ALLURION TECHNOLOGIES, INC.

Previous wording

The following discussion and analysis includes information that our management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion and analysis should be read together with the unaudited consolidated financial statements as of and for the three and six months ended June 30, 2025 and June 30, 2024 included in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements as of and for the years ended December 31, 2024 that are included in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 2025 (together, the "Annual Report on Form 10-K"). This discussion may contain forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the sections titled “Cautionary Statement Regarding Forward-Looking Statements” and “Risk Factors” in our Annual Report on Form 10-K and this Quarterly Report on Form 10-Q. For purposes of this section, all references in this discussion and analysis to “Allurion,” the “Company”, “we,” “us,” or “our” refers to the business and operations of Allurion Technologies, Inc. and its consolidated subsidiaries following the consummation of the Business Combination and to Legacy Allurion and its consolidated subsidiaries prior to the consummation of the Business Combination. “Legacy Allurion” refers to Allurion Technologies, LLC, which was previously known as Allurion Technologies Opco, Inc. (formerly Allurion Technologies, Inc.) prior to the consummation of the Business Combination.

Current wording

The following discussion and analysis includes information that our management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion and analysis should be read together with the unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2025 and September 30, 2024 included in this Quarterly Report on Form 10-Q, and the audited consolidated financial statements as of and for the years ended December 31, 2024 that are included in our Annual Report on Form 10-K filed with the SEC on March 27, 2025 as amended by Amendment No. 1 to the Annual Report on Form 10-K filed with the SEC on August 19, 2025 (together, the "Annual Report on Form 10-K"). This discussion may contain forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in the sections titled “Cautionary Statement Regarding Forward-Looking Statements” and “Risk Factors” in our Annual Report on Form 10-K and this Quarterly Report on Form 10-Q. For purposes of this section, all references in this discussion and analysis to “Allurion,” the “Company”, “we,” “us,” or “our” refers to the business and operations of Allurion Technologies, Inc. and its consolidated subsidiaries following the consummation of the Business Combination and to Legacy Allurion and its consolidated subsidiaries prior to the consummation of the Business Combination. “Legacy Allurion” refers to Allurion Technologies, LLC, which was previously known as Allurion Technologies Opco, Inc. (formerly Allurion Technologies, Inc.) prior to the consummation of the Business Combination.

Previous wording

Allurion is a leading medical device company that is focused on creating a best-in-class weight loss platform to treat obese and overweight patients. Our platform, the Allurion Program (the "Allurion Program"), features the world’s first and only swallowable, procedureless™ intragastric balloon for weight loss (the "Allurion Balloon") and offers artificial intelligence ("AI")-powered remote patient monitoring tools, a proprietary behavior change program, secure messaging and video telehealth that are delivered by the Allurion Virtual Care Suite ("VCS").

Current wording

Allurion is a leading medical device company that is focused on creating a best-in-class weight loss platform to treat obese and overweight patients. Our platform, the Allurion Program (the "Allurion Program"), features the world’s first and only swallowable, procedure-less intragastric balloon for weight loss (the "Allurion Smart Capsule") and offers artificial intelligence ("AI")-powered remote patient monitoring tools, a proprietary behavior change program, secure messaging and video telehealth that are delivered by the Allurion Virtual Care Suite ("VCS").

Previous wording

The Allurion Program was designed to achieve metabolically healthy weight loss, which entails losing weight, maintaining that weight loss, and maintaining or increasing muscle mass in the process. Unlike other options that lead to short-term weight loss and muscle wasting, the Allurion Program is intended to deliver longer lasting results while reducing fat and not muscle. We believe the Allurion Program is also synergistic in combination with other weight loss therapies, including glucagon-like peptide 1 ("GLP-1") receptor agonists.

Current wording

The Allurion Program is designed to achieve metabolically healthy weight loss, which entails losing weight, maintaining that weight loss, and maintaining or increasing muscle mass in the process. Unlike other options that lead to short-term weight loss and muscle wasting, the Allurion Program is intended to deliver longer lasting results while reducing fat and not muscle. We believe the Allurion Program is also synergistic in combination with other weight loss therapies, including glucagon-like peptide 1 ("GLP-1") receptor agonists.

Previous wording

Our proprietary intragastric balloon, the Allurion Balloon, is swallowed as a capsule under the guidance of a health care provider without surgery, endoscopy, or anesthesia for placement.

Current wording

Our proprietary intragastric balloon, the Allurion Smart Capsule, is swallowed as a capsule under the guidance of a health care provider without surgery, endoscopy, or anesthesia for placement.

Previous wording

For Allurion Program patients: Every current Allurion Program patient receives an Allurion Connected Scale ("Allurion Connected Scale") and access to our mobile app (the "App"), which integrates data from the Allurion Connected Scale to conveniently monitor weight, muscle mass, body fat, activity, sleep, and several other critical metrics. The App can also enable secure messaging and video telehealth with the patient’s care team and can deliver content from Allurion’s proprietary behavior change program - and library of 100 weight loss actions related to diet, nutrition, exercise, mental health, sleep, goal setting, and a number of other topics - directly to the patient. The App is available in 15 languages.

Current wording

For Allurion Program patients: Every current Allurion Program patient receives an Allurion Connected Scale ("Allurion Connected Scale") and access to our mobile app (the "App"), which integrates data from the Allurion Connected Scale to conveniently monitor weight, muscle mass, body fat, activity, sleep, and several other critical metrics. The App can also enable secure messaging and video telehealth with the patient’s care team and can deliver content from Allurion’s proprietary behavior change program—a library of 100 weight loss actions related to diet, nutrition, exercise, mental health, sleep, goal setting, and a number of other topics—directly to the patient. The App is available in 15 languages.

Previous wording

In addition to its use by Allurion Balloon patients, we believe the VCS can potentially be a platform for optimal long-term follow up after other medical and surgical weight loss interventions in the future. We have incorporated a Treatment Tracking and Clinic-Led Onboarding feature into the VCS that enables seamless onboarding and management of patients undergoing one or multiple weight loss treatments, including gastric balloons such as the Allurion Balloon, surgery, or medication, and in April 2024, launched the VCS in the United States for patients utilizing other weight loss treatments, including anti-obesity medications and bariatric surgery.

Current wording

In addition to its use by Allurion Smart Capsule patients, we believe the Allurion VCS can potentially be a platform for optimal long-term follow up after other medical and surgical weight loss interventions in the future. We have incorporated a Treatment Tracking and Clinic-Led Onboarding feature into the VCS that enables seamless onboarding and management of patients undergoing one or multiple weight loss treatments, including gastric balloons such as the Allurion Balloon, surgery, or medication, and in April 2024, we launched the VCS in the United States for patients utilizing other weight loss treatments, including anti-obesity medications and bariatric surgery.

Previous wording

Our Allurion Program products are currently sold in Europe, the Middle East, Africa, Latin America, Canada and the Asia-Pacific region.

Current wording

Our Allurion Program products are currently sold in Europe, the Middle East, Africa, Latin America, Canada and the Asia-Pacific region. We have submitted our premarket application for approval by the U.S. Food and Drug Administration ("FDA") for sale of our Allurion Program in the United States.

Previous wording

Since our inception, we have incurred significant operating losses. Our ability to generate revenue and achieve cost improvements sufficient to achieve profitability will depend on the successful further development and commercialization of our products and receipt and maintenance of regulatory approvals. We generated revenue of $9.0 million and $21.2 million for the six months ended June 30, 2025 and 2024, respectively, and incurred losses from operations of $14.2 million and $20.7 million for those same periods, respectively. We expect to continue to incur net losses for the foreseeable future as we focus on obtaining regulatory approvals for our products in new markets, refining our sales and marketing strategies, and continuing research and development efforts to further enhance our existing products. Further, following the closing of the Business Combination, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. As a result, we will need additional funding for expenses related to our operating activities, including selling, marketing, general and administrative, and research and development expenses.

Current wording

Since our inception, we have incurred significant operating losses. Our ability to generate revenue and achieve cost improvements sufficient to achieve profitability will depend on the successful further development and commercialization of our products and receipt and maintenance of regulatory approvals. We generated revenue of $11.6 million and $26.5 million for the nine months ended September 30, 2025 and 2024, respectively, and incurred a net loss of $22.7 million and net income of $2.4 million for those same periods, respectively. We expect to continue to incur net losses for the foreseeable future as we focus on obtaining regulatory approvals for our products in new markets, refining our sales and marketing strategies, and continuing research and development efforts to further enhance our existing products. Further, following the closing of the Business Combination, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. As a result, we will need additional funding for expenses related to our operating activities, including selling, marketing, general and administrative, and research and development expenses.

Previous wording

Because of the numerous risks and uncertainties associated with obtaining and maintaining regulatory approval, market acceptance of our products, product development and enhancement, and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve profitability, we expect to finance our operations through a combination of equity offerings and debt financings. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to reduce or terminate our operations. See the subsections entitled — “Liquidity and Capital Resources” and “Recent Developments” below.

Current wording

Because of the numerous risks and uncertainties associated with obtaining and maintaining regulatory approval, market acceptance of our products, product development and enhancement, and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve profitability, we expect to finance our operations through a combination of equity offerings and debt financings. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to reduce or terminate our operations. See the subsections titled — “Liquidity and Capital Resources” and “Recent Developments” below.

Previous wording

On January 7, 2025, we entered into an Omnibus Amendment (the “Omnibus Amendment”) by and among us, Allurion Technologies, LLC (“Allurion OpCo”), Allurion Australia Pty Ltd, Allurion France, and RTW Investments, LP (together with its affiliates, “RTW”) and certain of its affiliates, to amend (i) the Note Purchase Agreement, dated as of April 14, 2024 (as amended, the “Amended Note Purchase Agreement”), by and among us, RTW and Acquiom Agency Services LLC, the Revenue Interest Financing Agreement, dated as of February 9, 2023 (as amended, the “Revenue Interest Financing Agreement”), by and among us and RTW (such financing, the “Revenue Interest Financing”) and the additional Revenue Interest Financing Agreement, dated as of October 30, 2024 (as amended, the “New RIFA”), by and among us and RTW (collectively, the “Existing Documents”).

Current wording

On January 7, 2025, we entered into an Omnibus Amendment (the “Omnibus Amendment”) by and among us, Allurion Technologies, LLC (“Allurion OpCo”), Allurion Australia Pty Ltd, Allurion France, and RTW Investments, LP (together with its affiliates, “RTW”) and certain of its affiliates, to amend (i) the Note Purchase Agreement, dated as of April 14, 2024 (as amended, the “Amended Note Purchase Agreement”), by and among us, RTW and Acquiom Agency Services LLC, (ii) the Revenue Interest Financing Agreement, dated as of February 9, 2023 (as amended, the “Revenue Interest Financing Agreement”), by and among us and RTW (such financing, the “Revenue Interest Financing”) and (iii) the additional Revenue Interest Financing Agreement, dated as of October 30, 2024 (as amended, the “New RIFA”), by and among us and RTW (collectively, the “Existing Documents”).

Previous wording

The Omnibus Amendment requires (i) us and Allurion OpCo to maintain certain minimum balances of unrestricted cash in controlled accounts in the United States in the amounts corresponding to the calculations set forth therein, and (ii) us to receive minimum trailing 12-month consolidated Revenue (as defined in the Existing Documents) at amounts designated in the Omnibus Amendment, tested quarterly beginning with the 12-month period ending September 30, 2025. The Omnibus Amendment also requires that (i) Allurion France shall have successfully regained marketing authorization from the Agence Nationale de Sécurité du Médicament (“ANSM”) to resume the Commercialization (as defined in the Existing Documents) of the Product (as defined in the

Current wording

The Omnibus Amendment requires (i) us and Allurion OpCo to maintain certain minimum balances of unrestricted cash in controlled accounts in the United States in the amounts corresponding to the calculations set forth therein, and (ii) us to receive minimum trailing 12-month consolidated Revenue (as defined in the Existing Documents) at amounts designated in the Omnibus Amendment, tested quarterly beginning with the 12-month period ending September 30, 2025. The Omnibus Amendment also requires that (i) Allurion France shall have successfully regained marketing authorization from the Agence Nationale de Sécurité du Médicament (“ANSM”) to resume the Commercialization (as defined in the Existing Documents) of the Product (as defined in the Existing Documents) in France on or prior to December 31, 2025, which occurred in February 2025 as discussed further below, and (ii) Allurion OpCo shall have received marketing authorization from the U.S. Food and Drug Administration (the “FDA”) for the commercialization of the Product in the United States no later than June 30, 2026.

Previous wording

On April 15, 2025, we entered into the Second Amendment to Note Purchase Agreement (the “Second Amendment to Note Purchase Agreement") with the purchasers of the RTW Convertible Notes (the "Purchasers") and RTW, as agent for the purchasers, which amended the Amended Note Purchase Agreement to reflect additional conversion and other provisions, including provisions permitting the conversion of a portion of the RTW Convertible Notes at reduced conversion prices, resulting in the potential issuance of additional shares, which was approved by our stockholders at the Special Meeting of Stockholders held on April 10, 2025.

Current wording

Purchase Agreement") with the purchasers of the RTW Convertible Notes (the "Purchasers") and RTW, as agent for the purchasers, which amended the Amended Note Purchase Agreement to reflect additional conversion and other provisions, including provisions permitting the conversion of a portion of the RTW Convertible Notes at reduced conversion prices, resulting in the potential issuance of additional shares, which was approved by our stockholders at the Special Meeting of Stockholders held on April 10, 2025.

Previous wording

In the event such Market Capitalization Condition is triggered, the Purchasers also have the right to provide us notice to convert up to an additional $5.0 million of aggregate principal amount of the RTW Convertible Notes into shares of Common Stock at an agreed conversion rate. We have the right to accept or reject such conversion in our sole discretion. The parties will mutually agree on the agreed conversion rate, provided that it is not more than 298.5075 shares of Common Stock per $1,000 principal amount of the RTW Convertible Notes, reflecting a floor conversion price of $3.35 per share of Common Stock (such rate, the “Floor Conversion Rate”).

Current wording

In the event such Market Capitalization Condition is triggered, the Purchasers also have the right to provide us notice to convert up to an additional $5.0 million of aggregate principal amount of the RTW Convertible Notes into shares of Common Stock at an agreed conversion rate. We have the right to accept or reject such conversion in our sole discretion. The parties will mutually agree on the agreed conversion rate, provided that it is not more than 298.5075 shares of Common Stock per $1,000 principal amount of the RTW Convertible Notes, reflecting a floor conversion price of $3.35 per share of Common Stock (such rate, the “Floor Conversion Rate”). On November 4, 2025, the Purchasers provided notice of conversion of $5.0 million of principal amount of the RTW Convertible Notes at the Floor Conversion Rate, for an aggregate of 1,492,539 shares of Common Stock, which notice was accepted by us on November 5, 2025.

Previous wording

On July 7, 2025, we announced that we submitted to the FDA the fourth and final module of our pre-market approval (“PMA”) application, which included additional supportive analyses from our AUDACITY trial that meet both of the pre-specified co-primary endpoints. Topline results announced previously showed that the AUDACITY trial met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects.

Current wording

On July 7, 2025, we announced that we submitted to the FDA the fourth and final module of our pre-market approval (“PMA”) application, which included additional supportive analyses from our AUDACITY trial that meet both of the pre-specified co-primary endpoints. Topline results announced previously showed that the AUDACITY trial met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at

Previous wording

Additional analyses submitted in our PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p= .0142).

Current wording

Additional analyses submitted in our PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p = .0142). At 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p = .0006).

Previous wording

The Restructuring Plan includes a reduction in force of approximately 70 employees, or approximately 65% of its workforce, which we expect to substantially complete by the end of the third quarter of 2025. As part of this Restructuring Plan, we expect to incur severance and severance-related charges of approximately $1.5 million. Our estimated restructuring charges is based on a number of assumptions. Actual results may differ materially and we may also incur other charges or cash expenditures not currently contemplated or that cannot be currently estimated due to events that may occur as a result of, or be associated with, the Restructuring Plan.

Current wording

The Restructuring Plan includes a reduction in force of approximately 70 employees, or approximately 65% of our workforce, which is substantially complete. As part of this Restructuring Plan, we expect to incur severance and severance-related charges of approximately $1.5 million. Our estimated restructuring charges are based on a number of assumptions. Actual results may differ materially and we may also incur other charges or cash expenditures not currently contemplated or that cannot be currently estimated due to events that may occur as a result of, or be associated with, the Restructuring Plan.

Previous wording

On January 24, 2025, we entered into a securities purchase agreement (the “January 2025 Securities Purchase Agreement”) with certain accredited investors named therein, pursuant to which we agreed to issue and sell 1,240,000 shares of Common Stock (the “January 2025 Offering”) and 1,240,000 accompanying common warrants (the “January 2025 Warrants”) to purchase up to 1,240,000 shares of Common Stock upon exercise of the January 2025 Warrants in a concurrent private placement (the “January 2025 Private Placement”), at an offering price of $6.00 per share and accompanying January 2025 Warrant. The January 2025 Offering and January 2025 Private Placement closed on January 27, 2025 with net proceeds of approximately $5.8 million, after deducting the placement agent fees and estimated offering expenses payable by the Company.

Current wording

On November 11, 2025, we entered into a securities purchase agreement (the "November 2025 Securities Purchase Agreement") with certain accredited investors named therein, pursuant to which we agreed to issue and sell 2,994,012 shares of our Common Stock and accompanying common warrants to purchase up to 2,994,012 shares of Common Stock (the "November 2025 Private Placement Warrants"), for an aggregate purchase price of approximately $5.0 million at a purchase price of $1.67 per share and accompanying November 2025 Private Placement Warrant.

Previous wording

We believe that our performance and future success depend on many factors that present significant opportunities but also pose risks and challenges, including those discussed below and in the “Risk Factors” section of our Annual Report on Form 10-K.

Current wording

We believe that our performance and future success depend on many factors that present significant opportunities but also pose risks and challenges, including those discussed below and in the “Risk Factors” section of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K.

Previous wording

Regulatory approval and timing and efficiency of new product introductions. We must successfully obtain timely approvals, maintain regulatory approval, successfully implement any remediation programs required by regulators to resume sales of the Allurion Balloon, and introduce new products that gain acceptance with health care providers. For our sales to grow, we will also need to obtain regulatory approval of our existing product and any new products or modifications/enhancements to our existing products in the markets that we operate in and new markets as applicable.

Current wording

Regulatory approval and timing and efficiency of new product introductions. We must successfully obtain timely approvals, maintain regulatory approval, successfully implement any remediation programs required by regulators to resume sales of the Allurion Smart Capsule, and introduce new products that gain acceptance with health care providers. For our sales to grow, we will also need to obtain regulatory approval of our existing product and any new products or modifications/enhancements to our existing products in the markets that we operate in and new markets as applicable.

Previous wording

We derive revenue from the sale of the Allurion Balloon to customers, which are either distributors or health care providers. The Allurion Balloon is the foundation of the Allurion Program, a holistic weight loss program that offers patients the opportunity to receive, and clinic and other health care providers the ability to deliver, behavior change assistance through their use of our remote patient support and monitoring tools.

Current wording

We derive revenue from the sale of the Allurion Smart Capsule to customers, which are either distributors or health care providers. The Allurion Smart Capsule is the foundation of the Allurion Program, a holistic weight loss program that offers patients the opportunity to receive, and clinic and other health care providers the ability to deliver, behavior change assistance through their use of our remote patient support and monitoring tools.

Previous wording

The loss on extinguishment of debt consists of the loss recognized upon the termination of our Fortress Term Loan and RTW Convertible Notes.

Current wording

The loss on extinguishment of debt consists of the loss recognized upon the termination of our term loan facility with Fortress Credit Corp. (the "Fortress Term Loan") and RTW Convertible Notes.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited)

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

Revenue decreased $8.4 million, or 71%, to $3.4 million and decreased $12.2 million, or 58%, to $9.0 million for the three and six months ended June 30, 2025, respectively, compared to the same period in 2024. The decrease in revenue was primarily the result of the distributor transitions initiated in the second quarter of 2025, lower investment in sales and marketing as we move our strategy from business to business to customer and away from direct to customer, as well as the temporary suspension of sales in France. The decrease was also driven by selling less or no product to certain distributors and accounts to manage our credit risk.

Current wording

Revenue decreased $2.7 million, or 50%, to $2.7 million and decreased $14.9 million, or 56%, to $11.6 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024. The decrease in revenue was primarily the result of the distributor transitions initiated in the second quarter of 2025, lower investment in sales and marketing as we move our strategy to "business to business to customer" and away from direct to customer, as well as the temporary suspension of sales in France. The decrease was also driven by selling less or no product to certain distributors and accounts to manage our credit risk.

Previous wording

Cost of revenue decreased $1.9 million, or 68%, to $0.9 million for the three months ended June 30, 2025, and decreased $3.0 million, or 57%, to $2.3 million for the six months ended June 30, 2025 compared to the same periods in 2024. The decrease in cost of revenue was a direct result of decreased gastric balloon units sold.

Current wording

Cost of revenue decreased $0.9 million, or 40%, to $1.4 million for the three months ended September 30, 2025, and decreased $3.9 million, or 52%, to $3.7 million for the nine months ended September 30, 2025 compared to the same periods in 2024. The decrease in cost of revenue was a direct result of decreased gastric balloon units sold, partially offset by an increase in manufacturing expense, as less labor and overhead was absorbed due to lower production volumes.

Previous wording

Gross profit decreased $6.5 million, or 72%, to $2.5 for the three months ended June 30, 2025, and decreased $9.2 million, or 58%, to $6.7 million for the six months ended June 30, 2025 compared to the same periods in 2024. The decrease in gross profit was primarily the result of a decrease in revenue and sales volume of our gastric balloon system.

Current wording

Gross profit decreased $1.8 million, or 58%, to $1.3 million for the three months ended September 30, 2025, and decreased $11.0 million, or 58%, to $8.0 million for the nine months ended September 30, 2025 compared to the same periods in 2024. The decrease in gross profit was primarily the result of the decrease in revenue and sales volume of our gastric balloon system coupled with lower production volumes leading to less absorption of labor and overhead.

Previous wording

Sales and marketing expenses decreased $6.8 million, or 53%, to $6.0 million for the six months ended June 30, 2025, as compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $3.8 million decrease in salaries and related benefit costs due to lower headcount as a result of a restructuring implemented during the fourth quarter of 2024, a $2.5 million decrease in marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, and a $0.3 million decrease in shipping and logistics expenses.

Current wording

Sales and marketing expenses decreased $2.1 million, or 40%, to $3.1 million for the three months ended September 30, 2025, compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $1.1 million decrease in salaries and related benefit costs due to lower headcount as a result of restructurings implemented during the fourth quarter of 2024 and the third quarter of 2025, a $0.9 million decrease in marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, and a decrease of $0.1 million of facilities expense as a result of terminating our Paris leases.

Previous wording

Sales and marketing expenses decreased $4.3 million, or 64%, to $2.4 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $2.2 million decrease in salaries and related benefit costs due to lower headcount as a result of a restructuring implemented during the fourth quarter of 2024, a $1.4 million decrease in marketing spend driven by a reorganization of our selling and marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, and a $0.6 million decrease in shipping and logistics expenses.

Current wording

Sales and marketing expenses decreased $8.9 million, or 49%, to $9.2 million for the nine months ended September 30, 2025, as compared to the same period in 2024. The decrease in sales and marketing expenses was the result of a $4.9 million decrease in salaries and related benefit costs due to lower headcount as a result of restructurings implemented during the fourth quarter of 2024 and the third quarter of 2025, a $3.4 million decrease in marketing spend driven by a reorganization of our selling and marketing spend focusing on more efficient channels and geographies, a decrease of $0.2 million of facilities expense as a result of terminating our Paris leases, and a $0.2 million decrease in professional and outside services.

Previous wording

Research and development expenses decreased $2.5 million, or 58%, to $1.8 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $1.6 million decrease in costs related to the AUDACITY clinical trial as the fourth and final module of the PMA was submitted to the FDA and a $0.8 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024.

Current wording

Research and development expenses decreased $1.2 million, or 37%, to $2.0 million for the three months ended September 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $0.9 million decrease in costs related to the AUDACITY clinical trial once the fourth and final module of the PMA was submitted to the FDA in June 2025, a $0.2 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructurings implemented during the fourth quarter of 2024 and the third quarter of 2025, a decrease of $0.1 million in procedure reimbursement costs, and a decrease of $0.1 million in outside consulting costs.

Previous wording

Research and development expenses decreased $5.6 million, or 56%, to $4.4 million for the six months ended June 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $3.0 million decrease in costs related to the AUDACITY clinical trial as the fourth and final module of the PMA was submitted to the FDA and a $1.6 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024.

Current wording

Research and development expenses decreased $6.8 million, or 51%, to $6.4 million for the nine months ended September 30, 2025, compared to the same period in 2024. The decrease in research and development expenses was primarily the result of a $3.9 million decrease in costs related to the AUDACITY clinical trial once the fourth and final module of the PMA was submitted to the FDA in June 2025, a $1.9 million decrease attributable to salaries and related benefit costs due to lower headcount as a result of the restructurings implemented during the fourth quarter of 2024 and the third quarter of 2025, a $0.4 million decrease in outside consulting costs, and a $0.3 million decrease in procedure reimbursement costs.

Previous wording

General and administrative expenses decreased $2.1 million, or 28%, to $5.2 million for the three months ended June 30, 2025, compared to the same period in 2024. The decrease in general and administrative expenses was primarily the result of a $1.8 million decrease in legal and professional fees, inclusive of $1.4 million in one-time legal fees in connection with the Amended Note Purchase Agreement with RTW and a $1.3 million decrease attributable to salaries, benefits and related costs due to lower headcount as a result of the restructuring implemented during the fourth quarter of 2024. This decrease was partially offset by a $0.8 million increase in bad debt expense.

Current wording

General and administrative expenses decreased $4.5 million, or 22%, to $16.2 million for the nine months ended September 30, 2025, compared to the same period in 2024. The decrease in general and administrative expenses was primarily the result of a net $2.4 million decrease attributable to salaries, benefits and related costs due to lower headcount as a result of the restructurings implemented during the fourth quarter of 2024 and the third quarter of 2025, inclusive of $0.9 million of restructuring charges, a $2.3 million decrease in legal and professional fees, inclusive of $1.4 million in one-time legal fees in connection with the Amended Note Purchase Agreement with RTW during the comparative period, a decrease of $0.3 million for insurance expense, and a decrease of $0.3 million of IT expense as a result of cost saving initiatives. These decreases were partially offset by a $0.7 million increase in bad debt expense.

Previous wording

Interest expense decreased $0.4 million, or 100%, to zero for the three months ended June 30, 2025 and $2.3 million, or 100%, to zero for the six months ended June 30, 2025, compared to the same periods in 2024. The decrease in interest expense was due the termination of our Fortress Term Loan in April 2024.

Current wording

Interest expense decreased $2.3 million, or 100%, to zero for the nine months ended September 30, 2025, compared to the same periods in 2024. The decrease in interest expense was due the termination of our Fortress Term Loan in April 2024.

Previous wording

The $2.1 million and $7.7 million gains attributable to the change in fair value of warrants for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, were due to mark to market fluctuations in our warrant liabilities due to the decline in value of our Common Stock during the periods.

Current wording

The $1.5 and $9.2 million gain attributable to the change in fair value of warrants for the three and nine months ended September 30, 2025, respectively, compared to $9.7 and $14.2 million in the same periods in 2024, respectively, were due to mark to market fluctuations in our warrant liabilities due to the decline in value of our Common Stock.

Previous wording

The $4.5 million and $1.2 million losses (as restated) attributable to the change in fair value of debt for each of the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, was due to mark to market fluctuations in our convertible debt.

Current wording

The $1.3 million and $2.5 million loss attributable to the change in fair value of debt for each of the three and nine months ended September 30, 2025, respectively, compared to $7.9 and $16.0 million in the same periods in 2024, respectively, were due to mark to market fluctuations in our convertible debt.

Previous wording

The $0.1 million gain and $3.8 million loss (as restated) attributable to the change in fair value of the Revenue Interest Financing and PIPE Conversion Option for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, was due to mark to market fluctuations in our Revenue Interest Financing during the period driven by an increase in the discount rate.

Current wording

The $2.6 and $6.3 million loss attributable to the change in fair value of the Revenue Interest Financing and PIPE Conversion Option for the three and nine months ended September 30, 2025, respectively, compared to a $0.5 million gain and $7.6 million loss in the same periods in 2024, respectively, was due to mark to market fluctuations in our Revenue Interest Financing during the period driven by a decrease in the discount rate.

Previous wording

The $0.1 million and $1.0 million gains attributable to the change in the fair value of earn-out liabilities for the three and six months ended June 30, 2025, respectively, compared to the same periods in 2024, were due to the decline in value of our Common Stock during the periods.

Current wording

The less than $0.1 million loss and $1.0 million gain attributable to the change in the fair value of earn-out liabilities for the three and nine months ended September 30, 2025, respectively were due to the decline in value of our Common Stock.

Previous wording

The $0.7 million loss on extinguishment of debt for both the three and six months ended June 30, 2025 was due to the loss on extinguishment of the RTW Convertible Notes in connection with the Second Amendment to Note Purchase Agreement. The $8.7 million loss attributable to the loss on extinguishment of debt for both the three and six months ended June 30, 2024 was due to the loss on extinguishment of our Fortress Term Loan in April 2024.

Current wording

Loss on extinguishment of debt was zero for the three months ended September 30, 2025, and 2024. Loss on extinguishment of debt decreased $8.1 million, or 92%, to $0.7 million for the nine months ended September 30, 2025, compared to the same period in 2024. This decrease was due to $0.7 million loss on the extinguishment of the RTW Convertible Notes in connection with the Second Amendment to Note Purchase Agreement in the second quarter of 2025 and the $8.7 million loss on extinguishment of our Fortress Term Loan in April 2024.

Previous wording

The change in Other income (expense), net for the three months ended June 30, 2025 compared to the same period in 2024 was a loss of $0.4 million. primarily driven by a $0.2 million decrease in other income. The change in Other income (expense), net for the six months ended June 30, 2025 compared to the same period in 2024, was a loss of $0.8 million driven by a $0.9 million loss related to the Share Obligation during the current six month period.

Current wording

The change in Other income, net for the three months ended September 30, 2025 compared to the same period in 2024 was a loss of $0.6 million attributable to a $0.5 million decrease related to fluctuations in exchange rates of foreign currencies. The change in Other income, net for the nine months ended September 30, 2025 compared to the same period in 2024 was a loss of $1.4 million, primarily driven by a $0.8 million loss related to the Company's obligation to issue certain shares under the Omnibus Amendment during the current nine month period and a $0.7 million decrease in other income.

Previous wording

We recorded a provision for income taxes of less than $0.1 million and $0.1 million for the three and six months ended June 30, 2025, respectively. These provisions for income taxes are due to net income in certain foreign jurisdictions.

Current wording

We recorded a provision for income taxes of less than $0.1 million and $0.1 million for the three and nine months ended September 30, 2025, respectively. These provisions for income taxes are due to net income in certain foreign jurisdictions.

Previous wording

Since our inception, we have primarily obtained cash to fund our operations through the sale of Common Stock and preferred stock, issuance of term loans, and issuance of convertible debt instruments. As of June 30, 2025, we had $12.7 million in cash and cash equivalents. We incurred operating losses of $14.2 million and $20.7 million for the six months ended June 30, 2025 and 2024, respectively. We incurred cash outflows from operating activities of $17.1 million and $17.6 million during the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $233.0 million. We expect to continue to generate operating losses for the foreseeable future.

Current wording

Since our inception, we have primarily obtained cash to fund our operations through the sale of Common Stock and preferred stock, issuance of term loans, and issuance of convertible debt instruments. As of September 30, 2025, we had $6.1 million in cash and cash equivalents. We incurred operating losses of $23.9 million and $33.1 million for the nine months ended September 30, 2025 and 2024, respectively. We incurred cash outflows from operating activities of $23.6 million and $29.0 million during the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $244.9 million. We expect to continue to generate significant operating losses for the foreseeable future.