Immupharma PLC TERM SHEET SIGNED $14 MILLION FUNDING FOR LUPUZOR (0955U)

TIDMIMM

RNS Number : 0955U

Immupharma PLC

27 July 2015

27 JULY 2015

IMMUPHARMA PLC

CLINICALTRIALS.GOV REGISTRATION OF LUPUZOR(TM) PIVOTAL PHASE III TRIAL

TERM SHEET SIGNED WITH US INVESTOR TO SECURE UP TO

$14 MILLION FUNDING FOR LUPUZOR(TM)

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company is delighted to announce that registration with the U.S. National Institutes of Health - ClincialTrials.gov website has now gone 'live' confirming Lupuzor's(TM) pivotal Phase III trial protocol and the current clinical commencement and completion of the study. Further details can be viewed at: ClincialTrials.gov.

ImmuPharma has also signed a Term Sheet with a US investor for a proposed private placement to fund the clinical trial. The initial instalment of funding consists of a convertible loan of US$2,000,000 plus additional capital of up to $12,000,000, at the Company's discretion, subject to certain criteria, over a two year period. Further disclosure on the financial terms of this agreement (the "Agreement") will be announced following the signature of full agreement anticipated in the next few weeks.

Lupuzor(TM) (active name Rigerimod, also known as IPP-201101 and P140), is ImmuPharma's lead compound for the treatment of Lupus, (Systemic Lupus Erythematosus or "SLE"), a chronic, potentially life-threatening autoimmune disease. Lupuzor(TM) has been granted Fast Track status by the US FDA and approved to start Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile. Simbec-Orion, a leading full service international Clinical Research Organisation specialising in Rare & Orphan conditions and with previous direct experience in Lupus trials, is conducting these trials. As part of the collaboration agreement with Simbec-Orion, as announced in January this year, it will invest a part of its internal invoiced costs in ordinary shares in ImmuPharma at a price of 150p. Furthermore, based on the French research tax credit (Crédit Impôt Recherche - CIR), ImmuPharma France will receive a tax return in the range of 25% of the incurred costs. The combination of the current funding mechanisms including the new US investor 'Agreement' should be sufficient to complete this current pivotal Phase III trial of Lupuzor(TM).

Since the commencement of work with Simbec-Orion, a number of key and necessary steps have been undertaken including detailed technical feasibility, site selection as well as completion of the regulatory process in each selected country where the trials will be conducted. Key European and US sites have now been identified and it is anticipated that about 15 sites in the US and 20 sites in Europe will be enrolled. Recruitment could be completed during the summer of 2016. Patient dosing is expected to commence this autumn.

Further updates on progress will be provided in due course.

ENDS

For further information please contact:

 
                                           + 44 (0) 20 7152 
 ImmuPharma plc                                        4080 
 Dimitri Dimitriou, Chief Executive 
  Officer 
 Dr Robert Zimmer, President 
  and Chief Scientific Officer 
 Lisa Baderoon, Head of Investor 
  Relations                            + 44 (0) 7721 413496 
 
 Panmure, Gordon & Co., NOMAD 
  & Broker                             +44 (0) 20 7886 2500 
 Hugh Morgan 
  Fred Walsh 
  Duncan Monteith

This information is provided by RNS

The company news service from the London Stock Exchange

END

MSCSEAFFMFISESW

Immupharma (LSE:IMM)
Historical Stock Chart
From Jun 2024 to Jul 2024