The Interview Dr. Ekkehart

Steinhuber CEO of Innovacell Biotechnologie AG

Innovacell Biotechnologie AG is a privately-held Phase III cell therapy company based in Innsbruck, Austria. The company is engaged in the clinical development and commercialization of autologous (i.e. patient’s own cells), minimally invasive cell therapies. INNOVACELL’s personalized products are potentially curative once-in-a-lifetime treatments, which re-establish functionality of sphincter muscles in patients, e.g. with stress urinary incontinence (SUI) or faecal incontinence (FI).

ICES13 is in late-stage clinical development (Phase III) for SUI patients, and ICEF15 is in mid-stage testing (Phase IIb) for persons with FI. Each product is comprised of, autologous myoblast cell suspensions that are implanted by means of specifically designed, proprietary and CE-marked injectors.

Dr. Ekkehart Steinhuber has been the CEO of Innovacell AG since 2007. He spent 25 years at Sandoz at the executive and senior management level. His recent roles were CEO Hungary; Global Co-ordinator, Pandemic Preparedness; Divisional Director of Pharmaceuticals, responsible for development, production, logistics and quality assurance in Austria; and CEO at Sandoz Representative Office in Vietnam. Dr. Steinhuber earned his Ph.D. in business administration and studied at the universities of Innsbruck and Vienna.

Q

Can you give an overview of Innovacell and its organisational

structure?

Innovacell was founded in 2000 as a spin-off from the Medical University of Innsbruck. The number of staff is 25. Innovacell pursues a pronounced outsourcing concept and deploys several, highly qualified experts in their field as consultants, especially in order to develop and operate its multi-national clinical trial program within time and budget. Based on the cost-effective, existing working and business relationship Innovacell aims to work with consultants in the future as required. Consultants with profound industrial experience will be key in order to access networks effectively and maintain a competitive edge in the market.

Q 40

You recently raised €8.3M from Buschier, Fides, HYBAG and private

investors. Were there any challenges that needed to be overcome?

The capital increase was subscribed by existing www.finance-monthly.com

shareholders. The timely achievement of milestones in the clinical development for ICES13 and ICEF15 has been the prerequisite for financing of the company.

In order to continue on its agreed expansion course, Innovacell acquired fresh capital: shareholders in the firm, which is developing cell-therapy for the treatment of stress-urinary incontinence (ICES13) and faecal incontinence, have agreed on a capital expansion of 8.3 million Euro. This will take effect in two tranches. The main shareholders are the financial investors Buschier, Fides, HYBAG und the private equity firm, uni venture.

Q

Innovacell is a biotechnology firm focused on the area of tissue

engineering and it operates one of Europe's largest and most modern production facilities for the proliferation of the body's own tissue cells. Can you tell us more about ICES13 and ICEF15?

Innovacell´s therapeutic approach, for the first time offers the patients a curative, natural, autologous cell-based treatment concept that can achieve a regeneration of the sphincter muscle tissue and potentially recovery for life.

According to market reports the number of patients suffering from incontinence is huge and growing. The number of women in the 7 major markets of the world suffering from Stress Urinary Incontinence is 46.5 million and men and woman suffering from faecal incontinence is 32.2 million.

ICES13 is the Company’s lead-product in development for the treatment of SUI in females. The product has demonstrated safety and efficacy in a Phase IIb clinical study, and regulators have approved Phase III trial protocols. The Company started the Phase III

trial in May 2012 and expects to complete patient enrollment beginning 2013 and to have 3M interim data available around MY13.

ICEF15, INNOVACELL’s second clinical product candidate, is in mid-stage clinical development for FI of man and woman. Based on positive data from two completed Phase I/II pilot studies, regulators have approved a Phase IIb study. INNOVACELL expects to initiate the Phase IIb study during 1H13.

Q

2011 saw global economic turmoil; do you think this has impacted on your

2012 strategy?

Definitely it had an impact on our market entry strategy for Japan and USA. We are now pursuing and out–licensing strategy rather than financing the market entry via the capital markets.

Contact: Dr. Ekkehart Steinhuber Innovacell Biotechnologie AG CEO Mitterweg 24, 6020 Innsbruck

Tel: +43 / 512 / 573680-0 Fax: +43 / 512 / 573680-5 ekkehart.steinhuber@innovacell.com office@innovacell.com