Maat Pharma · EURONEXT:MAAT
Maat Pharma — Investor Presentation (August 2022)
32 slides from Maat Pharma's investor presentation, August 2022
Slide 1: MaaT Pharma: Microbiota as a Therapy
MaaT Pharma Microbiota as a Therapy Company Presentation August 2022
Slide 2: Disclaimer
Disclaimer This document has been prepared by MaaT Pharma (the "Company") and is for information and No representation, warranty or undertaking, express or implied, is made as to the accuracy, background purposes only. completeness or appropriateness of the information and opinions contained in this
Slide 3: A Uniquely-Positioned Microbiome Company
A Uniquely-Positioned Microbiome Company Listed on Euronext (MAAT) Pioneering development of Microbiome Ecosystem Therapies to address hematological malignancies and oncology Differentiated approach, lead asset in Phase III in aGvHD Multi-asset clinical and preclinical pipeline with near-term, value
Slide 4: Host–Microbiota Interactions are Critical for a Functional Immune System
Host – Microbiota Interactions are Critical for a Functional Immune System A rich and diversified gut ecosystem actively modulates the immune system functionality • A diversified microbiome contributes to the education and modulation of our immune system throughout life • Bacterial richness and mucu
Slide 5: Diversity matters! Higher gut microbiome diversity is associated with…
Diversity matters! Higher gut microbiome diversity is associated with … Liquid Tumors Solid Tumors Higher survival rate in patients Lower incidence and lower Higher response rate to ICI* in patients receiving allo-HSCT *,1 mortality from aGvHD*,2 with metastatic melanoma3 -30% mortality aGvHD 1 MaaT
Slide 6: MaaT Pharma's MET platform has generated a diverse line of product candidates
MaaT Pharma’s Microbiome Ecosystem Therapy (MET) platform has generated a diverse line of product candidates Microbiome Ecosystem cGMP Therapies (MET) Platform Native Co-cultured MaaT013 MaaT033 MaaT03X Indication-specific designed High diversity ecosystem (from clinical data) Full ecosystem
Slide 7: Looking ahead: addressing growing market opportunities with severe medical need
Looking ahead: addressing growing market opportunities with severe medical need MaaT03X MaaT03X MaaT033 >200,000 patients1 ~ 22,000 patients1 MaaT013 ~ 2,000 patients1 Long-term 3rd line Prevention of Solid Tumors in complications combination with Expansion SR GI 10x >10x TAM aGvHD of HSCT ICI (Immu
Slide 8: Hemato-Oncology
Hemato-Oncology
Slide 9: MaaT013 and MaaT033 aim to restore the gut microbiota to improve survival
MaaT013 and MaaT033 aim to restore the gut microbiota to improve survival in patients with liquid tumors Intestinal dysbiosis is associated with higher mortality in hemato-oncology Chemotherapy Allogenic Hematopoietic Stem Cell Patients with liquid Antibiotics Transplantation (allo-HSCT) tumors Irra
Slide 10: Hemato-Oncology: Treatment of acute Graft-vs-host-Disease (aGvHD)
Hemato-Oncology Treatment of acute Graft-vs-host-Disease (aGvHD)
Slide 11: MaaT013: restore the microbiome to cure acute GI graft vs. host disease
aGvHD MaaT013: restore the microbiome to cure acute Gastro-Intestinal graft vs. Host disease. Characteristics Pooled microbiota: a high-richness, high-diversity, full ecosystem, Microbiome Ecosystem Therapy containing ButycoreTM Administration 3 doses (150 mL enema bag) Available Clinical Data HER
Slide 12: HERACLES Phase 2 Clinical Trial: Promising results in very severe GI aGvHD
aGvHD HERACLES Phase 2 Clinical Trial Phase 2 Promising results in a very severe (III-IV) GI aGvHD population • N=24 patients, 96% grade III (4% grade IV), 2nd line (Steroid-resistant) • Very good safety and tolerability profile Gastro Intestinal Overall Survival (OS) Overall Response Rate (GI- ORR1
Slide 13: HERACLES: MaaT013 increases Responders' gut microbiome diversity
aGvHD Phase 2 HERACLES: MaaT013 increases Responders’ gut microbiome diversity Microbiota Diversity *** 0.0006 * 0.0360 ** 5 0.0056 S h a n n o n I n d e x ( O T U le v e l) n.s. 0.2624 n.s. 0.2345 * 0.0426 4 3 n.s. 0.1383 2 1 0 V1 V2 V3 V4 M aaT013 Responders Non-responders MaaT013 August 2022 Corp
Slide 14: Early Access Program: Promising confirmation in advanced, severe GI aGvHD
aGvHD EAP Early Access Program (EAP): Promising confirmation in an advanced, severe and more diverse GI aGvHD population • N=52 83% SR; 94% grade III, Up to 6 lines of prior treatment (median: 3 ; 77% received ruxolitinib) • Good tolerability and safety profile in a fragile population Gastro Intesti
Slide 15: The ARES Phase 3 study is designed to establish MaaT013 as 3rd line agent
aGvHD The ARES Phase 3 study is designed to establish MaaT013 as Phase 3 the 3rd line agent in GI aGvHD treatment • Pivotal single-arm trial of MaaT013 as 3rd line (steroid-resistant & ruxolitinib-resistant) in n=75 GI-aGvHD patients • Primary endpoint: GI-ORR at Day28 EUROPE : USA: First patient
Slide 16: Hemato-Oncology: Allogeneic-HSCT Complication Prevention
Hemato-Oncology Allogeneic-HSCT Complication Prevention
Slide 17: MaaT033: An optimized oral capsule to restore and maintain a healthy gut microbiome
Hemato- Oncology MaaT033: An optimized oral capsule to restore and maintain a healthy gut microbiome in patients with severe dysbiosis Characteristics Pooled microbiota: high-richness, high-diversity, full ecosystem, Microbiome Ecosystem Therapy containing ButycoreTM Administration Oral (a lyophiliz
Slide 18: Phase Ib CIMON study aimed to determine MaaT033 dose
AML Phase Ib CIMON study aimed to determine MaaT033 dose for Phase 1 further clinical development 6 centers August 2022 Corporate Presentation 18
Slide 19: Phase Ib CIMON study: Positive topline engraftment and safety data
AML Phase 1 Phase Ib CIMON study : Positive topline engraftment and safety data • First clinical POC of MaaT033 oral formulation Robust and persistent engraftment Good safety profile: • 21 patients exposed, 20 completed. • 100% drug compliance. • 4/4 positive DSMB meetings Dose selected for pl
Slide 20: CIMON results open an attractive market opportunity in allo-HSCT
MaaT033 Allo-HSCT CIMON results open an attractive market opportunity: Improving survival in patients receiving allo-HSCT 100% United States EU 5 Japan c. 7,800 c. 9,600 c. 3,000 primary primary primary procedures procedures procedures CIMON Additional 7%-10% recurrent procedures Approximately 22,50
Slide 21: Immuno-Oncology: Solid Tumors
Immuno-Oncology Solid Tumors
Slide 22: A diverse gut microbiome increases survival in patients receiving ICI
I/O A diverse gut microbiome increases survival in patients receiving immune checkpoint inhibitors (ICI) FMT from ICI responders to ICI non-responding • Immune check-point inhibitors (ICI) therapies have patients with metastatic melanoma established themselves as key therapeutic options in solid tum
Slide 23: MaaT013 ensures high diversity and contains strains that improve ICI response
MaaT013 I/O MaaT013 ensures high diversity and contains specific bacterial Sponsored by strains that have been identified to improve ICI response Higher microbiome richness better response rate to ICI in patients with metastatic melanoma MaaT013 Gopalakrishnan et al, Science 2018 Ongoing Phase IIa
Slide 24: Proprietary gutPrint platform synergizes multi-source data
MaaT03X Proprietary gutPrint® platform synergizes multi-source data to I/O generate innovative and indication-specific microbiome ecosystem therapies gutPrint® is the engine that drives MaaT Pharma’s MET product candidate generation capabilities to broaden and strengthen the pipeline August 2022 Cor
Slide 25: MaaT03X: Modulate the gut microbiome to improve response to ICI treatment
MaaT03X MaaT03X: Modulate the gut microbiome to improve response to I/O Immune Checkpoint Inhibitors treatment in solid tumors Customizable, donor-independent, Characteristics scalable process High richness, co-cultured, designed ecosystem Administration Oral (proprietary lyophilized capsule) Develo
Slide 26: Building Europe's largest specialized cGMP manufacturing facility
Building Europe’s largest specialized cGMP manufacturing facility for Microbiome Ecosystem Therapies Partnership with Building a dedicated 1,500 square meter site (which could be doubled). Designed to support commercial manufacturing of MaaT013 and MaaT033 and clinical manufacturing of MaaT03X produ
Slide 27: Key Upcoming Milestones
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Slide 28: Delivering on our objectives
Delivering on our objectives Clinical program Milestones announced at IPO Status (Nov 2021) MaaT013 (pooled enema) Onco-hematology Launch of the first Phase 3 trial in FDA & EMA Orphan Drug Designation oncology in the world Completion of Phase 1b trial and MaaT033 (pooled capsule) Post allo-HSCT pos
Slide 29: Looking ahead
Looking ahead Clinical program Next Step Expected timeline MaaT013 (pooled enema) Intermediate review H1 2023 Onco-hematology FDA & EMA Orphan Drug Designation ORR H2 2023 MaaT033 (pooled capsule) Launch of Phase 2/3 Q4 2022 Post allo-HSCT PHOEBUS (pivotal) MaaT013 (pooled enema)* H1 2023 Immuno-onc
Slide 30: Meaningful milestones in both the near and long term
Meaningful milestones in both the near and long term Intermediate review 2022 2023 2024 2025 Results Launch H2 H1 H2 H1 H2 H1 H2 H1 H2 Graft-vs-Host-Disease MaaT013 (pooled enema) Phase 3 ARES FDA & EMA Orphan Drug in EU (pivotal)1 Designation ORR Overall Survival Post-allogeneic HSCT complications
Slide 31: Key differentiators of MaaT Pharma from other microbiome competitors
Key differentiators of MaaT Pharma from other microbiome competitors Leveraging the complexity of Manufacturing the microbiome versatility Pioneering a full ecosystem cGMP manufacturing scalability approach to restore for both native and co-cultured host/microbiome immune products and building of a
Slide 32: Thank You
THANK YOU 32