GCIImmuPharma hails FY21 results as it progresses clinical pipeline
(IMM ) has hailed the progress during the twelve months to 31 December 2021, as the company tells investors that it is focusing on delivering pipeline progression.
Specifically, the specialist drug discovery and development company is focused on bringing its two late-stage clinical assets, Lupuzor™ and P140 for CIDP closer to commercialisation.
In fact, ImmuPharma announced today that its US partner, Avion Pharmaceuticals, has fully committed to taking lead asset Lupuzor™ - a novel specific drug therapy which ImmuPharma believes has the potential to be an effective treatment for Lupus - into phase III clinical trials.
The two companies signed an exclusive agreement for Lupuzor™ back in 2019, with Avion agreeing to fund a new international Phase 3 trial and the commercialisation of Lupuzor™ in the US. Today’s news, which paves the way for commercialisation clarity, follows the recent successful discussions with the US FDA based on a positive readout of the recent PK study.
The Board said it is confident that there are a number of routes to market for Lupuzor™, including corporate collaborations - it says “positive discussions” with a number of potential commercial partners for Lupuzor™ in key territories outside of the US are now underway.
Lupuzor™ is also being developed to treat the neurological disorder, chronic inflammatory demyelinating polyneuropathy, and preparations are now being made for a phase II/III study.
ImmuPharma’s early-stage anti-infectives portfolio, which is born out of its peptide technology at ImmuPharma Biotech, includes two core programs in preclinical development; BioAMB and BioCin, which the firm believes have the best commercial opportunity and speed to market.
To date, further preclinical studies are expected in the second half of 2022 for both BioAMB and BioCin, respectively. Commercial partnering discussions for BioAM are also ongoing.
The operating loss for the year ended 31 December 2021 was £6.6m, up from £5.6m for the year ended 31 December 2020. The research and development expenditure was £3.7m, up from £2.4m in 2020, with P140 related expenditure was the main reason for this increase.
The company’s cash and cash equivalents as at 31 December 2021 amounted to £1.6m compared to £5.9m in 2020, with the decrease caused by the research and development expenditure related to PK study, exceptional costs and repayment of convertible loan notes.
ImmuPharma acknowledged that its overall financial strategy is to maintain a tight control over cash resources whilst enabling continued progress of the company’s key development assets.
Tim McCarthy, ImmuPharma’s CEO stated: “We have created positive and constructive developments within the business, with a focus on delivery of pipeline progression, meeting key future milestones and having a much more commercially driven corporate strategy.”
“With a now fully reviewed and assessed R&D development pipeline, we remain focused on bringing our two late-stage clinical assets, Lupuzor™ and P140 for CIDP closer to the market.
We are also focused on ensuring earlier stage assets, specifically within anti-infectives, progress, with a key strategy on securing partnering opportunities over the medium term.”
He commented: “We were delighted to secure the successful fundraising in late 2021, as it demonstrated that our corporate repositioning efforts, since the Board changes, were recognised by our existing shareholders and partner, Avion (Alora Pharmaceuticals).”
In terms of outlook, he said: “In closing, we look forward to sharing value enhancing newsflow over the next period and we would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including, CNRS and Avion.”
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