FRACTYL HEALTH, INC.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 12, 2025
GUTS$0.93+3.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0000950170-25-070275
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-107297
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 108 previous paragraphs and 152 current paragraphs.
74 unchanged; 26 reworded; 46 added; 6 removed; 2 previous and 6 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (46)
Current report
Revita
Current report
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 Germany Real-World Registry study on an ongoing basis.
Current report
We have completed enrollment of the REVEAL-1 Cohort, REMAIN-1 Midpoint Cohort and REMAIN-1 Pivotal Cohort.
Current report
Revita - Ongoing REMAIN-1 Pivotal Study
Current report
REVEAL-1 Cohort: in June 2025, we announced positive 3-month data from the REVEAL-1 Cohort of our ongoing REMAIN-1 pivotal study. As of June 23, 2025, 22 participants had been treated in the REVEAL-1 Cohort, with 3-month follow-up data available for 13 individuals. The profile of the REVEAL-1 Cohort closely mirrors that of the REMAIN-1 Midpoint and Pivotal Cohorts, with an average age of 49 and a gender distribution of 11 women and 2 men. All participants had previously been treated with a GLP-1 therapy for durations ranging from approximately 5 months to 3 years, with a median total body weight (“TBW”) loss of 20.9% while on therapy. Fifteen percent of participants had pre-diabetes at baseline. At 3 months, 12 of 13 participants either lost or maintained their weight after GLP-1 discontinuation and a single Revita procedure. Notably, 6 of 13 experienced further weight loss. Median weight remained stable through 3 months (TBW change of 0.46% / ~ 1 pound was within the margin of error for daily weight measurement), compared to the typical 5-6% (10–15 pounds) rebound seen in other clinical studies such as SURMOUNT-41,2. Only one participant experienced weight regain similar to that seen after tirzepatide withdrawal. Early signs also point to excellent weight stability following Revita procedure, with essentially no weight change between 1 and 3 months (median weight gain at 1 month: 0.43% and 3 months: 0.46%). Consistent with prior studies of Revita, the procedure was well tolerated, with no unanticipated or serious adverse effects reported. No new safety concerns were observed.
Current report
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 report
Rejuva
Current report
In May 2025, we presented new preclinical data from Rejuva in an oral session at the American Society of Gene and Cell Therapy (“ASGCT”) 2025 Annual Meeting. The data highlight RJVA-001’s potential to deliver durable, nutrient-responsive GLP-1 secretion from pancreatic beta cells, mimicking natural hormone regulation with low circulating levels of GLP-1, offering a potentially profound mechanistic advantage over pharmacologic GLP-1 drugs. RJVA-001 also showed strong efficacy, targeted delivery, and a favorable safety profile, reinforcing its readiness for first-in-human studies. The data showed that a single-dose RJVA-001 led to durable, dose-dependent metabolic improvements in a well-established mouse model of diabetes (db/db).
Current report
In June 2025, we presented new preclinical data from Rejuva at the American Diabetes Association’s (“ADA”) 85th Scientific Sessions. We demonstrated that a single dose of Rejuva was well-tolerated in healthy mice and prevented weight gain and hyperglycemia following a switch to a high-fat diet. Importantly, these data highlight Rejuva’s distinct mechanism of action. The Smart GLP-1 design of Rejuva enables nutrient-responsive secretion, exerting no physiologic effect under healthy metabolic conditions and only activating in the presence of metabolic stress. This targeted activity, which mimics the body's endogenous GLP-1 physiology, highlights the potential for Rejuva to offer superior potency and tolerability.
Current report
1 Aronne et al. JAMA. 2024;331(1):38–48. doi:10.1001/jama.2023.24945
Current report
2 Wilding et al. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564
Current report
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 report
Fractyl Health and Bariendo Letter of Intent
Current report
In June 2025, we entered into a non-binding Letter of Intent (the "LOI") with Bariendo Inc. ("Bariendo") to evaluate a potential collaboration related to the use of Revita as a post–GLP-1 weight maintenance intervention, pending FDA approval. Bariendo is a U.S.-based obesity care platform focused on delivering minimally invasive endoscopic procedures through a national network of hospital and ambulatory endoscopy centers. Under the LOI, Bariendo has expressed its intent to work with us to assess operational readiness and support pre-commercial planning activities related to the potential integration of Revita into its clinical service offerings. These activities may include clinical workflow design, provider training, health economic analysis, and the development of referral pathways.
Current report
Intellectual Property Update
Current report
In June 2025, we announced that the United States Patent and Trademark Office issued two new patents that expand and strengthen our intellectual property portfolio related to duodenal resurfacing. Since 2011, we have built an extensive patent estate, which now includes 32 granted U.S. patents and approximately 40 pending U.S. applications, in addition to numerous foreign issued patents and pending applications. The two newly issued patents, U.S. Patent No. 12,329,439 (issued June 17, 2025) and U.S. Patent No. 12,303,185 (issued May 20, 2025), are both titled “Electrical energy ablation systems, devices and methods for the treatment of tissue” and are directed to ablating duodenal mucosa using various forms of energy, including thermal and non-thermal electrical energy. These patents further reinforce our leadership position in the development of duodenal resurfacing technologies.
Current report
Germany Real-World Registry
Current report
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 report
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 report
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 report
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 report
Table. Germany Real-World Registry Study Weight and Blood Sugar Data Post-Revita Procedure
Current report
Median values shown. Fractyl Health internal data, n=9.
Current report
Thirty-four participants are currently enrolled in the Germany Real-World Registry study. While the study is no longer enrolling new patients, we will continue protocol-defined follow-up of participants and share outcomes on an ongoing basis.
Current report
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 report
Selling, general and administrative expenses decreased by $1.3 million, or 21.1%, during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, primarily due to a decrease in stock-based compensation.
Current report
Other Income (Expense), Net
Current report
Comparison of six months ended June 30, 2025 and 2024
Current report
Research and Development Expenses
Current report
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 report
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 report
Selling, General and Administrative Expenses
Current report
Other Income (Expense), Net
Current report
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 report
$8.0 million gain from the change in fair value of the 2022 Convertible Notes and $2.5 million net interest income, offset by a $1.6 million loss from the change in fair value of the 2023 Notes.
Current report
S-3 Registration Statement
Current report
At-The-Market Offering
Current report
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 report
August 2025 Offering
Current report
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.
Showing the first 40 of 46 passages. Open the source sections for the rest.
Removed paragraphs (6)
Previous report
On January 31, 2025, we approved a Strategic Reprioritization pursuant to which we are prioritizing our REMAIN-1 pivotal study and advancing Rejuva into first-in-human studies in T2D, and have paused additional investment in our Revita programs for T2D, which consist of the REVITALIZE-1 study and the Germany Real-World Registry study. For the REVITALIZE-1 study, participants with inadequately controlled T2D, who are on at least one glucose lowering agent ("GLA") and previously randomized, will continue to be followed per protocol to 48 weeks. Participants randomized to the sham arm will be offered an opportunity to receive the Revita DMR procedure (crossover) once unblinded. Participants who crossover and undergo the Revita DMR procedure are being followed per protocol. We are following the existing participants in the Germany Real-World Registry per protocol and continue to report on clinical, health economic, and patient-relevant outcomes from this study on an ongoing basis.
Previous report
Ongoing REMAIN-1 Pivotal Study
Previous report
(1) REVEAL-1 Cohort: in January 2025, we reported positive preliminary results from the REVEAL-1 Cohort. In April 2025, we announced additional positive early data from the REVEAL-1 Cohort. At the time of the announcement, 15 participants had been treated with Revita, with 1-month follow-up data available for the first 7 participants. There were not any safety or tolerability concerns reported in the 15 participants treated to date, consistent with Revita’s favorable safety profile from pooled data across more than 100 treated participants. At 1-month post-procedure, 7 participants experienced an average weight regain of just 1.2%, compared to the ~3% typically observed at this time period after GLP-1 discontinuation based on prior clinical studies. We anticipate presenting incremental 3-month data in June 2025 for the REVEAL-1 Cohort which we believe will provide additional early validation of Revita’s potential.
Previous report
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. Our primary focus will be to evaluate its safety and tolerability. The study is also designed to provide an early indication of its potential efficacy and help determine the optimal dose for a future Phase 3 study. We plan to investigate RJVA-001 in a patient population with uncontrolled T2D who are on a GLP-1 drug and between one and three other non-insulin GLAs.
Previous report
In June 2025, we plan to submit our first CTA module to regulators for RJVA-001, with additional filings following shortly thereafter. Pending regulatory authorization, we expect to dose our first patients with RJVA-001 and to report preliminary data in 2026.
Previous report
Other Income, Net
Reworded paragraphs (26)
Previous wording
We are a metabolic therapeutics company focused on breaking the pattern of treatment of metabolic diseases, including obesity and type 2 diabetes ("T2D"). We aim to develop durable disease-modifying therapies that are designed to provide long-term maintenance of metabolic health without requiring lifetime treatment by targeting the organ-level root causes of obesity and T2D.
Current wording
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 requiring lifetime treatment. Our therapeutic approach targets the organ-level root causes of obesity and T2D and is intended to move beyond chronic, symptom-focused disease management.
Previous wording
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, research and development activities for our product candidates. 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.
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 our Strategic Reprioritization.
Previous wording
(1) REVEAL-1 Cohort: an open-label cohort enrolling 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: 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.
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. We have completed key preclinical in vivo studies to support a CTA for RJVA-001, a locally administered AAV9 viral vector with a transgene designed to express human GLP-1 hormone from an insulin promoter in a nutrient-responsive manner, for the treatment of
Current 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.
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 IPO 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 convertible preferred stock, sales of our common stock in our public offerings 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 three months ended March 31, 2025 and 2024, we incurred net losses of $23.7 million and $3.3 million, respectively. As of March 31, 2025, we had an accumulated deficit of $439.0 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 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:
Previous wording
(2) REMAIN-1 Midpoint Cohort: we have completed enrollment of the 45 participants of the randomized REMAIN-1 Midpoint Cohort in the fourth quarter of 2024, and we remain on track to report the first randomized 3-month data from this cohort in the third quarter of 2025.
Current wording
REMAIN-1 Midpoint Cohort: we have completed enrollment of the 45 participants of the randomized REMAIN-1 Midpoint Cohort and remain on track to report the first randomized 3-month data from this cohort in September of 2025. We anticipate presenting 6-month data from this cohort in the first quarter of 2026.
Previous wording
(3) 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.
Current 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.
Previous wording
T2D, and achieved regulatory alignment with European authorities in the first quarter of 2025 on our planned first-in-human study design and patient population. In June 2025, we plan to submit our first CTA module to regulators for RJVA-001, with additional filings following shortly thereafter. Pending regulatory authorization, we expect to dose our first patients with RJVA-001 and to report preliminary data in 2026, which we believe could lead to a potentially first-in-class, smart, durable gene therapy designed to reprogram the pancreas to deliver natural metabolic control.
Current 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.
Previous wording
Research and development expenses increased by $5.0 million, or 34.7%, during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to the advancements made in our Revita and Rejuva programs, as well as personnel-related expenses. Revita related expenses increased by $2.2 million primarily due to a $1.9 million increase in clinical expenses due to progress made in our REMAIN-1 study and a $0.7 million increase in device development and production costs, partially offset by a $0.6 million decrease in collaborative medical research expenditures. Rejuva-related expenditures increased by $2.5 million due to continued development in our Rejuva program, primarily due to a $1.8 million increase in gene therapy research and contract manufacturing expenses as well as a $0.6 million increase in device development effort. Personnel-related expenses, including salaries, bonuses and other compensatory benefits, increased by $2.2 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. These expenses were partially offset by decreases in stock-based compensation and facility expenses. The stock-based compensation decrease of $1.4 million was primarily due to more restricted stock units outstanding in the first quarter of 2024 as well as performance-based awards granted in the first quarter of 2024 being recognized under an accelerated method. A reversal of stock compensation expenses was also recognized as a result of the cancelation of unvested awards of employees affected by the Strategic Reprioritization. Our allocated facility expenses decreased by $0.4 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
Research and development expenses increased by $4.4 million, or 26.2%, during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, primarily due to the advancements made in our Revita and Rejuva programs, partially offset by a decrease in stock-based compensation.
Previous wording
Other income, net, of $1.0 million during the three months ended March 31, 2025 was primarily attributable to a $0.8 million gain from the change in fair value of warrant liabilities and $0.5 million of net interest income, partially offset by a $0.3 million loss from the change in fair value of the 2023 Notes. Other income, net, of $18.2 million during the three months ended March 31, 2024 was primarily attributable to a $10.4 million gain from the change in fair value of warrant liabilities, a $6.7 million gain from the change in fair value of the 2023 Notes and the 2022 Convertible Notes, as well as a $1.1 million net interest income.
Current 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.
Previous wording
Selling, general and administrative expenses decreased by $1.8 million, or 25.4%, during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to a decrease in stock-based compensation, partially offset by the increased professional services as well as personnel-related expenses. Stock-based compensation decreased by $2.4 million primarily due to more restricted stock units outstanding in the first quarter of 2024 as well as performance-based awards granted in the first quarter of 2024 being recognized under an accelerated method. Professional services expenses increased by $0.3 million primarily due to increased consulting costs as well as costs associated with the preparation of our Registration Statement on Form S-3 filed on March 3, 2025. Personnel-related expenses, including salaries, bonuses and other compensatory benefits, increased by $0.2 million compared with the first quarter of 2024 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 $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.
Previous wording
Changes in fair value of warrant liabilities and changes in fair value of the 2022 Convertible Notes were mainly a result of the fluctuation of the value of the underlying shares of our common stock. Changes in fair value of the 2023 Notes were primarily driven by a combination of the fluctuation of market interest rates and the accrual of the interest on the notes payable. In addition, net interest income mainly represented interest earned from our cash deposits and the decrease in interest income was primarily driven by a combination of decreased deposit balances and lowered short-term interest rates.
Current wording
Changes in fair value of warrant liabilities and changes in fair value of the 2022 Convertible Notes were mainly a result of the fluctuation of the value of the underlying shares of our common stock. Changes in fair value of the 2023 Notes were primarily driven by a combination of interest on the notes payable and the fluctuation of market interest rates.
Previous wording
On January 11, 2022, we entered into a financing arrangement with certain lenders in which we issued the 2022 Convertible Notes in exchange for an aggregate principal amount of $20.1 million. On July 11, 2023, we repaid $0.1 million in cash to one of the original lenders and issued amended and restated convertible notes to certain of the lenders in replacement of, but not in payment of, the remainder of the 2022 Convertible Notes. Following these amendments, $20.9 million in aggregate principal under the 2022 Convertible Notes remained outstanding, accruing interest at the rate of 10% per year until they were paid or converted in full. Pursuant to the terms of the Convertible Notes, effective upon the closing of our IPO on February 6, 2024, all of the outstanding principal plus accrued interest under the 2022 Convertible Notes of $22.1 million automatically converted into 1,841,321 shares of our common stock at a conversion price equal to 80% of the public offering price per share of $15.00, or $12.00.
Current wording
On January 11, 2022, we entered into a financing arrangement with certain lenders (the “2022 Lenders”) in which we issued convertible promissory notes in exchange for an aggregate principal amount of $20.1 million (the “2022 Convertible Notes”). On July 11, 2023, we repaid $0.1 million in cash to one of the 2022 Lenders and issued amended and restated convertible notes to certain of the lenders (the “Continuing 2022 Lenders”) in replacement of, but not in payment of, the remainder of the 2022 Convertible Notes. Following these amendments, $20.9 million in aggregate principal under the 2022 Convertible Notes remained outstanding, accruing interest at the rate of 10% per year until they were paid or converted in full. Pursuant to the terms of the 2022 Convertible Notes, effective upon the closing of our IPO on February 6, 2024, all of the outstanding principal plus accrued interest under the 2022 Convertible Notes of $22.1 million automatically converted into 1,841,321 shares of our common stock at a conversion price equal to 80% of the public offering price per share of $15.00, or $12.00
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 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, 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.
Previous wording
As of March 31, 2025, the balance of the 2023 Notes was carried at its fair value of $29.4 million.
Current wording
As of June 30, 2025, the balance of the 2023 Notes was carried at its fair value of $30.0 million.
Previous wording
On March 3, 2025, we filed with the SEC, and on March 13, 2025, we amended, a Registration Statement on Form S-3 (File No. 333-285522) (as amended, the “Registration Statement”). The Registration Statement contains a base prospectus, which covers the offering, issuance and sale by us of up to $300.0 million in the aggregate of the securities from time to time in one or more offerings, and a sales agreement prospectus supplement 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 under a sales agreement, dated March 3, 2025 with Jefferies LLC as sales agent.
Current 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.
Previous wording
To date, we have financed our operations primarily through sales of convertible preferred stock, sales of common stock in the IPO and debt financings. We have a history of operating losses and had an accumulated deficit of $439.0 million as of March 31, 2025.
Current wording
To date, we have financed our operations primarily through sales of convertible preferred stock, sales of common stock in public offerings and debt financings. We have a history of operating losses and had an accumulated deficit of $466.9 million as of June 30, 2025.
Previous wording
Based on our current business plans, we believe that our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditures requirements into the fourth quarter of 2025, through multiple key clinical and regulatory milestones. As of March 31, 2025, we had cash and cash equivalents of $42.1 million and net working capital of $28.2 million, which is not sufficient to fund our current operating plan for at least twelve months from the issuance date of this Quarterly Report on Form 10-Q. Without additional financing, we will not be able to comply with the minimum liquidity covenant related to our 2023 Notes. We expect to seek additional funds through equity or debt financings or through collaboration or licensing transactions or other sources. We may be unable to obtain equity or debt financings or enter into collaboration or licensing transactions and, if necessary, we will be required to implement cost reduction strategies which could curtail or delay our current operating plans. As a result, 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. The unaudited interim condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Current wording
Based on our current business plans, we believe that our existing cash and cash equivalents, after considering the net proceeds received from the August 2025 Offering, will be sufficient to fund our operating expenses and capital expenditures requirements into 2026, through multiple key clinical and regulatory milestones. As of June 30, 2025, we had cash and cash equivalents of $22.3 million and net working capital of $4.9 million, which, combined with the net proceeds of $20.7 million from the August 2025 Offering, is not sufficient to fund our current operating plan for at least twelve months from the issuance date of this Quarterly Report on Form 10-Q. Without additional financing, we will not be able to comply with the minimum liquidity covenant related to our 2023 Notes. We expect to seek additional funds through equity or debt financings or through collaboration or licensing transactions or other sources. We may be unable to obtain equity or debt financings or enter into collaboration or licensing transactions and, if necessary, we will be required to implement cost reduction strategies which could curtail or delay our current operating plans. As a result, 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. The unaudited interim condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Previous wording
Adequate additional funds may not be available to us on acceptable terms, or at all. Market volatility resulting from pandemics, monetary policy changes, or other factors could also adversely impact our ability to access capital as and when needed. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Additional debt financings and convertible preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute your ownership interest.
Current wording
Adequate additional funds may not be available to us on acceptable terms, or at all. Market volatility resulting from pandemics, monetary policy changes, or other factors could also adversely impact our ability to access capital as and when needed. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Additional debt financings and convertible preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of additional warrants, which could potentially dilute your ownership interest.
Previous wording
Cash used in operating activities of $25.1 million for the three months ended March 31, 2025 was primarily driven by spending on our ongoing clinical studies, Rejuva-related research activities, professional services related to our corporate and general administrative activities, as well as personnel-related expenses, including salaries, bonuses, and other compensatory benefits. Cash used in operating activities resulted primarily from our net loss of $23.7 million adjusted for net non-cash expense of $0.6 million, primarily consisting of $1.4 million in stock-based compensation, $0.4 million non-cash operating lease expense and $0.3 million depreciation, offset by $0.8 million non-cash gain from the change in fair value of warrant liabilities and $0.8 million non-cash gain from the change in fair value of notes payable. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of 1.9 million.
Current wording
Cash used in operating activities of $46.3 million for the six months ended June 30, 2025 was primarily driven by spending on our ongoing clinical studies, Rejuva-related research activities, professional services related to our corporate and general administrative activities, as well as personnel-related expenses, including salaries, bonuses, and other compensatory benefits. Cash used in operating activities resulted primarily from our net loss of $51.6 million adjusted for net non-cash expense of $4.0 million, primarily consisting of $3.2 million in stock-based compensation, $0.8 million non-cash operating lease expense and $0.6 million depreciation, partially offset by $0.5 million non-cash gain from the change in fair value of warrant liabilities and $0.2 million non-cash gain from the change in fair value of notes payable. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of 1.3 million.
Previous wording
Cash used in operating activities of $11.7 million for the three months ended March 31, 2024 was primarily driven by personnel-related expenses, including salaries, bonuses, and other compensatory benefits, and spending on our ongoing REVITALIZE-1 study, Rejuva-related research activities, as well as professional services related to our corporate and general administrative activities. Cash used in operating activities resulted primarily from our net loss of $3.3 million adjusted for net non-cash income of $11.8 million, primarily consisting of $7.3 million non-cash gain from the change in fair value of notes payable, and $10.4 million non-cash gain from the change in fair value of warrant liabilities, offset by $5.2 million in stock-based compensation and $0.7 million of non-cash operating lease expense. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of $3.4 million.
Current wording
Cash used in operating activities of $30.4 million for the six months ended June 30, 2024 was primarily driven by spending on our ongoing Revita clinical studies, Rejuva-related research activities, professional services related to our corporate and general administrative activities, as well as personnel-related expenses, including salaries, bonuses, and other compensatory benefits. Cash used in operating activities resulted primarily from our net loss of $20.6 million adjusted for net non-cash income of $12.4 million, primarily consisting of $15.1 million gain from change in fair value of warrant liabilities and $7.6 million gain from change in fair value of notes payable (non-cash portion), offset by $9.0 million in stock-based compensation, $1.1 million non-cash operating lease expense and $0.2 million depreciation. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of $2.5 million.
Previous wording
Cash used in investing activities for the three months ended March 31, 2025 and 2024 were related to the purchase of property and equipment. The decrease in the three months ended March 31, 2025 compared with the three months ended March 31, 2024 was primarily due to our spending on leasehold improvement, office furniture and information technology equipment as we moved into our new office and laboratory space in Burlington, MA in the first quarter of 2024.
Current wording
Cash used in investing activities for the six months ended June 30, 2025 and 2024 were related to the purchase of property and equipment. The decrease in the six months ended June 30, 2025 compared with the six months ended June 30, 2024 was primarily due to our spending on leasehold improvement, office furniture and information technology equipment as we moved into our new office and laboratory space in Burlington, MA in the first quarter of 2024.
Previous wording
Cash provided by financing activities of $0.2 million for the three months ended March 31, 2025 was primarily driven by the proceeds of $0.3 million from stock option exercises, partially offset by $0.1 million of principal payments made on finance lease obligations.
Current wording
Cash provided by financing activities of $1.7 million for the six months ended June 30, 2025 was primarily driven by net proceeds of $1.6 million from the issuance of common stock in connection with our ATM offering and $0.3 million from stock option exercises, partially offset by $0.2 million of principal payments made on finance lease obligations.
Previous wording
Cash provided by financing activities of $101.0 million for the three months ended March 31, 2024 was primarily driven by the $103.7 million capital raised from the IPO, net of discounts and commissions, partially offset by $2.9 million payments of public offering costs made to third-party service providers. We also received proceeds of $0.2 million from stock option exercises.
Current wording
Cash provided by financing activities of $101.0 million for the six months ended June 30, 2024 was primarily driven by the $103.7 million capital raised from the IPO, net of discounts and commissions, partially offset by $2.9 million payments of public offering costs made to third-party service providers. We also received proceeds of $0.2 million from stock option exercises.
Previous wording
As of March 31, 2025, our lease commitments reflect payments due for our operating and finance leases. The operating leases include our corporate office and laboratory space in Burlington, MA that will expire in June 2034. The finance leases represent leases of laboratory equipment used in our Rejuva pre-clinical activities. As of March 31, 2025, our future contractual commitments for our leases were $56.7 million, of which $55.4 million were related to our operating leases. For additional information on our leases and timing of future payments, please see Note 7— "Commitments and Contingencies" to the unaudited condensed consolidated financial statements included in this Quarterly Report on this Form 10-Q.
Current wording
As of June 30, 2025, our lease commitments reflect payments due for our operating and finance leases. The operating leases include our corporate office and laboratory space in Burlington, MA that will expire in June 2034. The finance leases represent leases of laboratory equipment used in our Rejuva pre-clinical activities. As of June 30, 2025, our future contractual commitments for our leases were $55.2 million, of which $54.1 million were related to our operating leases. For additional information on our leases and timing of future payments, please see Note 7— "Commitments and Contingencies" to the unaudited condensed consolidated financial statements included in this Quarterly Report on this Form 10-Q.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
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, research and development activities for our product candidates.
Current report — wording carried from elsewhere
Change in fair value of warrant liabilities was mainly a result of the fluctuation of the value of the underlying shares of our common stock. Change in fair value of the 2023 Notes were primarily driven by a combination of interest on the notes payable and the fluctuation of market interest rates.
Current report — wording carried from elsewhere
The following table summarizes our condensed consolidated results of operations for the six months ended June 30, 2025 and 2024.
Current report — wording carried from elsewhere
Revenue and Cost of Goods Sold
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Registration Statement on Form S-3