Fractyl Health, Inc 8-K, filed Aug 12, 2025
Fractyl Health, Inc. (GUTS)
About this 8-K
Fractyl Health, Inc filed this 8-K on August 12, 2025.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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.
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2025, Fractyl Health, Inc. announced its financial results for the quarter ended June 30, 2025 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 2.02 of this Current Report (including Exhibit 99.1 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relates to Item 2.02 and shall be deemed to be furnished, and not filed:
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
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. |
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Date: |
August 12, 2025 |
By: |
/s/ Harith Rajagopalan |
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Harith Rajagopalan, M.D., Ph.D. |
Exhibit 99.1
Fractyl Health Announces Second Quarter 2025 Financial Results and Business Updates
Randomized 3-month REMAIN-1 Midpoint Cohort data expected in September 2025
Positive 3-month REVEAL-1 Cohort data showed single Revita® procedure sustained weight loss after GLP-1 discontinuation; incremental 6-month open-label data expected in Q4 2025
Top-line REMAIN-1 Pivotal Cohort 6-month data and PMA filing expected in H2 2026
$23M underwritten public offering expected to extend cash runway through key upcoming 3-and 6-month randomized data readouts from REMAIN-1 Midpoint Cohort
Conference call today at 4:30 p.m. ET
BURLINGTON, Mass., August 12, 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 second quarter 2025 financial results and provided business updates highlighting continued momentum across its Revita and Rejuva platforms. To support this clinical and strategic progress, the Company recently completed a $23 million underwritten public offering, which is expected to extend its cash runway through key upcoming 3-and 6-month randomized data readouts from the REMAIN-1 Midpoint Cohort.
"Fractyl is entering a critical time in the Company’s growth. With enrollment complete in our REMAIN-1 Pivotal Cohort, randomized data in post-GLP-1 weight maintenance anticipated from the Midpoint Cohort next month, and the Rejuva gene therapy platform moving toward the clinic, we are making significant progress toward transforming the standard of care for people with chronic metabolic diseases like obesity and T2D,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “We believe Revita could pioneer a new therapeutic area in weight maintenance, helping patients sustain the hard-won benefits after discontinuing GLP-1 drugs. With our recent capital raise enhancing our financial position through key upcoming clinical milestones, we believe we’re well-positioned to advance these category-defining platforms and bring much-needed solutions to patients in some of the most prevalent diseases in healthcare."
Recent Highlights and Upcoming Milestones
Revita®
The Company is evaluating Revita in the REMAIN-1 pivotal study, which includes three distinct patient cohorts: the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort, and the REMAIN-1 Pivotal Cohort.
REVEAL-1 Cohort
The REVEAL-1 Cohort is an open-label cohort enrolling individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. After stopping the GLP-1 drug, participants receive the Revita treatment in an open-label setting and take part in a structured diet and lifestyle program. REVEAL-1 is designed to provide early, real-world insights on how Revita performs after GLP-1 discontinuation.
REMAIN-1 Midpoint Cohort
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 have not yet taken GLP-1 drugs, are initiated on tirzepatide at the time of enrollment, and treated with the drug to achieve at least 15% total body weight loss. Participants then discontinue tirzepatide and are randomized to undergo either Revita or a sham procedure with a 2:1 treatment allocation. The initial efficacy analysis will be conducted after approximately 45 subjects have completed 12 weeks of follow-up. This Cohort is intended to provide an important early, randomized readout of Revita’s potential to maintain weight loss following GLP-1 discontinuation.
REMAIN-1 Pivotal Cohort
The REMAIN-1 Pivotal Cohort is a randomized, double-blind cohort of 315 participants to evaluate the safety and efficacy of Revita in maintaining weight loss after GLP-1 discontinuation. The first co-primary endpoint is defined as the percent of total body weight regain from the time of tirzepatide discontinuation in Revita versus sham patients through 6-month follow up. The primary objective is to demonstrate the benefit of Revita versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita treated participants at 1 year to demonstrate the durability of the Revita procedure for weight maintenance following discontinuation of a GLP-1 based therapy.
Germany Real-World Registry Study
The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7-10% (inclusive), a BMI of ≤45 kg/m2, and were on at least one glucose-lowering agent (GLA).
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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
Rejuva®
Rejuva is Fractyl’s gene therapy platform designed to deliver long-term remission of T2D and obesity by durably reprogramming metabolic hormone signaling within pancreatic islet cells. The lead product candidate from the platform, RJVA-001, is being advanced for patients with inadequately controlled T2D.
Business Updates
Second Quarter 2025 Financial Results
Research and Development Expenses: R&D expenses were $21.2 million for the quarter ended June 30, 2025, compared to $16.8 million for the same period in 2024, primarily reflecting continued advancement of the REMAIN-1 clinical study and the Rejuva program.
Selling, General and Administrative Expenses: SG&A expenses were $4.9 million, compared to $6.2 million in the second quarter of 2024, primarily driven by lower stock based compensation expenses.
Net Loss: Net loss was $27.9 million for the quarter ended June 30, 2025, compared to $17.2 million for the same period in 2024, largely due to the fluctuation in the non-cash change in fair value of notes and warrants and partially driven by increase in operating expenses of $3.1 million.
Cash Position: As of June 30, 2025, Fractyl had approximately $22.3 million in cash and cash equivalents. Based on current business plans, and after considering the net proceeds from its August 2025 underwritten offering, the Company believes its cash position will fund operations into 2026.
Webcast and Conference Call Information
Fractyl will host a conference call to discuss its second quarter financial results and provide business updates on Tuesday, August 12, 2025, at 4:30 p.m. ET. A live webcast of the conference call can be accessed in the “Events” section of Fractyl’s website at ir.fractyl.com. 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 32 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 www.fractyl.com.
About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in obesity. 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 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and has completed enrollment.
About Rejuva®
Fractyl Health’s Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company has submitted the first Clinical Trial Application (CTA) module for RJVA-001 in T2D to regulators, and if the CTA is authorized, the Company expects to dose the first patients with RJVA-001 and report preliminary data in 2026.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our anticipated financial performance, including cash and cash equivalents, for any period of time, the impact of the Company’s August 2025 underwritten offering, including stockholder approval of Tranche B warrants or the potential exercise of any warrants, the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any Investigational New Drug (IND)-enabling studies, IND applications or Clinical Trial Applications, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, redefining the future of metabolic disease treatment, positioning our Company at the forefront of 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 sub-assembly components for Revita and for the materials for its Rejuva gene therapy platform for preclinical studies, and its ongoing clinical studies; 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 Quarterly Report on Form 10-Q 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.
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
Fractyl Health, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
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June 30, |
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December 31, |
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Cash and cash equivalents |
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$ |
22,291 |
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$ |
67,464 |
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Restricted cash |
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4,255 |
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4,255 |
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Working capital (1) |
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4,856 |
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51,988 |
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Total assets |
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62,006 |
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108,077 |
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Notes payable, long-term |
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29,985 |
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30,162 |
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Total liabilities |
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80,218 |
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79,653 |
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Total stockholders’ equity (deficit) |
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(18,212 |
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28,424 |
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(1) Working capital is defined as total current assets less total current liabilities.
Fractyl Health, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited, in thousands)
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Three Months Ended |
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Six Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
$ |
— |
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$ |
43 |
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$ |
— |
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$ |
76 |
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Cost of goods sold |
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— |
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24 |
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0 |
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43 |
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Gross profit |
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— |
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19 |
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0 |
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33 |
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Operating expenses: |
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Research and development |
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21,151 |
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16,762 |
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40,586 |
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31,186 |
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Selling, general and administrative |
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4,928 |
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6,242 |
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10,252 |
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13,374 |
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Total operating expenses |
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26,079 |
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23,004 |
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50,838 |
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44,560 |
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Loss from operations |
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(26,079 |
) |
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(22,985 |
) |
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(50,838 |
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(44,527 |
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Other income (expense), net: |
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Interest income, net |
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226 |
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1,375 |
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729 |
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2,473 |
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Change in fair value of notes payable |
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(1,673 |
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(304 |
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(1,956 |
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6,382 |
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Change in fair value of warrant liabilities |
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(348 |
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4,703 |
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477 |
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15,149 |
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Other expense, net |
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(15 |
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(18 |
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(36 |
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(28 |
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Total other income (expense), net |
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(1,810 |
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5,756 |
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(786 |
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23,976 |
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Net loss and comprehensive loss |
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(27,889 |
) |
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(17,229 |
) |
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(51,624 |
) |
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(20,551 |
) |