Nuformix Plc · LSE:NFX
Nuformix — Investor Presentation (November 2022)
26 slides from Nuformix's investor presentation, Nov 9, 2022
Slide 1: Unlocking Therapeutic Potential in Fibrosis & Oncology
Unlocking Therapeutic Potential in Fibrosis & Oncology Corporate Presentation, 9 November 22 Corporate Presentation – August 2021
Slide 2: Disclaimer
Disclaimer This document has been prepared by Nuformix plc (the "Company") and is being made available for the sole purpose of providing the recipients with background information about the Company. It does not constitute or form part of any offer or invitation to sell or issue or any solicitation o
Slide 3: Nuformix: Who we are
Nuformix: Who we are LEADERSHIP TEAM Dr Dan Gooding Dr Julian Gilbert Ms Maddy Kennedy Executive Director, Founder Non-Executive Chairman Non-Executive Director • >20 years in pharma in commercial, technical & • >30 years in pharma in commercial, technical & • Over 20 years of experience in life sci
Slide 4: Nuformix: What we do
Nuformix: What we do NFX is a drug development company leveraging its expertise, technology and IP to fundamentally change the therapeutic and commercial potential for known drugs > Strategy: Progress risk-reduced programmes to proof-of-concept and out-license for commercialisation > Disease Focus:
Slide 5: Our Expertise in Drug Repurposing Allows Nuformix to Maximise Commercial Opportunities
Our Expertise in Drug Repurposing Allows Nuformix to Maximise Commercial Opportunities Discovery, development & IP protection of new, differentiated drug forms enables new high-value applications Enhance the therapeutic Various advantages Making a bigger difference potential and commercial gained fr
Slide 6: NXP002: Summary of IPF Disease Process and Physiology
NXP002: Summary of IPF Disease Process and Physiology Stimulus: Smoke, pollution, debris, exacerbation… Eventual death from Consequence: respiratory failure Lung tissue injury (suffocation) Response: Inflammation driving excess wound healing Patients become Progression: breathless, wheelchair Fibros
Slide 7: NXP002: Clear unmet medical need in IPF
NXP002: Clear unmet medical need in IPF High-mortality rare disease High patient unmet need > Devastating, degenerative respiratory disease caused > Only two currently approved treatments (pirfenidone by progressive scarring (fibrosis) in the lung and nintedanib) > Irreversible and currently fatal d
Slide 8: NXP002: Significant Commercial Opportunity in IPF
NXP002: Significant Commercial Opportunity in IPF Fast-growing market driven by orally delivered IPF market in 7 major markets1: Largest market is US, Ofev® (nintedanib) & Esbriet® (pirfenidone) followed by UK, Italy, Japan, Germany, France, Spain US launches 2014 Global Sales 8.4% • Esbriet: 2021 C
Slide 9: NXP002: Strong underlying rationale for development for IPF
NXP002: Strong underlying rationale for development for IPF Tranilast Background: Strong mechanistic alignment: > Invented by Kissei Corporation, Japan > Secured approvals throughout Asia for: Anti-inflammatory Inhibits multiple fibrosis-related inflammatory o Asthma: First oral treatment for use in
Slide 10: NXP002: Growing evidence base supports development for IPF
NXP002: Growing evidence base supports development for IPF Oral tranilast in bleomycin (BLM) model1 – gatekeeper for IPF Tranilast also effective in model of liver fibrosis (NASH)2 Pandemic initiated a new wave of clinical research investigating oral delivery for COVID19-induced fibrosis – results s
Slide 11: Anti-fibrotic highlights – human IPF tissue dose response
NXP002: Anti-fibrotic highlights – human IPF tissue dose response Col1a1 is a key biomarker for fibrosis 10000 24h 48h 8000 72h 96h Col1A1 (pg/mL) 6000 4000 2000 0 Vehicle NXP002 75µM NXP002 100µM NXP002 200µM Pirfenidone 2.5mM High Challenge End-Stage ‘Close-to-Patient’ Model: Tranilast significant
Slide 12: NXP002: Strategy and IP address key development challenges
NXP002: Strategy and IP address key development challenges Tranilast isn’t viable orally in IPF Deep-lung delivery essential > Anti-fibrotic and anti-inflammatory effects appears to > Fibrosis ingression occurs from the lung periphery require tissue/plasma levels of tranilast of ~100 µM > Innovation
Slide 13: Inhalation highlights – LPS challenge dose response
NXP002: Inhalation highlights – LPS challenge dose response *Dosing 30 minutes pre-challenge, data 4 hours post-challenge 150 1000 2000 800 (pg/mL) MCP-1 (pg/mL) (pg/mL) (pg/mL) 1500 TGF b(pg/mL) TNFa (pg/mL) 100 600 1000 TNF-⍺ MCP-1 400 TGF-β 50 500 200 BLQ BLQ 0 0 0 icl e S 2 2 2 2 P) e S 2 2 2 2
Slide 14: NXP002: Pre-clinical development strategy has discharged key risks
NXP002: Pre-clinical development strategy has discharged key risks Building Inhalation Tolerability, PK/PD & Translational Story (LPS Challenge) Demonstrates Inhaled Inhaled Inhaled NXP002 can exert Tolerability PK LPS Challenge pharmacology via inhalation Demonstrates LPS challenge in pre- LPS chal
Slide 15: NXP002: Pre-clinical Summary
NXP002: Pre-clinical Summary > NXP002 can inhibit key markers of fibrosis and inflammation in a high-challenge, ‘close to patient’ IPF disease model o Consistently positive effects seen when NXP002 was dosed alone on both fibrotic and inflammatory markers > NXP002 in combination with SoC’s significa
Slide 16: NXP002: Potential development plan outline
NXP002: Potential development plan outline Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2022 2023 2024 PRECLINICAL PHASE 1 Inhalation Non- GLP Phase 1: Safety, PK and Feasibility GLP Tox Tox optional Pharmacology Today Feasibility Phase 1-Ready Phase 1 package package package Development related inflexion po
Slide 17: NXP002: Programme out-licensing in IPF by development stage
NXP002: Programme out-licensing in IPF by development stage Development Stage No. of Deals Average Upfront Fee Average Total Deal Value Pre-clinical 2 £67m £328m Phase 1 7 £61.5 £425m Phase 2 2 £235m £1.15bn Phase 3 2 £1.7bn £6.4bn 16
Slide 18: NXP002: Programme highlights
NXP002: Programme highlights NXP002 (new form of Tranilast) Preclinical stage asset with robust IP repurposed as a novel inhaled protection - Nuformix strategy is to treatment for idiopathic out-license this asset with targeted BD pulmonary fibrosis (IPF) activities already underway Strong literatur
Slide 19: NXP004: Background
NXP004: Background > Focused on the development of patented cocrystal forms of the small molecule, olaparib. > Olaparib belongs to a class of molecules known as PARP inhibitors, which are becoming a mainstay in the treatment of certain cancers. > Marketed by AstraZeneca as Lynparza, olaparib was the
Slide 20: NXP004: Background
NXP004: Background > Initial product had limitations due to the high dose (400mg/BID) and issues with low drug solubility under biorelevant conditions, resulting in a high pill burden o 8 x 50 mg capsules (400 mg) given twice daily under fasted conditions > Required bio-enhancement technologies enha
Slide 21: NXP004: Lynparza to dominate PARP inhibitor market landscape
NXP004: Lynparza to dominate PARP inhibitor market landscape PARP inhibitor forecasts by indication PARP inhibitor sales forecasts • Date for generic product entry: – US: March 2027 – upheld by granted patents relating to the molecule as a DNA damage repair agent in cancer. – Europe: March 2029 – he
Slide 22: NXP004: Proprietary cocrystals offer a potential opportunity
NXP004: Proprietary cocrystals offer a potential opportunity > Nuformix has patented two families of novel olaparib cocrystals with a broad range of enhanced physico-chemical properties. > Even at the earliest date for generic entry, this still leaves sufficient time for Nuformix to: o Validate its
Slide 23: NXP004: Dissolution data for v1.0 olaparib cocrystals
NXP004: Dissolution data for v1.0 olaparib cocrystals LynparzaⓇ: Achieves a concentration in simulated intestinal fluid of ~350µg/mL – unformulated Series A cocrystals show promising dissolution enhancement 22
Slide 24: NXP004: Dissolution data v2.0 olaparib cocrystals
NXP004: Dissolution data v2.0 olaparib cocrystals Olaparib Form A (as supplied) Olaparib Form A (micronised) 2.0 Cocrystal A 2.0 Cocrystal B 2.0 Cocrystal C 2.0 Cocrystal D 2.0 Cocrystal E Lynparza Ⓡ: Unformulated v2.0 cocrystals hit the 350µg/mL target indicating potential for similar in-vivo perfo
Slide 25: NXP004: Outlook
NXP004: Outlook > Current head-to-head dissolution studies on-going vs marketed Lynparza product > Formulation development opportunities identified o NFX generated significant experience and know-how following NXP001 clinical programme > Progression to ‘gatekeeper’ pre-clinical pharmacokinetic model
Slide 26: Nuformix: Summary
Nuformix: Summary Focus New therapies with attractive commercial potential in fibrosis and oncology Potential to derive value in the short-term through further Assets development and /or BD and licensing Board / Highly experienced with extensive and relevant expertise Leadership Low cost base Fully