FRACTYL HEALTH, INC. (GUTS) SEC Filings & Earnings Calls

Execution risk from workforce reduction and program discontinuation

“45% headcount reduction and discontinuation of Rejuva gene therapy program may impact operational capabilities and future revenue potential.”

Potential additional charges from impairment or other exit activities

“Company may incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the workforce reduction, including potential impairment charges.”

Study ongoing; final data rely on database lock at 12 months

“REMAIN-1 is an ongoing study; final data rely on database lock at 12 months.” · word for word

Delisting risk: potential loss of exchange listing, reduced liquidity, and negative investor sentiment.

“Item 3.01: received a delisting notice or transferred listing to another exchange.”

Nasdaq delisting risk

“As previously reported, on March 13, 2026, we received a letter from the Listing Qualifications Department of Nasdaq notifying us that the listing of our common stock was not in compliance with Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”) for continued listing on the Nasdaq Global Market, as the minimum bid price of the Company’s comm”

Clinical trial failure pressure: pivotal data still pending; regulatory submission uncertain

“Topline 6-month data from REMAIN-1 Pivotal Cohort expected early Q4 2026; FDA De Novo submission potential late Q4 2026”

Going concern uncertainty

“we have concluded that substantial doubt exists about our ability to continue as a going concern for at least one year after the date that these financial statements are issued” · word for word

Cash runway limited

“our available cash and cash equivalents balance of $47.1 million as of June 30, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into early 2027” · word for word

Clinical trial risk

“The Midpoint Cohort is not powered for formal statistical significance, and results are descriptive.” · word for word

Clinical trial failure pressure: Revita pivotal data readout in Q4 2026 is binary risk.

“Topline 6-month randomized data from REMAIN-1 Pivotal Cohort expected in early Q4 2026.”

Cash runway limited: into early 2027 only, beyond pivotal data but not to profitability.

“cash runway guidance into early 2027” · word for word

Going concern uncertainty

“we have concluded that substantial doubt exists about our ability to continue as a going concern for at least one year after the date that these financial statements are issued.” · word for word

Capital dependency

“We will require substantial additional capital beyond the proceeds from our prior financings to fund our operations.” · word for word

Clinical Trial Failure Risk

“At target performance, defined as positive primary endpoint data in the REMAIN-1 pivotal study by December 31, 2026, 100% of the options become eligible to vest.” · word for word

Going Concern Risk

“We have incurred significant net losses since inception, we expect to continue to incur significant net losses for the foreseeable future and may never achieve or sustain profitability, and we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.” · word for word

Clinical Development Risk

“Clinical studies are expensive, time-consuming, difficult to design and implement, and have an uncertain outcome. Further, we may encounter substantial delays in our clinical studies.” · word for word

Regulatory Approval Risk

“The regulatory clearance and certification processes of the U.S. Food and Drug Administration (the “FDA”), comparable foreign regulatory authorities and notified bodies, are lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certifi”

Dependence on Single Product Candidate

“We are substantially dependent on the success of our lead product candidate, Revita ® , and our lead gene therapy product candidate, RJVA-001, in the Rejuva ® platform. If we are unable to obtain marketing authorization or certification for and commercialize any of our current or future product candidates in a timely manner, our business will be harmed.” · word for word

Capital Requirement Risk

“We require substantial additional capital or must implement other business strategies to execute our operating plan and continue to operate as a going concern. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future comme”

Clinical trial risk: pivotal data not yet available; post-hoc analyses may not predict pivotal results.

“topline 6-Month data expected in early Q4 2026” · word for word

Regulatory risk: De Novo submission and FDA approval uncertain.

“De Novo submission expected in late Q4 2026” · word for word

Competition from GLP-1 drugs and other weight loss therapies.

“Approximately 30 million patients are projected to be on GLP-1s by 2035” · word for word

Clinical and regulatory risk: Revita and Rejuva programs may fail to meet endpoints or gain approval.

“Revita is for investigational use only under U.S. law. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies.”

Cash runway limited to early 2027; need for additional financing if milestones are delayed.

“Fractyl’s current cash and cash equivalents are expected to fund its operations through early 2027.” · word for word

Clinical trial risk: pivotal data not yet available; 6-month data from REMAIN-1 Midpoint Cohort expected Q1 2026; topline pivotal data H2 2026

“Topline 6-month data from REMAIN-1 Pivotal Cohort expected H2 2026”

Going concern uncertainty

“we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.” · word for word

Covenant breach risk

“without additional financing, we may not be able to comply with the minimum liquidity covenant related to our 2023 Notes by the end of 2026.” · word for word

No approved products

“We have no products approved for commercial sale in the United States and have not generated any revenue from product sales.” · word for word