Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes and other information included elsewhere in this Annual Report on Form 10-K. In addition to historical data, this discussion contains forward-looking statements about our business, results of operations, cash flows, financial condition and prospects based on current expectations that involve risks, uncertainties, assumptions, and other important factors. Our actual results could differ materially from such forward-looking statements. Factors that could cause or contribute to those differences include, but are not limited to, those identified below and those discussed in Part I, Item 1A. Risk Factors and the section titled "Forward-Looking Statements" included elsewhere in this Annual Report on Form 10-K. Additionally, our historical results are not necessarily indicative of the results that may be expected for any period in the future. We use words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "potential," "seek," "should," "will," "would," and similar expressions to identify forward-looking statements.

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, see Part I, Item 1, "Business."

Key Developments During 2025

During the year ended December 31, 2025, we made significant progress advancing our two product candidates:

Revita.We completed enrollment of the REMAIN-1 Pivotal Cohort in July 2025, a randomized, double-blind, sham-controlled pivotal study evaluating the safety and efficacy of Revita in maintaining weight loss after GLP-1 based therapy discontinuation. We completed randomization of the pivotal cohort in February 2026, with topline six-month data anticipated in the early fourth quarter of 2026.

Strategic Reprioritization.On January 31, 2025, we announced our Strategic Reprioritization, announcing we paused investment in our Revita for T2D, including the REVITALIZE-1 study and the Germany Real-World Registry study. Our decision to pause these studies was not driven by any safety or efficacy concerns. We continue to follow existing participants per protocol and report outcomes on an ongoing basis for these studies. The Strategic Reprioritization included a workforce reduction impacting 22 employees, or approximately 17% of our workforce, and has been substantially implemented.

Rejuva.We completed key preclinicalin vivo studies to support clinical trial applications ("CTAs") for RJVA-001, our lead gene therapy candidate and subsequently submitted CTAs for RJVA-001 in T2D to regulators in the EU (Netherlands) and Australia in the second half of 2025, advancing the program toward its anticipated first-in-human study. We also advanced RJVA-002, our dual GIP/GLP-1 gene therapy candidate, through preclinical development.

Anticipated 2026 Revita Milestones

With randomization complete,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.

Anticipated 2026 Rejuva Milestones

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 $81.5 million as of December 31, 2025, combined with $4.1 million in subsequent proceeds from Tranche A warrant exercises received in January 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 "Liquidity and Capital Resources-Funding Requirements and Going Concern" below and Part I, Item 1A, "Risk Factors-Risks Related to Our Financial Condition and Capital Requirements."

Components of our Consolidated Results of Operations

Revenue and Cost of Goods Sold

To date, we have generated revenue in Germany since the limited pilot commercial launch of Revita in the first quarter of 2023. We have not generated any revenue in the U.S. and do not expect to generate any revenue there unless and until we successfully complete clinical development and obtain marketing approvals for one or more of our product candidates. On January 31, 2025, we approved a Strategic Reprioritization, in which we have paused investment in our Revita programs for T2D, which consists of the REVITALIZE-1 study and the Germany Real World Registry study. As a result, we have not generated any revenue in 2025.

Cost of goods sold primarily consist of material costs, direct labor, and manufacturing overhead costs. We currently manage the final assembly and testing of Revita in the manufacturing space at our headquarters in Burlington, Massachusetts. We contract with third-party manufacturers to produce certain key parts of our single-use devices and consoles.

Operating Expenses

Research and Development Expenses

Research and development expenses primarily consist of personnel-related expenses, including salaries, bonuses, fringe benefits and stock-based compensation expense, for employees engaged in research and development functions. These expenses also include external costs associated with our ongoing clinical studies, including payments to clinical sites and our clinical research organization ("CRO") and clinical manufacturing costs, as well as fees paid to third party consultants and contractors for engineering, quality assurance and regulatory support. In addition, research and development expenses include costs associated with our preclinical research and Chemistry, Manufacturing, and Controls ("CMC") activities related to our Rejuva gene therapy platform.

We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses and other current assets or as other long-term assets, which are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.

A significant portion of our research and development costs have been, and will continue to be, external costs. We track these external costs - such as fees paid to our CRO, preclinical study vendors and other third parties in connection with our product engineering, sub-assembly component manufacturing and manufacturing process development, clinical studies, preclinical studies, and other research activities - on a program-by-program basis. We also use a portion of our personnel and infrastructure resources for our research and development efforts, which are shared across multiple programs under development, and as such, are not tracked on a program-by-program basis. The following table reflects our research and

development expense, including direct program-specific expense summarized by program, indirect expenses, and personnel-related expenses recognized during each period presented:

We expect our research and development expenses to decrease in the near term as a result of the completion of randomization in the REMAIN-1 pivotal study, as spending shifts from enrollment-related activities to patient follow-up and data collection. This decrease may be partially offset by costs associated with initiating the Rejuva first-in-human study.

Selling, General and Administrative Expenses

Selling, general and administrative expenses primarily consist of personnel-related costs, including salaries, bonuses, fringe benefits and stock-based compensation expense, for our personnel and external contractors involved in our executive, finance, legal, and other administrative functions. Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including costs associated with obtaining and maintaining our patent portfolio and professional fees for accounting, auditing, tax, legal services, and other consulting expenses.

We expect our selling, general and administrative expenses to stay stable in the near term. If marketing approval or certification for our product candidate is obtained, we anticipate that our selling, general and administrative expenses will increase over time as we expand our commercial and administrative function to support our transition towards commercial readiness and the potential launch, as well as pursue payor coverage and reimbursement for our current and future product candidates.

Other Income (Expenses), Net

Other income (expense), net is primarily comprised of interest income, change in fair value of notes payable, and change in fair value of warrant liabilities.

Interest Income

Interest income is primarily generated from cash interest earned on our cash, cash equivalents, and restricted cash balances.

Change in Fair Value of Notes Payable

In January 2022, we entered into a financing arrangement with certain lenders in which we issued convertible promissory notes (the "2022 Convertible Notes"). Upon the closing of our IPO in February 2024, all outstanding principal plus accrued interest under the 2022 Convertible Notes were converted into our common stock. The 2022 Convertible Notes were marked to market to their fair value as of the time of the conversion before being reclassified to equity.

In September 2023, we entered into a credit agreement with certain lenders that provides for term loans (the "2023 Notes"). We elected the fair value option to account for these notes payable, which are re-measured at the end of each reporting period with changes in fair value recognized as a component of other income (expense), net. We will continue to recognize changes in fair value of the notes payable until they are repaid in cash.

Change in Fair Value of Warrant Liabilities

In January 2014, we issued a fully vested warrant to purchase shares of our Series B convertible preferred stock in connection with a loan and security agreement entered into in January 2014. In connection with our IPO in February 2024,

warrants to purchase our convertible preferred stock converted into warrants to purchase our common stock and related liabilities were reclassified to additional paid-in capital.

In July 2023, we issued fully vested warrants to purchase shares of our common stock in connection with the issuance of the amended and restated 2022 Convertible Notes. In September 2023, we issued fully vested warrants to purchase shares of our common stock or convertible preferred stock in connection with the 2023 Notes. In August 2025, we issued fully vested warrants to purchase shares of our common stock in connection with our August 2025 Offering.

These warrants were classified as liabilities on our consolidated balance sheet and were initially recorded at fair value on the grant date. They are subsequently remeasured to fair value at the end of each reporting period and at exercise with changes in fair value recognized as a component of other income (expense), net. We will continue to recognize changes in fair value of the warrant liabilities until the warrants are exercised or expire.

Critical Accounting Policies and Significant Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of 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 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.

While our significant accounting policies are described in more detail in Note 2 - "Significant Accounting Policies" of our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies used in the preparation of our consolidated financial statements require the most significant judgments and estimates. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our audited consolidated financial condition and results of operations.

Determination of the Fair Value of Notes Payable

We elected the fair value option to account for our 2023 Notes, and remeasure the fair value at each reporting date. The fair value of the 2023 Notes as of December 31, 2025 and 2024 was estimated using a discounted cash flow model by discounting projected future cash flows associated with the 2023 Notes to their present value. The discount rate used in the model is based on observable market yields for similarly rated instruments, adjusted for any specific risks inherent in the 2023 Notes, which is a level 3 fair value measurement and requires judgment to determine at each period end.

Accrued Research and Development Expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of these estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and development expenses include fees paid to:

We base our expenses related to preclinical and clinical studies on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions that conduct and manage preclinical and clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of participants and the completion of clinical study milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Results of Operations

The following table summarizes our consolidated results of operations for the years ended December 31, 2025 and 2024:

Revenue and Cost of Goods Sold

Revenue and cost of goods sold during the year ended December 31, 2024, was related to our pilot commercial launch in Germany. In January 2025, we approved a Strategic Reprioritization in which we paused investment in our Revita program for T2D, which also included the pilot commercial launch in Germany. Therefore, we did not recognize any revenue in 2025.

Research and Development Expenses

Research and development expenses increased by $4.1 million, or 5.8%, during the year ended December 31, 2025, as compared to the year ended December 31, 2024, primarily due to the advancements made in our Revita and Rejuva programs.

Revita-related expenses increased by $3.0 million, mainly due to a $6.1 million increase in clinical related expenses, partially offset by a $2.0 million decrease in collaborative medical research expenditures and a $1.1 million decrease in Revita related engineering expenses. Increases in clinical expenses were primarily driven by the positive progress made in our REMAIN-1 study, partially offset by reduced expenses from the REVITALIZE-1 study as a result of our Strategic Reprioritization, which also contributed to the decrease in collaborative medical research expenditures. Revita related engineering expenses decreased as our development efforts gradually shifted to validation and regulatory approval support

activities. Rejuva-related expenses increased by $4.5 million as we advanced preclinical CMC activities and clinical preparation work in support of the RJVA-001 first-in-human study.

Personnel related expenses decreased by $2.3 million, which was mainly the result of a $3.6 million decrease in stock-based compensation expense, partially offset by a $1.3 million increase in bonuses, severance and associated payroll taxes. Allocated facilities expenses also decreased by $1.2 million due to the expenses incurred when we moved into our new office and laboratory space in Burlington, MA in the first quarter of 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses decreased by $0.8 million, or 3.6%, during the year ended December 31, 2025 as compared to the year ended December 31, 2024, primarily due to decreased personnel-related expenses of $2.9 million driven by a $4.1 million decrease in stock-based compensation expense, partially offset by a $1.2 million increase in salary, bonus and severance expenses. This personnel-related decrease was partially offset by a $1.8 million increase in offering costs primarily associated with the issuance of warrants in the August 2025 Offering and a $0.7 million increase in legal, audit, investor relations and other administrative expenses incurred to support our operation as a public company.

Other Income (Expense), Net

Other expense, net, of $44.1 million during the year ended December 31, 2025, was primarily attributable to a $40.9 million loss from the change in fair value of warrant liabilities, a $4.7 million loss from the change in fair value of notes payable, partially offset by $1.5 million in net interest income. Other income, net, of $24.8 million during the year ended December 31, 2024, was primarily attributable to a $17.9 million gain from the change in fair value of notes payable, a $2.8 million gain from the change in fair value of warrant liabilities, and $4.1 million in net interest income.

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. Interest income earned from our cash deposits decreased by $2.6 million mainly due to lower overall deposit balances and lower interest rate during 2025 as compared to 2024.

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.

Liquidity and Capital Resources

We manage our cash and capital structure to maximize shareholder return, maintain 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.

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 drawn on September 7, 2023, resulting in net proceeds of approximately $28.4 million. The second tranche, with a principal amount of $15.0 million, would have been extended upon our achievement of certain operating and funding milestones as defined in the Credit Agreement, by July 31, 2024. The Credit Agreement also provides for a third tranche with an uncommitted principal amount of $20.0 million that may be extended to us, subject to the 2023 Lenders' prior written consent in their sole discretion. Due to a shift in business strategy 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 December 31, 2025, we were in compliance with the financial covenants and other terms of the arrangement. Our obligations under the Credit Agreement are collateralized by substantially all of our assets, including our intellectual property, but excluding certain customary and agreed upon assets.

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 was payable in kind and added to the outstanding principal amount of the 2023 Notes. Monthly principal payments of 1.5% of the aggregate outstanding principal balance, including accrued PIK interest, were originally scheduled to commence on September 30, 2026. Under the terms of the Credit Agreement, we had the right to extend the first principal payment date to September 30, 2027, provided that certain financing milestones defined in the Credit Agreement were achieved on or prior to September 30, 2026. Having achieved those milestones during 2024, we exercised that election, and principal payments are now scheduled to commence on 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") of the principal and accrued PIK interest paid. The aggregate Exit Fee of the 2023 Notes is 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 December 31, 2025, the balance of the 2023 Notes was carried at its fair value of $30.6 million.

S-3 Registration Statement

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.

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. As of December 31, 2025, we issued and sold 4,701,960 shares of our common stock under the ATM Offering 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. No shares were sold under the Sales Agreement subsequent to December 31, 2025. 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 will be terminated effective April 6, 2026 and no further sales will be made thereunder after such date.

August 2025 Offering

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

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

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

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

The August 2025 Offering closed on August 7, 2025, from which we received approximately $22.6 million of net proceeds, after deducting underwriting commissions and offering expenses, excluding any potential future proceeds from the exercise of the Tranche A Warrants and Tranche B Warrants.

In December 2025, the conditions necessary to call the Tranche A warrants were satisfied and we exercised our call option. As of December 31, 2025, Tranche A Warrants were exercised to purchase 21,904,261 shares of our common stock for total proceeds of $23.0 million, $4.1 million of which was not received until January 2026. The remaining unexercised 500 warrants were cancelled on December 30, 2025 upon expiration of the warrant call.

As of December 31, 2025, certain holders exercised Tranche B warrants at an exercise price of $1.05 per share resulting in the issuance of 757,759 shares of our common stock for net proceeds of $0.8 million.

September 2025 Offering

On September 26, 2025, we entered into an underwriting agreement with BofA Securities, Inc. and Evercore Group L.L.C., as representatives of several underwriters, pursuant to which we issued and sold 60,000,000 shares of our common stock, at

a price to the public of $1.00 per share. The securities were issued pursuant to the S-3 Registration Statement and a related prospectus supplement filed with the SEC (the "September 2025 Offering").

The September 2025 Offering closed on September 29, 2025, from which we received approximately $56.0 million of net proceeds, after deducting underwriting commissions and offering expenses.

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 $556.3 million as of December 31, 2025. Management believes that our available cash and cash equivalents of $81.5 million as of December 31, 2025, combined with $4.1 million subsequent proceeds received in January 2026 from the Tranche A warrant exercises, 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. In addition, without additional financing, we may not be able to comply with the minimum liquidity covenant related to our 2023 Notes by the end of 2026. Given the inherent risk and uncertainty of future cash flow estimates as well as the minimum liquidity covenant requirement, we have concluded that substantial doubt exists about our ability to continue as a going concern for at least 12 months from the issuance date of this Annual Report on Form 10-K. The accompanying consolidated financial statements 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 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.

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.

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:

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 U.S. 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 financing 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.

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 Part I, Item 1A, "Risk Factors-Risks Related to Our Financial Condition and Capital Requirements."

We will require substantial additional capital beyond the proceeds received 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 net change in cash, cash equivalents and restricted cash for the years ended December 31, 2025 and 2024 was as follows:

Operating Activities

Cash used in operating activities of $90.3 million for the year ended December 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 $141.0 million adjusted for net non-cash loss of $51.0 million, primarily consisting of $40.9 million non-cash loss from changes in the fair value of warrant liabilities, $0.4 million non-cash loss from change in fair value of notes payable, $6.7 million stock-based compensation expense, $1.6 million non-cash operating lease expense, $1.1 million depreciation expense and $0.3 million non-cash interest expense. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of $0.4 million.

Cash used in operating activities of $65.5 million for the year ended December 31, 2024 was primarily driven by spending on Revita and Rejuva clinical and preclinical 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 $68.7 million adjusted to exclude net non-cash income of $6.4 million, primarily consisting of $17.9 million non-cash gain from change in fair value of warrant liabilities and $5.8 million non-cash gain from change in fair value of notes payable, offset by $14.4 million in stock-based compensation, $1.9 million non-cash operating lease expense, $0.7 million depreciation and $0.3 million non-cash interest expense. Cash used in operating activities was also impacted by changes in working capital and other assets and liabilities of $9.6 million.

Investing Activities

Cash used in investing activities for the years ended December 31, 2025 and 2024 was related to the purchase of property and equipment. The decrease in the year ended December 31, 2025 as compared with the year ended December 31, 2024 was primarily due to our spending on leasehold improvements, 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.

Financing Activities

Cash provided by financing activities of $105.0 million for the year ended December 31, 2025 was primarily driven by $85.4 million net proceeds received from our equity offerings, including $22.6 million from the August 2025 Offering, $56.0 million raised from the September 2025 Offering and $6.8 million from the ATM Offering. We also received proceeds of $19.7 million from warrant exercises and $0.3 million from option exercises. These financing cash inflows are partially offset by $0.4 million principal payments made on finance lease obligations.

Cash provided by financing activities of $101.2 million for the year ended December 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 $0.6 million from stock option exercises. These financing cash inflows are partially offset by $0.2 million 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 December 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 laboratory equipment used in our Rejuva preclinical activities. As of December 31, 2025, our future contractual commitments for our leases were $52.3 million, of which $51.5 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 consolidated financial statements included in this Annual Report on this Form 10-K.

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 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- "Significant Accounting Policies" to our audited consolidated financial statements for the years ended December 31, 2025 and 2024 included elsewhere in this Annual Report on Form 10-K for more information.

JOBS Act Accounting Election

We are an "emerging growth company" within the meaning of the Jumpstart Our Business Act of 2012 ("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.