TIDMPRTC
PureTech Health PLC
21 July 2021
21 July 2021
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Completes $68
Million Series D Financing
Proceeds expected to be used primarily to support a Phase 3
trial of Vedanta's lead candidate VE303 in Clostridioides difficile
infection (CDI) and a Phase 2 trial of VE202 in inflammatory bowel
disease (IBD)
Topline data from Phase 2 trial of VE303 in CDI are anticipated
in Q3 2021
Vedanta plans to initiate Phase 2 trial of VE202 for treatment
of mild to moderate ulcerative colitis in H2 2021
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company announces that
its Founded Entity, Vedanta Biosciences ("Vedanta"), completed a
$68 million Series D financing and provided a pipeline update.
The Series D financing was led by affiliates of Magnetar
Capital. Other participants in the financing were new and existing
investors including Verition Fund Management, Fosun Health Capital,
co-founder PureTech Health, Rock Springs Capital, Skyviews Life
Science, JSR Corporation, SymBiosis LLC, Shumway Capital, Health
for Life Capital (Seventure Partners) and other institutional
investors. The round also includes a $25 million investment from
Pfizer as part of the Pfizer Breakthrough Growth Initiative, which
was announced in January 2021.
Vedanta plans to use the proceeds to advance its pipeline of
defined bacterial consortia, including progressing VE303 into a
Phase 3 clinical trial in patients at high risk for recurrent CDI,
initiating a Phase 2 clinical trial of VE202 in mild to moderate
ulcerative colitis and continuing to advance programs in additional
indications.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Completes $68 Million Series D Financing
Proceeds expected to be used primarily to support a Phase 3
trial of lead candidate VE303 in Clostridioides difficile infection
(CDI) and a Phase 2 trial of VE202 in inflammatory bowel disease
(IBD)
Topline data from Phase 2 trial of VE303 in CDI are anticipated
in Q3 2021
Plans to initiate Phase 2 trial of VE202 for treatment of mild
to moderate ulcerative colitis in H2 2021
CAMBRIDGE, MA, July 21, 2021 - Vedanta Biosciences, Inc. , a
leading clinical-stage microbiome company developing a new category
of oral therapies using defined bacterial consortia manufactured
from clonal cell banks, today announced the closing of a $68
million Series D financing and provided a pipeline update.
The Series D financing was led by affiliates of Magnetar
Capital. Other participants in the financing were new and existing
investors including Verition Fund Management, Fosun Health Capital,
co-founder PureTech Health, Rock Springs Capital, Skyviews Life
Science, JSR Corporation, SymBiosis LLC, Shumway Capital, Health
for Life Capital (Seventure Partners), and other institutional
investors. The round also includes a $25 million investment from
Pfizer as part of the Pfizer Breakthrough Growth Initiative, which
was announced in January 2021.
Vedanta plans to use the proceeds to advance its pipeline of
defined bacterial consortia, including progressing VE303 into a
Phase 3 clinical trial in patients at high risk for recurrent CDI,
initiating a Phase 2 clinical trial of VE202 in mild to moderate
ulcerative colitis, and continuing to advance programs in
additional indications.
"We are delighted to welcome the new investors in our Series D
round and are grateful to our existing shareholders and partners
for their continued support," said Bernat Olle, Ph.D., Co-Founder
and Chief Executive Officer of Vedanta Biosciences. "Since our last
funding round, we have made significant progress advancing defined
bacterial consortia as a new modality for infectious and
immune-mediated diseases. This most recent financing, together with
the support we receive from BARDA for our CDI program, will enable
us to advance mid- and late-stage programs in CDI and IBD, as well
as support early exploratory clinical studies in additional
indications."
"Drugs based on defined bacterial consortia are a promising new
therapeutic modality with the potential to transform medicine, and
Vedanta is the leader in this category, with a state-of-the-art
discovery platform, field-leading GMP manufacturing capabilities,
and an advanced pipeline," said Ted Koutouzis, M.D., Managing
Director of Fiscus Venture and Reimagined Ventures, affiliates of
Magnetar. "We are proud to support the company's efforts."
Vedanta's Pipeline
Vedanta Biosciences is developing a potential new category of
oral therapies based on rationally defined consortia of bacteria
derived from the human microbiome. All of the company's pipeline
programs are wholly owned.
Company-Sponsored Programs
VE303 for the Prevention of Recurrence in High-risk Patients
with Clostridioides difficile (CDI) Infection
-- VE303 consists of 8 clonal human commensal bacterial strains
selected for their ability to provide colonization resistance to C.
difficile.
-- In a Phase 1 healthy-volunteer study, VE303 showed rapid,
durable, and dose-dependent colonization and accelerated gut
microbiota restoration after a course of antibiotics.
-- Vedanta is currently evaluating VE303 in a Phase 2 clinical
trial in patients at high risk of recurrent CDI and will report
results from this trial in Q3 2021.
-- In 2020, Vedanta was awarded up to $76.9 million of federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
75A50120C00177, to partially fund the development of VE303. This
was the first-ever grant from BARDA in the microbiome field.
-- The company expects to complete the build-out of its Phase 3
and commercial launch cGMP manufacturing facility for supply of
VE303 by the end of 2021.
-- The company plans to initiate a Phase 3 trial in mid-2022.
VE202 for the Treatment of Inflammatory Bowel Disease (IBD)
-- VE202 consists of 16 clonal human commensal bacterial strains
selected for their ability to induce regulatory T cells in the gut
mucosa, decolonize pro-inflammatory organisms, and strengthen the
epithelial barrier.
-- In June 2021, Vedanta presented positive Phase 1 topline data
of VE202 in healthy volunteers at the International Human
Microbiome Consortium Congress. VE202 was generally safe and well
tolerated at all doses and demonstrated durable and dose-dependent
colonization.
-- Vedanta plans to initiate a Phase 2 clinical trial of VE202
in patients with mild to moderate ulcerative colitis in the second
half of 2021.
-- VE202 is being developed in part through funding provided by
the Pfizer Breakthrough Growth Initiative.
VE800 for the Treatment of Advanced and Metastatic Tumors
-- VE800 consists of 11 clonal human commensal bacterial strains
selected for their ability to induce CD8+ T cells, potentiate
anti-tumor activity, and enhance the effects of checkpoint
inhibitors.
-- The company is nearing completion of Stage 1 of an open-label
Phase 1 study to evaluate the safety and initial clinical activity
of VE800 in combination with Bristol Myers Squibb's Opdivo(R)
(nivolumab) in 54 patients across select types of advanced or
metastatic cancers.
-- This trial is being done under a collaboration and supply
agreement with Bristol Myers Squibb.
-- To date, VE800 has demonstrated an acceptable safety and
tolerability profile, though the observed response rates did not
meet the prespecified criteria to expand into the next stage of the
study. Vedanta is analyzing blood, stool, and tumor samples from
patients in whom response or disease control was observed, to
profile patient subtypes that might benefit from microbiome
manipulation. The company plans to present the results at a future
medical conference.
-- The company will continue work to identify cancer settings
and patient populations that might benefit from microbiome
manipulation with its defined bacterial consortia.
Preclinical Programs
-- VE707 is a preclinical program for the prevention of
infection by several problematic Gram-negative Enterobacteriaceae,
which are some of the most common hospital-acquired pathogens.
Vedanta has received funding from Combating Antibiotic Resistant
Bacteria Biopharmaceutical Accelerator (CARB-X) of up to $7.4
million, plus up to $3.5 million more if certain milestones are
met, to advance VE707. The company expects to select a development
candidate in H2 2021.
Investigator-Sponsored Studies
VE416 in Peanut Allergy
-- VE416 consists of 7 bacterial strains of the Clostridia
class, which were selected based on the ability to induce immune
tolerance in the gut.
-- A Phase 1/2, investigator-sponsored clinical study is
underway at Massachusetts General Hospital, exploring use of VE416
both as a monotherapy and in combination with an oral peanut
immunotherapy over the course of several months.
-- Topline data from the Phase 1/2 clinical trial is expected to
be reported in 2022, subject to investigator timelines.
VE303 in Hepatic Encephalopathy
-- A new Phase 2 investigator-sponsored trial evaluating VE303
in patients with hepatic encephalopathy (HE) was recently initiated
by the University of Michigan Hospitals-Michigan Medicine. The
randomized, double-blind, placebo-controlled trial is planned to
enroll up to 18 adult patients with a confirmed diagnosis of
cirrhosis and history of at least one episode of overt HE.
FJS Consultants Limited acted as a placement agent for Vedanta's
investors in China. BARDA is the Biomedical Advanced Research and
Development Authority, part of the Office of the Assistant
Secretary for Preparedness and Response at the U.S. Department of
Health and Human Services.
About Vedanta Biosciences
Vedanta Biosciences is leading the development of a potential
new category of oral therapies for immune-mediated diseases using
defined bacterial consortia manufactured from clonal cell banks.
The company's approach bypasses the need to rely on direct sourcing
of donor fecal material of inconsistent composition, thus
overcoming challenges related to safety, quality, and scalability
that limit donor-derived approaches. The clinical pipeline includes
product candidates being evaluated for the treatment of C.
difficile infection, inflammatory bowel diseases, advanced or
metastatic cancers, and food allergy. These investigational
therapies are grounded in pioneering research - published in
leading journals including Science, Nature, and Cell - that
identified bacteria that induce a range of beneficial immune
responses. The company's platform includes what is believed to be
the largest library of bacteria derived from the human microbiome,
high-throughput methods for bacterial consortium design, vast
datasets from human interventional studies, and state-of-the-art
capabilities for cGMP-compliant manufacturing of defined bacterial
consortia. Vedanta Biosciences controls a foundational intellectual
property portfolio covering compositions of matter and methods of
use for classes of bacteria that play key roles in human health.
Vedanta Biosciences was founded by PureTech Health (Nasdaq: PRTC,
LSE: PRTC) and a global team of scientific co-founders who
pioneered the modern understanding of the interaction between the
immune system and the microbiome.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders. This pipeline,
which is being advanced both internally and through PureTech's
Founded Entities, is comprised of 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech's most
recently filed Annual Report on Form 20-F. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the interface between
those systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Ownership Information
PureTech's percentage ownership of Vedanta Biosciences following
the financing is approximately 41.4% on a diluted basis. This
calculation of PureTech's holding includes issued and outstanding
shares as well as options and warrants to purchase shares, but
excludes unallocated shares authorized to be issued pursuant to
equity incentive plans.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
Company'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, expectations regarding Vedanta's use of proceeds from the
Series D financing, including expectations regarding the use of the
funding to support a Phase 3 trial of VE303 and a Phase 2 trial of
VE202, the potential clinical benefit of VE303, VE202 and Vedanta's
other product candidates, the anticipated timing of initiation and
topline data from Vedanta's planned and ongoing clinical trials and
those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. 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 the Company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
_________
DISCLAIMER
CARB-X funding for this research is sponsored by Cooperative
Agreement Number IDSEP160030 from ASPR/BARDA and by awards from
Wellcome Trust, and the Bill & Melinda Gates Foundation. The
contents are solely the responsibility of the authors and do not
necessarily represent the official views of CARB-X or any of its
funders.
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