: April 22, 2010 Interim Report January – June 2010: August 11, 2010 Interim Report January – September 2010: October 27, 2010 Year-end Report 2010: February 10, 2011 The reports will be available from these dates at www.activebiotech.com.

Lund, November 5, 2009 Active Biotech AB (publ)

Tomas Leanderson President and CEO

Review report Introduction

We have reviewed the interim report of Active Biotech AB (Corporate identity number 556223-9227) as of September 30, 2009 and the nine-month period then ending. The Board of Directors and the President are responsible for the preparation and 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 report based on our review.

Focus and scope of the 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 consists of making inquiries, primarily of persons responsible for financial and accounti§ng matters, and applying analytical and other review procedures. A review has a different direction and is substantially more limited in scope than an audit conducted in accordance with Standards of Auditing in Sweden, RS, 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 opinion 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, in all material respects, the accompanying interim report for the Group has not been prepared in accordance with IAS 34 and the Annual Accounts Act and the interim report for the Parent Company has not been prepared in accordance with the Annual Accounts Act.

Malmö, November 4, 2009

KPMG AB David Olow Authorized Public Accountant

About Active Biotech

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, as well as ANYARA for use in cancer targeted therapy, primarily of renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex™ for RA. Please visit www.activebiotech.com for more information.

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 5, 2009 at 8:30 a.m.

Active Biotech AB PO Box 724, SE-220 07 Lund Sweden Tel: +46 (0)46-19 20 00 Fax: +46 (0)46-19 11 00