TIDMPRTC
RNS Number : 3301F
PureTech Health PLC
20 February 2018
20 February 2018
PureTech Health plc
Trading Statement
PureTech Health plc ("PureTech Health," "PureTech" or the
"Company," LSE: PRTC), comprised of PureTech Health plc and its
subsidiaries (together, the "Group"), an advanced, clinical-stage
biopharmaceutical company, today issued the following trading
statement for the financial year ended 31 December 2017.
Daphne Zohar, Co-founder and Chief Executive Officer of PureTech
Health, commented:
"We have had an exciting and productive year at PureTech Health,
including positive clinical results from two pivotal stage
affiliates that are now filing for FDA approval. It is both
inspiring and humbling to have brought these programmes from
academic discovery to the verge of potential commercial launch
where they could have a huge impact on people's lives. We look
forward to building on these successes and to delivering results to
our shareholders from the many valuable components of our pipeline.
We are also extremely pleased with the recent IPO of our affiliate,
resTORbio which is now valued at over $538 million (as of 19
February 2018) on NASDAQ and expects to announce Phase 2b clinical
trial results for its lead indication later this year. This is a
clear demonstration of the value which can be achieved from our
pipeline. We believe that PureTech Health is on the cusp of major
value inflection points across multiple affiliates as well as
through our next wave of internally-funded immunology-focused
programmes."
Operational Highlights
During 2017, the Group continued to make significant progress
across its advanced pipeline of seven clinical and seven
preclinical programmes focused on the crosstalk and biological
processes associated with the brain-immune-gut (BIG) axis. During
2017, PureTech Health reported positive clinical results from two
pivotal stage affiliates, Akili and Gelesis, and anticipates
regulatory filings from both affiliates with the U.S. Food and Drug
Administration (FDA) in the first half of 2018:
-- Akili Interactive Labs, an affiliate of PureTech Health
developing prescription digital medicines, achieved the primary
endpoint in a pivotal study of an investigational digital medicine
for paediatric ADHD. AKL-T01, the lead investigational digital
medicine from the Project:EVO(TM) platform, successfully showed a
statistically significant improvement compared to an active control
(p=0.006) on the predefined primary endpoint, a composite score
from the Test of Variables of Attention (T.O.V.A.(R)), an objective
measure of sustained attention and inhibitory control. Akili is
advancing a broad pipeline of programmes to treat cognitive
deficiency and improve symptoms associated with medical conditions
across neurology and psychiatry, including
attention-deficit/hyperactivity disorder (ADHD), cognition in major
depressive disorder (MDD), autism spectrum disorder (ASD),
Parkinson's disease, multiple sclerosis (MS) and various
neuroinflammatory diseases. Akili is also developing complementary
and integrated clinical monitors and measurement-based care
applications; and
-- Gelesis, an affiliate of PureTech Health developing
first-in-class mechanotherapeutics to treat chronic diseases
related to the gastrointestinal (GI) pathway, achieved significant
weight loss with an excellent safety profile in its pivotal Gelesis
Loss of Weight (GLOW) clinical trial with Gelesis100. The study
achieved and exceeded one of two co-primary endpoints, with 58% of
adults in the Gelesis100 treatment arm achieving 5% or more weight
loss. The percentage of patients who achieved 5% or more weight
loss was statistically significant compared to placebo (p=0.0028).
Additionally, almost twice as many adults on Gelesis100 lost 10% or
more of their body weight compared to the placebo group (p=0.027).
Gelesis' second product candidate, Gelesis200, created from the
same proprietary technology as Gelesis100, is optimised to induce
weight loss and improve glycaemic control in people with type 2
diabetes. Having completed a first-in-man study demonstrating
positive efficacy and safety results, Gelesis has initiated a
six-month efficacy proof-of-concept study (LIGHT-UP) in people with
prediabetes or untreated diabetes, with results expected this year.
Gelesis is advancing a broad pipeline of programmes using its novel
and tuneable orally administered hydrogel platform for the
treatment of other obesity-related co-morbidities, including liver
diseases such as non-alcoholic steatohepatitis (NASH) and
non-alcoholic fatty liver disease (NAFLD), along with GI disorders
such as inflammatory bowel disease (IBD) and intestinal
mucositis.
PureTech's other affiliates continued to advance innovative
candidates through clinical development:
-- resTORbio (NASDAQ: TORC), an affiliate of PureTech Health focused on the development and commercialisation of novel therapeutics for the treatment of aging-related diseases, advanced its RTB101 and RTB101/RAD001 candidates for the selective inhibition of the target of rapamycin complex 1 (TORC1) pathway into a Phase 2b clinical study in respiratory tract infections in the elderly. The study, which is expected to read out in the second half of 2018, will evaluate the effectiveness of RTB101 alone or in combination with RAD001 in reducing the incidence of respiratory tract infections (RTIs) in elderly patients at increased risk of morbidity and mortality related to RTIs. RTB101 and RAD001 (along with more than 75 issued patents) were in-licensed from Novartis in March 2017 for aging-related indications. These proprietary and selective mTORC1 inhibitors have potential broad application to conditions associated with aging, including immunosenescence (aging of the immune system), neurodegenerative diseases, and organ dysfunction;
-- Vedanta Biosciences, an affiliate of PureTech Health
developing a new category of therapies for immune-mediated and
infectious diseases based on rationally-defined consortium of human
microbiome-derived bacteria, initiated a Phase 1a/1b clinical trial
of VE303, its lead, orally-administered, product candidate. VE303
is the first known investigational drug consisting of
rationally-defined bacterial consortium in powder form to enter the
clinic and is being evaluated for the treatment of recurrent C.
difficile infection (rCDI). Key in-house manufacturing milestones
have also been achieved, which places a Phase 2 study of VE303 on
track to start in 2018. Additionally, the collaboration with
Janssen Biotech, Inc. on VE202 for inflammatory bowel disease
continues and is anticipated to enter the clinic in the second half
of 2018. Vedanta Biosciences is also working in collaboration with
leading oncology researchers around the world, to gather data from
interventional human clinical studies of checkpoint inhibitors for
its immuno-oncology platform. In collaboration with its cofounder,
Dr Kenya Honda, Vedanta Biosciences is advancing a candidate
consisting of a rationally-defined bacterial consortium that
potentiates cytotoxic CD8+ T-cells, which are key modulators of
checkpoint therapy responses. Vedanta Biosciences intends to file
an IND for that immuno-oncology candidate in 2018. Vedanta
Biosciences is also planning for the initiation of a Phase 1
clinical trial of food allergy candidate VE416 in the second half
of 2018;
-- Karuna, an affiliate of PureTech Health focused on targeting
muscarinic receptors for the treatment of central nervous system
(CNS) disorders including schizophrenia and Alzheimer's Disease,
has developed a single capsule co-formulation of its proprietary
combination of trospium chloride and xanomeline (KarXT). A
dose-ranging study using the single capsule formulation is
underway, following which a Phase 2 clinical trial for
schizophrenia will begin in the third quarter of 2018;
-- Follica, an affiliate of PureTech Health developing an
innovative platform to address androgenetic alopecia, has made
additional progress toward the initiation of the RAIN pivotal study
in androgenetic alopecia as well as the identification and testing
of next-generation, proprietary compounds based on the Group's
intellectual property. The Follica RAIN pivotal study is expected
to commence following the completion of an ongoing optimisation
study; and
-- Sonde Health, an affiliate of PureTech Health developing a
voice-based technology platform for monitoring and diagnosing
mental and physical medical conditions, has collected voice data
from over 3,000 subjects as part of the ongoing validation of its
vocal biomarker technology for the detection of depression,
suicidality, and Parkinson's disease. The Company has also
initiated research and development to expand its proprietary
technology in Alzheimer's, respiratory and cardiovascular disease,
and other health and wellness conditions. Sonde's Vocal Biomarker
programme has demonstrated the potential to effectively screen and
monitor for disease using information obtained from an individual's
voice on commonly-owned devices and has the potential to
fundamentally change the way mental and physical health is
monitored and diagnosed.
The Group has also grown its internally-funded,
immunology-focused pipeline by generating compelling pre-clinical
data and securing key intellectual property for:
-- a novel approach harnessing the lymphatic system to enable
certain drugs for the treatment of inflammatory and auto-immune
disease and cancer to potentially have greater efficacy by
targeting those drugs directly to lymph nodes. The technology could
also enable oral administration of medicines that otherwise would
not be orally bioavailable;
-- a milk exosome-based technology designed to enable the oral
administration of biologics, nucleic acids (eg. siRNA, mRNA,
antisense oligonucleotides), and complex small molecules;
-- a monoclonal antibody therapeutic approach to target newly
discovered immunosuppressive mechanisms in pancreatic cancer, and
other solid tumours; and
-- a technology that targets local inflammation to achieve a
therapeutic effect without systemic immunosuppression.
More widely in 2017, PureTech Health continued to build on its
leading intellectual property position, with more than 100 patents
and patent applications issued or filed since 1 January 2017. This
brought the Group's total number of owned and licensed patents and
applications to more than 400, including:
-- 10 new patents issued in the US and Japan for the Vedanta
Biosciences microbiome platform technology;
-- additional composition of matter, methods of use, and methods
of making allowances in the EU, Japan, Russia, and South Korea for
the Gelesis weight loss technology;
-- broad coverage for methods of assessing mental and physical
condition from human speech for the Sonde vocal biomarkers
technology; and
-- more than 75 issued and pending patents licensed relating to resTORbio's TORC1 programme.
PureTech Health has a scalable infrastructure capable of
supporting the future growth of its business. The Group further
strengthened its leadership by adding business, scientific, and
commercial leaders to its team, including Bharatt Chowrira, PhD,
JD, as President and Chief of Business and Strategy.
Financial Highlights
The Group had cash reserves* at 31 December 2017 of $242.1
million (31 December 2016: $281.5 million), of which $126.7 million
(31 December 2016: $192.1 million) was held at the Company level.
PureTech Health owns approximately 9.8 million of resTORbio's
publicly traded common shares, which represented $147 million at
the IPO offer price of $15.00 and is $184 million at the time of
this Trading Update based on the final trading price of $18.76 on
16 February 2018.
*Cash reserves consists of cash, cash equivalents and US
Treasuries, including those with maturities beyond one year. Group
cash reserves are inclusive of subsidiaries consolidated within the
Group's consolidated statement of financial position as well as
affiliates in which the Company owns a minority interest and which
are not included in the Group's consolidated statement of financial
position.
The Board believes that the value of PureTech Health's holdings
in its growth stage affiliates ("Growth Stage Holdings Value")
increased substantially from 31 December 2016 to 31 December 2017
driven by the noteworthy progress made over the year. Specifically,
this sizable increase is due in large part to (i) the resTORbio
programme launch with an in-license of lead clinical candidates
from Novartis, clinical advancement of those candidates, private
financings and a successful initial public offering bringing the
PureTech Health holdings value in resTORbio to $184 million as of
16 February 2018, (ii) the positive results from the Akili pivotal
clinical trial of its lead product candidate, (iii) the positive
results from the Gelesis100 pivotal clinical trial of its lead
product candidate, (iv) the initiation of Vedanta Biosciences'
Phase 1a/1b clinical trial for the treatment of recurrent C.
difficile infection and in-licensing of an immuno-oncology
candidate, (v) clinical advancement of the Karuna programme, (vi)
Entrega's collaboration with Eli Lilly and Company and (vii) new
internally-developed and funded immunology programmes not included
in the 2016 Net Asset Value (NAV).
Despite the notable growth in value, the Board, in consultation
with its strategic advisors and key shareholders, has decided not
to disclose its internal valuations of its growth stage affiliates
going forward, commencing as of 31 December 2017. The Company's
view is that such disclosure, on balance, may not be in the best
interests of PureTech Health and its shareholders. The Company
maintains a conservative approach to valuation and the Company
believes that it may be creating an artificially low external
benchmark for the programmes and affiliates that may otherwise be
ascribed substantially higher valuations by potential partners,
investors and acquirers.
The Group's affiliates continued to attract external funding
from key partners and investors. Some key financial highlights:
-- On 25 January 2018, resTORbio announced the pricing of its
initial public offering (IPO) on NASDAQ raising gross proceeds of
$97.8 million. The IPO followed successful Series A and Series B
financing rounds in 2017 that yielded a combined $65 million in
proceeds. The Series B financing was led by OrbiMed and included
participation from Fidelity Management & Research Company, Rock
Springs Capital, Quan Capital and Nest Bio. PureTech Health
invested $19.0 million in resTORbio prior to its IPO and invested
$3.5 million in the IPO. After giving effect to the IPO and
overallotment, PureTech Health owns approximately 34.2% of
resTORbio, which represented $147 million at the IPO offer price of
$15.00 and is $184 million at the time of this Trading Update based
on the final trading price of $18.76 on 16 February 2018;
-- Vedanta Biosciences was awarded a research grant of up to
$5.4 million from CARB-X (Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator) to support clinical testing of its
lead oral product candidate, VE303, a novel human-microbiome drug
candidate, to address serious bacterial infections. Vedanta
Biosciences also closed/realised the second tranche ($25 million)
of its 2016 financing round;
-- Entrega announced $5 million in equity and research funding
from Eli Lilly and Company to investigate the application of
Entrega's peptide delivery technology to certain Lilly products and
therapeutic candidates;
-- Follica secured $11.8 million in financing from PureTech
Health and LightHouse Capital Partners; and
-- The Sync Project was acquired in February 2018 by Bose
Corporation as part of a strategic decision to move that technology
to a more consumer-facing path. As a result of the transaction, the
Group recovered almost all of the invested capital in the Sync
Project, demonstrating the Group's disciplined approach to managing
its portfolio and strict focus on capital allocation.
Upcoming Milestones
Over the next 12 months, PureTech Health anticipates reaching
several key milestones, including:
-- regulatory filings anticipated from both Akili and Gelesis
with the FDA in the first half of 2018;
-- results anticipated from the Akili proof-of-concept clinical
trial looking at cognition in depression;
-- results anticipated from the Gelesis200 LIGHT-UP study for
weight loss and glycaemic control in people with prediabetes or
type 2 diabetes;
-- results anticipated from the resTORbio Phase 2b clinical
trial in elderly individuals at increased risk of respiratory tract
infections in the second half of 2018;
-- results anticipated from the Vedanta Biosciences VE303
(recurrent C. difficile infections programme) Phase 1 clinical
trial in healthy volunteers in the first half of 2018;
-- initiation of the Vedanta Biosciences VE202 (collaboration
with Janssen Biotech, Inc. for inflammatory bowel disease) Phase 1
clinical trial anticipated in the second half of 2018;
-- initiation of the Vedanta Biosciences VE416 Phase 1 clinical
trial in food allergy anticipated in the second half of 2018;
-- filing of an investigational new drug (IND) application for
VE800, Vedanta Biosciences' cancer immunotherapy candidate; and
-- initiation of a Phase 2 clinical trial in schizophrenia by
Karuna with the co-formulated candidate KarXT expected in the third
quarter of 2018.
Ownership of PureTech Health's Growth Stage Affiliates (as at 31
December 2017)
Programme PureTech Health
Ownership*
--------------------- ----------------
Akili 54.32%
--------------------- ----------------
Gelesis 20.98%
--------------------- ----------------
Vedanta Biosciences 71.51%
--------------------- ----------------
Karuna 76.00%
--------------------- ----------------
Follica 55.63%
--------------------- ----------------
Entrega 73.87%
--------------------- ----------------
Alivio 82.84%
--------------------- ----------------
Commense 90.00%
--------------------- ----------------
Sonde 93.08%
--------------------- ----------------
resTORbio 44.21%
--------------------- ----------------
Vor 81.34%
--------------------- ----------------
Nybo 93.51%
--------------------- ----------------
Additional internally-funded
programmes focus on the
immune/lymphatics system
---------------------------------------
*Relevant ownership interests were calculated on a diluted basis
as of 31 December 2017, including issued and outstanding shares,
outstanding options and warrants, and written commitments to issue
options, but excluding unallocated shares authorised to be issued
pursuant to equity incentive plans and any shares issuable upon
conversion of outstanding convertible promissory notes.
The Group plans to issue its 2017 Annual Report and Results for
the year ended 31 December 2017, based on its audited statutory
accounts, on Thursday, 12 April 2018.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
For more information, please contact:
PureTech Health +1 617 651 3156
Daphne Zohar, Chief Executive
Officer
Allison Mead Talbot, Director,
Communications and Investor
Relations
FTI Consulting (Communications
adviser to PureTech Health) +44 (0) 20 3727 1000
Ben Atwell
Rob Winder
About PureTech Health
PureTech Health is an advanced, clinical-stage biopharmaceutical
company developing novel medicines targeting serious diseases that
result from dysfunctions in the nervous, immune, and
gastrointestinal systems (brain-immune-gut or the "BIG" axis),
which together represent the adaptive human systems. PureTech
Health is at the forefront of understanding and addressing the
biological processes and crosstalk associated with the BIG axis. By
harnessing this emerging field of human biology, PureTech Health is
pioneering new categories of medicine with the potential to have
great impact on people with serious diseases. PureTech Health is
advancing a rich pipeline of innovative therapies that includes two
pivotal stage programmes, multiple human proof-of-concept studies
and a number of early clinical and pre-clinical programmes.
PureTech's rich research and development pipeline has been advanced
in collaboration with some of the world's leading scientific
experts, who along with PureTech's team of biopharma pioneers,
entrepreneurs and seasoned Board, identify, invent, and clinically
de-risk new medicines. With this experienced team pursuing cutting
edge science, PureTech Health is building the biopharma company of
the future focused on improving and extending the lives of people
with serious disease. For more information, visit
www.puretechhealth.com or connect with us on Twitter
@puretechh.
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to
PureTech's future prospects, developments and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the Company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither PureTech Health nor any other party intends to update or
revise these forward-looking statements, whether as a result of new
information, future events or otherwise.
Currency and rounding
Unless otherwise indicated, references to US dollar or $ are to
the lawful currency of the United States. Certain data in this
trading statement, including percentages, have been rounded.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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