ADDED
Solely for purposes of this disclosure, shares of common stock held by executive officers, directors and certain stockholders of the registrant as of such date have been excluded because such holders may be deemed to be affiliates.
Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States ( U.S.
References to 2025 and 2024 refer to the year ended December 31, 2025 and the year ended December 31, 2024, respectively.
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.
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 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.
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.
REMOVED
Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP.
References to 2024 and 2023 refer to the year ended December 31, 2024 and the year ended December 31, 2023, respectively.
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.