Slide 1: Mabion operational update and outlook October-November 2020
MABION operational update and outlook October-November 2020
Slide 2: Zastrzeżenie / Disclaimer
ZASTRZEŻENIE / DISCLAIMER ▪ Niniejszy dokument („Dokument”) został opracowany przez ▪ This document ("Document") has been drawn up by Mabion Mabion S.A. Informacje zawarte w Dokumencie zebrano i S.A. The information contained in the Document has been przygotowano z dochowaniem należytej staranności,
Slide 3: Presenting Team
PRESENTING TEAM Dirk Kreder, PhD, MBA Sławomir Jaros, PhD, MBA CEO CSO, COO President of the MB Member of the MB Grzegorz Grabowicz, MBA Adam Pietruszkiewicz CFO Member of the Supervisory Member of the MB Board delegated to perform duties as Member of the MB 3
Slide 4: Mabion as integrated biopharmaceutical company with growing and diversified portfolio
MABION AS INTEGRATED BIOPHARMACEUTICAL COMPANY WITH A GROWING AND DIVERSIFIED PORTFOLIO BASED ON SOPHISTICATED COMPETENCIES IN BIOLOGICAL DRUGS research & development clinical development (up & downstream, up-scale & characteristics, (analytics, sample logistics, immunometric analytics, validation,
Slide 5: Mabion's diversified R&D portfolio
MABION’S DIVERSIFIED R&D PORTFOLIO commercialization molecule/drug clinical indication characteristics status partner approach registration phase in the rituximab oncology (NHL) and biosimilar drug EU and clinical phase I in partnered for the EU (MabionCD20) autoimmunology (RA) in approved therapies
Slide 6: Our foundation towards EMA and FDA registration
OUR FOUNDATION TOWARDS EMA AND FDA REGISTRATION: DEVELOPING RELATIONSHIP WITH AGENCIES BY FREQUENT REGULATORY CONSULTATIONS AND HARMONIZATION OF FDA AND EMA RECOMMENDATIONS EU regulators interactions outcomes/requests: ✓ MabionCD20 analytical approach confirmed by EMA/German Agency – addressing the
Slide 7: Mabion back on track with MabionCD20 to enter very attractive markets
MABION „BACK ON TRACK” WITH MABIONCD20 TO ENTER VERY ATTRACTIVE MARKETS MabionCD20 – making further crucial steps towards registration, in line with plan outlined in July 2020 • signed agreement with a top global CRO for the clinical bridging study in RA (necessary for the EU registration and first
Slide 8: Top-notch CRO contracted to support high-quality data generation
TOP-NOTCH CRO CONTRACTED TO SUPPORT HIGH-QUALITY DATA GENERATION contract research organization Phase 1/2 trial to demonstrate preparatory tasks 4Q 2020 – 2Q 2021 the biosimilarity between MabionCD20 and comparators: est date of CTA filings 1Q 2021 MabThera (EU reference clinical indication rheumato
Slide 9: Development of the full-scale process in line with the previously communicated plan
DEVELOPMENT OF THE FULL-SCALE PROCESS IN LINE WITH THE PREVIOUSLY COMMUNICATED PLAN 1 validation of manufacturing process confirming that it is feasible to repeatedly achieve the validation completed required quality of the product by using defined process control parameters 2 stability study cont
Slide 10: Thorough execution of the previously communicated plan
THOROUGH EXECUTION OF THE PREVIOUSLY COMMUNICATED PLAN accomplished near-term activities scientific advice procedures completed for the EU filing clinical trial application full-scale validation completed commencing clinical PK study clinical PK study protocol finalized application for p
Slide 11: Assumed timeline of the CD20 full-scale application process in EMA
ASSUMED TIMELINE OF THE CD20 FULL-SCALE APPLICATION PROCESS IN EMA process validation stability testing – required for filing stability testing - continuation analytical characterization clinical trial preparation treatment and reporting EMA’s marketing authorization procedure closing of dossier, fi
Slide 12: MabionCD20: as data is generated, the likelihood of success is increasing
MABIONCD20: AS DATA IS GENERATED, THE LIKELIHOOD OF SUCCESS IS INCREASING Risk Amount of Data Generated Establishment Submission Initial Additional Resubmission Cell line Clone of in-vitro Phase I BE Phase III and characteriza- Preclinical data , Review and development selection mode
Slide 13: Regular ongoing collaboration with Mylan
REGULAR ONGOING COLLABORATION WITH MYLAN ▪ Uninterrupted and engaged day-to-day collaboration ▪ Dedicated Mylan teams from several countries are engaged in several workstreams in the Mabion-Mylan cooperation ▪ Mylan is actively contributing to frequent interactions with regulators, working hand-in-h
Slide 14: Robust long-term prospects for the rituximab market
ROBUST LONG-TERM PROSPECTS FOR THE RITUXIMAB ▪ Key findings from the L.E.K. Consulting report - Rituximab is a well-established molecule with volumes forecast to remain stable; biosimilars are expected to continue to take share from the reference products Mabthera/Rituxan - Total rituximab molecule
Slide 15: Existing capabilities and capacity allow Mabion to extend its pipeline
EXISTING CAPABILITIES AND CAPACITY ALLOW MABION TO EXTEND ITS PIPELINE Mabion has started to initiate new projects leveraging its assets, based on a solid foundation of strong competencies, • Complementary projects do not affect the core activities • Financed from independent sources, obtaining targ
Slide 16: CD20 orphan drug program
CD20 ORPHAN DRUG PROGRAM Mabion’s collaboration with a biopharmaceutical company focused on the development and commercialization of pharmaceuticals for rare diseases with unmet needs offers additional attractive opportunities for the commercialization of MabionCD20. Orphan diseases - key characteri
Slide 17: COVID-19 opportunities – vaccine
COVID-19 OPPORTUNITIES – VACCINE Vaxine project Vaxine is an Australian biotechnology company focused on the development of innovative vaccines against Partner seasonal and pandemic viruses. Vaxine develops vaccine based on recombinant protein (unlike competitors based on mRNA, DNA, inactivated viru
Slide 18: COVID-19 opportunities – therapeutic antibody
COVID-19 OPPORTUNITIES – THERAPEUTIC ANTIBODY IcanoMAB project IcanoMAB is a private biotech company headquartered in Germany focusing on the pre-clinical stages and Partner development of antibodies for the treatment of cancer, immune-system and inflammation-related-diseases including COVID-19. The
Slide 19: Mabion's business development activities at BIO-Europe 2020
MABION’S BUSINESS DEVELOPMENT ACTIVITIES AT BIO-EUROPE 2020 ▪ 2020 business development activities: - supported by Plexus Ventures - two dozen meetings with potential customers and partners - several follow up meetings scheduled, and NDA’s closed - collaboration with “PolishBiotech” sponsored by Pol
Slide 20: Cash flow outline until expected market authorization by EMA
CASH FLOW OUTLINE FOR THE UPCOMING PERIODS UNTIL EXPECTED MARKET AUTHORIZATION BY EMA activities (estimated needs) 2H 2020 1H 2021 2H 2021 1H 2022 2H 2022 2023 - R&D (clinical development, stability, analytical similarity, MabionCD20 comparability assessment) (70% of indicated amount) max 75-85 mPLN
Slide 21: Founders continue to strongly support the business
FOUNDERS CONTINUE TO STRONGLY SUPPORT THE BUSINESS, CONFIRMED WITH INCREASING FINANCIAL INVOLVEMENT ▪ As previously declared (in March’20) Founding Fathers strongly support Mabion with additional funding, having deep faith in Mabion’s fundamental value and near-term value growth potential ▪ July 202
Slide 22: Mabion transforming into a fully-fledged integrated biopharmaceutical company
MABION TRANSFORMING INTO A FULLY-FLEDGED INTEGRATED BIOPHARMACEUTICAL COMPANY UNLEASHING ADDITIONAL GROWTH POTENTIAL Mabion is transforming from a one-product biotech company into a fully integrated biopharmaceutical company with an expanding portfolio MabionCD20 project is on track for submission a
Slide 23: Value fundamentals of Mabion
VALUE FUNDAMENTALS OF MABION MabionCD20 asset moving PLNm critical competences in towards marketing bioengineering and authorization manufacturing allowing broadening of R&D portfolio in team of dedicated additional markets and seasoned proprietary technologies employees with enabling high productiv
Slide 24: Mabion S.A. contact details
Mabion S.A. Kompleks Naukowo-Przemysłowy Biotechnologii Medycznej ul. gen. M. Langiewicza 60 95-050 Konstantynów Łódzki tel: +48 42 207 78 90 kontakt IR - cc group Piotr Owdziej tel: +48 22 440 1 440 mail: piotr.owdziej@ccgroup.pl Katarzyna Mucha tel: +48 22 440 1 440 mail: katarzyna.mucha@ccgroup.p