Puretech Health Plc · LSE:PRTC
Puretech Health — Investor Presentation (July 2019)
49 slides from Puretech Health's investor presentation, July 2019
Slide 1: July 2019
July 2019
Slide 2: Important Information
Important Information The following presentation, including any printed or electronic and growth and other data about our industry. This data involves reports-presentations.php. copy of these slides, the talks given by the presenters, the a number of assumptions and limitations, and you are cautione
Slide 3: Executive Team and Board of Directors
Team with proven track record of developing new therapeutics and building shareholder value Daphne Zohar Bharatt Chowrira, PhD, JD Eric Elenko, PhD Executive Team Founder & Chief Executive Officer PureTech, President & Chief of Business and Strategy Co-founder & Chief Innovation Officer Board Member
Slide 4: PureTech: advanced clinical stage biopharma company that has created new categories of medicine
PureTech: advanced clinical stage biopharma company that has created new categories of medicine Through PureTech’s own activities and those of its Affiliates, it has: Relationships with 9 major pharma companies or their investment arms COLLABORATIVE RAPID & DEVELOP DRUG DISCOVERY CAPITAL- INTERNALLY
Slide 5: Model drives development of new medicine and accretion of value via three paths
Model drives development of new medicine and accretion of value via three paths Advance platform * Advance internal programs through components via non- Derive value from equity growth of affiliates development and commercialization dilutive partnerships and optionality to spin out further affiliate
Slide 6: Committed to execution: value-driving milestones since July 2018
Committed to execution: PureTech team and its Affiliates have achieved numerous value-driving milestones since July 2018 Regulatory Partnerships FDA clearance for PLENITYTM PureTech collaboration with Roche (Gelesis100) Up to $36M in upfront payments, research support, and preclinical milestones
Slide 7: A highly valued network of world-renowned collaborators
A highly valued network of world-renowned collaborators Rox Anderson, MD: Harvard Medical School; Massachusetts General Hospital Massachusetts General Hospital Donald Ingber, MD, PhD: Harvard University Caroline Apovian, MD: Boston Medical Center Lee Kaplan, MD, PhD: Harvard Medical School; Louis Ar
Slide 8: PureTech's Highlighted Programs
PureTech’s Highlighted Programs Note: Lines represent the most advanced stage of each product candidate; not comprehensive of preclinical programs. Collaborators Product Candidate* PureTech Ownership** Initial Indication(s) Preclinical Phase 1 Phase 2 Phase 3 LYT-100, 100% (Internal) Lymphedema (~1M
Slide 9: The lymphatic system is key to the BIG Axis
The lymphatic system is key to the BIG Axis: We are harnessing key functions of the lymphatic system to develop PureTech’s internal programs Maintaining balance of fluid Our programs: LYT-100 (lymphedema), CNS lymphatics Addressing disorders involving lymphatic flow and lymphatic vessel restoration
Slide 10: PureTech's internal programs: Harnessing the lymphatic system
PureTech’s internal programs: Harnessing the lymphatic system Discovery Preclinical Phase 1 Phase 2 Phase 3 COLLABORATORS OUR PROGRAMS LYT-100 Lymphedema POC study in patients planned for 2020 Deupirfenidone LYT-200 Solid Tumors Expect to file IND in H1 2020 Anti-Galectin-9 MAb LYT-210 Solid Tumors
Slide 11: Case Study: Novel approaches to treating lymphatic flow disorders
Case Study: Novel approaches to treating lymphatic flow disorders The Challenge/Opportunity Existing Approaches • Millions of patients suffer from lymphedema • Mechanical treatment (e.g., compression, after injury, cancer, or infections physical therapy) pushes lymph around—not curative • Fibrosis a
Slide 12: LYT-100 is designed to address underlying mechanisms of lymphedema
LYT-100 (deupirfenidone) is designed to address underlying mechanisms of lymphedema: fibrosis and inflammation Feedback loop drives lymphedema Lymphatic injury TGF-β1 induced triggers local fibrosis impairs Inflammation inflammation lymphatic flow * ** Inflammation Fibrosis promotes TGF-β stain impa
Slide 13: Functional analogue anti-fibrotic reduced tail volume and fibrotic tissue in mouse model
A functional analogue anti-fibrotic molecule reduced established tail volume and fibrotic tissue in mouse tail model of lymphedema Mouse tail model of lymphedema mimics human Functional analogue anti-fibrotic drug reduced pathophysiology and tissue changes* fibrotic tissue thickness and tail volume
Slide 14: LYT-100 studied in single ascending dose study in healthy volunteers
LYT-100 has been studied in a single ascending dose study in healthy volunteers and shown favorable tolerability with promising PK – testing in lymphedema patients is planned in 2020 Pre-clinical Clinical Planned LYT-100 has shown to have anti- LYT-100 showed favorable PK to PureTech is advancing LY
Slide 15: LYT-100 potential development plan overview
LYT-100 potential development plan overview 2020: Expected 2020: Expected Phase Ib completion initiation • Multiple ascending • Patient proof-of-concept and dose and food- biomarker study in Stage I-II effect study in breast-cancer related healthy volunteers lymphedema (~73% of cases)* Completed Exp
Slide 16: LYT-100 has potential to address lymphatic flow conditions beyond lymphedema
LYT-100 has potential to address lymphatic flow conditions beyond lymphedema Fibrotic diseases of the lung7 and other organs have reduced lymphatic function Initial focus on arm Additional types of lymphedema lymphedema with millions of patients3 Target inflammation and fibrosis to restore lymphatic
Slide 17: Case Study: Targeting immunologically silent tumors with mAbs
Case Study: Targeting immunologically silent tumors with mAbs The Challenge/Opportunity Existing Approaches • Low survival rate for many solid tumors, including • Immuno-suppressed tumor microenvironment makes pancreatic, colorectal cancer, and cholangiocarcinoma tumors “cold” • Large unmet need for
Slide 18: LYT-200: Aimed at galectin-9, a key node in cancer immuno-suppression
LYT-200: Aimed at galectin-9, a key node in cancer immuno-suppression Galectin-9 Promotes expansion of Is a global immune regulator and mediates CD8 MDSCs immuno-suppression in tumors through MDSCs multiple mechanisms Galectin-9 High expression in cancer tissue and blood Induces Treg cell correlates
Slide 19: Multiple lines of pre-clinical data supporting therapeutic potential of LYT-200
Multiple lines of pre-clinical data supporting therapeutic potential of LYT-200 Single agent activity in KPC T cell activation with LYT-200 in patient • LYT-200 showed favorable (pancreatic cancer) model derived organoid model biophysical properties in pre-clinical 800 studies: • Affinity less than
Slide 20: LYT-210: Monoclonal antibody aimed at immuno-suppressive γδ1 T cells
LYT-210: Monoclonal antibody aimed at immuno-suppressive γδ1 T cells Immunosuppressive γδ1 T cells TUMOR PROGRESSION Solid tumors harbor immunosuppressive γδ1 T cells that correlate with tumor aggressiveness/worse survival Works through multiple pathways to cause immuno-suppression in the tumor micr
Slide 21: Multiple lines of pre-clinical data supporting therapeutic potential of LYT-210
Multiple lines of pre-clinical data supporting therapeutic potential of LYT-210 Single agent activity in KPC T-cell activation with an anti-δ1 mAb in patient • LYT-210 showed favorable biophysical (pancreatic cancer) model derived organoid model properties in pre-clinical studies: 15 • Affinity was
Slide 22: Immunosuppressive & pathogenic gamma delta T cells are an important new target
Immunosuppressive & pathogenic gamma delta (γδ) 1 T cells are an important new target – Anti-Delta-1 antibody is key to targeting both solid tumors and GI autoimmunity Immunosuppressive memory γδ1 Pathogenic inflammatory γδ1 T cells invade tumors & secrete memory T cells in mesenteric immunosuppress
Slide 23: Numerous expected milestones for existing programs
Numerous expected milestones for existing programs potentially driving PureTech’s value Product Candidate 2019 2020 2021 LYT-100 In-licensing POC study in patients with lymphedema planned for 2020 And continued… LYT-200 Nominate lead clinical candidate IND filing & initiation of Ph1b study in so
Slide 24: LSE Main Market / FTSE-indexed: PRTC
LSE Main Market / FTSE-indexed: PRTC – Market capitalization ~$939M (~£751M) as of July 19, 2019; 1.25 USD:GBP* 282,493,867 outstanding shares as of June 30, 2019 Group** cash and short term investments of $425.0M ($177.7M at the PureTech Health level) as of December 31, 2018 Headquartered in Boston
Slide 25: PureTech: Developing BIG Medicines
PURETECH Developing BIG Medicines i s1¢ IMMUNE GUT PURETECH
Slide 26: Affiliate and Internal Programs – Details (1 of 3)
PureTech’s Affiliate and Internal Programs – Details (1 of 3) Product PureTech Indication Potential Key Differentiation Milestones Achieved Expected milestones Candidate* Ownership** (US Patient Population) LYT-100 100% Lymphedema (~1M) Product candidate for lymphedema with • Acquired LYT-100 in Q3
Slide 27: Affiliate and Internal Programs – Details (2 of 3)
PureTech’s Affiliate and Internal Programs – Details (2 of 3) Product PureTech Indication Potential Key Differentiation Milestones Achieved Expected milestones Candidate* Ownership** (US Patient Population) VE303 57.4% rCDI (100 – 120K per year) Developing a new category for immune- • Announced succ
Slide 28: Affiliate and Internal Programs – Details (3 of 3)
PureTech’s Affiliate and Internal Programs – Details (3 of 3) Product PureTech Indication Potential Key Differentiation Milestones Achieved Expected milestones Candidate* Ownership** (US Patient Population) VOR33 30.2% AML (~60K) Advancing a new approach to selectively • Obtained ex vivo proof-of-co
Slide 29: Case Study: New mechanism for treating psychosis and cognitive impairments
Case Study: New mechanism for potentially treating psychosis and cognitive impairments The Challenge/Opportunity Existing Approaches • Psychosis, negative symptoms, and cognitive • Antipsychotics are the mainstay therapy targeting dopamine impairments in schizophrenia, Alzheimer’s pathways, however
Slide 30: Karuna Therapeutics
Karuna Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Selective Muscarinic Receptor KarXT Targeting for CNS Disorders 31.6% R* Therapeutic candidate targeting muscarinic receptors for CNS disorders MILESTONES ACHIEVED KEY CATALYS
Slide 31: Case Study: Rationally-defined, immune modulating non-pathogenic human microbes
Case Study: Rationally-defined, immune modulating non-pathogenic human microbes The Challenge/Opportunity Existing Approaches • The human microbiome is increasingly • Many existing IBD (~3M patients) interventions are limited by implicated in various immune-mediated toxicities and systemic immune su
Slide 32: Vedanta Biosciences
Vedanta Biosciences Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval VE303, VE202, VE416, Microbiome-Derived Modulators VE800 for Immune & Infectious Disease 57.4%* Microbiome-derived modulators for immune-mediated and infectious d
Slide 33: Broad pipeline targeting immunological and infectious diseases
Broad pipeline targeting immunological and infectious diseases with high unmet need Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval VE303, VE202, VE416, Microbiome-Derived Modulators VE800 for Immune & Infectious Disease 57.4%* In
Slide 34: Case Study: Orally administered mechano-therapeutic platform for GI disorders
Case Study: Orally administered mechano-therapeutic platform for GI disorders The Challenge/Opportunity Existing Approaches • Obesity represents the largest and growing health • Pharmaceuticals are systemically and centrally acting with problem in the world with 1.9B adults overweight potential for
Slide 35: Gelesis recently secured FDA Clearance for PLENITY
Gelesis recently secured FDA Clearance for PLENITYTM Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Plenity, Gelesis200, Mechanotherapeutics for GS500, GS300, GS400 GI-Related Diseases 19.7% R* FDA Cleared Novel approach to treat
Slide 36: Upcoming Gelesis milestones
Upcoming Gelesis milestones Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Plenity, Gelesis200, Mechanotherapeutics for GS500, GS300, GS400 GI-Related Diseases 19.7% R* FDA Cleared PRODUCT RESEARCH FOCUS PRE-CLINICAL CLINICAL PIV
Slide 37: Akili has recently filed with the FDA
AKL-T01 is an investigational therapy, for which Akili is currently pursuing clearance with FDA. It is not approved or cleared for use in the U.S. or by foreign regulatory authorities. Akili has recently filed with the FDA Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3
Slide 38: Advanced product pipeline focusing on neurological and psychiatric indications
AKL-T01 is an investigational therapy, subject of a pending application with FDA. It is not approved or cleared for use in the U.S. or by foreign regulatory authorities. Advanced product pipeline focusing on neurological and psychiatric indications Product Candidate(s) Focus PRTC Ownership Preclinic
Slide 39: resTORbio
resTORbio Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Immunotherapies for RTB101 Aging-Related Diseases 27.8%* Therapeutic candidate for the treatment of aging-related diseases MILESTONES ACHIEVED KEY CATALYSTS • Positive clin
Slide 40: Follica
Follica Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Regenerative Biology Platform for FOL-004, FOL-005 Androgenetic Alopecia & Skin 77.9% R* Rejuvenation Regenerative biology platform MILESTONES ACHIEVED KEY CATALYSTS • Contin
Slide 41: Regenerative biology platform for androgenetic alopecia
Regenerative biology platform for androgenetic alopecia Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Regenerative Biology Platform for FOL-004, FOL-005 Androgenetic Alopecia & Skin 77.9% R* Rejuvenation • Pioneering technology
Slide 42: Sonde
Sonde Product Candidate Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval Vocal Biomarkers to Monitor and Sonde Manage CNS Disorders 55.8%* Vocal biomarkers to extract clinically meaningful health information from everyday voice interactions MILESTONES
Slide 43: Alivio
Alivio Product Candidate(s) Focus PRTC Ownership Preclinical Phase 1 Phase 2 Phase 3 / Pivotal FDA Filing Clearance/Approval ALV-306, ALV-304, Targeted Disease ALV-107 Immunomodulation 82.8%* Targeted disease immunomodulation for acute and chronic inflammatory disorders OVERVIEW MILESTONES ACHIEVED
Slide 44: LYT-200 and LYT-210: novel therapeutics targeting immunosuppressive mechanisms in oncology
LYT-200 and LYT-210: Developing novel therapeutics which target newly discovered immunosuppressive mechanisms in oncology mAb to Galectin-9 1.0 Fraction survival) Dectin 1 activation on macrophages by αGalectin-9 Galectin 9 promotes pancreatic carcinoma 0.5 and peritumoral immune tolerance Control p
Slide 45: Galectin-9: Fundamental modulator of the immune system
Galectin-9: Fundamental modulator of the immune system Galectin-9 Promotes expansion of Is a global immune regulator in health and CD8 MDSCs disease (pregnancy, inflammation, auto- MDSCs immune disease, cancer) Galectin-9 Mediates multiple pathways of immuno- Induces Treg cell suppression in tumors
Slide 46: LYT-200: Anti-Galectin-9 mAb program – examples of pre-clinical data
LYT-200: Anti-Galectin-9 mAb program – examples of pre-clinical data Patient derived samples used Galectin-9 expression increased in tumors Treatment reduced tumor volume with anti-Gal-9 mAb shows activity PBMC Normal PBMC Patient Tumor Infiltrate in pancreatic cancer mouse model % cells expressing
Slide 47: Planned Phase 1a/1b study design using LYT-200
Planned Phase 1a/1b study design using LYT-200 in patients with metastatic solid tumors Dose escalation and dose expansion study ** 2nd ClinicalClinical AdvisoryInvestigators Board held at ASCO 2019 Dose Finding (all comers), Safety, Tolerability, RP2D, PK/PD Filip Janku Osama Rahma Safety and effic
Slide 48: Immunosuppressive γδ1 T cells exert multiple pro-tumorigenic functions
Immunosuppressive γδ1 T cells exert multiple pro-tumorigenic functions Solid tumors (pancreatic, melanoma, glioblastoma, breast cancer etc.) harbor immunosuppressive and TUMOR PROGRESSION pro-tumorigenic γδ1 T cells Circulating immunosuppressive γδ1 T cells predict unfavorable response to anti- Pro-
Slide 49: LYT-210: Anti-Delta-1 mAb program preclinical data
LYT-210: Anti-Delta-1 mAb program- preclinical data supporting biological rationale for targeting gamma-delta-1 T cells Immunosuppressive γδ1 T cells are enriched in γδ1 T cells adopt a distinct effector memory pancreatic cancer tissue phenotype suggesting they are actively 80 immunosuppressive γδ T