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Milestones

The following milestones stand out in Cellerix´s growth:

Year

Financial milestone

Clinical development milestones

2004

Cellerix was formed within the Genetrix Group.
Cellerix closes a series A financing round worth €1.3 million led by Genetrix and the Management Team.

Cellerix is licensed as a Pharmaceutical Company.
The Phase II clinical trial with Ontaril® for treatment of complex perianal fistulas starts.

2005

Cellerix closes a serie A financing round worth €4.3 million led by Genetrix and private investors.

Orphan drug designation for Ontaril® in Europe is granted.

2006

Cellerix closes the first tranche of a series A financing round in November.

The Phase II trial of Ontaril® (acute phase) is successfully completed.
Cx501 is granted orphan drug status in Europe.

2007

Cellerix closes a series B financing round worth €27.2 million led by Life Science Partners (Netherlands), Ventech (France) and Ysios Asset Management (Spain). International Corporate Venture Funds (Novartis (Switzerland) and Roche (Switzerland)) as well as other financial investors (Genera (Spain) and Biopartners (Spain)), existing shareholders (Genetrix y Nerel) and the Management Team also participated in this round.
Cellerix concludes a licensing agreement with Axcan Pharma Inc. to develop Ontaril® in North America (Canada, USA and Mexico), an agreement that could be worth as much as US$40 million in the form of an upfront payment and milestone payment.

The Phase III clinical trial (FATT I) with Ontaril® for treating complex perianal fistulas in patients without inflammatory bowel disease starts.
The Phase II clinical trial of Cx501 for the treatment of recessive dystrophic epidermolysis bullosa gets underway.

2008

Secured €10 million facility from venture debt provider ETV Capital.
Completion of top Management Team.

Ontaril®: Recruitment of 214 patients in 20 centers completed for FATT I study; First patient in in FATT II study.
Cx501: First 3 phase II patients demonstrate safety and engraftment at 21 days.
Cx601: First patient successfully treated with Cx601 on compassionate use.
North-America: pre-IND meeting held with FDA with very positive outcome.

2009

Close of series C round (€28.2 million)

Safety of allogeneic eASCs demonstrated (compassionate use program)

Start of Cx601 phase I/II trial (allogeneic treatment of complex perianal fistula in Crohn’s patients)

Cx601 is granted Orphan Drug designation

Cx-1 (method of manufacturing, composition and therapeutic use of the artificial dermis) granted in Europe

Results of first phase III trial in Ontaril® (non-Crohn)

Results of Ontaril® retrospective study

2010

The Cellerix GMP plant was the first plant approved for marketing of advanced therapies (ATMPs) in Spain.

Phase II results Cx501
Phase II results Cx601
Proof of concept in animals Cx602
IND preparation Cx611
Proof of concept in animals Cx621

PROYECTOS CO-FINANCIADOS DENTRO DEL P.N. DE INVESTIGACIÓN CIENTÍFICA, DESARROLLO E INNOVACIÓN TECNOLÓGICA 2004-2007

FIT-010000-2006-95; FIT-010000-2006-97; FIT-010000-2006-61; FIT-010000-2006-63; FIT-010005-2007-1

PTQ04-03-00510; PTQ06-01-00119; PTQ06-01-00120

CIT-010000-2005-27; CIT-010000-2005-15; PSE-090100-2006-3

PIE704/2005; PIE705/2005; PIE412/2006; PIE192/2007;

39/2006; 6/2007; 8/2007

PROYECTOS CO-FINANCIADOS DENTRO DEL P.N. DE INVESTIGACIÓN CIENTÍFICA, DESARROLLO E INNOVACIÓN TECNOLÓGICA 2008-2011

PTQ08-02-07402; PTQ08-02-07224; PTQ08-02-07368; PTQ09-01-00012

PSE-010000-2008-7; PSE-010000-2009-3; CEN-20091016; PCT-010000-2009-24; IPT-010000-2010-40

DEX-570000-2008-30


PIE257/2008; PIE255/2008; PIE283/2009; PIE178/2009; PIE204/2010; PIE205/2010

10/2008; 9/2008; 32/2009; 38/2010