GUTS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• You should read the following discussion and analysis of our financial condition and results of operations together with (i) our unaudited condensed consolidated financial statements and related notes, appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the audited consolidated financ…

• 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 man…

• Key Developments During the Three Months Ended March 31, 2026

• Revita. REMAIN-1 Midpoint Cohort. In January 2026, we announced 6-month randomized data. As of January 29, 2026, across the prespecified efficacy population (n=40, with five participants excluded per protocol due to diet and lifestyle noncompliance and only included in the safety population), Revita…

• Rejuva. We completed key preclinical in vivo studies to support clinical trial applications (“CTAs”) for RJVA-001, our lead gene therapy candidate and subsequently submitted CTAs for RJVA-001 in T2D to regulators in the EU (Netherlands) and Australia in the second half of 2025. In April 2026, we rec…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes and other information included elsewhere in this Quarterly Report on Form 10-Q. In addition to his…

• We are a metabolic therapeutics company pioneering pattern-breaking treatments for metabolic diseases, including obesity and type 2 diabetes (“T2D”). We are focused on developing durable disease-modifying therapies that are designed to provide long-term maintenance of metabolic health without requir…

• Since our formation in 2010, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, acquiring or discovering product candidates, securing related intellectual property rights and conducting discovery, resea…

• The Revita DMR System (“Revita”) is approved in Europe under a Conformitè Europëenne (“CE mark”) and has received reimbursement authorization through NUB in Germany for the treatment of T2D. In the first half of 2023, we initiated a limited commercial pilot in a single center in Dusseldorf, Germany.…

• We have also paused additional investment in the REVITALIZE-1 clinical study of Revita in T2D and the Germany Real-World Registry study. We are continuing to follow existing participants in both studies per protocol and will report clinical, health economic, and patient-relevant outcomes from the Ge…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• We are a smaller reporting company as defined in Item 10(f)(1) of Regulation S-K. As a result, pursuant to Item 305(e) of Regulation S-K, we are not required to provide the information required by this Item 3.

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• We are exposed to interest rate risk, credit risk, foreign currency risk, and inflation risk. These market risks arise in the normal course of business. There have been no material changes to the information included under Part II, Item 7A, Quantitative and Qualitative Disclosures About Market Risk,…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• There were no material changes during the period covered in this Quarterly Report on Form 10-Q to the Risk Factors previously disclosed in Part I, Item 1A of the Annual Report, other than as set forth below.

• Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which could negatively impact the market price and liquidity of our common stock and our ability to access the capital markets.

• In order to maintain this listing, we must satisfy the continued listing requirements and standards of Nasdaq, including a minimum closing bid price requirement for our common stock of $1.00 per share. As previously reported, on March 13, 2026, we received a notification letter from Nasdaq notifying…

• If we are unable to regain compliance within the applicable cure period, including any available extension, our common stock would be subject to delisting from Nasdaq. A delisting of our common shares could negatively impact us by, among other things, (i) reducing the liquidity and market price of o…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• Risks Related to Our Financial Condition and Capital Requirements

• 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, which may make it difficult for you to evaluate our current business and predict o…

• Medical device and biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a metabolic therapeutics company with a limited operating history in developing medical devices and biopharmaceutical products, which makes it difficult to e…

• In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by medical device and biopharmaceutical companies developing products in rapidly evolving fields. We also may need to transition from a company …

• 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.

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• During the three months ended March 31, 2026, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• During the three months ended September 30, 2025, Harith Rajagopalan, Chief Executive Officer and Director, adopted a Rule 10b5-1 trading arrangement on August 29, 2025 that is intended to satisfy the affirmative defense of Rule 10b5‑1(c) for the sale of up to 483,885 shares of the Company’s common …

• Other than described above, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.