NOVEMBER 2020 - PURETECH HEALTH
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November 2020
Important information
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are subject to various risks, uncertainties and assumptions that could
measures, as we believe these measures provide information that is Jumpstart Our Business Startup Act of 2012, as amended, and is
cause actual results to differ materially from those anticipated or implied
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in our forward-looking statements due to a number of factors including,
These non-IFRS financial measures do not have any standardized or institutions that are accredited investors (as such terms are defined
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other companies. For certain non-IFRS financial measures, there are no The Company’s business is subject to a number of risks and
directly comparable amounts under IFRS. These non-IFRS financial uncertainties. These risks are described in the Company’s most recent References in the following presentation to our “Controlled Founded
measures should not be viewed as alternatives to measures of financial Annual Report and Accounts which can found on the Company’s web Entities” refer to Alivio Therapeutics, Inc., Follica, Incorporated, Entrega,
performance determined in accordance with IFRS. site at https://www.puretechhealth.com/reports-presentations and in the Inc., Vedanta Biosciences, Inc., and Sonde Health, Inc. References to
Company's Registration Statement on Form 20-F, as amended, which our “Non-Controlled Founded Entities” refer to Akili Interactive Labs,
This document and the Presentation contain statements that are or may
was declared effective by the Securities and Exchange Commission on Inc., Karuna Therapeutics, Inc., Vor Biopharma, Inc., Gelesis, Inc., and,
be forward-looking statements. These statements are based on our
November 12, 2020. for all periods prior to December 18, 2019, resTORbio, Inc.
management’s current beliefs, expectations and assumptions about
future events, conditions and results, and on information currently
2
PureTech team has a track record of outperforming
Daphne Zohar Bharatt Chowrira, PhD, JD Eric Elenko, PhD
Founder & Chief Executive Officer President & Chief of Business & Strategy Co-founder & Chief Innovation Officer
Built team, scientific network & pipeline; Recognized as a top leader in Former COO Auspex (acq by Teva $3.5B), Nektar ($3B+ Co-inventor of KarXT & other PureTech programs;
biotech by EY, Scientific American, BioWorld & others; Board Member MC), GC SIRNA (acq by Merck $1.1B) McKinsey, UCSD
Joseph Bolen, PhD Joep Muijrers, PhD Stephen Muniz, Esq
Chief Scientific Officer Chief of Portfolio Strategy Co-founder & Chief Operating Officer
Former CSO Millennium (acq. by Takeda $8.8B), Moderna, Former Portfolio Manager at Life Sciences Partners, a leading Former Partner Locke Lorde; Board Member
TA Head Oncology BMS European biotech investor group
Oversaw R&D of products supporting 23 regulatory approvals
Were in C-suite of companies acquired for more than $13B in aggregate 3
World class board of directors and R&D committee
Harvard, Co-Founder of
Former CEO & Board Millennium (acq. by
Member at Sanofi, Takeda $8.8B) &
Former President & Abgenix (acq. by Former President of
Christopher Viehbacher Board Member at GSK Raju Kucherlapati, PhD Amgen $2.2B) John LaMattina, PhD Pfizer Global R&D
Board Chairman Board and R&D Committee Board and R&D Committee
MIT, Award winning
materials science
pioneer, Former
member of the United
States FDA’s SCIENCE Former CEO Pearson,
Board, was awarded Former MacArthur
the Queen Elizabeth Foundation Chair, Founder &
Robert Langer, ScD Prize for Engineering Dame Marjorie Scardino Former Twitter Board Kiran Mazumdar-Shaw Chairperson, Biocon
Board and R&D Committee Board Board
Director of CATCH at
MIT, HHMI, Nobel MGH/MIT, Professor at
Prize in Medicine, HMS, Former Chief of
Scientific Advisory Medicine at MGH,
Board at Mitobridge & Former EVP of Board Director Alnylam,
Robert Horvitz, PhD MPM Capital Ben Shapiro, MD Research at Merck Dennis Ausiello, MD Former Pfizer Board
R&D Committee Chair and Board Advisor R&D Committee and Board Advisor R&D Committee and Board Advisor
Our board and R&D committee contributed to regulatory approvals of approximately 30 drugs,
led multiple multi-billion dollar strategic transactions, and co-founded multiple companies4
Track record of outpacing industry averages
PureTech has demonstrated a strong track record of clinical advancement;
Particularly notable in the stages where industry failures are typically high
24 products and Percent of clinical trials where outcome supports progression to next phase of clinical development:
product candidates
83%
Phase 1
of which: 63%
12 are clinical stage
Phase 2
90%
31%
and:
67%
2 Phase 3
58%
were taken from inception to
FDA & European 50%
Regulatory Clearances Phase 1, 2, & 31
11%
PureTech2 Industry Average 3
1 The cumulative percentages are calculated by multiplying the individual phase percentages listed above; 2 Percentages include all clinical trials advanced through at least Phase 1 by PureTech or its Founded Entities from
2009 onward, and not all product candidates were investigated in a Phase 1 clinical trial; Phase 1 (n = 5/6), Phase 2 (n = 9/10), Phase 3 (n = 2/3); Figures include Akili and Gelesis which are regulated as medical devices;
3 Industry average data measures the probability of clinical trial success of therapeutics by calculating the number of programs progressing to the next phase vs. the number progressing and suspended. BIO,
5
Biomedtracker, Amplion (2015) Clinical Development Success Rates 2006 – 2015. This study did not include therapeutics regulated as devices.
A unique collaborative research & development model for advancing new medicines
Disease focused drug discovery based on proprietary insights and
collaboration with the world’s leading experts on Brain, Immune, Gut
The Brain-Immune-Gut (BIG) Axis: ~70% of immune cells and 500M neurons converge in the GI tract
6
Existing value & near-term upside
Founded Entities1 Wholly Owned Pipeline
OUR PROGRAMS Discovery Preclinical Phase 1 Phase 2 Phase 3
LYT-100 Lymphatic flow disorders, incl. Initiation of Phase 2a POC study in
Deupirfenidone lymphedema H2 2020
LYT-100 Long COVID3 respiratory Initiation of Phase 2 study in
Deupirfenidone complications & related sequelae H2 2020
LYT-100 Other fibrotic & inflammatory
Deupirfenidone disorders, such as IPF
(KRTX) LYT-200
78.3% Equity 21.0% Equity FDA Cleared, Anti-Galectin-9 Solid tumors IND and initiation of Phase 1 study in 2020
12.7% Equity Phase 3 Ready Phase 3 Ready mAb
plus Royalties plus Royalties CE Mark
plus Royalties LYT-210
Anti-Delta-1 mAb Solid tumors
Schizophrenia (~2.7M) Androgenetic alopecia (~90M) Overweight and obesity (~150M)
LYT-300
Oral Neurological
Completed
Allopregnanolone indications In progress
Discovery • GlyphTM Technology Platform (Lymphatic Targeting)
Programs: • OrasomeTM Technology Platform (Oral Biotherapeutics)
• Meningeal Lymphatics Platform
Cash at PureTech Parent Level
50.4% Equity Phase 2 78.6% Equity Preclinical 45.8% Equity Phase 1
High-risk CDI (100-120K/year) Interstitial cystitis/bladder pain (~4 – 12M) Respiratory risk detection and monitoring
$387.2M Cash Equivalents and Short-Term
Investments at PureTech Parent Level as of
September 30, 20204
FDA Cleared,
72.9% Equity Preclinical 34.0% Equity 11.8% Equity Preclinical
CE Mark
Oral delivery of drugs Pediatric ADHD (~6.4M) Acute myeloid leukemia (~60K)
Approximately $1B Raised with Top-Tier Investors in Founded Entities since January 20172
1This figure represents the stage of development for each Founded Entity’s most advanced product candidate. While PureTech maintains ownership of equity interests in its Founded Entities, the Company does not, in all cases, maintain control over these entities (by virtue of (i) majority voting control and (ii) the
right to elect representation to the entities’ board of directors) or direct the management and development efforts for these entities. Consequently, not all such entities are consolidated in the financial statements. Where PureTech maintains control, the entity is referred to as a Controlled Founded Entity in this report
and is consolidated in the financial statements. Where PureTech does not maintain control, the entity is referred to as a Non-Controlled Founded Entity in this report and is not consolidated in the financial statements. As of June 30, 2020, Controlled Founded Entities include Alivio Therapeutics, Inc., Follica,
Incorporated, Entrega, Inc., Vedanta Biosciences, Inc. and Sonde Health, Inc., and Non-Controlled Founded Entities include Akili Interactive Labs, Inc., Gelesis, Inc., Karuna Therapeutics, Inc., and Vor Biopharma Inc. Relevant ownership interests for Founded Entities were calculated on a diluted basis (as
opposed to a voting basis) as of June 30, 2020, including outstanding shares, options and warrants, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. Ownership of Vor is based on the assumption that all future tranches of the most recent financing round are funded.
Karuna ownership is calculated on an outstanding voting share basis as of October 31, 2020. 2Funding figure includes private equity financings, public offerings or grant awards. Funding figure excludes upfront payments and future milestone considerations received in conjunction with partnerships and 7
collaborations such as those with Roche, Boehringer Ingelheim, Imbrium Therapeutics L.P., Shionogi & Co., Ltd. or Eli Lilly. Funding figure assumes all future tranches are funded in the Vor Series B financing round. Calculated as of January 1, 2017 to June 30, 2020. 3Long COVID is a term being used to describe
the emerging and persistent complications following the resolution of COVID-19 infection. 4PureTech Level Cash Reserves at September 30, 2020 represent cash balances and short-term investments held at PureTech Health LLC, PureTech Management, Inc., PureTech Health PLC, PureTech Securities
Corporation of $372.0 million and held at PureTech LYT Inc., our internal pipeline, of $15.2 million, all of which are wholly owned entities of PureTech, excluding cash balances and short-term investments of $38.3 million held at Controlled Founded Entities which are not wholly owned.
PureTech’s value components versus market capitalization
Relative Value of KRTX Stake Plus Cash to PureTech (PRTC) Market Cap1 Value Components of Other Assets
Akili (MDD cognitive FDA clearance & CE Mark for EndeavorRxTM Founded Entities3
Key PRTC impairment) and CE Mark for Plenity®
milestones: Follica (male AGA) Karuna & Follica positive FDA EOP2 meetings
$1,400
readouts Vedanta Ph1 readouts for IBD
($M)
KRTX Global COVID-
$1,200
Phase 2 clinical 19 sell-off
34.0% FDA Cleared, 21.0% Equity FDA Cleared, 78.3% Equity Phase 3
trial readout Equity CE Mark + Royalties CE Mark + Royalties Ready
$1,000
Implied
Value
$800 of Other
Assets
50.4% 78.6% 45.8%
Phase 2 Preclinical Phase 1
$600 Equity Equity Equity
Cash
$400
PRTC generates 12.7% equity of
$45.0M from $2.6B MC2
KRTX $250M 72.9% 11.8%
$200 post KRTX Preclinical Preclinical Phase 3
raise PRTC generates $200.9M KRTX equity sale Equity Equity Royalties
equity sale Ready
28.4% equity from KRTX equity sale 18.1% equity
post-sale generating
31.6% Equity post-raise 20.4% equity post-sale
$- $101.6M Wholly Owned Pipeline
LYT-100 LYT-200/210/300 Discovery Platforms
PRTC Market Cap
Phase 1 Preclinical Preclinical
PRTC Stake in KRTX
Source: FactSet market data as of November 16, 2020
1Includes cash and cash equivalents. 2As of November 16, 2020. 3This figure represents the stage of development for each Founded Entity’s most advanced product candidate. While PureTech maintains ownership of equity interests in its Founded Entities,
the Company does not, in all cases, maintain control over these entities (by virtue of (i) majority voting control and (ii) the right to elect representation to the entities’ board of directors) or direct the management and development efforts for these entities.
Consequently, not all such entities are consolidated in the financial statements. Where PureTech maintains control, the entity is referred to as a Controlled Founded Entity in this report and is consolidated in the financial statements. Where PureTech does not
maintain control, the entity is referred to as a Non-Controlled Founded Entity in this report and is not consolidated in the financial statements. As of June 30, 2020, Controlled Founded Entities include Alivio Therapeutics, Inc., Follica, Incorporated, Entrega,
Inc., Vedanta Biosciences, Inc. and Sonde Health, Inc., and Non-Controlled Founded Entities include Akili Interactive Labs, Inc., Gelesis, Inc., Karuna Therapeutics, Inc., and Vor Biopharma Inc. Relevant ownership interests for Founded Entities were 8
calculated on a diluted basis (as opposed to a voting basis) as of June 30, 2020, including outstanding shares, options and warrants, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. Ownership of Vor is based on
the assumption that all future tranches of the most recent financing round are funded. Karuna ownership is calculated on an outstanding voting share basis as of October 31, 2020.
Karuna (PRTC Ownership: 12.7% plus royalties*)
Selectively activating muscarinic acetylcholine receptors in the brain
Innovation Validation Value Realization
living with Built top team of CNS experts led by former Nasdaq IPO, Phase 2 data
~2.7M schizophrenia in the US Lilly executive Steven Paul, MD KarXT for treatment of acute psychosis in patients with
schizophrenia met the primary endpoint with a clinically
Current antipsychotics have significant Completed tolerability POC meaningful 11.6 point improvement on the PANSS total score
side effects and poor adherence compared to placebo (p
Vedanta (PRTC Ownership: 50.4%*)
Developing a new class of drugs to modulate the human microbiome
Upcoming Milestones and Value
Innovation Validation Realization
Rationally-defined consortia of gut bacteria; manufactured from pure Four clinical-stage
cell banks to produce drug product of known bacterial isolates; programs in development VE800
orally administered to modulate microbial communities and immune Results from first-in-
~60K
responses
VE303 (high-risk C. difficile)
demonstrated accelerated
gut microbiota restoration
2021
patient study in solid
tumors
100 leukemia
Acute myeloid – 120K patients in theTreated
US using antibiotics which
high-risk CDI cases per after antibiotics in a Phase VE416
damage the microbiome
year in the US 1a/1b study Results from Phase
VE202 (IBD) demonstrated 1/2 study for food
colonization after antibiotics allergies
IBD interventions limited by in two Phase 1 studies in
~3M toxicities and systemic VE303
IBD patients in the US healthy volunteers
immune suppression Results from Phase 2
VE800 (advanced or
2020 study in high-risk CDI
metastatic cancers) with
Allergen avoidance and
OPDIVO® (nivolumab); VE202
Results from Phase 1
~2.5M desensitization therapies
published in Nature
healthy subject
Living with peanut allergy in the US may not prove cost-effective VE416 (food allergy) being studies for IBD
evaluated in a Phase 1/2
study
>66K/year Strong IP portfolio
Metastatic and/or advanced MSS Checkpoint inhibitors are only
CRC, gastric, melanoma patients in effective in 20 – 30% of patients $71.1M in total Series C
the US
*As of June 30, 2020, PureTech’s percentage ownership of Vedanta Biosciences was approximately 50.4 percent on a diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued
pursuant to equity incentive plans. 10Wholly Owned Pipeline with multiple near-term catalysts
PureTech’s brings its successful track record with Founded Entities to build Wholly Owned Pipeline
Harnessing the lymphatic system & other immunological
mechanisms Overview of Wholly Owned Pipeline
OUR PROGRAMS Discovery Preclinical Phase 1 Phase 2 Phase 3
1
Maintaining balance of fluid LYT-100 Lymphatic flow disorders, incl. Initiation of Phase 2a POC study in
Deupirfenidone lymphedema H2 2020
Addressing disorders related
to lymphatic flow and LYT-100 Long COVID* respiratory Initiation of Phase 2 study in
lymphatic vessel restoration Deupirfenidone complications and related sequelae H2 2020
LYT-100 Other fibrotic & inflammatory
2
Deupirfenidone disorders, such as IPF
Driving therapeutics through
The mesenteric the lymphatics…
LYT-200
lymph nodes are Anti-Galectin-9 mAb
Solid tumors IND and initiation of Phase 1 study in 2020
…where immune cells are
the major interface programmed & traffic
between the gut and LYT-210
Solid tumors
immune system Anti-Delta-1 mAb
3
Immune modulation LYT-300
Oral Neurological
Completed
Allopregnanolone indications
Targeting galectin-9 and In progress
immunosuppressive γδ1 T
cells & with fully human mAbs
• GlyphTM Technology Platform (Lymphatic Targeting)
Discovery
• OrasomeTM Technology Platform (Oral Biotherapeutics)
Programs:
• Meningeal Lymphatics Platform
*Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection.
11LYT-100 (deupirfenidone) is designed to potentially overcome significant challenges
associated with pirfenidone, a successful anti-inflammatory and anti-fibrotic drug
LYT-100 discovery process Patients discontinue current standard of care for idiopathic pulmonary fibrosis (IPF)
A healthy lymphatic system Damaged lymphatics due to dose-limiting toxicity (DLT). Despite limitations, lack of viable alternatives
drains interstitial fluid fail to drain leads to significant continued revenues.
Esbriet WW Sales
1400
WW Sales ($M)
1200
1000
800
World’s leading lymphedema experts with proprietary 600
insights & unpublished data:
400
200
0
2014 2015 2016 2017 2018 2019 2020
Babak Mehrara Stanley Rockson
Memorial Sloan Kettering Stanford Medicine
Current IPF therapies Esbriet (pirfenidone) and Ofev (nintedanib) are efficacious but poorly
PureTech senior team member knowledge of LYT-100
clinical data & relationships (Auspex/Teva) tolerated with DLTs
12Pirfenidone is an efficacious drug for IPF and uILD, but its usage is limited by tolerability
Pirfenidone reduces proportion of patients with >10%
decline in forced vital capacity (FVC) or death in IPF1
Pirfenidone is associated with significant
tolerability issues
• In a single-dose (801 mg) study in healthy
older adults3:
– 44% experienced nausea
– 38% experienced dizziness
– 19% had a moderate adverse event
Pirfenidone reduces FVC decline based on site spirometry in – 6% had a severe adverse event
unclassifiable progressive fibrosing interstitial lung disease2
• Approximately 50% of patients taking
pirfenidone discontinue, dose adjust, or
switch therapies leading to suboptimal
disease management4
1 Noble, P., et al. European Respiratory Journal (2016) 47:243-253
2 ERS 2019: http://bit.ly/2lJ9WCC
3 Rubino, C. M., et al. Pulmonary pharmacology & therapeutics (2009)
4 Cottin, V., et al. ERJ Open Research (2018)
13LYT-100 potential clinical advantages with pirfenidone’s de-risked clinical profile
Pirfenidone LYT-100 | Deupirfenidone – new chemical entity
Short half-life and metabolic profile create limitations including: Differentiated PK profile provides potential advantages including:
Limited exposure Enhanced exposure
Tolerability issues Improved tolerability Deuteration modifies metabolism
but retains pharmacology
Dose-limited benefits Benefits not limited by dose
Frequent TID dosing & significant pill burden issues1 Less frequent dosing & reduced pill burden
No Composition of Matter Patent Issued Composition of Matter Patent - exclusivity up to 2033
Currently under Orphan Drug Exclusivity Potential for Orphan Drug Exclusivity for IPF and other orphan indications
Pirfenidone demonstrates therapeutic potential of an anti-inflammatory and anti-fibrotic agent
Pirfenidone approved for IPF and has breakthrough designation for Multiple late-stage and real-world efficacy studies in IPF, including
uILD >12 single-center studies2
Multiple preclinical models of fibrotic disorders of the lung, kidney, Proof-of-concept studies in FSGS, uILD, radiation-induced fibrosis,
liver, and other systems1 and other inflammatory and fibrotic diseases
19 large pills per day
2 Ruwanpura, S., et al. American Journal of Respiratory Cell and Molecular Biology (2020)
3 Gulati S., Luckhardt TR., Drug, Healthcare and Patient Safety (2020) 14LYT-100: Clinical data demonstrates favorable pharmacokinetics
Phase 1 single dose crossover study in 8000
LYT-100 (801 mg)
healthy volunteers (N=24):
Plasma concentration (ng/ml)
LYT-100 well-tolerated and favorable PK
6000 Pirfenidone (801 mg)
Mean %
Parameter
Improvement 4000
Half-Life (h) +13%
2000
Cmax (ng/mL) +25%
AUClast (ng*hr/mL) +35%
0
0 6 12 18 24
Time (h)
Potential for enhanced exposure & increased
anti-fibrotic and anti-inflammatory activity vs. pirfenidone
15LYT-100 Phase 1 multiple ascending dose and food effect studies demonstrate tolerability
and favorable pharmacokinetic profile
• Double-blind, randomized, multiple ascending dose study in
healthy volunteers at 100, 250, 500, 750* mg BID LYT-100 or Adverse LYT-100
Pooled All LYT-100
placebo Events †
1000 mg BID,
Placebo, N=10 cohorts, N=30
occurring in N=6
• LYT-100 well tolerated at all doses, including an additional >1 participant n (%) n (%)
n (%)
1000 mg BID cohort
• No severe adverse events and all treatment-related adverse
Nausea 0 0 3 (10.0%)
events were mild and transient with no discontinuations
• No dose response for any type of AE, and no maximum
tolerated dose was reached Abdominal
1 (10.0%) 0 2 (6.7%)
discomfort
• LYT-100 has reduced Cmax food effect – the increase in Cmax
with fasting was less than pirfenidone – and we intend to
Abdominal
explore the use of LYT-100 in future studies without regard to 0 0 3 (10.0%)
distension
when food is consumed
• Pharmacokinetics results and modeling suggest Headache 2 (20.0%) 2 (33.3%) 7 (23.3%)
LYT-100 can be given BID with similar exposure levels as
pirfenidone 801mg TID
LYT-100 was well-tolerated and has potential for BID dosing at exposure similar to pirfenidone
* Protocol originally specified 750 mg BID as maximum dose. 750 mg BID was well tolerated and a 1000 mg BID cohort was added;
† Adverse Events (AE) possibly or probably related to treatment; does not include AEs not related to treatment 16LYT-100 has potential to address a range of inflammatory and fibrotic conditions
Pulmonary complications Lymphatic system diseases Other fibrotic & inflammatory disorders
~130K ~1M >4.5K
in the United States in the United States in the United States
with IPF or uILD overall with lymphedema are diagnosed with FSGS/year
Secondary lymphedema occurs in breast
Idiopathic pulmonary fibrosis (IPF) cancer and other cancer patients2,
Unclassifiable interstitial lung including gynecological and head and Focal segmental glomerulosclerosis
disease (uILD); Long COVID1 respiratory neck cancer patients3,4 (FSGS); Radiation-induced fibrosis
complications and related sequelae Primary lymphedema includes rare, pediatric
lymphatic diseases
Clinical validation based on
Validation: Pirfenidone approved Validation: LYT-100 proprietary,
multiple investigator sponsored
worldwide preclinical POC
trials with pirfenidone
IPF registration-enabling studies being planned;
Phase 2 initiation in H2 2020 (Long COVID respiratory Phase 2a POC initiation in 2020 Evaluating future indications
complications and related sequelae)
1Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection. 2 Cormier et al., Cancer 2010;116(22):5138-49; 3 Hayes et al.,Gynecol Oncol. 2017;146(3):623-629; 4 Ridner et al.,
Lymphat Res Biol. 2016;14(4):198-205 17Common convergent mechanisms in interstitial lung diseases including COVID-19
Healthy lung Interstitial lung disease
Poorly
Triggers tolerated
treatments
Genetic risk
Viral infection
Environmental
exposure
Smoking
Unknown
Lack of early Need for
detection and multimodal
intervention mechanisms
Inflammation and fibrosis contribute to interstitial lung diseases including IPF and Long COVID1
1Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection. Image: https://doi.org/10.1038/nrdp.2017.74
18Enduring high unmet need in interstitial lung diseases including IPF
Progressive fibrosing ILDs
Estimated diagnosed prevalence of IPF in the
U.S., EU5, and Japan (2015-25E)1
160,000
140,000
iNSIP
Chronic
120,000 CTD-ILDs
fibrotic HP
g/f PF
100,000
patients
Japan
80,000
EU5
US
60,000 IPF
40,000
Sarcoidosis
20,000
uILD
0 Drug-
2015 2017 2019 2021 2023 2025
induced ILD Other ILDs
Major opportunity to improve care in IPF and address other interstitial lung diseases
1Chart; GlobalData Opportunity Analyzer Idiopathic Pulmonary Fibrosis Opportunity Analysis and Forecast
CTD: Connective Tissue Disease; g/f PF: Genetic and/or Familial Pulmonary Fibrosis; iNSIP: Idiopathic Non-specific Interstitial Pneumonia; IPAF: Interstitial Pneumonia with Autoimmune Features; HP: Hypersensitivity Pneumonitis; 19LYT-100’s target profile is valued by pulmonologists
PREFERENCE SHARES BY PRODUCT (% of New Patient Starts, Survey of 100 Pulmonologists)1
~$2.9B market2 Another Treatment OFEV Esbriet LYT-100
100%
80%
~30%
~45% ~45%
% IPF Patients
60% ~30%
~20%
40%
~50%
20% ~40% ~30%
0% ~5% ~5% ~5%
Current Market Profile X 3 Profile Y
Select quotes from survey Profile X Profile Y
“I would switch 100% of my Esbriet patients
(Safety/Tolerability (Safety/Tolerability &
assuming it has equal or better efficacy due to the Benefit) Efficacy Benefit)
side effect profile”
Reduction in frequency and severity of Reduction in frequency and severity of
side effects side effects
Comparable efficacy to pirfenidone Likely to have enhanced efficacy
“With [LYT-100], I don’t see a reason to use 5-20% discontinuation rate LYT-100: Long COVID1 respiratory complications and related sequelae
Rationale Trial Design
Multimodal mechanism of action LYT-100 showed anti-fibrotic and anti- Global, randomized, placebo-controlled trial
inflammatory activity will evaluate LYT-100 in non-critical COVID-19
patients with respiratory complications
120000 Control N = up to 168
Plasma TNFα concentration 90
100000
minutes of oral pretreatment,
80000 Pirfenidone 100mg/kg Primary outcome
pg/mL
60000 Pulmonary function testing
40000 LYT-100 at same
dose, 100mg/kg Secondary endpoints
20000
Safety and tolerability
0
LPS Model (Rodents), n=6-8 per group, 100mg/mL Pharmacokinetics
Acute inflammatory biomarkers
Pirfenidone mechanisms in
acute and chronic interstitial lung diseases Hospitalization events
High proportion of mild, moderate & severe Reduces pro-inflammatory cytokines: IL-6, TNF-α Imaging and patient reported outcomes
COVID-19 patients (up to 53%) show signs of
lung fibrosis at three weeks post symptom Suppresses TGF-β and downstream signaling
Topline results expected H2 2021
onset2
Tens of millions of people have been infected by COVID-19;
Data increasingly demonstrate the longer-term complications of COVID-19, yet the majority of therapeutics only target the acute phase
1 Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection
2 Li, K., Fang, Y., Li, W. et al. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol 30, 4407–4416 (2020). https://doi.org/10.1007/s00330-020-06817-6 21LYT-100 development plan overview
Completed Planning IPF studies 2020: Expected Phase 2a POC initiation in lymphedema
Acute toxicity Additional PK and higher dose studies planned Patient proof-of-concept and biomarker study in breast
cancer-related, upper limb secondary lymphedema
CMC and formulation work ongoing
ADME IPF registration-enabling studies and FDA Primary Endpoint
discussions being planned Safety and tolerability
CMC and cGMP
Secondary Endpoints
clinical supply H2 2020: Expected Phase 2 initiation
Bioimpedance spectroscopy
in Long COVID1
Tonometry (fibrosis)
In silico PK modeling LYT-100 for Long COVID respiratory
Serum inflammatory biomarkers
complications and related sequelae
Relative limb volume
Single dose crossover Primary Endpoint
Validated patient reported outcomes measuring:
study in healthy Pulmonary function testing
volunteers ‒ Physical functioning
Secondary Endpoints
Safety and tolerability ‒ Limb heaviness, pain and tightness
Preclinical validation Pharmacokinetics ‒ Quality of life impact
Acute inflammatory biomarkers
Imaging
Exploring for a range of lung dysfunction conditions,
Patient reported outcomes including uILDs
1 Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection.
22LYT-200: Targeting galectin-9, a fundamental immunosuppressor in cancer
Foundational biology: Mechanism of action:
Galectin-9 modulates multiple pathways of cancer immunosuppression
disabling immune mediated cancer attack
LYT-200 has potential single agent activity, as well as combination CD8
treatment potential with chemo- and immunotherapies Promotes
expansion of
MDSCs
Proof-of concept in preclinical models MDSCs
Galectin-9
Galectin-9 blockade:
Inhibits tumor growth and increases survival in pancreatic cancer Induces Treg cell
models (KPC) differentiation and
Inhibits tumor growth in standard melanoma model outperforming anti- stability Tumor
Treg
PD-1 treatment
Induces accumulation and activation of intra-tumoral cytotoxic T cells
Th1
Restores T cell activity in patient derived organoids
M2
M1
Induces apoptosis
Biomarker opportunity: of Th1 and
CD8+ T cells
Blood and tissue expression increased in multiple tumor types, CD8 Switching M1 to
M2 macrophage
correlating with worse survival
Image adapted from J Mol Biol; 428 (16): 3266-3281; 2016
Treg = T regulatory cell; MDSC = myeloid derived suppressor cell; M1/M2 = tumor associated macrophage (TAM)1 (immunoactive) and 2 (immunosuppressed) cell; Th1 = T helper1 cell 23LYT-200: Multiple lines of preclinical data supporting therapeutic potential
Note: For patient-derived organoids, n = 20 tumor samples; Success defined as: >20% upregulation of at least two out of three T cell activation markers; success
achieved in 60% of tumors with majority showing >2 fold activation
Single agent activity in KPC T cell activation with LYT-200 in patient- LYT-200 drug properties make it an
(pancreatic cancer) model derived organoid model excellent clinical clone:
A model where anti-PD1s do not work High affinity and specificity for galectin-9
800
Desired function: Blocking galectin-9
mediated immunosuppression
Robust activity in preclinical studies:
Tumor weight (mg)
600 – Single agent causes tumor reduction in
pancreatic and melanoma mouse
models
400
– Observed ~50% tumor reduction with
LYT-200 vs. ~22% tumor reduction
with anti-PD1 in melanoma model
200
– Increase in intra-tumoral CD8 T cells in
combination with anti-PD1
– Activation of intra-tumoral immunity in
patient-derived tumor models
n = 10 / arm
P < 0.01
24LYT-200: Planned Phase 1 study design in patients with metastatic solid tumors
Dose escalation and dose expansion study Clinical investigators
** 2nd Clinical Advisory Board held at ASCO 2019
Dose Finding (CRM)
(all comers), safety, tolerability, RP2D, PK/PD, exploratory
Filip Janku Osama Rahma
Safety and efficacy
Neil Segal Aparna Parikh
– with exploratory endpoints –
Pancreatic Cholangiocarcinoma Other amenable
Chemo combination Colorectal GI/non-GI indications
Manji Gulam Zev Wainberg
Further expansion aimed at enabling
accelerated approval single agent and/or combo Richard Carvajal
25…With multiple near-term value drivers expected
Product PureTech
Candidate Ownership* 2020 2021 2022
LYT-100 100% Results from Ph1 MAD & initiation of Ph2a POC in lymphedema Results from Ph2a POC in patients with breast cancer related lymph
Wholly Owned Pipeline
LYT-100 100% Initiation of Ph2 in Long COVID** respiratory complications & related sequelae Results from Ph2 in Long COVID respiratory complications & related sequelae
LYT-200 100% IND filing; Initiation of Ph1 in solid tumors Results from Ph1 study in solid tumors
LYT-210 100% Preclinical and biomarker studies Preclinical and biomarker studies
LYT-300 100% Initiation of first-in-human clinical studies
Discovery
100% Nomination of preclinical candidate(s) Results from non-human primate POC; Publishing key preclinical data
Programs Topline results from multiple
Plenity® 21.0% Targeted US commercial launch; European CE Mark granted Full US launch clinical studies
Entities with Royalty Interests
Non-Controlled Founded
GS100 21.0% Seeking FDA input for expanding Plenity label to treat adolescents
GS200 21.0% Results from Ph2 in patients with T2D and pre-diabetes
GS300 21.0% Initiation of Ph2 in NASH/NAFLD Additional strategic partnerships
GS500 21.0% Initiation of Ph3 in functional constipation
KarXT 12.7% End-of-Ph2 meeting, Initiation of first Ph 3 Initiations of second Ph3 & open-label, long-term safety study
FOL-004 78.3% End-of-Ph2 meeting Initiation of Ph3 program in AGA
New clinical candidate selections
VE303 50.4% Results from Ph2 in high-risk CDI
Controlled Founded Entities
VE416 50.4% Results from Ph1/2 for food allergy
VE202 50.4% Results from Ph1 healthy subject studies for IBD Initiation of Ph2 in IBD
VE800 50.4% Results from first-in-patient clinical trial in solid tumors Progress of discovery/preclinical
Sonde One programs
(Respiratory) 45.8% Launched Sonde One for Respiratory
ALV-107 78.6% IND filing
ENT-100 72.9% Continued advancement of platform
EndeavorRxTM 34.0% FDA cleared & European CE Mark granted in pediatric ADHD
Limited to
Founded
Interest
Entities
Equity
VOR33 11.8% Pre-IND meeting with the FDA Initiation of Ph1 in acute myeloid leukemia
Potential financings & strategic transactions across Founded Entities
Product candidate related to the Brain
Product candidate related to the Immune system *Relevant ownership interests for Founded Entities were calculated on a diluted basis (as opposed to a voting basis) as of June 30, 2020, including outstanding shares, options and warrants,
Product candidate related to the Gut but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. Ownership of Vor is based on the assumption that all future tranches of the most recent financing
round are funded. Karuna ownership is calculated on an outstanding voting share basis as of October 31, 2020. **Long COVID is a term being used to describe the emerging and persistent
B Key milestones are bolded
complications following the resolution of COVID-19 infection. 26
indicates completed milestone
Indicates partially completed milestoneProgression of PureTech going forward
Advance Wholly Owned Pipeline through development and commercialization, including pipeline expansion
OUR PROGRAMS Discovery Preclinical Phase 1 Phase 2 Phase 3
LYT-100
Lymphatic flow disorders, incl. lymphedema
Deupirfenidone
Drive product candidates
LYT-100
Deupirfenidone
Long COVID1 respiratory complications and related sequelae forward through clinical
development & potential
LYT-100 Other fibrotic & inflammatory disorders, such as IPF
commercialization
Deupirfenidone
LYT-200
Solid tumors
Pipeline growth
Anti-Galectin-9 mAb
and expansion
LYT-210
Solid tumors
Anti-Delta-1 mAb Partner/spin out
non-core applications
LYT-300 Completed
Oral Neurological indications
Allopregnanolone In progress
Derive value from equity growth of Founded Entities
27
1Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infectionNasdaq Global Market & LSE Main Headquartered in Seaport, Boston
Market / FTSE-indexed: PRTC ~33%
Board & Management
Market capitalization $1.05B (£797.23M) as ~56% Disclosed Shareholders
of November 16, 2020; 1.32 USD:GBP Analyst Coverage
~10%
Other Shareholders
Piper Sandler & Co. Peel Hunt LLP
285,743,794 outstanding shares as of
September 30, 2020 Edward A. Tenthoff Peter Welford
Disclosed Shareholders as of September 30,
Peel Hunt LLP Liberum 2020 include Invesco Asset Management
Limited, Baillie Gifford & Co., Lansdowne
$387.2M Cash Equivalents and Short- Amy Walker Alistair Campbell Partners LLP, Miller Value Partners,
Term Investments at PureTech Parent Recordati S.p.A. Pharmaceutical Company,
Level as of September 30, 20201 M&G Investment Management, LTD.
1PureTech Level Cash Reserves at September 30, 2020 represent cash balances and short-term investments held at PureTech Health LLC, PureTech Management, Inc., PureTech Health PLC,
PureTech Securities Corporation of $372.0 million and held at PureTech LYT Inc., our internal pipeline, of $15.2 million, all of which are wholly owned entities of PureTech, excluding cash balances
and short-term investments of $38.3 million held at Controlled Founded Entities which are not wholly owned. 28Q&A
PureTech has a successful model for bringing breakthrough medicines to patients…
Boundless Unbiased Scientific Value
INNOVATION VALIDATION REALIZATION
Collaborate with world’s Rigorous and disciplined Develop internally, partner,
leading domain experts approach to develop, de- or advance through
on disease-specific risk and validate the subsidiary – monetization
discovery theme through candidates in a cost- through strategic or equity
the lens of BIG AxisTM effective way transactions
biology
Capital efficient approach generates substantial capital to support focused development
30…With a history of execution & validation since IPO
JUN 2015 DEC 2016 SEP 2017
PureTech London Successful Karuna Successful Gelesis pivotal
IPO proof-of-concept study study for weight loss
DEC 2019 JAN 2020 JAN – MAY 2020
Gelesis commercial Successful Akili study PureTech generated
DEC 2017 partnership with Ro for in ADHD with and $245M from equity
Successful Akili pivotal study US launch of Plenity without stimulants sales1
for pediatric ADHD DEC 2019
Successful Akili study DEC 2019 MAR 2020 JUN 2020
in MDD cognitive Successful Follica PureTech FDA clearance and
JAN 2019 impairment study in male initiated LYT-100
Vedanta seminal IO androgenetic alopecia Phase 1 MAD CE Mark for Akili's
research published study EndeavorRxTM
in Nature APR 2019 JUN 2020
FDA clearance of JUN 2019
Karuna
NOV 2019 CE Mark for
Gelesis’ Plenity®
Nasdaq IPO Successful Karuna Gelesis' Plenity
Phase 2 trial for
schizophrenia JUN 2020
Karuna completed successful
end-of-Phase 2 meeting with FDA JUN 2020
Follica positive end-of-Phase 2 meeting with FDA
Proven track record of value creation, JUN 2020
Two successful Vedanta Phase 1 studies for IBD
credibility and transparency
AUG 2020
PureTech generated $101.6M
from equity sales2
SEP 2020
PureTech plans US listing on Nasdaq Global Market
1$200.9 million in proceeds from the January 22, 2020 sale of 2.1 million Karuna common shares and $45.0 million in proceeds from the May 25, 2020 sale of 555.5 thousand Karuna common shares. 2$101.6 million in proceeds from the August 26, 2020 sale
of 1.3 million Karuna common shares. 31Appendix A: Wholly Owned Pipeline
32Lymphedema: A chronic progressive disease with no FDA approved therapies
~1M individuals in the US A progressive disease with
disability, disfigurement, and
have lymphedema risks of serious comorbidities1
including
~500K breast cancer
survivors with secondary
lymphedema
Current treatment options
include compression, physical
~20% of all new breast therapy, and surgery
cancer patients who undergo (liposuction, lymphovenous
surgery2 transplant)
1 Patient image: “A comprehensive overview on the surgical management of secondary lymphedema of the upper and lower extremities related to prior oncologic therapies; Figure 1” by Garza et al., 2017 is licensed under CC BY 4.0. 2. DiSipio et al., 2013,
Lancet Oncology 33Injury to the lymphatics blocks fluid flow and creates inflammation and fibrosis
HEALTHY ARM LYMPHEDEMATOUS ARM
Surgery and
radiation damage
Normal lymphatics drain Damaged lymphatics lymphatics
fluid from tissue create blocked flow
Fluid pumped from arm Fluid accumulates, causing
Healthy arm through lymphatic vessels inflammation and fibrosis Lymphedema
fluorescent fluorescent
tracer image tracer image
Patient images: Kataru et al., 2019, Translational Res.
34Lymphedema: A feedback loop between inflammation and fibrosis
A healthy lymphatic system Damaged lymphatics
drains interstitial fluid fail to drain
Immune cell infiltration in Fibrosis in arm tissue impairs
arm promotes fibrosis2 flow and blocks regeneration3
Control
Lymphedema
Healthy lymphatics maintain
fluid homeostasis1
CD45 stain TGF-β stain
1 Rockson et al., 2019, Nat Rev Dis Primer
2 Gousopolos et al., 2016, JCI Insight – CD-45 stain
3 Avraham et al., 2010; Am J Pathology – TGF-β stain 35Preclinical model mimics human pathophysiology and tissue changes
A healthy lymphatic system Damaged lymphatics
drains interstitial fluid fail to drain
Mouse tail lymphatics Lymphatic damage blocks flow1
40
pLYT-100: Once-daily treatment reduced swelling in preclinical models
Mouse lymphedema model: ablation 120 Treatment
Control begins
Change in tail volume, %
of tail lymphatics results in chronic 100 LYT-100
tail swelling, inflammation and
fibrosis 80
60
LYT-100
control
40
2 wks 4 wks
WT WT 20
0
Tail Systemic treatment
surgery (Q.D. oral gavage; 400 mg/kg/d) 0 1 2 3 4 5 6
Time in weeks
Drug started at 2 weeks
post-surgery 2 weeks 2 weeks
N=7: LYT-100
6 weeks
N=7: control carboxymethycellulose (CMC)
6 weeks
Control LYT-100
37LYT-100: Designed to address underlying mechanisms of lymphedema
Preclinical plasma concentrations of TNFα with LYT-100 In vitro reduction of TGF-β induced soluble collagen
versus control production (mouse fibroblasts)
LYT-100
reduced
TGF-β
induced
fibrosis
36%
reduction
38Long COVID1 respiratory complications and related sequelae
Serious post-acute respiratory complications are an emerging issue for those who survive
Recent publications suggest a high proportion of mild, moderate and
severe COVID-19 patients show signs of lung fibrosis at three weeks
post symptom onset
In SARS, patients can develop persistent pulmonary fibrosis2 and up
to 1/3 of SARS and MERS patients have pulmonary fibrosis after
recovery3
Many interstitial lung diseases (ILDs) are characterized by
inflammation and fibrosis, which can result in impaired lung function
and progressive pulmonary fibrosis
Clinical trials in the post-acute setting are important as millions of people have been infected by COVID-19
1 Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection.
2 Xie, L. Chest Journal. June 2005.
3 Das, K. Indian Journal of Radiology and Imaging. Vol. 27 2017. 39LYT-100: Focal segmental glomerulosclerosis (FSGS)
Segmental
lesion in
FSGS
Rare, progressive fibrotic No specific treatments Clinical proof of concept with LYT-100 has favorable PK
kidney disease that can designed to reduce fibrosis pirfenidone in FSGS demonstrated over pirfenidone which
lead to kidney failure and and inflammation in study conducted by NIH enables lower dosing and
dialysis1 (N=21)2: potentially improved safety
Current treatment with
>4,500 individuals immunosuppression is – 25% median improvement in
develop FSGS every symptomatic and often the rate of decline of
year in the US ineffective in preventing glomerular filtration rate
relapse and progression to – Projected renal survival
end-stage renal disease prolonged by ~55%
1Sim et al., 2016, Am J Kidney Dis
2Cho et al., 2007, CJASN
Image: (L) Chiang & Inagi, 2010, Nat Rev Nephrol; (R) Stokes et al., 2006, Kidney International 40LYT-210: Monoclonal antibody aimed at immunosuppressive γδ1 T cells
Immunosuppressive γδ1 T cells
TUMOR PROGRESSION
Solid tumors harbor immunosuppressive
γδ1 T cells that correlate with tumor
aggressiveness / lower rate survival
Works through multiple pathways to cause
immunosuppression in the tumor micro-
environment
Restrict and suppress
cytotoxic αβ T cell activity
Restrict cytotoxic γδ T
LYT-210 is a fully human monoclonal IgG1 cells activity
Immunosuppressive cytokine
antibody (cross reacts with monkey) production (exp. IL17)
Inhibit maturation and antigen Chemoattract MDSCs,
presentation of DCs TAMs neutrophils
Pro-tumor γδ1 T cells
Image adapted from CellPress: REVIEW: γδ T Cells: Unexpected Regulators of Cancer Development and Progression.
DC = dendritic cell; TAM = tumour associated macrophage; MDSC = myeloid derived suppressor cell; IL17 = interleukin 17 41LYT-210: Multiple lines of preclinical data supporting therapeutic potential
Single agent activity in KPC LYT-210 candidate clone has excellent
T cell activation with an anti-δ1 mAb in
(pancreatic cancer) model drug properties:
patient-derived organoid model
(Published in Cell)
Colorectal cancer High affinity and specificity/ selectivity for
pathogenic γδ1 T cells
Species cross reactivity to enable IND
tox
Desired function: Inducing ADCC/ADCP
and activating suppressed effector T
cells in patient-derived tumor models
Proof of principle in animal models:
Colorectal cancer liver metastases – Targeting immunosuppressive γδT
cells significantly prolongs survival in
a KPC model
n = 10 / arm – Targeting immunosuppressive γδT
P =0.009 cells synergizes with checkpoint
inhibitors in melanoma and lung
cancer models
Note: For patient-derived organoids: Analyzed n = 19 tumor samples; success defined as: >20% upregulation of at least two out of three T cell activation markers; Success achieved in 63% of tumors with majority showing >2-fold activation
Cell. 2016 Sep 8;166(6):1485-1499; * Tool antibody that blocks mouse immunosuppressive γδ T cells 42LYT-300: Oral allopregnanolone for a range of neurological disorders
Despite FDA approval, 60-hr IV infusion
has greatly limited Zulresso usage
IV (60 hr infusion)
Oral administration can enable usage across
a range of neurological conditions
Rationale
Allopregnanolone Dog/NHP pilot PK studies show robust systemic
IV formulation FDA exposure
Approved LYT-300 Dose proportionality demonstrated (rat and dog)
Lymphatic transport increases in higher species1
Lipophilicity enables efficient loading (>30% total
capsule weight)
Validation of therapeutic levels in human plasma will
Oral administration
guide CNS indication selection
FIH2 studies planned for 2021
1Trevaskis, N. L. et al. Front. Physiol. 11, 1–11 (2020).
2First in human 43Additional programs in Wholly Owned Pipeline
Three discovery programs designed to harness the lymphatic system
Platform Application/Focus
Employs the body’s natural lipid absorption and transport process to orally
GlyphTM
administer drugs via the lymphatic system by bypassing first-pass
Technology Platform
metabolism
Enables oral administration of macromolecule therapeutic payloads to
OrasomeTM
potentially allow the body to produce its own therapeutic proteins that are
Technology Platform
otherwise administered exclusively by injection
Gut-Immune
Discovery Research Application/Focus
Aims to correct lymphatic dysfunction in the brain by targeting specific cell
Meningeal Lymphatics
types to potentially improve outcomes for a range of neurodegenerative and
Platform
neuroinflammatory conditions that are currently not effectively treated
Brain-Immune
44PureTech is well-positioned to unleash the potential of oral biotherapeutics
Limitations of protein-based therapeutics Potential advantages of the OrasomeTM technology
– Intravenous or subcutaneous administration platform:
– infusion reactions, barrier for repeat dosing
– Lengthy scale-up timeline + Orally administered (flexible repeat dosing)
Limitations of mRNA-based therapeutics and vaccines + Body manufactures the therapeutic proteins
– Intravenous, intramuscular or subcutaneous + Very low immune and cell toxicity
administration (protein synthesis in GI tract)
– infusion reactions, co-medications needed for dosing, + Low dose requirement for protein production
very limited repeat dose options
– Formulation-based immune and cellular toxicities
(protein synthesis by liver hepatocytes)
– High dose requirement for protein production
*Grand View Research, 2017, Biologics Market Analysis By Source (Microbial, Mammalian), By Products (Monoclonal Antibodies, Vaccines, Recombinant Proteins, Antisense, RNAi), By Disease Category, By Manufacturing, & Segment Forecasts, 2018 –
2025. 45Glyph Technology Platform: Harnessing the natural lipid-trafficking pathways to transport
drugs via the lymphatics
Traditional Small Molecules Lymphatic Trafficking Prodrugs
Subject to first-pass metabolism Bypasses first-pass metabolism
46Glyph Technology Platform: Designed to utilize natural lipid transport system to enable
lymphatic targeting
Lipid prodrugs provide multiple opportunities to enhance
small molecule drugs
A
A Transport to
mesenteric lymph
nodes
B
Enable oral route via
B
first-pass bypass
Trevaskis, N. L., et al. Nat. Rev. Drug Discov. 14, 781–803 (2015).
47Glyph Technology Platform: Exploring therapeutic approaches enabled by trafficking via
the lymphatic system
Lipid prodrugs provide multiple opportunities to enhance small
molecule drug distribution
A
Immuno-oncology Immunomodulation
A Transport to
mesenteric
lymph nodes
Metabolic/GI-Lymphatic
Neurosteroids
B
Enable oral route Allopregnanolone (LYT-300)
B via first-pass Oncology
bypass
Antivirals/Antifungals
Category
Legend: Example
48Appendix B: Founded Entities
49Gelesis (PRTC Ownership: 21.0% plus royalties*)
FDA cleared for the broadest patient population of any weight management product
Innovation Validation Value Realization
individuals in the US with Proprietary approach to potentially alter the FDA Clearance & European CE Mark
~150M overweight and obesity course of chronic diseases FDA cleared Plenity®1 for the broadest patient population of any
within Plenity’s label weight management product (BMI 25-40 kg/m2)
Planned and completed POC studies
Existing prescribed therapeutics for obesity Successful phase 3 pivotal trial (59% lost average of 10% of
Planned Phase 2 study
have potential for serious safety concerns their weight (22 pounds) over 6 months)
Launching with both primary care and telemedicine (Ro
Advised by world’s leading experts: collaboration)
Identified and in-licensed the core IP Partnership for commercialization in China ($35M up front; future
from collaborator and biomaterials milestones up to $388M plus royalties)
leader Alessandro Sannino, PhD Developing therapeutics to target chronic diseases such as NASH/
NAFLD, Mucositis/IBD, functional constipation
Upcoming Milestones
Full US launch of Plenity in 2021
Results from GS200 Phase 2 in weight management & glycemic
control in prediabetes & T2D in 2021
Initiation of GS500 Phase 3 study in functional constipation in 2020
Co-invented additional key IP around
Plan to seek FDA input on requirements for expanding Plenity label
a novel class of biocompatible,
to treat adolescents
superabsorbent hydrogels
Initiation of GS300 Phase 2 study in NASH/NAFLD in 2020
*As of June 30, 2020, PureTech’s percentage ownership of Gelesis was approximately 21.0 percent on a diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued pursuant to
equity incentive plans and assumes all committed tranches are funded in the Series 3 Growth financing round. PureTech has a right to royalty payments as a percentage of net sales from Gelesis.; 1Important Safety Information: Plenity is contraindicated in
patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide. Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully. Avoid use in patients with the
following conditions: esophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); or complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility. Use with 50
caution in patients with active GI conditions such as gastro-esophageal reflux disease (GERD), ulcers or heartburn. The overall incidence of adverse events (AEs) in the Plenity group was no different than the placebo group. The most common side effects
were diarrhea, distended abdomen, infrequent bowel movements, and flatulence. For the safe and proper use of Plenity, refer to U.S. Instructions for Use or the EU Instructions for Use.You can also read
