Fractyl Health Announces Multiple Presentations at the Upcoming Digestive Disease Week (DDW) 2024 Conference and the German Diabetes Association (DDG) Annual Meeting
April 30 2024 - 8:38AM
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 it will present new data from its ongoing real-world registry
study of Revita for T2D at the upcoming German Diabetes Association
(DDG) Annual Meeting taking place May 8-11, 2024, in Berlin,
Germany. The Company will also present an oral abstract with new
preclinical data on the potential of Rejuva to durably impact liver
metabolic health during the 2024 Digestive Disease Week (DDW)
taking place May 18-24, 2024, in Washington, D.C.
Details of the presentations are provided below.
German Diabetes Association (DDG) Annual
Meeting
- Presentation Title: A Prospective Post-Market
Clinical Follow-Up Registry to Evaluate Real-World Effectiveness of
Duodenal Mucosal Resurfacing in Patients with Type 2 Diabetes
- Poster Number: P01.02 (Paper-ID: 68228)
- Poster Area: Posterwalk 1: Prediabetes and
Type 2 Diabetes (Clinical)
- Location: Level 1 – Poster Area
- Presentation Date & Time: Thursday, May 9,
2024, from 2:07 p.m. – 2:14 p.m. ET
Digestive Disease Week (DDW)
- Presentation Title: Single-Dose GLP-1-Based
Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide
Withdrawal and Reduces Hepatic Triglycerides in a Murine Model of
Obesity
- Abstract Number: 4029196
- Session Title: AGA Basic Science Plenary
- Location: 103AB at the Walter E. Washington
Convention Center
- Presentation Date & Time: Sunday, May 19,
2024, from 4:00 p.m. - 5:30 p.m. ET
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 TD2 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 https://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 inadequately controlled T2D despite multiple
medicines and insulin, called 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 H2 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 our participation at conferences, the promise
and potential impact of our preclinical or clinical trial data, the
design, initiation, timing and results of clinical enrollment and
any clinical trials or readouts, 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; 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 notified bodies, are 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 Annual Report on Form 10-K
filed with the Securities and Exchange Commission (the “SEC”) on
April 1, 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 Beth Brett, Corporate
Communications bbrett@fractyl.com, 720.656.6544
Investor Contact Stephen Jasper Gilmartin Group
stephen@gilmartinir.com, 619.949.3681
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