TIDMPRTC
PureTech Health PLC
17 October 2023
17 October 2023
PureTech Health plc
PureTech to Present at Two Upcoming Investor Conferences
Company summarizes third quarter progress across its Wholly
Owned Pipeline and Founded Entities
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases, today
announced that members of the management team will participate in
fireside chats at two upcoming investor conferences. Webcasts of
the presentations will be available at
https://investors.puretechhealth.com .
Jefferies London Healthcare Conference
Presenters: Daphne Zohar, Founder and Chief Executive Officer,
and Julie Krop, M.D., Chief Medical Officer
Date: Wednesday, November 15, 2023
Evercore ISI 6 (th) Annual Healthcare Conference
Presenters: Daphne Zohar, Founder and Chief Executive Officer,
and Julie Krop, M.D., Chief Medical Officer
Date: Wednesday, November 29, 2023
Commenting on the third quarter progress, Daphne Zohar, Founder
and Chief Executive Officer of PureTech, said:
"It has been a very productive third quarter across our Wholly
Owned Pipeline and Founded Entities, with multiple milestones
reached as well as the continued progression toward several more
major catalysts by the end of this year.
" Across our Wholly Owned Pipeline, we are looking forward to
data from two clinical trials by the end of 2023, including data
from the Phase 1b trial of LYT-200 in oncology, and the Phase 2a
trial of LYT-300 in a validated clinical model of anxiety.
"Recently, we have been increasing our focus on our central
nervous system (CNS) programs, including LYT-300 and LYT-310, that
originated from our Glyph(TM) technology platform. Our increased
focus reflects the historic success we've had in CNS by enabling
drugs with proven human efficacy to realize their full therapeutic
potential by applying an innovative solution to a previous
limitation. As a result, we have now generated an additional two
programs based on our Glyph platform, expanding our CNS pipeline to
seven programs.
"Our increasing focus on this proven strategy for treating brain
diseases builds on the success we had with KarXT and we are also
pleased to note the important milestone of Karuna's submission of a
New Drug Application to the U.S. Food and Drug Administration (FDA)
for KarXT for the treatment of schizophrenia. If approved, KarXT,
invented at PureTech, will be the third therapeutic candidate to be
taken from inception at PureTech to FDA regulatory approval.
"We plan to provide more guidance on our capital allocation and
returns strategy in the fourth quarter. We look forward to another
catalyst-rich quarter and continuing to deliver on our mission of
changing the lives of patients with devastating diseases."
Key Highlights & Progress
Wholly Owned Programs
-- LYT-100 (deupirfenidone), is currently in development for the
treatment of conditions involving inflammation and fibrosis,
including idiopathic pulmonary fibrosis (IPF).
o Progressed Phase 2b dose-ranging trial of LYT-100
(deupirfenidone) in patients with idiopathic pulmonary fibrosis
(IPF). Topline results are expected in 2024. We plan to pursue a
streamlined development program for LYT-100 in IPF and are using
the same endpoints that have supported past approvals. Pending
positive clinical and regulatory feedback, we intend to advance the
program into a Phase 3 trial. We believe the results of the Phase
2b trial, together with a Phase 3 trial, could serve as the basis
for registration in the U.S. and other geographies.
o Presented expanded data from a completed trial of LYT-100 in
healthy older adults, which informed the two doses selected for the
ongoing, global Phase 2b dose-ranging trial of LYT-100 (ELEVATE
IPF) in patients with IPF. In addition to supporting the improved
tolerability of LYT-100 versus the FDA-approved dose of
pirfenidone, the new data presented supported the selection of a
higher dose of LYT-100 with the potential for improved efficacy
that is now being evaluated in ELEVATE IPF.
-- LYT-300 (oral allopregnanolone) is an oral prodrug of
allopregnanolone, enabled by our Glyph(TM) technology platform,
that is currently in development for the treatment of a range of
neurological and neuropsychological conditions, including anxiety,
mood disorders and Fragile X-associated Tremor/Ataxia Syndrome
(FXTAS).
o Progressed a Phase 2a proof-of-concept trial of LYT-300 using
a validated clinical model of anxiety in healthy volunteers.
Results are expected by the end of 2023.
o Awarded up to $11.4 million from the U.S. Department of
Defense to advance LYT-300 for Fragile X-associated Tremor/ Ataxia
Syndrome (FXTAS). The Phase 2 trial of LYT-300 in FXTAS in
collaboration with the University of California, Davis is expected
to initiate in 2024.
-- LYT-310 (oral cannabidiol [CBD]), is currently in development
for the treatment of epilepsies and other neurological
indications.
o A Phase 1 clinical trial of LYT-310 is expected to begin in
the fourth quarter of 2023.
-- LYT-200 (anti-galectin-9 mAb) is currently in development for
the treatment of metastatic/locally advanced solid tumors,
including urothelial and head and neck cancers, and hematological
malignancies, such as acute myeloid leukemia (AML).
o Progressed a Phase 1b trial of LYT-200 in combination with
tislelizumab in urothelial and head and neck cancers. Topline
results are expected in 2024.
o Progressed a Phase 1b trial evaluating LYT-200 as a single
agent for the treatment of AML. Initial results from a subset of
patients are expected by the end of 2023.
Founded Entities
-- Karuna Therapeutics (Nasdaq: KRTX) (Karuna) submitted a New
Drug Application to the U.S. Food and Drug Administration (FDA) for
the potential approval of KarXT for the treatment of
schizophrenia.
-- Vedanta dosed the first patient in the Phase 2 COLLECTiVE202
clinical study of VE202 for the treatment of ulcerative colitis.
The FDA also granted Fast Track designation to VE202. The phase 3
RestoratiVE303 pivotal study of VE303, designed for the prevention
of recurrent Clostridioides difficile infection, is expected to
initiate in the coming months.
-- Akili, Inc. (Nasdaq: AKLI) (Akili) announced its strategic
plan to transition from a prescription to a non-prescription
business model. Akili is on track to submit its adult clinical
trial data later this year to the FDA for over-the-counter (OTC)
authorization of EndeavorOTC, and is planning to submit data to the
FDA to convert its pediatric prescription product, EndeavorRx , to
OTC in 2024.
-- Sonde Health has partnered with Together, an AI-based health
assistant, to provide enhanced mental health detection and
monitoring through its new Mental Vitals feature. This
collaboration integrates Sonde's technology into the Together app,
allowing users to access advanced voice analysis for early
detection of symptoms related to depression and anxiety.
-- PureTech will not move forward with the contemplated plan of
merger with Gelesis and will instead focus on other strategic
business initiatives.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to giving life to new classes of medicine to change the lives of
patients with devastating diseases. The Company has created a broad
and deep pipeline through its experienced research and development
team and its extensive network of scientists, clinicians and
industry leaders that is being advanced both internally and through
its Founded Entities. PureTech's R&D engine has resulted in the
development of 27 therapeutics and therapeutic candidates,
including two (Plenity(R) and EndeavorRx(R)) that have received
both US FDA clearance and European marketing authorization and a
third (KarXT) that has been filed for FDA approval. A number of
these programs are being advanced by PureTech or its Founded
Entities in various indications and stages of clinical development,
including registration enabling studies. 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.
For more information, visit www.puretechhealth.com or connect
with us on X, formerly known as Twitter, @puretechh .
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation those related to our and our Founded Entities'
plans, future prospects, objectives, developments, strategies and
expectations, the progress and timing of clinical trials and data
readouts, the timing of potential Investigational New Drug (IND)
and NDA submissions, and the timing of regulatory approvals or
clearances from the FDA. The forward-looking statements are based
on current expectations and are subject to known and unknown risks,
uncertainties and other important factors that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to, the following:
our history of incurring significant operating losses since our
inception; our need for additional funding to achieve our business
goals, which may not be available and which may force us to delay,
limit or terminate certain of our therapeutic development efforts;
our limited information about and limited control or influence over
our Non-Controlled Founded Entities; the lengthy and expensive
process of preclinical and clinical drug development, which has an
uncertain outcome and potential for substantial delays; potential
difficulties with enrolling patients in clinical trials, which
could delay
our clinical development activities; side effects, adverse
events or other safety risks which could be associated with our
therapeutic candidates and delay or halt their clinical
development; our ability to obtain regulatory approval for and
commercialize our therapeutic candidates; our ability to realize
the benefits of our collaborations, licenses and other
arrangements; our ability to maintain and protect our intellectual
property rights; our reliance on third parties, including clinical
research organizations, clinical investigators and manufacturers;
our vulnerability to natural disasters, global economic factors,
geo-political actions and unexpected events; and those risks,
uncertainties and other important factors described under the
caption "Risk Factors" in our Annual Report on Form 20-F for the
year ended December 31, 2022 filed with the SEC and in our other
regulatory filings. These forward-looking statements are based on
assumptions rega rding 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, we disclaim any obligation to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact:
PureTech EU media U.S. media
Public Relations Ben Atwell, Rob Winder Nichole Sarkis
publicrelations@puretechhealth.com +44 (0) 20 3727 1000 +1 774 278 8273
Investor Relations ben.atwell@FTIconsulting.com nichole@tenbridgecommunications.com
IR@puretechhealth.com
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