GUTS

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management identifies a massive market opportunity in the approximately 1 million patients discontinuing GLP-1 therapies monthly, who currently face rapid weight regain without a durable alternative. Revita's clinical thesis is supported by 1-year randomized data showing patients maintained over 80% of prior weight loss compared to 46% in the sham arm, suggesting a potential plateau in weight maintenance rather than just delayed regain. The pivotal REMAIN-1 study is strategically enriched for complete ablation length and higher run-in weight loss, the two variables management identified as primary drivers of treatment effect size. The safety profile is highlighted as a key adoption driver, with zero device-related serious adverse events and only mild, transient treatment-emergent adverse events reported in the midpoint cohort. Management views the rise of oral GLP-1s as a demand engine rather than a threat, as easier initiation likely leads to higher absolute volumes of future discontinuations requiring an off-ramp. Strategic positioning focuses on leveraging existing GI clinical workflows and endoscopy suites, requiring no new site of care for rapid commercial integration. The company has maintained fiscal discipline, reducing cash outlay post-randomization to ensure the current $47.1 million runway extends through the pivotal data readout and potential FDA submission. Anticipate reporting top-line 6-month primary endpoint data from the REMAIN-1 pivotal cohort in early Q4 2026, followed by 12-month data in Q1 2027. Plan to submit a potential FDA de novo marketing application in late Q4 2026, supported by feedback that Revita's safety profile is consistent with a moderate-risk classification. Guidance assumes both co-primary endpoints in the pivotal trial are powered above 95% based on midpoint cohort performance and enrichment strategies. Expect to dose the first patient in the Rejuva-001 gene therapy study imminently, with preliminary safety and feasibility data anticipated in the second half of 2026. Commercial strategy assumes a targeted launch into 100 to 200 high-throughput U.S. centers of excellence where bariatric and metabolic endoscopy expertise already exists. The Medicare GLP-1 Bridge demonstration, launched July 1, 2024, is viewed as a critical catalyst for payer convergence on the need for durable, non-pharmacological solutions. Final regulatory pathway determination (de novo vs. PMA) remains subject to the FDA's review of the complete safety data set included in the future submission. Management explicitly stated they do not plan to raise capital before pivotal data is in hand, Management stated that the company is funded through definitive data and that there is no planned capital raise before the pivotal data readout. Rejuva-001 clinical development is funded within the existing runway and is not expected to compete with Revita for capital resources. Management declined to provide specific volume numbers ahead of the September Investor Day but emphasized that the health economic value proposition is higher than previously realized. Physician training is expected to be rapid, as the procedure leverages existing endoscopic skills and typically requires fewer than five procedures for proficiency. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Payers are expected to focus on the pivotal trial's specific patient profile, including the 15% run-in weight loss threshold and prior GLP-1 use. Medicare has expressed specific concerns regarding muscle mass loss and frailty in elderly populations on GLP-1s, which may favor a procedural maintenance option. Revita is expected to qualify for transitional pass-through payment from day one of launch due to its Breakthrough Device status and novelty within the CPT schema. CMS recently reaffirmed rules that ensure these payment mechanisms remain in place for the next several years. Management claims a broad patent estate covering both thermal and non-thermal ablation for metabolic conditions, including post-GLP-1 weight maintenance. The company intends to defend its market position as the first-mover in duodenal ablation innovation. The study utilizes staggered sentinel dosing, requiring a 14-day safety monitoring period for the first patient before others in the cohort can be dosed. Initial data will focus strictly on safety, feasibility of device delivery, and tolerability rather than long-term efficacy.

This article first appeared on GuruFocus. Cash Position: $47.1 million in cash and cash equivalents as of June 30, 2026. R&D Expenses: $13.8 million for Q2 2026, down from $21.2 million in Q2 2025. SG&A Expenses: $5.3 million for Q2 2026, up from $4.9 million in Q2 2025. Net Loss: $25.5 million for Q2 2026, compared with a net loss of $27.9 million in Q2 2025. Adjusted EBITDA: Negative $16.3 million for Q2 2026, improved from negative $24 million in Q2 2025. Cash Used in Operations: Approximately $16 million in Q2 2026. Warning! GuruFocus has detected 2 Warning Signs with GUTS. Is GUTS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Fractyl Health Inc (NASDAQ:GUTS) reported positive one-year randomized data from the REMAIN-1 midpoint cohort, showing Revita patients maintained over 80% of GLP-1-induced weight loss versus 46% for sham, with no patients reinitiating GLP-1 therapy. The company highlighted an unusually clean safety profile for Revita, with zero device or procedure-related serious adverse events through one year and only four mild, transient adverse events in the entire midpoint cohort. The REMAIN-1 pivotal cohort is well-powered above 95% on both co-primary endpoints and enriched for variables associated with greater treatment effect, including a median ablation length of 16 cm and mean run-in weight loss of 18.3%. Fractyl Health Inc (NASDAQ:GUTS) has a clear regulatory path with FDA feedback indicating Revita's safety profile is consistent with a moderate-risk device classification, and it remains on track for a potential de novo submission in late Q4 2026. The company is funded through early 2027, extending beyond the pivotal data readout and potential de novo submission, with no plans to raise capital before pivotal data is in hand. Fractyl Health Inc (NASDAQ:GUTS) received clinical trial authorization in the Netherlands and ethics committee approval in Australia for RJVA-001, the first AAV-based gene therapy candidate for type 2 diabetes, with initial data expected in the second half of 2026. Fractyl Health Inc (NASDAQ:GUTS) reported a net loss of $25.5 million for Q2 2026, though this was an improvement from the $27.9 million loss in the same period of 2025. The company's cash position stands at $47.1 million, which provides runway only into early 2027, creating potential financing needs if pivotal data or regulatory milestones are delayed. The ATM facility remains closed, and management has stated it does not plan to raise capital before pivotal data, which could limit financial flexibility if unexpected costs arise. The pivotal study's success depends on maintaining high retention rates and low medication resumption, which are operational risks that could impact the final data readout. The company faces uncertainty regarding payer reimbursement criteria for Revita, as payers may impose strict requirements around prior GLP-1 use, weight loss thresholds, and documented discontinuation before covering the procedure. The Rejuva gene therapy program is in early stages, with the first patient dosing pending site activation, and the company has not provided a timeline for FDA discussions, indicating potential delays in this pipeline asset. Q: What is the expectation for reimbursement upon approval, particularly regarding transitional coverage for emerging technologies given the breakthrough device designation, and what are the risks related to the filing timeline or De Novo versus PMA pathway? Additionally, what size of commercial infrastructure will be needed to support Revita?A: Harith Rajagopalan, CEO, explained that CMS's transitional pass-through payment mechanism has a clear statutory requirement, and breakthrough devices that achieve clearance or approval automatically qualify if they are novel and don't fit into an existing CPT schema. He noted that CMS recently reaffirmed this rule, providing confidence that Revita can have reimbursement from day one at launch. Regarding commercial infrastructure, he outlined a targeted and efficient center of excellence model focused on the top 100-200 endoscopy health systems, which perform at least half of endoscopies in the US. The company plans to leverage existing strong relationships with endoscopists focused on bariatric and metabolic endoscopy, enabling a smaller, highly focused team targeting high-throughput centers. Q: Can you confirm whether the final Statistical Analysis Plan (SAP) was submitted and if there was any response or correspondence with the FDA regarding recent tweaks? Also, can you speak to the extent of the patent estate as it relates to other ablation technologies, particularly for weight maintenance, given the potential de novo approval rather than a PMA?A: Harith Rajagopalan, CEO, confirmed the final SAP was submitted and the company is "locked and loaded" heading into database lock. He noted there was a response from the FDA, but it was down in the schema of details rather than high-level, with nothing of materiality to discuss. Regarding patents, he stated the company has a very broad and comprehensive patent estate as the leader in duodenal ablation innovation. The issued US patents cover not only their specific methods and devices but also broadly cover both thermal and non-thermal ablation modalities for post-GLP-1 weight maintenance, type 2 diabetes, and related conditions, and the company intends to defend that market. Q: Regarding profitability, what procedure volume per center is embedded in the assumption that Fractyl can be profitable with a targeted launch into the top 100-200 US centers, and how quickly do you expect trained physicians to ramp to that level?A: Harith Rajagopalan, CEO, declined to provide specific numbers, deferring to the upcoming Investor Day in September. However, he noted that the health economic value from Revita, based on 50 patients with one year of follow-up from REVEAL-1 and REMAIN-1, is greater than previously realized, which increases confidence in potential profitability. On training, he stated that based on observations across multiple studies, it takes less than five procedures for a physician to feel comfortable performing the procedure. The company expects to continue its successful preceptorship program, leveraging the fact that the procedure builds on existing physician skills and is not anatomy-altering, with a compelling safety profile. Q: What criteria do you expect payers or Medicare to impose around prior GLP-1 use, degree of prior weight loss, BMI, or documented discontinuation before reimbursing for Revita?A: Harith Rajagopalan, CEO, expects payers to look carefully at the patient population studied and pre-specified in the pivotal trial, likely focusing on at least 15% run-in weight loss and use of a GLP-1-based therapy. He noted that in recent conversations with payers, Medicare is particularly concerned about muscle mass loss and frailty associated with GLP-1s in the elderly population. With the Medicare bridge program expecting millions of patients to start GLP-1s and the program having a shelf life of about 18 months, payers are thinking hard about the implications of many patients needing to discontinue next year. Q: Are patients staying on GLP-1 therapy longer, or is the discontinuation rate about the same at one year, given physicians now have more experience with these medications?A: Harith Rajagopalan, CEO, stated that meta-analyses suggest the median duration of time on therapy remains in the six to nine-month range, with no significant change observed. He noted that data quality is somewhat impaired due to more people getting drugs from online pharmacies. Preliminary observations on oral GLP-1s suggest patients are staying on lower doses or not titrating as much as expected. He emphasized that the million discontinuers per month remains a "jaw-dropping" number, as these patients who have achieved clinically meaningful weight loss now face rapid weight regain, representing a huge opportunity for Revita. Q: Can you comment on the HbA1c secondary endpoint and what you anticipate the early Q4 readout of Revita will show? Do you expect it to be comparable with previous cohorts?A: Harith Rajagopalan, CEO, explained that the REMAIN pivotal study includes secondary analyses on cardiometabolic parameters including lipids and HbA1c. However, very few patients in the study were diagnosed with prediabetes at randomization, with HbA1c levels in the low fives. He expects the signal to show glycemic stability through six months rather than dramatic improvements, which alone is valuable because these patients are at high risk of developing prediabetes. The clinical signal for glycemic effects will likely take more time to mature than the six-month readout will provide. Q: What are the key outstanding points regarding going down the de novo status for Revita, and what are the key points to get to IND status in discussions with the FDA for Rejuva?A: Harith Rajagopalan, CEO, stated that the key point for Revita's de novo pathway is the FDA's review of safety data from the pivotal study, which will be included in the submission. Given the blinded safety data with regular DSMB reviews, the company is encouraged by the safety profile. For Rejuva, the plan is to generate safety, feasibility, and preliminary efficacy data from the OUS first-in-human study before approaching the FDA, though no timeline has been established for that discussion. Q: What preliminary data should we expect from the Rejuva program later this year, and can you provide early thoughts on Revita pricing?A: Harith Rajagopalan, CEO, indicated that the most important initial communication for Rejuva will be the safety and tolerability of RJVA-001 through the first 14-day sentinel period, along with the safety and feasibility of the device delivery, as this unlocks the rest of the dosing in the cohort. On Revita pricing, he deferred to the upcoming Investor Day where the company will present its view on the health economic value proposition, noting For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Fractyl Health, Inc.? Here are five stocks we like better. Revita showed durable weight-loss maintenance: Patients retained more than 80% of prior GLP-1-related weight loss one year after stopping therapy, versus 46% for sham treatment. The company also reported roughly 78% maintenance in its open-label cohort. Pivotal data and regulatory milestones are approaching: Fractyl completed enrollment in the REMAIN-1 trial, expects six-month top-line results in early Q4 2026, and is targeting a potential FDA De Novo submission later in Q4. Financially, Fractyl reported improved losses and runway: Second-quarter net loss narrowed to $25.5 million, while $47.1 million in cash is expected to fund operations into early 2027. The company does not plan to raise capital before pivotal trial results. Fractyl Health (NASDAQ:GUTS) said its Revita endoscopic procedure showed durable weight-maintenance results one year after patients discontinued GLP-1 therapy, while the company reaffirmed plans to report pivotal trial data in early fourth-quarter 2026 and pursue a potential FDA De Novo submission later in the year. Chief Executive Officer Dr. Harith Rajagopalan said the company’s strategy is centered on offering patients a one-time procedural option to help maintain weight loss after stopping GLP-1 medicines. He cited the company’s July 15 release of one-year randomized data from the midpoint cohort of the REMAIN-1 study. → MarketBeat Week in Review – 08/03 - 08/07 According to Rajagopalan, patients treated with Revita maintained more than 80% of weight loss previously achieved with GLP-1 therapy one year after discontinuation, compared with 46% in the sham group. He said the treatment effect persisted from month six through month 12 while blinding was maintained, and no participant in that cohort restarted GLP-1 therapy. Fractyl also pointed to findings from its open-label REVEAL-1 cohort, where participants maintained about 78% of prior weight loss through one year after a single Revita procedure. Rajagopalan said the results address the question of whether Revita produces sustained separation from sham treatment or merely delays weight regain. → Quantum Earnings Week: Winners and Losers Are Finally Emerging The company completed randomization in February for the REMAIN-1 pivotal cohort, enrolling more than 300 participants at more than 30 sites with more than 20 operators. Rajagopalan described the study as the largest sham-controlled gastrointestinal endoscopy pivotal trial for a novel therapeutic device. The pivotal trial was designed to enrich for two factors associated with a greater treatment effect in earlier data: complete ablation and greater run-in weight loss. The pivotal cohort had a median ablation length of 16 centimeters and a mean run-in weight loss of 18.3%, management said. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War REMAIN-1 has two co-primary endpoints. The first measures the difference between Revita and sham in percentage of total body weight regained at six months. The second is a responder endpoint requiring at least 50% of patients to maintain at least 5% total body weight loss at 12 months, based on an FDA-mandated performance goal. Rajagopalan said Fractyl estimates both endpoints are powered above 95% based on data generated to date. In the midpoint cohort, 73% of patients in the modified intent-to-treat population met the 12-month responder threshold, while the rate exceeded 90% among patients receiving complete ablations. The company said retention in the pivotal study remains above 90%, medication resumption is below its modeled assumptions, and blinded adverse-event trends remain consistent with prior studies. The final six-month study visit was scheduled for August, with database lock expected in the following weeks. Fractyl expects to report top-line six-month primary endpoint results in early Q4 2026 and top-line 12-month data in the first quarter of 2027. Rajagopalan said the final statistical analysis plan has been submitted to the FDA, and agency correspondence related to it concerned detailed elements rather than material issues. Management said it has received FDA feedback indicating that Revita’s safety profile is consistent with a moderate-risk device classification rather than a high-risk classification. The company continues to target a potential De Novo marketing submission in late Q4 after the six-month pivotal data readout, although Rajagopalan said the FDA will make its final pathway determination after reviewing the complete safety dataset. Through one year in the REMAIN-1 midpoint cohort, Fractyl reported no device- or procedure-related serious adverse events. There were four mild treatment-emergent adverse events, all of which resolved within two days, according to management. Rajagopalan said the company believes Revita could qualify for CMS transitional pass-through payment upon regulatory clearance because it holds breakthrough device designation and, in the company’s view, meets novelty and pricing-related criteria for the program. He said the applications are reviewed on a quarterly cycle and that Fractyl believes the mechanism could support reimbursement from the time of launch if the device is cleared. For commercialization, Fractyl plans a targeted center-of-excellence model focused initially on major health systems and endoscopy centers. Rajagopalan said the top 100 to 200 endoscopy health systems perform at least half of U.S. endoscopies. He said the company expects that a focused commercial team could support high-throughput centers with existing bariatric and metabolic endoscopy capabilities. The CEO said physicians generally became comfortable with the procedure in fewer than five cases in company studies, supported by a preceptorship model. He added that Revita uses skills endoscopists already possess and is intended to be a one-time, non-anatomy-altering intervention. Fractyl also reported progress for Rejuva, its gene-therapy platform. During the second quarter, the company received clinical trial authorization in the Netherlands for a Phase I/II first-in-human study of RJVA-001 and later received ethics committee approval in Australia. RJVA-001 is designed as a one-time beta cell-targeted gene therapy intended to enable nutrient-responsive GLP-1 expression in the pancreas. The candidate is delivered through an endoscopic ultrasound-guided infusion. Management said the initial trial will focus primarily on safety, tolerability, and the feasibility and safety of pancreatic delivery. The study uses staggered sentinel dosing, with the first participant monitored for at least 14 days before additional patients in that cohort can be dosed. Fractyl expects to dose the first patient after site activation and enrollment and plans to report preliminary data in the second half of 2026. Rajagopalan said the company does not yet have a timeline for seeking an FDA investigational new drug application for Rejuva. Chief Financial Officer Lara Smith Weber said second-quarter research and development expense was $13.8 million, down from $21.2 million a year earlier, primarily due to lower spending on the Revita and Rejuva programs. Selling, general and administrative expense increased to $5.3 million from $4.9 million, driven mainly by higher stock-based compensation. Fractyl reported a net loss of $25.5 million for the quarter, compared with a $27.9 million net loss in the prior-year period. Adjusted EBITDA was negative $16.3 million, improving from negative $24 million a year earlier. As of June 30, Fractyl had $47.1 million in cash and cash equivalents. Cash used in operations totaled about $16 million during the second quarter. Management said its cash runway extends into early 2027, beyond the anticipated pivotal data readout and through a potential late-Q4 De Novo submission. The company said its at-the-market facility remains closed and that it does not plan to raise capital before pivotal data are available. Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control. The company's lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Fractyl Health Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

One-year REMAIN-1 Midpoint Cohort data show Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablations — the first randomized evidence of durable, drug-free weight maintenance One-year open-label REVEAL-1 Cohort data provide real-world evidence of durable weight maintenance, with patients maintaining approximately 78% of their prior GLP-1-induced weight loss after a single Revita procedure REMAIN-1 Pivotal Cohort topline data on track for early Q4 2026, paving the way for potential FDA De Novo submission in post-GLP-1 weight maintenance in late Q4 2026 Cash runway guidance into early 2027, beyond anticipated Pivotal data readout and FDA De Novo Submission Conference call today at 4:30 p.m. ET BURLINGTON, Mass., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced second quarter 2026 financial results and provided business updates. The Company also reiterated all previously disclosed 2026 Revita® clinical and regulatory milestones, including topline 6-month randomized data from the REMAIN-1 Pivotal Cohort expected in early Q4 2026, and its cash runway guidance into early 2027. “With one-year randomized data for the REMAIN-1 Midpoint Cohort and open label data for REVEAL-1 Cohort, we have the clearest evidence yet that a single Revita procedure can meaningfully reduce weight regain after GLP-1 discontinuation, with the greatest benefit observed in patients who received an adequate dose of duodenal ablation,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl. “Together with a favorable one-year safety profile and cash runway into early 2027, these results give us continued confidence in the design and execution of our ongoing REMAIN-1 Pivotal Cohort, with topline six-month data on track for early Q4 2026 and a potential FDA De Novo submission to follow later in the quarter. As we approach these anticipated milestones, we are also building the commercial infrastructure needed to bring Revita to the patients with the greatest need.” Select Recent Revita Clinical Highlights Fractyl is studying Revita in the REMAIN-1 weight maintenance program, which is designed to evaluate Revita's potential to maintain weight loss following GLP-1 based therapy discontinuation. The REMAIN-1 program includes three distinct participant cohorts that are conducted under a single IDE: the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort. In June 2026, Fractyl reported one-year data from the open-label REVEAL-1 Cohort, showing that participants who underwent a single Revita procedure experienced a mean total body weight change of 5.3% after GLP-1 discontinuation (n=15), maintaining approximately 78% of their prior GLP-1-induced weight loss. These findings provide real-world evidence and support Revita’s potential to be a compelling procedural therapy for post-GLP-1 weight maintenance. In July 2026, Fractyl reported one-year randomized data from the REMAIN-1 Midpoint Cohort demonstrating durable weight maintenance after a single Revita procedure. The treatment effect was greatest in a pre-specified optimized population, combining complete duodenal ablation (>14 cm) with higher GLP-1-induced run-in weight loss (≥17.5%), where Revita-treated participants maintained approximately 84% of their GLP-1-induced weight loss compared to 46% in sham participants (least squares mean weight regain of 4.1% versus 13.5% of body weight; n=10 versus 8 for Revita versus sham). No device- or procedure-related serious adverse events occurred through one year, and no new device-related treatment-emergent adverse events were observed between six and 12 months. These randomized, sham-controlled results provide direct read-through to the REMAIN-1 Pivotal Cohort ahead of its topline six-month readout in early Q4 2026. Commercial Readiness In June 2026, Fractyl strengthened its commercial leadership team with the appointment of Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy. Mr. Zumdahl brings experience building reimbursement and health economic infrastructure for breakthrough procedural therapies, most recently at Inari Medical, and joins Fractyl as the Company prepares for the anticipated REMAIN-1 Pivotal Cohort topline readout in early Q4 2026. Fractyl plans to provide additional detail on its commercial strategy and market opportunity at an upcoming Investor Day in September. Fractyl Forward: Reiterating Path to Pivotal Readout and Potential Regulatory Submission With one-year data now reported from both the REVEAL-1 Cohort and the REMAIN-1 Midpoint Cohort, and randomization of the REMAIN-1 Pivotal Cohort complete, Fractyl is advancing toward its two remaining anticipated 2026 milestones: pivotal readout and potential U.S. regulatory submission. The Company reiterates its previously announced cash runway into early 2027, beyond the anticipated pivotal data readout. Early Q4 2026: Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort. Late Q4 2026: Potential U.S. Food and Drug Administration (FDA) De Novo marketing application submission in post-GLP-1 weight maintenance. Q1 2027: Topline one-year data from the REMAIN-1 Pivotal Cohort. As in all applications, the FDA indicated that final pathway determinations will be made following review of the complete safety dataset, which the Company intends to include in its potential De Novo marketing application submission. Rejuva® Development Progress and Anticipated 2026 Rejuva Milestones Rejuva is Fractyl’s gene therapy platform designed to enable long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones. The lead product candidate, RJVA-001, is being advanced for patients with inadequately controlled T2D. The second candidate, RJVA-002, is a preclinical-stage dual GIP/GLP-1 gene therapy designed to treat obesity. In April 2026, Fractyl received clinical trial application (CTA) authorization for RJVA-001 in the Netherlands. Fractyl also plans to conduct the clinical trial for RJVA-001 at sites in Australia. In July 2026, Fractyl received ethics committee approval in Australia. Fractyl reiterates its anticipated 2026 Rejuva milestone: H2 2026: First-in-human dosing of RJVA-001, subject to site activation, and expected reporting of preliminary data. Second Quarter 2026 Financial Results Research and Development Expenses: R&D expenses were $13.8 million for the quarter ended June 30, 2026, compared to $21.2 million for the same period in 2025. The decrease of $7.3 million was primarily related to reduced spending on Fractyl’s Revita and Rejuva programs. Selling, General and Administrative Expenses: SG&A expenses were $5.3 million for the quarter ended June 30, 2026, compared to $4.9 million for the same period in 2025. The increase of $0.4 million was primarily driven by higher stock compensation expenses. Net Loss: For the quarter ended June 30, 2026, Fractyl reported a net loss of $25.5 million, compared to net loss of $27.9 million for the same period in 2025. The decrease in net loss of $2.4 million was driven by a $7.0 million reduction in operating expenses, $0.3 million lower non-cash loss from change in fair value of debt, $0.2 million higher interest income, partially offset by $5.1 million higher non-cash loss from change in fair value of warrant liabilities. Adjusted EBITDA: Adjusted EBITDA was negative $16.3 million for the quarter ended June 30, 2026, compared to negative $24.0 million for the same period in 2025. The decrease in the non-GAAP adjusted loss of $7.7 million was primarily due to reduced operating expenses excluding stock compensation expenses. Cash Position: As of June 30, 2026, Fractyl had approximately $47.1 million in cash and cash equivalents. Based on current business plans, the Company believes its cash position will fund operations into early 2027. Webcast and Conference Call InformationFractyl will host a conference call to discuss its second quarter financial results and provide business updates on Monday, August 10, 2026, 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 is a clinical-stage metabolic therapeutics company advancing two differentiated candidates designed to target the root causes of obesity and T2D: Revita, a procedural therapy in pivotal development for post-GLP-1 weight maintenance, and Rejuva, an AAV-based gene therapy platform with its lead candidate RJVA-001 entering first-in-human clinical studies. Fractyl’s goal is to advance metabolic disease treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts. About Revita Revita is Fractyl’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 for investigational use only in the United States and is CE marked in the European Union and United Kingdom. About Rejuva Fractyl’s Rejuva platform is developing next-generation AAV-based, locally delivered gene therapies for the treatment of obesity and T2D. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas, with the goal of offering novel, disease-modifying therapies that address the underlying root causes of disease. The platform’s lead candidate, RJVA-001, has received Clinical Trial Authorization in the Netherlands to initiate a Phase 1/2 first-in-human clinical trial in T2D, the first clinical-stage program from the Rejuva platform. Fractyl expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026, subject to site activation. Fractyl also plans to conduct the clinical trial for RJVA-001 at sites in Australia and has received ethics committee approval in Australia. Additional Rejuva candidates, including RJVA-002 (a dual GIP/GLP-1 gene therapy candidate designed to treat obesity), remain in preclinical development. In the United States, Rejuva is in preclinical development. No Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (the FDA), and Rejuva has not been approved or authorized by the FDA for use in humans. Non-GAAP Financial Measures This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (GAAP), including Adjusted EBITDA, which is a non-GAAP financial measure as defined in Regulation G promulgated under the Securities Exchange Act of 1934. This non-GAAP financial measure is provided as supplemental information to Fractyl’s financial measures presented in this press release in accordance with GAAP. The Company defines Adjusted EBITDA as net loss adjusted to exclude (i) interest income, net, (ii) depreciation expense, (iii) stock-based compensation expense, (iv) change in fair value of notes payable and (v) change in fair value of warrant liabilities. Management believes Adjusted EBITDA provides useful supplemental information to investors regarding the Company’s core operating performance and facilitates period-to-period comparisons by excluding items that are non-cash or non-operational in nature and may vary in magnitude. Adjusted EBITDA is also used by management in evaluating the Company’s operating performance and in planning and forecasting activities. The non-GAAP financial measures used by Fractyl may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Fractyl’s financial results prepared and reported in accordance with GAAP. This non-GAAP measure should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Loss to Adjusted EBITDA” later in this press release. Forward-Looking StatementsThis 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 expected initiation, timing, design, endpoints, site activation, and conduct of the RJVA-001 first-in-human clinical trial in the Netherlands and the RJVA-001 clinical trial in Australia; the timing and results of first-in-human dosing and reporting of preliminary data; Fractyl’s regulatory strategy, including submissions to and communications with regulators in the European Union, Australia, and other jurisdictions; the promise, potential impact, and mechanism of action of RJVA-001 and Fractyl’s Rejuva platform; Fractyl’s anticipated financial performance, including cash and cash equivalents, for any period of time; Fractyl’s expected cash runway; the promise and potential impact of Fractyl’s preclinical or clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; the content, information used for, timing or results of any Investigational New Drug (IND)-enabling studies, IND applications, or CTAs; communications with regulators regarding the REVEAL-1 Cohort, the potential launch or commercialization of any of Fractyl’s product candidates or products, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; the potential treatment population or benefits for any of Fractyl’s product candidates or products; Fractyl’s regulatory strategy, including potential use and benefits of the De Novo pathway (FDA pre-submission feedback is advisory and non-binding, and there is no assurance that FDA will accept a De Novo marketing application submission or that the Revita DMR System will receive marketing authorization); Fractyl’s commercial readiness activities and the development of commercial infrastructure; the timing and content of any planned Investor Day or similar event; Fractyl’s strategic and product development objectives and goals; 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 Fractyl’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 risks that are discussed more fully in Fractyl’s filings with the Securities and Exchange Commission (the SEC) including the “Risk Factors” section of Fractyl’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents Fractyl subsequently files with or furnishes to the SEC, including Fractyl’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 10, 2026. These forward-looking statements are based on management’s current estimates and expectations. While Fractyl may elect to update such forward-looking statements at some point in the future, Fractyl disclaims any obligation to do so, even if subsequent events cause Fractyl’s views to change. Contact Brian Luque, Head of Investor Relations and Corporate [email protected], 951.206.1200 (1) Working capital is defined as total current assets less total current liabilities.

Fractyl Health, Inc. GUTS reported positive one-year results from the randomized, sham-controlled Midpoint Cohort of its REMAIN-1 study, demonstrating that the investigational Revita duodenal mucosal resurfacing system helped patients maintain a significant portion of GLP-1-induced weight loss after discontinuing tirzepatide. Patients who underwent the Revita procedure retained up to 84% of their GLP-1-associated weight loss in a year, compared with 46% in the sham group, while the therapy continued to exhibit a favorable safety and tolerability profile. The latest data strengthen the investment case for Fractyl by supporting Revita's potential to address the growing need for durable weight maintenance following GLP-1 discontinuation, a market with limited treatment options. The encouraging findings also de-risk the company's upcoming catalysts, including top-line six-month data from the REMAIN-1 Pivotal Cohort expected in early fourth-quarter 2026 and a potential FDA De Novo marketing application submission later in the quarter, both of which could serve as important value-driving events. Shares of GUTS have surged almost 14% since the announcement yesterday. In the year-to-date period, shares of the company have lost 58.7% compared with the industry’s 1.7% decline. The S&P 500 increased 10.3% in the same time frame. The positive REMAIN-1 Midpoint Cohort results strengthen Fractyl's long-term growth prospects by reinforcing Revita's potential to become the first procedural therapy for durable weight maintenance after GLP-1 discontinuation, an emerging market with significant unmet need. As more patients discontinue GLP-1 drugs due to cost, side effects or long-term treatment burden, Revita could offer a one-time, minimally invasive alternative to preserve weight loss. The encouraging data also improve the likelihood of favorable pivotal study outcomes and regulatory progress, potentially paving the way for commercialization, broader physician adoption and a meaningful revenue opportunity if approved. GUTS currently has a market capitalization of $126.9 million. Image Source: Zacks Investment Research Beyond the encouraging efficacy findings, Revita continued to demonstrate a favorable safety profile for a year. No device or procedure-related serious adverse events were reported, while no new device-related treatment-emergent adverse events were observed between the six and 12-month follow-up periods. Overall treatment-emergent adverse event rates remained comparable between the Revita and sham groups at 24% and 25%, respectively, indicating a generally mild peri-procedural safety profile. Notably, one participant in the sham arm was newly diagnosed with type 2 diabetes during the study, whereas no such cases were reported among Revita-treated patients. The company noted that Revita is designed as a one-time, minimally invasive endoscopic procedure that remodels the duodenal lining to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. The REMAIN-1 Midpoint Cohort enrolled 45 adults with obesity who had achieved at least 15% weight loss on tirzepatide before discontinuing therapy and being randomized in a double-blind, sham-controlled trial. Although the Midpoint Cohort was not powered to establish statistical significance, the study was designed to characterize treatment effects and support the execution of the larger pivotal trial. Fractyl also highlighted that the Midpoint Cohort achieved a 73% weight-maintenance responder rate in the modified intention-to-treat population, rising to 91% among patients receiving complete duodenal ablation, comfortably exceeding the FDA's pre-specified performance goal of more than 50% for the pivotal study. Looking ahead, the company expects to report top-line six-month data from the fully enrolled REMAIN-1 Pivotal Cohort in early fourth-quarter 2026, followed by a potential FDA De Novo marketing application submission later in the quarter. Revita has already received the FDA's Breakthrough Device designation for weight maintenance in patients with obesity discontinuing GLP-1 therapies and is currently CE marked in the European Union and the United Kingdom. Going by the data provided by Grand View Research, the global obesity treatment market size is projected to grow from $29 billion in 2026 to $60.5 billion by 2030, at a CAGR of 22.3%. The industry is driven by several key factors, including the rising global prevalence of obesity and its associated comorbidities, such as diabetes, cardiovascular diseases and hypertension. In June, Fractyl reported positive one-year results from the open-label REVEAL-1 study, showing that patients retained nearly 78% of their GLP-1-induced weight loss in a year after discontinuing therapy following a single Revita procedure. The results also showed a mean weight regain of just 5.3%, substantially lower than the roughly 15% regain reported in published studies after GLP-1 withdrawal alone, with one-third of participants continuing to lose additional weight. Currently, GUTS carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the broader medical space are West Pharmaceutical WST, Intuitive Surgical ISRG and Cardinal Health CAH, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. West Pharmaceutical reported first-quarter 2026 earnings per share of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%. Intuitive Surgical reported first-quarter 2026 adjusted EPS of $2.50, which beat the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion surpassed the Zacks Consensus Estimate by 6.2%. Intuitive Surgical has an estimated long-term earnings growth rate of 14.3%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%. Cardinal Health reported a third-quarter fiscal 2026 adjusted EPS of $3.17, which beat the Zacks Consensus Estimate by 13.2%. Revenues of $60.94 billion missed the Zacks Consensus Estimate by 2.3%. Cardinal Health has an estimated long-term earnings growth rate of 17%. CAH’s earnings surpassed estimates in the trailing four quarters, the average surprise being 10.3%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Fractyl Health, Inc. (GUTS) : Free Stock Analysis Report Intuitive Surgical, Inc. (ISRG) : Free Stock Analysis Report Cardinal Health, Inc. (CAH) : Free Stock Analysis Report West Pharmaceutical Services, Inc. (WST) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Participants retained ~78% of GLP-1 induced total body weight loss one year after discontinuation and a single Revita procedure 5.3% mean weight change observed with Revita (n=15); published third-party studies after GLP-1 withdrawal alone have shown ~15% weight regain at similar time points 33% of patients continued to lose further weight one year after discontinuing a GLP-1 Next anticipated Revita® clinical data readouts are one-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 and topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 BURLINGTON, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced positive one-year results from its open-label REVEAL-1 Cohort. The REVEAL-1 Cohort is an open-label study in 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. The REVEAL-1 data show that patients who underwent a single Revita procedure maintained approximately 78% of their prior GLP-1-induced weight loss at one year, with 33% of patients continuing to lose weight one year after discontinuing a GLP-1. The new results highlight Revita’s potential to be a compelling procedural therapy for post-GLP-1 weight maintenance. Key Findings: Hard-to-treat GLP-1 responder population: Participants lost ~24% total body weight (>50 lbs.) on GLP-1 drugs prior to enrollment (duration on GLP-1 therapy ranging from five months to five years.) Patients were enrolled who had lost at least 15% total body weight on GLP-1 medicines, with 17 of 22 participants having greater than 17.5% total body weight loss on GLP-1 drugs. Safety and complete efficacy data through one year are available for 22 and 15 participants, respectively. Sustained weight maintenance through one year: Participants maintained stable weight after a single Revita procedure, with a mean total body weight change of 5.3% ± 2.1% (LS means ± SE; n=15) at one year. An efficacy estimand in the full analysis set demonstrated similar results, with mean total body weight change of 5.8% ± 2.0% (LS means ± SE; n=22). Participants retained ~78% of their drug-induced weight loss at one year. 33% of participants continued to lose weight at one year. Published third-party studies1,2 report ~15% weight regain by this time point after GLP-1 withdrawal alone (see Figure 1 below). Across this cohort, ablation length clustered narrowly around its median ablation length and the study therefore does not have power to detect an ablation length dose response. 100% of patients in the REVEAL-1 Cohort maintained at least 5% of GLP-1-induced weight loss through one year: This ≥5% threshold is the responder definition used as the second co-primary endpoint in the REMAIN-1 Pivotal Cohort, which evaluates a responder rate among the Revita treated participants at one year to assess the durability of the Revita procedure for weight maintenance after GLP-1 discontinuation. Sustained glycemic control through one year: Minimal change in HbA1c levels was observed after the Revita procedure (0.08% ± 0.08%; LS means ± SE from MMRM; n=15), compared to the ~0.4% increase in HbA1c seen post-GLP-1 discontinuation in the STEP-1 trial extension2 of GLP-1 withdrawal. This suggests Revita may help stabilize cardiometabolic parameters gained on GLP-1 therapy after the drug is stopped. Excellent tolerability: No procedure-related serious adverse events and no new treatment emergent adverse events were observed. Mild treatment-emergent adverse events occurred in eight of 22 participants (36%), were transient, self-limited, and all occurred within the first month of treatment. No late device-related adverse events were observed, and all adverse events were consistent with prior Revita experience and similar to routine upper endoscopy findings. Reproducible procedure performance: As previously reported, average ablation length was approximately 16 cm (n=22), consistent with Revita European real-world experience and the ongoing REMAIN-1 Pivotal study, supporting the potential translatability of results and scalability of technique. Figure 1: Total Body Weight Change Over Time Following GLP-1 Discontinuation and Revita Treatment. GLP-1 weight loss from weeks -52 to 0 are illustrative based on average weight loss and time on medication in REVEAL-1 subjects. Projected regain citation: Budini et al., eClinicalMedicine. 2026;93:103796. FAS = full analysis set, GLP-1 = glucagon-like peptide-1, TBW = total body weight. “As a gastroenterologist, what's compelling here is the mechanism and the simplicity. Revita targets the duodenum, a root contributor to metabolic disease, through a single endoscopic procedure that fits within routine GI practice,” said Dr. Shailendra Singh, Director of Bariatric Endoscopy at West Virginia University. “Seeing patients sustain their weight loss a full year after one procedure, without staying on chronic medication, shows the potential for Revita to be a meaningfully different option than what we have today. And with a tolerability profile observed to date in line with a routine upper endoscopy, this is the kind of durable, procedure-based approach I could see fitting naturally into how we care for these patients.”         “GLP-1 medicines have transformed obesity care, but they were never designed to be taken forever, and the field's answer so far has been to keep patients on a drug indefinitely. Even the newest maintenance strategies ask people to switch from a weekly medication to a daily medication, live with ongoing side effects, and still regain some of the weight they worked so hard to lose. That is not the off-ramp patients are asking for,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl. “With one-year REVEAL-1 data now showing durable weight maintenance after a single Revita procedure, and without any continued drug therapy, we believe Revita points to a fundamentally different path: a potentially one-time, root-cause approach to holding onto weight loss after GLP-1 discontinuation. We look forward to building on these open-label results with complementary one-year randomized data from our REMAIN-1 Midpoint Cohort in Q3 2026, followed by topline results from our REMAIN-1 Pivotal Cohort in early Q4 2026.” About REVEAL-1 The REVEAL-1 Cohort (n=22) is an open-label study in individuals living 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 based therapy, participants receive 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. To date, 22 participants have been treated in the REVEAL-1 Cohort and are included in safety and efficacy analyses. Five participants withdrew or were lost to follow up and two participants experienced protocol deviations. The profile of the REVEAL-1 Cohort closely mirrors that of the REMAIN-1 Midpoint and Pivotal Cohorts, with an average age of 50 and a gender distribution of 86% women. All 22 participants had previously been treated with a GLP-1 therapy for durations ranging from approximately 5 months to 5 years, with a mean total body weight loss of 24% while on therapy and a mean body weight of 80 kg ± 3 kg (SEM) at the time of intervention. 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 Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom. About Fractyl Health Fractyl Health is a clinical-stage metabolic therapeutics company advancing two differentiated candidates designed to target the root causes of obesity and T2D: Revita, a procedural therapy in pivotal development for post-GLP-1 weight maintenance, and Rejuva, an AAV-based gene therapy platform with its lead candidate RJVA-001 entering first-in-human clinical studies. Fractyl’s goal is to advance metabolic disease treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts. 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 clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation and stabilize cardiometabolic parameters; the translatability of results and scalability of technique related to Revita; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; 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; our strategic and product development objectives and goals; 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 our 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 risks that are discussed more fully in our filings with the Securities and Exchange Commission (the SEC) including the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents we subsequently file with or furnish to the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026. These forward-looking statements are based on management’s current estimates and expectations. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. Contact Brian Luque, Head of Investor Relations and Corporate [email protected], 951.206.1200 ¹ Aronne et al. JAMA. 2024;331(1):38–48. doi:10.1001/jama.2023.24945² Wilding et al. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfe8a68b-c93d-4766-9f1b-58dea83109bf

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Fractyl Health (GUTS) is back on investor radar after reporting first quarter net income of US$9.22 million and securing Clinical Trial Application authorization in the Netherlands for its RJVA-001 gene therapy in type 2 diabetes. See our latest analysis for Fractyl Health. The recent 1 month share price return of 93.53% and 3 month share price return of 130.9% suggest strong short term momentum, even though the 1 year total shareholder return is still down 38.22%. If Fractyl Health's early gene therapy progress has your attention, this could be a good time to look across the sector and check out 33 healthcare AI stocks. With Fractyl Health still reporting a loss of US$140.954 million over the last year, but trading at just US$0.95 per share and a market cap of about US$116.4 million, is this a discounted entry, or is the market already pricing in future growth? With Fractyl Health last closing at $0.95 and the most followed narrative pointing to a fair value of $10.00, the gap between price and expectations is wide and firmly tied to very ambitious growth and margin assumptions. Read the complete narrative. Want to understand why this fair value sits so far above today’s price? The core of the narrative leans on rapid revenue expansion, rising margins, and a much richer future earnings multiple than the wider medical equipment sector. Curious which assumptions have to line up to bridge that gap. Result: Fair Value of $10.00 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this optimistic story still hinges on unproven clinical outcomes and ongoing heavy R&D spend. This could extend losses and force further equity dilution. Find out about the key risks to this Fractyl Health narrative. The bullish fair value of $10.00 leans heavily on future earnings, yet on today’s numbers Fractyl Health trades at a P/B of 15.9x, compared with 2.3x for the US Medical Equipment industry and 5.4x for peers. That premium leaves little room for error if the growth story slips. To see how this price based view compares with the underlying numbers, take a closer look at the detailed valuation breakdown in the See what the numbers say about this price — find out in our valuation breakdown. The mix of enthusiasm and caution in this story is clear, so do not wait too long to look under the hood yourself and weigh the trade off between upside and risk. To see what concerns other investors are focused on, review the 4 important warning signs If Fractyl Health has sharpened your focus on high conviction opportunities, do not stop here; broaden your watchlist with other targeted ideas that fit your style. Target potential upside in smaller companies by scanning the 28 elite penny stocks with strong financials that still show solid financial footing. Zero in on quality at a price by checking companies in the 47 high quality undervalued stocks that combine stronger balance sheets with compelling valuations. Dial back risk while staying invested by reviewing the 68 resilient stocks with low risk scores that screen well on resilience and financial health. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include GUTS. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Interested in Fractyl Health, Inc.? Here are five stocks we like better. Revita remains on track for pivotal six-month data in early Q4 2026, with the company saying the REMAIN-1 trial has enrolled more than 300 patients and retention is above 90%. Fractyl also expects to file for FDA De Novo clearance in late Q4 2026 using the pivotal data plus supporting studies. Management highlighted progress on regulatory and reimbursement plans, citing prior favorable FDA feedback on the De Novo pathway and potential eligibility for the CMS/FDA RAPID coverage pathway. The company also plans to submit a Category III CPT code application this summer, which could support future commercialization economics. Fractyl advanced its Rejuva gene therapy platform into the clinic after receiving Dutch authorization for a first-in-human phase I/II study of RJVA-001, with first dosing targeted for the second half of 2026. The company ended Q1 with about $63.2 million in cash and said it expects funding into early 2027. Fractyl Health (NASDAQ:GUTS) said it remains on track to report pivotal data for its Revita therapy in early fourth quarter 2026, as management highlighted clinical, regulatory and reimbursement developments during the company’s first-quarter 2026 earnings call. Chief Executive Officer Dr. Harith Rajagopalan framed Revita as a potential treatment option for patients who discontinue GLP-1 therapies and then face weight regain. He said more than 1 million people discontinue GLP-1s each month in the U.S., and cited weight regain of roughly 10% of total body weight within six months and 15% by 12 months after stopping therapy. → MercadoLibre Boldly Invests in Growth: Discount Deepens “Revita is being built for that moment,” Rajagopalan said, referring to the period after GLP-1 discontinuation when patients may choose between resuming chronic drug therapy or accepting the risk of weight rebound. Rajagopalan said the REMAIN-1 pivotal cohort completed randomization in February, enrolling more than 300 participants across more than 30 sites in the United States. He described it as “the largest sham-controlled GI endoscopy pivotal trial ever conducted.” → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? The company expects top-line six-month primary endpoint data from the pivotal cohort in early Q4 2026. The first co-primary endpoint measures percent total body weight regain at six months in Revita participants versus sham after discontinuation of tirzepatide. The second co-primary endpoint is a 52-week responder rate, defined as the percentage of Revita-treated participants who maintain at least 5% total body weight loss from pre-tirzepatide levels through one year. Rajagopalan said participant retention in the trial remains “well over 90%,” medication resumption rates remain below the company’s modeled assumptions and the blinded adverse event profile remains consistent with prior studies. He also said the company remains on track for an FDA submission in late Q4 2026 using six-month pivotal data. → MP Materials Is Quietly Building a Rare Earth Powerhouse Management also pointed to upcoming data releases before the pivotal readout. In Q2, the company expects 12-month open-label data from the REVEAL-1 cohort. In Q3, it expects 12-month randomized sham-controlled data from the REMAIN-1 midpoint cohort. Rajagopalan said the company intends to analyze those data through the same dose-response and run-in weight-loss lenses it previously used. Fractyl said it presented REMAIN-1 midpoint cohort six-month data at Digestive Disease Week, where the study was selected for the meeting’s press program. Rajagopalan said the presentation marked the first peer-reviewed setting in which the company presented dose-response analysis and patient-selection findings to a broad clinical audience. The company also convened a clinical advisory board with gastroenterologists and metabolic medicine physicians during the meeting. Rajagopalan said discussions supported the company’s view of Revita’s mechanism, procedural rationale and pivotal study design. In response to an analyst question, he said feedback from physicians at the meeting was “incredibly positive,” adding that physicians involved in the clinical infrastructure could form part of a potential commercial foundation if Revita reaches the market. Rajagopalan reiterated that Fractyl previously received favorable FDA feedback on its De Novo classification request, which the company said supported its view that Revita’s safety profile is consistent with a moderate-risk, rather than high-risk, device classification. During the Q&A, Rajagopalan said the De Novo pathway relies on a “totality of clinical evidence” rather than a single statistical result. He said Fractyl intends to submit data from REVEAL-1 and the REMAIN-1 midpoint cohort as part of the regulatory package, along with the pivotal data. Fractyl also discussed the RAPID coverage pathway announced by CMS and FDA for eligible breakthrough devices. Rajagopalan said the company believes Revita may be positioned to benefit from the pathway because it has FDA breakthrough device designation in weight maintenance after GLP-1 discontinuation and Type 2 diabetes. He said the pathway could potentially accelerate the reimbursement timeline if Revita reaches the market, though he noted it remains early in implementation. The company said it remains on track to file a Category III CPT code application this summer, with a code expected to become effective in summer 2027. Rajagopalan also said transitional pass-through payment from CMS may support hospital economics if Revita is commercialized. Fractyl also provided an update on Rejuva, its GLP-1 gene therapy platform. The company recently received authorization from regulatory authorities in the Netherlands to begin a phase I/II first-in-human study of RJVA-001, the first clinical candidate from the platform. Rajagopalan described RJVA-001 as a one-time beta cell-targeted gene therapy designed to enable nutrient-responsive physiological GLP-1 expression within the pancreas. The therapy is delivered through a minimally invasive endoscopic ultrasound-guided infusion into the pancreas. The company plans to conduct the study at other sites in Europe and in Australia, where a clinical trial application has been submitted. Feedback from Australian regulators is expected in the third quarter. Subject to site activation, Fractyl expects to dose the first patient and report preliminary data in the second half of 2026. In response to analyst questions, Rajagopalan said the initial study uses a three-by-three design and that early evaluation will focus on safety and feasibility within the first one to two weeks after dosing. Preliminary pharmacokinetic and pharmacodynamic signals are expected roughly eight weeks after dosing, when GLP-1 expression levels should reach target levels. He said the first dose is intended to be an active dose, while emphasizing a cautious approach because this is the first use of this route of administration for the disease. Chief Financial Officer Lara Smith Weber said research and development expenses were $15.6 million in the first quarter of 2026, compared with $19.4 million in the same period in 2025. The decrease was primarily tied to reduced spending on Revita and Rejuva, as well as lower personnel-related costs. Selling, general and administrative expenses were $5.2 million, compared with $5.3 million a year earlier. Fractyl reported net income of $9.2 million, compared with a net loss of $23.7 million in the prior-year period. Smith Weber said the shift was driven by a $30.1 million non-cash accounting change in the fair value of warrant liabilities and “does not reflect a change in our underlying operating performance.” Adjusted EBITDA was negative $18 million, compared with negative $23 million in the first quarter of 2025. Fractyl ended the quarter with approximately $63.2 million in cash and cash equivalents. Smith Weber said the company expects its cash position to fund operations into early 2027, beyond the anticipated REMAIN-1 pivotal data readout and through a potential De Novo submission in late Q4 2026. Rajagopalan added that the company’s ATM facility remains closed and said Fractyl does not plan to raise capital before pivotal data are in hand. Fractyl Health, Inc is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control. The company's lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Fractyl Health Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Fractyl Health Inc (NASDAQ:GUTS) has made significant progress with its RUVIDA pivotal trial, completing randomizations with over 300 participants across more than 30 sites in the U.S. The company has received favorable FDA feedback on its de novo classification request, confirming RUVIDA's safety profile as moderate-risk. Fractyl Health Inc (NASDAQ:GUTS) has a strong financial position, with a cash runway extending into early 2027, allowing them to reach pivotal data without a planned capital raise. The company is actively building a commercial path for RUVIDA, with favorable market dynamics due to the growing number of GLP-1 initiators and potential CMS reimbursement pathways. Fractyl Health Inc (NASDAQ:GUTS) is advancing its REJUVA gene therapy platform, having received authorization from EU regulatory authorities to initiate a Phase 1/2 study, marking a significant step in clinical development. The company faces the challenge of addressing post-GLP-1 weight regain, a significant issue for patients discontinuing GLP-1 therapy. There are uncertainties related to the regulatory approval process, particularly concerning the de novo submission and the need for comprehensive data to support it. Fractyl Health Inc (NASDAQ:GUTS) reported a negative adjusted EBITDA of $18 million for Q1 2026, indicating ongoing financial losses despite reduced operating expenses. The company has not yet approached the FDA regarding the REJUVA platform, indicating potential delays in U.S. regulatory progress. Fractyl Health Inc (NASDAQ:GUTS) is reliant on successful pivotal trial outcomes and regulatory approvals to achieve commercial success, which carries inherent risks and uncertainties. Warning! GuruFocus has detected 2 Warning Signs with GUTS. Is GUTS fairly valued? Test your thesis with our free DCF calculator. Q: Can you walk us through the enrollment timelines and target product profile for Rejuva, and what should we expect from the preliminary dataset in the second half of the year? A: Subject to site activation, there is a several-week run-in period for first patients. This is a three-by-three study design, where initial patients will be treated at an initial dose. We will evaluate safety, feasibility, and initial PK/PD from those three individuals before escalating to the next dosing regime. We expect to see preliminary PK and PD signals roughly 8 weeks after dosing, when GLP-1 expression levels should reach their target levels. Q: Is an all-comer pivotal success required for de novo submission, or could a subgroup data influence the regulatory package? A: The de novo pathway has a different clinical threshold than a PMA, focusing on the totality of clinical evidence rather than any single p-value. We are confident in the pivotal trial's success and believe there is flexibility in the de novo pathway. Regarding German commercial use, we continue to follow patients and will provide updates once a reasonable number have hit three years. Q: Will the de novo marketing application submission include one-year data from the REVEAL-1 and REMAIN-1 midpoint cohorts? A: Yes, we will submit all data to the FDA, including REVEAL-1 and REMAIN-1 midpoint cohort data, to contribute to the totality of evidence. The FDA will consider all available evidence when making their marketing authorization decision in the de novo pathway. Q: Can you comment on the first dose cohort for the Rejuva 001 study? Should we think of it as an active dose? A: The first dose should be an active dose, and patients should benefit from it. We are cautious in our approach, prioritizing patient safety, but optimistic about seeing active signals after administration. Q: Could you talk about DDW and the feedback received from physicians and clinicians? A: DDW is a great meeting for us, attended by leaders in GI endoscopy. We received positive feedback on our pivotal study and commercialization plan from physicians across the U.S. The clinical infrastructure and physician relationships we've built provide a strong foundation for commercial distribution. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Next anticipated Revita® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance reaffirmed Clinical Trial Application authorization of RJVA-001 first-in-human study in the Netherlands for T2D; first-in-human dosing anticipated in second half of 2026 reiterated Cash runway guidance into early 2027, beyond anticipated Pivotal data readout reiterated Conference call today at 4:30 p.m. ET BURLINGTON, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced first quarter 2026 financial results and provided business updates. The Company also reiterated all previously disclosed 2026 Revita® clinical and regulatory milestones, including topline 6-month randomized data from the REMAIN-1 Pivotal Cohort expected in early Q4 2026, and its cash runway guidance into early 2027. “We believe Revita has the potential to offer a transformational new approach to durable weight maintenance and a clinically needed off ramp from GLP-1 therapy. Our first quarter results reflect continued execution across every dimension of our business toward that goal,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl. “Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort remains on track for early Q4 2026. This registrational study is prospectively designed and statistically powered to demonstrate Revita’s potential effect across the full cohort, with enrichment in participants with higher run-in weight loss and longer ablation length. Ahead of that readout, we expect to report 1-year REVEAL-1 Cohort data in Q2 2026 and 1-year REMAIN-1 Midpoint Cohort randomized data in Q3 2026. Fractyl stands alone in developing the first potential procedural option for post-GLP-1 weight maintenance, and with cash runway into early 2027, we are funded beyond the anticipated pivotal data readout.” Select Recent Revita Clinical Highlights The Company is studying Revita in the REMAIN-1 weight maintenance program, which is designed to evaluate Revita's potential to maintain weight loss following GLP-1 based therapy discontinuation. The REMAIN-1 program includes three distinct participant cohorts that are conducted under a single IDE: the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort. In January 2026, Fractyl announced compelling 6-month randomized REMAIN-1 Midpoint Cohort data showing durable weight maintenance with Revita after GLP-1 discontinuation. Participants with above median GLP-1-associated weight loss experienced approximately 70% less post-GLP-1 weight regain with Revita versus sham at 6 months. These pilot study results support the pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance. In February 2026, Fractyl completed participant randomization in the REMAIN-1 Pivotal Cohort. In March 2026, Fractyl reported post-hoc analyses from the REMAIN-1 Midpoint Cohort showing a statistically significant ablation length (i.e., dose)-dependent treatment effect on post-GLP-1 weight maintenance at 6 months. In participants with above median GLP-1-induced weight loss who received greater than 14 cm duodenal ablation, Revita participants retained 88% of GLP-1-induced weight loss at six months compared to only 60% in sham participants. In March 2026, Fractyl also reported that it had received pre-submission feedback from the U.S. Food and Drug Administration (FDA) acknowledging that the safety profile of the Revita DMR System, based on clinical data from over 300 procedures, is consistent with a Class II device classification. Fractyl Forward: Reiterating Anticipated 2026 Revita Milestones With randomization of the REMAIN-1 Pivotal Cohort complete, Fractyl is advancing toward multiple anticipated clinical and regulatory milestones toward pivotal readout and potential U.S. regulatory submission. The Company reiterates its previously announced cash runway into early 2027, beyond the anticipated pivotal data readout. Q2 2026: 1-year REVEAL-1 Cohort data. Q3 2026: 1-year REMAIN-1 Midpoint Cohort randomized data. Early Q4 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort. Late Q4 2026: Potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance. As in all applications, the FDA indicated that final pathway determinations will be made following review of the complete safety dataset, which the Company intends to include in its potential De Novo marketing application submission. Rejuva® Development Progress and Anticipated 2026 Rejuva Milestones Rejuva is Fractyl’s gene therapy platform designed to enable long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones. The lead product candidate, RJVA-001, is being advanced for patients with inadequately controlled T2D. The second candidate, RJVA-002, is a preclinical-stage dual GIP/GLP-1 gene therapy designed to treat obesity. In April 2026, we received CTA authorization in the Netherlands for RJVA-001, enabling initiation of the anticipated Phase 1/2 first-in-human study evaluating RJVA-001 in adults with inadequately controlled T2D. Subject to site activation, we expect to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026. We also plan to conduct the study at sites in Australia, where a CTA has been submitted and regulatory feedback is expected in the third quarter of 2026. H2 2026: First-in-human dosing of RJVA-001, subject to site activation, and expected reporting of preliminary data. First Quarter 2026 Financial Results Research and Development Expenses: R&D expenses were $15.6 million for the quarter ended March 31, 2026, compared to $19.4 million for the same period in 2025. The decrease was primarily related to reduced spending on our Revita and Rejuva programs, as well as lower personnel-related expenses. Selling, General and Administrative Expenses: SG&A expenses were $5.2 million for the quarter ended March 31, 2026, consistent with $5.3 million for the same period in 2025. Net Income (Loss): For the quarter ended March 31, 2026, Fractyl reported a net income of $9.2 million, compared to net loss of $23.7 million for the same period in 2025. The shift was primarily driven by a $30.1 million non-cash accounting change in fair value related to our warrant liabilities and does not reflect a change in our underlying operating performance. Operating expenses for the quarter ended March 31, 2026 were $3.9 million lower compared to the same period in 2025. Adjusted EBITDA: Adjusted EBITDA was negative $18.0 million for the quarter ended March 31, 2026, compared to negative $23.0 million for the same period in 2025. The decrease in the non-GAAP adjusted loss was primarily due to the decrease in operating expenses. Cash Position: As of March 31, 2026, Fractyl had approximately $63.2 million in cash and cash equivalents. Based on current business plans, the Company believes its cash position will fund operations into early 2027. Webcast and Conference Call Information Fractyl will host a conference call to discuss its first quarter financial results and provide business updates on Tuesday, May 12, 2026, 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 clinical-stage metabolic therapeutics company advancing two differentiated candidates designed to target the root causes of obesity and T2D: Revita, a procedural therapy in pivotal development for post-GLP-1 weight maintenance, and Rejuva, an AAV-based gene therapy platform with its lead candidate RJVA-001 entering first-in-human clinical studies. Fractyl’s goal is to advance metabolic disease treatment from chronic management toward prevention and reversal of disease. 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 for investigational use only in the United States and is CE marked in the European Union and United Kingdom. About Rejuva Fractyl Health’s Rejuva platform is developing next-generation AAV-based, locally delivered gene therapies for the treatment of obesity and T2D. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas, with the goal of offering novel, disease-modifying therapies that address the underlying root causes of disease. The platform’s lead candidate, RJVA-001, has received Clinical Trial Authorization in the Netherlands to initiate a Phase 1/2 first-in-human clinical trial in T2D, the first clinical-stage program from the Rejuva platform. Fractyl expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026, subject to site activation. Additional Rejuva candidates, including RJVA-002 (a dual GIP/GLP-1 gene therapy candidate designed to treat obesity), remain in preclinical development. In the United States, Rejuva is in preclinical development. No Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (the FDA), and Rejuva has not been approved or authorized by the FDA for use in humans. Non-GAAP Financial Measures This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (GAAP), including Adjusted EBITDA, which is a non-GAAP financial measure as defined in Regulation G promulgated under the Securities Exchange Act of 1934. This non-GAAP financial measure is provided as supplemental information to Fractyl’s financial measures presented in this press release in accordance with GAAP. The Company defines Adjusted EBITDA as net income (loss) adjusted to exclude (i) interest income, net, (ii) depreciation expense, (iii) stock-based compensation expense, (iv) change in fair value of notes payable and (v) change in fair value of warrant liabilities. Management believes Adjusted EBITDA provides useful supplemental information to investors regarding the Company’s core operating performance and facilitates period-to-period comparisons by excluding items that are non-cash or non-operational in nature and may vary in magnitude. Adjusted EBITDA is also used by management in evaluating the Company’s operating performance and in planning and forecasting activities. The non-GAAP financial measures used by Fractyl may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Fractyl’s financial results prepared and reported in accordance with GAAP. This non-GAAP measure should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. A reconciliation of Adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this press release. 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 expected initiation, timing, design, endpoints, site activation, and conduct of the RJVA-001 first-in-human clinical trial; the timing and results of first-in-human dosing and reporting of preliminary data; our regulatory strategy, including submissions to and communications with regulators in the European Union, Australia, and other jurisdictions; the promise, potential impact, and mechanism of action of RJVA-001 and our Rejuva platform; our anticipated financial performance, including cash and cash equivalents, for any period of time, our strategic reprioritization and related workforce reduction, including its implementation and the expected costs and benefits, if any; our expected cash runway; the promise and potential impact of our preclinical or clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REVEAL-1 Cohort, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; the content, information used for, timing or results of any Investigational New Drug (IND)-enabling studies, IND applications, or CTAs; communications with regulators regarding the REVEAL-1 Cohort, the potential launch or commercialization of any of our product candidates or products, the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; the potential treatment population or benefits for any of our product candidates or products; our regulatory strategy, including potential use and benefits of the De Novo pathway (FDA pre-submission feedback is advisory and non-binding, and there is no assurance that FDA will accept a De Novo marketing application submission or that the Revita DMR System will receive marketing authorization); our strategic and product development objectives and goals; 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 our 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 risks that are discussed more fully in our filings with the Securities and Exchange Commission (the SEC) including the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents we subsequently file with or furnish to the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026. These forward-looking statements are based on management’s current estimates and expectations. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. Contact Brian Luque, Head of Investor Relations and Corporate Development [email protected], 951.206.1200 (1) Working capital is defined as total current assets less total current liabilities.