Immupharma Regulatory News (IMM)

ImmuPharma PLC

("ImmuPharma" or the "Company")

ImmuPharma Files Groundbreaking New Patent Application for P140: First-in-Class 'Immunormalizer' for Precision Diagnosis and Treatment of Autoimmune Diseases

ImmuPharma PLC (LSE: IMM), a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics, today announces the filing of a groundbreaking new patent application for its lead asset P140, the world's first "Immunormalizer." The patent application which provides the potential for 20 years of commercial exclusivity, discloses a novel diagnostic test and precision treatment approach, identifying a subpopulation of patients with Type M immune disorder that are P140 super-responders. This approach can be used to treat up to 50 autoimmune diseases ("AutoIDs"), representing a major step forward in precision medicine.

Key advantages of P140's precision treatment approach

· First-in-class mechanism: A pioneering therapeutic approach offering a breakthrough alternative to current immunosuppressive therapies.

· Safety by design: Selectively targets patients with Type M immune disorder in a safe and effective manner, avoiding the infection and cancer risks linked to existing treatments.

· Precision diagnosis: A simple test can rapidly identify patients likely to benefit from P140 and monitor treatment response in real time.

· Clinical relevance: Demonstrated efficacy in human biology, supporting the potential for full remission in patients.

Transforming Patient Care and Clinical Trials

The new diagnostic test is expected to:

· Shorten the time to diagnosis, reducing years of uncertainty for patients.

· Improve patient selection for clinical trials, lowering placebo effects and accelerating results.

· Enable smaller, faster, and more successful trials, significantly increasing the probability of regulatory approval.

A New Era in Autoimmune Disease Treatment

Extensive research by ImmuPharma Biotech, led by Dr. Sébastien Goudreau and Dr. Laura Mauran-Ambrosino, has identified a new sub-type of immune disorder, Type M immune disorder, where P140 selectively targets patients having this sub-type, enabling a precision approach that combines accurate diagnosis with tailored treatment.

P140 is a first-in-class Immunormalizer and works by restoring immune homeostasis - the finely regulated balance of the immune system. Autoimmune diseases are characterized by an imbalance in the immune system. In Type M patients, treatment with P140 directly normalizes this imbalance, leading to a stable and healthy immune response.

Unlike conventional immunosuppressants or conventional immunomodulators, P140 does not block or weaken the immune system. Instead P140 has a distinct mechanism of action in patients with Type M immune disorder. This enables identification of patients that are "super-responders" to P140 treatment.

The new patent filing provides the potential for 20 years of commercial exclusivity for both the diagnostic test and P140 therapy, positioning ImmuPharma as a leader in the next generation of autoimmune disease treatments.

Market Opportunity

Autoimmune diseases affect more than 400 million people worldwide, with a therapeutic market valued at over $100 billion annually. Current treatments remain limited and often unsafe, highlighting a major unmet medical need.

In parallel, the autoimmune diagnostics market represents a rapidly growing opportunity, valued at over $10 billion globally, as healthcare systems increasingly adopt precision diagnostics.

ImmuPharma's novel diagnostic test, designed to identify patients with Type M immune disorder, not only strengthens the value proposition of P140 but also creates an independent commercial opportunity with potential for earlier adoption and partnerships.

With this dual platform - first-in-class therapy plus precision diagnostic - ImmuPharma is pioneering a new era of precision medicine in autoimmune disease, offering accurate diagnosis and a groundbreaking treatment with the potential to achieve full remission.

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

"The new patent on P140 is the result of impressive and dedicated research by ImmuPharma Biotech and is truly a game changer for ImmuPharma. The discovery of a new mechanism of action and identification of Type M, a sub-type of auto-immune disorders, greatly expands the scope ofP140 across a wide range of autoimmune diseases and the filing of a patent application directed towards this discovery significantly enhances the business case due to the potential for long-term increased revenues.

This combination makes P140 a unique and extremely valuable asset, particularly with the potential for 20 years of commercial exclusivity, and will add enormous traction to our current discussions with potential global partners of P140."

Dr Sébastien Goudreau CSO of ImmuPharma, added:

"We are delighted that our innovative research methods have provided the internally generated (and externally validated) scientific data to support this new patent application on P140, proving that our research approach is highly effective in the extremely competitive landscape of pharmaceutical development.

These new insights will de-risk clinical trials by enabling the use of validated approaches for patient stratification, thereby increasing the likelihood of identifying individuals who are more responsive across a wide range of autoimmune diseases.

Apart from the enhanced commercial opportunity, we are also conscious of the fact that P140 will be able to help patients to be diagnosed more quickly and in turn provide an effective and safe treatment which doesn't exist today"

Ends

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.

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.

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

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

Scientific Background on P140 and the New Patent

The New Patent Application

Over the last two years, ImmuPharma's R&D subsidiary ImmuPharma Biotech (IB), led by Dr. Sébastien Goudreau and Dr. Laura Mauran-Ambrosino, has been exploring the full potential of P140 across a broad spectrum of autoimmune diseases ("AutoIDs"), beyond its original focus on systemic lupus erythematosus (SLE).

The new patent application covers both:

· Identification of Type M patients.

· Therapeutic use of P140 in these patients.

Confirmation of Mechanism of Action (MOA): A First-in-Class Immunormalizer

P140 is a first-in-class Immunormalizer and works by restoring immune homeostasis - the finely regulated balance of the immune system. Autoimmune diseases are characterized by an imbalance in the immune system. In Type M patients, treatment with P140 directly normalizes this imbalance, leading to a stable and healthy immune response.

Unlike conventional immunosuppressants or conventional immunomodulators, P140 does not block or weaken the immune system. Instead, it selectively normalizes abnormal immune activity, shifting the system back to its natural equilibrium.

This direct engagement with the root cause of autoimmune disease offers:

· A mechanism that is disease-modifying, not just symptom-managing.

· A safety profile built on restoring balance rather than suppressing immunity.

· The potential for durable remission and even curative outcomes in autoimmune disorders.

Together, these features make P140 the first therapy able to normalize immune function and offer the possibility of full remission - something no current treatment has achieved.

Diagnostic of Type M Immune Diseases

Today, autoimmune diseases are mostly diagnosed through symptoms and a small set of one-time blood tests (e.g., ANA), which are often imprecise and delay diagnosis by years. ImmuPharma's new diagnostic test, provides an objective and precise alternative. By identifying Patients having a new sub-type of immune disorder (Type M)and confirming pathway engagement, the test enables both patient selection and real-time monitoring of treatment response.

Benefits include:

· Faster, more accurate diagnosis (including asymptomatic patients).

· Reduction in false positives.

· Simple test rapid turnaround, and precise results.

Implications for P140's Clinical Program

The discovery of the Type M immune disorder has multiple positive impacts for the P140 clinical program:

· Enables precise patient selection.

· Allows real-time response monitoring.

· Validated in human biology.

Instead of relying solely on clinical symptoms, this simple diagnostic test identifies patients that respond most effectively to P140 treatment, while treatment effects can be monitored well before symptoms improve.

Expected outcomes for clinical trials:

· Lower placebo effect.

· Earlier detection of efficacy.

· Higher response rates versus placebo.

· Smaller, faster, more efficient trials with higher probability of success.

Treatment of Type M Immune Diseases

For patients, the pathway is straightforward:

· A physician prescribes ImmuPharma's diagnostic test to determine Type M immune status (e.g. Type M SLE, Type M CIDP, Type M RA, etc.).

· A sample is collected and analyzed, with results returned within one week.

· If positive, the patient may be prescribed P140 therapy, offering the potential for full remission.