Martinsried/Munich, 12 June 2015. The Executive Management Board of Medigene AG (MDG1, Frankfurt, Prime Standard) today resolved, with the approval of the company's Supervisory Board, a financing measure for the ongoing clinical and preclinical development of its immunotherapy platforms. Medigene plans a cash capital increase with subscription rights for existing shareholders by offering up to approx. 5.6 million new shares. Any new shares not subscribed for will be offered to selected institutional investors as private placements.
In addition, the Executive Board and Supervisory Board of Medigene AG today resolved to settle the payment in the value of EUR 700,000 announced by Medigene on 11 May 2015 for the achievement of a milestone in the clinical development of dendritic cell (DC) vaccines, as planned, in the form of new shares. This leads to a capital increase through contributions in kind by issuing 66,370 new shares.
Cash capital increase by issuing new shares: The company intends to increase its share capital of EUR 14,051,815.00 (new share capital following registration of the capital increase through contributions in kind) up to a total of EUR 19,645,993.00 by issuing up to 5,594,178 new shares with partial utilisation of authorised capital of up to EUR 5,594,178.00. The new shares may be subscribed by cash contributions and will be offered to existing shareholders by way of indirect subscription rights through Baader Bank AG, Unterschleissheim, Germany. The subscription ratio is five for two, which means that five existing shares entitle the holder to subscribe to two new shares. There will be no organised trading of subscription rights. The subscription period for the new shares is scheduled to run from 16 June 2015 until 12 noon CEST on 30 June 2015. The subscription price of the new shares is planned to be determined on 26 June 2015 and will be based on the volume weighted average price (VWAP) of Medigene shares (XETRA electronic trading system of Frankfurt Stock Exchange) from the beginning of the subscription period until close of trading on 25 June 2015, with a possible discount yet to be specified. The maximum subscription price will be EUR 9.50 per new share taking into account the VWAP of the last 30 trading days before today's announcement. The final subscription price is scheduled for publication in the German Federal Gazette on 26 June 2015 as well as on the website of Medigene AG (www.medigene.de). Medigene intends to raise gross proceeds of around EUR 40 million with this capital increase.
Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, commented: "With the planned financing we will be well positioned to advance our complementary T cell-based platforms in the field of cancer immunotherapy to the next stages of development. We intend to validate our highly innovative therapies in our own clinical trials and make these available as soon as possible for physicians and patients. Primarily we plan to accelerate the clinical development of our T-cell receptor (TCR) technology and develop up to 10 TCR lead candidates as well as to start three clinical TCR trials. This capital measure should therefore enable us to complete the ongoing DC vaccine trial, to advance the clinical validation of our TCR technology and to extend our cash reach at least until the second half of 2019."
Use of the issuing proceeds: Medigene intends to use the proceeds from the offering of new shares primarily for the clinical development of its immunotherapy platforms for T-cell receptor (TCR)-modified adoptive T-cell therapy and dendritic cell (DC) vaccines, including ongoing process development in accordance with good manufacturing practice (GMP), as well as to finance the preclinical development of TCR technology and T-cell specific antibody technology (TABs). Proceeds would be invested primarily in the preparation and conduction of several clinical trials with the TCR-modified T-cell therapy as well as in the ongoing clinical phase I/II study with DC vaccines. Medigene plans to develop up to 10 lead candidates for the TCR technology in the next years and aims to initiate up to three clinical TCR trials, the first to be started in the first half of 2016 (IIT phase I study with participation of Medigene, subject to grant funding). Medigene-sponsored trials are planned to start in the second half of 2017 and in the second half of 2018.
The cash capital increase will be executed by Baader Bank AG as Global Coordinator and Sole Bookrunner.
Capital increase through contributions in kind by issuing new shares: For the achievement of a milestone in the clinical development with the dendritic cell (DC) vaccines, 66,370 new shares will be issued to the investing shareholders of Medigene Immunotherapies GmbH (formerly Trianta Immunotherapies GmbH) as part of a capital increase through contributions in kind with partial utilisation of authorised capital. The number of these new shares was calculated on the basis of the volume weighted average price (VWAP) of Medigene shares in the 30-day period prior to and the 30-day period after 11 May 2015 respectively, 11 May 2015 being the date on which the milestone was achieved. The calculated VWAP is approx. EUR 10.55. The milestone payment was agreed as part of the purchase price in the acquisition of Trianta which took place in January 2014.
Rights offering and issuing prospectus: Further details regarding the cash capital increase will be provided in the relevant rights offering, which is scheduled for publication in the German Federal Gazette and on the website of Medigene AG (www.medigene.de) on 15 June 2015. The public offering of shares as part of the cash capital increase and the admission of the new shares from both capital increases for trading on the regulated market (Prime Standard) of the Frankfurt Stock Exchange are based on an issuing prospectus submitted to the German Financial Supervisory Authority (BaFin) that has yet to be approved. Approval of the prospectus is expected on 12 June 2015, from which date onwards the prospectus will be available at www.medigene.de).
About Medigene's Immunotherapies: Medigene is working on three complementary immunotherapy strategies for the treatment of different forms and stages of cancer with focus on T-cells. The role of these white blood cells is to identify and combat pathogens. However, they frequently fail to recognize cancer cells. Medigene's immunotherapies activate, prepare and "train" patients' own T-cells to detect and destroy tumour cells specifically. On the other hand, unwanted T-cells, such as in the case of autoimmune diseases, can be identified and removed. The aim is to combat diseases effectively and over longer periods.
Medigene is developing new generation antigen-tailored dendritic cell vaccines (DCs), T-cell receptor-based adoptive T-cell therapies and T-cell-specific monoclonal antibodies (TABs).
The DC vaccines are currently being evaluated in a company-sponsored clinical trial in acute myeloid leukaemia (AML). Further studies utilizing Medigene's DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme including patients with diverse malignancies.
For the TCR platform, the activities are focused on the preparation of the first clinical trial with TCR product candidates and on the further development of a GMP compliant production process. In addition, novel TCRs with specificities for promising tumour-associated antigens will be isolated and further characterised. Medigene plans to participate in an academic Phase I trial for the treatment of haematological malignancies which is projected to commence in the first half of 2016, subject to grant funding.
Regarding Medigene's TABs platform, proof of technology was established in preclinical experiments. Further preclinical development continues with the aim of achieving proof of principle.
More information, as well as audio visual aids about Medigene's immunotherapies, can be found at www.medigene.com/
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. Medigene concentrates on the development of personalized T cell immunotherapies with a focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. For more information, please visit www.medigene.com.