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Item 2 — Management's Discussion and Analysis
Fractyl Health, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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You should read the following discussion and analysis of our financial condition and results of operations together with (i) our unaudited condensed consolidated financial statements and related notes, appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended December 31, 2025 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”), on March 24, 2026 (“Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, contains forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” sections of this Quarterly Report on Form 10-Q and our Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Business Overview
We are a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (“T2D”). Our Revita® and Rejuva® candidates are designed to target root causes of metabolic diseases, allowing us to advance metabolic disease treatment from chronic management towards prevention and reversion of the disease. For a detailed description of our business, product candidates, and development programs, refer to our Annual Report.
Key Developments During the Three Months Ended June 30, 2026
Revita. REVEAL-1 Cohort.
In June 2026, we announced positive one-year results from the REVEAL-1 Cohort providing real world-evidence of durable weight maintenance after a single Revita procedure. Participants retained approximately 78% of their GLP-1-induced weight loss at one year, with a mean total body weight change of 5.3% ± 2.1% (LS means ± SE; n=15), and 33% continued to lose weight; by comparison, published third-party studies report approximately 15% weight regain by this time point after GLP-1 withdrawal alone. All participants maintained at least 5% of their GLP-1-induced weight loss through one year, consistent with the responder definition used as the second co-primary endpoint in the REMAIN-1 Pivotal Cohort. An efficacy estimand in the full analysis set was consistent, with a mean total body weight change of 5.8% ± 2.0% (LS means ± SE; n=22). Glycemic control was maintained, with minimal change in HbA1c (0.08% ± 0.08%; LS means ± SE from MMRM; n=15) versus the approximately 0.4% increase observed after GLP-1 discontinuation in the STEP-1 trial extension. Consistent with prior studies of Revita, the procedure was well tolerated. No procedure-related serious adverse events and no new treatment-emergent adverse events were observed. Mild treatment-emergent adverse events occurred in eight of 22 participants (36%), were transient and self-limited, and all occurred within the first month of treatment. No late device-related adverse events were observed, and all adverse events were consistent with prior Revita experience and similar to routine upper endoscopy findings.
Revita. REMAIN-1 Midpoint Cohort.
In July 2026, we announced one-year data from the REMAIN-1 Midpoint Cohort. In the full modified intention-to-treat (“mITT”) population (N=45), a single Revita procedure reduced weight regain by approximately 40% versus sham at one year (least-squares mean weight regain of 7.8% versus 13.0% of body weight; n=29 versus 16 for Revita versus sham). The Midpoint Cohort is not powered for formal statistical significance, and results are descriptive. Participants who received complete duodenal ablation (>14 cm) maintained approximately 81% of GLP-1-induced weight loss at one year, compared with 48% in sham participants (least-squares mean weight regain of 4.8% versus 13.0% of body weight; n=17 versus 16 for Revita versus sham), reflecting a reduction in weight regain of over 60% versus sham, consistent with earlier findings that more complete duodenal ablation drives greater treatment effect. In an optimized population of participants who received complete duodenal ablation (>14 cm) and had higher GLP-1 run-in weight loss (≥17.5%), Revita maintained approximately 84% of GLP-1-induced weight loss at one year versus 46% with sham (least-squares mean weight regain of 4.1% versus 13.5% of body weight; n=10 versus 8 for Revita versus sham). As a reference point for the Pivotal Cohort, the proportion of Revita participants maintaining at least 5% total body weight loss relative to their pre-tirzepatide weight at one year was 73% in the Midpoint Cohort mITT population, rising to 91% in those with complete duodenal ablation (>14 cm). No device- or procedure-related serious adverse events occurred, and no new device-related treatment-emergent adverse events were observed between six and 12 months. Overall treatment-emergent adverse event rates were comparable between arms
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through one year (24% Revita versus 25% sham).
Rejuva.
In April 2026, we received clinical trial application (“CTA”) authorization in the Netherlands for RJVA-001, our lead gene therapy candidate, enabling initiation of the anticipated Phase 1/2 first-in-human study evaluating RJVA-001 in adults with inadequately controlled T2D. Subject to site activation, we expect to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026. We also plan to conduct the study at sites in Australia. In July 2026, we received ethics committee approval in Australia. We also advanced RJVA-002, our dual GIP/GLP-1 gene therapy candidate, through preclinical development.
Anticipated 2026 Revita Milestones
With randomization complete of the REMAIN-1 Pivotal Cohort, we are advancing toward multiple anticipated clinical and regulatory milestones toward pivotal readout and potential U.S. regulatory submission. In March 2026 in connection with its regulatory strategy, the Company received pre-submission feedback from the FDA in which it acknowledged that the safety profile of the Revita DMR System, based on clinical data from over 300 procedures, is consistent with a Class II device classification. As in all applications, the FDA indicated that final pathway determinations will be made following review of the complete safety dataset which the Company intends to include in its potential De Novo marketing application submission.
•Topline six-month randomized data from the REMAIN-1 Pivotal Cohort in the early fourth quarter of 2026.
•Potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance in the late fourth quarter of 2026.
•Topline one-year data from the REMAIN-1 Pivotal Cohort in the first quarter of 2027.
Anticipated 2026 Rejuva Milestones
•First-in-human dosing of RJVA-001, subject to site activation, and expected reporting of preliminary data in the second half of 2026.
We are pursuing opportunities to strengthen our balance sheet and fund our path towards potential commercialization, leveraging the achievement of clinical data milestones.
Management believes that our available cash and cash equivalents balance of $47.1 million as of June 30, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into early 2027. Importantly, we are well funded through multiple key clinical and regulatory milestones in 2026, including the anticipated topline six-month randomized data from the REMAIN-1 Pivotal Cohort, anticipated De Novo marketing application submission in post-GLP-1 weight maintenance, and initial dosing and preliminary data from our RJVA-001 clinical program. For additional information regarding our liquidity, funding requirements and going concern assessment, see “Funding Requirements and Going Concern” below and the section titled “Risk Factors” in our Annual Report.
Components of our Condensed Consolidated Results of Operations
There have been no material changes to the components of our results of operations described in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report, except as stated below.
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The following table reflects our research and development expenses, including direct program-specific expenses summarized by program, indirect expenses, and personnel-related expenses recognized during each period presented:
Three Months Ended June 30, Six Months Ended June 30,
(in thousands) 2026 2025 2026 2025
Direct program-specific expenses:
Revita $ 3,676 $ 8,181 $ 8,642 $ 14,935
Rejuva 2,010 4,661 3,913 7,878
Total direct program-specific expenses 5,686 12,842 12,555 22,813
Indirect expenses 2,059 1,840 3,950 3,853
Personnel-related expenses (including stock-based compensation) 6,067 6,469 12,905 13,920
Total research and development expenses $ 13,812 $ 21,151 $ 29,410 $ 40,586
Critical Accounting Policies and Significant Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are described in more detail in Note 2 – “Significant Accounting Policies” to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q as well as Note 2 – “Significant Accounting Policies” to our audited financial statements as of and for the year ended December 31, 2025 included in our Annual Report.
Results of Operations
Comparison of three months ended June 30, 2026 and 2025
The following table summarizes our condensed consolidated results of operations for the three months ended June 30, 2026 and 2025.
Three Months Ended June 30, Change
(in thousands) 2026 2025 Amount %
Operating expenses:
Research and development $ 13,812 $ 21,151 $ (7,339 ) (34.7 %)
Selling, general and administrative 5,284 4,928 356 7.2 %
Total operating expenses 19,096 26,079 (6,983 ) (26.8 %)
Loss from operations (19,096 ) (26,079 ) 6,983 (26.8 %)
Other expense, net (6,442 ) (1,810 ) (4,632 ) 255.9 %
Net loss and comprehensive loss $ (25,538 ) $ (27,889 ) $ 2,351 (8.4 %)
Research and Development Expenses
Research and development expenses decreased by $7.3 million, or 34.7%, during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease was primarily related to reduced spending on our Revita and Rejuva programs.
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Revita-related expenses decreased by $4.5 million primarily due to decreased clinical expenses. Rejuva-related expenses decreased by $2.7 million, primarily driven by lower spending on drug product manufacturing, device engineering, and pre-clinical research activities, partially offset by costs incurred to advance the program toward clinical readiness.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $0.4 million, or 7.2%, during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The increase was primarily driven by higher stock compensation expenses.
Other Expense, Net
Other expense, net, of $6.4 million during the three months ended June 30, 2026 was primarily attributable to a $5.5 million loss from the change in fair value of our warrant liabilities and a $1.4 million loss from the change in fair value of the 2023 Notes (as defined below), partially offset by $0.4 million of net interest income. 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 our warrant liabilities, partially offset by $0.2 million of net interest income.
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. The higher loss from the change in fair value of warrant liabilities during the three months ended June 30, 2026 was mainly related to the warrants issued as part of the equity financing completed in August 2025. 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.
Comparison of six months ended June 30, 2026 and 2025
The following table summarizes our condensed consolidated results of operations for the six months ended June 30, 2026 and 2025.
Six Months Ended June 30, Change
(in thousands) 2026 2025 Amount %
Operating expenses:
Research and development $ 29,410 $ 40,586 $ (11,176 ) (27.5 %)
Selling, general and administrative 10,506 10,252 254 2.5 %
Total operating expenses 39,916 50,838 (10,922 ) (21.5 %)
Loss from operations (39,916 ) (50,838 ) 10,922 (21.5 %)
Other income (expense), net 23,596 (786 ) 24,382 (3,102.0 %)
Net loss and comprehensive loss $ (16,320 ) $ (51,624 ) $ 35,304 (68.4 %)
Research and Development Expenses
Research and development expenses decreased by $11.2 million, or 27.5%, during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease was primarily related to reduced spending on our Revita and Rejuva programs, as well as lower personnel-related expenses.
Revita-related expenses decreased by $6.3 million primarily due to decreased clinical expenses. Rejuva-related expenses decreased by $4.0 million, primarily driven by lower spending on drug product manufacturing, device engineering, and pre-clinical research activities, partially offset by costs incurred to advance the program toward clinical readiness. Personnel-related expenses decreased by $1.0 million, primarily driven by lower headcount as a result of our strategic reprioritization in the first quarter of 2025.
Selling, General and Administrative Expenses
Selling, general and administrative expenses during the six months ended June 30, 2026 were $10.5 million, consistent with the $10.3 million incurred during the six months ended June 30, 2025.
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Other Income (Expense), Net
Other income, net, of $23.6 million during the six months ended June 30, 2026 was primarily attributable to a $24.6 million gain from the change in fair value of our warrant liabilities and $1.0 million of net interest income, partially offset by a $2.0 million loss from the change in fair value of the 2023 Notes. 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 our warrant liabilities and $0.7 million of net interest income.
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. The higher gain from the change in fair value of warrant liabilities during the six months ended June 30, 2026 was mainly related to the warrants issued as part of the equity financing completed in August 2025. 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.
Non-GAAP Financial Measures
In addition to our results determined in accordance with U.S. GAAP, we also evaluate our performance using Adjusted EBITDA, a non-GAAP financial measure. We define Adjusted EBITDA as net loss adjusted to exclude (i) interest income, net, (ii) depreciation expense, (iii) stock-based compensation expense, (iv) changes in the fair value of notes payable and (v) changes in the fair value of warrant liabilities.
We present Adjusted EBITDA as supplemental information because management believes it provides additional insight into our operating performance and facilitates comparisons of our results from period to period by excluding items that are non-cash or non-operational in nature and may vary in magnitude. Management uses Adjusted EBITDA in evaluating our operating performance and in planning and forecasting future periods.
Adjusted EBITDA should not be considered in isolation or as a substitute for, or superior to, net loss or any other measure of financial performance prepared in accordance with GAAP. Adjusted EBITDA does not reflect interest income, depreciation, stock-based compensation expense, or changes in the fair value of certain financial instruments, each of which may be significant. In addition, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable.
A reconciliation of net loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA is presented below.
Three Months Ended June 30, Six Months Ended June 30,
(in thousands) 2026 2025 2026 2025
Net loss $ (25,538 ) $ (27,889 ) $ (16,320 ) $ (51,624 )
Interest income, net (431 ) (226 ) (1,024 ) (729 )
Depreciation 278 270 559 560
EBITDA (25,691 ) (27,845 ) (16,785 ) (51,793 )
Stock-based compensation expense 2,496 1,785 5,027 3,191
Change in fair value of notes payable 1,382 1,673 1,992 1,956
Change in fair value of warrant liabilities 5,484 348 (24,571 ) (477 )
Adjusted EBITDA $ (16,329 ) $ (24,039 ) $ (34,337 ) $ (47,123 )
Liquidity and Capital Resources
We manage our cash and capital structure to maintain our financial condition and maintain flexibility for future strategic initiatives. We continuously assess our working capital needs, debt and leverage levels, debt maturity schedule, capital expenditure requirements and future investments.
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Loan and Security Agreements
2023 Notes
On September 7, 2023, we entered into a credit agreement, as amended from time to time (the “Credit Agreement”), with Symbiotic Capital Opportunities Holding, L.P. and Catalio Structured Opportunities AIV I LP (the “2023 Lenders”) that provided for term loans up to an aggregate principal amount of $45.0 million (the “2023 Notes”) in two tranches. The first tranche, with a principal amount of $30.0 million, was extended on September 7, 2023, resulting in net proceeds of approximately $28.4 million. The second tranche, with a principal amount of $15.0 million, would have been extended upon our achievement of certain operating and funding milestones as defined in the Credit Agreement, by July 31, 2024. Due to a shift in business strategy 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.
The Credit Agreement, as amended, contains financial covenants, including a minimum liquidity covenant requiring us to maintain a minimum $10.0 million balance in cash and cash equivalents on deposit in accounts, subject to certain exceptions. As of June 30, 2026, we were in compliance with the minimum liquidity covenant and other terms of the arrangement.
The outstanding balances under the 2023 Notes bear interest at a floating annual rate equal to the greater of 5.5% above the Wall Street Journal prime rate or 13.25%. On and prior to September 30, 2024, 6.0% of the interest is payable in kind and added to the outstanding principal amount of the 2023 Notes. Beginning September 30, 2026, we were required to make principal payments in the amount of 1.5% of the aggregate principal amount outstanding, including accrued PIK interest, each month. Under the terms of the Credit Agreement, the first principal payment date may be extended to September 30, 2027, at our election, if certain financing milestones as defined in the Credit Agreement are achieved on or prior to September 30, 2026. During 2024, we achieved the defined milestones and elected to extend the first principal payment date to September 30, 2027. In addition, upon any principal payment, we are required to make an additional payment to the 2023 Lenders of a 6.0% fee (the “Exit Fee”), over the principal and accrued PIK interest paid. The aggregate Exit Fee of the 2023 Notes should equal to 6.0% of the total commitment of $45.0 million plus all accrued PIK interest. All remaining outstanding principal balance, accrued interest and Exit Fee on the 2023 Notes shall be due and payable on the maturity date of September 7, 2028.
As of June 30, 2026, the balance of the 2023 Notes was carried at its fair value of $30.4 million.
S-3 Registration Statement
On March 3, 2025, we filed a Registration Statement on Form S-3 with the 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.
At-The-Market Offering
On March 3, 2025, concurrently with the filing of the S-3 Registration Statement, we entered into a sales agreement with Jefferies LLC as sales agent (the “Sales Agreement”) and filed a 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. During the term of the ATM Offering, we issued and sold 4,701,960 shares of our common stock at a weighted average price of $1.53 per share, resulting in net proceeds of approximately $6.8 million, after deducting commissions and offering expenses. On March 23, 2026, we notified Jefferies LLC of our intention to terminate the Sales Agreement pursuant to its terms. As a result, the Sales Agreement was terminated effective April 6, 2026 and no further sales have been or will be made thereunder after such date.
August 2025 Warrants
In connection with our underwritten public offering that closed on August 7, 2025 (the “August 2025 Offering”), we issued warrants to purchase shares of our common stock, including the Tranche A and Tranche B Warrants (collectively the “August 2025 Warrants”). For additional information regarding the August 2025 Offering and the terms of the August 2025 Warrants, refer to Note 1 to the consolidated financial statements included in our Annual Report.
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All Tranche A Warrants were exercised or expired by December 31, 2025. No Tranche B Warrants were exercised during the three and six months ended June 30, 2026. As of June 30, 2026, Tranche B Warrants to purchase 21,147,002 shares of our common stock remained outstanding, each with an exercise price of $1.05 per share, subject to certain adjustments, and expiring on October 3, 2030.
Funding Requirements and Going Concern
Our future success is dependent on our ability to develop product candidates, generate significant revenue, and upon our ability to attain profitable operations. We are subject to a number of risks similar to other early-stage life science companies, including, but not limited to, successful discovery and development of our product candidates, raising additional capital with favorable terms, development by our competitors of new technological innovations, protection of proprietary technology and market acceptance of our products. The successful discovery and development of product candidates requires substantial capital which may not be available to us on favorable terms or not at all.
To date, we have financed our operations primarily through our equity and debt financings. We have a history of operating losses and had an accumulated deficit of $572.6 million as of June 30, 2026. Based on our current business plans, we believe that our available cash and cash equivalents of $47.1 million as of June 30, 2026, will be sufficient to fund our operating expenses and capital expenditure requirements into early 2027, through multiple key clinical and regulatory milestones. Our estimate as to how long we expect our existing cash and cash equivalents will be able to continue to fund our operating expenses and capital expenditure requirement is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. However, we believe our existing cash resources will not be sufficient to fund our current operating plan for at least twelve months from the issuance date of this Quarterly Report on Form 10-Q. As a result, we have concluded that substantial doubt exists about our ability to continue as a going concern for at least one year after the date that these financial statements are issued. 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.
Management intends to mitigate the conditions and events that raise substantial doubt about our ability to continue as a going concern entity by (i) negotiating other cash equity, debt or strategic financing, (ii) continuing to pursue the necessary regulatory approvals to launch commercially in the U.S. market, and (iii) executing cost-cutting measures to manage cash burn. However, there can be no assurances that the current plans will generate any liquidity to us or be available on terms acceptable to us.
Because of the numerous risks and uncertainties associated with product development, and because the extent to which we may enter into collaborations with third parties for the development of our product candidates is unknown, we may incorrectly estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:
•the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned Revita clinical studies, and ongoing preclinical development for our current and future product candidates;
•the scope, prioritization and number of our research and development programs;
•the scope, costs, timing and outcome of regulatory review of our product candidates;
•the costs of securing manufacturing materials for use in preclinical and clinical studies and, for any product candidates for which we receive regulatory approval, use as commercial supply;
•our ability to seek, establish and maintain a collaboration to develop our product candidate with a collaborator, including the financial terms and any cost-sharing arrangements of any such collaboration;
•the costs and timing of future commercialization activities for any of our product candidates for which we receive regulatory approval;
•the amount and timing of revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approvals;
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•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims;
•the extent to which we may acquire or in-license other products, product candidates, technologies or intellectual property, as well as the terms of any such arrangements; and
•the costs of continuing to expand our operations and operating as a public company.
Identifying potential product candidates and conducting preclinical testing and clinical studies is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales in the United States or elsewhere. In addition, our product candidates, if approved, may not achieve commercial success. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
Our expectation with respect to our ability to fund current planned operations is based on estimates that are subject to risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to management and there can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, and we may need to seek additional funds sooner than planned.
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.
If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may have to significantly delay, reduce or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
For additional information on risks associated with our substantial capital requirements, please see the section titled “Risk Factors” in our Annual Report.
We will require substantial additional capital beyond the proceeds from our prior financings to fund our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and development programs or future commercialization efforts.
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods presented:
Six Months Ended June 30,
(in thousands) 2026 2025
Net cash used in operating activities $ (38,378 ) $ (46,278 )
Net cash used in investing activities — (546 )
Net cash provided by financing activities 3,978 1,651
Net decrease in cash, cash equivalents and restricted cash $ (34,400 ) $ (45,173 )
Operating Activities
Cash used in operating activities of $38.4 million for the six months ended June 30, 2026 was primarily driven by spending on our ongoing clinical studies, Rejuva-related research and clinical readiness 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 $16.3 million adjusted for
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net non-cash activities of $18.1 million. These non-cash activities primarily consisted of a $24.6 million non-cash gain from the change in fair value of warrant liabilities, a $0.1 million non-cash gain from the change in fair value of notes payable, $5.0 million in stock-based compensation expense, $0.9 million non-cash operating lease expense, and $0.6 million depreciation expense. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of $3.9 million.
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 activities of $4.0 million. These non-cash activities primarily consisted 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.
Investing Activities
We did not have any investing related cashflow activities for the six months ended June 30, 2026. Cash used in investing activities for the six months ended June 30, 2025, was primarily related to the purchase of laboratory and manufacturing equipment.
Financing Activities
Cash provided by financing activities of $4.0 million for the six months ended June 30, 2026 was related to $4.1 million proceeds received in January 2026 from Tranche A warrants that were exercised in December 2025 and $0.2 million proceeds received from issuance of common stock under employee stock purchase plan, partially offset by $0.3 million principal payments made on finance lease obligations. 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.
Contractual Obligations and Commitments
We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods.
As of June 30, 2026, 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, 2026, our future contractual commitments for our leases were $49.3 million, of which $48.8 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.
We have also entered into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies, manufacturing, and other services and products for operating purposes. These contracts typically do not contain any minimum purchase commitments and provide for termination upon notice. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.
Recent Accounting Pronouncements
See Note 2—“Summary of Significant Accounting Policies” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for more information.
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JOBS Act Accounting Election
We are an “emerging growth company” within the meaning of the JOBS Act. Section 107(b) of the JOBS Act provides that an emerging growth company can leverage the extended transition period, provided in Section 102(b) of the JOBS Act, for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. We have elected to use this extended transition period and, as a result, our financial statements may not be comparable to companies that comply with public company effective dates. We have also elected to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.
We would cease to be an emerging growth company on the date that is the earliest of (1) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (2) the last day of our fiscal year following the fifth anniversary of the date of the completion of our IPO; (3) the date on which we have issued more than $1.0 billion in non-convertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.