RCS - PureTech Health PLC - PRTC to Present at Upcoming Conferences + Progress

Puretech HealthAnnouncement

17/10/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231017:nRSQ3600Qa&default-theme=true

RNS Number : 3600Q  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 (https://puretechhealth.com/) (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
(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® and EndeavorRx®) 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
(http://www.puretechhealth.com/)  or connect with us on X, formerly known as
Twitter, @puretechh (https://twitter.com/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 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, 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 (mailto:publicrelations@puretechhealth.com)   +44 (0) 20 3727 1000           +1 774 278 8273

 Investor Relations                                                               ben.atwell@FTIconsulting.com   nichole@tenbridgecommunications.com

 IR@puretechhealth.com

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAEASEXFDKDFEA