Earnings summaries and quarterly performance for FRACTYL HEALTH.
Executive leadership at FRACTYL HEALTH.
Harith Rajagopalan, M.D., Ph.D.
Detailed
Chief Executive Officer
CEO
JD
Jay D. Caplan
Detailed
President and Chief Product Officer
LA
Lisa A. Davidson
Detailed
Chief Financial Officer and Treasurer
ST
Sarah Toomey
Detailed
General Counsel and Corporate Secretary
TK
Timothy Kieffer, Ph.D.
Detailed
Chief Scientific Officer
Board of directors at FRACTYL HEALTH.
Research analysts who have asked questions during FRACTYL HEALTH earnings calls.
Michael DiFiore
Evercore ISI
3 questions for GUTS
Also covers: AMGN, AMLX, BIIB +8 more
WW
William Wood
B. Riley Securities
3 questions for GUTS
Also covers: ALT, IMUX, LCTX +3 more
MU
Michael Ulz
Morgan Stanley
2 questions for GUTS
Also covers: ALNY, ARWR, FATE +8 more
WI
Whitney Ijem
Canaccord Genuity Inc.
2 questions for GUTS
Also covers: ARCT, BOLD, NTLA +4 more
AN
Avraham Novick
Morgan Stanley
1 question for GUTS
Also covers: VIR
CM
Chi Meng Fong
BofA Securities
1 question for GUTS
Also covers: BHC, BYSI, EXEL +2 more
Jason Gerberry
Bank of America Merrill Lynch
1 question for GUTS
Also covers: ALKS, AMPH, ARWR +21 more
JP
John Pancari
Evercore ISI
1 question for GUTS
Also covers: ALLY, BFH, CFG +16 more
Rohit Bhasin
Morgan Stanley
1 question for GUTS
Also covers: MIRM, VKTX
Recent press releases and 8-K filings for GUTS.
Fractyl Provides Clinical Data Update for Revita in Post-GLP-1 Weight Maintenance
GUTS
New Projects/Investments
Product Launch
Guidance Update
- Fractyl's Revita is an outpatient endoscopic treatment targeting post-GLP-1 weight rebound.
- Recent Reveal-1 open-label data in 17 patients showed an average regain of only 1.5% of total body weight at six months after stopping GLP-1s, compared to an expected 10%+ regain.
- The company expects to release six-month randomized data from 45 patients in January.
- The pivotal Remain-1 study (315 patients) is fully enrolled, with six-month data expected in the second half of 2026, leading to an FDA filing for approval in the post-GLP-1 obesity setting.
- Revita has Breakthrough Device Designation from the FDA, which could lead to an accelerated approval process, potentially within nine months for positive pivotal data.
Dec 3, 2025, 6:45 PM
Fractyl Health Presents Positive Revita Data for Post-GLP-1 Weight Maintenance
GUTS
New Projects/Investments
Product Launch
Guidance Update
- Fractyl Health (GUTS) is developing Revita, an endoscopic treatment designed to prevent post-GLP-1 weight rebound, a challenge faced by an estimated 6 million people annually who discontinue GLP-1 medications.
- Recent Reveal-1 open-label data from 17 patients at six months showed that Revita patients regained only 1.5% of total body weight after stopping GLP-1s, significantly less than the expected 10%+ regain, and maintained stable glucose control with an HbA1c change of 0.04%.
- The Remain-1 Midpoint pilot study (45 patients) demonstrated a 10-kilogram difference in weight change at three months, with the Revita arm losing 2 kilograms and the sham arm regaining 8 kilograms after GLP-1 discontinuation.
- Key upcoming catalysts include six-month randomized data from the Remain-1 Midpoint study in January, followed by full pivotal data from the 315-patient Remain study in the second half of 2026.
- Revita has received Breakthrough Device Designation from the FDA, which could lead to an accelerated review process, with approvals for such devices typically taking about nine months after positive pivotal data.
Dec 3, 2025, 6:45 PM
Fractyl Health Reports Positive 6-Month REVEAL-1 Study Results
GUTS
New Projects/Investments
- Fractyl Health, Inc. announced positive 6-month results from its open-label REVEAL-1 Cohort for its Revita procedure, demonstrating sustained weight maintenance after GLP-1 discontinuation.
- Participants who received a single Revita procedure showed a mean total body weight change of 1.5% \u00b1 1.3% at 6 months, in contrast to approximately 10% weight regain typically observed in third-party studies after GLP-1 withdrawal alone.
- The study also reported minimal change in HbA1c levels (0.04% \u00b1 0.08%) and excellent tolerability, with no procedure-related serious adverse events.
- The company anticipates several key clinical readouts in 2026, including 6-month randomized data from the REMAIN-1 Midpoint Cohort in January 2026 and a potential Revita PMA filing in H2 2026.
Dec 2, 2025, 12:05 PM
Fractyl Health Reports Q3 2025 Financials and Advances Clinical Programs
GUTS
Earnings
Guidance Update
New Projects/Investments
- Fractyl Health reported a net loss of $45.6 million for Q3 2025, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants.
- As of September 30, 2025, the company held $77.7 million in cash and cash equivalents, with a cash runway projected to extend into early 2027, funding key milestones.
- The company announced positive three-month data from the Remain One Midpoint cohort, where Revita-treated patients lost an additional 2.5% of total body weight after GLP-1 discontinuation, contrasting with a 10% regain in the sham group.
- Enrollment for the Remain One pivotal cohort was completed in Q2 2025, with over 60% of patients randomized by October 31st, and full randomization anticipated in early 2026.
- Key upcoming catalysts include six-month data from Reveal One in Q4 2025, six-month randomized data from Remain One Midpoint in Q1 2026, and top-line pivotal data and potential PMA submission in H2 2026.
Nov 12, 2025, 9:30 PM
Fractyl Health Reports Q3 2025 Results, Extends Cash Runway, and Advances Clinical Programs
GUTS
Earnings
Guidance Update
New Projects/Investments
- Fractyl Health reported a net loss of $45.6 million for the third quarter ended September 30, 2025, compared to $23.2 million for the same period in 2024, with the variance primarily driven by a $23.5 million non-cash accounting change in fair value related to warrants.
- As of September 30, 2025, the company had approximately $77.7 million in cash and cash equivalents, and $83 million in underwritten offerings are expected to extend its cash runway into early 2027.
- In September 2025, positive 3-month randomized data from the REMAIN-1 Midpoint Cohort showed Revita-treated patients lost an additional 2.5% of total body weight after discontinuing GLP-1 medication, while sham-treated patients regained 10%. Fractyl anticipates reporting 6-month primary endpoint data from the REMAIN-1 Pivotal Cohort and potentially filing a Premarket Approval (PMA) application in H2 2026.
- New preclinical data for RJVA-002, a dual GIP/GLP-1 gene therapy for obesity, demonstrated approximately 30% weight loss over five weeks in a preclinical model. The company has also submitted the first Clinical Trial Application (CTA) module for RJVA-001 in T2D, with preliminary data expected in 2026 if authorized.
Nov 12, 2025, 9:05 PM
Fractyl Health Announces Positive REMAIN-1 Midpoint Cohort Data for Revita
GUTS
New Projects/Investments
Guidance Update
- Fractyl Health announced positive randomized, double-blind control data from the REMAIN-1 midpoint cohort, demonstrating that its Revita treatment prevented weight regain three months after GLP-1 discontinuation.
- In the study, Revita patients lost an additional 2.5% body weight, while sham patients regained 10% of their weight, resulting in a 12.5% statistically significant treatment difference (p=0.014).
- The company projects having cash to fund operations into early 2027, covering key milestones such as top-line pivotal data and potential PMA filing in 2H 2026.
- Revita has received FDA Breakthrough Device designation for post-GLP-1 weight maintenance.
Sep 26, 2025, 12:00 PM
Fractyl Health Provides Positive Midpoint Data for REMAIN-1 Study and Updates Pivotal Cohort Timeline
GUTS
Product Launch
New Projects/Investments
Guidance Update
- Fractyl Health's Revita demonstrated clear activity in the REMAIN-1 Midpoint Cohort Study, with patients experiencing 2.5% further weight loss after discontinuing GLP-1s, versus 10% weight regain in sham-treated patients (p=0.014) at 3 months, alongside an excellent safety and tolerability profile with no Revita-related serious adverse events or Grade II+ adverse events.
- The REMAIN-1 Pivotal Cohort is fully enrolled 3 months ahead of schedule, with randomization expected to complete in early 2026 and 6-month primary endpoint data and potential PMA filing anticipated in H2 2026.
- Revita is positioned as a potential backbone therapy in obesity, addressing the significant unmet need for durable weight maintenance after GLP-1 discontinuation, and has received FDA Breakthrough Device designation.
Sep 26, 2025, 12:00 PM
Fractyl Health Announces Pricing of Common Stock Offering
GUTS
- Fractyl Health announced the pricing of an underwritten offering of 60 million shares of its common stock at $1.00 per share.
- The gross proceeds from the offering are expected to be approximately $60 million, with estimated net proceeds of approximately $56.0 million after deducting underwriting discounts and commissions and other offering expenses.
- The offering is expected to close on or about September 29, 2025.
- The company believes these net proceeds, combined with existing cash and cash equivalents, will be sufficient to fund its operating expenses and capital expenditure requirements into early 2027.
Sep 26, 2025, 11:20 AM
Fractyl Health Reports Positive Interim Results for Revita in Weight Maintenance Study
GUTS
Product Launch
New Projects/Investments
Guidance Update
- Fractyl Health announced positive 3-month interim results from its REMAIN-1 Midpoint Cohort study for Revita, a therapy aimed at post-GLP-1 weight maintenance.
- At 3 months, Revita-treated patients showed an additional 2.5% total body weight loss after stopping tirzepatide, contrasting with a 10% weight regain in sham-treated patients (p=0.014).
- The Revita procedure demonstrated excellent safety and tolerability over the 3-month period, with no Revita-related serious adverse events or Grade II+ adverse events.
- The company anticipates 6-month data from the Midpoint Cohort in Q1 2026 and 6-month topline primary endpoint data and a potential PMA filing for the Pivotal Cohort in H2 2026.
Sep 26, 2025, 11:05 AM
Fractyl Health Provides Updates on Revita and Rejuva Clinical Programs
GUTS
New Projects/Investments
Guidance Update
- Fractyl Health is advancing two key strategies: Revita, an FDA Breakthrough Device endoscopic procedure for durable weight maintenance post-GLP-1 therapy, and Rejuva, a gene therapy platform targeting pancreatic biology.
- The REMAIN-1 Pivotal Cohort for Revita is on track to complete randomization in early 2026, with 6-month topline primary endpoint data and potential PMA filing in H2 2026. This cohort was fully enrolled 3 months ahead of schedule.
- Recent clinical data for Revita's REMAIN-1 Midpoint Cohort showed patients experienced 2.5% further weight loss at 3 months after stopping GLP-1s, compared to 10% weight regain in sham-treated patients (p=0.014).
- The Rejuva gene therapy platform's RJVA-001 program had its first Clinical Trial Application (CTA) module submitted in the EU in May 2025, with preliminary data anticipated in 2026.
Sep 26, 2025, 11:00 AM
Quarterly earnings call transcripts for FRACTYL HEALTH.
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