# EDGAR Filing Document

**Accession Number:** 0001572616
**File Stem:** 0001193125-25-218508
**Filing Date:** 2025-9
**Character Count:** 52677
**Document Hash:** 936c2b0c514d8096dfc7ba297a05a303
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-218508.hdr.sgml**: 20250926

**ACCESSION NUMBER**: 0001193125-25-218508

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 36

**CONFORMED PERIOD OF REPORT**: 20250926

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250926

**DATE AS OF CHANGE**: 20250926

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** FRACTYL HEALTH, INC.
- **CENTRAL INDEX KEY:** 0001572616
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 273553477
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41942
- **FILM NUMBER:** 251345407

**BUSINESS ADDRESS:**
- **STREET 1:** 3 VAN DE GRAAFF DRIVE
- **STREET 2:** SUITE 200
- **CITY:** BURLINGTON
- **STATE:** MA
- **ZIP:** 01803
- **BUSINESS PHONE:** 781-902-8800

**MAIL ADDRESS:**
- **STREET 1:** 3 VAN DE GRAAFF DRIVE
- **STREET 2:** SUITE 200
- **CITY:** BURLINGTON
- **STATE:** MA
- **ZIP:** 01803

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Fractyl Health, Inc.
- **DATE OF NAME CHANGE:** 20210617

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Fractyl Laboratories Inc.
- **DATE OF NAME CHANGE:** 20130320

?xml version='1.0' encoding='ASCII'? 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): September 26, 2025

## Fractyl Health, Inc.

#### (Exact name of Registrant as Specified in Its Charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-41942** | **27-3553477** |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission<br>File Number)** | **(IRS Employer<br>Identification No.)** |

---

---

| | |
|:---|:---|
| **3 Van de Graaff Drive**<br> **Suite 200** |  |
| **Burlington, Massachusetts** | **01803** |
| **(Address of Principal Executive Offices)** | **(Zip Code)** |

---

#### Registrant's Telephone Number, Including Area Code: (781) 902-8800

#### (Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

#### Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, $0.00001 par value per share | GUTS | The Nasdaq Global Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.**  |

---

On September 26, 2025, Fractyl Health, Inc. (the "Company") issued a press release announcing 3-month interim results from its REMAIN-1 Midpoint Cohort, a distinct patient cohort assessing the potential of the Revita DMR System ("Revita") to maintain weight loss after GLP-1 discontinuation. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

As described in the accompanying press release, the Company will host a conference call and live audio webcast today, September 26, 2025 at 8:00 a.m., Eastern Time, to discuss the presentation of data described above.

The live audio webcast may be accessed through the "Events" section of the Company's website at ir.fractyl.com. A copy of the presentation to be used by the Company during the conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any of the Company's filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

The Company's website and any information contained on the Company's website are not incorporated into this Current Report on Form 8-K.

---

| | |
|:---|:---|
| **Item 8.01** | **Other Events.**  |

---

On September 26, 2025, the Company reported 3-month interim data from its REMAIN-1 Midpoint Cohort, a randomized, double-blind, sham-controlled cohort designed to evaluate Revita in adults with obesity who achieved at least 15% total body weight loss with tirzepatide. The REMAIN-1 Midpoint Cohort is a randomized, double-blind cohort of 45 participants to assess the potential of Revita to maintain weight loss after GLP-1 discontinuation. Participants are individuals with obesity who prior to participation had not yet taken GLP-1 drugs, were initiated on tirzepatide at the time of enrollment, and treated with tirzepatide to achieve at least 15% total body weight loss. Participants then discontinued tirzepatide and were randomized to undergo either Revita or a sham procedure with a 2:1 treatment allocation. The REMAIN-1 Midpoint Cohort is designed to be identical to the ongoing Pivotal Cohort, serving as an important interim randomized readout to assess Revita's potential to maintain weight loss after GLP-1 discontinuation. The key points from the most recent 3-month data cut are summarized below.

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At 3 months, Revita-treated patients lost an additional 2.5% total body weight after stopping tirzepatide, while sham patients regained 10% (p=0.014). These results are clinically and statistically significant and provide randomized, blinded evidence that drug-free, durable weight maintenance is possible at 3 months. They further support Revita as a potential first-in-class treatment in a new therapeutic category in obesity care: post-GLP-1 weight maintenance.

<u>Key Findings:</u> 

• The study met its 3-month interim efficacy endpoint with strong statistical significance (p=0.014), delivering 2.5% further weight loss with Revita (n=29) even after stopping tirzepatide, versus 10% weight regain in sham-treated patients (n=16).

• No Revita-related SAEs or Grade II+ AEs were observed through 3 months. Side effects were infrequent, mild, and transient, consistent with prior Revita clinical study experience.

• These data strengthen confidence in the ongoing Pivotal Cohort study, which is on track to complete randomization in early 2026, with 6-month topline primary endpoint data and a potential PMA filing anticipated in H2 2026.

<u>Upcoming Milestones</u> 

• The REMAIN-1 Midpoint Cohort is ongoing, with 6-month data expected in Q1 2026. The REMAIN-1 Pivotal Cohort has completed enrollment, and the Company remains on track to randomize patients in early 2026 and deliver 6-month topline primary endpoint data and potentially file a PMA in H2 2026. These milestones are designed to evaluate Revita as the first potential therapy for post-GLP-1 weight maintenance.

#### Cautionary Regarding Forward-Looking Statements
This Current Report on Form 8-K 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 are forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding the promise and potential impact of our product candidates, including Revita's potential for preserving weight loss after GLP-1 drug discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort; the potential treatment population or benefits for any of our product candidates or products; 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, redefining the future of metabolic disease treatment, and positioning our Company at the forefront of the global opportunity for metabolic care or a late-stage, pre-commercial company poised to redefine metabolic care; 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; 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 sub-assembly components for Revita; the regulatory approval process of the FDA and comparable foreign regulatory authorities is 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 for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 12, 2025 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.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

---

---

| | |
|:---|:---|
| **Exhibit**<br> **No.** | **Description** |
| 99.1 | [Press Release dated September 26, 2025](d870124dex991.htm) |
| 99.2 | [Conference Call Presentation dated September 26, 2025](d870124dex992.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  |  | **Fractyl Health, Inc.** |
| Date: September 26, 2025 | By: | /s/ Harith Rajagopalan |
|  |  | **Harith Rajagopalan, M.D., Ph.D.** <br>Co-Founder, Chief Executive Officer and Director <br>(Principal Executive Officer) |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g870124g0925213932816.jpg)

**Fractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita***<sup>®</sup>* 

**Maintained Weight Loss After GLP-1 Discontinuation** 

*Pilot study met key 3-month efficacy endpoint with strong statistical significance (p=0.014); Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients* 

*Revita procedure demonstrated excellent safety and tolerability to date, consistent with prior clinical studies* 

*Results validate pivotal study design and reinforce Revita's potential to be the first therapy for post-GLP-1 weight maintenance* 

*Company to host investor call and webcast today at 8:00 a.m. ET* 

**BURLINGTON, Mass., September 26, 2025 (GLOBE NEWSWIRE)** – Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced groundbreaking results from the REMAIN-1 Midpoint Cohort, supporting the potential for Revita to be the first therapy to preserve weight loss after GLP-1 drug discontinuation. At 3 months, Revita-treated patients lost an additional 2.5% total body weight after stopping tirzepatide, while sham patients regained 10% (p=0.014). These results are clinically and statistically significant and provide randomized, blinded evidence that drug-free, durable weight maintenance is possible. They further support Revita as a potential first-in class treatment in a new therapeutic category in obesity care: post-GLP-1 weight maintenance.

"One of the biggest challenges in obesity medicine today is what happens when patients stop GLP-1 therapy, whether because of cost, insurance coverage, or side effects. We know weight regain almost always follows," said Shelby Sullivan, M.D., Professor of Medicine at the Geisel School of Medicine at Dartmouth University. "The REMAIN-1 3-month results are the first randomized, controlled evidence suggesting that a one-time endoscopic procedure may help maintain drug-free weight loss after GLP-1 discontinuation. The treatment difference we saw in this study, with Revita patients continuing to lose weight while sham patients rapidly regained weight, is striking. If these findings continue to hold with more data, duodenal mucosal resurfacing could represent a novel and much-needed solution to the largest gap in obesity care: post-GLP-1 weight maintenance."

**REMAIN-1 Midpoint Cohort Study Design** 

The REMAIN-1 Midpoint Cohort (N=45) is a randomized, double-blind, sham-controlled study designed to evaluate Revita in adults with obesity who achieved at least 15% total body weight loss with tirzepatide. After discontinuing the drug, participants were randomized 2:1 to Revita or a sham endoscopic procedure. The key efficacy endpoint was total body weight change in Revita versus sham at 3 months.

The Midpoint Cohort is designed to be identical to the ongoing Pivotal Cohort, serving as an early readout to reinforce confidence in the pivotal program and provide initial validation of the study design and endpoints.

**Key Findings** 

Data shared are for the treatment period of up to 3 months. The Midpoint Cohort is ongoing, with 6-month randomized data expected in Q1 2026.

------

![LOGO](g870124g0925213932816.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Clear evidence of Revita activity:** The study met its 3-month efficacy endpoint with strong statistical significance (p=0.014), delivering 2.5% further weight loss with Revita (n=29) even after stopping tirzepatide, versus 10% weight regain in sham-treated patients (n=16).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Excellent safety and tolerability through 3 months**: No Revita-related SAEs or Grade II+ AEs were observed.
Side effects were infrequent, mild, and transient, consistent with prior Revita clinical study experience.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Positive readthrough to pivotal study**: These data strengthen confidence in the ongoing Pivotal Cohort
study, which is on track to complete randomization in early 2026, with 6-month topline primary endpoint data and potential PMA filing expected in H2 2026.

***3-Month Post-Procedure Total Body Weight Change from Baseline (%)***

![LOGO](g870124g0925212641682.jpg)

"These results are a defining milestone for Fractyl and the obesity community. For the first time, randomized, blinded data show that Revita may dramatically prevent weight regain after GLP-1 discontinuation at 3 months. This is a compelling demonstration that targeting the gut may provide a remarkable and clinically significant improvement in obesity," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "The implications are profound. Patients want durable weight loss without the need for chronic medical therapy. The Revita clinical profile in this study suggests we have the potential to create a new standard of care in obesity with a disease-modifying intervention that allows us to progress from chasing weight loss to sustaining health with a durable metabolic reset."

**Upcoming Milestones** 

The REMAIN-1 Midpoint Cohort is ongoing, with 6-month data expected in Q1 2026. The REMAIN-1 Pivotal Cohort has completed enrollment, and the Company remains on track to randomize patients in early 2026 and deliver 6-month topline primary endpoint data and potentially file a PMA in H2 2026. These milestones are designed to evaluate Revita as the first potential therapy for post-GLP-1 weight maintenance and to open a new therapeutic category in obesity care.

------

![LOGO](g870124g0925213932816.jpg)

**Webcast Information** 

Fractyl will host a live webcast today, Friday, September 26, 2025, at 8:00 a.m. ET, to discuss the REMAIN-1 Midpoint Cohort data. The live event can be accessed in the "Events" section of Fractyl's website at <u>ir.fractyl.com.</u> The webcast will be archived and available for replay for at least 30 days after the event.

**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'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. The Company has a robust and growing IP portfolio, with 33 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign issued patents and pending applications. Fractyl is based in Burlington, MA. For more information, visit <u>www.fractyl.com</u>.

**About Revita***<sup>®</sup>*

Fractyl Health's lead product candidate, Revita, is based on the company's insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 drugs, called REMAIN-1, was initiated in the third quarter of 2024 and has completed enrollment.

**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 are forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding the promise and potential impact of our product candidates, including Revita's potential for preserving weight loss after GLP-1 drug discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort; the potential treatment population or benefits for any of our product candidates or products; 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, redefining the future of metabolic disease treatment, and positioning our Company at the forefront of the global opportunity for metabolic care or a late-stage, pre-commercial company poised to redefine metabolic care; 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

------

![LOGO](g870124g0925213932816.jpg)

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 sub-assembly components for Revita; the regulatory approval process of the FDA and comparable foreign regulatory authorities is 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 for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 12, 2025 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** 

Media Contact

Jessica Cotrone, Head of Corporate Communications

jcotrone@fractyl.com, 978.760.5622

Investor Contact

Brian Luque, Head of Investor Relations and Corporate Development

IR@fractyl.com, 951.206.1200

## Exhibit 99.2

**Exhibit 99.2**![LOGO](g870124g10a01.jpg)

Positive Randomized Data from REMAIN-1 Midpoint Cohort StudyRevita®: Unlocking Durable Weight Maintenance After GLP-1 Discontinuation September 26, 2025Revita is for Investigational Use Only in the US Under Federal Law <br>Positive Randomized Data from REMAIN-1 Midpoint Cohort StudyRevita®: Unlocking Durable WeightMaintenance After GLP-1 DiscontinuationSeptember 26, 2025Revita is for Investigational Use Only in the US Under Federal Law

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![LOGO](g870124g11a01.jpg)

2 Legal DisclaimerThe study database has not been locked as this is an ongoing study, and the data are subject to further cleaning and validation.Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this presentation include, without limitation, statements regarding the promise and potential impact of our product candidates, including Revita's potential for preserving weight loss after GLP-1 drug discontinuation; the design, initiation, timing, primary and secondary endpoints, and results of clinical enrollment and any clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort; 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, our cash runway and financial conditions, 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, redefining the future of metabolic disease treatment, and positioning our Company at the forefront at the global opportunity for metabolic care; 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 Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the Securities and Exchange Commission (the "SEC") on August 12, 2025 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.Industry DataThis presentation also contains estimates, projections and other information concerning our industry, our business and the markets in which we operate. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research, surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this presentation, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors.TrademarksThis presentation may contain trademarks, service marks, trade names and copyrights of the Company and other companies, which are the property of their respective owners. The use herein does not imply an affiliation with, or endorsement by, the owners of these trademarks, service marks, trade names and copyrights. Third-party logos herein may represent be provided simply for illustrative purposes only. Inclusion of such logos does not necessarily imply affiliation with or endorsement by such firms or businesses. There is no guarantee that the Company will work, or continue to work, with any of the firms or businesses whose logos are included herein in the future. future.This presentation shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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![LOGO](g870124g12a01.jpg)

3Hypothesis: Endoscopic duodenal ablation designed to provide:Safe, well-tolerated, straightforward procedureHighly effective metabolic disease modificationDurable weight and metabolic impact designed to last for yearsEvidence: Revita clinical experience has already shown:Sustained improvements in weight and HbA1c1,2,4Early outcomes at 1 and 3 months translated to 2 years of durable benefit1, 2Excellent safety and tolerability profile2, 3, 4, 5Healthy duodenumDiseased duodenumPost-TargetingNormal gut-to-brain signaling via satiety hormones metabolic balanceDiet-induced mucosal changes duodenal dysfunction, insulin resistance, weight gainRegenerated mucosa restored signaling, durable weight maintenance and glycemic controlTargeting Duodenal Mucosa for a Durable Metabolic ResetRevita: A Potential Breakthrough in Obesity CarePioneering the possibility of a durable metabolic reset without chronic therapy 1. Fractyl Health press release dated August 5, 2025. 2. van Baar et al. Diabetes Res Clin Pract.2022 Feb:184:109194. 3. Mingrone et al. Gut.2022 Feb;71(2):254-264. 4. van Baar et al. Gut.2020 Feb;69(2):295-303. 5. van Baar et al. JHEP Rep.2019 Nov 5;1(6):429-437

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4Majority of patients discontinue GLP-1s within 1 year2: Weight and metabolic rebound occur rapidly upon discontinuation1First symptoms are profound hunger and food noise, usually occurring within weeks of treatment discontinuationRevita is the first and only FDA Breakthrough Device targeting this gap3 High unmet need and hard-to-treat patient population for Revita's first clinical demonstration in obesity1. Adapted from Aronne et al. JAMA. 2023 Dec 11;331(1):38–48. 2. Blue Health Intelligence, Issue Brief May 2024. 3. Revita is currently being studied under an open Investigational Device Exemption (IDE) in the US and holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy. GLP-1=glucagon-like peptide-1Why Lose 20 Pounds of Fat Just to Gain it All Right Back? GLP-1s drive weight loss – but can't deliver long-term results aloneREMAIN-1 program modeled off Lilly's SURMOUNT-4 tirzepatide discontinuation study1:

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5 Key TakeawaysClear evidence of Revita activity: At 3 months, Revita patients experienced 2.5% further weight loss after stopping GLP-1s, vs 10% weight regain in sham-treated patients (p=0.014)Excellent safety and tolerability through 3 months: No Revita-related SAEs or Grade II+ AEs observed, consistent with prior Revita clinical study experience3.Positive readthrough to pivotal study: Midpoint data supports the rapidly progressing pivotal study. Pivotal Cohort is on track to complete randomization in early 2026; 6-month topline primary endpoint and potential PMA filing in H2 20261Potential backbone therapy in obesity: Addressing high unmet need in post-GLP-1 weight maintenance population opens the door for Revita as a potential backbone therapy across the spectrum of obesity and metabolic disease 1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. AE=adverse event, PMA=premarket approval, SAE=serious AE, GLP-1=glucagon-like peptide-1Remain-1 Midpoint Cohort Supports Revita's Safety, Efficacy, and Strategic Potential

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6 1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. BMI=body mass index, GLP-1=glucagon-like peptide-1, PMA=premarket approval, TBWL=total body weight loss, T2D=type 2 diabetes REMAIN-1 Pivotal Program OverviewMidpoint Cohort: designed to reinforce confidence in pivotal studyREVEAL-1Cohortn ~ 20 REMAIN-1Midpoint Cohortn ~ 45 REMAIN-1Pivotal Cohortn ~ 315Rationale Post-GLP-1 weight maintenance in a real-world setting Randomized, controlled pilot study Randomized, controlled pivotal studyDesign •Open-label •Tirzepatide run-in phase •Double-blind Revita vs sham (2:1) •Tirzepatide run-in phase •Double-blind Revita vs sham (2:1)Participants With obesity (BMI> 30 kg/m2) prior to GLP-1 and >15% TBWL with GLP-1 drug With obesity (BMI 30-45 kg/m2) without T2D and GLP-1 drug naive With obesity (BMI 30-45 kg/m2) without T2D and GLP-1 drug naiveAnticipated Milestones1 ?1-mo data: April 2025?3-mo data: June 2025•6-mo data: Q4 2025•1-yr data: Q2 2026 ?Enrollment: Q4 2024?3-mo data: Sept 2025•6-mo data: Q1 2026 ?Enrollment: Q2 2025•Randomization: Early 2026•6-mo primary endpoint and potential PMA filing: H2 2026

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7 1. Aronne et al. JAMA. 2024;331(1):38–48. doi:10.1001/jama.2023.24945. 2. Wilding et al. Diabetes Obes Metab.2022 Aug;24(8):1553-1564. 3. Fractyl Health press release dated June 23, 2025. GLP-1Rx weight loss from months -12 to 0 are illustrative based on average weight loss and time on medication in REVEAL-1 subjects. Data for Revita shown are median ± interquartile range. GLP-1Rx=glucagon-like peptide-1 therapyREVEAL-1: Encouraging Weight Maintenance at 3 MonthsPreviously reported open-label data provided an early positive signalTotal Body Weight Change (%) GLP-1Rx Post-GLP-1Rx RevitaOff GLP-1Rx Post-Revita (n=13)On GLP-1Rx Off GLP-1Rx1,2RevitaTime (Months) Time Post-GLP-1Rx (Months) Off GLP-1Rx Post-Revita (n=13)On GLP-1Rx Off GLP-1Rx1,2Total Body Weight Change (%) 12 of 13 with less than predicted regain (6 of 13 lost weight): median 0.46% at 3 months vs expected 5-6%1,2Shared in June 20253

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8 REMAIN-1 Midpoint Cohort Study in Weight MaintenanceFirst randomized sham-controlled study in post-GLP-1 weight maintenance1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. 2. Aronne et al. JAMA. 2023 Dec 11;331(1):38–48.GLP-1=glucagon-like peptide, TBW= total body weight, TBWL= total body weight loss, TZP= tirzepatide, T2D=type 2 diabetes Patient PopulationAdults with obesity (BMI 30-45 kg/m2)GLP-1 naïve; no T2DN=45 Efficacy Endpoints% TBW change Revita vs sham at 3 and 6 monthsStudy DesignRandomized (2:1 Revita vs sham), double-blind, sham-controlled Tirzepatide administration to achieve 15% TBWL, then discontinuedDiet and lifestyle counseling throughoutTirzepatide Initiation and Titration\* to Achieve 15% TBWLRevitaTreatmentn=~30Weight at3 and 6 months n=~30Discontinue Tirzepatide,2:1 Randomization Sham Proceduren=~15Weight at3 and 6 monthsn=~15Study DesignAnticipated Milestones1Midpoint Cohort 3-mo data: Sept 2025•Midpoint Cohort 6-mo data: Q1 2026\*Tirzepatide run-in modeled from SURMOUNT-4 trial2

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9 REMAIN-1 Midpoint Cohort Patient Disposition Strong study execution, high retention, scalable procedure Tirzepatide run-in and dose-escalation period was approximately 16-26 weeks. Sham procedure consisted of placing the Revita catheter into the duodenum for a minimum of 30 minutes with no manipulations of the device or activation of the catheter 46 Screened for Eligibility 46 Enrolled in Tirzepatide Run-In 29 Revita Treatment Figure 1. Patient Disposition 16 Sham Procedure 29 3-Mo Follow-Up 16 3-Mo Follow-up 45 Safety Population45 Efficacy Population 46 Achieved 15% TBWL Randomized (2:1) 1 Excluded During Screening Endoscopy (Duodenitis) No dropouts between baseline visit and screening endoscopyConsistent procedure performance (average ablation length ~16 cm) supports scalability of technique100% retention through 3 months

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10 Balanced, Representative Study Population Supports Generalizability of Results1. Fractyl Health REVEAL-1 data disclosure https://ir.fractyl.com/static-files/8110e855-b50a-4333-b551-678d5e854663. 2. Fractyl Health data on file. \*Patients with a diagnosis of pre-diabetes in their medical history. \*\* Per protocol definition of pre-diabetes: screening HbA1c between 5.7% and 6.5% and/or screening fasting plasma glucose between 100 to 125 mg/dL. Tirzepatide run-in and dose-escalation period was approximately 16-26 weeks. Sham procedure consisted of placing the Revita catheter into the duodenum for a minimum of 30 minutes with no manipulations of the device or activation of the catheter. BMI=body mass index, SD=standard deviation, TZP=tirzepatide, TBW=total body weight Demographic/Characteristic Revita (n=29) Sham (n=16) Total (N=45)Age, yrs, mean (SD) 44 (14) 40 (11) 43 (13)Sex, no. (%)Male 6 (21) 3 (19) 9 (20)Female 23 (79) 13 (81) 36 (80)Body Weight Pre-TZP, kg, mean (SD) 100 (16) 99 (15) 99 (15)BMI Pre-TZP, kg/m2, mean (SD) 37 (4) 36 (4) 37 (4)Pre-diabetes Diagnosis\*, no. (%) 3 (10) 0 (0) 3 (7)Pre-diabetes at Screening\*\*, no. (%) 14 (48) 5 (31) 19 (42)

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11Both Arms Achieved 18% Weight Loss on Tirzepatide Priorto RandomizationTirzepatide run-in and dose-escalation period was approximately 16-26 weeks. Sham procedure consisted of placing the Revita catheter into the duodenum for a minimum of 30 minutes with no manipulations of thedevice or activation of the catheter. TZP=tirzepatide.Table 2: Post-tirzepatide Run-in Characteristics• Baseline and Run-incharacteristics balancedacross treatment arms• Wide baseline weight rangedemonstrates relevanceacross diverse obesitypatientsCharacteristicRevita(n=29)Sham(n=16)Total(N=45)Body Weight, kg,Post-TZP Baseline, mean (SD) 82 (13) 81 (13) 82 (13)Min, Max Baseline 64, 115 59, 103 59, 115TBW Change on TZP, %, mean (SD) -18 (2) -18 (2) -18 (2)BMI, kg/m2, mean (SD)Post-TZP Baseline, mean (SD) 30 (3) 30 (4) 30 (4)Min, Max Baseline 25, 37 24, 38 24, 38Post-TZP Waist Circumference, cm, mean (SD) 92 (10) 96 (13) 94 (11)All patients achieved meaningful weight loss on GLP-1s, creating a rigorous "stress test" ofRevita's ability to prevent weight regain

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127 58 08 59 09 50 1 3Least-squares mean (LS mean) estimates were derived from a mixed model for repeated measures (MMRM), with treatment, visit, and treatment×visit interaction as fixed effects, andbaseline weight and as a covariate. LS means are presented at the overall mean baseline to standardize comparisons between groups. Error bars represent standard errors of the LSmeans. Absolute total body weight changes calculated from post-tirzepatide grand mean baseline value at week -1. GLP-1= glucagon-like peptide 1, LS=least squares, SEM=standarderror of the meanClear Evidence of Revita ActivityStudy met 3-month efficacy endpoint with strong statistical significanceFigure 2: Total Body Weight Change by MonthTotal Body WeightChange from Baseline (kg)Time (Months)10.3 kg TreatmentDifference at 3 Months(p=0.014)+8.2 ± 3.5 kg-2.1 ± 2.2 kgRevita (n=29) (LS Mean±SEM)Sham (n=16) (LS Mean±SEM)

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50-2.5 ± 2.7% 12.5% Treatment Difference at 3 Months (95% CI, -18.4 to -2.1%) [GRAPHIC APPEARS HERE]-50 1 3Time (Months)[GRAPHIC APPEARS HERE]Least-squares mean (LS mean) estimates were derived from a mixed model for repeated measures (MMRM), with treatment, visit, and treatment×visit interaction as fixed effects, andbaseline weight as a covariate. LS means are presented at the overall mean baseline to standardize comparisons between groups. Error bars represent standard errors of the LS means. 13Percent total body weight changes calculated from post-tirzepatide baseline value at week -1. CI=confidence interval, GLP-1= glucagon-like peptide 1, LS=least-squares, SEM=standarderror of the mean

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No treatment-emergent serious Table 3: Treatment-Emergent Adverse EventsRevita(n=29) Sham(n=16) Total(N=45) adverse events related to device orprocedure• \*1 SAE (cholecystitis) > 60 days post- randomization—unrelated todevice or procedure• 4 mild procedure-related events(Grade I) in Revita, 0 in Sham•No TEAE-related study discontinuations•Compelling safety and tolerability profile consistent with prior Revita clinical experience Patients Experiencing Any TEAEn, % of subjects with events 7 (24)1 (6)8 (18)[GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]TEAEs by Grade, n 12113[GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]Grade ≥III TEAEs, n, % 1\* (8) 0 (0) 1\* (8) Grade II TEAEs, n, % 0 (0) 0 (0) 0 (0) Grade I TEAEs, n, % 11 (92) 1 (100) 12 (92)[GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]Related TEAEs\*\*, n 404Diarrhea000Abdominal discomfort101Nausea101Vomiting000Dry mouth101Sore Throat101 [GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]Clavien-Dindo Classification1: Standardized FDA recommended system for TEAE grading: Grade I: minor, any deviation from normal course without requiring treatment; Grade II: requiring treatment; Grade III: requiring surgical, endoscopic, radiologic intervention; Grade IV: Life-threatening, requiring ICU; Grade V: Death\*\*Related TEAEs are defined as definitely or probably related to the device and or procedure. Interim data reported are subject to further clinical evaluation committee review and adjudication. 1. Dindo et al. Annals of Surgery 240(2):p 205-213, August 2004. ICU=intensive care unit, GLP-1=glucagon-like peptide-1, TEAE= treatment-emergent adverse event.

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Patient population• Adults with obesity (BMI 30-45 kg/m2)• GLP-1 naïve; no T2D• N=~ 315 Co-primary endpoints• % TBW regain: Revita vs sham at 6 months; and• Responder rate: % participants who maintain weight loss at 12 months Study design• Randomized (2:1 Revita vs Sham), double-blind, sham- controlled• TZP administration to achieve ≥ 15% TBWL, then discontinued[GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]• Diet and lifestyle counseling throughout Anticipated milestones1• Complete randomizations: early 2026• Pivotal Cohort data: 6-month primary endpoint H2 2026• Potential PMA filing: H2 2026 [GRAPHIC APPEARS HERE]Tirzepatide Study Design Discontinue RevitaTreatment Weightat 6 months Weightat 12 months Initiation andTitration to Achieve≥ 15% TBWL Tirzepatide2:1Randomization ShamProcedure Weightat 6 months [GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factorsto these and other estimates and expectations. BMI=body mass index, GLP-1=glucagon-like peptide 1, TBW= total body weight, TBWL= total body weight loss, TZP= tirzepatide, T2D=type 2 15diabetes.

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16 Observed 3-Month Treatment Effect Supports Potential Success in 6-Month Pivotal Cohort Primary Endpoint-505101520250136 Total Body Weight Change from Baseline (%) Time (Months) Sham arm expected to continue weight gain Revita arm expected to maintain weightIllustrative12.5% difference at 3 months (p=0.014)Mucosa healed post-Revita5 half-lives post-TZP

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450400350 First site [GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE][GRAPHIC APPEARS HERE]REMAIN-1 EnrollmentMidpoint Cohort enrolled REMAIN-1 Pivotal Cohort fully enrolled[GRAPHIC APPEARS HERE]3 months ahead of scheduleHigh site and patient enthusiasmpoints to unmet need 300 activated250 200150100500Aug '24 Sep'24 Oct ' 24 Nov ' 24 Dec ' 24 Jan ' 25 Feb ' 25 Mar ' 25 Apr ' 25 Multicenter U.S. study with community and academic site participation[GRAPHIC APPEARS HERE]Demand outstripped capacity at some centers Rapid enrollment in first pivotal weight maintenance study reflects real-world clinical interest, physician engagement, and patient demand – key signals of commercial uptake potential[GRAPHIC APPEARS HERE]17

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GI endoscopists focused on obesity and metabolic disease therapies are currently participating in clinical studies An estimated800k will get an endoscopy [GRAPHIC APPEARS HERE]Potential candidates for Revita procedure[GRAPHIC APPEARS HERE]18

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19 Midpoint Cohort achieved its goal: Clear evidence of Revita's activity Highly encouraging safety and tolerability profileBuilds confidence in powering assumptions for pivotalMomentum and acceleration into next steps1:Midpoint Cohort: Anticipate 6-month results from these 45 subjects in Q1 2026Pivotal Cohort: Study is fully enrolled and randomizing ahead of forecast. Anticipate completing randomizations in early 2026; topline primary endpoint and potential PMA filing in H2 2026Potential backbone therapy in obesity: Proof-of-concept validated in post-GLP-1 weight maintenance Opens the door for Revita as potentially first-line therapy in obesity and metabolic disease, add-on to GLP-1, etc.1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. GLP-1=glucagon-like peptide 1, PMA=premarket approval3-Month Midpoint Results Support Revita's Opportunity to Fundamentally Alter the Landscape of Obesity Treatment

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20 Significant Clinical Milestones for Revita in Weight Maintenance Over the Next 12 Months1. These forward-looking statements are based on management's current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. PMA=premarket approvalKey anticipated milestones12025 2026Platform Indication Program Recent accomplishments Q4 Q1 Q2 Q3 Q4Revita(Outpatient endoscopic procedural therapy) Weight Maintenance REVEAL-1 Cohort(Open Label) ?Durable 3-mo data shared(June 2025) 6-month open-label data in Q4 2025 1-year open-label data in Q2 2026 REMAIN-1 Midpoint Cohort ?3-mo sham-controlled data demonstrated prevention of weight regain(Sept 2025) Randomized 6-month data in Q1 2026 REMAIN-1 Pivotal Cohort ?Completed enrollment(May 2025) Complete randomization in early 2026 6-month primary endpoint data and potential PMA filing in H2 2026