MOLOGEN AG interim report as of June 30, 2015 Key data 2. H H Change % Revenues Profit (loss) from operations (EBIT)

Transcription

1 Interim report as of June 30, 2015

2 MOLOGEN AG interim report as of June 30, 2015 Key data 2 Highlights Slight decline in research and development expenses EBIT improved accordingly Ongoing recruitment for IMPALA and IMPULSE studies Start of the phase I study in HIV with MGN1703 Capital increase with gross proceeds of 28 million KEY DATA In million Q Q Change % H H Change % Revenues Profit (loss) from operations (EBIT) Expense structure Personnel expenses Research & Development expenses Earnings per share in (basic) Cash flows from operating activities June 30, 2015 Dec 31, 2014 Change % Cash and cash equivalents Shareholders equity Equity ratio 91% 88% 3 Total assets Number of employees

3 MOLOGEN AG interim report as of June 30, 2015 Contents 3 CONTENTS Interim management report as of June 30, The MOLOGEN share 14 Interim statement as of June 30, 2015 Statement of comprehensive income 16 Statement of financial position 17 Statement of cash flows 18 Statement of changes in equity 19 Condensed notes to the interim financial statements 20 Responsibility statement 27 Financial calendar / imprint 28

4 MOLOGEN AG interim report as of June 30, 2015 Interim management report 4 INTERIM MANAGEMENT REPORT A June 30, 2015 Slight decline in research and development expenses to 5.2 million Accordingly, EBIT improved to -6.9 million Successful capital increase: gross proceeds total 28.3 million In the first half of 2015, the focus was above all on the clinical trials with the lead product MGN1703. MOLOGEN proceeded with both the IMPALA (colorectal cancer) and IMPULSE (lung cancer) studies in the reporting period and continues to enroll patients. The expenses for research and development (R&D) amounted to 5.2 million, compared with 5.9 million in the same period of the previous year. EBIT improved from -7.9 million to -6.9 million. As at June 30, 2015, cash and cash equivalents totaled 34.9 million (December 31, 2014: 13.6 million), which is due to the successful completion of a capital increase in April General conditions Overall economic development Global economy stabilizes after weak start to the year IMF lowers growth forecast for 2015 to 3.3% In its August report, the International Monetary Fund (IMF) has predicted global growth of 3.3% for 2015, which represents a downward correction of 0.2% on its prior forecast in January The IMF projects a gradual pickup in the recovery of advanced economies and a slowdown in the growth of emerging market and developing economies. Although China s development in the first half of the year was slightly more positive than had been expected, its low rate of growth and the associated impact on Asian economies continues to be highlighted as a major risk for the development of the global economy. Further specified risks include the political conflict in Russia, which is likely to lead to a recession in the short term at least, and the negative effects of the low oil price on oil-exporting emerging and developing nations. The fact that the Greece crisis has still not been resolved is also continuing to cause great uncertainty in Europe, in particular. Development of the pharmaceutical and biotechnology industries Global sales increase for drugs expected to be up to US$1.3 trillion in 2018 Oncology is the indication with highest sales worldwide The pharmaceuticals market is recording robust growth. Market research company IMS Institute for Healthcare Informatics (IMS) is predicting that total global expenditure on drugs will rise to around US$1.3 trillion by 2018, which is around 30% higher than had been estimated in 2013.

5 MOLOGEN AG interim report as of June 30, 2015 Interim management report 5 The field of oncology plays a major role. In its World Cancer Report 2014, the World Health Organization (WHO) assumes a sharp increase in new cancer incidences. This number could increase by 40% in the next decade, which means that by 2025, 20 million people could develop cancer each year across the globe. The growth rates in the oncology market are correspondingly high. The market researcher EvaluatePharma is predicting a global market volume of more than US$153 billion in this area for This equates to average annual sales growth of around 11%. Oncology is therefore the therapeutic area with the highest growth rates and, according to the market research company's projections, it will remain the indication with the strongest sales worldwide in the long term, with an expected sales share of around 14% by Investments of the pharmaceutical industry in innovative cancer therapies therefore remain high. According to the IMS, its share in the total of all product developments is more than 30%. An area that is looking particularly promising is the emerging field of cancer immunotherapies, which have increasingly become the focus of cancer research over the last two to three years. However, despite good prospects, the industry continues to be faced with significant challenges. These include the broadening of market shares for generics, as well as stricter laws and approval regulations. Conditions for market approvals and subsequent market penetration are also becoming complicated in many countries due to health care reforms, which almost always result in cost cutting. New trends can be observed as pharmaceutical companies react to expiring patents and shrinking product pipelines. Companies are developing new business segments and making increased investments in the development of niche products and personalized medicine or intensifying their activities in the area of mergers and collaborations. New opportunities are likewise arising for the biotechnology sector due to increased demand for innovative drugs and treatment methods, above all in the area of oncology. In this context, the business prospects for MOLOGEN can be assessed as very positive in the long term. Course of business Continued focus on conducting clinical trials with MGN1703: patients recruited for IMPALA (colorectal cancer) and IMPULSE (lung cancer) Start of phase I/IIa clinical study of MGN1703 in HIV-infected patients Research and development (R&D) In the first half of 2015, MOLOGEN s R&D above all advanced the two clinical studies for its lead product, the immunotherapy MGN1703: a randomized IMPULSE clinical trial for lung cancer and a phase III IMPALA pivotal study in the indication colorectal cancer. Patients are currently still being recruited for both studies. In the first six months of 2015, research and development results were presented at major international scientific conferences. This included further data on MGN1703 from a safety study conducted in the USA in 2013 and findings on individual patients from the IMPACT clinical study.

6 MOLOGEN AG interim report as of June 30, 2015 Interim management report 6 Furthermore, the Danish Aarhus University Hospital initiated a phase I/IIa clinical trial to treat HIV patients with MGN1703. The first patients have already been enrolled in the study. R&D expenses In the first six months of 2015, MOLOGEN carried out activities requiring expenditures and investments in the amount of 5.2 million according to plan (first half of 2014: 5.9 million). These mainly reflected expenses from the procurement of raw materials for manufacturing investigational medicinal products in the reference period which were not recognized under expenses in the reporting period. R&D expenses million H H Composition of the product pipeline (As of: June 30, 2015) Preclinic Phase I Phase II Phase III / Approval EnanDIM Oncology & Anti-Infectives MGN Other solid tumors MGN Small cell lung cancer MGN Colorectal cancer MGN1331 Leishmaniasis MGN1333 Hepatitis B MGN HIV MGN1601 Renal cancer MGN Malignant melanoma 1 IND (Investigational New Drug) filed in US; safety trial in US completed in Collaboration with Max-Delbrueck-Center for Molecular Medicine and Charité Universitaetsmedizin, Berlin 3 Collaboration with University Hospital Aarhus, Denmark Oncology Oncology & Infectious diseases Infectious diseases Immunotherapy MGN1703 The immunotherapy MGN1703 is MOLOGEN s most advanced product candidate. The immunomodulator and TLR9 agonist is currently being investigated in the IMPALA, IMPULSE and TEACH clinical studies for the indications colorectal cancer, small cell lung cancer and HIV.

7 MOLOGEN AG interim report as of June 30, 2015 Interim management report 7 Pivotal study on colorectal cancer (IMPALA) Patient enrollment for the IMPALA study started in September 2014 and continued over the course of the first half-year of The IMPALA study is an international phase III multicentric, randomized, open-label, two-arm clinical trial. Based on the findings of the sub-group analyses of the IMPACT study, the IMPALA study includes patients with metastatic colorectal cancer in whom a response to first-line chemotherapy treatment has been confirmed with or without biological agents (biologics). The aim of the study is to demonstrate that a switch-maintenance therapy with the cancer immunotherapy MGN1703 leads to a prolongation of overall survival in patients with metastatic colorectal cancer. The primary endpoint is therefore overall survival. The secondary endpoints include progression-free survival, toxicity, safety, and quality of life (QoL). Around 540 patients from around 120 centers in eight European countries, including the five largest European pharmaceutical markets, will participate in the study. Patient enrollment is expected to be completed in the second half of The study will be evaluated once a certain number of specified events have occurred, which is currently estimated to be reached 12 to 18 months after completion of patient recruitment. Lung cancer study (IMPULSE) The enrollment of patients for the IMPULSE study which started in March 2014 also carried on in the reporting period. The primary endpoint of this IMPULSE study is overall survival. The trial will compare MGN1703 against the best standard of care. The study will include patients who are suffering from an extensive disease stage of small-cell lung cancer (SCLC) and whose tumors have responded to four cycles of the standard first-line therapy with chemotherapeutics. The study intends to enroll 100 patients overall. The intention is to have concluded patient recruitment by the end of The evaluation of the study is expected to take place twelve months after completion of patient enrollment. With this IMPULSE study, MOLOGEN is expanding the scope of the cancer immunotherapy MGN1703 by a further indication for which there is a high unmet medical need. HIV study (TEACH study) In the second quarter 2015, a collaboration with the Danish Aarhus University Hospital was agreed to carry out an early-phase study with MGN1703 to treat HIV (Human Immunodeficiency Virus) patients. This is the first time that MGN1703 is being evaluated in patients with diseases other than cancer. The potential range of applications of the product could be expanded as a result. The aim of the TEACH study is to determine whether the immunotherapy with MGN1703 can activate the immune system in HIV patients to enhance killing of the HIV infected cells. Aarhus University Hospital is conducting the trial in two hospital centers in Denmark and has already received respective funding from the American Foundation for AIDS research (amfar). MOLOGEN provides the immunomodulator MGN1703.

8 MOLOGEN AG interim report as of June 30, 2015 Interim management report 8 The study commenced in June 2015 with the enrollment of the first patients. The intention is that between 14 and 16 patients will participate in the study overall. Patient recruitment will be concluded over the next few months. TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial of MGN1703 in HIV-infected patients. Participants will receive four weeks of MGN1703 therapy (60 mg s.c. twice weekly). During these four weeks, each participant will be closely monitored for the safety and therapeutic effects of the drug. The primary endpoint of the study is the change in proportions of activated natural killer cells in the patients. Secondary study endpoints include, among others, a collection of virological, immunological, pharmacodynamic and safety data. Safety and tolerability study in the USA In March 2015, MOLOGEN presented detailed pharmacokinetic (PK) and pharmacodynamic (PD) data from a phase I study with the cancer immunotherapy MGN1703 in healthy volunteers for the first time within a poster presentation at the 2nd Immunotherapy of Cancer Conference (ITOC-2) in Munich, Germany. The data from this phase I study was shown in comparison to data from two clinical trials with cancer patients. The findings support the dosing regimen of the ongoing studies IMPULSE in small cell lung cancer and IMPALA in colorectal cancer. PK and PD data are important parameters for the administration of drugs as they lead to conclusions on the optimum dosing for the best effect of a drug. The presented data revealed that healthy volunteers and cancer patients showed similar immune activation on treatment with MGN1703. In addition, the data supports the twice-weekly dosing regimen which is used in the current IMPALA, IMPULSE and TEACH studies. In these studies, patients are treated subcutaneously with 60mg MGN1703 twice each week. MGN1703 has an Investigational New Drug (IND) designation from the FDA, which is an essential requirement for conducting clinical trials in the USA. Phase II study for colorectal cancer (IMPACT) IMPACT was a randomized, placebo-controlled, clinical phase II study assessing the efficacy of MGN1703 as a switch-maintenance therapy after first-line treatment of patients with metastatic colorectal cancer. The study was completed in In January 2015 at the Gastrointestinal Cancers Symposium in San Francisco, USA, MOLOGEN presented data on overall survival of patient subgroups from the IMPACT study. The results showed that patients who responded to induction therapy may benefit the most from a switch maintenance treatment with MGN1703. These results are reflected in the IMPALA and IMPULSE studies, where "response to induction therapy" is one of the main inclusion criteria. In May 2015, updated data on a subgroup of patients with long-term progression-free survival (PFS) from the IMPACT trial was presented at the 51st Annual Meeting of the American Society of Clinical Oncology

9 MOLOGEN AG interim report as of June 30, 2015 Interim management report 9 (ASCO) in Chicago, USA. The data collected in April 2015 revealed a PFS ranging from 44 months to 51 months for these patients. Cancer immunotherapy MGN1601 The active principle of cancer immunotherapy MGN1601 corresponds to a therapeutic vaccination. The clinical ASET study for phase I/II with MGN1601 was successfully concluded in A continuative study is currently being planned. Cancer immunotherapy MGN1404 MOLOGEN is cooperating with facilities of the Charité-Universitätsmedizin Berlin and the Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch. As part of the cooperation, Charité is conducting a phase I clinical study to test the safety and tolerability of MGN1404 in the treatment of malignant melanoma. The study will also gather data on the mechanism of action. A total of nine patients are scheduled to be admitted into the study. Patients are currently still being recruited for the study. Financial performance and financial position Marginal decline in R&D expenditure to 5.2 million (H1 2014: 5.9 million) EBIT has improved to -6.9 million (H1 2014: million) Average cash utilized per month of 1.2 million (H1 2014: 1.3 million per month) Cash and cash equivalents total 34.9 million (December 31, 2014: 13.6 million) Overall, the company s financial performance and financial position developed according to plan. The cash and cash equivalents available on the reporting date cover the short-term financial needs of the company. Results of operations In the first half of 2015, MOLOGEN s revenues were up a little year-on-year, at 0.04 million, but remained at a low level overall (reference period H1 2014: 0.01 million). They result from the sale of goods and services in the area of research. Other operating income amounted to 2 thousand and was therefore at prior year s level. At 2.5 million, the cost of materials was below the previous year's figure (H1 2014: 3.7 million) and primarily incurred in connection with the conduction of clinical studies. In particular, this included costs for external services of 2.4 million (H1 2014: 2.7 million). The costs of raw materials, supplies and goods for the manufacture of investigational medicinal products accrued in the reference period were not recognized in the reporting period. Other operating expenses increased to 1.8 million (H1 2014: 1.5 million), which is partly attributable to the increased expenses arising from staff recruitment and the cooperation with the Free University of Berlin (FU Berlin). At 2.6 million, personnel expenses were slightly down on the previous year (H1 2014: 2.7 million). When compared with the first half of 2014, higher cost of wages and salaries was offset by lower expenses in relation to employee share options being granted.

10 MOLOGEN AG interim report as of June 30, 2015 Interim management report 10 The scheduled depreciation and amortization of assets was on a par with the same period of the previous year, at 52 thousand. Finance income decreased to 2 thousand in the first half of 2015 due to the significantly lower interest rates compared with the prior-year period (H1 2014: 14 thousand). Of the total expenses, 5.2 million was used for research and development projects, which represents a decline of approximately 12% (H1 2014: 5.9 million). The year-on-year decrease in R&D expenditure is above all attributable to the lower cost of materials. In the first half of 2015, EBIT increased to -6.9 million and was therefore 1.0 million above the value in the reference period (H1 2014: -7.9 million). EBIT million H H Net assets and financial situation On March 24, 2015, the Executive Board of MOLOGEN resolved, with the approval of the Supervisory Board, to make partial use of the authorized share capital in accordance with Section 4 Para. 3 of the Articles of Association and to carry out a capital increase with subscription rights for the shareholders. The issue of up to 5,657,875 new shares (equating to 33.33% of the previous share capital) was intended to raise the share capital from 17.0 million to up to 22.6 million. The expected inflow of funds through the capital increase will further strengthen the share capital base as well as fund the company's research and development programs, especially in relation to the IMPALA and IMPULSE clinical studies and to fund ongoing business operations needed for this purpose. The dividend entitlement of the new shares applies from January 1, With the Supervisory Board's consent, the Executive Board set the subscription price for new shares at 5.00 per share on March 30, MOLOGEN successfully placed new shares in the full amount of 5,657,875 units. The purchase price as part of the private placement was set at 5.00 per new share and therefore corresponded with the subscription price for existing shareholders. Through the issue of 5,657,875 new no-par bearer shares, the share capital was raised from 16,973,626 to 22,631,501. Gross proceeds from the issue totaled around 28.3 million. The capital increase was recorded in the relevant Commercial Register on April 27, The total assets have increased to 36.0 million (December 31, 2014: 15.1 million). The capital increase and concomitant strengthening of both cash and cash equivalents and the share capital had a notably more positive effect on the balance sheet total than on the cash burn and accumulated deficit, which increased as a result of the net loss for the period.

11 MOLOGEN AG interim report as of June 30, 2015 Interim management report 11 As at June 30, 2015, assets comprised a very high share of cash and cash equivalents amounting to 34.9 million (December 31, 2014: 13.6 million). The income from the capital increase significantly exceeded cash burn within the scope of operating activities. Including investments and expenses for equity procurement, cash utilization stood at 6.9 million (H1 2014: 7.7 million). Cash and cash equivalents million Jun. 30, Dec. 31, In the reporting period, MOLOGEN was always in a position to comply with all its financial obligations. The volume of the investments made in the first half of 2015 was less than the scheduled depreciation and amortization. At 0.43 million, non-current assets as at June 30, 2015 were slightly below the level on the prior year s reporting date (December 31, 2014: 0.44 million). Equity and liabilities are influenced by the reported equity capital in the amount of 32.8 million (December 31, 2014: 13.3 million). The equity ratio increased from 88% as at December 31, 2014 to 91% as a result of the capital increase. Equity ratio % Jun. 30, 2015 Dec. 31, % 91% As at June 30, 2015, current liabilities amounted to 3.2 million and were therefore above the level on the prior year s reporting date (December 31, 2014: 1.7 million). This increase was attributable to trade payables, especially in relation to clinical trials, as well as all other liabilities. Other financial liabilities amounted to 21.6 million in total as at June 30, 2015 (December 31, 2014: 21.8 million) and were essentially due to the conclusion of short-term service contracts for the IMPALA and IMPULSE clinical trials that commenced in fiscal year The calculation of other financial liabilities was based on the assumed scheduled development of the company's business activities. Liquidity development In the first half of 2015, cash flows used for operating activities in the amount of 4.7 million were below the prior year's value (H1 2014: 6.5 million) and were mostly committed to research and development. The lower outflows from operating activities primarily resulted from a lower loss for the period and increased current liabilities.

12 MOLOGEN AG interim report as of June 30, 2015 Interim management report 12 Cash flows from operating activity million H H Cash flows from investing activities have decreased, from 6.0 million in the first half of 2014 to million in the first half of In the same period of the previous year, fixed-term deposit of 6.0 million reached maturity. This was reported as a payment under cash flows from investing activities. Due to the capital increase in April 2015, cash flows from financing activities which amount to 26.1 million were also significantly up on the corresponding value in the reference period, which had been influenced by the fund inflows from the cash capital increase carried out in February 2014 (H1 2014: 14.7 million). Monthly cash consumption (taking into account incoming payments from sales as well as costs of equity procurement) amounted to an average of 1.2 million per month in the first half-year of 2015 and was therefore slightly lower than the value of 1.3 million in the same period of the prior year. Average monthly cash consumption million H H Supplementary report Executive Board changes The following changes to the Executive Board of MOLOGEN were announced on July 23, The Supervisory Board appointed Dr. med. Mariola Söhngen, co-founder of PAION AG, and Chief Medical Officer (CMO) up to October 31, 2015, as Member of the Executive Board and new Chief Executive Officer (CEO) of MOLOGEN AG with effect from November 1, She will be in charge of Research, Business Development, Strategy and Partnering. The current CEO of MOLOGEN, Dr. Matthias Schroff, will resign from his post on October 31, 2015 and will be leaving the Executive Board with effect from December 31, 2015, by mutual agreement with the Executive and Supervisory Boards. Jörg Petraß (Chief Financial Officer; CFO) will also be leaving the Executive Board on expiration of his tenure as Ordinary Executive Board Member, which is due to run out on December 31, 2015.

13 MOLOGEN AG interim report as of June 30, 2015 Interim management report 13 Election to the Supervisory Board The Annual General Meeting on July 29, 2015 re-elected Oliver Krautscheid to the Supervisory Board. In addition, the Supervisory Board once again unanimously voted Oliver Krautscheid to the position of Chairman of the Supervisory Board. Forecast, opportunities and risk report Forecast report The statements made in the management report of the annual financial statements as at December 31, 2014 on the objectives in the areas of research and development, cooperations and partnerships, earnings and liquidity development as well as personnel remain valid (cf. Annual Report 2014, page 36 f.). Opportunities and risks report The opportunities and risks, including their assessment, as presented in the management report of the annual financial statements as at December 31, 2014 essentially continue unchanged (cf. Annual Report 2014, pages 39 ff.).

14 MOLOGEN AG interim report as of June 30, 2015 MOLOGEN share 14 THE MOLOGEN SHARE As in the previous year, the German stock market continued to develop positively in the first half of In the second quarter, the DAX climbed to a new record high of more than 12,300 points, before a downward trend set in, which was attributable to the Greece crisis, among other factors. Despite this, the DAX closed the first half of 2015 with a strong improvement of around 12% since the start of the year. In the same period, the relevant indices for MOLOGEN of DAXsubsector Biotechnology and DAXsector Pharma & Healthcare also recorded gains of 18% and 23%, respectively. In contrast, the MOLOGEN share price fell over the first six months of the current financial year, from 6.06 at the start to 4.80 by the half-year-end. This represents a decline of 21%. With the exception of a clear but very short-lived upward trend, which pushed the XETRA price to 7.89 at the end of March and even resulted in the trading price on the Frankfurt Exchange rising to almost 9.00, MOLOGEN shares registered a continuous decline over the first quarter. In the second quarter, the price fluctuated around the 5.00-mark. The average daily trading volume of MOLOGEN shares was 21,477 units in the first half of This is a slight decline on the previous year s volume of 24,362 units. As a result of the capital increase carried out in April 2015, the issuance of 5,657,875 new shares raised MOLOGEN AG s share capital to 22,631,501. The gross proceeds from the issue of 28.3 million will above all be used for funding clinical trials with the lead product candidate MGN1703. This has helped attract new, in part international, investors. Since the capital increase, Deutsche Balaton Aktiengesellschaft holds a stake of around 5% in MOLOGEN. The free float remains in the region of 54%. Especially in the run-up to the capital increase, the company held many meetings with investors during roadshows in major financial centers throughout Europe and in the USA in the reporting period. In additional, MOLOGEN attended various national and international capital market conferences.

15 MOLOGEN AG interim report as of June 30, 2015 MOLOGEN share 15 Performance of the MOLOGEN share in the first half of % MOLOGEN AG DAXsector Pharma & Healthcare DAXsubsector Biotechnology 100% 50% January 2, 2015 June 30, 2015 Key share data (ISIN DE , Prime Standard) XETRA H H Number of shares outstanding on June, 30 22,631,501 16,973,626 Market capitalization on June, 30 (million ) First trading day ( ) Last trading day ( ) High ( ) Low ( ) Average daily trading volume (shares) 21,477 24,362 Shareholder structure as of June 30, 2015 (estimates)

16 MOLOGEN AG interim report as of June 30, 2015 Statement of comprehensive income 16 STATEMENT OF COMPREHENSIVE INCOME (IFRS) EUR 000 H Q H Q Revenues Other operating income Cost of materials -2,517-1,437-3,689-1,810 Personnel expenses -2,617-1,288-2,650-1,198 Depreciation and amortization Other operating expenses -1, , Profit (loss) from operations -6,903-3,722-7,892-3,816 Finance costs Finance income Profit (loss) before taxes -6,901-3,721-7,878-3,810 Tax result Profit (loss) for the period/ comprehensive income -6,901-3,721-7,878-3,810 Loss carried forward -84,235-87,415-67,157-71,225 Accumulated deficit -91,136-91,136-75,035-75,035 Basic earnings per share (in ) Diluted earnings per share (in )

17 MOLOGEN AG interim report as of June 30, 2015 Statement of financial position 17 STATEMENT OF FINANCIAL POSITION (IFRS) EUR 000 June 30, 2015 December 31, 2014 ASSETS Non-current assets Intangible assets Property, plant and equipment Current assets 35,587 14,613 Cash and cash equivalents 34,928 13,563 Inventories Other current assets 625 1,007 Income tax receivables 6 13 Total assets 36,015 15,053 EQUITY AND LIABILITIES Non-current liabilities 7 8 Deferred income 7 8 Current liabilities 3,216 1,747 Trade payables 2,417 1,315 Other current liabilities and deferred income Liabilities to banks Shareholders equity 32,792 13,298 Issued capital 22,632 16,974 Capital reserves 101,296 80,559 Accumulated deficit -91,136 84,235 Total 36,015 15,053

18 MOLOGEN AG interim report as of June 30, 2015 Statement of cash flows 18 STATEMENT OF CASH FLOWS (IFRS) EUR 000 H H Cash flows from operating activities Loss for the period before taxes -6,901-7,878 Depreciation and amortization of intangible assets and property, plant and equipment Other non-cash expenses and income Change in trade receivables, inventories and other assets Change in trade payables and other liabilities 1, Net cash used in operating activities -4,692-6,477 Cash flows from investing activities Cash payments to acquire property, plant and equipment Cash payments to acquire intangible assets -2-6 Proceeds from financial investments within the cash management and forecast (fixed-term deposits with a term of more than three months) 0 6,000 Net cash used in investing activities Cash flows from financing activities Cash proceeds from issuing shares 26,095 14,665 Net cash used in financing activities 26,095 14,665 Effect of exchange rate changes on cash 0-3 Total changes in cash and cash equivalents 21,365 14,112 Cash and cash equivalents at the beginning of the period 13,563 8,765 Cash and cash equivalents at the end of the period 34,928 22,877

19 MOLOGEN AG interim report as of June 30, 2015 Statement of changes in equity 19 STATEMENT OF CHANGES IN EQUITY (IFRS) EUR 000 except share data Issued Capital Capital Reserves Accumulated Deficit Shareholder`s Equity Number of Share Capital ordinary shares As of 12/31/ ,419,512 15,420 66,721-67,157 14,984 Capital increase in exchange for cash contributions 1,541,244 1,541 13,031 14,572 12, Value of services rendered by employees (according to IFRS 2) Loss for the period -7,878-7,878 As of 06/30/ ,973,626 16,974 80,330-75,035 22,269 As of 12/31/ ,973,626 16,974 80,559-84,235 13,298 Capital increase in exchange for cash contributions 5,657,875 5,658 20,437 26,095 Value of services rendered by employees (according to IFRS 2) Loss for the period -6,901-6,901 Rounding difference -1-1 As of 06/30/ ,631,501 22, ,296-91,136 32,792

20 MOLOGEN AG interim report as of June 30, 2015 Notes 20 CONDENSED NOTES for the period from January 1 to June 30, 2015 A. General information on the company Mologen AG (hereinafter: MOLOGEN) is a stock corporation as defined under the law of the Federal Republic of Germany with its headquarters in Berlin (Fabeckstraße 30, Berlin, Germany). It was founded on January 14, 1998 and is registered in the Commercial Register of the Local Court at Berlin- Charlottenburg under the number HRB B. The shares of the company are listed on the Regulated Market (Prime Standard) at the Frankfurt Stock Exchange under ISIN DE The objective of the company is the research, development and marketing of products in the area of molecular medicine. In particular, this encompasses the research and development of biomolecular vaccines, application-related clinical research for biomolecular tumor therapy and somatic gene therapy. The main focus of research is the MIDGE and dsllm technologies patented by MOLOGEN. These facilitate the use of DNA as a drug for diseases that were previously untreatable or for which treatment is insufficient. B. General information on the financial statements These condensed interim financial statements of MOLOGEN have not been audited or reviewed. They were prepared in accordance with IFRS as applied as at the reporting date, June 30, 2015, and as adopted by the European Union (EU) and in accordance with the IAS 34 (Interim Financial Reporting), and they should be read together with MOLOGEN s audited financial statements as at December 31, 2014, which were prepared in accordance with IFRS as adopted by the EU. The accounting and measurement methods continued unchanged from December 31, No accounting standards that were established for the first time or had been changed for the reporting period had any material effect on MOLOGEN's interim financial statements. The reporting period for these condensed interim financial statements is the period from January 1, 2015 to June 30, The comparison period for these condensed interim financial statements for statement of cash flows and statement of changes in equity is the period from January 1, 2014 to June 30, The comparison period for these condensed interim financial statements for the statement of comprehensive income is the period from January 1, 2014, to June 30, 2014 and the period from April 1, 2014, to June 30, The functional and presentation currency in the financial statements is the euro ( ). To improve readability, numbers are rounded and stated in thousands of euros ( 000), unless otherwise specified. MOLOGEN still does not prepare segment reporting. In relation to this, please refer to the explanations presented in the Notes in accordance with IFRS for fiscal year 2014.