Fractyl Health to Present at Piper Sandler 2nd Annual Virtual Obesity Day
June 25 2024 - 7:00AM
Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic
therapeutics company focused on pioneering new approaches for the
treatment of obesity and type 2 diabetes (T2D), today announced
that Dr. Harith Rajagopalan, CEO of Fractyl Health, and Dr. Timothy
Kieffer, CSO of Fractyl Health, will participate in a virtual
fireside chat at the upcoming Piper Sandler 2nd Annual Virtual
Obesity Day on Wednesday, June 26, 2024 at 9:30 a.m. EDT.
The Company will discuss the acceleration of its weight
maintenance clinical study, which it recently announced, as well as
the recent preclinical data it presented at the American Diabetes
Association’s 84th Scientific Session, which showed greater, more
durable weight loss for its GLP-1 pancreatic gene therapy Rejuva
vs. semaglutide. The oral presentation was chosen as the top
abstract out of 8,000 submissions at the meeting.
For additional information and link to the webcasted event,
please contact your Piper Sandler representative.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on
pioneering new approaches to the treatment of metabolic diseases,
including obesity and T2D. Despite advances in treatment over the
last 50 years, obesity and T2D continue to be rapidly growing
drivers of morbidity and mortality in the 21st century. Fractyl
Health’s goal is to transform metabolic disease treatment from
chronic symptomatic management to durable disease-modifying
therapies that target the organ-level root causes of disease.
Fractyl Health is based in Burlington, MA. For more information,
visit www.fractyl.com or www.twitter.com/FractylHealth.
About Revita
Fractyl Health’s lead product candidate, Revita®, is based on
the company’s insights surrounding the potential role of the gut in
obesity and T2D. Revita is designed to remodel the duodenal lining
via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to
edit abnormal intestinal nutrient sensing and signaling mechanisms
that are a potential root cause of metabolic disease. Revita has
received a CE mark in Europe and, in January 2022, received
reimbursement authorization through NUB in Germany for the
treatment of T2D. In the United States, Revita is for
investigational use only under US law. A pivotal study of Revita in
patients with T2D who are inadequately controlled on any glucose
lowering agent, REVITALIZE-1, is currently enrolling in the United
States and Europe. A pivotal study of Revita in patients with
obesity after discontinuation of GLP-1 based drugs, called
REMAIN-1, is anticipated to initiate in Q3 2024.
About Rejuva Fractyl Health’s Rejuva® platform
focuses on developing next-generation adeno-associated virus
(AAV)-based, locally delivered gene therapies for the treatment of
obesity and T2D. The Rejuva platform is in preclinical development
and has not yet been evaluated by regulatory agencies for
investigational or commercial use. Rejuva leverages advanced
delivery systems and proprietary screening methods to identify and
develop metabolically active gene therapy candidates targeting the
pancreas. The program aims to transform the management of metabolic
diseases by offering novel, disease-modifying therapies that
address the underlying root causes of disease.
Forward-Looking Statements This press release
contains 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, statements regarding the promise and
potential impact of our preclinical or clinical trial data, the
design, initiation, timing and results of clinical enrollment and
any clinical studies or readouts, the content, information used
for, timing or results of any IND-enabling studies or IND
applications, the potential launch or commercialization of any of
our product candidates or products, the potential treatment
population for any of our product candidates or products, and our
strategic and product development objectives and goals, including
with respect to enabling long-term control over obesity and type 2
diabetes without the burden of chronic therapies. These statements
are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause the
Company’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the
Company’s limited operating history; the incurrence of significant
net losses and the fact that the Company expects to continue to
incur significant net losses for the foreseeable future; the
Company’s need for substantial additional financing; the Company’s
ability to continue as a going concern; the restrictive and
financial covenants in the Company’s credit agreement; the lengthy
and unpredictable regulatory approval process for the Company’s
product candidates; uncertainty regarding its clinical studies; the
fact that the Company’s product candidates may cause serious
adverse events or undesirable side effects or have other properties
that may cause it to suspend or discontinue clinical studies, delay
or prevent regulatory development, prevent their regulatory
approval, limit the commercial profile, or result in significant
negative consequences; additional time may be required to develop
and obtain regulatory approval or certification for the Company’s
Rejuva gene therapy candidates; the Company’s reliance on third
parties to conduct certain aspects of the Company’s preclinical
studies and clinical studies; the Company’s reliance on third
parties for the manufacture of the materials for its Rejuva gene
therapy platform for preclinical studies and its ongoing clinical
studies; the regulatory approval process of the FDA, comparable
foreign regulatory authorities and lengthy, time-consuming and
inherently unpredictable, and even if we complete the necessary
clinical studies, we cannot predict when, or if, we will obtain
regulatory approval or certification for any of our product
candidates, and any such regulatory approval or certification may
be for a more narrow indication than we seek; and the potential
launch or commercialization of any of Company’s product candidates
or products and our strategic and product development objectives
and goals, and the other factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (the “SEC”) on May 13, 2024 and
in our other filings with the SEC. These forward-looking statements
are based on management’s current estimates and expectations. While
the Company may elect to update such forward-looking statements at
some point in the future, the Company disclaims any obligation to
do so, even if subsequent events cause its views to change.
Contacts
Corporate Contact Lisa Davidson, Chief
Financial Officer ir@fractyl.com, 781.902.8800
Media Contact Jessica Cotrone, Corporate
Communicationsjcotrone@fractyl.com,
978.760.5622
Investor ContactStephen Jasper Gilmartin
Groupstephen@gilmartinir.com, 619.949.3681
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