Nuformix Regulatory News (NFX)

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31 January 2018

Nuformix Plc

("Nuformix" or "the Company")

Positive Results from NXP002 Pilot Study in Lung and Liver Fibrosis

Nuformix, the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces a positive outcome following innovative pilot studies in multiple fibrotic diseases for its NXP002 programme.

Summary

· Positive indication of efficacy using cutting-edge human tissue disease models

· Demonstration that NXP002 inhibits fibrosis in functional human tissue via a dual-action, significantly addressing both inflammation and fibrosis components responsible for disease progression

· Results show a profound effect in inhibiting established human fibrotic disease, offering future benefits to a wide spectrum of patients

· Proven safety and tolerability offers significant advantages over competitor products

· Rapidly growing markets already valued in multiple billions

Working in parallel with the University of Newcastle and Fibrofind and their proprietary fibrosis research models, Nuformix has completed pilot pre-clinical studies that further validate the potential for its NXP002 programme in successfully and safely treating fibrosis.

Fibrotic disease is typically associated with high patient mortality, increasing prevalence and a lack of safe and effective treatments. Using cutting-edge human tissue disease models, the studies have focussed on the potential for NXP002 to halt progression in established lung and liver fibrosis. The results demonstrate that NXP002 strongly inhibits fibrosis in functional human tissue via a dual-action, which significantly addresses both the inflammation and fibrosis components responsible for fibrotic disease progression.

Following success in these innovative pilot studies Nuformix has commenced additional studies to further support progress to use in patients, which will run in parallel to Nuformix's human pharmacokinetic studies for NXP002.

Dr Dan Gooding, CEO, Nuformix plc, said: "Traditional pre-clinical fibrosis models offer limited utility as they don't recreate the disease in a genetically or physiologically relevant way, meaning success doesn't always translate into patients. In contrast, the studies conducted at Newcastle University and Fibrofind put the Nuformix NXP002 programme as close to patient as possible. The results show a profound effect in inhibiting established fibrotic disease, importantly at exposure levels that we know are well-tolerated in patients and levels which the team are confident can consistently be delivered using Nuformix proprietary drug forms.

"We can take great confidence from our pilot data, particularly in lung fibrosis, where we are able to study living human disease tissue. Our data demonstrates NXP002 is superior to recently approved treatments, whilst also providing the additional benefit of vastly increased tolerability in long-term use, which is not currently possible.

"These results give us great confidence in what will happen when NXP002 reaches patients and robustly support entry to patient proof-of-concept studies immediately after completion of our pharmacokinetic studies."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Enquiries:

About Fibrosis

Fibrosis is a degenerative disease affecting most vital organs. Healthy tissue becomes scarred and impaired, ultimately resulting in organ failure. Fibrotic conditions (e.g. lung fibrosis) are typified by high patient mortality and are globally recognized as a major unmet medical need. Despite alarming growth rates, current treatments are either non-existent or offer marginal clinical benefits whilst causing side effects so severe that many patients elect to stop treatment.

About NXP002

NXP002 targets a key mechanistic pathway shared by many forms of fibrosis, meaning effective oral delivery of NXP002 could treat multiple fibrotic diseases. Despite demonstrable promise in several fibrotic conditions, poor oral efficacy of the currently marketed drug form means it is unable to exploit its full anti-fibrotic potential. NXP002's cocrystal drug form will enable consistent and efficacious oral delivery, creating the potential to treat multiple fibrotic conditions whilst removing severe treatment side effects. NXP002 is an example of Nuformix's strategy to use an approved drug with a strong safety profile in new indications. Recognised safety and human precedence combine to reduce development risk and increase speed to clinic versus traditional biotech models.

Nuformix plc

Nuformix is a pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs. Nuformix' risk-mitigated development strategy has resulted in a pipeline of discoveries through which it has developed and patented novel cocrystal forms of approved small molecules.

Nuformix has created an IP portfolio containing a range of granted patents covering cocrystal forms of five small molecule drugs. Nuformix is targeting high-value unmet needs with its lead programmes in oncology supportive care: NXP001 and fibrosis: NXP002.

Nuformix was established in Cambridge in 2008 and has invested into pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities and revenues from products under development. Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.