Nanoform Finland Oyj · OMXHEX:NANOFH
Nanoform Finland Oyj — Investor Day (December 2025)
103 slides from Nanoform Finland Oyj's investor day presentation, Dec 16, 2025
Slide 1: Nanoform Capital Markets Day: Breakthrough Strategy
Nanoform Capital Markets Day Breakthrough Strategy Breaching ‘The Wall’ in 2 Places: Small & Large Molecules Viikinkaari 4, Helsinki December th, 2025 Nanoform.com16 | @nanoform
Slide 2: Disclaimer
Disclaimer Forward-Looking Statements This presentation contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” believe,” “est
Slide 3: Agenda
AGENDA 09.00 CEO Edward Hæggström, Chairman Miguel Calado and Board Member Jeanne Thoma - Nanoform Strategy 2026-2030 09.10 CFO Albert Hæggström - New midterm business targets 2030 09.20 Director Intellectual Property Winfried Ness - Nanoenzalutamide European IP landscape 09.30 Dr. Katja Dreyer, Dir
Slide 4: Nanoform Strategy 2026-2030
CEO Edward Hæggström, Chairman Miguel Calado, Nanoform Board Member Breaker Slide Jeanne Thoma Option 2 Nanoform Strategy 2026-2030 Nanoform.com | @nanoform 4
Slide 5: Breakthrough Strategy
Nanoform Capital Markets Day Breakthrough Strategy Breaching ‘The Wall’ in 2 Places: Small & Large Molecules Viikinkaari 4, Helsinki December th, 2025 Nanoform.com16 | @nanoform
Slide 6: Nanoform technologies break the wall
Nanoform Strategy 2026-2030 Nanoform technologies break the wall CESS® for small molecules BioLine for biologics Clinical data with several major Patients treated with Nanoformed clients support nanoforming as a medicines with 5 years significant technology in the major industrial shift from IV to S
Slide 7: Midterm business targets 2030
Nanoform Breaker Slide CFO Albert Hæggström Option 2 Midterm business targets 2030 Nanoform.com | @nanoform 7
Slide 8: What has happened in the industry since the IPO?
What has happened in the industry since the IPO? Nr of new approvals flat... Source: U.S. Food and Drug Administration (FDA); IQVIA Institute for Human Data Science; Statista; Nature Nanoform.com | @nanoform 8
Slide 9: Enormous growth in R&D spending in last five years
Despite an enormous growth in R&D spending in last five years 2018 2025 350 Global pharmaceutical R&D spending 2010-2024E (USDbn) 450 Global pharmaceutical R&D spending 2014-2030E (USDbn) 400 300 2018-2024 ACTUAL: CAGR 8.8% 366 357 339 348 2018-2024 ESTIMATE: CAGR 2.5% 350 329 317 250 301 306 300 20
Slide 10: Pre-Clinical and Clinical Success Rates
Global Pharmaceutical Industry’s Pre-Clinical and Clinical Success Rates Source: Company information; Takebe, Imai & Ono (2018), Clinical and Translational Science (11) (Pre-clinical to Phase I); Biotechnology Innovation Organization, Biomedtracker and Amplion, Clinical Development Success Rates 200
Slide 11: From non-GMP to GMP (small molecules)
From non-GMP to GMP (small molecules) Transition probability from non-GMP to GMP ➢ Total industry number: 20-25% ➢ New technologies: anecdotal guesstimate by industry veterans: ~5% ➢ CDMOs using mature technologies and choosing projects selectively: ~50% ➢ Nanoform assumption at IPO 2020: ~20-25% ➢
Slide 12: Transition into GMP targeted to reach industry levels by 2030
Transition into GMP targeted to reach industry levels by 2030 Cumulative nr of non-GMP Cumulative nr of GMP projects Share of projects moving into projects GMP >300 >30 20-25% 300 30 20% 200 20 >100 10% 100 10 >5 0 0 0% 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2020 2021 2022 2023
Slide 13: From preclinical to first market launches in 10 years
From preclinical to first 3 market launches in 10 years (2020 to 2030) 2030 target nr 1 300 3 30 medicines non-GMP GMP projects launched projects by 2030 by 2030 by 2030 Nanoform.com | @nanoform 13
Slide 14: Mid-term annual income potential by 2030
‘is Nanoform mid-term annual income potential by 2030
Slide 15: Income growth target 2030
Income growth target 2030 target nr 2 Cumulative Income* Revenue growth milestones >EUR 30m > 50% CAGR >EUR 30m by 2030 2026-2030 by 2030 * Revenue + other operating income (milestones, fees, royalties, profit shares etc.) Nanoform.com | @nanoform 15
Slide 16: Large investments in 2020-25 lead to moderate cost growth
Large investments in 2020-25 lead to moderate cost growth in 2026-30 Build brand, Built customer base, Cost* Scaled-up SAP, Scada, nanoforming growth kgs to tons Workiva, TrackWise factory < 5% CAGR in 2020-25 eQMS, ISO 27001, In 2020-25 2026-2030 IFRS, QC labs, AI etc. *Operating costs ex options (
Slide 17: Profitability target by 2030
Profitability target by 2030 2030 target nr 3 Income* Cost** >30% growth growth EBIT margin > 50% CAGR < 5% CAGR by 2030 2026-2030 2026-2030 *Revenue + other operating income (milestones, fees, royalties, profit shares etc.) **Operating costs ex options (COGS + employee costs + other operating costs
Slide 18: Nanoform midterm business targets 2030
Nanoform midterm business targets 2030 3 Income* nanoformed growth EBIT margin medicines > 50% CAGR > 30% by 2030 launched 2026-2030 by 2030 * Revenue + other operating income (milestones, fees, royalties, profit shares etc.) Nanoform.com | @nanoform 18
Slide 19: Nanoenzalutamide European IP landscape
Winfried Ness Nanoform Breaker Director Intellectual Slide Property Option 2 Nanoenzalutamide European IP landscape Nanoform.com | @nanoform 19
Slide 20: Enzalutamide
Enzalutamide Until 2002 there was a need for a more effective therapy for metastatic prostate cancer beyond traditional androgen deprivation therapy (ADT) with medicaments ▪ leading to medical castration (Leuprorelide) or ▪ blocking androgen receptors (Bicalutamide) The concept for enzalutamide bega
Slide 21: Enzalutamide created problems
Enzalutamide created problems On one hand On the other hand The development of a pharmaceutical formulation for enzalutamide faced several significant technological challenges ➢ Very poor aqueous solubility ➢ Time to market was key ➢ Crystallization tendency of the pure substance ➢ Stability issues
Slide 22: Why came the tablets later
Why came the tablets later The substance still has disadvantages The capsules had disadvantages - Difficult to swallow Xtandi - Very poor aqueous solubility 40 mg, 20 x 9 mm - Crystallization tendency of the pure substance - High pill burden with 4 capsules, 40 mg dose each - Stability issues - Size
Slide 23: Tablets approved after 2017 but still not good enough
The tablets were approved in/ after 2017 but are still not good enough 5 to 6 years later TABLETS based on ASD technology were approved and launched 2012 2017 / 2018 / 2019 BUT Xtandi capsules Xtandi tablets Xtandi tablets - The tablets are still too big, better than 40 mg 20 x 9 mm 40 mg 10 mm 80 m
Slide 24: Challenges
To develop a better alternative you have to take 2 challenges/hurdles Challenges • Patent hurdle • Technology hurdle nanoform.com | @nanoform
Slide 25: High level summary
High level summary 2010 2015 2020 2025 2030 2035 EP 1 893 196 B1 UCLA Substance, Basic Patent 29.06.2026 25.06.2028 EP 3 725 778 B1 Astellas Solid amorphous dispersion with a polymer 11.09.2033 Most critical patent and … … it is technically nearly impossible to develop an alternative without making
Slide 26: High level summary
High level summary 2010 2015 2020 2025 2030 2035 EP 1 893 196 B1 UCLA Substance, Basic Patent 29.06.2026 25.06.2028 EP 3 725 778 B1 Astellas Solid amorphous dispersion with a polymer 11.09.2033 Most critical patent 1. Sandoz 7. AET 2. Zentiva 8. Maiwald 3. Dr. Schön 9. Accord 4. Hamm Witkopp 10. Kut
Slide 27: High level summary
High level summary 2010 2015 2020 2025 2030 2035 2040 EP 1 893 196 B1 Univ California Substance, Basic Patent 29.06.2026 25.06.2028 US 7 709 517 B2 UC Basic Patent Enzalutamide a compound seleted from 13 Aug 2027 (incl PTA) EP 3 725 778 B1 Astellas Formulation – solid amorphous dispersion 11.09.2033
Slide 28: Is there a way out?
Is there a way out? Xtandi capsules Technology hurdle 40 mg 20 x 9 mm Xtandi tablets 40 mg 10 mm Xtandi tablets 80 mg 17 mm Enzalutamide tablets ? ? Is there still room for improvement? nanoform.com | @nanoform
Slide 29: YES there is !!
YES there is !! The magic word is Polymer embedded Nanoparticles - PeN - There is a now newly invented, patented and alternative technology platform to ASD available - It can be applied to all substances having the same disadvantages like Enzalutamide substances like Apalutamide, Encorafenib, …… (ve
Slide 30: YES it is !!
YES it is !! Technology hurdle solved Nanoform Xtandi capsules Technology hurdle 40 mg 20 x 9 mm Xtandi tablets 40 mg 10 mm Xtandi tablets 80 mg 17 mm Enzalutamide tablets 160 mg What about the patent hurdle nanoform.com | @nanoform
Slide 31: It is possible
It is possible 2010 2015 2020 2025 2030 2035 EP 1 893 196 B1 UCLA Substance, Basic Patent 29.06.2026 25.06.2028 EP 3 725 778 B1 Astellas Solid amorphous dispersion with a polymer 11.09.2033 Most critical patent and It is nearly impossible to develop an alternative tablet without infringing this pate
Slide 32: Nanoenzalutamide European roadmap & commercial launch
Dr. Katja Dreyer Director Onconcept & Specialty Generics, Nanoform BreakerGmbH Helm Pharmaceuticals Slide Option 2 Nanoenzalutamide European roadmap & commercial launch Nanoform.com | @nanoform 32
Slide 33: Header
Header Page 15 Nanoform.com | @nanoform 33
Slide 34: Our value proposition: enhancing patient needs and commercial viability
OUR VALUE PROPOSITION: ENHANCING PATIENT NEEDS AND COMMERCIAL VIABILITY Nanoenzalutamide tablets 160 mg 8.0mm 13.5x6.5mm 16x8mm 18x 8mm Originator availabale dosage forms / Xtandi® 17.1x9mm 10x 4.5mm 20.0x9mm 8 nanoform ONConcept® oleae Flexible Dosage Options Offering flexible daily dose and dose a
Slide 35: Our journey: milestones from 2021 to 2030
OUR JOURNEY MILESTONES FROM 2021 TO 2030 2030: @) 2028: Launch 026: Submission, icensing Agreement 2025: Production, = Pivotal Studies, Licensing Agreement 2024: Pilot Bioequivalence Results Partnership Formation and Expansion The partnership started in 2021 and expanded in 2022 through entry into a
Slide 36: Xtandi flagship product in Astellas/Pfizer oncology pipeline
FLAGSHIP PRODUCT IN ASTELLAS/PFIZER ONCOLOGY PIPELINE, DRIVING GROWTH AND COMBINATION STRATEGIES XTANDI® — — * Global Sales Powerhouse: $6.2Bn in 2024 US: $2.5Bn | Europe: ~$2Bn * Cornerstone in Prostate Cancer Therapy: Sustained growth trajectory with predicted increasing sales - Broad Label Covera
Slide 37: Header
Header Page 15 Nanoform.com | @nanoform 37
Slide 38: Nanoenzalutamide US launch roadmap
Kurt Nielsen Nanoform Managing Breaker Director Slide Expert Insights Option 2 Nanoenzalutamide US launch roadmap Nanoform.com | @nanoform 38
Slide 39: Background and Context for US NanoEnzalutamide Market
Background and Context for US NanoEnzalutamide Market A Large, Durable US Market with a Real Patient Problem • Xtandi® is a multi-billion-dollar US prostate cancer therapy, taken daily by patients over long treatment durations • The standard regimen requires multiple large capsules, creating real-wo
Slide 40: What We Have Done So Far
What We Have Done So Far De-Risked the Asset • Advanced Nano-Enzalutamide to GMP-ready formulations suitable for late-stage development • Generated initial human pharmacokinetic (PK) data, reducing early clinical uncertainty • Built strong, non-infringing IP around single table 120 mg / 160 mg dose
Slide 41: What We Are Going to Do (Strategy)
What We Are Going to Do (Strategy) • Pursue multiple US regulatory Optionality That Drives Speed and Reduces Risk pathways in parallel, rather than a single bet • Preserve flexibility across ANDA and 505(b)(2) filing options • Maintain the ability to pursue AB- rated or differentiated launch strateg
Slide 42: Execution and Value Capture
What Are We Going to Do (Execution and Value Capture) Turning Regulatory Progress into US Commercial Value • Select the fastest approvable US path while retaining fallback options • Engage FDA early to minimize approval delays and regulatory surprises • Use IP strategy to protect launch timing and c
Slide 43: A Patient-Centric Product with a Disciplined US Launch Strategy
A Patient-Centric Product with a Disciplined US Launch Strategy Large, durable market: Xtandi® represents a multi- billion-dollar US franchise with long treatment durations, creating sustained generic opportunity Real patient differentiation: Smaller, swallowable 120 mg / 160 mg doses address adhere
Slide 44: Nanoenzalutamide regulatory strategy
Johanna Kause Nanoform Breaker Slide Chief Quality Officer Option 2 Nanoenzalutamide regulatory strategy Nanoform.com | @nanoform 44
Slide 45: Drug Substance, Drug Product Intermediate, Drug Product
Drug Substance (DS) or Drug Product Intermediate Drug Product Active Pharmaceutical Ingredient (API) A material produced during the drug Final dosage form, containing the manufacturing process that is not yet drug substance and excipients (e.g. The specific chemical compound or the final product but
Slide 46: Evolution of GMP at Nanoform
Evolution of GMP* at Nanoform 2020-2025: Building • From a single-API clinical manufacturing site to a multi-API commercial manufacturing site with an in- house QC laboratory • 4 GMP inspections by the Finnish Medicines Agency 2026-3030: Expanding • Expansion of commercial manufacturing authorizatio
Slide 47: Regulatory steps for an Active Substance
Regulatory steps for an Active Substance • A Marketing Authorization Application (MAA) contains parts for the Drug Substance (API) and Drug Product • The Drug Substance part can be submitted • as part of the Marketing Authorization Application or • as a separate dossier, referred to as Active Substa
Slide 48: Nanoenzalutamide Supply Chain
Nanoenzalutamide Supply Chain Page ASMF/DMF Nanoform ASMF/DMF 15 Marketing Authorization Application Nanoform.com | @nanoform 48
Slide 49: Regulatory Strategy (Nanoenzalutamide)
Regulatory Strategy (Nanoenzalutamide) • The regulatory strategy and regulatory procedure for the Drug Product is selected by the MA applicant • For Nanoenzalutamide • EU (hybrid generic via decentralized procedure) and US (TBD) • For regulatory success of the Drug Product, Nanoform will: • Maintain
Slide 50: Nanoenzalutamide regulatory timeline
Nanoenzalutamide regulatory timeline Q1/2026 Q2/2026 2026-2030 Active Substance Master Drug Master File ready eCTD* dossier available File ready for submission for submission for submissions A DMF can be submitted Applicable in EU, US, An ASMF is submitted 6 months prior to the Japan and other toget
Slide 51: 3 Nanoformed medicines launched by 2030
Antonio da Silva Nanoform Breaker Slide Chief of Business Operations Option 2 3 Nanoformed medicines launched by 2030 Nanoform.com | @nanoform 51
Slide 52: Kernel Pipeline
Kernel Pipeline Page 15 Nanoform.com | @nanoform 52
Slide 53: Kernel development pathway
Kernel development pathway NF FDF prototype(s) selection (physicochem. & dissolution) NF intermediate NF intermediate NF FDF DP NF DS lead(s) selection lead(s) selection NF FDF prototype(s) prototype(s) Tablet selection Dossier Filling release (physicochem. & (rodent) selection (dog) upscaled and TT
Slide 54: Activity plan
Activity plan 2026 2027 2028 2029 2030 Nano Enzalutamide New Markets Nano Apalutamide Nano Encorafenib Gliora Nano Kernel #5 Nano Kernel #6 Nano Kernel #7 Nano Kernel #8 Nano Kernel #9 Nano Kernel #10 Process Development (R&D activities including nanoDS and nanoFormulation development) Nano DS Clini
Slide 55: Plant Plan
Plant Plan Lines 2026 2027 2028 2029 2030 GMP1 GMP2 GMP3 EMEA, FDA, PMDA Ready 10 ton/year Facility Under Installation Clinical Manufacturing License Commercial Manufacturing License nanoform.com | @nanoform 55 PUBLIC
Slide 56: Why we invested in Nanoencorafenib
Steen Vangsgaard, CEO A.forall Group NV Nanoform Breaker& Slide Tiago Geraldeso,Option 2 Director IMGA Investment Why we invested in Nanoencorafenib Nanoform.com | @nanoform 56
Slide 57: Who is Aforall Pharma?
Who is Aforall Pharma? Aforall – Value-added generic medicines, asset light specialty pharma. • Develop and register products (partner to get access to relevant technologies) • Establish and manage supply chains • Launch, commercialize/out-license products Value-added generic medicines: • 3 Ps: Pati
Slide 58: Why encorafenib and Brafmed
Why encorafenib and Brafmed Benefits of nanoformed encorafenib: • Reduced pill burden (6 to 1) - enhanced patient compliance - better patient outcomes • Competitive advantage over generic encorafenib/life-cycle management option Nanoforms technology: • High yield & promising results • Platform techn
Slide 59: Why Futurum Tech invested in the Brafmed project?
| | ‘a \\ ea gestao de ativos m sgoic Why Futurum Tech invested in the Brafmed project? Nanoform Investor’s call, 16 December 2025
Slide 60: IMGA and Futurum Tech Venture Capital Fund
IMGA and Futurum Tech Venture Capital Fund Main facts and figures im|g{a| i_m|g{a| FUTURUM TECH Largest independent asset manager in Portugal, with over 6 billion euro in AuMs at the end of 2025. * Over 35 years of experience, mostly in the mutual fund industry (UCITS open ended funds: 33 funds) * O
Slide 61: Futurum Tech Venture Capital Fund and Brafmed
Futurum Tech Venture Capital Fund and Brafmed i_m|g|a| Why did the Futurum Tech Fund invested in the Brafmed project FUTURUM TECH he oe BRAFMED What we were looking for: en DY PF Yr BP Good strategic fit with the Fund’s Investment thesis Strong and complete team Cutting edge products / technology So
Slide 62: GLIORA partnership with Nanoform
Sreevatsa Natarajan Nanoform Co-Founder Breaker and CEO Slide Revio Therapeutics Option 2 GLIORA partnership with Nanoform Nanoform.com | @nanoform 62
Slide 63: Page
Page 15 Nanoform.com | @nanoform 63
Slide 64: Speaker Introduction
02 Speaker Introduction Sreevatsa Natarajan Co-Founder Chief Executive Officer Scientist-entrepreneur with more than ~25 years of global R&D and business experience in the life sciences industry. Holds dual Masters’ Degrees in Chemistry & Pharmacokinetics from Birla Institute of Technology & Science
Slide 65: About Revio Therapeutics
About Revio Therapeutics Adding life to medicines What we do Why — — Al-enabled new product Existing medicines often sub- development engine — focused optimal — residual unmet need on 505(b)(2) / Hybrid products Untapped opportunities for improvement & repositioning into new indications 03 How —_ Al
Slide 66: Why Glioma: Global Burden, Care Evolution & Unmet Need
04 nanoform reviotx Why Glioma srt power High-Grade Glioma (HGG) & Glioblastoma (GBM) — Global Burden, Care Evolution & Unmet Need | Annual Incidence Radiotherapy TTFields + TMZ (2017) —_ External beam RT establishes EF-14: +4.9 mo OS gain 7 benefit (1970s-). (20.9 vs 16.0) HGG (incl. GBM): = 0.20M
Slide 67: Why GLIORA
05 Why GLIORA Power of local treatment that synergizes with current standard of care nanoform reviotx small is powerful Long-acting, locally delivered, intra-tumoral, thermo-responsive hydrogel containing TMZ + OLA for patients with resectable high-grade gliomas OLA - Olaparib Long-Acting Treatment
Slide 68: Why Nanoform
Why Nanoform 4§nanoform reviotx small is powerful® Enabling technology that perfectly fits the requirements for GLIORA Technology Aspects Required | Reproducibly & efficiently | Strong IP cover on the process & I Experience in developing | GBM disease area generate nano-sized nano-sized API - CESS®
Slide 69: Promising Data: GLIORA Progress So Far & Next Steps
Promising Data nanoform revio tx GLIORA: Progress So Far & Next Steps Product concept crystallized; RNU-U87 xenograft rat model nn Clear FTO; IP filing underway = — mom “i a2. snus | J m Sweaals Hydrogel concept formulation Strong product IP moat that is i cone (with a different API) proven imbued w
Slide 70: Why GLIORA will succeed
Why GLIORA will succeed #nanoform reviotx GLIORA is a highly de-risked program with several success factors in place and a high IP & capability moat against competition small is powerful® Both drugs already proven & synergistic in Glioma Nanoform has successfully developed similar product prototypes
Slide 71: Path Ahead & Next Steps
Path Ahead & Next Steps “nanoform revio tx De-risked development plan in place Through 2026 2H 2024 | 1H 2025 | 2H2025 | 1H 2026 | 2H 2026 | 1H 2027 | 2H 2027 | 1H 2028 | 2H 2028 | 1H 2029 | 2H 2029 — Product prototype and animal studies Regulatory filings (to initiate clinical trials) Commercial pa
Slide 72: Nanoform's CESS rocket science
Ari Kauppinen, Sr Scientist Nanoform Breaker Tuomas Malve, Slide Sr Engineer OptionSr2Scientist Petteri Helander, Nanoform’s CESS® rocket science Nanoform.com | @nanoform 72
Slide 73: CESS process throughput – Success recipe
CESS® process throughput – Success recipe API throughput 𝑘𝑔Τℎ = 𝑦 ⋅ 𝑓𝐶𝑂2 ⋅ 𝑆 ⋅ 𝐸 API solubility in CO2 Factor Main contributor Range CO2 flowrate 𝒚 API nature, p, Ts 0.01 – 20 g/kg API saturation 𝒇𝑪𝑶𝟐 Pump capacity 6 – 300 kg/h 𝑺 Vessel residence time, dissolution aids 50 – 100 %…
Slide 74: Throughput and cost evolution 2021-2025
2021 2025 Demonstrators – Throughput & cost evolution 1 48 485 96 970 100000 1 10000 0,1 Target 2025 Log throughput Log cost Throughput 9.7∙104x 1000 Current record 0,01 Cost 2∙10-5x Throughput 4.8∙104x Cost 4∙10-5x 100 0,001 Baseline 2021 10 Throughput 1x 0,00004 0,0001 0,00002 Cost 1x 1 1 0,0000
Slide 75: R&D Fleet Control Hardware Standardization
R&D Fleet Control Hardware Standardization • All R&D lines upgraded to a common hardware platform • Based on modern IEC 61499 standard enabling industry 4.0 • Faster development cycles • Critical for meeting scale-up timelines Page 15 Nanoform.com | @nanoform 75
Slide 76: Control Room Brings Efficiency
Control Room Brings Efficiency R&D Fleet Control Room Control Data … Nanoform.com | @nanoform 76
Slide 77: Streamlined Data Flow
Streamlined Data Flow Process Control Data Data Analysis and System Historian Reporting Tools Nanoform.com | @nanoform 77
Slide 78: Science of Particle Formation in CESS
Science of Particle Formation in CESS® Dissolution Nanoforming Collection 1000 bar 1 bar Solution Suspension Solid mixture Nanoform.com | @nanoform 78
Slide 79: Controlling supercritical-CO2 and API
Controlling supercritical-CO2 and API CO2 jet Particle Engineering video ➢ Thermodynamic path sets CO2 and API behavior Nanoform.com | @nanoform 79
Slide 80: Seeing CESS
Seeing CESS® ➢ In standard CESS-lines nanoforming is indirectly measured. ➢ Here we show a rare look into API+scCO2 nanosuspension 1) Thermodynamic path A 2) Thermodynamic path B → Large crystals → Nanoparticles in CO2 video video, trimmed UV-vis absorbance spectrum Time 1 Time 2 Particle growth: pe
Slide 81: A large biologics market is forming in subcutaneous delivery
Peter Hänninen Nanoform Breaker Chief Development Slide Officer Option 2 A large biologics market is forming in subcutaneous delivery of monoclonal antibodies Nanoform.com | @nanoform 81
Slide 82: Future of Biologics Delivery & Formulation
Future of Biologics Delivery & Formulation Subcutaneous delivery will become the dominant standard (>50%) for new and marketed biologics. Suspension formulations enable high drug concentrations → lower injection volumes, making them a preferred choice. Particle properties are critical for suspension
Slide 83: Biologics will dominate future value creation
Biologics (and more specifically antibodies and GLP-1s) will dominate future value creation for the industry By 2030 biologics will represent 57% of industry sales and two thirds of the Top100 sellers Antibodies and GLP-1s are the primary future revenue pools and market growth drivers for the pharma
Slide 84: Fundamentals of the IV-to-SC Switch
Fundamentals of the IV-to-SC Switch Improved Safety Faster to Inject and Tolerabiity Tecentriq Hyqreza IRR1s vs IV ~7 min vs 30–60 minutes Market Growth Share Growth Darzalex Faspro ↓~3x Opdivo Qvantig 3–5 minute injection vs 30 Rybrevant SC ↓~5x minutes DARZALEX Faspro ~96% Ocrevus Zunovo US conver
Slide 85: Innovative Approaches to Address the High-Dose Challenge
Innovative Approaches to Address the High-Dose Challenge • About 140 biologics are currently on the market. [1] • No marketed products contain more than 200 mg/ml protein concentration, and typically closer to 100 mg/ml, due to increasing viscosity that renders a product non-injectable and the risk
Slide 86: Antibody formulations high dose is a challenge for SC delivery
All antibody formulations are injected, and their high dose is a challenge for SC delivery Antibody Administered by Dose > 400mg formulations Dose > 200mg Injection launched or in P3* 321 235 428 428 (55 %) (75 %) 55 - 75% of antibody formulations likely require enabling technologies to be administe
Slide 87: Technology Landscape – As Seen by Head of Pharmaceutical Development, Merck
Technology Landscape – As Seen by the Head, Pharmaceutical Development, Biologics, Merck Nanoform.com | @nanoform 87
Slide 88: Limited Technology Availability Drives Acquisitions and Exclusive Deals
Limited Technology Availability is Driver for Strategic Positioning in the Market through Acquisitions and Exclusive Deals Nanoform.com | @nanoform 88
Slide 89: Halozyme Dominated Exclusivity Matrix
Halozyme Dominated Exclusivity Matrix Makes Biologics Developers Thirsty for Alternatives Target Receptor Acumen Alexion/AZ Amgen Argenx BMS Lilly JnJ Merck Novartis Regeneron Roche Takeda ViiV OTHERS Amyloid A4 protein Halozyme 4 C2 Halozyme 1 C5 Halozyme 10 CD20 Halozyme 8 CD38 Halozyme 12 EGFRxME
Slide 90: Future of Biologics Delivery & Formulation
Future of Biologics Delivery & Formulation Subcutaneous delivery will become the dominant standard (>50%) for new and marketed biologics. Suspension formulations enable high drug concentrations → lower injection volumes, making them a preferred choice. Particle properties are critical for suspension
Slide 91: Working with large pharma: What we have done and learnt
Maria Lume Nanoform DirectorBreaker Biologics Slide Option 2 Working with large pharma: What we have done and learnt Nanoform.com | @nanoform 91
Slide 92: Bio process evolution 2021-2025
Bio process evolution 2021-2025 2500 25 Kg Manufactured 2000 20 Line hours 1500 15 1000 10 500 5 0 0 2021 2022 2023 2024 2025 Kg Manufactured Line hours ▪ Manual control of the BIO process ▪ Automated process ▪ First customer projects ▪ 1000x scale-up completed ▪ Setting up the quality control metho
Slide 93: Bio Line Forms Dry Particles as Small as 50 nm
Nanoform's Bio Line Forms Dry Particles as Small as 50 nm Exhaust 1 API containing feed solution is pumped into nebulizer 5 Nanoparticle 2 Feed solution is nebulized into mist droplets and mixed with the collection carrier gas Ionization 4 Solvent 3 Mist is transported into the drying chamber via a
Slide 94: Consistent Spherical Particles, Tunable in Size
Consistent Spherical Particles, Tunable in Size, Distinct from those Produced by Conventional Techniques PSD dn50 dv50 PSD dn50 dv50 PSD dn50 dv50 (nm) 250 450 (nm) 375 1065 (nm) 425 2080 Tunable particle size distribution in the Nanoform Biologics – highly spherical particles retained Takeda data:
Slide 95: Nanoformed Particles are compact structures with high packing density
Nanoformed Particles are compact structures with high packing density. (Method: Focused Ion Beam-Scanning Electron Microscopy (FIB-SEM) FIB-SEM analyses in collaboration with University of Helsinki, Institute of Biotechnology, EMBI Nanoform.com | @nanoform 95
Slide 96: Applications of the Nanoformed Biologics
Applications of the Nanoformed Biologics Particles in suspension Dry Protein particles Optical microscopy (bright field mode) Protein concentration exceeding 400 mg/mL can be achieved Nanoform.com | @nanoform Video embedded
Slide 97: No change on particles in the suspension after 6 months
No change on particles in the suspension – after 6 months Time zero at +25°C Time zero at +4°C Diluted to 200 mg/mL dry mass to enable acquiring of sharp images Sample stored for 6 months at +4°C and +25°C, 600 mg/mL dry mass, 300 mg/mL API. 6 months at +25°C 6 months at +4°C Nanoform.com | @nanofor
Slide 98: High concentrations validated by large pharma partners
Our ability to develop very high concentrations of stable, injectable biological material has been validated by large pharma partners Protein concentrations >400 mg/ml Batch Aggregrates % Monomer+dimer % Viscosity: ~70 cp. Bulk (blue) 0,63 99,37 Injection force: 8-9N Nano (red) 0,23 99,77 Syringe: 2
Slide 99: Applications of the Nanoformed Biologics – pulmonary delivery
Applications of the Nanoformed Biologics – pulmonary delivery Inhalation Time zero 3-month 6-month Fig. 1 Formulated semaglutide powder by SEM at 25K magnification Fig. 2 Semaglutide deep lung deposition profiles measured using Next Generation Impactor (NGI) Analytical Methods for Stability trial at
Slide 100: Takeda in-vivo data confirm promising in-vitro data
Takeda in-vivo data confirm promising in-vitro data nanoform.com | @nanoform CONFIDENTIAL
Slide 101: Q&A
Nanoform Breaker Slide Option Q&A 2 Nanoform.com | @nanoform 101
Slide 102: Closing remarks, Q&A
Nanoform Breaker Slide CLOSING Q & A2 Option REMARKS www.nanoform.com San Diego - New York - Lisbon - Oxford – London - Cambridge - Bordeaux - Stockholm – Budapest - Helsinki 102 Nanoform.com | @nanoform
Slide 103: Contact details
CEO Edward Hæggström edward.haeggstrom@nanoform.com +358 50 317 54 93 CFO Albert Hæggström albert.haeggstrom@nanoform.com +358 40 161 4191 DIR Henri von Haartman hvh@nanoform.com +46 76866 50 11 Nanoform.com | @nanoform