GUTS

These and other factors could cause results to differ materially from those expressed in the estimates made by the independent third parties and by us. ii FORWARD-LOO KING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that can involve substantial risks and uncertainties.
All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy (including our Strategic Reprioritization, as defined herein), prospective products, or product candidates, plans regarding or status of clinical trials or studies and their design, our plans for readouts of interim or final results, product approvals, communications with or submissions to the U.S.
Food and Drug Administration (the “FDA”), research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management, the anticipated use of or impact of the net proceeds from the ATM Offering, the August 2025 Offering and the September 2025 Offering, and the timing of any of the foregoing are forward-looking statements.
Forward-looking statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about: • the timing, progress and results of preclinical and clinical studies for our current and future product candidates, including statements regarding the timing of initiation and completion of studies and related preparatory work, the period during which the results of the studies will become available and our research and development programs; • the timing, scope or likelihood of regulatory submissions, filings, clearances, certifications and approvals, including final regulatory authorizations, approval certifications or clearance of our product candidates; • our ability to develop and advance product candidates into, and successfully complete, clinical studies; • our expectations regarding the size of the patient populations for our product candidates, if authorized, approved, certified or cleared for commercial use; • the implementation of our business model and our strategic plans for our business, product candidates and technology; • our commercialization, marketing and manufacturing capabilities and strategy, as well as our product development strategy; • the pricing and reimbursement of our product candidates, if authorized, approved or cleared; • the scalability and commercial viability of our manufacturing methods and processes, including our plans to maintain our in-house manufacturing facility, even after commercialization of any of our product candidates; • the rate and degree of market acceptance and clinical utility of our product candidates; • our ability to establish or maintain collaborations or strategic relationships or obtain additional funding; • our competitive position; • the scope of protection we and/or any future licensors are able to establish and maintain for intellectual property rights covering our product candidates; • the status, breadth and strength of our intellectual property portfolio and its ability to protect our innovations; • our ability to obtain patent coverage for our products; iii • our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; • developments and projections relating to our competitors and our industry; • our expectations related to the use of proceeds from our financing activities; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our ability to continue as a going concern; • the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; • the impact of laws and regulations; • our expectations regarding the time during which we will be an emerging growth company and smaller reporting company under the JOBS Act; and • the impact of adverse macroeconomic conditions, geopolitical events and potential future public health crises, including epidemics and pandemics.
These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of risks, uncertainties and assumptions described in Part I, Item 1A.
The principal risks and uncertainties affecting our business include the following: • We have a limited operating history in developing medical devices and biopharmaceutical products, have not completed any pivotal clinical studies and have no products approved for commercial sale in the United States (“U.S.”), which may make it difficult for you to evaluate our current business and predict our future success and viability; • We have incurred significant net losses since inception, we expect to continue to incur significant net losses for the foreseeable future and may never achieve or sustain profitability, and we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern; • We require substantial additional capital or must implement other business strategies to execute our operating plan and continue to operate as a going concern.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts; • The regulatory clearance and certification processes of the U.S.
Further, we may encounter substantial delays in our clinical studies; • We currently conduct and may in the future conduct clinical studies for our product candidates outside the U.S., and the FDA or comparable foreign regulatory authorities may not accept data from such studies; • We may not be able to submit investigational device exemptions (“IDEs”) or IDE supplements or comparable documents in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or comparable foreign regulatory authorities may not permit us to proceed; • We may experience delays, interruptions or additional costs in obtaining and maintaining government regulatory approvals, licenses, certifications or reimbursements as a result of federal government shutdowns, reduced staffing or funding lapses.
Such delays or disruptions could adversely affect our ability to develop, commercialize or market our product candidates, or to receive payments or reimbursements in a timely manner; • We may not be able to submit investigational new drug applications (“INDs”) or IND amendments with the FDA, clinical trial applications (“CTAs”) or comparable documents with regulatory bodies in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or other comparable foreign regulatory authorities may not permit us to proceed; • We are substantially dependent on the success of our lead product candidate, Revita ® , and our lead gene therapy product candidate, RJVA-001, in the Rejuva ® platform.
If we are unable to obtain marketing authorization or certification for and commercialize any of our current or future product candidates in a timely manner, our business will be harmed; • Our long-term prospects depend in part upon discovering, developing and commercializing product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.
We intend to identify and develop novel product candidates, which makes it difficult to predict the time, cost and potential success of our current product candidates, and other product candidates we may develop in the future; v • Additional time may be required to develop and obtain regulatory approval or certification for our Rejuva gene therapy candidates because we expect them to be regulated as a combination product; • We cannot be certain that our Rejuva gene therapy candidates will successfully complete preclinical and clinical studies, or that they will not cause significant adverse events or toxicities.
There can be no assurance that any development problems we experience in the future related to our Rejuva gene therapy candidates or any of our research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved; • We may not be able to gain the support of leading hospitals and key thought leaders, or to publish the results of our clinical studies in peer-reviewed journals, which may make it difficult to establish the Revita DMR procedure and/or our Rejuva gene therapy candidates as a standard of care, if approved, and may limit our revenue growth and ability to achieve profitability; • We have not yet studied the ability of Revita to be used in repeated procedures.
If we are unable to demonstrate the safety and improved glycemic effects of Revita for repeat use, it could have a material adverse effect on the clinical utility and commercial adoption of the device; • We have never obtained marketing authorization for a product candidate in the U.S. and we may be unable to obtain, or may be delayed in obtaining, marketing authorization for any product candidate in the U.S.; • We substantially rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations (“CROs”), to conduct certain aspects of our preclinical studies and clinical studies.
If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain marketing authorization of or commercialize our product candidates and our business could be substantially harmed; • If we decide to establish new collaborations in the future, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans; • We contract with third parties for the manufacture and supply of sub-assembly components for Revita and for the materials for our Rejuva gene therapy platform for preclinical studies and our ongoing clinical studies, and expect to continue to do so for additional clinical studies and ultimately for commercialization.
If we are unable to obtain and maintain patent protection for our current product candidate, any future product candidates we may develop and our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our current product candidate, any future product candidates we may develop and our technology may be adversely affected; and • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory marketing authorization. vi PA RT I Item 1.
Our Company We are a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (“T2D”).
Our Revita ® and Rejuva ® candidates are designed to target root causes of metabolic diseases, allowing us to advance metabolic disease treatment from chronic management towards prevention and reversion of the disease.
According to the Centers for Disease Control approximately 115 million people in the U.S. have prediabetes and/or are living with obesity, and an additional approximately 27 million people have T2D and are potentially on medical therapy.
According to a Kaiser Family Foundation Health Tracking Poll from November 2025, approximately 12% of adults are taking glucagon-like peptide-1 (“GLP-1”) drugs (an increase of 6 percentage points from May 2024), translating to approximately 30 million patients potentially on therapies that require chronic administration and do not correct the underlying disease of obesity.
The Revita DMR System (“Revita”), our lead product candidate, is based on our insights surrounding the potential role of the gut in obesity.
Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease.
FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based therapy.
We have received favorable FDA feedback on our De Novo classification request for Revita and anticipate submitting a potential De Novo marketing application in the late fourth quarter of 2026.
We are evaluating 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 study 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, which are designed to collectively establish the clinical and regulatory foundation for Revita in weight maintenance. • The REVEAL-1 Cohort (n=22) 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 based therapy. • The REMAIN-1 Midpoint Cohort (n=45) is a randomized, double-blind, sham-controlled pilot study to assess the potential of Revita to maintain weight loss after GLP-1 based therapy discontinuation. • The REMAIN-1 Pivotal Cohort (n=315) is a randomized, double-blind, sham-controlled pivotal study to evaluate the safety and efficacy of Revita in maintaining weight loss.
Enrollment of all three cohorts is complete and the REMAIN-1 Midpoint Cohort and REMAIN-1 Pivotal Cohort are fully randomized, as described further under “Ongoing REMAIN-1 Clinical Study” below.
We are also developing Rejuva, our novel and locally administered, adeno-associated virus (“AAV”)-delivered pancreatic gene therapy platform.
Rejuva is designed to enable long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones.
Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas.
Our lead candidate from the Rejuva platform, RJVA-001, is designed to be delivered to the pancreas via a single endoscopic intervention to enable pancreatic beta cells to express GLP-1 locally via nutrient-responsive control.
This gene therapy approach enables physiologic GLP-1 secretion without the high circulating levels that contribute to side effects seen with systemic GLP-based drugs.
Our second candidate from the Rejuva platform, RJVA-002, is a dual GIP/GLP-1 gene therapy and is currently in preclinical development.
RJVA-002 expands the Rejuva platform into obesity, targeting dual incretin biology with the goal of achieving durable, well-tolerated, weight loss from a single intervention.
Additional information regarding the Rejuva platform is described under “Rejuva Platform Description” and “Preclinical Data Overview: Rejuva Gene Therapy Platform” below.
We believe Revita and Rejuva have the potential to revolutionize treatment across the spectrum of obesity and T2D, align the clinical and economic interests of key stakeholders around the long-term regression of metabolic disease, and, at their fullest potential, significantly reduce the burden of metabolic disease globally.
The following table summarizes our development pipeline and potential clinical opportunities across the spectrum of metabolic disease, from obesity (with or without prediabetes) to advanced T2D.
Our approach builds on over a decade of our research and the accumulation of independently published, supportive preclinical and clinical evidence, all implicating the gut and pancreas as validated, untapped targets in obesity and T2D.
By targeting duodenal dysfunction, Revita aims to provide durable weight maintenance solutions, addressing a critical gap in current long-term obesity care.
To date, we have evaluated Revita in over 500 participants across multiple clinical studies at sites in South America, Europe and the U.S., with favorable safety and tolerability, glycemic control and weight maintenance data.
In preclinical head-to-head studies, Rejuva gene therapy candidates demonstrated weight reduction in a disease-relevant diet-induced obesity (“DIO”) mouse model, along with improvement in glycemic control and delayed T2D progression in a disease-relevant db/db mouse model compared to chronic administrations of semaglutide (the active agent in Ozempic and Wegovy).

and 627 more.

Gone since FY2024

These and other factors could cause results to differ materially from these expressed in the estimates made by the independent third parties and by us. ii FORWARD-LOO KING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that can involve substantial risks and uncertainties.
All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, our ability to continue as a going concern, business strategy (including our Strategic Reprioritization, as defined herein), prospective products, or product candidates, plans regarding or status of clinical trials or studies and their design, our plans for readouts of interim or final results, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management and the timing of any of the foregoing are forward-looking statements.
Forward-looking statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about: • the timing, progress and results of preclinical and clinical studies for our current and future product candidates, including statements regarding the timing of initiation and completion of studies and related preparatory work, the period during which the results of the studies will become available and our research and development programs; • the timing, scope or likelihood of regulatory submissions, filings, clearances, certifications and approvals, including final regulatory approval certifications or clearance of our product candidates; • our ability to develop and advance product candidates into, and successfully complete, clinical studies; • our expectations regarding the size of the patient populations for our product candidates, if approved, certified or cleared for commercial use; • the implementation of our business model and our strategic plans for our business, product candidates and technology; • our commercialization, marketing and manufacturing capabilities and strategy, as well as our product development strategy; • the pricing and reimbursement of our product candidates, if approved or cleared; • the scalability and commercial viability of our manufacturing methods and processes, including our plans to maintain our in-house manufacturing facility, even after commercialization of any of our product candidates; • the rate and degree of market acceptance and clinical utility of our product candidates; • our ability to establish or maintain collaborations or strategic relationships or obtain additional funding; • our competitive position; • the scope of protection we and/or any future licensors are able to establish and maintain for intellectual property rights covering our product candidates; • developments and projections relating to our competitors and our industry; • our expectations related to the use of proceeds from our initial public offering (“IPO”); iii • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our ability to continue as a going concern; • the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; • the impact of laws and regulations; • our expectations regarding the time during which we will be an emerging growth company and smaller reporting company under the JOBS Act; and • the impact of adverse macroeconomic conditions, geopolitical events and potential future public health crises, including epidemics and pandemics.
These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of risks, uncertainties and assumptions described in Part I.
The principal risks and uncertainties affecting our business include the following: • We have a limited operating history in developing medical devices and biopharmaceutical products, have not completed any pivotal clinical studies and have no products approved from commercial sale in the United States, which may make it difficult for you to evaluate our current business and predict our future success and viability; • We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future and may never achieve or sustain profitability; • We will require substantial additional capital or must implement other business strategies to execute our operating plan and continue to operate as a going concern.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts; • The regulatory approval process of the U.S.
Further, we may encounter substantial delays in our clinical studies; • We currently conduct and may in the future conduct clinical studies for our product candidates outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies; • We may not be able to file investigational device exemptions (“IDEs”) or IDE supplements or comparable documents in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or comparable foreign regulatory authorities may not permit us to proceed; • We may not be able to submit investigational new drug applications (“INDs”) or IND amendments, clinical trial applications (“CTAs”) or comparable documents in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or comparable foreign regulatory authorities may not permit us to proceed; • We are substantially dependent on the success of our lead product candidate, Revita, and if we are unable to obtain marketing approval or certification for and commercialize any of our current or future product candidates in a timely manner, our business will be harmed; • Our long-term prospects depend in part upon discovering, developing and commercializing product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.
We intend to identify and develop novel product candidates, which makes it difficult to predict the time, cost and potential success of our current product candidates, and other product candidates we may develop in the future; • Additional time may be required to develop and obtain regulatory approval or certification for our Rejuva gene therapy candidates because we expect them to be regulated as a combination product; • We cannot be certain that our Rejuva gene therapy candidates will successfully complete preclinical and clinical studies, or that they will not cause significant adverse events or toxicities.
There can be no assurance that any development problems we experience in the future related to our Rejuva gene therapy candidates or v any of our research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved; • We may not be able to gain the support of leading hospitals and key thought leaders, or to publish the results of our clinical studies in peer-reviewed journals, which may make it difficult to establish the Revita DMR procedure and/or our Rejuva gene therapy candidates as a standard of care, if approved, and may limit our revenue growth and ability to achieve profitability; • We have not yet studied the ability of Revita to be used in repeated procedures.
If we are unable to demonstrate the safety and efficacy of Revita for repeat use, it could have a material adverse effect on the clinical utility and commercial adoption of the device; • We have never obtained marketing approval for a product candidate in the United States and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any product candidate in the United States; • We substantially rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations (“CROs”), to conduct certain aspects of our preclinical studies, and clinical studies.
If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain marketing authorization of or commercialize our product candidates and our business could be substantially harmed; • If we decide to establish new collaborations in the future, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans; • We contract with third parties for the manufacture of sub-assembly components for Revita and for the materials for our Rejuva gene therapy platform for preclinical studies and our ongoing clinical studies, and expect to continue to do so for additional clinical studies and ultimately for commercialization.
If we are unable to obtain and maintain patent protection for our current product candidate, any future product candidates we may develop and our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our current product candidate, any future product candidates we may develop and our technology may be adversely affected; and • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval. vi PA RT I Item 1.
Our Company We are a metabolic therapeutics company focused on breaking the pattern of treatment of metabolic diseases, including obesity and type 2 diabetes (“T2D”).
According to the Centers for Disease Control and the International Diabetes Federation, approximately 100 million people in the United States have prediabetes and/or are living with obesity, and an additional 25 million people have T2D and are on medical therapy.
According to a Kaiser Family Foundation Health Tracking Poll from May 2024, approximately 6% of adults are taking glucagon-like peptide-1 (“GLP-1”) drugs, translating to approximately 10 million patients on therapies that require chronic administration and do not correct the underlying disease of obesity.
Our goal is to develop durable disease-modifying therapies that are designed to provide lasting metabolic health by targeting root causes of obesity and T2D – without lifelong treatment.
Building on the growing recognition of the gut's role in metabolic disease, our founders designed novel, differentiated, disease-modifying therapies aiming to shift patient care from management to prevention and remission.
The Revita DMR System, or Revita, our lead product candidate, is an investigational outpatient procedural therapy designed to durably modify duodenal dysfunction, a major pathologic consequence of a high fat and high sugar diet, which can cause obesity and T2D.
The duodenum regulates the human metabolic response to food intake, and modern diets drive dysfunctional hyperplasia of the duodenal mucosa.
This results in alterations to physiologic signaling that affect glucose control and satiety.
The Revita DMR System is designed to enable durable and repeatable metabolic improvement via hydrothermal ablation of the dysfunctional duodenal mucosa to address duodenal pathology and consequent metabolic disease progression directly.
Currently, our Revita clinical program is focused on patients living with obesity who want to maintain their weight loss after GLP-1 drug discontinuation.
We have obtained Breakthrough Device designation from the FDA for the Revita DMR System, as an adjunct to diet and exercise, to perform hydrothermal ablation of the duodenal mucosa, or the Revita DMR procedure, for use in the maintenance of weight loss after discontinuation of GLP-1-based therapy.
This designation may enable prioritized FDA review of any marketing application we may submit for Revita within the designated indication, as well as the potential for an early or accelerated decision on reimbursement by the Centers for Medicare & Medicaid Services (the “CMS”).
We are evaluating Revita in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort which includes both a midpoint analysis and a pivotal analysis.
Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort.
The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses.
The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index (“BMI”) between 30 and 45 kg/m 2 who are not currently on a GLP-1 drug.
Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham.
Midpoint Analysis of Randomized Cohort: The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis.
These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort: The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation.
The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease (“CVD”) risk factors, body composition and pre-diabetes status.
All patients enrolled in the study will receive diet and lifestyle counseling.
In January 2025, we reported positive preliminary results from the REVEAL-1 open-label cohort of the REMAIN-1 study.
Initial findings from the first patient, as of a cutoff date of January 13, 2025, showed successful weight maintenance at one month following GLP-1 drug discontinuation and Revita DMR procedure.
Additional data from the REVEAL-1 cohort are anticipated to be presented in the first quarter of 2025.
As of February 15, 2025 recruitment for the REMAIN-1 study has generated significant interest, with over 189 patients enrolled across 13 clinical study sites in six months since first site activation, reflecting strong engagement from both patients and physicians.
We believe this momentum underscores the urgent need for effective post-GLP-1 weight maintenance solutions.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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