ImmuPharma’s potential blockbuster candidate for the treatment of Lupus, Lupuzor, is in preparatory steps for its Phase III clinical trial following advanced discussions with a potential partner. An agreement is expected to be signed before these preparations complete, after which the partner can then conduct the trial. While ImmuPharma has yet to release any specific details of the agreement as the partnership is not yet finalised, we find it a very positive development and an endorsement for Lupuzor that it is in advanced stages with this potential partner. While cautious of the risks, our stance remains Buy.
Lupuzor Approaches Pivotal Phase III Trial
ImmuPharma has commenced preparatory steps for Lupuzor’s crucial Phase III trial, following advanced discussions and the completion of due diligence with a potential partner that has “expertise in late stage clinical development”*. An agreement is expected to be completed and signed while these preparations continue, after which the partner can conduct the trial using the positively amended SPA granted by the US FDA. The trials would be funded by both parties. The group is also awaiting results of the Phase I/IIa trial of its ‘Nucant’ cancer programme and is developing its peptide technology platform with the CNRS, IECB and University of Bordeaux.
ImmuPharma’s H1’14 results showed an operating loss of £1.82m versus £1.85m a year earlier, which included R&D expenditure of £820k (primarily from developing its Phase I/IIa anti-cancer candidate) and admin expenses of £998k. CapEx of £334k was spent principally on the research laboratory in Bordeaux, and a c.£2.2m loan was taken out to settle Euro denominated payments due to a weak US$ rate and has now been repaid.
Alternative Development Candidates Show Some Weakness
Pharmaceutical firm Lilly recently discontinued the development of its potential Lupus treatment, Tabalumab, due to insufficient efficacy, the latest of a number of candidates to fail clinical trials. We understand that these drugs work to suppress the immune system whereas Lupuzor is the only late-stage candidate that attempts to modulate it through a natural effect. We believe this is why Lupuzor has delivered promising results with minimal safety issues to date.
While Lupuzor’s progress is positive in our view, there are no firm details of the way the partnership and drug development would work and as such we feel it is best not to speculate. Our target price remains unchanged, but we have updated our forecasts. We highlight that the group currently generates no revenues and due to the nature of drug development companies any changes to our expectations could affect our valuation materially. Share dilution could also be a factor. However, our stance remains Buy