Michael DiFiore

William Wood

Michael Ulz

Whitney Ijem

Avraham Novick

Chi Meng Fong

Jason Gerberry

John Pancari

Rohit Bhasin

- 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**.  **[1572616_2158990_1]** 
- 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).  **[1572616_2158990_1]** **[1572616_2158990_3]** 
- 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**.  **[1572616_2158990_1]** **[1572616_2158990_12]** 
- Revita has received **FDA Breakthrough Device designation** for post-GLP-1 weight maintenance.  **[1572616_2158990_1]**

Fractyl Health Announces Positive REMAIN-1 Midpoint Cohort Data for Revita

- **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.  **[1572616_2158962:8]** **[1572616_2158962:11]** 
- 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**.  **[1572616_2158962:8]** **[1572616_2158962:12]** **[1572616_2158962:13]** 
- 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**.  **[1572616_2158962:7]** **[1572616_2158962:8]** **[1572616_2158962:13]** **[1572616_2158962:14]**

Fractyl Health Provides Positive Midpoint Data for REMAIN-1 Study and Updates Pivotal Cohort Timeline

- 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.  **[1572616_2158944:8]** 
- 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**.  **[1572616_2158944:8]** **[1572616_2158944:9]** **[1572616_2158944:17]**  This cohort was fully enrolled 3 months ahead of schedule.  **[1572616_2158944:24]** 
- 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).  **[1572616_2158944:20]** **[1572616_2158944:22]** 
- 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**.  **[1572616_2158944:8]** **[1572616_2158944:9]** **[1572616_2158944:31]**

Fractyl Health Provides Updates on Revita and Rejuva Clinical Programs

- **Fractyl Health** announced the pricing of an underwritten offering of **60 million shares** of its common stock at **$1.00 per share**.  **[1572616_0001193125-25-218515_d140541dex991.htm:0]** **[1572616_0001193125-25-218515_d140541dex11.htm:42]** 
- 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.  **[1572616_0001193125-25-218515_d140541dex991.htm:0]** **[1572616_0001193125-25-218515_d140541d8k.htm:1]** 
- The offering is expected to close on or about **September 29, 2025**.  **[1572616_0001193125-25-218515_d140541dex991.htm:0]** **[1572616_0001193125-25-218515_d140541d8k.htm:1]** 
- 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**.  **[1572616_0001193125-25-218515_d140541d8k.htm:1]**

Fractyl Health Announces Pricing of Common Stock Offering

- 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**.  **[1572616_0001193125-25-218508_d870124dex991.htm:0]** **[1572616_0001193125-25-218508_d870124dex992.htm:0]** **[1572616_0001193125-25-218508_d870124d8k.htm:1]** 
- 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).  **[1572616_0001193125-25-218508_d870124dex991.htm:0]** **[1572616_0001193125-25-218508_d870124d8k.htm:2]** 
- 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.  **[1572616_0001193125-25-218508_d870124dex991.htm:0]** **[1572616_0001193125-25-218508_d870124d8k.htm:2]** 
- 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**.  **[1572616_0001193125-25-218508_d870124dex991.htm:1]** **[1572616_0001193125-25-218508_d870124d8k.htm:2]**

FRACTYL HEALTH (GUTS)