# EDGAR Filing Document

**Accession Number:** 0001572616
**File Stem:** 0001193125-26-028228
**Filing Date:** 2026-1
**Character Count:** 47456
**Document Hash:** a348d60066a2285be2ba9b34ff9c0e01
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-028228.hdr.sgml**: 20260129

**ACCESSION NUMBER**: 0001193125-26-028228

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 30

**CONFORMED PERIOD OF REPORT**: 20260129

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260129

**DATE AS OF CHANGE**: 20260129

**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:** 26574871

**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**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 29, 2026<br>

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Fractyl Health, Inc.

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

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| | | |
|:---|:---|:---|
| Delaware | 001-41942 | 27-3553477 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission 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<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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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:**

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

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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 January 29, 2026, Fractyl Health, Inc. (the "Company" or "Fractyl") issued a press release announcing 6-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, January 29, 2026 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 January 29, 2026, the Company reported 6-month data from its REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita<sup>®</sup> for weight maintenance following GLP-1 drug discontinuation.

**Key Six-Month Findings**

Data reflect outcomes through 6 months of follow-up. The REMAIN-1 Midpoint Cohort is ongoing, with 12-month randomized data expected in Q3 2026. The Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis, and p-values are provided to describe the strength and consistency of observed treatment effects.

**Strong, continued weight maintenance benefit in patients with above median GLP-1 induced weight loss:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Across the prespecified efficacy population (n=40, with five participants excluded per protocol due to diet and lifestyle noncompliance and only included in the safety population), Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months (p=0.07, one-sided), consistent with meaningful and sustained attenuation of the expected post-GLP-1 rebound trajectory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•An exploratory analysis of patients who achieved above median weight loss during GLP-1 run-in (n=20) showed that Revita-treated participants experienced 4.2% weight regain versus 13.3% with sham at 6 months, corresponding to an approximately 70% relative reduction in post-GLP-1 weight regain (LS mean difference -9.1%; p=0.004, one-sided).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•As expected, treatment-by-run-in weight loss interaction terms suggested a meaningful relationship between degree of GLP-1-associated weight loss and the magnitude of Revita benefit.

**Supportive cardiometabolic and appetite-related exploratory endpoint results consistent with observed weight maintenance:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Revita-treated patients demonstrated improvements in cardiometabolic lipid parameters versus sham at 6 months, including increased HDL cholesterol (15.5 vs 3.9 mg/dL; p=0.01, one-sided) and reduced triglyceride-to-HDL ratio (-0.2 vs +0.4; p=0.03, one-sided), indicating improved metabolic regulation following GLP-1 discontinuation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Patient-reported outcomes showed meaningful reductions in sweet-food craving versus sham (1.8 vs 3.4; p=0.04, one-sided), supporting a gut-mediated mechanism for attenuated post-GLP-1 appetite drive and weight regain.

**Excellent safety and tolerability:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Revita continued to demonstrate a favorable safety and tolerability profile through six months, with no treatment-emergent serious adverse events related to the device or procedure, no study discontinuations due to adverse events

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•No new related adverse events were observed between 3- and 6-month follow up.

**Progress in US Regulatory Strategy**

Based on ongoing interactions with the U.S. Food and Drug Administration (FDA) and the encouraging safety and tolerability profile observed to date, Fractyl requested feedback from the FDA on potentially reclassifying Revita under the De Novo pathway, rather than a Premarket Approval (PMA). The De Novo pathway is intended for novel medical devices with low-to-moderate risk profiles and may enable a more efficient, risk-based regulatory review process. The Company expects FDA feedback on the De Novo request in the second quarter of 2026.

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**Advancing Toward Value-Driving Catalysts in 2026:**

Fractyl is advancing toward multiple anticipated clinical and regulatory milestones across its REMAIN-1 weight maintenance program, supporting a clear and sequential path toward pivotal readout and potential U.S. regulatory submission:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•February 2026: Complete randomizations in REMAIN-1 Pivotal Cohort

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q2 2026: FDA feedback on De Novo pathway request

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q2 2026: 1-year REVEAL-1 Cohort data

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q3 2026: 1-year REMAIN-1 Midpoint Cohort randomized data

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•H2 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•H2 2026: Potential FDA filing in 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 the Company's 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 the Company's product candidates or products; the Company's regulatory strategy, including potential benefits of the De Novo pathway; the Company's 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 the 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 factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 12, 2025 and in the Company's 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.

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| | |
|:---|:---|
| **Exhibit No** | **Description** |
| 99.1 | [<u>Press Release dated January 29, 2026</u>](guts-ex99_1.htm) |
| 99.2 | [<u>Conference Call Presentation dated January 29, 2026</u>](guts-ex99_2.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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **Fractyl Health, Inc.** |
| Date: | January 29, 2026 | By:  | /s/ Harith Rajagopalan |
|  |  |  | **Harith Rajagopalan, M.D., Ph.D.**<br>Co-Founder, Chief Executive Officer and Director <br>(Principal Executive Officer) |

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## Exhibit 99.1

**Exhibit 99.1**

**Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita**<sup>®</sup>**After GLP-1 Discontinuation**

*Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability*

*Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months*

*Results support pivotal study design and further substantiate Revita's potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026*

*Based on ongoing interactions and favorable safety data to date, the Company has requested FDA feedback on reclassifying Revita under the De Novo pathway, which is expected in Q2 2026*

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

**BURLINGTON, Mass., January 29, 2026 (GLOBE NEWSWIRE)** – Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company developing disease-modifying solutions for obesity and type 2 diabetes, today announced positive six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita® for weight maintenance following GLP-1 drug discontinuation. These results reinforce the biological rationale for Revita, support the potential durability of effect, and provide increased confidence in the ongoing REMAIN-1 pivotal study.

"These pilot study results build on our prior clinical experience and represent another important validation and step toward establishing Revita as a potential first-in-class therapy for post-GLP-1 weight maintenance," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health. "These findings reinforce our confidence in our development strategy, trial design and potential regulatory pathway as we advance toward pivotal readout and potential FDA submission later this year."

**Key Six-Month Findings**

Data reflect randomized outcomes through 6 months of follow-up. The REMAIN-1 Midpoint Cohort is ongoing, with 12-month randomized data expected in Q3 2026. The Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis, and p-values are provided to describe the strength and consistency of observed treatment effects.

**Strong, continued weight maintenance benefit:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Across the prespecified efficacy population (n=40, with five participants excluded per protocol due to diet and lifestyle noncompliance and only included in the safety population), Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months (p=0.07, one-sided), consistent with meaningful and sustained attenuation of the expected post-GLP-1 rebound trajectory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•An exploratory analysis of patients who achieved above median weight loss during GLP-1 run-in (n=20) showed that Revita-treated participants experienced 4.2% weight regain versus 13.3% with sham at 6 months, corresponding to an approximately 70% relative reduction in post-GLP-1 weight regain (LS mean difference -9.1%; p=0.004, one-sided).

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•As expected, treatment-by-run-in weight loss interaction terms suggested a meaningful relationship between degree of GLP-1-associated weight loss and the magnitude of Revita benefit.

**Supportive cardiometabolic and appetite-related exploratory endpoint results consistent with observed weight maintenance:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Revita-treated patients demonstrated improvements in cardiometabolic lipid parameters versus sham at 6 months, including increased HDL cholesterol (15.5 vs 3.9 mg/dL; p=0.01, one-sided) and reduced triglyceride-to-HDL ratio (-0.2 vs +0.4; p=0.03, one-sided), suggesting improved metabolic regulation following GLP-1 discontinuation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Patient-reported outcomes showed meaningful reductions in sweet-food craving versus sham (1.8 vs 3.4; p=0.04, one-sided), supporting a gut-mediated mechanism for attenuated post-GLP-1 appetite drive and weight regain.

**Excellent safety and tolerability:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Revita continued to demonstrate favorable safety and tolerability results through six months, with no treatment-emergent serious adverse events related to the device or procedure, and no study discontinuations due to adverse events.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•No new related adverse events were observed between 3- and 6-month follow up.

"What is particularly compelling about these six-month data is the consistency of the metabolic signal," said Dr. Adarsh Thaker, M.D., Assistant Professor of Medicine, David Geffen School of Medicine at UCLA. "These patients are typically at highest risk for rapid weight regain after discontinuation, with GLP-1 mediated weight loss followed by sudden drug discontinuation. Seeing a large attenuation in rebound in this population, together with supportive metabolic and appetite-related findings, provides even further evidence that Revita may be addressing underlying biological drivers of post-GLP-1 weight regain rather than simply delaying it. I cannot wait to see the pivotal REMAIN-1 results later this year."

**Progress in US Regulatory Strategy**

Based on ongoing interactions with the U.S. Food and Drug Administration (FDA) and the encouraging safety and tolerability data observed to date, Fractyl requested FDA feedback on potentially reclassifying Revita under the De Novo pathway, rather than a Premarket Approval (PMA). The De Novo pathway is intended for novel medical devices with low-to-moderate risk profiles and may enable a more efficient, risk-based regulatory review process. The Company expects FDA feedback regarding the potential for use of the De Novo pathway in the second quarter of 2026.

**Advancing Toward Value-Driving Anticipated Catalysts in 2026:**

Fractyl is advancing toward multiple anticipated clinical and regulatory milestones across its REMAIN-1 weight maintenance program, supporting a clear and sequential path toward pivotal readout and potential U.S. regulatory submission:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•February 2026: Complete randomizations in REMAIN-1 Pivotal Cohort

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q2 2026: FDA feedback on potential for use of De Novo pathway

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q2 2026: 1-year REVEAL-1 Cohort data

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Q3 2026: 1-year REMAIN-1 Midpoint Cohort randomized data

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•H2 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•H2 2026: Potential FDA marketing application submission in post-GLP-1 weight maintenance

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**Conference Call and Webcast** 

Fractyl Health will host a conference call and webcast today, January 29, 2026, at 8:00 a.m. Eastern Time. To access the live conference call by phone, dial 1-877-425-9470 (domestic) or 1-201-389-0878 (international), and provide the access code 13758486. A live webcast of the conference call 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 disease-modifying treatments that address the root causes of obesity and type 2 diabetes. The Company's approach targets organ-level dysfunction to enable durable metabolic control without the burden of chronic therapy. Fractyl is headquartered in Burlington, Massachusetts.

**About Revita®**

Revita is Fractyl Health's lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. Revita has received FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is investigational in the United States and is CE marked in the European Union and United Kingdom.

**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 regulatory strategy, including potential benefits of the De Novo pathway; 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 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 September 30, 2025, filed with the Securities and Exchange Commission on November 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

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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.

**Investor Contact:**

Lara Smith Weber

CFO

IR@fractyl.com

617-835-5912

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## Exhibit 99.2

![Slide 1](guts-ex99_2s1.jpg)

January 29, 2026 Positive 6-Month Randomized Datafrom REMAIN-1 Midpoint Cohort - Accelerating Momentum Towards Revita's Potential Approval and Launch Revita is for investigational use only in the United States. Revita has a CE mark in the EU/UK. Exhibit 99.2

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![Slide 2](guts-ex99_2s2.jpg)

Legal disclaimer The 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 REVEAL-1 and REMAIN-1 Cohorts; 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, our regulatory strategy, including potential benefits of the De Novo pathway, the potential treatment population or benefits for any of our product candidates, our expected 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 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 September 30, 2025 filed with the Securities and Exchange Commission (the "SEC") on November 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 data This 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. Trademarks This 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.©2026 Fractyl Health, Inc. All Rights Reserved.

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![Slide 3](guts-ex99_2s3.jpg)

Accelerating Momentum Towards Revita'sFDA Submission and Potential Commercial Launch Positive 6-Month Data from REMAIN-1 Midpoint Cohort Strong evidence of sustained weight maintenance vs. sham with excellent safety and tolerability profile Patients with greater1 GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months (p=0.004, one-sided) Reinforced confidence in ongoing pivotal study Progress in US Regulatory Strategy Requested to reclassify Revita under the De Novo pathway (vs. PMA); FDA feedback expected Q2 2026 Potential to enable a more efficient, risk-based regulatory review process and reduce cost Advancing Commercial Readiness Leveraging well-understood FDA Breakthrough and CMS TPT timelines Focused, capital-efficient go-to-market strategy aligned with existing endoscopy care pathway 1. Above median. Abbreviations: CMS, Centers for Medicare and Medicaid Services; FDA, Food and Drug Administration; GLP-1, glucagon-like peptide-1; PMA, premarket approval; TPT, Transitional Pass-Through.

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![Slide 4](guts-ex99_2s4.jpg)

Revita®: Potential new backbone therapy in obesity A one-time, < 1 hr endoscopic procedure designed to address gut-level metabolic dysfunction Abbreviations: FDA, Food and Drug Administration; GLP-1, glucagon-like peptide-1. Single outpatient endoscopic procedure Consistent clinical results across studies FDA Breakthrough Device designation Performed by endoscopists; leverages familiar skills Up to 2 years of durable activity after a single treatment across multiple clinical studies 2026 is a pivotal and registrational year in post-GLP-1 weight maintenance Positive 6-month Midpoint Cohort data Provides increased confidence in the ongoing pivotal study

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![Slide 5](guts-ex99_2s5.jpg)

REMAIN-1 midpoint cohort study in weight maintenance Pilot randomized study designed to inform effect size and pivotal study execution 1 p values are provided to describe the strength and consistency of observed treatment effects Abbreviations: GLP-1, glucagon-like peptide; R, randomization; T2D, type 2 diabetes; TBW, total body weight; TBWL, total body weight loss; TZP, tirzepatide. Patient population Adults with obesity(BMI 30-45 kg/m2) GLP-1 naïve; no T2D Efficacy endpoints % TBW change from baseline Revita vs sham at 3, 6 and 12 months Study design Randomized (2:1 Revita vs Sham), double-blind, sham-controlled TZP administration to achieve≥ 15% TBWL, then discontinued Diet and lifestyle counseling throughout Sample size n=45 Not powered for formal hypothesis testing1 Tirzepatide initiationand titration\* to achieve≥ 15% TBWL Revita treatment(n≈30) Weight at 3, 6, & 12 months (n≈30) Sham procedure (n≈15) Weight at 3, 6, & 12 months (n ≈15) Study design Discontinue TZP 2:1 R©2026 Fractyl Health, Inc. All Rights Reserved.

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Abbreviations: R, randomization; TBWL, total body weight loss; TZP, tirzepatide. 1. Prospectively defined pre-specified protocol deviations due to consecutive non-adherence to diet/lifestyle requirements per blinded dietitian REMAIN-1 midpoint cohort patient disposition High retention rate through 6 months of follow-up 44/45 participants (98%) completed 6-month follow-up Efficacy analysis includes all participants who followed protocol-specified diet and exercise requirements Screened N=46 Enrolled TZP run-in N=46 Achieved ≥15% TBWL (2:1 R) N=46 Patient disposition Sham procedure (n=16) 6-month follow-up 6-month follow-up Discontinued (n=1) Efficacy population (n=40) Safety population (n=45) Protocol deviations (n=5)1 Revita treatment(n=29) Screen failed (n=1)

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REMAIN-1 midpoint cohort body weight change Revita outperformed Sham; post-tirzepatide weight regain <50% expected Change from baseline through 6 months analyzed using a mixed model for repeated measures (MMRM); LS mean ± SEM shown; one-sided p-value reported. 1Aronne et al. JAMA. 2023 Dec 11;331(1):38–48 . 2Wilding et al. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. 3 Excluded 5 subjects per protocol from efficacy analysis; included in safety assessment Abbreviations: BL, baseline; GLP-1, glucagon-like peptide-1; LS, least-squares; SEM, standard error of the mean.©2026 Fractyl Health, Inc. All Rights Reserved. Total Body Weight Change from BL (LS Mean % ± SEM) 6-Month Body Weight Change3 Revita n=24 Sham n=16 Revita reduced post-tirzepatide weight regain vs. sham at 6 months (p=0.07 with only n=40) ~30% of Revita-treated patients maintained or continued to lose weight We believe these results in n=40 validate REMAIN-1 pivotal study design Expected Regain1,2 4.5% 7.5% p=0.07

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Revita demonstrated greatest benefit in patients with above median GLP-1-induced weight loss Change from baseline through 6 months analyzed using a mixed model for repeated measures (MMRM); LS mean ± SEM shown; one-sided p-value reported. 1Aronne et al. JAMA. 2023 Dec 11;331(1):38–48 . 2Wilding et al. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. 3 Excluded 5 subjects per protocol from efficacy analysis; included in safety assessment 4 Exploratory analysis Abbreviations: BL, baseline; GLP-1, glucagon-like peptide-1; LS, least-squares; SEM, standard error of the mean.©2026 Fractyl Health, Inc. All Rights Reserved. Total Body Weight Change from BL (LS Mean % ± SEM) 6-Month Body Weight Change3 Revita n=13 Sham n=7 Patients with greater weight loss on GLP-1s are at highest risk for weight regain following discontinuation2 REMAIN-1 was intentionally designed to randomize those with at least 15% TBWL on tirzepatide because these represent a population at high-risk of weight regain Analyzed impact of run-in %TBWL on primary efficacy parameters In these patients, Revita reduced weight regain by approximately 70% versus sham at 6 months (p=0.004)4 Expected Regain1,2 4.2% 13.3% p=0.004

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Improvements in cardiometabolic lipid profile at 6 months consistent with improved insulin sensitivity and lipid handling: Improved HDL-C Improved TG:HDL ratio Patient-reported outcomes suggest trend toward improved appetite regulation consistent with biological hypothesis of duodenal control of food craving Reduced craving intensity, particularly for sweet foods CoEQ Parameter Craving control 2.3 (0.7) 3.1 (1.0) 0.21 Craving for sweet 1.8 (0.6) 3.4 (0.8) 0.04 Cardiometabolic and food craving parameters consistent with attenuated post-GLP-1 rebound LS Mean change from BL (SEM)1 Cardiometabolic Parameter Revita (n = 24) Sham (n = 16) p-value Triglycerides, mg/dL 9.1 (11.2) 27.5 (15.2) 0.11 LDL-C, mg/dL 3.9 (6.2) 3.9 (8.9) 0.44 HDL-C, mg/dL 15.5 (3.1) 3.9 (4.3) 0.01 VLDL-C, mg/dL 1.9 (2.2) 5.7 (3.0) 0.10 Triglyceride : HDL ratio -0.2 (0.2) 0.4 (0.3) 0.03 HbA1c, % 0.1 (0.04) 0.2 (0.06) 0.14©2026 Fractyl Health, Inc. All Rights Reserved. Abbreviations: BL, baseline; GLP-1, glucagon-like peptide-1; HbA1c, glycated hemoglobin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; LS, least-squares; mg/dL, milligrams per deciliter; mg/L, milligrams per liter; SEM, standard error of the mean; TG:HDL, triglyceride-to-HDL ratio; VLDL-C, very low-density lipoprotein cholesterol. 1 Excluded 5 subjects per protocol from efficacy analysis; included in safety assessment

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Treatment-EmergentAdverse Events (TEAEs) Revita (n = 29) Sham (n = 16) Total (N = 45) Patients experiencing any TEAE n, (%) of subjects with event 8 (28) 2 (13) 10 (22) TEAEs by grade, n (%) 13 3 16 Grade ≥3 TEAEs 1 (8) 0 (0) 1\* (6) Grade 2 TEAEs 1 (8) 1 (33) 2\*\* (13) Grade 1 TEAEs 11 (85) 2 (67) 13 (81) Related TEAEs†, n 4 0 4 Abdominal discomfort 1 0 1 Nausea 1 0 1 Dry mouth 1 0 1 Sore throat 1 0 1 \*1 SAE (cholecystitis) > 60 days post-randomization – unrelated to device or procedure. \*\*2 Grade 2 AEs (Revita-hypertension/worsening high blood pressure, Sham-urinary tract infection) >200 days post-randomization - unrelated to device or procedure. †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. Clavien-Dindo Classification1: Standardized FDA-recommended system for TEAE grading: Grade 1: Minor, any deviation from the normal course without requiring treatment. Grade 2: Requiring treatment. Grade 3: Requiring surgical, endoscopic, radiologic intervention. Grade 4: Life-threatening, requiring ICU. Grade 5: Death. 1Dindo et al. Annals of Surgery 240(2):p 205-213. Abbreviations: AE, adverse event; ICU, intensive care unit; GLP-1, glucagon-like peptide-1; TEAE, treatment-emergent AE. Excellent safety and tolerability through 6 months No new related Treatment-Emergent AEs between 3-month and 6-month follow-up©2026 Fractyl Health, Inc. All Rights Reserved. No Treatment-Emergent Serious AEs related to device or procedure No TEAE-related study discontinuations Related TEAEs only mild in severity and temporary Safety and tolerability consistent with prior Revita clinical experience

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Addressing key risks for the ongoing REMAIN-1 pivotal study Abbreviations: SAP, statistical analysis plan; T2D, type 2 diabetes.©2026 Fractyl Health, Inc. All Rights Reserved. Excellent safety/tolerability and proof-of-concept efficacy results in Midpoint Cohort Midpoint Cohort gives confidence that pivotal study is appropriately powered for success Pivotal Cohort proceeding well and ahead of plan Safety consistent with prior Revita studies; no new signals Magnitude and durability of effect consistent across Revita clinical studies in T2D and weight maintenance Observed treatment effect aligns with pivotal powering assumptions Observed effect size within (or above) range assumed in pivotal power calculations Key prognostic covariates identified and prespecified in SAP Midpoint data support statistical model and endpoint sensitivity Randomization pacing ahead of original timelines Site performance consistent with expectations Randomization, retention, and follow-up rates within plan

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REMAIN-1 pivotal study in weight maintenance Pivotal Cohort fully enrolled; ~ 95% randomized 1These 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. Abbreviations: BMI, body mass index; GLP-1, glucagon-like peptide 1; R, randomization; TBW, total body weight; TBWL, total body weight loss; TZP, tirzepatide; T2D, type 2 diabetes. 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 monthsand Responder rate:% participants who maintain at least 5% TBWL at 12 months Study design Randomized (2:1 Revita vs Sham), double-blind, sham-controlled TZP administration to achieve≥ 15% TBWL, then discontinued Diet and lifestyle counseling throughout Anticipated milestones1 Complete randomizations: Feb 2026 Pivotal cohort data:6-month primary endpointH2 '26 Potential Regulatory filing:H2 '26 Study design Tirzepatide initiationand titration\* to achieve≥ 15% TBWL Revita treatment Weight at 6 months Weight at 12 months Shamprocedure Weight at 6 months Discontinue Tirzepatide 2:1 R©2026 Fractyl Health, Inc. All Rights Reserved.

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Potential for a more efficient US regulatory path Anticipated FDA feedback on potential use of De Novo pathway in Q2 2026 Interactive dialogue with FDA regarding encouraging safety and tolerability data to date In light of these discussions, the company has requested feedback from FDA on potentially reclassifying Revita under the De Novo pathway instead of PMA Potential to enable a more efficient, risk-based regulatory review process©2026 Fractyl Health, Inc. All Rights Reserved. Source: FDA device classification regulations (21 CFR); FDA device classification regulations (21 CFR). Both De Novo and PMA pathways require demonstration of reasonable assurance of safety and effectiveness. Abbreviations: FDA, Food and Drug Administration; PMA, premarket approval. De Novo Classification PMA (Premarket Approval) Intended Device Risk Class I or II (low to mid risk) Class III (high risk) Clinical EvidenceRequired Scaled to risk; often smaller and more targeted Extensive clinical data with potentially larger and costlier studies Statutory FDA Review Timeline 150 FDA days 180 FDA days Downstream Optionality Creates predicate for future 510(k)s No predicate created Capital Efficiency Potentially more capital-efficient Potentially capital-intensive FDA Regulatory Pathways: De Novo vs. PMA

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REMAIN-1 Midpoint 6 Mo Data Jan 2026 Leveraging well-understood FDA Breakthrough and CMS TPT timelines Timing subject to regulatory, CMS and AMA review cycles. 1TCET (Transitional Coverage of Emerging Technologies) represents potential upside and not required for launch. Abbreviations: AMA, American Medical Association; CMS, Centers of Medicare and Medicaid Services; COE, centers of excellence; CPT, Current Procedural Terminology; FDA, Food and Drug Administration; TPT, Transitional Pass-Through.©2026 Fractyl Health, Inc. All Rights Reserved. US regulatory and reimbursement alignment Potential FDA Submission H2 2026 Category III CPT Code Effective, if approved CMS Transitional Pass-Through (TPT) Application TPT Effective (Target), if approved Potential FDA Approval(Target) REMAIN-1 Pivotal 6 Mo data H2 2026 Category III CPT Code Application FDA Breakthrough Device Designation Initial US Reimbursement with Category III CPT Code and CMS TPT Payment US Commercial Launch at COEs FDA Breakthrough Device designation and CMS TPT profile may support early US commercialization at hospital-based Centers of Excellence (COEs), if approved

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Targeted and efficient commercial model at Revita Centers of Excellence if approved Abbreviation: CMS, Centers of Medicare and Medicaid Services; COE, centers of excellence; CPT, Current Procedural Terminology©2026 Fractyl Health, Inc. All Rights Reserved. Delivered in endoscopy suites (~ 2,000–4,000 endoscopy suites across the U.S. alone) Planned COE launch with a targeted sales force in centers of excellence (likely ~50 centers in year 1, with already established relationships at clinical centers and Bariendo) Estimated capacity of ~1,200 procedures annually per center once fully operational Procedure has a short learning curve (typically mastered within ~4 cases) Candidate Sites for Revita Launch Revita Midpoint & Pivotal Sites Capital-efficient model may leverage existing infrastructure

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Near-term anticipated clinical catalysts and value-creation through to potential FDA submission in H2 20261 1These 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. Abbreviations: PMA, premarket approval. Revita Outpatient endoscopic procedural therapy 2026 Key Anticipated Milestones1 Indication Program Recent accomplishments Q1 Q2 Q3 Q4 Weight Maintenance REVEAL-1 Cohort (Open Label) Durable 6-mo data shared (Dec '25) 1-year data REMAIN-1 Midpoint Cohort 3-mo sham-controlled data showed prevention of weight regain (Sept '25) Randomized6-mo datain late Jan '26 1-year data REMAIN-1 Pivotal Cohort Completed enrollment (May '25) Complete randomization in Feb '26 FDA Feedback on De Novo Pathway 6-mo primary endpoint data& potential FDA submission©2026 Fractyl Health, Inc. All Rights Reserved.

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Key takeaways: Path to pivotal data, FDA submission, reimbursement and commercial readiness©2026 Fractyl Health, Inc. All Rights Reserved. Clinical evidence: Weight maintenance through 6 months with excellent safety and supportive cardiometabolic and food-craving signals Pivotal study on-track: Midpoint Cohort gives confidence that pivotal study is appropriately powered Regulatory progress: Potential for a more efficient U.S. regulatory path via De Novo; FDA feedback expected Q2 2026 Commercial readiness: Clear reimbursement pathway and focused Centers of Excellence launch creating a predictable path to value creation, if approved

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![Slide 18](guts-ex99_2s18.jpg)© 2026 Fractyl Health, Inc. All Rights Reserved. Investor Relations Lara Smith Weber CFO 617-835-5912 IR@fractyl.com Thank you