PRELIMINARY RESULTS 2013: a year of substantial progress for the year ended 31 December 20139th June 2014 - 10:43 am
ImmuPharma PLC (LSE:IMM), (“ImmuPharma” or the “Company”), the specialist drug discovery and development company, is pleased to announce its preliminary audited results for the year ended 31 December 2013.
- Discussions continue with potential partners in parallel to discussions with Contract Research Organisations and alternative financing organisations for LupuzorTM’s pivotal Phase III programme – Special Protocol Assessment (SPA) and Fast Track Designation granted by FDA.
- Granted an amended SPA by the FDA in 2013 reducing the number of patients required to complete Phase III.
- Manufactured drug product for phase III. Plan to file the non-clinical part (except DMF) of the NDA (New Drug Application) to the FDA.
- Established world class Scientific Advisory Board of prominent physicians and advisors in the field of lupus to provide guidance and support for LupuzorTM’s phase III programme.
Nucant programme IPP-204106
- Cancer: Phase I/IIa clinical trial ongoing with the next generation “polyplexed Nucant” formulation in three European hospitals including the prestigious Institute Jules Bordet in Belgium.
- New exciting indications discovered:
- Cancer: Development of novel applications of the Nucant family of peptides targeting combination therapies.
- Angiogenesis: age-related macular degeneration, diabetic retinopathy.
CNRS Collaboration and the University of Bordeaux (co-owned patents):
- Collaboration established with the University of Bordeaux in coordination with the CNRS to identify and patent novel peptide drugs.
- New technology patented with a target first application in diabetes.
Darwin £50 million Equity Finance Facility
- Signed a £50 million equity finance facility with Darwin Strategic Limited
- Cash position as at 31 December 2013 of £5.4m (2012: £8.9m)
- Loss for the period of £3.7m (2012: £3.8m)
- Basic and diluted loss per share was 4.52p (2012: 4.71p)
- Continued successful relationship with the CNRS, the largest fundamental research institute in Europe
Commenting on the year’s performance and outlook Dimitri Dimitriou, Chief Executive Officer said:
2013 has been a year of substantial progress on all fronts. We have been working hard to continue the clinical development of LupuzorTM and the cancer Nucant programme. We were pleased to have obtained an amended SPA from the US FDA thereby reducing the cost of Phase III for LupuzorTMand manufactured enough drug product for phase III and launch. Further, we have been delighted with the appointment of such a prestigious group of experts in the field of lupus on our Scientific Advisory Board. The £50 million equity finance facility secured from Darwin Strategic has been a key development, providing additional strength for the company and the future advancement of LupuzorTM. Our Nucant programme continues to progress, and we look forward to providing more information on its novel potential uses during 2014. Last but not least, building on our long standing relationship with the CNRS and our peptide expertise, we are capitalising on pioneering research at the University of Bordeaux in France with some of the first targets being in diabetes and virology. We would like to thank our shareholders and the CNRS, our research partner, for their support and we look forward to providing further updates during the remainder of 2014.