FRACTYL HEALTH, INC.

Previous wording

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. This pilot has since been paused, pursuant to our Strategic Reprioritization.

Current wording

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. This pilot has since been paused, pursuant to the strategic reprioritization we announced on January 31, 2025 (“Strategic Reprioritization”).

Previous wording

We are evaluating Revita in the REMAIN-1 pivotal study, which is designed to include three distinct patient cohorts:

Current wording

We are evaluating Revita in the REMAIN weight maintenance program, which is designed to include three distinct patient cohorts:

Previous wording

REVEAL-1 Cohort: an open-label cohort of 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. After stopping the GLP-1 drug, 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.

Current wording

REVEAL-1 Cohort (n=22): 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. After stopping the GLP-1 drug, 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.

Previous wording

REMAIN-1 Midpoint Cohort: a randomized, double-blind cohort of 45 participants to assess the potential of Revita to maintain weight loss after GLP-1 discontinuation. Participants are individuals with obesity who have not yet taken GLP-1 drugs, are initiated on tirzepatide at the time of enrollment, and treated with the drug to achieve at least 15% total body weight loss. Participants then discontinue tirzepatide and are randomized to undergo either Revita or a sham procedure with a 2:1 treatment allocation. The initial efficacy analysis will be conducted after approximately 45 subjects have completed 12 weeks of follow-up. The randomized Midpoint Cohort serves as an important early randomized readout to assess Revita’s potential to maintain weight loss after GLP-1 discontinuation.

Current wording

REMAIN-1 Midpoint Cohort (n=45): a randomized, double-blind, sham-controlled pilot study to assess the potential of Revita to maintain weight loss after GLP-1 discontinuation. Participants are individuals with obesity who have not yet taken GLP-1 drugs, are initiated on tirzepatide at the time of enrollment, and treated with the drug to achieve at least 15% total body weight loss. Participants then discontinue tirzepatide and are randomized to undergo either Revita or a sham procedure with a 2:1 treatment allocation. The key efficacy endpoint is total body weight change in Revita versus sham at 3 months. The randomized Midpoint Cohort serves as an important early randomized readout to assess Revita’s potential to maintain weight loss after GLP-1 discontinuation.

Previous wording

REMAIN-1 Pivotal Cohort: a randomized, double-blind cohort of 315 participants to evaluate the safety and efficacy of Revita in maintaining weight loss. The first co-primary endpoint is defined as the percent of total body weight regain from the time of tirzepatide discontinuation in Revita versus sham patients through 6-month follow up. The primary objective is to demonstrate a benefit of Revita versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita treated participants at 1 year to demonstrate the durability of the Revita procedure for weight maintenance after discontinuation of a GLP-1 based therapy.

Current wording

REMAIN-1 Pivotal Cohort (n=315): a randomized, double-blind, sham-controlled pivotal study to evaluate the safety and efficacy of Revita in maintaining weight loss. The first co-primary endpoint is defined as the percent of total body weight regain from the time of tirzepatide discontinuation in Revita versus sham patients through 6-month follow up. The primary objective is to demonstrate a benefit of Revita versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita treated participants at 1 year to demonstrate the durability of the Revita procedure for weight maintenance after discontinuation of a GLP-1 based therapy. The responder rate is defined as the percentage of participants who received the Revita procedure who maintain at least 5% total body weight loss from pre‑tirzepatide (week -21) to week 52.

Previous wording

In addition, we are developing Rejuva, a gene therapy platform which is designed to enable long-term remission of T2D and obesity by durably reprogramming metabolic hormone function in the pancreatic islet cells. The lead product candidate from this platform, RJVA-001, is being advanced for patients with inadequately controlled T2D. In June 2025, we submitted the first module of the CTA in Europe for RJVA-001. RJVA-001 is designed to express glucagon-like peptide-1 (GLP-1) locally in pancreatic beta cells using nutrient-responsive control, potentially enabling physiologic hormone secretion without the high circulating levels that contribute to side effects seen with systemic GLP-1 drugs.

Current wording

The lead product candidate from this platform, RJVA-001, is being advanced for patients with inadequately controlled T2D. RJVA-001 is designed to express GLP-1 locally in pancreatic beta cells using nutrient-responsive control, in a single intervention, potentially enabling physiologic hormone secretion without the high circulating levels that contribute to side effects seen with systemic GLP-1 drugs. We have submitted the first Clinical Trial Application (“CTA”) module for RJVA-001 in T2D to regulators, and if the CTA is authorized, the Company expects to dose the first patients with RJVA-001 and report preliminary data in 2026.

Previous wording

We do not have any products approved for sale in the United States. To date, we have financed our operations primarily through the proceeds from sales of our convertible preferred stock, sales of our common stock in our public offerings and debt financings.

Current wording

We do not have any products approved for sale in the United States. To date, we have financed our operations primarily through the proceeds from sales of our equity and debt financings.

Previous wording

We have incurred significant operating losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of one or more of our current or future product candidates in the United States. For the six months ended June 30, 2025 and 2024, we incurred net losses of $51.6 million and $20.6 million, respectively. As of June 30, 2025, we had an accumulated deficit of $466.9 million. As discussed further in Liquidity and Capital Resources—Funding Requirements and Going Concern, substantial doubt exists about our ability to continue as a going concern. The accompanying unaudited interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. We expect to continue to incur significant losses for the foreseeable future and we expect these losses to increase substantially if and as we:

Current wording

We have incurred significant operating losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of one or more of our current or future product candidates in the United States. For the nine months ended September 30, 2025 and 2024, we incurred net losses of $97.2 million and $43.7 million, respectively. As of September 30, 2025, we had an accumulated deficit of $512.5 million. As discussed further in Liquidity and Capital Resources—Funding Requirements and Going Concern, substantial doubt exists about our ability to continue as a going concern. We expect to continue to incur significant losses for the foreseeable future and we expect these losses to increase substantially if and as we:

Previous wording

Revita - Ongoing REMAIN-1 Pivotal Study

Current wording

Revita - Ongoing REMAIN Weight Maintenance Program

Previous wording

We anticipate presenting incremental 6-month data for the REVEAL-1 Cohort in the fourth quarter of 2025, and incremental 1-year data in the second quarter of 2026.

Current wording

REVEAL-1 Cohort: we anticipate presenting 6-month data for the REVEAL-1 Cohort in the fourth quarter of 2025, and 1-year data in the second quarter of 2026.

Previous wording

REMAIN-1 Pivotal Cohort: we have completed enrollment of the REMAIN-1 Pivotal Cohort ahead of schedule. We expect to complete randomization of 315 participants to Revita versus sham in the first half of 2026, with 6-month primary endpoint data anticipated in the second half of 2026. We anticipate submitting a Premarket Approval application (“PMA”) with the FDA in the second half of 2026.

Current wording

REMAIN-1 Pivotal Cohort: we have completed enrollment of the REMAIN-1 Pivotal Cohort. As of October 31, 2025, randomization was complete in 194 participants and the procedure was well-tolerated, with no unanticipated or device/procedure related serious adverse effects reported. No new safety concerns were observed. We expect to complete randomization of 315 participants to Revita versus sham in early 2026, with 6-month topline primary endpoint data anticipated in the second half of 2026. We anticipate potentially submitting a Premarket Approval (“PMA”) application with the FDA in the second half of 2026.

Previous wording

In the first quarter of 2025, we achieved alignment with European authorities on a patient population and study design for the RJVA-001 first-in-human study. In June 2025, we announced the submission of the first module of the CTA in Europe for RJVA-001. Pending regulatory authorization, we expect to dose the first patients with RJVA-001 and report preliminary data in 2026. We believe Rejuva could be a potentially first-in-class, smart, durable gene therapy designed to reprogram the pancreas to provide improved metabolic control.

Current wording

Pending regulatory authorization, we expect to dose the first patients with RJVA‑001 and report preliminary data in 2026. We believe Rejuva could be a potentially first-in-class, smart, durable gene therapy designed to reprogram the pancreas to provide improved metabolic control.

Previous wording

The upcoming Phase 1/2 first in human study is designed to be an open-label, multicenter, single ascending dose study evaluating the safety, tolerability, and preliminary efficacy of RJVA-001 in adults with inadequately controlled T2D despite use of multiple glucose-lowering agents, including GLP-1 receptor agonists. Participants will undergo a standardized medication run-in and GLP-1 washout before receiving RJVA-001 delivered via endoscopic ultrasound-guided intrapancreatic infusion. The preliminary study design comprises three escalating dose cohorts (up to 3 participants each) which will be followed by an optional expansion cohort of up to 10 additional participants treated at the selected optimal dose. Participants will be monitored for 12 months for safety, glucose control, immune response, and GLP-1 expression, and enrolled in a long-term follow-up study for up to 5 years. Primary endpoints include safety and tolerability. Secondary endpoints include change in HbA1c, fasting plasma glucose, and time-in-range as measured by continuous glucose monitoring ("CGM"). Exploratory endpoints assess beta-cell function, metabolic biomarkers, cardiovascular risk markers, and transgene expression.

Current wording

The upcoming Phase 1/2 first in human study is designed to be an open-label, multicenter, single ascending dose study evaluating the safety, tolerability, and preliminary efficacy of RJVA-001 in adults with inadequately controlled T2D despite use of multiple glucose-lowering agents, including GLP-1 receptor agonists. Participants will undergo a standardized medication run-in and GLP-1 washout before receiving RJVA-001 delivered via endoscopic ultrasound-guided intrapancreatic infusion. The preliminary study design comprises three escalating dose cohorts (up to 3 participants each) which will be followed by an optional expansion cohort of up to 10 additional participants treated at the selected optimal dose. Participants will be monitored for 12 months for safety, glucose control, immune response, and GLP-1 expression, and enrolled in a long-term follow-up study for up to 5 years. Primary endpoints include safety and tolerability. Secondary endpoints include change in HbA1c, fasting plasma glucose, and time-in-range as measured by continuous glucose monitoring. Exploratory endpoints assess beta-cell function, metabolic biomarkers, cardiovascular risk markers, and transgene expression.

Previous wording

In 2023, we initiated the Germany Real-World Registry, a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7–10% (inclusive), BMI ≤45 kg/m 2, and were on at least one glucose-lowering agent ("GLA").

Current wording

In 2023, we initiated the Germany Real-World Registry study, a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants’ per-protocol target entry criteria included a baseline Hemoglobin A1c (“HbA1c”) between 7–10% (inclusive), BMI ≤45 kg/m 2, and treatment with at least one glucose-lowering agent (“GLA”).

Previous wording

As of July 7, 2025, at baseline, the first 9 participants with 2 years of follow-up had a median age of 62 years, median weight of 104 kg (229 lbs.; BMI 32 kg/m²), and a median HbA1c of 9.6%, despite being on up to three GLAs.

Current wording

As of October 31, 2025, the first 30 participants with 1 year of follow-up had, at baseline, a mean age of 60 years, a mean weight of 102 kg (225 lbs; BMI 33 kg/m²), and a mean HbA1c of 8.8%, despite being on up to three GLAs.

Previous wording

In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through 2 years of follow-up, as shown in the table below. These findings highlight the potential of a single Revita treatment to deliver durable weight maintenance in a real-world setting.

Current wording

After a single Revita procedure, these 30 participants achieved a mean total body weight loss of 8.0% with weight decreasing from 102 kg to 94 kg at 3 months, a result that was sustained throughout 1 year post-procedure (94 kg) (Table 1, Figure 3). Notably, 28 of 30 participants lost weight, 20 of 30 participants experienced at least a 5% weight reduction, and 12 of 30 participants saw weight reductions of 10% or more. In parallel, mean HbA1c decreased by 1.0% at 3 months, from 8.8% at baseline to 7.7%, and this improvement was sustained throughout 1 year post-procedure (7.9%) (Table 1) with 83% (25/30) of participants on stable or reduced GLAs. In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through 1 year of follow-up (Table 1).

Previous wording

Table. Germany Real-World Registry Study Weight and Blood Sugar Data Post-Revita Procedure

Current wording

Table 1. Germany Real-World Registry Study Weight and Blood Sugar Data Post-Revita Procedure (n=30)

Previous wording

Median values shown. Fractyl Health internal data, n=9.

Current wording

Mean ± SEM values shown. Fractyl Health internal data.

Previous wording

After a single Revita procedure, these 9 participants achieved a median weight loss of 9.6% with weight decreasing from 104 kg to 97 kg at 1 year, a result that was sustained throughout 2 years. Notably, 7 of 8 participants experienced at least a 5% weight reduction, and 5 of 8 saw reductions of ≥10%. Only one participant, with a history of cortisone therapy known to cause weight gain, experienced modest weight gain (4.5%). In parallel, median HbA1c reduced by 1.6%, from 9.6% at baseline to 7.2% at 1 year, and this improvement was sustained throughout 2 years (7.0%), even as participants reduced or stabilized their use of GLAs. Three patients were on a GLP-1 drug at the time of study entry and were still on a GLP-1 drug through 2 years of follow-up. No device- or procedure-related serious adverse events have been reported to date.

Current wording

No device- or procedure-related serious adverse events have been reported to date.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Previous wording

Our significant accounting policies are described in more detail in Note 2 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q as well as Note 2 to our audited financial statements as of and for the year ended December 31, 2024 included in our Annual Report. There have been no material changes to the accounting policies most critical to aid in fully understanding and evaluating our unaudited condensed consolidated financial condition and results of operations contained in our Annual Report.

Current wording

Our significant accounting policies are described in more detail in Note 2 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q as well as Note 2 to our audited financial statements as of and for the year ended December 31, 2024 included in our Annual Report. Our critical accounting estimates related to warrant liabilities, as described below, have been updated from what we disclosed in the “Critical Accounting Policies and Significant Estimates” section of the Management’s Discussion and Analysis of Financial Condition and Results of Operation in our Annual Report. For a complete discussion of our updated critical accounting estimates related to warrant liabilities, see Note 2 to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Revita-related expenses increased by $2.3 million primarily due to a $2.8 million increase in clinical expenses, partially offset by a $0.4 million decrease in device development expenses. The increase in clinical expenses was primarily driven by the positive progress made in our REMAIN-1 study, partially offset by reduced expenses from the REVITALIZE-1 study as a result of our Strategic Reprioritization. Rejuva-related expenditures increased by $3.1 million due to continued development in our Rejuva gene therapy program. These increases were partially offset by a decrease of $0.7 million in stock-based compensation expenses.

Current wording

Revita-related expenses decreased by $0.6 million primarily due to a $0.1 million decrease in clinical related expenses and a $0.5 million decrease in collaborative medical research expenditures. Decreases in clinical related expenses were primarily driven by reduced expenses from the REVITALIZE-1 study as a result of our Strategic Reprioritization, partially offset by the positive progress made in our REMAIN-1 study. Rejuva-related expenditures were comparable to those incurred in the same period in 2024. In addition, stock-based compensation expenses decreased by $0.9 million.

Previous wording

Other expense, net, of $1.8 million during the three months ended June 30, 2025 was primarily attributable to a $1.7 million loss from the change in fair value of the 2023 Notes and a $0.3 million loss from the change in fair value of warrant liabilities, partially offset by $0.2 million of net interest income. Other income, net, of $5.8 million during the three months ended June 30, 2024 was primarily attributable to a $4.7 million gain from the change in fair value of warrant liabilities and $1.4 million of net interest income, partially offset by a $0.3 million loss from the change in fair value of the 2023 Notes.

Current wording

Other expense, net, of $22.9 million during the three months ended September 30, 2025 was primarily attributable to a $21.2 million loss from the change in fair value of warrant liabilities and a $1.9 million loss from the change in fair value of the 2023 Notes, partially offset by $0.2 million of net interest income. Other income, net, of $0.6 million during the three months ended September 30, 2024 was primarily attributable to a $2.3 million gain from the change in fair value of warrant liabilities and $0.9 million of net interest income, partially offset by a $2.6 million loss from the change in fair value of the 2023 Notes.

Previous wording

The following table summarizes our condensed consolidated results of operations for the six months ended June 30, 2025 and 2024.

Current wording

The following table summarizes our condensed consolidated results of operations for the nine months ended September 30, 2025 and 2024.

Previous wording

Revenue and cost of goods sold during the six months ended June 30, 2024 was related to our pilot commercial launch in Germany. As part of the Strategic Reprioritization, we paused our commercial efforts in Germany in the first quarter of 2025.

Current wording

Revenue and cost of goods sold during the nine months ended September 30, 2024 was related to our pilot commercial launch in Germany. As part of the Strategic Reprioritization, we paused our commercial efforts in Germany in the first quarter of 2025.

Previous wording

Research and development expenses increased by $9.4 million, or 30.1%, during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024, primarily due to the advancements made in our Revita and Rejuva programs.

Current wording

Research and development expenses increased by $7.9 million, or 15.6%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to the advancements made in our Revita and Rejuva programs.

Previous wording

Revita-related expenses increased by $4.4 million primarily due to a $5.2 million increase in clinical expenses, partially offset by a $0.7 million decrease in collaborative medical research expenditures. Increases in clinical expenses were primarily driven by the positive progress made in our REMAIN-1 study, partially offset by reduced clinical expenses from the REVITALIZE-1 study as a result of our Strategic Reprioritization. Rejuva-related expenditures increased by $5.7 million due to continued development in our Rejuva gene therapy program.

Current wording

Revita-related expenses increased by $3.8 million primarily due to a $5.0 million increase in clinical related expenses, partially offset by a $1.2 million decrease in collaborative medical research expenditures. Increases in clinical expenses were primarily driven by the positive progress made in our REMAIN-1 study, partially offset by reduced expenses from the REVITALIZE-1 study as a result of our Strategic Reprioritization. Rejuva-related expenditures increased by $5.7 million due to continued development in our Rejuva gene therapy program.

Previous wording

Salaries, bonuses and other compensatory benefits increased by $2.1 million as a result of our effort to bring certain clinical and scientific resources in house as well as severance expenses related to the Strategic Reprioritization. The increase was offset by a decrease in stock-based compensation of $2.1 million. In addition, our allocated facility expenses decreased by $0.6 million primarily due to the expenses incurred when we moved into our new office and laboratory space in Burlington, MA in the first quarter of 2024.

Current wording

The increases above were partially offset by a $3.0 million decrease in stock-based compensation and a $0.7 million decrease in our allocated facility expenses primarily due to the expenses incurred when we moved into our new office and laboratory space in Burlington, MA in the first quarter of 2024.

Previous wording

Selling, general and administrative expenses decreased by $3.1 million, or 23.3%, during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024, primarily due to a $3.7 million decrease in stock-based compensation, partially offset by a $0.4 million increase in personnel-related expenses, including salaries, bonuses and other compensatory benefits, as a result of the expansion of our general and administrative workforce to support our operation as a public company.

Current wording

Selling, general and administrative expenses decreased by $2.7 million, or 14.8%, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to a $3.7 million decrease in stock-based compensation, partially offset by a $0.3 million increase in personnel-related expenses, including salaries, bonuses and other compensatory benefits, as a result of the expansion of our general and administrative workforce to support our operation as a public company. In the third quarter of 2025, we also incurred $0.5 million professional service fees related to the issuance of the warrants in connection with the August 2025 Offering. See the “Liquidity and Capital Resources” section below for details about the August 2025 Offering and its associated warrants.

Previous wording

Other expense, net, of $0.8 million during the six months ended June 30, 2025 was primarily attributable to a $2.0 million loss from the change in fair value of the 2023 Notes, partially offset by a $0.5 million gain from the change in fair value of warrant liabilities and $0.7 million of net interest income. Other income, net, of $24.0 million during the six months ended June 30, 2024 was primarily attributable to a $15.1 million gain from the change in fair value of warrant liabilities, a

Current wording

Other expense, net, of $23.7 million during the nine months ended September 30, 2025 was primarily attributable to a $20.7 million loss from the change in fair value of warrant liabilities and a $3.8 million loss from the change in fair value of the 2023 Notes, partially offset by $0.9 million of net interest income. Other income, net, of $24.6 million during the nine months ended September 30, 2024 was primarily attributable to a $17.4 million gain from the change in fair value of warrant liabilities, a $8.0 million gain from the change in fair value of the 2022 Convertible Notes and $3.4 million net interest income, partially offset by a $4.2 million loss from the change in fair value of the 2023 Notes.

Previous wording

On September 7, 2023, we entered into a credit agreement, as amended from time to time, with Symbiotic Capital Opportunities Holding, L.P. and Catalio Structured Opportunities AIV I LP, or the Lenders, that provides for term loans in an aggregate principal amount of $45.0 million, or the 2023 Notes, payable in two tranches (the “Credit Agreement”). The first tranche, with a principal amount of $30.0 million, was extended on September 7, 2023, resulting in net proceeds of approximately $28.4 million. The second tranche, with a principal amount of $15.0 million, would have been extended upon our achievement of certain operating and funding milestones as defined in the 2023 Notes, by July 31, 2024. The 2023 Notes also provide for a third tranche with an uncommitted principal amount of $20.0 million that may be extended to us, subject to the Lenders’ prior written consent in their sole discretion. Due to a shift in business strategy expansion to include the weight maintenance study, we decided not to pursue the milestones required to access the second tranche. As a result, the second tranche was not extended.

Current wording

On September 7, 2023, we entered into a credit agreement, as amended from time to time (the “Credit Agreement”), with Symbiotic Capital Opportunities Holding, L.P. and Catalio Structured Opportunities AIV I LP (the “2023 Lenders”) that provided for term loans up to an aggregate principal amount of $45.0 million (the “2023 Notes”) in two tranches. The first tranche, with a principal amount of $30.0 million, was extended on September 7, 2023, resulting in net proceeds of approximately $28.4 million. The second tranche, with a principal amount of $15.0 million, would have been extended upon our achievement of certain operating and funding milestones as defined in the Credit Agreement, by July 31, 2024. The Credit Agreement also provides for a third tranche with an uncommitted principal amount of $20.0 million that may be extended to us, subject to the 2023 Lenders’ prior written consent in their sole discretion. Due to a shift in business strategy expansion to include the weight maintenance study, we decided not to pursue the milestones required to access the second tranche. As a result, the second tranche was not extended.

Previous wording

The Credit Agreement, as amended, contains financial covenants including a minimum liquidity covenant requiring us to maintain a minimum $10.0 million balance in cash and cash equivalents on deposit in accounts, subject to certain exceptions. As of June 30, 2025, we were in compliance with the financial covenants and other terms of the arrangement.

Current wording

The Credit Agreement, as amended, contains financial covenants a minimum liquidity covenant requiring us to maintain a minimum $10.0 million balance in cash and cash equivalents on deposit in accounts, subject to certain exceptions. As of September 30, 2025, we were in compliance with the minimum liquidity covenant and other terms of the arrangement.

Previous wording

The outstanding balances under the 2023 Notes bear interest at a floating annual rate equal to the greater of 5.5% above the Wall Street Journal prime rate or 13.25%. On and prior to September 30, 2024, 6.0% of the interest is payable in kind and added to the outstanding principal amount of the 2023 Notes. Beginning September 30, 2026, we are required to make principal payments in the amount of 1.5% of the aggregate principal amount outstanding, including accrued PIK interest, each month. Under the terms of the Credit Agreement, the first principal payment date can be extended to September 30, 2027, at our election, if certain financing milestones as defined in the 2023 Notes are achieved on or prior to September 30, 2026. During 2024, we achieved the defined milestones and elected to extend the first principal payment date to September 30, 2027. In addition, upon any principal payment, we are required to make an additional payment to the Lenders of a 6.0% fee, or the Exit Fee, over the principal and accrued PIK interest paid. The aggregate Exit Fee of the 2023 Notes should equal to 6.0% of the total commitment of $45.0 million plus all accrued PIK interest. All remaining outstanding principal balance, accrued interest and Exit Fee on the 2023 Notes shall be due and payable on the maturity date of September 7, 2028.

Current wording

The outstanding balances under the 2023 Notes bear interest at a floating annual rate equal to the greater of 5.5% above the Wall Street Journal prime rate or 13.25%. On and prior to September 30, 2024, 6.0% of the interest is payable in kind and added to the outstanding principal amount of the 2023 Notes. Beginning September 30, 2026, we are required to make principal payments in the amount of 1.5% of the aggregate principal amount outstanding, including accrued PIK interest, each month. Under the terms of the Credit Agreement, the first principal payment date may be extended to September 30, 2027, at our election, if certain financing milestones as defined in the Credit Agreement are achieved on or prior to September 30, 2026. During 2024, we achieved the defined milestones and elected to extend the first principal payment date to September 30, 2027. In addition, upon any principal payment, we are required to make an additional payment to the 2023 Lenders of a 6.0% fee (the “Exit Fee”), over the principal and accrued PIK interest paid. The aggregate Exit Fee of the 2023 Notes should equal to 6.0% of the total commitment of $45.0 million plus all accrued PIK interest. All remaining outstanding principal balance, accrued interest and Exit Fee on the 2023 Notes shall be due and payable on the maturity date of September 7, 2028.

Previous wording

As of June 30, 2025, the balance of the 2023 Notes was carried at its fair value of $30.0 million.

Current wording

As of September 30, 2025, the balance of the 2023 Notes was carried at its fair value of $30.8 million.

Previous wording

On March 3, 2025, we filed a Registration Statement on Form S-3 with the U.S. Securities and Exchange Commission ("SEC"), which was subsequently amended on March 13, 2025 (as amended, the “S-3 Registration Statement”). The S-3 Registration Statement became effective on March 18, 2025. It contains a base prospectus, which covers the offering, issuance and sale of up to $300.0 million in the aggregate of the securities from time to time in one or more offerings.

Current wording

Statement”). The S-3 Registration Statement became effective on March 18, 2025. It contains a base prospectus, which covers the offering, issuance and sale of up to $300.0 million in the aggregate of the securities from time to time in one or more offerings.

Previous wording

Concurrently with the filing of the S-3 Registration Statement, we filed a sales agreement prospectus supplement under an at-the-market offering (the "ATM Offering") covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $100.0 million of our common stock that may be offered, issued and sold from time to time. During the six months ended June 30, 2025, we issued and sold 997,404 shares of our common stock under the ATM Offering at a weighted average price of $1.71 per share resulting in net proceeds of approximately $1.6 million, after deducting the underwriting discount and commissions as well as related offering expenses. In July 2025, the Company issued and sold an additional 371,223 shares of its common stock under the ATM Offering at a weighted average price of $1.53 per share, resulting in net proceeds of approximately $0.6 million, after deducting the underwriting discount and commissions.

Current wording

Concurrently with the filing of the S-3 Registration Statement, we filed a sales agreement prospectus supplement under an at-the-market offering (the “ATM Offering”) covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $100.0 million of our common stock that may be offered, issued and sold from time to time. During the nine months ended September 30, 2025, we issued and sold 1,368,627 shares of our common stock under the ATM Offering at a weighted average price of $1.66 per share resulting in net proceeds of approximately $2.1 million, after deducting underwriting discounts and commissions as well as related offering expenses. In October 2025, we issued and sold an additional 3,333,333 shares of our common stock under the ATM Offering at a weighted average price of $1.47 per share, resulting in net proceeds of approximately $4.8 million, after deducting underwriting discounts and commissions.

Previous wording

On August 6, 2025, we entered into an underwriting agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), in connection with the underwritten offering, issuance and sale by us of 19,047,619 shares of our common stock, warrants to purchase up to 19,047,619 shares of our common stock (the “Tranche A Warrants”) and warrants to purchase 19,047,619 shares of our common stock (the “Tranche B Warrants”). The combined offering price for each share of our common stock, accompanying Tranche A Warrant and accompanying Tranche B Warrant was $1.05. The securities were issued pursuant to the S-3 Registration Statement and a related prospectus supplement filed with the SEC.

Current wording

On August 6, 2025, we entered into an underwriting agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), in connection with the underwritten offering, issuance and sale by us of 19,047,619 shares of our common stock, warrants to purchase up to 19,047,619 shares of our common stock (the “Tranche A Warrants”) and warrants to purchase 19,047,619 shares of our common stock (the “Tranche B Warrants”). The combined offering price for each share of our common stock, accompanying Tranche A Warrant and accompanying Tranche B Warrant was $1.05. The securities were issued pursuant to the S-3 Registration Statement and a related prospectus supplement filed with the SEC (the “August 2025 Offering”).

Previous wording

Each Tranche A Warrant has an exercise price per share of our common stock equal to $1.05, subject to certain adjustments. The Tranche A Warrants are exercisable at any time on or after August 7, 2025 and will expire on August 7, 2027. The Tranche A Warrants are callable at our option following the release of 3-month randomized midpoint clinical data from the ongoing REMAIN-1 study, subject to satisfaction of certain conditions including that the average trading price of the stock exceeds $1.37 per share for 15 consecutive trading days and a minimum daily trading volume threshold.

Current wording

Each Tranche A Warrant has an exercise price per share of common stock equal to $1.05, subject to certain adjustments. The Tranche A Warrants are exercisable at any time on or after August 7, 2025 and will expire on August 7, 2027. The Tranche A Warrants are callable at our option following the release of 3-month randomized midpoint clinical data from the ongoing REMAIN-1 study, which data was published on September 26, 2025, subject to satisfaction of certain conditions including that the average trading price of the stock exceeds $1.37 per share for 15 consecutive trading days and a minimum daily trading volume threshold.

Previous wording

Each Tranche B Warrant has an exercise price per share of our common stock equal to $1.05, subject to certain adjustments. The Tranche B Warrants are exercisable upon receipt of stockholder approval as may be required by the applicable rules and regulations of The Nasdaq Global Market (the “Tranche B Warrant Stockholder Approval”) and will expire on the date that is five years from the date of the Tranche B Warrant Stockholder Approval.

Current wording

Each Tranche B Warrant has an exercise price per share of common stock equal to $1.05, subject to certain adjustments. The Tranche B Warrants are exercisable upon receipt of the Tranche B Warrant Stockholder Approval, which was obtained at the Special Meeting of Stockholders and the Tranche B Warrants became exercisable on October 3, 2025. The Tranche B Warrants will expire on October 3, 2030, which is the date that is five years from the date of the Tranche B Warrant Stockholder Approval.

Previous wording

In addition, we granted Ladenburg a 30-day option to purchase up to an additional 2,857,142 shares of our common stock, along with associated Tranche A Warrants and Tranche B Warrants, at the combined public offering price of $1.05 per share, less underwriting discounts and commissions. On August 6, 2025, Ladenburg exercised the option to purchase additional shares of our common stock, along with associated Tranche A and Tranche B Warrants, in full.

Current wording

In addition, we granted Ladenburg a 30-day option to purchase up to an additional 2,857,142 shares of our common stock, along with associated Tranche A Warrants and Tranche B Warrants, at the combined public offering price of $1.05 per share, less underwriting discounts and commissions. On August 6, 2025, Ladenburg exercised the option to purchase additional shares of our common stock, along with associated Tranche A Warrants and Tranche B Warrants, in full.