TiGenix Business and Financial Update for the First Half of 2015

TiGenix announced its Business and Financial Update for the first half of 2015 and recent significant events.

• Cx601 reached major value inflection points 
  • Cx601 met the primary endpoint of its European Phase III trial in complex perianal fistulas in Crohn's disease patients. The positive results confirm the efficacy and safety of Cx601 and allow for filing for marketing authorisation in Europe in the first quarter of 2016
  • Clear approval path for Cx601 in the United States with the Food and Drug Administration's (FDA) endorsement of the Company's pivotal Phase III trial through a Special Protocol Assessment (SPA). Manufacturing for the clinical trial, scheduled to start towards the end of 2016, secured with Lonza
  • Significant strengthening of intellectual property with two key patents granted, one in Europe and the other in the United States
• Expansion of TiGenix pipeline into cardiology with a new platform of allogeneic cardiac stem cells through the acquisition of Coretherapix and its lead product, AlloCSC-01, which is in a Phase II clinical trial for acute myocardial infarction
• Safety and tolerability of Cx611 confirmed in a Phase I sepsis challenge trial. Phase II efficacy study in severe sepsis expected to be initiated in the fourth quarter of 2015
• Cash position at 30 June 2015 of EUR 22.7 million

"The major achievements recently announced are highly significant steps towards fully realising our potential and will have a tremendous impact on the company and its future", said Eduardo Bravo, CEO of TiGenix. "We have full commercial rights to Cx601 with positive Phase III data, ready for filing in Europe, with a clear, FDA endorsed pathway for filing in the United States, in a potential two billion Euro market. We have recently acquired Coretherapix, a company with a platform of cardiac stem cells, whose lead compound AlloCSC-01 for acute myocardial infarction is in a very advanced Phase II clinical trial. And, with Cx611, we expect to start a Phase II trial in severe sepsis, the leading cause of death in hospitals in the western world. We are extremely proud of being one of the few companies that can offer such a promising near-term future."

Financial Update

Financial results for the first half-year of 2015

• During the first six-month period of 2015, total revenues increased by 14% to EUR 0.9 million compared to EUR 0.8 million in the same period of 2014, mainly driven by royalties and other operating income received from Sobi.
• Research and development expenses for the first six-month period of 2015 amounted to EUR 7.7 million, compared to EUR 5.1 million for the same period in 2014, representing a 51% increase which is mainly attributable to clinical trial activities such as the conclusion of the ADMIRE pivotal Phase III trial for Cx601 and the Phase I Sepsis Challenge trial of Cx611, as well as other key activities necessary in filing for marketing authorisation for Cx601 in Europe.
• General and administrative expenses remain at the same level as the previous period and amounted to EUR 2.8 million.
• As a result of the above, the operating loss amounted to EUR 9.6 million compared to EUR 7.1 million during the same period of 2014. This increase is attributable to a higher spend on research and development activities.
• The net financial loss of the first six months of 2015 amounted to EUR 1.1 million compared to EUR 0.2 million during the same period of 2014. Net financial loss comprises financial income, financial expenses and foreign exchange differences.
• During the first six months of 2015, the loss from discontinued operations amounted to EUR 0.0 million compared to EUR 1.8 million in the same period in 2014.
• As a result of the above, the loss for the first six-month period amounted to EUR 10.6 million, compared to EUR 9.2 million for the same period in 2014, representing an increase of 15%.

Outlook

TiGenix expects to take the following steps within the next 18 months:

• Q4 2015:   start Phase IIa study of Cx611 in severe sepsis
• Q4 2015:   complete patient enrolment for Phase II trial for AlloCSC-01 in acute myocardial infarction
• Q1 2016:   file for marketing authorisation for Cx601 in Europe
• H2 2016    begin patient enrolment for Phase III trial of Cx601 in complex perianal fistulas in Crohn's disease patients in the United States
• H2 2016:   interim analysis of Phase II trial of AlloCSC-01 in acute ischaemic cardiac disease

More info at  www.tigenix.com