Immupharma Regulatory News (IMM)

11 November 2022

ImmuPharma PLC

("ImmuPharma" or the "Company")

Avion confirms its continued support to the Lupuzor™ clinical program in Lupus

whilst exploring broader collaboration opportunities

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to update the market on a recent meeting in Atlanta, USA with our US partner, Avion Pharmaceuticals, LLC ("Avion") for strategic discussions around ImmuPharma's Lupuzor™ clinical program.

This included Avion continuing its support to the clinical program of Lupuzor™ for Lupus, as well as a wider discussion on how the two companies could potentially further collaborate.

Key highlights:

· Lupuzor™ for Lupus clinical program to be redesigned on key protocols following written response from FDA, in order to enhance the probability of success.

· Potential of product sales revenues for ImmuPharma by introducing certain Avion drugs into the European market.

Lupuzor™ for Lupus

At the recent meeting in Atlanta, Avion confirmed its support for the Lupuzor™ clinical program in Lupus. This follows on from the receipt in September of the written response from the Food and Drug Administration ("FDA") to the Type C meeting.

In its written response, the FDA provided significant and extremely valuable guidance on the study protocol, that could be amended, to improve the regulatory outcome. This primarily focussed on a recommendation to explore higher dosing levels (given the robust safety profile of Lupuzor™) than have been used in the clinical program to date, to enhance the probability of meeting the primary endpoint of statistically significant efficacy. The ImmuPharma/Avion team, together with external advisors, are preparing a proposed updated clinical programme. This is considering either a Phase 2 dose ranging study to identify the optimum dose level, followed by a Phase 3 study with that optimum dose; or alternatively a Phase 2/3 adaptive study which would encompass the same dose ranging, albeit within one continuous study. The chosen route will be agreed with the FDA. Further details on the study design and progress of the program will be communicated to the market once the FDA has been consulted and their response has been provided.

Potential Distribution Agreement

We have agreed to explore the opportunity of a mutually beneficial route to allow ImmuPharma to introduce certain Avion products into the European market. If this is successful, this would generate top-line product sales revenue for the first time in ImmuPharma's history and contribute net positive cash flow to the Company.

We in turn, have identified an established European partner who could provide the infrastructure to market and distribute the products.

Discussions are to be progressed as to the legal, regulatory and commercial aspects of such a collaboration and we will provide further details in due course.

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:

"We have had extremely positive discussions with Avion over the last month and, following receipt of the written response from the FDA, we have agreed to redesign the clinical program for Lupuzor™ to encompass the recommendations from the FDA, with a view to enhancing the probability of success. In addition, our discussions have developed the potential of a much broader collaboration whereby we would be working in partnership to introduce certain Avion products into the European market."

Responding, Art Deas, CEO of Avion, said:

"We continue to be very supportive of Lupuzor™ and to work with ImmuPharma to find the optimum way forward for Lupuzor™ in its clinical program. As a supportive and involved partner with ImmuPharma, we will continue to look at new initiatives to create value by working effectively and diligently with the team at ImmuPharma."

This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

Ends

Notes to Editors

About ImmuPharma PLC

ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases and anti-infectives. The lead program, Lupuzor™, is a first-in class autophagy immunomodulator for the treatment of Lupus and preclinical analysis suggest therapeutic activity for many other autoimmune diseases that share the same autophagy mechanism of action.

For additional information about ImmuPharma please visit www.immupharma.co.uk

About Avion Pharmaceuticals LLC

Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to develop, acquire and market a portfolio of innovative pharmaceutical products in the Women's Health and other therapeutic categories aligned with its mission to improve the quality of patient lives. Avion Pharmaceuticals focuses on identifying opportunities to develop, acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfil unmet medical needs.

For more information, visit www.avionrx.com.

About Lupus (Systemic Lupus Erythematosus / SLE)

Lupus is a chronic inflammatory disease which is thought to affect some 5 million individuals worldwide. The current standard of care still consists of drugs which have many side-effects and limited efficacy. Despite the need for an effective treatment, only two therapies, namely GlaxoSmithKline's Benlysta and more recently, Astra Zeneca's Saphnelo, have been approved to treat the condition over the past 50 years. As such, there clearly exists an unmet medical need for a drug that has a strong efficacy and safety profile.

ImmuPharma's LEI (Legal Entity Identifier) code : 213800VZKGHXC7VUS895.