TxCell has reported its revenues as of December 31, 2014 and updates on forthcoming milestones.
During the year 2014, the company generated revenues of €1,327 thousand, including €1,083 thousand for the fourth quarter of 2014. This compares with a revenue of €17 thousand for the year 2013, recorded during the fourth quarter of 2013.
The revenue of €1,083 thousand for the fourth quarter of 2014 comes exclusively from the Ovasave® partnership with Ferring/Trizell. This corresponds to:
• The revenue of €83 thousand relating to the amortization of the payment of €1 million received after the agreement signature on December 12, 2013;
• The revenue of €1,000 thousand relating to the first patient enrolment in the Ovasave phase IIb clinical study.
Cash and cash equivalents:
Cash and cash equivalents stood at €13.9 million at December 31, 2014, compared with €14.9 million at September 30, 2014 and €0.7 million at December 31, 2013. This amount includes the gross payment of €1.7 million zero rate loan (Prêt à Taux Zéro Innovation (PTZI)) granted by Bpifrance to advance Ovasave through clinical development. The PTZI is not deductible from the credit base of Research Tax Credit and represents an additional financing tool for research and development activities.
Highlights of the period:
• Start of the international and multi-center phase IIb study for Ovasave, TxCell’s lead product candidate from its ASTrIA platform for refractory Crohn’s disease. This study will enroll 160 patients and will be conducted in 6 European countries.
• Obtaining Orphan Drug Designation in Europe for Col-Treg, TxCell’s second product candidate, in noninfectious uveitis (autoimmune uveitis), a rare disease and a leading cause of blindness in the developed world and with currently few therapeutic options. This designation follows the presentation of Col-Treg efficacy and good tolerability results, obtained in an auto-immune uveitis model.
• Assignment of Ovasave collaboration, option, development and license agreement to Trizell - Ferring remains the intended final commercializing party. Both companies are affiliates of the Dr Frederik Paulsen Foundation. Ovasave will benefit from the additional focus and expertise that Trizell will supply in advanced therapies area, i.e. cellular and gene therapies.
• Start of Col-Treg “proof of principle” clinical study in steroid refractory auto-immune uveitis patients, planned to start mid-2015;
• Ovasave and Col-Treg regulatory status update in the United States, expected mid-2015;
• Opinion of the First Data and Safety Monitoring Board (DSMB) meeting for Ovasave phase IIb study, expected end of 2015;
• Top line results of Col-Treg “proof of principle” clinical study, expected mid-2016;
• Top line results of Ovasave phase IIb clinical study, expected at the end of 2016 to early 2017.
“The results from TxCell’s fourth quarter of 2014 confirms our pipeline advancement continues on schedule, with positive results obtained for Col-Treg in an auto-immune uveitis model and the launch of one of the largest controlled clinical study for Ovasave, a personalized T-cell immunotherapy product,” said Damian Marron, CEO, TxCell. “During this period, TxCell moved its innovative programs forward in line with plans while maintaining a tight control on expenditure. The year 2015 should be rich in key milestones to further develop the company and its products, with the aim to further create value.”
• 27th Annual ROTH Conference, March 8-11, 2015
• ARM’s (Alliance for Regenerative Medicine) 3rd Annual Regen Med Investor Day, March 25, 2015
• ARVO (Association for Research in Vision and Ophthalmology) 2015 Annual Meeting, May 3-7, 2015
• 18th Annual ISCT (International Society for Cellular Therapy) Meeting, May 27-30, 2015
• The European Society of Ophthalmology (SOE) 2015 Congress, June 6-9, 2015