Developing Innovative Peptides April 2020 ImmuPharma Listed on - - PowerPoint PPT Presentation

Developing Innovative Peptides

April 2020

plc

• Listed on AIM (LSE:IMM) & Euronext

Growth Brussels (ALIMM)

• Pipeline of innovative peptide products
• Portfolio from early to late stage
• Lupuzor™ - lead product for Lupus -

gearing up to start optimised Phase III international trial

• US partner ‘Avion’ signed in Q4 2019 -

funding Lupus trial

• Discovery labs in France

ImmuPharma

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Recent update

£1.5 million Subscription

• Issue of 15,000,000 new ordinary shares of 10P each comprising:
• £200k from Dr Robert Zimmer (President & CSO of IMM)
• £1.3m with Lanstead Capital (major shareholder)
• Proceeds will be used primarily to fund:
• Expansion of the Company’s R&D programmes; and
• General working capital

Expansion of R&D programmes - 4 therapy areas

• Autoimmunity; Anti-Infectives; Metabolism & Cancer

Highlights

• Strengthened advisory team for Lupuzor™ intl. Phase III trial
• Proof of Concept study planned for Lupuzor™ in CIDP patients
• New BioGlucagon product - potential market launch in 2022
• 3 new Anti-Infective programmes including BioAMP-B

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 13m shares placed with Lanstead at 10p per share = £1.3m  IMM receives the proceeds back over 24 months starting in July 2020  Amount received on monthly basis dependent on 20-day volume weighted average share price (VWAP) each month  If VWAP exceeds 13.33p Benchmark Price, IMM gets proportionately more, if lower, proportionately less  Agreement reflects confidence of management and Lanstead in the future of IMM Further supportive investment with Lanstead following:  £4.43m investment and sharing agreement in February 2016, where IMM received >£5.0m  £2.66m investment in June 2019 which was invested in ongoing sharing agreement with Lanstead, currently ahead on cumulative settlements to date

£1.3m Lanstead Subscription

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Key programmes

Autoimmunity

Lupuzor™ for Lupus & CIDP

Anti- infective

BioAmp-B

Metabolism

BioGlucagon Innovative Peptides

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Lupuzor™

• Lupuzor™ (forigerimod) is

more than just Lupus

• Many more indications
• Multifunctional
• Underlying mechanism of

action of Lupus occurs in other diseases

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Lupuzor™ for Lupus

Lupus

• Autoimmune chronic inflammatory disease
• Unmet market need - lack of safe and effective treatments
• Multi-billion sales potential
• Patients*: >5m globally | 1.5m lupus sufferers in EU/US/Japan
• GSK’s approval of Benlysta in 2011 paves the path to market

Lupuzor™

• Novel mechanism that modulates (not blocks) immune system
• Outstanding safety profile

Attractive economics

• Lupus patients treated by specialists = low marketing costs
• Benlysta priced at approx. US$40,000 / per patient / per year
• Lupuzor™ anticipated to have competitive pricing with higher margins

* source: Lupus Foundation of America ‘www.lupus.org’ (2019) 7

Lupuzor™ fully funded for lupus – US deal with Avion

• New ‘optimized’ international Phase III trial
• Exclusive rights for US with Avion
• Lupuzor ™ Phase III funded up to $25m
• Milestones up to $70m & tiered double-digit

royalties up to 17%

• Data from Phase III trial allows approvals in

key ex-US markets

• Discussions continue with potential partners

for Lupuzor™ outside of US

• HQ: Georgia USA with >200 employees
• Fully integrated in drug development, sales

and marketing

• Focus on Rheumatology, Neurology, Endocrine

and Women’s Health

• Annual sales >$250m, strong growth (50% pa)
• Strong balance sheet, well funded
• Focus on low competition / high margin

branded opportunities

• Sustained pipeline of new opportunities

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Avion’s strengthened advisory team

• Collaboration with leading Lupus patient group & formation of Board of KOLs
• Key decisions/next steps agreed prior to FDA meeting to include:
• Structure of optimised intl. Phase III Lupuzor™ trial
• Demographics and patient inclusion criteria
• Guidance on key territories where trial to be conducted

As part of the Phase III trial, these advisors will provide:

• Support and expedition to identify / recruit Lupus patients for trial
• Promotion to patient steering groups to raise awareness of Lupuzor™ to

Lupus patients and clinicians throughout trial

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Lupuzor™ for CIDP

• CIDP* is a neurological disorder targeting the body’s nerves
• Symptoms: fatigue and weakness, numbness, tingling in limbs
• Unique MOA** of Lupuzor™*** demonstrates effectiveness in auto-

immune diseases including ‘CIDP’

• CIDP could be granted ‘Orphan Drug Designation’ due to the unmet

clinical need with ~50-100k patients in the US/EU

• Fast approval process could apply
• Sales potential > $500m annually
• Currently no effective approved drug on the market
• Next steps:
• ‘Proof of Concept’ study in CIDP patients based on the strong

data already gained within IMM’s Lupus dossier

• Partnering opportunities

*Chronic Inflammatory Demyelinating Polyneuropathy ** Mechanism of Action ***Also known as Forigerimod or P140

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Metabolism – ‘New’ BioGlucagon

• BioGlucagon is a potential new rescue therapy for low

sugar events in diabetes

• Existing glucagon products; poor solubility,

inconvenient - variable dosing creates risks for patients

• BioGlucagon has 100% solubility, can be formulated in

pre-filled syringe pens and could be used in insulin pumps

• Sales of existing products approx. $500m (p.a.)
• Next steps:
• Bio equivalence study, with potential market

launch date in 2022

• Partnering opportunities

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Anti-Infectives – ‘New’ BioAMP-B

Anti-fungal opportunity

• BioAMP-B is a novel peptide-based drug that offers a

potential improvement on Amphotericin-B (“Amp-B”)

• Amp-B one of the few effective treatments for serious

and life threatening fungal infections such as aspergillosis (lung infection)

• Leading AMP-B, ‘Ambisome’ causes serious kidney

toxicity in c.15% of patients

• BioAMP-B’s target profile has superior safety profile to

Ambisome

• Sales of Ambisome in 2019 were $407m (p.a.)
• Next steps:
• Bio equivalence study, with potential market

launch date in 2022

• Partnering opportunities

*The World Health Organisation ** (National Academy of Medicine: 2016)

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Not just a Lupus story

• value enhancing news flow & milestones

Autoimmunity Anti-Infectives Metabolism

BioGlucagon filing, target launch Lupuzor™ ex US partnering opportunities BioGlucagon preparation for bioequivalence study Bio-AMP-B bioequivalence study Avion Phase III Lupuzor™ progress updates BioGlucagon bioequivalence study Avion Phase III Lupuzor™ progress updates CIDP ‘POC’ preparation Bio-AMP-B preparation for bioequivalence study Bio-AMP-B partnering opportunities Bio-AMP-B filing, target launch

2020 2021 2022

Avion Phase III Lupuzor™ progress updates BioGlucagon partnering opportunities

2020 2021 2022

CIDP ‘POC’ study

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Investment summary

• Latest investment from Lanstead
• Strong endorsement of IMM’s technology platform
• Lupuzor™ fully funded by US partner Avion
• Moving into optimised Phase III intl. trial
• Near term inflexion points
• Continued strong news flow
• Partnering opportunities
• Lupuzor™ in key territories outside of US
• Lupuzor™ for CIDP
• BioGlucagon & BioAmP-B

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