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Active Biotech Interim / Quarterly Report 2013

Apr 25, 2013

3133_rns_2013-04-25_c6dcfdcb-df04-496e-9f80-95f9185cdd30.pdf

Interim / Quarterly Report

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Active Biotech AB Interim Report January – March 2013

Laquinimod

  • first patient enrolled in CONCERTO, the third Phase III placebo-controlled study for the treatment of relapsing-remitting multiple sclerosis
  • data presented at AAN showed reduced disability progression for multiple sclerosis patients who commenced

early treatment with laquinimod compared with delayed treatment

Tasquinimod

• the Phase III study is proceeding according to plan

ANYARA

  • Phase II/III study in renal cell cancer concluded
  • Results presented:
  • study did not achieve primary clinical endpoint
  • doubling of progression-free survival and overall survival in 25 percent of patients
  • planning of the continued clinical development ongoing

57-57 (paquinimod)

• clinical trial in systemic sclerosis concluded, evaluation underway

ISI

• focus on submission of patents

Other information

• Active Biotech raised SEK 270 M through a directed share issue to Investor

Jan - Mar Jan - Dec
(SEK M) 2013 2012 2012
Net sales 2.4 2.6 227.9
Operating loss -77.0 -100.7 -163.2
Net loss -78.0 -99.0 -175.0

For further information, please contact:

Tomas Leanderson, President and CEO Tel: +46 (0)46-19 20 95 Hans Kolam, CFO Active Biotech AB Tel: +46 (0)46-19 20 44 (Corp. Reg. No. 556223-9227)

Box 724, SE-220 07 Lund Tel: 046 (0)46-19 20 00

This report is also available at www.activebiotech.com Fax: +46 (0)46-19 11 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 company Teva Pharmaceutical Industries Ltd (June 2004) covering the development and commercialization of laquinimod. 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 the annualized relapse rate and significantly slowed progression of disability. On August 1, 2011, the initial results were announced from the second Phase III BRAVO study. The BRAVO findings supported the direct effect of laquinimod in the central nervous system (CNS) and were in line with the results of the first laquinimod Phase III trial, ALLEGRO. In July 2012, Teva submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). If the application is successful, laquinimod could be approved in Europe by year-end 2013. In addition to the ongoing MS clinical trials, laquinimod has undergone clinical Phase II trials for the treatment of Crohn's disease and Lupus.

– On March 6, 2013, enrollment of the first patient was announced in the CONCERTO study – the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod (0.6 mg and 1.2 mg) in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). The multinational, randomized, double blind, placebo-controlled study will aim to enroll approximately 1,800 patients at more than 300 sites globally (http://clinicaltrials.gov/show/NCT01707992). Along with the primary endpoint of time to confirmed disability progression, the study will also examine the impact of laquinimod on endpoints such as percentage change in brain volume and other clinical and MRI markers of disease activity.

  • On March 21, 2013, top-line results were presented from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start RRMS patients. The study compared the efficacy of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start). Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of laquinimod (11.8% risk of confirmed disability progression vs. 16.7%, HR = 0.62, p < 0.0038).

Tasquinimod

– an immunomodulatory, anti-metastatic substance for the treatment of prostate cancer

The development of tasquinimod is principally focused on the treatment of prostate cancer. Tasquinimod is an immunomodulatory, anti-metastatic substance that indirectly affects the tumor's ability to grow and spread. 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 tasquinimod, 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 Active Biotech's compound, tasquinimod. Under the terms of the agreement, Active Biotech granted Ipsen exclusive rights to commercialize tasquinimod worldwide, except for North and South America and Japan, where Active Biotech retains all commercial and marketing rights. Both companies will co-develop tasquinimod for the treatment of castrate-resistant prostate cancer (CRPC), with the possibility of developing tasquinimod in other cancer indications. In December 2012, patient enrollment was successfully completed to the ongoing clinical Phase III trial for tasquinimod, with 1,245 randomized patients as planned in the clinical protocol. In October 2012, Ipsen initiated a proof-of-concept clinical trial to evaluate the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first-line docetaxel-based chemotherapy. In addition, Ipsen has initiated a proof-of-concept clinical trial with tasquinimod to evaluate the safety and efficacy of tasquinimod in advanced or metastatic hepatocellular, ovarian, renal cell and gastric carcinomas in patients whose condition has nonetheless deteriorated after standard therapies. Furthermore, an investigator-sponsored clinical Phase I trial (CATCH) is under way to determine the recommended dose of tasquinimod in combination with cabazitaxel in patients with mCRPC.

– The ongoing clinical Phase III trial is a global, randomized, double-blind, placebo-controlled study of mCRPC patients. The aim of the study is to confirm tasquinimod's efficacy on the disease, with radiological progression-free survival (PFS) as the primary endpoint and overall survival (OS) as secondary endpoint.

ANYARA – fusion protein for immunological treatment of renal cell cancer

ANYARA is a TTS (Tumor Targeted Superantigen) compound that makes cancer treatment tumor-specific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported in connection with interim analysis in Phase II/III and from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. 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. ANYARA has been granted orphan-drug status by the EMA for the indication renal cell cancer.

– In January 2013, the initial results were presented from the concluded Phase II/III clinical study in advanced renal cell cancer. The results showed that the study did not achieve its primary endpoint of showing prolonged overall survival (OS) in the intention to treat (ITT) population. A subgroup, comprising about 25 percent of the patients with low/normal levels of base line IL-6 and expected anti-superantigen antibody levels, showed a statistically significant treatment advantage on both OS (p=0.02, HR=0.59) and progression-free survival (PFS). In North America and Western Europe, this subgroup accounts for 40-50% of the total number of advanced renal cell cancer patients. The safety profile was favorable and in line with that observed earlier. Active Biotech plans to continue the development of ANYARA jointly with a partner after completed analysis of study data and discussions with relevant authorities.

Paquinimod (57-57)

– novel oral immunomodulatory compound for the treatment of systemic sclerosis

Paquinimod is a quinoline compound primarily intended for the treatment of systemic sclerosis. This rare disease is classified as an orphan drug indication. In February 2011, paquinimod was granted orphan medicinal product status in Europe for the indication systemic sclerosis. 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.

– An explorative clinical study in systemic sclerosis has been concluded. The study includes nine patients. The primary endpoint of the study is to document the safety profile of paquinimod therapy in this patient group and to study the effect on disease-related biomarkers.

ISI (Inhibition of S100 interactions)

– preclinical project based on the mode of action of quinoline compounds

Active Biotech is conducting a 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 mode 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 showed 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 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 project is proceeding according to plan. Efforts are centered on building up a patent portfolio around the compounds that interact with S100 proteins. When this goal has been achieved, a decision will be taken on a clinical development strategy and selection of the first candidate drug is planned for 2014.

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 February 2013, MediGene announced that the planned Phase IIa study in primary biliary cirrhosis (PBC), a chronic liver disease, will be expanded to include more patients and an extended treatment period. The aim is to confirm the mode of action of RhuDex in autoimmune diseases and facilitate the continued development of the drug. The study will be initiated in 2014 at the latest. For more information and the latest news about RhuDex, see www.medigene.com.

Events after the end of the period

Tasquinimod

Active Biotech and Ipsen update the analysis plan for the 10TASQ10 trial evaluating tasquinimod in the treatment of prostate cancer

– On April 25, 2013, Active Biotech and Ipsen announced that the companies have updated the analysis plan for the 10TASQ10 trial, a global Phase III clinical trial evaluating tasquinimod in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not yet received chemotherapy.

The companies plan to conduct the primary progression-free survival (PFS) analysis for the 10TASQ10 trial in 2014, at the same time as the first interim overall survival (OS) analysis. Timing of the OS interim analysis will be determined by the number of OS events. The specified number of radiographic PFS events for the primary endpoint will have been exceeded at the time of the interim OS analysis. For further information, please visit www.activebiotech.com.

Professor Tomas Leanderson, President & CEO Active Biotech stated: "To harness both PFS and OS data while the study is still blinded secures that this analysis plan provides us with the most robust data set in order to progress the development of the TASQ project."

DSMB

– In April 2013, the independent Data and Safety Monitoring Board (DSMB), which is monitoring the ongoing Phase III trial 10TASQ10, recommended that the study continue in accordance with the protocol since no safety-related issues were noted.

Financial information Comments on the Group's results for the period January – March 2013

Net sales amounted to SEK 2.4 M (2.6) and included service and rental revenues.

The operation's research and administration expenses amounted to SEK 79.4 M (103.2), of which research expenses amounted to SEK 75.2 M (99.4). The decrease in expenses was attributable to planned lower costs for the ongoing clinical Phase III trial of tasquinimod for the treatment of prostate cancer, which was fully enrolled in December 2012. Under the partnership agreement with Ipsen, Active Biotech will receive clinical, regulatory and commercial milestone payments on fulfillment of defined goals. Provided that these milestones are met, the Phase III trial will be financed in full by Ipsen. The other research projects – the Phase III trial for the ANYARA renal cell cancer project, the explorative study for the 57-57 project and the preclinical research project ISI – only had a marginal impact on the cost development between the years. The out-licensed projects, laquinimod and RhuDex, are financed by the relevant partners.

The operating loss for the period amounted to SEK 77.0 M (loss: 100.7). The earnings trend compared with the preceding year was attributable to lower costs for the ongoing TASQ clinical Phase III study, since it is now fully enrolled and the patients are in the treatment phase. Administration expenses totaled SEK 4.2 M (3.8). The net financial expense for the period amounted to SEK 1.6 M (income: 1.0) and the loss after tax was SEK 78.0 M (loss: 99.0).

Cash flow, liquidity and financial position, Group

Cash and cash equivalents at the end of the period amounted to SEK 471.3 M, compared with SEK 216.7 M at the end of 2012. Ipsen's milestone payment upon full enrollment of the Phase III study of TASQ for the treatment of prostate cancer, totaling SEK 81.6 M, was received according to contract on January 4, 2013 and a directed share issue to Investor was implemented during the period and generated approximately SEK 270 M after issue expenses.

Cash flow for the period was SEK 254.7 M (neg: 86.7), of which cash flow from operating activities accounted for a negative SEK 13.1 (neg: 84.8). Cash flow from financing activities totaled SEK 267.8 M (neg: 2.0), of which the directed share issue to Investor raised SEK 270 M.

Investments

Investments in tangible fixed assets amounted to SEK 0.0 M (0.0).

Comments on the Parent Company's results and financial position

Net sales for the period amounted to SEK 5.3 M (5.4) and operating expenses to SEK 87.3 M (111.1). The Parent Company's operating loss for the period was SEK 82.0 M (loss: 105.7).

Net financial income amounted to SEK 0.1 M (income: 1.4) and the loss after financial items was SEK 81.9 M (loss: 104.3). Cash and cash equivalents including short-term investments totaled SEK 462.6 M at the end of the period, compared with SEK 208.9 M on January 1, 2013.

Shareholders' equity

Consolidated shareholder's equity at the end of the period amounted to SEK 533.7 M, compared with SEK 339.9 M at year-end 2012. The number of shares outstanding at the end of the period totaled 74,923,582.

At the end of the period, the equity/assets ratio for the Group was 61.7 percent, compared with 48.8 percent at year-end 2012. The corresponding figures for the Parent Company, Active Biotech AB, were 86.6 percent and 77.6 percent, respectively.

Organization

The average number of employees was 63 (78), of which the number of employees in the research and development organization accounted for 50 (66). At the end of the period, the Group had 63 employees. Following completion of the workforce reduction announced in 2012, the number of employees will be about 60.

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. Income from already signed agreements and existing cash and cash equivalents is expected to finance operations. 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 2012 Annual Report. The Group's operations are primarily conducted in the Parent Company why risks and uncertainties refer to both the Group and the Parent Company.

Consolidated profit and loss Jan. - March
SEK M 2013 2012 Full Year
2012
Net sales 2.4 2.6 227.9
Administrative expenses -4.2 -3.8 -15.8
Research and development costs -75.2 -99.4 -375.3
Operating profit/loss -77.0 -100.7 -163.2
Net financial items -1.6 1.0 -8.7
Profit/loss before tax -78.6 -99.6 -172.0
Tax 0.6 0.6 -3.1
Net profit/loss for the period -78.0 -99.0 -175.0
Comprehensive loss attributable to:
Parent Company shareholders -78.0 -99.0 -175.0
Non-controlling interests
Net profit/loss for the period -78.0 -99.0 -175.0
Comprehensive profit/loss per share before dilution (SEK) -1.10 -1.44 -2.54
Comprehensive profit/loss per share after dilution (SEK) -1.10 -1.44 -2.54
Statement of profit and loss and consolidated comprehensive income
Net profit/loss for the period -78.0 -99.0 -175.0
Other comprehensive income
Items that can not be reclassified into profit or loss
Change in revaluation reserve 1.8 1.8 7.2
Taxes attributable to other comprehensive income -0.4 -0.5 3.8
Total comprehensive profit/loss for the period -76.6 -97.7 -164.1
Total other comprehensive profit/loss for the period attributable to:
Parent Company shareholders -76.6 -97.7 -164.1
Non-controlling interests
Total comprehensive profit/loss for the period -76.6 -97.7 -164.1
Depreciation/amortization included in the amount of 3.2 3.2 12.9
Investments in tangible fixed assets 0.0
Weighted number of outstanding common shares before dilution (000s) 70 990 68 924 68 924
Weighted number of outstanding common shares after dilution (000s) 70 990 68 924 68 924
Number of shares at close of the period (000s) 74 924 68 924 68 924
Consolidated statement of financial position March 31 Dec. 31
SEK M 2013 2012 2012
Tangible fixed assets 380.8 382.9 381.5
Long-term receivables 0.0 0.0 0.0
Total fixed assets 380.8 382.9 381.5
Current receivables 13.1 8.1 98.6
Cash and cash equivalents 471.3 378.4 216.7
Total current assets 484.4 386.5 315.2
Total assets 865.2 769.4 696.7
Shareholders equity 533.7 404.8 339.9
Long-term liabilities 226.5 233.6 228.5
Current liabilities 105.0 131.0 128.3
Total shareholders equity and liabilities 865.2 769.4 696.7
Consolidated statement of changes in shareholders equity March 31 Dec. 31
SEK M 2013 2012 2012
Opening balance 339.9 502.0 502.0
Transfer from revaluation reserve 0.6 0.5 2.0
New share issue 269.9
Net loss for the period -76.6 -97.7 -164.1
Balance at close of period 533.7 404.8 339.9
Condensed consolidated cash-flow statement Jan. - March
SEK M 2013 2012 Full Year
2012
Loss after financial items -78.6 -99.6 -172.0
Adjustment for non-cash items, etc. 3.2 3.2 12.9
Cash flow from operating activities
before changes in working capital -75.4 -96.4 -159.1
Changes in working capital 62.3 11.6 -81.3
Cash flow from operating activities -13.1 -84.8 -240.4
Investments in tangible fixed assets 0.0
Cash flow from investing activities 0.0
New share issue 269.9
Loans raised/amortization of loan liabilities -2.1 -2.0 -8.1
Cash flow from financing activities 267.8 -2.0 -8.1
Cash flow for the period 254.7 -86.7 -248.5
Opening cash and cash equivalents 216.7 465.2 465.2
Closing cash and cash equivalents 471.3 378.4 216.7
March 31
Key figures 2013 2012 2012
Shareholders equity, SEK M 533.7 404.8 339.9
Equity per share, SEK 7.12 5.87 4.93
Equity/assets ratio in the Parent Company 86.6% 80.2% 77.6%
Equity/assets ratio in the Group 61.7% 52.6% 48.8%
Average number of annual employees 63 78 76
Consolidated profit and loss by quarter
2010 2011 2012 2013
SEK M Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Net sales 2.8 3.4 2.3 2.9 2.7 226.1 2.6 3.3 2.6 94.0 39.8 91.5 2.4
Administrative expenses -4.6 -7.1 -4.0 -7.3 -5.3 -4.4 -3.2 -4.0 -3.8 -4.2 -3.2 -4.7 4.2
Research and development costs -49.1 -47.6 -45.6 -74.9 -68.3 -80.1 -76.2 -93.9 -99.4 -109.7 -84.8 -81.3 75.2
Operating profit/loss -51.0 -51.4 -47.3 -79.3 -70.9 141.5 -76.8 -94.7 -100.7 -19.9 -48.2 5.5 -77.0
Net financial items -2.5 -3.3 -1.2 2.4 1.6 4.3 -2.8 -5.7 1.0 -5.3 -4.1 -0.4 -1.6
Profit/loss before tax -53.5 -54.8 -48.5 -76.8 -69.3 145.8 -79.6 -100.4 -99.6 -25.1 -52.3 5.1 -78.0
Tax - - - 12.6 - 1.2 0.6 7.2 0.6 0.6 0.6 -5.0 0.6
Net profit/loss for the period -53.5 -54.8 -48.5 -64.3 -69.3 147.0 -79.0 -93.2 -99.0 -24.5 -51.6 0.1 -78.0
Active Biotech Parent Company - Income Statement, condensed Jan. - March Full Year
SEK M 2013 2012 2012
Net sales 5.3 5.4 234.9
Administration expenses -8.5 -8.1 -33.1
Research and development costs -78.8 -103.0 -389.6
Operating profit/loss -82.0 -105.7 -187.8
Profit/loss from financial items:
Interest income and similar income-statement items 1.0 2.0 6.7
Interest expense and similar income-statement items -0.9 -0.6 -4.2
Profit/loss after financial items -81.9 -104.3 -185.3
Tax
Net profit/loss for the period -81.9 -104.3 -185.3
Statement of comprehensive income parent company
Net profit/loss for the period -81.9 -104.3 -185.3
Other comprehensive income
Total comprehensive profit/loss for the period -81.9 -104.3 -185.3
Active Biotech Parent Company - Balance sheet, condensed March 31 Dec. 31
SEK M 2013 2012 2012
Goodwill 125.2 141.3 129.2
Tangible fixed assets 0.7 1.2 0.8
Financial fixed assets 40.6 40.6 40.6
Total fixed assets 166.5 183.1 170.5
Current receivables 25.4 20.5 108.9
Short-term investments 420.2 265.4 189.5
Cash and bank balances 42.4 104.4 19.4
Total current assets 488.0 390.3 317.8
Total assets 654.4 573.4 488.3
Shareholders equity 567.0 460.1 379.1
Current liabilities 87.4 113.3 109.2
Total equity and liabilities 654.4 573.4 488.3

Any errors in additions 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 and accounting estimates and assumptions were applied to this interim report as were used in the preparation of 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.

Annual General Meeting 2013

The Annual General Meeting of Active Biotech AB (publ) is to be held on Wednesday, May 15, 2013 at 5:00 p.m. at Edison Park, Emdalavägen 16, Lund, Sweden. Shareholders who wish to participate in the Meeting must (a) be recorded in the register of shareholders maintained by Euroclear Sweden AB on Wednesday, May 8, 2013, and (b) notify the company of their intention to participate in the Meeting not later than Wednesday, May 8, 2013. Shareholders who have trustee-registered shares must temporarily reregister the shares in their own name with Euroclear Sweden to be entitled to participate in the Meeting.

This registration must be completed not later than Wednesday, May 8, 2013. Accordingly, shareholders must inform the trustee of this request in ample time prior to this date. Notice of participation can be made in writing to Active Biotech AB (publ), Attn. Susanne Jönsson, PO Box 724, SE-220 07 Lund, Sweden, by fax on +46 (0)46-19 20 50, by telephone on +46 (0)46-19 20 00 or by e-mail to [email protected]. The notice shall include name, personal/corporate registration number, number of shares held, daytime telephone number and, if applicable, the number of advisors (two at the most) that will accompany the shareholder at the Meeting. The notice of the Annual General Meeting is available in its entirety on the company's website www.activebiotech.com.

Financial calendar

Interim reports 2013: August 7 and November 7 Year-end report 2013: February 13, 2014

The reports will be available from these dates at www.activebiotech.com.

Lund, April 25, 2013 Active Biotech AB (publ)

Tomas Leanderson President and CEO

This interim report is unaudited.

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, tasquinimod for prostate cancer and ANYARA primarily for the treatment of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. The company also has one additional project in clinical development, the orally administered compound paquinimod (57-57) for systemic sclerosis. 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 April 25, 2013 at 8:30 a.m.