Fractyl Health's lead product candidate, Revita$(R)$, 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. Revita has US FDA Breakthrough Device Designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs, as well as in insulin-treated T2D. 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, was initiated in the third quarter 2024.

About Rejuva

Fractyl Health's Rejuva(R) 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, IND applications or Clinical Trial Applications, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits 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, and the timing of any of the foregoing. 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 November 12, 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 Communications

jcotrone@fractyl.com. 978.760.5622

Investor Contact

Stephen Jasper, Gilmartin Group

stephen@gilmartinir.com. 619.949.3681

 
                          Fractyl Health, Inc. 
            Selected Condensed Consolidated Balance Sheet Data 
                              (in thousands) 
                               (Unaudited) 
 
                                        September 30,    December 31, 
                                             2024            2023 
                                       ---------------  -------------- 
Cash and cash equivalents               $       84,664   $      33,209 
Restricted cash                                  4,255           4,570 
Working capital (1)                             71,934          24,460 
Total assets                                   126,924          76,212 
Notes payable, long-term                        30,317          55,152 
Total liabilities                               76,602         113,944 
Convertible preferred stock                         --         287,330 
Total stockholders' equity (deficit)            50,322        (325,062) 
 

(1) Working capital is defined as total current assets less total current liabilities.

 
                      Fractyl Health, Inc. 
       Condensed Consolidated Statements of Operations and 
                       Comprehensive Loss 
                         (in thousands) 
                           (Unaudited) 
 
                    Three Months Ended     Nine Months Ended 
                       September 30,         September 30, 
                    -------------------   ------------------- 
                      2024       2023       2024       2023 
                    --------   --------   --------   -------- 
Revenue             $     14   $     36   $     90   $    113 
Cost of goods sold         7         25         50         75 
                     -------    -------    -------    ------- 
   Gross profit            7         11         40         38 
Operating 
expenses: 
   Research and 
    development       19,004      9,382     50,190     27,872 
   Selling, 
    general and 
    administrative     4,797      4,502     18,171     10,021 
                     -------    -------    -------    ------- 
     Total 
      operating 
      expenses        23,801     13,884     68,361     37,893 
                     -------    -------    -------    ------- 
Loss from 
 operations          (23,794)   (13,873)   (68,321)   (37,855) 
                     -------    -------    -------    ------- 
Other income 
(expense), net: 
   Interest 
    income, net          947        226      3,420        797 
   Change in fair 
    value of notes 
    payable           (2,610)    (1,065)     3,772    (19,676) 
   Change in fair 
    value of 
    warrant 
    liabilities        2,293     (1,027)    17,442     (1,161) 
   Other expense, 
    net                   (9)        (8)       (37)       (16) 
                     -------    -------    -------    ------- 
     Total other 
      income 
      (expense), 
      net                621     (1,874)    24,597    (20,056) 
                     -------    -------    -------    ------- 
Net loss and 
 comprehensive 
 loss                (23,173)   (15,747)   (43,724)   (57,911) 
 

(END) Dow Jones Newswires

November 12, 2024 16:05 ET (21:05 GMT)